FDA microbiological limits for food

I've been doing some research online and it appears that the FDA and USDA do not have any specific microbiological criteria and any legislation for foods in the US. I have heard that Salmonella spp, E.coli O157 (and some other O variants), L.monocytogenes are invariably classified as zero-tolerant microbial pathogenic species in any product. But where in legislation can I find that it is zero-tolerant? What is the recall criteria for FDA regarding microbiological hazards such as salmonella or L.mono? There must be a criteria to test the samples. Thanks!

I've been doing some research online and it appears that the FDA and USDA do not have any specific microbiological criteria and any legislation for foods in the US. 

I have heard that (a)Salmonella spp, (b) [pathogenic] E.coli O157 (and some other [pathogenic] O variants), (c) L.monocytogenes are invariably classified as zero-tolerant microbial pathogenic species in any product.

 

What is the recall criteria for FDA regarding microbiological hazards such as salmonella or L.mono? There must be a criteria to test the samples

 

Thanks!

Hi jecco,

The terminology "zero tolerance" is in common use but has interpretive complications. For example can see this article-

 Factors Affecting Salmonella criteria for raw poultry.pdf   429.79KB   31 downloads

(a,b) where included in Regulatory, Product Microbiological Standards are typically associated with acceptance requirements such as Nil detection in X grams for a specified sampling/analytical program. The specifics vary with Country..

(c) Regulatory, Product Microbiological requirements, eg "Nil detection", typically depend on factors such as the food's consumption status eg RTE/NRTE. The specifics vary with Country.

You may like to browse through the various Global files compiled in the 2 links listed within this post  -

https://www.ifsqn.co...er/#entry138358

PS -  afaik USA does apply a Nil detection requirement for Salmonella on all imported seafood and for L.monocytogenes in RTE seafood.

PPS - JFI here is a FSIS Salmonella Guideline (2017) -

 FSIS Salmonella-Compliance-Guideline-SVSP-RTE-Appendix-A.pdf   783.66KB   52 downloads

For Listeria and from the FDA

https://www.fda.gov/...ready-eat-foods

Meat limits and methods

https://www.ams.usda...logical-testing     

NOTE: limits may change depending on an importing countries requirements

For Listeria and from the FDA

 

https://www.fda.gov/...ready-eat-foods

Hi kfromNE,

Thks above. The basic (FDA) conclusion seems fairly simple. Detection of L.monocytogenes in any FDA jurisdiction finished RTE product is not acceptable.

RTE products under USDA's  L.monocytogenes jurisdiction look to encounter similar requirements to FDA. As per this (2014) file

.  FSIS RTE Guidance for L.monocytogenes.pdf   1.03MB   40 downloads

The textual content for both FDA/USDA regarding usage of Listeria testing instead of  L.mono is IMO unclear/confusing.

Do establishments really take up tp 60 samples ?

Charles, given the enormous amount of these types of products that can be produced in a very very short period of time, 60 samples actually seems quite reasonable

These foodstuffs are also fed to high risk community members who are less likely to be able to fight off a mild case

As I've mentioned previously, there is a reason that the listeria sampling seems heavy handed

Hi Scampi,

Proper implementation of Haccp is supposed to reduce finished product testing.

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But where listeria occurs in RTE meat products-due in part to the types of machinery used, it has not, so the alternative is either A) ignore it or B) force more testing

Case in point https://www.swlawyer...n-Stevenson.pdf

The verbiage you want to look out for is "adulterated", which is includes the presence of undesirable microorganisms such as pathogens that contaminate the food.

The regulations basically consider these unwarranted organisms (pathogens) as not normally present in the product and thus render the product adulterated.

You can find mentions of this in the CFR, Title 21, part 117 & also in the Federal Food, Drug, and Cosmetic Act.

Ultimately you are responsible for identifying the pathogens of concern and taking appropriate action if these are detected.

The FDA listeria guidance is a good start, but it's not a regulation and is nothing more than recommendations and the agency's views on a topic.

The verbiage you want to look out for is "adulterated", which is includes the presence of undesirable microorganisms such as pathogens that contaminate the food.

The regulations basically consider these unwarranted organisms (pathogens) as not normally present in the product and thus render the product adulterated.

You can find mentions of this in the CFR, Title 21, part 117 & also in the Federal Food, Drug, and Cosmetic Act.

Ultimately you are responsible for identifying the pathogens of concern and taking appropriate action if these are detected.

The FDA listeria guidance is a good start, but it's not a regulation and is nothing more than recommendations and the agency's views on a topic.

^^^(red) - Very well observed !

.

The word "recommend" occurs 393 times in FDA's Salmonella Guidance document. It is a rather Herculean task to deduce how many of the recommendations are directly matched to Regulatory requirements. Presumably the only definitive solution is to additionally become an expert on CFR texts.

IMO (not a User) FSIS's Guidance documents contain better (albeit limited) presentations of how their recommendations are linked to Regulatory requirements. Their provision of a self-assessment tool in the Salmonella Guidance document is IMO worthy of note.

The OP contained <<< What is the recall criteria for FDA regarding microbiological hazards such as salmonella or L.mono? There must be a criteria to test the samples.>>>

As noted above "adulterated" is a key driver for possible recall action. The micro. criteria , predictably, include positive Salmonella / L.mono. detections. and are discussed in this context within the Guidance material. The direct use of "Listeria" detection data seemed more problematic to myself.

.

This may be of assistance. It at least spells out clear instructions by food category related to the risk of listeria contamination

https://www.canada.c...ml#envirosample

This may be of assistance. It at least spells out clear instructions by food category related to the risk of listeria contamination

 

https://www.canada.c...ml#envirosample

Hi Scampi,

Thks for above. Certainly offers a reduced laboratory load. The Canadian approach is similar although more intricate than that of EC. For example here is EC Decision tree -

 EC Decision Tree - L.monocytogenes.png   732.67KB   0 downloads

Afai can see, the USA's  L.monocytogenes Regulatory requirements for RTE products are unique with respect to their all-encompassing "zero tolerant" aspect.

i also noticed this recent (2020) review of International Listeria Regulatory Approaches which has a quite interesting section on the consequences of detection of Listeria/L.mono - 

 L.monocytogenes - Food Disposition.png   675.59KB   0 downloads

 Review,L.mono EMPG for RTE process,2020.pdf   1.22MB   20 downloads

It appears that Canada also has  zero tolerance in class 1 RTE products 

https://www.canada.c...: Sampling,High

If listeria is DETECTED, which in CFIA language means 0=good to sell >0= do not sell and notify CFIA

It appears that Canada also has  zero tolerance in class 1 RTE products 

https://www.canada.c...: Sampling,High

 

If listeria is DETECTED, which in CFIA language means 0=good to sell >0= do not sell and notify CFIA

Hi Scampi,

(Getting a bit OT)

The additional linked "Comments Received" Page is also well worth scrutinising, eg the list of exemptions at the end.

The main article also led me to this rather impressive Canadian text (2012) on controlling L.mono in the Meat Industry -

 Best Practices - Control of L.mono in the Canadian Meat Industry.pdf   645.22KB   10 downloads

Canada has always had a world class food safety system, learning from mistakes, like the maple leaf recall to prevent the reoccurance

We also had a massive water scandal (google Walkerton water crisis) and we've learned from that too

Every poultry plant I've ever worked at, if you had listeria detected, even if it were a floor drain..........no production would occur and no product would ship, until or unless 3 negative swabs came back from the same location

There was a salmonella shell egg recall in 2020, change to procedures between the egg board, CFIA and processors happened within days, not weeks or months

THanks everyone for the comments!

another question comes up to mind, why are there no specific criteria in the usa? 

Other countries like eu, japan does provide specific guidance to microbial contamination but why not US?

It is because US requires microbial management through procedures(FSMA etc)?

Thanks!

THanks everyone for the comments!

 

another question comes up to mind, why are there no specific criteria in the usa? 

Other countries like eu, japan does provide specific guidance to microbial contamination but why not US?

 

It is because US requires microbial management through procedures(FSMA etc)?

 

Thanks!

Hi jecc0,

I think the preceding Posts refute the above micro. generalisation .

Maybe correct to say there are few compilations of Regulatory US micro. limits, eg -

https://www.ifsqn.co...y-to-eat-food/#

afaik States do have local micro limits also.

I daresay the US currently tries to ensure that Safety/Risk-related aspects (eg HACCP) prioritize their Regulatory usage of micro. values which is probably not a bad starting Principle. (Historically a previous attempt to Regulate less selective micro. featues was a notable disaster).

Additionally, as previously noted, is the omnipresent leverage via adulteration.

Given the breadth and scope of food processing in the usa coupled with the glacial pace that regulatory changes happen at the federal level in the US, is a hill they may never be able to climb

The regulatory landscape is also different due to it being a republic and different from traditional parliamentary systems (UK, Canada, Japan, Australia as examples), so the powers of the federal government are not as clear cut as other nations

Given the breadth and scope of food processing in the usa coupled with the glacial pace that regulatory changes happen at the federal level in the US, is a hill they may never be able to climb

 

The regulatory landscape is also different due to it being a republic and different from traditional parliamentary systems (UK, Canada, Japan, Australia as examples), so the powers of the federal government are not as clear cut as other nations

  A few of my different thoughts expressed in emojis when reading this b/c it's very true. You forgot to mention the fun of having two different government agencies regulating food. 

Thanks once again!