Is this a High Risk Process?

Dear Charles

I am working in a manufacturing plant that produces sauces(different) variants, we are currently hot filling the sauces and decanting them into PP containers, we do have CCP's for the hot filling of the product

I am not sure whether this entire process should be considered high risk and why

Please advise

many thanks

A.B

Hi divesh,

I presume you are talking about something like -

The most common pasteurization approach used for acidified foods is the hot-fill and hold process.  This process normally involves heating the product to temperatures at or above 190degF and holding it at that temperature for "several" minutes followed by hot filling at temperatures at or above 180degF.

The answer to yr qury may depend on what you/others mean by a "high risk process"

What is the pH of finished product ?

Is the product ambient shelf-stable ?

Just as an opening, here is the SQF definition (seems potentially quite "inclusive")  –

High Risk Food Process(es)

A facility or segregated room or area that requires specific controls and/or a higher level of hygienic practice to prevent food contamination

Additionally, from the SQF Guidance –

High risk processes are those in which high risk foods are handled, exposed, stored, processed or packed.  

 

High risk food is food that may contain pathogenic microorganisms and will support the formation of toxins or growth of pathogenic microorganisms, and has a significant likelihood of growth causing illness or injury to a consumer if not properly produced, processed, distributed and/or prepared for consumption.  It may also apply to a food that is deemed high risk by a customer, declared high risk by the relevant food regulation or has caused a major foodborne illness outbreak (refer SQF Code, Appendix 2: Glossary).

 

Another quite inclusive description. From above, it is unclear to me if yr product is high risk or not. If product is RTE ambient stable, usually regarded as low risk food except for certain locations.

Another illustration that "people"  may find the answer to yr specific (hot fill) query not so simple –

hot fill usage applications.pdf   79.46KB   122 downloads

Hot filling sauce would not be considered High Risk - at most Medium Risk.

Hot filling sauce would not be considered High Risk - at most Medium Risk.

Hi jibrad,

Thks yr reply.

Can you explain the reason, eg the basis for yr opinion that the Process is Medium Risk ?

Hi divesh,

 

I presume you are talking about something like -

 

 

The answer to yr qury may depend on what you/others mean by a "high risk process"

 

What is the pH of finished product ?

Is the product ambient shelf-stable ?

 

Just as an opening, here is the SQF definition (seems potentially quite "inclusive")  –

 

Additionally, from the SQF Guidance –

Another quite inclusive description. From above, it is unclear to me if yr product is high risk or not. If product is RTE ambient stable, usually regarded as low risk food except for certain locations.

 

Another illustration that "people"  may find the answer to yr specific (hot fill) query not so simple –

 

hot fill usage applications.pdf

Dear Charles,

We have low acid product, but process with hot filling and low A.W, ambient stable, can it regarding as low risk process or low risk food?

Thanks

Best regards,

Jerald

we make a heat processed acidified food RTE shelf stable. Process is considered low risk, with some high risk process knowledge required. We have a schedule process we must follow prepared for us by a Process Authority. Heat penetration studies were done on all sku's to ensure that the time/temperature was sufficient and we monitor that plus equilibrium pH on finished product.

I DO NOT consider us high risk. If the vacuum is not created, the product cannot be sold. HOWEVER SQF must see the entire scheduled process on paper from the processing authority.  For shelf stable RTE you have to prove that the process includes a kill step and has lowered the pH so that the c. botulism spores cannot germinate

You really need to speak directly with your CB in detail about your process to ensure you are in the correct category. They had us in 15, but I have submitted a request for 18.

we make a heat processed acidified food RTE shelf stable. Process is considered low risk, with some high risk process knowledge required. We have a schedule process we must follow prepared for us by a Process Authority. Heat penetration studies were done on all sku's to ensure that the time/temperature was sufficient and we monitor that plus equilibrium pH on finished product.

 

I DO NOT consider us high risk. If the vacuum is not created, the product cannot be sold. HOWEVER SQF must see the entire scheduled process on paper from the processing authority.  For shelf stable RTE you have to prove that the process includes a kill step and has lowered the pH so that the c. botulism spores cannot germinate

 

You really need to speak directly with your CB in detail about your process to ensure you are in the correct category. They had us in 15, but I have submitted a request for 18.

Hi Scampi,

Add-on to a 2-year old thread. May/may not be SQF.

I assume your product  is categorized as a canned, shelf-stable  product.

I was under the impression that Canada is a relatively rare  example of a Country where the Regulatory viewpoint of all canned, shelf stable foods are defined to be high risk ?

@ tzecheak,

As implied in the previous posts in this thread, you first need to define what you/yr location/Standard mean by high/low risk ??

Charles, there is one set of regulations for RTE shelf stable. However, pickled items have the extra hurdle of a permanent low acid. Pickled foods are one of the products humans have been making for more than 1000 years. We always get put in the same category as say canned tune or salmon.........the chemical nature of which is incredibly different with different risks. 

Obviously the scheduled process needs to be adhered to for all products, but not all products have the same inherent protections. Our number concern is botulism naturally, but generally speaking, the process is exactly the same as it was 100+ years ago.

Charles, there is one set of regulations for RTE shelf stable. However, pickled items have the extra hurdle of a permanent low acid. Pickled foods are one of the products humans have been making for more than 1000 years. We always get put in the same category as say canned tune or salmon.........the chemical nature of which is incredibly different with different risks. 

 

Obviously the scheduled process needs to be adhered to for all products, but not all products have the same inherent protections. Our number concern is botulism naturally, but generally speaking, the process is exactly the same as it was 100+ years ago.

Hi Scampi,

I failed to find any current  Canada/CFIA food risk classification for any canned foods however i note the current SQF classification (with which I suspect some/most other GFSI-recognised FS Codes  would disagree) has high risk  -

Canning-Canned foods.png   143.29KB   2 downloads

SQF has 2 classifications for "canned" foods, 18 which is high risk and process knowledge needed-aseptic foods and 15, preserved foods manufacture. No, CFIA does not classify processors by risk. It is my understanding that they never have, they just have different hoops to jump through depending on your process and finished goods.

SQF has 2 classifications for "canned" foods, 18 which is high risk and process knowledge needed-aseptic foods and 15, preserved foods manufacture. No, CFIA does not classify processors by risk. It is my understanding that they never have, they just have different hoops to jump through depending on your process and finished goods.

Hi Scampi,

You're correct although IMO the text,as written, despite the mention of pickled foods in 18 is confusingly "scrambled". It looks like SQF have encountered internal problems in deciding which way to go, eg this is their 2010 table -

SQF canning,2010.png   127.54KB   2 downloads

I only just realized that cfia are apparently only responsible meat/poultry. Semi-USDA.

PS - JFI here is the British Columbia viewpoint (seemingly a maverick) -

Canned Products - British Columbia.pdf   513.18KB   34 downloads

Oh no, CFIA is responsible for far more than meat and poultry. They are the ONLY body responsible for ALL foods that are inter provincially traded. If your product (including meat) is not leaving the province OR being exported than the provincial inspectors are either on site, or spot visits are conducted. 

The new SAFE FOODS FOR CANADIANS regulations (due out any day now) have broadened CFIA's scope, and everyone will now be "painted with the same brush" the only exceptions will be producers with less than $30000/year in gross sales. 

CFIA has 20 chapters for meat/poultry inspection and they MUST follow the FSEP program. Honey, dairy, organic production (of any FG) maple sryup, eggs also have federally regulated program that are regularly inspected on site.  We are a federally registered processed product company and as such have regular inspections otherwise, we could not sell our product outside of our province.

Oh no, CFIA is responsible for far more than meat and poultry. They are the ONLY body responsible for ALL foods that are inter provincially traded. If your product (including meat) is not leaving the province OR being exported than the provincial inspectors are either on site, or spot visits are conducted. 

 

The new SAFE FOODS FOR CANADIANS regulations (due out any day now) have broadened CFIA's scope, and everyone will now be "painted with the same brush" the only exceptions will be producers with less than $30000/year in gross sales. 

 

CFIA has 20 chapters for meat/poultry inspection and they MUST follow the FSEP program. Honey, dairy, organic production (of any FG) maple sryup, eggs also have federally regulated program that are regularly inspected on site.  We are a federally registered processed product company and as such have regular inspections otherwise, we could not sell our product outside of our province.

Thks.

I blame their website -

http://www.inspectio...3/1332207173484

Actually, although it was not quite clear to me by whom, product risk classification does seem to be done but (some?) canned goods exempted (except in BC apparently) -

http://www.inspectio...30236419?chap=5

That second link is for L.mono only. So the implicated producers is based on incident history (not always/or ever on the science). Yes, the website is very very hard to navigate if you don't have to use it all the time. It's only going to get worse in the near future......the new reg's are less prescriptive, outcome based....which leaves too much room (IMHO) for industry to do whatever they want and cut corners left right and centre.

Dear Charles,

We have low acid product, but process with hot filling and low A.W, ambient stable, can it regarding as low risk process or low risk food?

Thanks

 

Best regards,

 

Jerald

Hi Jerald,

To illustrate the variability of interpretations of "high risk" I attach this short but, IMO, effectively presented comparison of usages. Basically the choice seems near-random unless appropriate logic is specified or, perhaps, cross-referenced. FDA/FSMA have afaik been working on a promised list of "High Risk"  Foods since 2014.

high risk foods,UK,.pdf   150.98KB   41 downloads

Regardless, with respect to yr specific query, i attach this US document which appears to imply that an initial (hot-fill) evaluation of low(er) risk was later switched to high(er) risk within the context of the article -

Production in residential vs commercial kitchens,2014.pdf   389.88KB   24 downloads

(see pg 16/24)

i daresay you can find other hot-fill publications with a reverse opinion. :smile:

SQF has 2 classifications for "canned" foods, 18 which is high risk and process knowledge needed-aseptic foods and 15, preserved foods manufacture. No, CFIA does not classify processors by risk. It is my understanding that they never have, they just have different hoops to jump through depending on your process and finished goods.

Low Acid Canned foods have very specific processing requirements and I would say they are definitely high risk. Fill weight and headspace being absolutely critical to the safety of the end product. A quick refresher on the CFIA website lists a number of other requirements. I would indicate it is high risk.

Low Acid Canned foods have very specific processing requirements and I would say they are definitely high risk. Fill weight and headspace being absolutely critical to the safety of the end product. A quick refresher on the CFIA website lists a number of other requirements. I would indicate it is high risk.

Hi meism,

IIRC this opinion only (officially) exists in Canada. Due, from memory, to the Canadian interpretation of "High Risk".

(ADDED - Must add that if SQF (USA) is considered "Official" then Post 9-10 confounds my comment)

Although it may well be possible to find random opinions that all RTE foods are automatically "High Risk".

The new Canadian reg's DO NOT include low pH/high acid foods......hallelujah  come on 2019

This is going to make my life so much better between CFIA and SQF, now the scientists are using their heads.

pH below 4.0 and shelf stable.........according to a leading researcher at USDA-ARS about as safe as you can get.......obviously there will still be a CCP for me, but I will no longer require a "process authority" to determine how we proceed

Random opinions...........is that based on science (I ask sarcastically knowing the answer)

The new Canadian reg's DO NOT include low pH/high acid foods......hallelujah  come on 2019

This is going to make my life so much better between CFIA and SQF, now the scientists are using their heads.

 

pH below 4.0 and shelf stable.........according to a leading researcher at USDA-ARS about as safe as you can get.......obviously there will still be a CCP for me, but I will no longer require a "process authority" to determine how we proceed

 

Random opinions...........is that based on science (I ask sarcastically knowing the answer)

^^ I would not bet on that.

pH < 4.0 sounds rather conservative ??

Principles of Acidified Foods.pdf   3.05MB   42 downloads

4.6 is the scientific maximum value for safety for botulism and it's growth

our pH is based on the flavor profile

And I've already checked with my inspector to make sure I was interpreting the regs correctly and got a direct response from CFIA as a whole.  I don't take chances with regulations, I err on the side of caution and ask questions directly

Hi Scampi,

Have you seen a  CFIA website Page defining how they classifiy "High Risk" foods ?

This topic previously came up in another thread and i could not find a specific current CFIA answer although i am fairly sure i have previously seen a  CFIA statement that  canned foods are High Risk for the same reasons as given in the oldish reference i previously attached from British Columbia.

PS - i deduce that yr CCP is based on pH < 4.6.

I also deduce that CFIA's no longer requiring a process authority for AF is opposite to USFDA (2017). Should be interesting.

@meism

Just to reiterate that afaik Canada is the only Country to officially classify LACF as High Risk. Counter-examples are of course welcome. :smile:

This is all I could find Charles, but I will add it hasn't been updated since 2015.  I can't get my hands on it at the moment, but ground meat and luncheon meat are in their very own special little risk category

http://www.inspectio...21716482?chap=6

High Risk Category

Loss of control of the process could result in a significantly high health risk. High risk category products or processes may involve any of the following criteria:

• The process involves a kill step to eliminate microbial contaminants, or a step to reduce them to an acceptable level. For example, pasteurization, sterilization, cooking, drying, fermentation, acidification.
• Hazards are inherent to the process and the product is considered ready to eat, without further processing by the consumer.
• The production involves a complex recipe. It may involve the use of chemical hazards (e.g. nitrates) or involve a product that addresses serious nutritional concerns.

Lower risk category products or processes may involve any of the following criteria:

• Hazards are inherent to the process but the processing controls are not designed to eliminate these hazards. Rather, the controls (such as proper sanitation and temperature control) are meant to prevent contamination or to prevent an increase to existing biological hazards. Product will be further processed by the consumer/client, who may need to follow specific handling and storage instructions. While it is necessary to minimize these hazards, deviations will moderately increase the health risks associated with the final product.
• Products are ready to eat but do not pose significant health hazards on their own. For example, thermal processing or aseptic processing for high-acid food, maple product processing, honey processing, freezing, packaging, drying of fruits.

The CFIA operates a national microbiological monitoring program. The monitoring program includes the random selection and testing of samples for a wide variety of domestic and imported products. Sample tests are done every year to monitor the level of microbiological contamination in the food supply. Testing is done for a variety of high risk pathogens, including E. coli, Listeria monocytogenes, Salmonella and Shigella.

This is all I could find Charles, but I will add it hasn't been updated since 2015.  I can't get my hands on it at the moment, but ground meat and luncheon meat are in their very own special little risk category

 

http://www.inspectio...21716482?chap=6

 

 

High Risk Category

Loss of control of the process could result in a significantly high health risk. High risk category products or processes may involve any of the following criteria:

• The process involves a kill step to eliminate microbial contaminants, or a step to reduce them to an acceptable level. For example, pasteurization, sterilization, cooking, drying, fermentation, acidification.
• Hazards are inherent to the process and the product is considered ready to eat, without further processing by the consumer.
• The production involves a complex recipe. It may involve the use of chemical hazards (e.g. nitrates) or involve a product that addresses serious nutritional concerns.

Lower Risk Category

Lower risk category products or processes may involve any of the following criteria:

• Hazards are inherent to the process but the processing controls are not designed to eliminate these hazards. Rather, the controls (such as proper sanitation and temperature control) are meant to prevent contamination or to prevent an increase to existing biological hazards. Product will be further processed by the consumer/client, who may need to follow specific handling and storage instructions. While it is necessary to minimize these hazards, deviations will moderately increase the health risks associated with the final product.
• Products are ready to eat but do not pose significant health hazards on their own. For example, thermal processing or aseptic processing for high-acid food, maple product processing, honey processing, freezing, packaging, drying of fruits.

 

Food microbiology

The CFIA operates a national microbiological monitoring program. The monitoring program includes the random selection and testing of samples for a wide variety of domestic and imported products. Sample tests are done every year to monitor the level of microbiological contamination in the food supply. Testing is done for a variety of high risk pathogens, including E. coli, Listeria monocytogenes, Salmonella and Shigella.

Hi Scampi,

Thks and Congratulations on yr searching skill !

One reason for difference in Gradings appears to be that CFIA have selected the "sensitivity" of the Manufacturing Process as a Priority criterion. This is sort of justifiable from a HACCP POV, ie a CCP (such as from cooking > RTE) will auto-generate a High Risk product. But, arguably, "suffers" from excluding shelf-life, etc criteria. (I'm not entirely clear as to whether the CFIA def. for "high risk" implies RTE goods only)

In contrast, other definitions have focussed more on Post-Production features like stability criteria, illness frequency statistics, etc, eg this UK definition -
 

 

High Risk Food is defined as:

 

“Ready to Eat food which can, in the right conditions, support the growth of pathogens”

 

In simple terms this means food that does not require any further cooking before it is consumed [but] that can become harmful to the consumer if not stored or handled correctly.

 Such examples of high risk foods would be:

• Cooked Hams
• Sandwich Fillings
• Prepared Salads
• Ready Meals
• Patés
• Dairy Cream Cakes
• Deserts containing dairy products
• Hot food such as rotisserie chickens, pies and pasties

High risk pre-packed food can normally be recognised by the fact it is stored in a temperature controlled environment such as a refrigerator or freezer, however, this is by no means a guarantee that the product is a high risk food. The other simple identification mark is that the product carries a “Use By” date rather than a “Best Before” date. Such food items may also carry guidance that once opened the shelf life is reduced further.

The partner to the above is  -
 

Low Risk Food is defined as:

 

“Ambient Stable Foods that do not normally support the growth of pathogens”

 

In simple terms this means food that does not require being held in a temperature controlled situation such as a freezer, refrigerator or heated display and will not become dangerous to consume under normal circumstances.

Such examples of low risk foods would be:

• Crisps & Corn Snacks
• Tinned Food
• Cooking Sauces In Jars
• Packet Breakfast Cereals
• Pastries & Cakes (Without Dairy Cream)
• Dried Pasta & Rice
• Sweets & Sugar Confectionery
• Table Sauces

Low risk foods can usually be identified by the shelf life they display. Low risk foods carry a “Best Before” or “Best Before End” shelf life. The important thing to remember is that some products that carry “best before” shelf life indications are safe up until they are opened. Once opened the shelf life can be greatly reduced and may require holding in refrigerated storage.

(One limitation of above definition is the exclusion of non-RTE foods)

http://www.thefoodsa...s/Low_Risk_Food

The CFIA (HACCP-type) definition of High/Low Risk is more wide-scoped inasmuch as it also handles (HACCP "Low-Risk") non-RTE foods which will be cooked before consumption. But it still seems (to me) intuitively illogical for something like canned foods (ambient stable ,shelf-life typically  "unlimited") to be considered "High Risk".

Swings and Roundabouts. :smile: