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Regulatory requirements for reporting micro issues with ingredients?


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#1 Drumstick

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Posted 13 May 2019 - 08:18 PM

Hi everyone,

 

To update our crisis management/recall procedures, I've been reading the FDA recall guidances and other information about the RFR and I still have some doubts about regulatory requirements. I've also been searching on this forum and I haven't found anything that specifically answers my questions.

 

If a customer (nor a retailer, neither a consumer) informs me that they have found a microbiological issue in an ingredient I have sold them, but they are going to "solve" the problem (heating or irradiating. not as a part of their process), should they report that to the RFR? should I? It's not yet in the supermarket shelves, it's in their warehouse, so does it fit in the definition of reportable food?

 

"...an article of food (other than dietary supplements or infant formula) for which there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals". Let's imagine that the problem is a low recount (<100 cfu/g generic) of E.coli in an ingredient that won't support its growth.

 

Apart from that, the FDA guidances for the RFR (https://www.fda.gov/...stablished-food) has the following Q&A:

 

I. Notifications

I.1 [Amended May 2010] If a responsible party (Party A) notifies the immediate previous source(s) and/or immediate subsequent recipient(s) of the article of food (Party B), as required by FDA, should Party B submit a report to FDA and provide a notification to Party B’s own immediate previous source(s) and/or immediate subsequent recipient(s)?

Yes, if Party B meets the definition of a responsible party, Party B should submit a report to FDA as soon as practicable, and within 24 hours after receiving the notification regarding the reportable food. FDA may require Party B to submit a report to FDA as soon as practicable, but in no case later than a time specified by FDA, and/or to provide a notification to Party B’s own immediate previous source(s) and/or immediate subsequent recipient(s) of the reportable food. See the response to Question I.5 for more information.

 

This confuses me so hard. Thoughts anyone?

 

Regards.


Edited by Drumstick, 13 May 2019 - 08:19 PM.


#2 smgendel

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Posted 17 May 2019 - 04:58 PM

You describe the problem as a low count of E. coli.  If by that you mean generic E. coli, that is not a hazard with a probability of causing harm.  If the E. coli count is for a pathogen, then it should be reported by the facility that discovers the problem. If the distinction between testing for generic E. coli as a quality indicator and testing for pathogenic E. coli as a safety control is not clear, please work with a consultant or someone familiar with food microbiology to be sure your Food Safety Plan will meet FDA expectations. 

 

If you are dealing with a pathogenic strain, I would be wary of the apparent proposed "solution" that you describe.  If the facility that found it is covered under FSMA they should have a Corrective Action Plan in place on how to handle situations like this.  As such, there should not be anything that is "not part of their process."  Assuming that your facility is covered under FSMA, you should also have a Corrective Action Plan in place. 



#3 Charles.C

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Posted 18 May 2019 - 03:29 PM

For those, like me, unfamiliar with USA Systems/Acronyms -

 

RFR = Reportable Food Registry

 

I anticipate that the quotations in OP were concocted by a Lawyer. Hence likely to be headache generating.


Kind Regards,

 

Charles.C


#4 Drumstick

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Posted 18 May 2019 - 04:11 PM

You describe the problem as a low count of E. coli.  If by that you mean generic E. coli, that is not a hazard with a probability of causing harm.  If the E. coli count is for a pathogen, then it should be reported by the facility that discovers the problem. If the distinction between testing for generic E. coli as a quality indicator and testing for pathogenic E. coli as a safety control is not clear, please work with a consultant or someone familiar with food microbiology to be sure your Food Safety Plan will meet FDA expectations. 

 

If you are dealing with a pathogenic strain, I would be wary of the apparent proposed "solution" that you describe.  If the facility that found it is covered under FSMA they should have a Corrective Action Plan in place on how to handle situations like this.  As such, there should not be anything that is "not part of their process."  Assuming that your facility is covered under FSMA, you should also have a Corrective Action Plan in place. 

Thank you for your answer, Smgendel. In my example, I was just trying to create a "grey" case, where a intermediate distributor (like a warehouse which receives 50 kg boxes of wheat, for example) within the supply chain informs a primary manufacturer (the company who put the wheat in the boxes) of a "potential" issue (that's why I said "E.coli generic", because without further information (a strain identification), it may be or not a health issue, right?)). In this specific example, the product wouldn't be in the supermarkets/restaurants/etc., so can do no harm because it has been detected faaaaar before it reaches the consumers in any form (even if the wheat could be consumed raw, which isn't the case). However, based on what I quoted from the regulations, the inmediate interpretation is that, even in that case, you have to report it to the Reportable Food Registry (Thank you @Charles.C, you're right; I'm neither very familiar with those USA acronyms, but after 8 hours reading through that stuff, I just assumed it as a well-known term).

 

Maybe the question is stupid, or something is missing in translation. However, I find it difficult to believe that nobody else had the same question before..

 

Regards.



#5 Charles.C

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Posted 19 May 2019 - 04:08 AM

Hi everyone,

 

To update our crisis management/recall procedures, I've been reading the FDA recall guidances and other information about the RFR and I still have some doubts about regulatory requirements. I've also been searching on this forum and I haven't found anything that specifically answers my questions.

 

If a customer (nor a retailer, neither a consumer) informs me that they have found a microbiological issue in an ingredient I have sold them, but they are going to "solve" the problem (heating or irradiating. not as a part of their process), should they report that to the RFR? should I? It's not yet in the supermarket shelves, it's in their warehouse, so does it fit in the definition of reportable food?

 

"...an article of food (other than dietary supplements or infant formula) for which there is a reasonable probability that the use of, or exposure to, such article of food will cause serious adverse health consequences or death to humans or animals". Let's imagine that the problem is a low recount (<100 cfu/g generic) of E.coli in an ingredient that won't support its growth.

 

Apart from that, the FDA guidances for the RFR (https://www.fda.gov/...stablished-food) has the following Q&A:

 

I. Notifications

I.1 [Amended May 2010] If a responsible party (Party A) notifies the immediate previous source(s) and/or immediate subsequent recipient(s) of the article of food (Party B), as required by FDA, should Party B submit a report to FDA and provide a notification to Party B’s own immediate previous source(s) and/or immediate subsequent recipient(s)?

Yes, if Party B meets the definition of a responsible party, Party B should submit a report to FDA as soon as practicable, and within 24 hours after receiving the notification regarding the reportable food. FDA may require Party B to submit a report to FDA as soon as practicable, but in no case later than a time specified by FDA, and/or to provide a notification to Party B’s own immediate previous source(s) and/or immediate subsequent recipient(s) of the reportable food. See the response to Question I.5 for more information.

 

This confuses me so hard. Thoughts anyone?

 

Regards.

 

Hi Drumstick,

 

Not in USA but from a very quick look at yr link, it seems (eg D5,D6) one possible criterion for initiating reporting to RFR would be whether the  "E.coli"  finding is sufficient to justify a Class 1 Recall.

 

I noted that the sub-linked  archive of reports does contain examples where reason for Class 1 recall  is given as "potential for contamination with E.coli ",eg -

 

Attached File  E.coli.PNG   8.43KB   1 downloads

 

I was unable to (rapidly) determine whether the "E.coli" in above example (and others) directly relates to or can include generic E.coli. It is probably detailed somewhere in the text (maybe also relates to a specific official sampling plan/specification).

I was also unable to determine whether only RTE items are relevant.

Seems likely that quantitative factors would also be involved, ie specifications.

 

I anticipate that  USA posters will know.


Kind Regards,

 

Charles.C


#6 smgendel

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Posted 19 May 2019 - 04:10 PM

One thing to consider when dealing with a pathogen in the supply chain is that the company that found the problem is unlikely to be the only one affected.  FDA will follow up on RFR reports for pathogens to track the problem forward and backward in the supply chain.  Their immediate goal is always to be sure that any products that represent a potential threat to health are removed from the market as quickly as possible.  



#7 Fishlady

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Posted 19 May 2019 - 06:07 PM

My understanding is that if the problem is serious enough to qualify for a class I recall, and the product has left your facility (which it obviously would if the customer reported it), then it needs to be reported to the RFR. As others have noted, generic E. Coli may not meet the criteria for class I recall, but pathogenic E. Coli likely would.



#8 Charles.C

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Posted 19 May 2019 - 10:24 PM

My understanding is that if the problem is serious enough to qualify for a class I recall, and the product has left your facility (which it obviously would if the customer reported it), then it needs to be reported to the RFR. As others have noted, generic E. Coli may not meet the criteria for class I recall, but pathogenic E. Coli likely would.

 

Hi Fishlady,

 

The immediate difficulty for me was that FDA's own website appears microbiologically ambiguous !

 

It's unclear what product or type of product is being discussed in OP?  eg a raw item scheduled for further processing ?

 

 Generic (non-toxigenic) E.coli is typically not classified as a pathogen however if an official micro. specification for a given Product is (FDA) found out of compliance, this may be sufficient to justify a Recall Class1 on grounds like the notoriously flexible "adulteration" ( = > > serious adverse health consequences ?)

 

@ Drumstick = Please clarify the nature/status (and identity if possible) of Product X, eg RTE ?


Kind Regards,

 

Charles.C


#9 Drumstick

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Posted 23 May 2019 - 04:30 PM

Thank you very much for all you answers @Charles.C, @smgendel and @Fishlady

 

Well, again I'm not a USA food legislation expert, but I always have heard that the FDA recall classification is sometimes a little bit incongruous (sometimes the same pathogen in similar products can be classified as different classes of recall). In fact I think I've read somewhere in one of their guidance documents something like "do not trust 100% on the recalls list to asses wheter or not you have to classify your recall as a class I". Maybe someone can confirm this.

 

 

Hi Fishlady,

 

The immediate difficulty for me was that FDA's own website appears microbiologically ambiguous !

 

It's unclear what product or type of product is being discussed in OP?  eg a raw item scheduled for further processing ?

 

 Generic (non-toxigenic) E.coli is typically not classified as a pathogen however if an official micro. specification for a given Product is (FDA) found out of compliance, this may be sufficient to justify a Recall Class1 on grounds like the notoriously flexible "adulteration" ( = > > serious adverse health consequences ?)

 

@ Drumstick = Please clarify the nature/status (and identity if possible) of Product X, eg RTE ?

 

Our products are sold as bakery ingredients, but it's not impossible to be consumed raw (i.e. sesame seeds). In fact, they are sold in bulk, in packages that are not oriented for the final consumer. However, I couldn't tell (because I don't know) if some clients just re-package them and sell them to final consumers to use them at their homes (as bakery ingredients of course); sometimes I think that our products have the same problem as the cookie dough: they are not intended to be eaten raw, but there are recipes that use it raw, and people who actually consume it raw. Don't know if this comparison makes sense for you, but I find it similar.

 

I see that my example caused more confusion than clarification, maybe there were too many variables (my fault). Let's imagine it's a hazard which INDEED may cause serious adverse health consequences (EHEC, Salmonella, or even foreign bodies i.e. pieces of glass); my customer informs me that they have found it in my product (NRTE, bakery ingredient), but his process (irradiation or heating for micro, screening/sieving for foreign bodies) will eliminate or reduce the hazard to a safe level . There's no recall, they solve the problem that I (allegedly :closedeyes: ) created. So the initial question should had been: do I have to report something that hasn't even provoke a recall just because "it would be considered a class I recall if ever reaches the consumer without being detected"? As per Fishlady and smgendel posts I guess the answer is yes:

 

 

One thing to consider when dealing with a pathogen in the supply chain is that the company that found the problem is unlikely to be the only one affected.  FDA will follow up on RFR reports for pathogens to track the problem forward and backward in the supply chain.  Their immediate goal is always to be sure that any products that represent a potential threat to health are removed from the market as quickly as possible.  

 

 

You're in the USA, so you probably understand FDA rules better than I do. I'll include that in our crisis management procedure ("always report to the RFR if the hazard detected could cause a class I recall", no matter where in the supply chain it happens).

 

Thank you very much for your time! 



#10 Charles.C

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Posted 23 May 2019 - 10:59 PM

Thank you very much for all you answers @Charles.C, @smgendel and @Fishlady

 

Well, again I'm not a USA food legislation expert, but I always have heard that the FDA recall classification is sometimes a little bit incongruous (sometimes the same pathogen in similar products can be classified as different classes of recall). In fact I think I've read somewhere in one of their guidance documents something like "do not trust 100% on the recalls list to asses wheter or not you have to classify your recall as a class I". Maybe someone can confirm this.

 

 

 

Our products are sold as bakery ingredients, but it's not impossible to be consumed raw (i.e. sesame seeds). In fact, they are sold in bulk, in packages that are not oriented for the final consumer. However, I couldn't tell (because I don't know) if some clients just re-package them and sell them to final consumers to use them at their homes (as bakery ingredients of course); sometimes I think that our products have the same problem as the cookie dough: they are not intended to be eaten raw, but there are recipes that use it raw, and people who actually consume it raw. Don't know if this comparison makes sense for you, but I find it similar.

 

I see that my example caused more confusion than clarification, maybe there were too many variables (my fault). Let's imagine it's a hazard which INDEED may cause serious adverse health consequences (EHEC, Salmonella, or even foreign bodies i.e. pieces of glass); my customer informs me that they have found it in my product (NRTE, bakery ingredient), but his process (irradiation or heating for micro, screening/sieving for foreign bodies) will eliminate or reduce the hazard to a safe level . There's no recall, they solve the problem that I (allegedly :closedeyes: ) created. So the initial question should had been: do I have to report something that hasn't even provoke a recall just because "it would be considered a class I recall if ever reaches the consumer without being detected"? As per Fishlady and smgendel posts I guess the answer is yes:

 

 

Hi Drumstick,

 

You seem to basically have 3 questions ? -

 

(1) is the food reportable

(2) if answer to (1) is Yes, who is responsible to (initially) report it to FDA?

(3) if answer to (1) is Yes, what is the scope of who, additionally to the person in (2) has to further submit reports toFDA ?

 

The closest (but only partial) practical analogy I could see to yr scenario in the QA of yr FDA link appeared to be D10.

 

For yr scenario, the initial decision for both (1) and (2)  appears to be the responsibility of the receiver which, offhand, seems logical.

 

The decision(s) in (3) are seemingly controlled by the 9 sub-sections of Section I. I agree these are head-bangers. If uncertain I  can only suggest to ask the FDA for clarification of the specific scenario. In general,

I deduce that the 9 Sub-sections  within Section I attempt to ensure rapid feedback to the FDA from ALL potentially involved parties. This seems logical.

 

IMO FDA should have included a typical example(s), albeit such would probably not be a simple flow chart  in some cases.

 

----------------------------------------------------------------------------------------------------------------------------------------------------------------------

I speculate that if all the product is to be processed by yr receiver using an officially validated treatment to "eliminate" the observed defect, then the receiver's answer  to (1) would be No. And the supplier then has no case to answer for this specific scenario. But only speculation.


Kind Regards,

 

Charles.C


#11 Fishlady

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Posted 24 May 2019 - 03:28 PM

FDA guidance states that if the problem is detected after it has left your control, then you must report it. So the supplier would be required to report; if the receiver’s actions will correct the problem, then they probably need to report, too. It would be best for both parties to verify this with their local FDA office.

https://www.fda.gov/.../77295/download



#12 Charles.C

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Posted 24 May 2019 - 10:17 PM

FDA guidance states that if the problem is detected after it has left your control, then you must report it. So the supplier would be required to report; if the receiver’s actions will correct the problem, then they probably need to report, too. It would be best for both parties to verify this with their local FDA office.

https://www.fda.gov/.../77295/download

 

Hi Fishlady,

 

Thks yr attachment.

 

The initial, crucial, paragraph as also noted in the OP seems to be -

 

The RFR requires a responsible  party to file a report through the RFR electronic portal  when there is a reasonable probability that the use of, or exposure to, an article of food will cause serious adverse health consequences or death to humans or animals. Such foods are “Reportable Foods.”

 

And, presumably, the opposite also applies.

 

So what is "reasonable probability" ? Only FDA know?

 

HACCP would, IMO, consider the likelihood of the hazard occurring at the consumer to be Low due to (assumed validatable)  "downstream processing".

 

Logically, FDA should have included more examples since there may well be many similar events. Maybe they like questions.


Edited by Charles.C, 25 May 2019 - 01:17 AM.
edited

Kind Regards,

 

Charles.C





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