Injury or affect of metal contaminants less than 7mm?
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
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.
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
For the elderly, many have swallowing difficulty, medically called dysphagia. For a couple of technical articles, see:
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 -
FDA 555.425 (1999) adulteration involving hard or sharp objects.pdf 136.55KB 244 downloads
Charles C
You can tell me where this information about france and Holland is described?
Sorry
abou Canada and Holland
Thank you
CFP
Interesting topic. I guess how to include the special risk group in India. If someone can help me with this.
Thank you,
Pragash
Can someone help me?
I am reaserchin about the limits for de contamination with metal, but i find only limits of FDA.
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: ).
fm1 - Netherland - Fysische verontreiniging van voedsel door productvreemde delen.pdf 97.14KB 113 downloads
fm5 - partial translation fm1 to English (Google).doc 30.5KB 133 downloads
fm2 - Canada, physical hazards 2008.pdf 1.15MB 177 downloads
fm3 - The Dirty Dozen_ Ways to Reduce the 12 Biggest Foreign Materials Problems (2003) - Food Safety Magazine.pdf 498.1KB 166 downloads
fm4 - foreign object hazards, 2012.pdf 579.64KB 258 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)
Thank you Charles
The documents attached are very usefull for me.
i don´t understand your question.
CFP
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:
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: ).
fm1 - Netherland - Fysische verontreiniging van voedsel door productvreemde delen.pdf
fm5 - partial translation fm1 to English (Google).doc
fm2 - Canada, physical hazards 2008.pdf
fm4 - 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?
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,
XYZ - Product Recalls.pdf 66.49KB 101 downloads
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
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
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.