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Injury or affect of metal contaminants less than 7mm?


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#1 QAD_Rebisco

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Posted 05 August 2013 - 04:18 AM

I would like to ask for more rationale on this regulation “Under the FFD&C Act, a food containing foreign objects is considered adulterated (21 U.S.C 342). See FDA’s “Compliance Policy Guide,” Sec. 555.425. In addition, foreign objects that are less than 0.3 inch (7 mm) may cause trauma or serious injury to persons in special risk groups, such as infants, surgery patients, and the elderly.” For infants, i can understand the risk since it was also supported by evidences and case studies. I need to know about the surgery patients and the elderly, how are they affected with foreign objects less than 7 mm (specifically metal)? I need evidences so I can include them on our Product Description’s Sensitive Population.

 

 

QA_RBC



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#2 Setanta

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Posted 05 August 2013 - 12:40 PM

Well, it would help to know what you made, but even if something is very small and you bite on it, you could break a tooth, cut your mouth, choke, just for starters.

 

S.


-Setanta         

 

 


#3 KTD

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Posted 07 August 2013 - 02:01 PM

The Compliance Guide you reference is based on a series of risk assessments conducted by Olsen - don't remember his last name. I thought I had a copy of ths relevant assessment, but can't locate it. I have attached a FSIS presentation from 2002 that outlined their thinking - pretty much the same today.

 

The risk to some surgery patients and the elderly is based on an increased level of difficulty in the body being able to expel FM, as well as an increased chance of bodily damage due to the involved body parts (mouth, throat, air ways, digestive tract) being more sensitive and frail.

Attached Files



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#4 Moyers

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Posted 07 August 2013 - 02:51 PM

For the elderly, many have swallowing difficulty, medically called dysphagia.  For a couple of technical articles, see:

http://www.ajpmonlin...0077-7/abstract

http://europepmc.org...P0fQ1F2Q7j3l.24



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#5 Charles.C

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Posted 07 August 2013 - 04:12 PM

The Compliance Guide you reference is based on a series of risk assessments conducted by Olsen - don't remember his last name. I thought I had a copy of ths relevant assessment, but can't locate it. I have attached a FSIS presentation from 2002 that outlined their thinking - pretty much the same today.

 

The risk to some surgery patients and the elderly is based on an increased level of difficulty in the body being able to expel FM, as well as an increased chance of bodily damage due to the involved body parts (mouth, throat, air ways, digestive tract) being more sensitive and frail.

Dear KTD,

 

The primary historical US reference is maybe this -

 

Olsen, A. R. (1998a). Regulatory action criteria for filth and other extraneous materials. I. Review of hard or sharp foreign objects as physical hazards in food. Regul. Toxicol. Pharmacol. 28, 181–189.

 

Unfortunately appears to require money (or a Library) to study. The last part (5) in series is accessible but only discusses the end results. From other refs, US and otherwise, looks like there were/are "oscillations" over how to interpret / regulate the portion below 7mm. AFAIK, Canada has (currently) set 2mm for a lower limit but not including vulnerable groups. Holland appears to have set 2mm and includes, at least,  some vulnerable groups (ca 2009).

I suspect a popular choice is to apply the "Precautionary Principle"

 

Rgds / Charles.C

 

PS - as you say, the early FDA rules look pretty much the same as today - 

Attached File  FDA 555.425 (1999) adulteration involving hard or sharp objects.pdf   136.55KB   172 downloads


Kind Regards,

 

Charles.C


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#6 CFP

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Posted 18 August 2013 - 07:05 PM

Charles C

You can tell me where this information about france and Holland is described?



#7 CFP

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Posted 18 August 2013 - 07:06 PM

Sorry

abou Canada and Holland

Thank you

CFP



#8 p.ramadoss

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Posted 19 August 2013 - 09:03 AM

Interesting topic. I guess how to include the special risk group in India. If someone can help me with this.

 

Thank you,

Pragash



#9 CFP

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Posted 19 August 2013 - 09:41 AM

Can someone help me?

I am reaserchin about the limits for de contamination with metal, but i find only limits of FDA.



#10 Charles.C

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Posted 20 August 2013 - 04:38 AM

Sorry

abou Canada and Holland

Thank you

CFP

Dear CFP

 

Please see attachments below.

fm1,fm2 refer directly yr query.

fm3 US oriented.

fm4 relatively Europe/Canada oriented.

I have added a machine (ie no guarantee of accuracy),  partial,  translation of fm1 to English (any Dutch speakers here welcome to edit it / repost :smile: ).

 

Attached File  fm1 - Netherland - Fysische verontreiniging van voedsel door productvreemde delen.pdf   97.14KB   69 downloads

Attached File  fm5 - partial translation fm1 to English (Google).doc   30.5KB   96 downloads

Attached File  fm2 - Canada, physical hazards 2008.pdf   1.15MB   122 downloads

Attached File  fm3 - The Dirty Dozen_ Ways to Reduce the 12 Biggest Foreign Materials Problems (2003) - Food Safety Magazine.pdf   498.1KB   118 downloads

Attached File  fm4 - foreign object hazards, 2012.pdf   579.64KB   176 downloads

 

Rgds / Charles.C

 

PS  I also recall, i think, posting another reference here (somewhere) to Belgium using a 2mm cutoff.

Regardless of above, I predict that many commercial recalls have been carried out on findings of product contamination of  < 2mm metal particles ?

 

PPS -  (added 27-02-2017 by Charles.C - Note that a "improved" translation of that given  in fm5 has been attached in post 17)


Edited by Charles.C, 16 February 2019 - 12:31 PM.
corrected red 2007 > 2017

Kind Regards,

 

Charles.C


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#11 CFP

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Posted 21 August 2013 - 11:26 AM

Thank you Charles

The documents attached are very usefull for me.

i don´t understand your question.

 

CFP



#12 Charles.C

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Posted 22 August 2013 - 05:35 AM

Dear CFP,

 

i don´t understand your question.

 

 

Sorry, my bad English. It was not intended as a direct question, more of a general / semi-rhetorical comment. :smile:  I have noticed that, in practice, for example in the USA, one often sees reports of recalls for any (small / large) size indication  of  metal contamination of food products. I daresay this is a result of a local legal  option for a supplier to choose to initiate a recall themself which  avoids possible "stronger" FDA regulatory actions. 

 

As a chronological comment, it seems that, as you originally noted, most of the early quantitative food-related risk analyses originated in USA. But major difficulties were involved with interpretation of the data in the sense of formulating operational guidelines.

 

The 1st paper of the series issued by Olsen et al (1998), mentioned earlier,  probably well-summarises the (English language) global situation at that time plus explains the USA, FDA's decision to issue their compliance document of 1999.  I haven't seen the original Olsen document but from later comments at a similar time period in other refs, there were mixed opinions in USA / elsewhere over the declared  US regulatory actions, particularly  for contamination at the smallest sizes, eg < 2mm. I believe the USA / USDA may have also originally liked the 2mm cut-off  but eventually decided to uniformly stay with 7mm  plus their restrictive caveats, more or less as in curent guidance document. If anyone  knows more details, I'm sure QADRebisco would welcome their input. :smile: 

 

Other countries clearly had / have different opinions, eg Canada apparently considers >= 2mm as a (general) (moderate risk) hazard. Perhaps Canada also includes this requirement within official evaluation of haccp plans where metal detection is a CCP and a metal detector is employed.? :dunno: 

 

As a side-comment, i did notice that one haccp interpretation of product distribution to the "general public" was taken as implying not inclusive of specially vulnerable groups and thereby avoiding any future complaints in case of metallic contamination of certain sizes. I don't quite see how one operationally implements such logic for a random retail product not specifically directed to babies, the elderly, etc ? Perhaps there is a global legal definition of "General Public" ? :uhm: 


Kind Regards,

 

Charles.C


#13 p.ramadoss

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Posted 22 August 2013 - 05:38 AM

Dear CFP

 

Please see attachments below.

fm1,fm2 refer directly yr query.

fm3 US oriented.

fm4 relatively Europe/Canada oriented.

I have added a machine (ie no guarantee of accuracy),  partial,  translation of fm1 to English (any Dutch speakers here welcome to edit it / repost :smile: ).

 

attachicon.giffm1 - Netherland - Fysische verontreiniging van voedsel door productvreemde delen.pdf

attachicon.giffm5 - partial translation fm1 to English (Google).doc

attachicon.giffm2 - Canada, physical hazards 2008.pdf

attachicon.giffm3 - The Dirty Dozen_ Ways to Reduce the 12 Biggest Foreign Materials Problems (2003) - Food Safety Magazine.pdf

attachicon.giffm4 - foreign object hazards, 2012.pdf

 

Rgds / Charles.C

 

PS  I also recall, i think, posting another reference here (somewhere) to Belgium using a 2mm cutoff.

Regardless of above, I predict that many commercial recalls have been carried out on findings of product contamination of  < 2mm metal particles ?

 

Really? Many commercial recalls have been carried out on product contamination with foreign bodies less than 2 mm?



#14 Charles.C

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Posted 22 August 2013 - 06:38 AM

Really? Many commercial recalls have been carried out on product contamination with foreign bodies less than 2 mm?

Dear p.ramadoss,

 

I used to inspect  various food products to USA so I examined the lists of supplier-recalled items with great interest. :biggrin:

 

I noticed the not infrequent appearance of products recalled, from memory, for items like "metallic dust particles". I unofficially interpret this as probably  <2mm ? :smile: (it is possible they were mainly child-related items, don't remember). 

Should be easy enough to check current situation if you are interested / concerned. The USA is a library of informative data. I shall be only too happy to be currently proven incorrect. :smile:

 

Offhand, Canada looks equally, possibly even more, concerned. India I have no idea though ?

 

Rgds / Charles.C

 

 

PS - i had a quick look on Google. Unfortunately, it seems the US recall lists are less descriptive / informative than they used to be so it's difficult to speculate on dimensions. Foreign object contamination in general seems to remain  one of the major causes of recalls on a frequency basis. Typically metal notices only seem to refer to metal fragments / mesh / wire etc. Plastic pieces also seem a quite common problem at the moment.

 

As a random example, here is a recent list of recalled products from one distributor, metal complaints look approx 15pct of total,

 

Attached File  XYZ - Product Recalls.pdf   66.49KB   64 downloads


Kind Regards,

 

Charles.C


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#15 QAD_Rebisco

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Posted 22 August 2013 - 10:15 AM

Dear Charles,

 

Thanks for the info. It's very useful for us. I would just like to clarify on this statement by FDA "The product contains a hard or sharp foreign object less than 7 mm in length and if a special-risk group, as defined in the background section, is among the intended consumers of the product" - it should be considered adulterated. Correct me if i'm wrong but my interpretation is, if your product is milk, cereals or anything intended for infants, elderly (who belongs to sensitive population) and was found with metal less than 7 mm (or even metal dust)...then your product is subject for recall. What about if your product is snack foods, say fabricated potato fries..its not intended for infants, but elders can eat of course. If there is a presence of metal contaminant less than 2 mm, is it also subject for recall? If yes, then what study was conducted to prove that they are really vulnerable. What if the contaminant is not embedded?

 

Mel


Edited by QAD_Rebisco, 22 August 2013 - 10:16 AM.


#16 Charles.C

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Posted 22 August 2013 - 02:40 PM

Dear QADRebisco,

 

I deduce you are only interested in the USA  scenario as a support mechanism.

 

Regret I don’t have any definitive  answers to yr queries.

 

One purely textual possibility may be related to interpretations of the word “intended” in yr quote.

 

Regarding recalls due to metal contamination, don’t forget that manufacturers / distributors have responsibilities for both safety and non-safety defects in their products / labelling as per the product specification. I presume a supplier-initiated recall could be related to a perception of either / both, ie  “damage limitation”.

 

Subtler aspects of “adulteration” might also be (supplier) considered of  possible future consequence, for example this (2003) extract –

 

Not all foreign objects are physical hazards. For example, tiny metal shavings sometimes generated by opening cans with a can opener do not normally pose a physical hazard. Other types of foreign objects that are not categorized as physical hazards include insects and mites and their fragments, evidence of rodents and birds such as their excreta, hairs and feathers, and molds and rots associated with decomposition and dirty machinery parts.

Foods containing these types of nonhazardous foreign matter may be deemed adulterated under Section 402(a)(3) of the FD&C Act in that ‘‘it consists in whole or in part of any filthy, putrid, or decomposed substance’’ or ‘‘it is otherwise unfit for food.’’

 

(Food Plant Sanitation, Hui, 2003)

 

It seemed to me that my quote in yr earlier thread is one example of an attempted  “flexible” FDA haccp interpretation, ie

 

B. Your HACCP plan for seafood salads at the "Vegetable Processing" CCP lists the critical limit of "No metal particles in excess of (b)(4) mm". This critical limit is not adequate to control metal fragments that may cause trauma or serious injury. FDA recommends a critical limit at metal detection of "no detectable metal fragments" because foreign objects that are less than (b)(4) mm may cause trauma or injury to persons in special risk groups, such as infants, surgery patients, and the elderly.

 

http://www.ifsqn.com...uct/#entry62814  )

 

( AFAIK, USFDA have only initiated direct [safety] action where a non-compliance with the 7mm criterion was involved. But then again, this may also be due to the other manufacturer alternatives as noted above ).

 

Regarding rationale, I noticed this convenient but perhaps rather  simplistic, non-medical guideline -

 

Smaller objects (2-6mm) are only a danger for people who depend on the care and attention of others for their food and drink; this is the case of small children, the ill and the elderly.

 

(Principles of Hygiene and FS Management, PIP, 2011)

 

I still anticipate that the 1st Olsen paper probably has the best technical answers.

 

Rgds / Charles.C


Edited by Charles.C, 23 August 2013 - 05:48 AM.
added refs

Kind Regards,

 

Charles.C


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#17 RonNL

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Posted 08 October 2015 - 11:50 AM

I am dutch and have modified the (google translate) english translation of the Dutch nVWA  article from 2009. This may clarify the meaning of the sentences. 

At this point in time the article from 2009 is not available anymore on official websites;  it was declared an obsolete article and it is not replaced by new regulations.



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