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Environmental monitoring for a NOT-RTE processing environment?

EMP Environmental Monitoring Sanitation Verification Raw Processing

Best Answer Charles.C, 04 December 2018 - 06:36 AM

Okay, 

Help me understand environmental monitoring for a NOT-RTE processing environment? I have loaded list of questions. 

 

1. What exactly is the purpose?

          Is it verifying hygienic zoning? is it validating sanitation practices? Is it proving a sterile environment? Stroking the GFSI ego? Selling swabbing kits? All ranting aside it is clear that I will have to do this thing so I need to know the PRIMARY objective so that it can be done properly.  

 

Process Haccp requires risk assessment. The risk assessment includes hazards from the environment. A significant hazard (or associated PRP) requires monitoring.

 

2. What kind of repercussions am I inviting by swabbing for indicator organisms in an environment that will likely have some level of contamination, after all we are washing dirt off of roots in this environment (its not going to be hygienic). What do I have to react to exactly? Do I have the leeway to survey for a period of time and then set my own action levels. Is it okay to accept a baseline pathogen load? 

Covered via surface swabbing micro. standards/guidelines. Detailed elsewhere in forum. eg -

https://www.ifsqn.co...ntact-surfaces/

 

On a related note - is zone 1 really zone 1 prior to a kill step? I'm not saying that it is okay for raw material processing surfaces to be filthy, but we can't honestly expect to find them sterile can we?  

depends on definition of zone 1

 

3. Can I limit the swabbing to only certain areas within the facility or even within the supply chain? We create a WIP item in our own facility but the final product is packaged at another location (all of it prior to kill step). Would an EMP at the final packaging site be sufficient? 

Covered via Scope of haccp plan / Risk Assessment / Sampling Plan.

 

I maybe understand at some level the value of EMP but I also fear that it is opening up a Pandora's box for a facility in which field debris is being washed from roots.  I also don't understand the logic of taking EMP to that level, once you pass the kill step where do you stop, the field? Do we need to be sanitizing dirt? 

Rhetorical.

 

We are likely hiring a consultant to set this up but I am really curious what the community has to say. 

 

Thanks in advance

 

Hi Ike,

 

See ^^^^.

 

Additionally, Regulatory Requirements, if any, would prioritize.

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#1 IKE

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Posted 04 December 2018 - 01:09 AM

Okay, 

Help me understand environmental monitoring for a NOT-RTE processing environment? I have loaded list of questions. 

 

1. What exactly is the purpose?

          Is it verifying hygienic zoning? is it validating sanitation practices? Is it proving a sterile environment? Stroking the GFSI ego? Selling swabbing kits? All ranting aside it is clear that I will have to do this thing so I need to know the PRIMARY objective so that it can be done properly.  

 

2. What kind of repercussions am I inviting by swabbing for indicator organisms in an environment that will likely have some level of contamination, after all we are washing dirt off of roots in this environment (its not going to be hygienic). What do I have to react to exactly? Do I have the leeway to survey for a period of time and then set my own action levels. Is it okay to accept a baseline pathogen load? 

 

On a related note - is zone 1 really zone 1 prior to a kill step? I'm not saying that it is okay for raw material processing surfaces to be filthy, but we can't honestly expect to find them sterile can we?  

 

3. Can I limit the swabbing to only certain areas within the facility or even within the supply chain? We create a WIP item in our own facility but the final product is packaged at another location (all of it prior to kill step). Would an EMP at the final packaging site be sufficient? 

 

I maybe understand at some level the value of EMP but I also fear that it is opening up a Pandora's box for a facility in which field debris is being washed from roots.  I also don't understand the logic of taking EMP to that level, once you pass the kill step where do you stop, the field? Do we need to be sanitizing dirt? 

 

We are likely hiring a consultant to set this up but I am really curious what the community has to say. 

 

Thanks in advance

 

 

 

 

 

 

 

 

 



#2 Charles.C

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Posted 04 December 2018 - 06:36 AM   Best Answer

Okay, 

Help me understand environmental monitoring for a NOT-RTE processing environment? I have loaded list of questions. 

 

1. What exactly is the purpose?

          Is it verifying hygienic zoning? is it validating sanitation practices? Is it proving a sterile environment? Stroking the GFSI ego? Selling swabbing kits? All ranting aside it is clear that I will have to do this thing so I need to know the PRIMARY objective so that it can be done properly.  

 

Process Haccp requires risk assessment. The risk assessment includes hazards from the environment. A significant hazard (or associated PRP) requires monitoring.

 

2. What kind of repercussions am I inviting by swabbing for indicator organisms in an environment that will likely have some level of contamination, after all we are washing dirt off of roots in this environment (its not going to be hygienic). What do I have to react to exactly? Do I have the leeway to survey for a period of time and then set my own action levels. Is it okay to accept a baseline pathogen load? 

Covered via surface swabbing micro. standards/guidelines. Detailed elsewhere in forum. eg -

https://www.ifsqn.co...ntact-surfaces/

 

On a related note - is zone 1 really zone 1 prior to a kill step? I'm not saying that it is okay for raw material processing surfaces to be filthy, but we can't honestly expect to find them sterile can we?  

depends on definition of zone 1

 

3. Can I limit the swabbing to only certain areas within the facility or even within the supply chain? We create a WIP item in our own facility but the final product is packaged at another location (all of it prior to kill step). Would an EMP at the final packaging site be sufficient? 

Covered via Scope of haccp plan / Risk Assessment / Sampling Plan.

 

I maybe understand at some level the value of EMP but I also fear that it is opening up a Pandora's box for a facility in which field debris is being washed from roots.  I also don't understand the logic of taking EMP to that level, once you pass the kill step where do you stop, the field? Do we need to be sanitizing dirt? 

Rhetorical.

 

We are likely hiring a consultant to set this up but I am really curious what the community has to say. 

 

Thanks in advance

 

Hi Ike,

 

See ^^^^.

 

Additionally, Regulatory Requirements, if any, would prioritize.


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Kind Regards,

 

Charles.C


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#3 IKE

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Posted 04 December 2018 - 06:58 AM

Thanks much Charles. Good insights regarding the HACCP plan connection. The link to the swabbing guidelines is very helpful. It is making more sense now. 

 

I will try to keep the griping down in the future. 



#4 Charles.C

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Posted 04 December 2018 - 07:14 AM

Thanks much Charles. Good insights regarding the HACCP plan connection. The link to the swabbing guidelines is very helpful. It is making more sense now. 

 

I will try to keep the griping down in the future. 

 

Hi Ike,

 

No problem. Gripes are interesting. :smile:

 

"Spoken in Haste, Repent at Leisure"


Kind Regards,

 

Charles.C


#5 Scampi

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Posted 04 December 2018 - 01:58 PM

I'm going to play devil's advocate here

 

You WILL test positive for listeria (although probably not monocytogenes ) Listeria is naturally present in soil. So if you're going to swab for listeria, I suggest that you DO NOT swab for the family but specifically for L.monocytogenes 

 

So if you swab for generic listeria and get a positive hit........then what?  You will never be able to eradicate it as it will be constantly coming into your plant via the soil. 

 

The repercussions can be mild (total plant shut down) to massive (product recall)............so I will repeat. make sure if your swabbing you are swabbing for L.Mono and not generic

 

 

What exactly are you processing...........roots....carrots? onions? turnip?  You said washing roots.........understanding your commodity will help here


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#6 VickieLew

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Posted 05 December 2018 - 06:51 PM

It seems that everyone that has replied so far, doesn't question the requirement or need for an environmental monitoring program for your facility.  I could be missing something....but I do question this.  Are you SURE you need an pathogen environmental monitoring program? 

I pulled this excerpt directly off of the FDA FSMA website:

"Product testing and environmental monitoring are also possible verification activities, required as appropriate to the food, facility, nature of the preventive control, and the role of that control in the facility’s food safety system. Environmental monitoring is required if the contamination of a ready-to-eat food with an environmental pathogen is a hazard the facility identified as requiring a preventive control."

1. Have you completed a hazard analysis, including hazard identification and risk assessment (severity x likelihood)? 

2. Did the hazard analysis identify a hazard requiring a preventive control? 

3. Where Is the hazard requiring control controlled?  

     A.  Is it controlled by your process in your facility?  

          1) at this process step? 

          2) at a later process step? 

     B.  Does your customer or customer's customer need to control the hazard? Can the item be consumed without further processing, irrespective of food safety?   

You are calling this a NON-RTE item, and your process descriptions supports that.  To me, it doesn't sound like you have a preventive control in place that requires monitoring, corrective actions and/or verification.  Pathogen environmental testing is a verification activity for Sanitation-Preventive controls, done to ensure that sanitary conditions are established and maintained throughout the process.

I recommend checking around with external experts, knowledgeable with your process and item, get their input...before spending too much on a consultant!

good luck!

 


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#7 Scampi

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Posted 05 December 2018 - 07:06 PM

VivkieLew...couldn't agree more......but it would appear BRC DEMANDS it and SQF requires at the very least a risk assessment to be done supporting your argument not to

We process shelf stable products with literally tons of research about the lack of pathogens ability to survive and even then SQF gave me the ridiculous run around...

CFIA has the same stand as you've mentioned above..................seems GFSI's at least partially think they know something the scientists do not


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#8 IKE

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Posted 05 December 2018 - 07:34 PM

VickieLew and Scampi

 

Thanks for chiming in. Yes we are stuck with the requirement thanks to GFSI. You are exactly right about FDA requirements and that was my response to the desk auditor, but alas it was deemed insufficient. His grounds for requirement was that GFSI is a "global" standard and therefore trumps our regulatory requirements (hence my snide remark about the GFSI ego stroking). I understand the point but it seems that they should provide a scientific rationale for the requirement. IMO the regulators are showing much better application of logic here than GFSI. 

 

And to clean up the rest of the questions. 

 

Scampi - I probably shouldn't delve deep into our process or product since it is a very novel product and it would give away who my employer is,  but out of your list of the veggies list I would say turnip is close. product begins as a raw root and the product that leaves our site is a dried "vegetable chip" that is still considered a WIP item until it is milled into a powder by a co-packer. The product we sell is the veggie powder. No kill step occurs until our customer. 

 

We do NOT sell to the general public and we verify our customer's application of a kill step. 

 

Yes all of my HACCP logic and our HACCP plan tells me we don't need this program,  unfortunately I can't seem to dissuade the auditors. Our SQF is done through NSF and our GMP was done by Merieuix and that auditor also mentioned that EMP is always required for their version of SQF so it is definitely a standard and not an auditor preference. 



#9 Scampi

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Posted 06 December 2018 - 02:02 PM

 

 

Yes all of my HACCP logic and our HACCP plan tells me we don't need this program,  unfortunately I can't seem to dissuade the auditors. Our SQF is done through NSF and our GMP was done by Merieuix and that auditor also mentioned that EMP is always required for their version of SQF so it is definitely a standard and not an auditor preference. 

 

What the BLEEEEEEEP is this?????????????  They are to follow the standard as written by SQFI where it CLEARLY states the EMP is risk based and if your RA has taken all factors/possibilities into account and comes up with a not required you are done with it!!!!!!!!!!


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#10 MsMars

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Posted 06 December 2018 - 02:18 PM

The guidance document may be where they got the "requirement" idea: 

 

What the SQF Code says:

2.4.8.1 A risk-based environmental monitoring program shall be in place for all food and pet food manufacturing processes. 

What does it mean?

An environmental monitoring program must be in place for food processes that are handled, exposed, stored, processed or packed. This program should be included for food processes of all risk levels.

 

Not saying that it's right or wrong, but knowing my SQF auditors (and FDA auditors, and USDA auditors...), the guidance doc tends to be the Gospel of auditing.


Edited by MsMars, 06 December 2018 - 02:18 PM.


#11 trubertq

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Posted 06 December 2018 - 02:42 PM

Don't swab for pathogens if it's not on the legislative list.

 

I have a client with a non-RTE product which is sold onto processors who require listeria free, this causes no end of problems for us as we have no kill step the product is raw, from the wild environment, and is only cleaned and boxed. I have to test for listeria for customers but once the competent authority saw Listeria on the sampling plan they hounded me for years until I finally got written confirmation from the food safety authority that this product is a primary product and is not required under EU 2073/2005 to be tested for listeria. The CA expected me to contact them every time I detected Listeria with a view to initiating a recall which is crazy stuff.

 

I don't know if the US has a similar piece of legislation as 2073/2005. 

 

So, in your situation I would check surfaces  for TVC and E coli. prior to start-up to ensure they had been properly cleaned and leave it at that. Risk assess it and prepare to stand your ground.


I'm entitled to my opinion, even a stopped clock is right twice a day

#12 Scampi

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Posted 06 December 2018 - 03:22 PM

This is CFIA's stance on listeria testing..............but I will add that my Cb didn't think this was good enough..............this plus 5+ research papers that prove listeria cannot survive in my product

 

http://www.inspectio...3/1370541911699

 

 

Fight hard

 

I just had to revise my RA to include silly things like employees touching a wall and then their elbow somehow touching the product......


Because we always have is never an appropriate response!


#13 IKE

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Posted 18 December 2018 - 11:55 PM

Thanks everyone for your comments. UPDATE on this. The reviewer kicked back my Corrective Action (to get a consultant and implement EMP). Instead, he stressed the need for a specific EMP risk-assessment, which I did. Within my risk assessment, I declared no need for an EMP and provided a justification for the NO decision. Justification was based on the fact that a kill-step is applied by customer and that it is declared as a raw product on the COA and product label. Site auditor was also agreeable to that decision, although, he was quite thorough in making sure we had all the declarations on the docs. The lesson I learned regarding this requirement. RISK ASSESSMENT will save you a lot of unnecessary work. The risk assessment was no different than the justification that we verbally provided the desk auditor, it simply wasn't documented. I'm grateful that the reviewer was able to steer me in the right direction because the desk auditor was steering me into the weeds for sure. My EMP program is a one-page document which contains the risk assessment, that's it. 

 

Also, we passed the certification audit.  :happydance:

 

 

 



#14 tmfoley68

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Posted 29 May 2019 - 04:47 PM

It seems that everyone that has replied so far, doesn't question the requirement or need for an environmental monitoring program for your facility.  I could be missing something....but I do question this.  Are you SURE you need an pathogen environmental monitoring program? 

I pulled this excerpt directly off of the FDA FSMA website:

"Product testing and environmental monitoring are also possible verification activities, required as appropriate to the food, facility, nature of the preventive control, and the role of that control in the facility’s food safety system. Environmental monitoring is required if the contamination of a ready-to-eat food with an environmental pathogen is a hazard the facility identified as requiring a preventive control."

1. Have you completed a hazard analysis, including hazard identification and risk assessment (severity x likelihood)? 

2. Did the hazard analysis identify a hazard requiring a preventive control? 

3. Where Is the hazard requiring control controlled?  

     A.  Is it controlled by your process in your facility?  

          1) at this process step? 

          2) at a later process step? 

     B.  Does your customer or customer's customer need to control the hazard? Can the item be consumed without further processing, irrespective of food safety?   

You are calling this a NON-RTE item, and your process descriptions supports that.  To me, it doesn't sound like you have a preventive control in place that requires monitoring, corrective actions and/or verification.  Pathogen environmental testing is a verification activity for Sanitation-Preventive controls, done to ensure that sanitary conditions are established and maintained throughout the process.

I recommend checking around with external experts, knowledgeable with your process and item, get their input...before spending too much on a consultant!

good luck!

You raised great questions! Curious what Non-RTE product this person is processing?

 

I am a NON-RTE processor of bulk processed fresh produce. If that were ALL we did I would not be required by regulation to conduct EM because all my customers for that product are further processors, I am however required to receive assurance of further processing from my processing customers that receive the non-RTE bulk processed fresh produce as an ingredient, furthermore the FDA does not test NON-RTE foods destined for further processing.

 

I have asked the FDA  questions in writing like they obviously never give a direct yes or no answer but this is what I got:  "What is the protocol for finding listeria in a Non-RTE food that is destined for further processing?"response was "the FDA does not sample foods labeled NON-RTE" I then asked "if ALL I produce is NON-RTE foods used as ingredients by further processors do I have to have an EMP" the answer was "the ultimate responsibility for the elimination of hazards falls to whomever takes finished product directly to the consumer, in the scenario described, your customer, it is a responsibility issue not a liability issue. EMP should be considered as it is beneficial as a verification of sanitation activities"

 

However because we are also a wholesale distributor who distributes what the FDA defines as "covered produce", which is produce likely to be eaten raw apples, pears etc., I personally DO have to have an EMP!

 

The produce industry has many quandaries since FSMA the greatest of which is, with a few exceptions for leafy greens and salads, there is no kill step which can be applied to fresh produce, if L. Monocytogenes is on produce prior to processing there is no way to 100% eliminate it and since the acceptable level of L. Monocytogenes on fresh cut produce is "absent per sample"! Chlorinated flume water with a concentration of 100-200ppm and pH of 6.0-7.5 was once upon a time considered a CCP it is now just a CP. Melons, summer squashes etc grow DIRECTLY on the ground in the dirt and no external wash or spray eliminates Listeria 100%!  You can get a log reduction, say  Sanidate 5.0 yields 2.3lg reduction in 5log surface inoculated cantaloupes and mechanical wash (by hand with a vegetable brush) + Sanidate 5.0 application only results in a 3.4log reduction in 5log surface inoculated cantaloupes and that is certainly NOT "absent per sample" which is the acceptable level.



#15 Charles.C

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Posted 30 May 2019 - 02:54 AM

You raised great questions! Curious what Non-RTE product this person is processing?

 

I am a NON-RTE processor of bulk processed fresh produce. If that were ALL we did I would not be required by regulation to conduct EM because all my customers for that product are further processors, I am however required to receive assurance of further processing from my processing customers that receive the non-RTE bulk processed fresh produce as an ingredient, furthermore the FDA does not test NON-RTE foods destined for further processing.

 

I have asked the FDA  questions in writing like they obviously never give a direct yes or no answer but this is what I got:  "What is the protocol for finding listeria in a Non-RTE food that is destined for further processing?"response was "the FDA does not sample foods labeled NON-RTE" I then asked "if ALL I produce is NON-RTE foods used as ingredients by further processors do I have to have an EMP" the answer was "the ultimate responsibility for the elimination of hazards falls to whomever takes finished product directly to the consumer, in the scenario described, your customer, it is a responsibility issue not a liability issue. EMP should be considered as it is beneficial as a verification of sanitation activities"

 

However because we are also a wholesale distributor who distributes what the FDA defines as "covered produce", which is produce likely to be eaten raw apples, pears etc., I personally DO have to have an EMP!

 

The produce industry has many quandaries since FSMA the greatest of which is, with a few exceptions for leafy greens and salads, there is no kill step which can be applied to fresh produce, if L. Monocytogenes is on produce prior to processing there is no way to 100% eliminate it and since the acceptable level of L. Monocytogenes on fresh cut produce is "absent per sample"! Chlorinated flume water with a concentration of 100-200ppm and pH of 6.0-7.5 was once upon a time considered a CCP it is now just a CP. Melons, summer squashes etc grow DIRECTLY on the ground in the dirt and no external wash or spray eliminates Listeria 100%!  You can get a log reduction, say  Sanidate 5.0 yields 2.3lg reduction in 5log surface inoculated cantaloupes and mechanical wash (by hand with a vegetable brush) + Sanidate 5.0 application only results in a 3.4log reduction in 5log surface inoculated cantaloupes and that is certainly NOT "absent per sample" which is the acceptable level.

 

Hi tmfoley,

 

Thks input on some realities. Obviously the RTE Produce Industry does (and presumably always will) have some fundamental difficulties with "Source".

 

The "mauve" portion above has some parallels to a query in another recent FDA thread  but which was focussed on RTE/NRTE "Labelling Requirements" (or, more accurately, lack of ..... ). That thread seemed even more confusing.

 

 

A few comments -

 

(1) USA may well be Globally  unique regarding their L.monocytogenes/Listeria "Rigor". However I accept that the historical justification is credible.

 

(2) FDA (unlike USDA) apparently (and strangely IMO) distance themselves regarding labelling issues for (both) RTE/NRTE. I recall that the FDA (labelling) Policy was quoted to be something like "the purveyor of product is responsible for its safety". Period.

 

(3) The terminology "absent" is obsolete (or should be). It was long ago replaced by more meaningful phrases like "not detected in 25g sample" (not that this is perfect from a practical viewpoint as you succinctly illustrate in yr Post however "elimination" is always a subjective term)

 

(4) Chlorination/Washing is still a CCP in at least one current Fresh Produce HACCP Plan (Canada). Or part of a Process-Wide OPRP in at least one other. (TBH,HACCP  "CP" is an American invention). :smile:

 

(5) Based on recent threads, both SQF/BRC seem to now be demanding EMP programs regardless of auditee risk analysis presentations supporting "no case to answer" . This is currently a fairly "hot" topic.

 

Frankly I'm surprised that Ike (Post 13) got SQF to accept his No-Risk/No Need EMP submission although haccp logic would definitely support it from a pathogen/user control POV.. Afai can remember this is the only so far reported SQF/No EMP success ???

 

It appears from yr Post that FDA are interpreting  all RTE designated items as justifying  EMP.  As per comment (2) above, queries on  "NRTE" will presumably overlap FDA labelling Policy issues. Tricky.


Kind Regards,

 

Charles.C


#16 tmfoley68

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Posted 30 May 2019 - 02:49 PM

Hi tmfoley,

 

Thks input on some realities. Obviously the RTE Produce Industry does (and presumably always will) have some fundamental difficulties with "Source".

 

The "mauve" portion above has some parallels to a query in another recent FDA thread  but which was focussed on RTE/NRTE "Labelling Requirements" (or, more accurately, lack of ..... ). That thread seemed even more confusing.

 

 

A few comments -

 

(1) USA may well be Globally  unique regarding their L.monocytogenes/Listeria "Rigor". However I accept that the historical justification is credible.

 

(2) FDA (unlike USDA) apparently (and strangely IMO) distance themselves regarding labelling issues for (both) RTE/NRTE. I recall that the FDA (labelling) Policy was quoted to be something like "the purveyor of product is responsible for its safety". Period.

 

(3) The terminology "absent" is obsolete (or should be). It was long ago replaced by more meaningful phrases like "not detected in 25g sample" (not that this is perfect from a practical viewpoint as you succinctly illustrate in yr Post however "elimination" is always a subjective term)

 

(4) Chlorination/Washing is still a CCP in at least one current Fresh Produce HACCP Plan (Canada). Or part of a Process-Wide OPRP in at least one other. (TBH,HACCP  "CP" is an American invention). :smile:

 

(5) Based on recent threads, both SQF/BRC seem to now be demanding EMP programs regardless of auditee risk analysis presentations supporting "no case to answer" . This is currently a fairly "hot" topic.

 

Frankly I'm surprised that Ike (Post 13) got SQF to accept his No-Risk/No Need EMP submission although haccp logic would definitely support it from a pathogen/user control POV.. Afai can remember this is the only so far reported SQF/No EMP success ???

 

It appears from yr Post that FDA are interpreting  all RTE designated items as justifying  EMP.  As per comment (2) above, queries on  "NRTE" will presumably overlap FDA labelling Policy issues. Tricky.

QUITE TRICKY and complicated even further by the fact for Produce Companies that do process and ALSO own a farm 21 CFR 117 yields to the Produce Safety Rule, even that is a bit muddled as they have changed the definition of processing for produce.  The industry argument leading up to FSMA was produce is not processed until you make it other than a "whole agricultural commodity" if it goes in a whole apple and comes out a whole apple it is not processed but FDA doesn't see it that way, they see fluming apples to remove field debris as "processing". Fortunately the WA Department of Agriculture stepped up and for apples they issue COA's that follow apple loads, however that is not true of MOST covered commodities and since the "written assurance" portion of the Produce Safety rule is not currently being enforced it makes supply chain controls/approval even more challenging and then some things are not covered by regulation at ALL like potatoes, winter squash, collard greens, tart cherries etc.

 

Then there is the issue of the failure to release ANY GUIDANCE on fresh cut processing that is not specific to RTE processing. We got excited when the "FRESH CUT" guidance came out for the 180 day comment period but all through it, it references ONLY RTE, THE ONLY thing in stone in writing on NON RTE processed produce is that it must be labeled "this product has not been processed to sufficiently reduce pathogens of a public health significance"  otherwise the FDA will consider it RTE!  We (our industry) have argued apples, pears etc if they are also considering them an RTE Food and saying they are processed but have not mandated any such warning, so which is it?? RTE is RTE or your going to define different levels of RTE....

 

Then the ENTIRE thing is complicated by FDA Investigators who do not understand when it comes to "non_conforming materials" in the produce world the disposition of the product is not up to the receiver, it is up to the USDA FSIS, Every produce company has to be a member of the Perishable Agricultural Commodities Trust and have a PACA License issued by the USDA  which dictates business practices in the produce industry and has established Good Delivery Guidelines for temperature, allowable percent of decay, damage etc. And for those of us in the east those guidelines are written to allow a commodity such as apples to de-grade in shipping. An apple can be loaded on the west coast and graded US#1 X Fancy but may only grade out at US #1 by the time it arrives to me and that is allowable. 

 

Here is an example I get a load of lettuce I believe it has over 15% allowable defects as dictated by PACA GDG, so I can call the shipper and they can choose to discount the product and ask me to work through it in good faith OR we can agree to call the USDA FSIS for an Inspection, EVEN IF say that load of lettuce has 30% defects, 2X the allowable GDG amount, the FSIS is STILL going to tell me I have to take the load and work though it in good faith because there is no sending that semi back to California to return the lettuce and 70% of the load is good, FSIS just confirms amount of loss on load! The FDA Investigator I had time before last literally had NO IDEA the USDA had any jurisdiction over landed produce! Produce that is not processed has no expiration date and because of how its brought to market can't use FIFO inventory methods either, another thing she didn't understand.  Back to apples they can be in cold storage for up to 12 mos, in the fall its possible I could get a load of apples from "new crop" and a load a 3 weeks later from cold storage. Even though I got the "new crop" apples first they are not the first to go out because they are newer than the cold storage apples.   There was SO MUCH the FDA didn't know about produce when these regs were written!



#17 Charles.C

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Posted 31 May 2019 - 03:32 AM

QUITE TRICKY and complicated even further by the fact for Produce Companies that do process and ALSO own a farm 21 CFR 117 yields to the Produce Safety Rule, even that is a bit muddled as they have changed the definition of processing for produce.  The industry argument leading up to FSMA was produce is not processed until you make it other than a "whole agricultural commodity" if it goes in a whole apple and comes out a whole apple it is not processed but FDA doesn't see it that way, they see fluming apples to remove field debris as "processing". Fortunately the WA Department of Agriculture stepped up and for apples they issue COA's that follow apple loads, however that is not true of MOST covered commodities and since the "written assurance" portion of the Produce Safety rule is not currently being enforced it makes supply chain controls/approval even more challenging and then some things are not covered by regulation at ALL like potatoes, winter squash, collard greens, tart cherries etc.

 

Then there is the issue of the failure to release ANY GUIDANCE on fresh cut processing that is not specific to RTE processing. We got excited when the "FRESH CUT" guidance came out for the 180 day comment period but all through it, it references ONLY RTE, THE ONLY thing in stone in writing on NON RTE processed produce is that it must be labeled "this product has not been processed to sufficiently reduce pathogens of a public health significance"  otherwise the FDA will consider it RTE!  We (our industry) have argued apples, pears etc if they are also considering them an RTE Food and saying they are processed but have not mandated any such warning, so which is it?? RTE is RTE or your going to define different levels of RTE....

 

Then the ENTIRE thing is complicated by FDA Investigators who do not understand when it comes to "non_conforming materials" in the produce world the disposition of the product is not up to the receiver, it is up to the USDA FSIS, Every produce company has to be a member of the Perishable Agricultural Commodities Trust and have a PACA License issued by the USDA  which dictates business practices in the produce industry and has established Good Delivery Guidelines for temperature, allowable percent of decay, damage etc. And for those of us in the east those guidelines are written to allow a commodity such as apples to de-grade in shipping. An apple can be loaded on the west coast and graded US#1 X Fancy but may only grade out at US #1 by the time it arrives to me and that is allowable. 

 

Here is an example I get a load of lettuce I believe it has over 15% allowable defects as dictated by PACA GDG, so I can call the shipper and they can choose to discount the product and ask me to work through it in good faith OR we can agree to call the USDA FSIS for an Inspection, EVEN IF say that load of lettuce has 30% defects, 2X the allowable GDG amount, the FSIS is STILL going to tell me I have to take the load and work though it in good faith because there is no sending that semi back to California to return the lettuce and 70% of the load is good, FSIS just confirms amount of loss on load! The FDA Investigator I had time before last literally had NO IDEA the USDA had any jurisdiction over landed produce! Produce that is not processed has no expiration date and because of how its brought to market can't use FIFO inventory methods either, another thing she didn't understand.  Back to apples they can be in cold storage for up to 12 mos, in the fall its possible I could get a load of apples from "new crop" and a load a 3 weeks later from cold storage. Even though I got the "new crop" apples first they are not the first to go out because they are newer than the cold storage apples.   There was SO MUCH the FDA didn't know about produce when these regs were written!

 

Hi tmfoley,

 

I get it. You are not happy. But unfortunately  the Fresh Produce Business has always been sort of stuck in "No Man's Land"  from a HACCP/FSMA POV.

 

I'm not in USA but It does seem odd that you need a USDA License to handle goods which are under the jurisdiction of the FDA.

 

TBH, based on IT knowledge and previous thread here, I understood that FDA are oblivious to the choice of labelling, ie  they simply ignore a NRTE label.. Hence USDA's disatisfaction from a safety POV.

 

I disagree yr opinion that  "fluming" is not "processing". I guess it comes down to definitions/semantics.

 

I also think that, offhand ,in the absence of evidence to the contrary, I would categorise an Apple as RTE. But I take yr (I think) point that if one is "processing" to achieve a RTE finished product, the input must logically be status "distinguishable".  TRICKY.

 

As for FSMA, Yr FPO Representative must be having an interesting time understanding their "Preventive" requirements.


Kind Regards,

 

Charles.C


#18 McForman

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Posted 31 May 2019 - 05:31 PM

Thanks everyone for your comments. UPDATE on this. The reviewer kicked back my Corrective Action (to get a consultant and implement EMP). Instead, he stressed the need for a specific EMP risk-assessment, which I did. Within my risk assessment, I declared no need for an EMP and provided a justification for the NO decision. Justification was based on the fact that a kill-step is applied by customer and that it is declared as a raw product on the COA and product label. Site auditor was also agreeable to that decision, although, he was quite thorough in making sure we had all the declarations on the docs. The lesson I learned regarding this requirement. RISK ASSESSMENT will save you a lot of unnecessary work. The risk assessment was no different than the justification that we verbally provided the desk auditor, it simply wasn't documented. I'm grateful that the reviewer was able to steer me in the right direction because the desk auditor was steering me into the weeds for sure. My EMP program is a one-page document which contains the risk assessment, that's it. 

 

Also, we passed the certification audit.  :happydance:

Did this still work on your Audit this year? I am finding out that my industry is having problems just using an RA and we don't even wash anything its all dry cleaning we remove FM from beans.



#19 Jpainter

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Posted 31 May 2019 - 09:04 PM

tmfoley68, 

 

USDA should not have any involvement unless either 1.) you are handling meat products, Low acid canned foods, Milk, or Pasteurized juices. FDA remains the sole regulatory agency for Fresh produce. I would look into this if I were you, sounds like USDA. Fluming is without s doubt "processing" this is a high risk activity. If flume water gets contaminated, you risk mass product contamination through a shared water source. I work with a fresh chile and although nearly all of the population will cook this product, I still consider it RTE because we do not provide a statement saying it must be cooked so there is a chance that it can be eaten raw. Charles makes some great points on this topic. 



#20 IKE

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Posted 31 May 2019 - 10:18 PM

McForman 

We haven't had another audit yet. That one was in DEC and our next is scheduled for NOV of this year. We have the same auditor coming so we should be okay on this topic. I have spent most of my career in the same business as you (removing FM from grains, seeds, and pulses) and I can see where your industry would be extremely frustrated by this. Your beans are harvested right off the ground and literally bring them right through the front door with dirt on time. So yes, of course your plant will be have some environmental hazards. It is usually dry but you still may have a salmonella concern in that case. I think for us, our Risk Assessment really hinged on the "proof" that the product cannot be consumed raw. We are an ingredient supplier ONLY, we don't sell anything to the public, so our product never will see a consumer in its raw state. If you are bagging your beans into a consumer package it may be a tougher sell to the auditor because you can't guarantee that they won't  be consumed raw.

 

Our milling partner has a similar issue, they don't provide a kill step either, but they only supply commercial users, so what they do to add bolster their case (that they are a raw processor) is collect an affidavit from all customers in which the customer declares that they apply the requisite kill-step.

 

Incidentally, they DO have an EMP program anyway. It is a very simple monthly swabbing routine in which they check zone 3 for indicator organisms of salmonella (the only major threat in a dry ambient environment). They haven't had a positive hit in the 3 years they have been doing it. Our plant and yours are different from them since they don't receive anything directly from the field they aren't bringing in dust and mud with their raw material. We would have a higher risk of finding something in our plants, yet we have to bring in dirt, it is kinda the nature of our business.

 

Someone in the supply chain has to separate the dirt from the commodity and whoever does will naturally have dirt in their plant. Oh how I wish the GFSI folks could understand that simple concept. 



#21 Leonard C Mapiye

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Posted 02 June 2019 - 12:59 AM

I just wanted to thank everyone who contributed to this as it also gave an insight into other colleagues approaches to EMP and HA as a whole .


Regards,

Leo


#22 McForman

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Posted 02 June 2019 - 12:40 PM

Jpai'tnter,

Its not the USDA its BRC and we don't use any water in our plant, all of my customers get a COA with a statement on it. Thanks for your reply.

tmfoley68, 

 

USDA should not have any involvement unless either 1.) you are handling meat products, Low acid canned foods, Milk, or Pasteurized juices. FDA remains the sole regulatory agency for Fresh produce. I would look into this if I were you, sounds like USDA. Fluming is without s doubt "processing" this is a high risk activity. If flume water gets contaminated, you risk mass product contamination through a shared water source. I work with a fresh chile and although nearly all of the population will cook this product, I still consider it RTE because we do not provide a statement saying it must be cooked so there is a chance that it can be eaten raw. Charles makes some great points on this topic. 



#23 McForman

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Posted 02 June 2019 - 12:50 PM

IKE,

Thanks for your reply, I wish you the best on your next audit, but just a heads up I know an auditor that took an RA for 3 plants and then at the 4th one decide it wasn't enough according to someone else in my industry which just adds to the headache. You are also right I can't use a guarantee because one of our consumers sells the product in open markets were the next consumer has to cook the beans at home. Do you know what the plant has for a corrective action if it does test positive, its not like I can spray sanitize.

   

McForman 

We haven't had another audit yet. That one was in DEC and our next is scheduled for NOV of this year. We have the same auditor coming so we should be okay on this topic. I have spent most of my career in the same business as you (removing FM from grains, seeds, and pulses) and I can see where your industry would be extremely frustrated by this. Your beans are harvested right off the ground and literally bring them right through the front door with dirt on time. So yes, of course your plant will be have some environmental hazards. It is usually dry but you still may have a salmonella concern in that case. I think for us, our Risk Assessment really hinged on the "proof" that the product cannot be consumed raw. We are an ingredient supplier ONLY, we don't sell anything to the public, so our product never will see a consumer in its raw state. If you are bagging your beans into a consumer package it may be a tougher sell to the auditor because you can't guarantee that they won't  be consumed raw.

 

Our milling partner has a similar issue, they don't provide a kill step either, but they only supply commercial users, so what they do to add bolster their case (that they are a raw processor) is collect an affidavit from all customers in which the customer declares that they apply the requisite kill-step.

 

Incidentally, they DO have an EMP program anyway. It is a very simple monthly swabbing routine in which they check zone 3 for indicator organisms of salmonella (the only major threat in a dry ambient environment). They haven't had a positive hit in the 3 years they have been doing it. Our plant and yours are different from them since they don't receive anything directly from the field they aren't bringing in dust and mud with their raw material. We would have a higher risk of finding something in our plants, yet we have to bring in dirt, it is kinda the nature of our business.

 

Someone in the supply chain has to separate the dirt from the commodity and whoever does will naturally have dirt in their plant. Oh how I wish the GFSI folks could understand that simple concept. 



#24 tmfoley68

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Posted 02 June 2019 - 10:35 PM

tmfoley68,

USDA should not have any involvement unless either 1.) you are handling meat products, Low acid canned foods, Milk, or Pasteurized juices. FDA remains the sole regulatory agency for Fresh produce. I would look into this if I were you, sounds like USDA. Fluming is without s doubt "processing" this is a high risk activity. If flume water gets contaminated, you risk mass product contamination through a shared water source. I work with a fresh chile and although nearly all of the population will cook this product, I still consider it RTE because we do not provide a statement saying it must be cooked so there is a chance that it can be eaten raw. Charles makes some great points on this topic.

You are incorrect/ ill informed. you have to be licensed by the USDA to trade in produce and ANYone who handles over a certain amt of produce annually is required by law to be a PACA licensee, because USDA governs fair, trade quality and grading. USDA FSIS performs all product quality and grade inspections and makes the suggested disposition of any product landed when quality is in dispute. PACA trading members cannot simply "kick" loads because a receiver deems the load non-conforming. I suggest you read the Perishable Agricultural Commodities Act (PACA) especially as it pertains to the Agricultural Marketing Service and Food Safety Inspection Service. If you ever bought over 2k pounds of chili's in a single day, or if they were frozen $230k annually, and you didn't have a PACA license issued by USDA you breaking the law.

It is mostly produce wholesalers, processors, grocery/c-store and restaurant chains who are aware it's required, many food processors who who use fresh or frozen produce as an ingredient are not aware of the requirement and USDA oversight of trade, quality and grade but very often when a dispute over one of those things arises they are made aware in th form of fines, people can even be blacklisted by the USDA and not allowed to trade in produce unless they become licensed and in some cases pay performance bonds.

I have 3 further processing customers who are HUGE companies and until they started using fresh produce/ minimally processed produce had no idea they were required to be licensed and that USDA sets terms one produce at 10 days etc etc but they have all become compliant before we signed a contract

https://www.ams.usda.../paca/licensing



#25 tmfoley68

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Posted 02 June 2019 - 10:43 PM

Also just because it can be confusing when the USDA says "specialty crops" it means fresh fruits and vegetables, non-specialty crops are industrial crops.







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