42 replies to this topic

[irheavyd]

We have a situation at our plant that could effect every plant in the country.  We smoke all our meats for starters.  And as we all know there is always going to be creosote in the product.  It is unavoidable.  As far as I know there are no regulatory anything in effect for this.  They are now putting every single product we have in the plant on hold and are talking about recalling everything for the past 6 months that we have made.  Every plant that smokes meat has this in the products.  What is your thoughts on this.  

[G M]

Who is putting it on hold?  The IIC, or area supervisor?

 

What clause are they citing as reason?  One of the super vague ones, or something specific?

[irheavyd]

USDA is tagging everything.  They have no explanation for it.  

[irheavyd]

This is absolutely insane.  There is not a plant anywhere that does not have this.

[irheavyd]

well they just came in and said it was creosote.  The originally said they did not know what it was.  

[SQFconsultant]

USDA is out of control right now, basically rudderless thus they are doing things without basis.  

 

Have you noticed that the FDA is on blackout for communications right now? I believe the same will be done to the USDA as that ship needs full re- organization reorganization and/or elimination - with that said I think the light at the end of the tunnel will take several more weeks.

 

What were they willing to put in writing to you?

[GMO]

I think we'd term this "polycyclic aromatic hydrocarbons" rather than creosote.  

 

When we were using smoked ingredients within one manufacturer, we did do some testing to ensure levels were low.  We found they were but mostly because the smoke house were cold smoking.  There have been maximum residue limits in food in the UK and EU for some time.

 

Here is a link to the UK Food Standards Agency website which references legislation and guidance over here which I know won't apply to you but it's a good source of different thinking about this:  Polycyclic aromatic hydrocarbons | Food Standards Agency

 

There's also a code of practice linked to that page.  It's got some good advice in there as even the wood used has an impact and also recommending filters etc.

 

I would have expected this to be part of your HACCP plan or preventive controls plan.  You should be considering chronic and long term conditions not just short term food safety risk.  If it's not there, now is the time to review it.  These PAHs are known (not suspected) carcinogens.  

[Scampi]

well they just came in and said it was creosote.  The originally said they did not know what it was.  

 

 

didn't know WHAT it was..............can you add more information?  what is the WHAT

[G M]

A lot of details missing here, and maybe the NR or MOI will have filled those in by today (I'd expect that kind of documentation within the first day from when the tag was issued).  

 

I suppose if there was a combination of smoke and condensation in the smokehouse you could get a mysterious dark droplet somewhere.

[GMO]

PAHs being a health risk in food is known but it is a good question on whether PAHs are specifically against the law in the US.  I found a 4 year old paper that said there are no specific legislative requirement for PAHs in the US.  As I've said before, that's not the case in other countries as they are known carcinogens.

 

Polycyclic Aromatic Hydrocarbons in Foods: Biological Effects, Legislation, Occurrence, Analytical Methods, and Strategies to Reduce Their Formation - PMC

 

Either way though the competent authorities, if looking to take action should be able to be far more scientific about what they are doing that for and also what specific legislation it is being raised against.  I'm not sure how broad US legislation is in this area.  While I'm a FSQI I can only retain so much and haven't had to use it a lot.  But there are some broad brush stroke rules in the UK and EU about not harming or misleading consumers which can lead you to fall foul of the law even without an MRL but I have to say it would be unusual.

 

I'm only assuming they actually mean PAHs.  "Creosote" is such an odd term to use.  I suppose on reflection they could mean drips of tar from the environment but if that's what you're getting I'd be really worried.  

Either way, if they are looking at this, I'd get your ducks in a row and include the risks of PAHs and what you do to minimise risk.  At least then there is some level of intent to reduce to a safe level.

[kox]

Creosotes are the principal chemicals responsible for the stability, scent, and flavor characteristic of smoked meat; the name is derived from Greek κρέας (kreas) 'meat' and σωτήρ (sōtēr) 'preserver'.[3] Wikipedia...

[irheavyd]

Thank you all for the info.  As of yet, no NR has been issued.  I find that to be extremely odd.  As far as I know, they have to supply scientific proof as to why they are putting products on hold.  All they have supplied to us besides hold tags is the following. 

On 1-24-25 numerous products were found to possibly be contaminated with black particles.  Multiple products have been retained at this time. So far products from as far back as August have been found with the black particles on them.  We are currently investigating the full extent of the possible contamination which includes products produced in ovens 4, 5, and 6.  As there are so many products the CSI will be unable to retain all affected products prior to production end on 1-24-25.  I just spoke to USDA inspector and he stated that on some of the products they are waiting for us to do corrective actions to before they can release them.  Apparently we can wipe off the black spots on some products and they will be fine.  They also want us to remove everything that is already packaged and repackage it all.  So, its ok in some products but not others.  They are calling it product contamination.

[irheavyd]

If they are going to do this to us, this could affect every plant in the country that produces smoked meats and products.  This very well could sink us because of there basic lack of knowledge and any regulatory restrictions or regulations regarding it.  They can't just say its adulterated without a regulation on it.

[GMO]

This seems bizarre.  So it almost looks as though they are stating the black particles are a foreign body?  Yet they're missing the entirely valid and high food safety risk of PAHs which if the black particles are drips of tar like substances from the smoker, wiping it will do no good.

 

By the way, for those of you guys working in smoking in the US, do you test for PAHs?  I used to do testing as part of our verification for incoming smoked ingredients in plants I've worked in.  But I'm surprised that nobody seems to be saying the same here nor that they'd considered it as a hazard?  If you're not doing so in your HACCP / preventive controls plan, you really should be.

Here's some more info.  Polycyclic Aromatic Hydrocarbons (PAHs)

[irheavyd]

Today they have issued a NR saying we have failed to follow 9CFR 416.4d, 416.13b and 416.13c.  Along with that i have 7 pages of products on USDA hold.  Absolutely mind blowing.  At the same time as this we have been dealing with a NOI as well.  The NOI is full of a bunch of BS as well.  The entire organization all the way up the ladder to Denver's district office is out of control and have no basis on science.  It's seems to be a personnel grudge at this point, or actually for some time now.  I am not sure that we are going to survive this.  Lawsuit is definitely going to have to happen.  Maybe call Congress 

[irheavyd]

I am still trying to figure out what the Hazard is at all according to current regulations.  This is still a part of the smoke process that can not be avoided and has been present for 100's of years.

[Scampi]

Did you follow your sanitation procedures?  I have to ask, because they still have to have just cause to put product on HOLD

 

What part of your procedures are they claiming you didn't follow?

[irheavyd]

They are saying that our ovens were not clean.  The creosote came from the pipes that blow the smoke into the oven.  They were coated with creosote(not very thick at all) which is unavoidable especially since they are running continuously for 16 hours a day.  We clean ovens daily and the pipes weekly.

[Scampi]

Understood-thanks for clarifying

 

the issue (for understanding only---I get  what you are saying) will be that they will have said your current sanitation process is not sufficient and historical "because that is the way the it's always been done" may not be sufficient cause without going to your legislators

 

and I'm guessing you have NEW inspectors???

 

I do know that Canada has VERY FEW actual smoke houses left due to the increasing push and expense to upgrade

[GMO]

Ah ok.  I have worked with cheese smoke houses in the UK and I accept that's probably a very different process to yours and was cold smoking but I would argue it's not inevitable.  It wouldn't be accepted in the UK.  The "creosote" or tar will contain carcinogens.  (Although the smoking will as well.  I'm still finding this bizarre that nobody else seems concerned by it but I accept nobody else seems interested on this thread.)

 

I suppose as well there is a very big difference between debris and contamination in general which builds up over the production shift and residue which is still there even after you clean because it's so ingrained.  

 

Difficult to know from your process but is there a way you can use SMED to improve your cleaning?  in this, you may be able to externalise some of what you do.  For example, if the pipes are the problem, can you get spares and a quick change process so that when you do clean you can give longer contact time and access within those pipes but swap in clean ones to continue use without impacting the production schedule?

[jfrey123]

Ah ok.  I have worked with cheese smoke houses in the UK and I accept that's probably a very different process to yours and was cold smoking but I would argue it's not inevitable.  It wouldn't be accepted in the UK.  The "creosote" or tar will contain carcinogens.  (Although the smoking will as well.  I'm still finding this bizarre that nobody else seems concerned by it but I accept nobody else seems interested on this thread.)

 

I suppose as well there is a very big difference between debris and contamination in general which builds up over the production shift and residue which is still there even after you clean because it's so ingrained.  

 

Difficult to know from your process but is there a way you can use SMED to improve your cleaning?  in this, you may be able to externalise some of what you do.  For example, if the pipes are the problem, can you get spares and a quick change process so that when you do clean you can give longer contact time and access within those pipes but swap in clean ones to continue use without impacting the production schedule?

 

I think the carcinogens thing gets overplayed when it comes to bbq.  Articles like this from UCLA still use a lot of the "may cause"/"may contribute" language that most of the studies have also used when "bbq gives you cancer" first hit the news a few years back.

Grilling meat raises cancer risk. Here are ways to lower it | UCLA Health

Article even cites that the HCAs and PAHs come from other common environmental factors such as car exhaust and industrial airborne pollutants.  Just saying I'm not totally sold that bbq will kill me when humans have been cooking meat on fire for at least a couple hundred thousand years.  I can go buy countless frozen pre-cooked items with grill marks on the meat right now (also a claimed cancer risk) so I'm not sure of the justification to allow that while prohibiting smoke residue.

 

But I will say with OP citing specific ovens being targeted in his process earlier in the thread, there could be a factor in those ovens that led to this buildup hitting an unreasonable level, eye of the beholder type thing.  Kinda silly that a smokehouse can get flagged for this while tens of thousands of open pit bbq restaurants are serving charred deliciousness by the pound.

[GMO]

 

Article even cites that the HCAs and PAHs come from other common environmental factors such as car exhaust and industrial airborne pollutants.  Just saying I'm not totally sold that bbq will kill me when humans have been cooking meat on fire for at least a couple hundred thousand years.  I can go buy countless frozen pre-cooked items with grill marks on the meat right now (also a claimed cancer risk) so I'm not sure of the justification to allow that while prohibiting smoke residue.

 

But I will say with OP citing specific ovens being targeted in his process earlier in the thread, there could be a factor in those ovens that led to this buildup hitting an unreasonable level, eye of the beholder type thing.  Kinda silly that a smokehouse can get flagged for this while tens of thousands of open pit bbq restaurants are serving charred deliciousness by the pound.

 

Yes PAHs are in other things but you don't ingest them.  A lot of the headlines on barbecue were confused because barbecue outside of the US does not normally involve high levels of smoking, it's normally just grilling.

 

There is strong evidence of links of PAHs with cancer which is why there are MRL in the EU.

 

For example:

Polycyclic aromatic hydrocarbons and cancer in man. | Environmental Health Perspectives | Vol. 104, No. 11

Exposure to multiple sources of polycyclic aromatic hydrocarbons and breast cancer incidence - ScienceDirect

Polycyclic Aromatic Hydrocarbons Detected in Processed Meats Cause Genetic Changes in Colorectal Cancers

 

There are many more.  Just search google scholar.

 

And 90% of PAH exposure is from food in some countries

Concentrations and dietary exposure to polycyclic aromatic hydrocarbons (PAHs) from grilled and smoked foods - ScienceDirect

 

The presence of tar or creosote for me is indicative of a process with high levels of PAHs within the smoke.  So my point is if the regulator is concerned about the creosote, I think they're missing the point.

 

But I also hope the op is considering long term chronic risks in their HACCP plan or US equivalent, because that is a requirement.

[G M]

Today they have issued a NR saying we have failed to follow 9CFR 416.4d, 416.13b and 416.13c.  Along with that i have 7 pages of products on USDA hold.  Absolutely mind blowing.  At the same time as this we have been dealing with a NOI as well.  The NOI is full of a bunch of BS as well.  The entire organization all the way up the ladder to Denver's district office is out of control and have no basis on science.  It's seems to be a personnel grudge at this point, or actually for some time now.  I am not sure that we are going to survive this.  Lawsuit is definitely going to have to happen.  Maybe call Congress 

 

I'm reading this as an interpretation of the concept of contamination based entirely on particle size, and the ability to organoleptically detect discreet particles. This appears to be a quality issue, not safety.

 

The smoke they deem acceptable is made up of particles of the same material that are too small to organoleptically distinguish as discreet objects.  This is objectively true considering that you are cleaning the smokehouse parts daily, and they are passing preoperational inspection.  The size of the particles should make no difference in the determination of whether of not it is an adulterant.

 

If the particles were of an unknown source, or the wood was incompletely combusted, then perhaps they have reason.  

[irheavyd]

There are no regulations in the US for PAH's as pf yet, so yes we are concerned, but not for this matter.  This is the NR:

On January 21st, 2025, at approximately 1530 hours, IPP observed the following noncompliance. While conducting a routine SSOP task, I

observed approximately 1⁄2 a cart of Skinless Old Fashioned Wieners lot: 25017 covered in black specks. The black specks ranged in size

from barely visible to approximately 1⁄4 inch by 1⁄4 inch. I notified the QC who could not identify the black substance covering the entire half

cart. I placed U.S. Retain tag B-45312203 on the cart and notified the QC that a noncompliance would be issued. After further investigation

 

the following list of products were found to have the same black specks. Additionally, U.S. Retain tags were applied to affected product:

I am issuing this noncompliance for the establishments failure to meet requirements set forth in 9CFR 416.4d, 416.13b, & 416.13c.

 

There NR is not truthful either.  There were no particles of the size they are saying and this is the fourth version of the NR.  There is also 8 pages of products on hold attached to the NR.  If they were that concerned they would be issuing a recall, so obviously they know they are wrong.

They are trying to get us to say it is a contaminate when under no regulation in the US is it listed as a contaminate. I have an ASKFSIS question and answer that says it is not a contaminate.  So, they should have no basis for putting the products on hold at all.  They have accepted our terminology as it being creosote so that right there is proof that they know it is not a contaminate.  Just by there handling of this whole thing and the way they are acting, they know they are in the wrong.  And now, they are trying to get us to admit something  that is not true. They want a corrective action, but I am not sure how to go about this without them forcing us to admit something is wrong when in fact there is nothing wrong.  

[G M]

 

There are no regulations in the US for PAH's as pf yet, so yes we are concerned, but not for this matter.  This is the NR:

On January 21st, 2025, at approximately 1530 hours, IPP observed the following noncompliance. While conducting a routine SSOP task, I

observed approximately 1⁄2 a cart of Skinless Old Fashioned Wieners lot: 25017 covered in black specks. The black specks ranged in size

from barely visible to approximately 1⁄4 inch by 1⁄4 inch. I notified the QC who could not identify the black substance covering the entire half

cart. I placed U.S. Retain tag B-45312203 on the cart and notified the QC that a noncompliance would be issued. After further investigation

 

the following list of products were found to have the same black specks. Additionally, U.S. Retain tags were applied to affected product:

I am issuing this noncompliance for the establishments failure to meet requirements set forth in 9CFR 416.4d, 416.13b, & 416.13c.

 

There NR is not truthful either.  There were no particles of the size they are saying and this is the fourth version of the NR.  There is also 8 pages of products on hold attached to the NR.  If they were that concerned they would be issuing a recall, so obviously they know they are wrong.

They are trying to get us to say it is a contaminate when under no regulation in the US is it listed as a contaminate. I have an ASKFSIS question and answer that says it is not a contaminate.  So, they should have no basis for putting the products on hold at all.  They have accepted our terminology as it being creosote so that right there is proof that they know it is not a contaminate.  Just by there handling of this whole thing and the way they are acting, they know they are in the wrong.  And now, they are trying to get us to admit something  that is not true. They want a corrective action, but I am not sure how to go about this without them forcing us to admit something is wrong when in fact there is nothing wrong.  

 

 

One issue claimed in the NR that could, at least theoretically, resolve it, would be to identify the substance. 

 

Smoke aerosols, from the smoke generator attached to the smokehouse, as identified on the product label "[fill in the blank with "natural smoke flavor" or whatever wording appears on the label]".

 

Eliminating "could not identify the black substance" puts the burden of proof on them.  The CFR they're citing are all about basic sanitation.  If you can establish that this is an ingredient, not filth, they don't seem to have much to stand on.

 

You are presumably documenting your preoperational inspection after cleanup, so I'm not sure what they're trying to get at with citing 416.13.  That part ought to be very easy to just show a record for and get it dismissed.  They haven't claimed anything about asking for the record and not receiving it in this.

Edited by G M, 10 February 2025 - 04:43 PM.