26 replies to this topic

[abhagat]

Hello,

Will placing 'ready-to-cook' instead of 'ready-to-eat' prevent any microbial liability for the company follows it's HACCP, GMPs, SOPs and SSOPs?

Thank you.

[Dai Williams]

Legally no the onus of responsibility tom produce safe food still the company responsibility, however your HACCP will be very different as the consumer heating step will eradicate microbial CCP as long as the heating instructions of consumer finished products are validated.

[abhagat]

I understand that the company will have a different HACCP, will need validated cooking instructions and has the moral and regulatory responsibility to produce safe food.

But my question is purely from a recall perspective. To give you an example:

Rich foods: Produced some frozen food like thingys, they found E. coli O121 in it, some people got sick, they told customers to JUST cook it, government said screw you and recall 1.5 years worth of product.

Could they have prevented such a recall if they would have just said "Ready to cook" instead of "Ready to eat".

Now this is US so things might be a little different for you Dai.

[Mendeljev]

Ready to eat for me is just opening something and eat it ...then offcourse this product should be safe to eat it !

If there is an extra handling needed, it's up to the producer to be very clear about it

That's why you need to put clear cooking instructions (like cook for 5 min at 200°C), storage instructions (keep refrigerated at 5°C) and shelflife on all products.

Consumer abuse will always happen somewhere, but the the tricky part is how one can show that the problem is caused by this abuse and not by the manufacturer.

The producer needs always be able to demonstrate that he has done everything to deliver safe foods and can show this with according registrations

[abhagat]

Sorry. Still does not answer it.

Even if you put 'clear' cooking instructions some consumers don't like it 'that hot'. Better way is to put something like "cook to an internal temperature of 165F".

Am not trying to be difficult. Also, MendelJev in this case the issue is not abuse, the product already had O121.

Just wondering if one puts "Ready to cook" instead of "Ready to eat" are they removed from the liability when some rebellious customer does not follow the cooking instructions on the label.

[Charles.C]

Dear abhagat,

IMEX a food labelled as ready-to-cook simply implies that the product is not (yet)(safety-wise) ready-to-eat ?.

Ready to Eat applies to any product intended for human consumption without further preparation steps. Note: Products that appear fully cooked or are customarily consumed without further preparation, but the label does not include cooking instructions, are by default considered RTE.

RTE fully cooked means that the products have been sufficiently cooked so that they are safe to eat as they are, with no further preparation required by the consumer. Note: Many of these products are customarily eaten hot, and heating instructions may be included on the label. This does not affect the classification of these products as RTE.

Some frozen RTE products require reheating for palatability. These frozen products are still safe to eat without this further preparation by the consumer and are therefore still considered RTE.
Some examples include: fully cooked hams, cooked beef, roast beef, pastrami, corned beef, hot dogs, meat loaves, meat and poultry salads, sliced luncheon meats, baked chicken, frozen entrees, and poultry rolls. These finished products must labeled in a manner that identifies them as RTE by the consumer.

Fresh or frozen entrees with fully cooked meat or poultry portions combined with fully cooked sauces, vegetables, pasta, or other ingredients are RTE products. These products are designed to be re-heated by the consumer, and may include instructions for re-heating.

Not Ready to Eat applies to products with cooking instructions or labeled with statements on the principal display panel such as “Cook Thoroughly, Cook and Serve, Not Ready to Eat, or For Safety and Quality- follow these cooking instructions.” These products are considered NRTE.

Maybe it depends on the product but for FSIS your suggestion would appear to be potentially classifiable as "misbranding".

eg see Slide No.3 of this attachment -

 Label101.PPT   361KB   159 downloads

Some situations can get quite complex, eg -

If a meat or poultry product that is processed to a time/temperature that traditionally is considered to attain a full cook, but the intended use of the product is such that the product is intended to receive a lethality treatment by the consumer, the product does not have to be labeled as RTE unless the product is defined by a standard of identify as an RTE product (e.g., hotdogs, franks, and pork with barbecue sauce). Such product may be identified as an NRTE product, provided that the labeling and validated cooking instructions (SHI) are adequate to discern that the product must be cooked for safety by the purchaser. An example of such product is a cooked, thick-sliced, center-cut ham slice on which the labeling indicates that the product is ready-to-cook and for safety the product must be cooked to attain a minimum temperature. On the other hand, a thin sliced ham product in case-ready packaging may state that the product is RTE without additional cooking and, as such, would not be required to bear preparation/cooking instructions. Both products may have been heat treated in the same manner, but the establishment would only have control for Lm in the RTE product.

Rgds / Charles.C


PS - Sorry, I missed your second post.

I think you are getting confused over the meaning of "food safety" with respect to the suppliers' responsibility vis-a-vis the consumer's health.

[mesophile]

Hi All,

I think the onus is DEFINITELY on the supplier. If they tested the product and found a virulent strain of e-coli present, a recall should have been conducted immediately by the manufacturer.

In Europe, regulation EC 2073/2005 states that all food producers have a legal obligation to produce safe food. Products containing this strain of E.coli would definitely not fall in to the "safe" category.

Also, there is a massive difference between ready to cook RTC and ready to eat RTE.

You also have to look at misguiding the consumer. If a consumer purchased the said RTE Rich Foods products over a number of weeks/months/years and then all of a sudden, a specific batch stated RTC instead, the company would still be liable. This is because the consumers have built up an understanding of what to do with the products and to change the instructions because a batch contains some nasty pathogens would not stand up in court - well not in any European court anyway.

It would be like buying Pepsi. You know exactly what do do with this and don't read the instructions on the packaging because you have purchased it before and have built up an understanding. However, lets say batch XYZ contains Campylobacter so Pepsi stick a label on the side of the cans stating "Ready to Cook, please oven cook for 45 minutes at 200'C". Would you really look at the packaging and follow the instructions before drinking?

Kind Regards

Simon

[abhagat]

Charles,

Based on the ppt. that you attached, you are right RTC would be "not(yet)(safety-wise) ready-to-eat".

However I do not agree with your statement: "Maybe it depends on theproduct but for FSIS your suggestion would appear to be potentiallyclassifiable as "misbranding"."

There is at least 1 big player in US that I have had personal experience withwho have recently switched one of their products from being RTE to RTC, you canguess why.

Food safety is a shared responsibility when you use the terms "farm tofork" whether you are referring to consumer or supplier. IMHO you willstart seeing more RTCs for this reason.


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

Simon,

Do you think: "If they tested the product and found a virulent strain ofe-coli present, a recall should have been conducted immediately by themanufacturer." applies to RTC?

I completely agree with your statement " If a consumer purchased the saidRTE Rich Foods products over a number of weeks/months/years and then all of asudden, a specific batch stated RTC instead, the company would still beliable." The company that I have brought up in the discussion, above, wentthrough a long, systematic transition from RTE to RTC which lasted a fewmonths and mainly included emptying out existing inventory, label reviews andpackage changes. I am not going to reveal much about that since this is apublic forum.

Also, I probably would not look at the label in the "Pepsi example"that you gave because of the "norm/habit". All of us work onauto-pilot sometimes.

But once again we are not looking for a way to swindle customer or misbrand.The reason I posted this is because I wanted to have a discussion on a rationalway to label a product that saves a company from destroying thousands of poundsof frozen product which will be cooked in the oven and would beperfectly safe for a customer.

Weed smoking and alcoholic customers may have different perception ofcooking time and temperature, but I think that is a separate discussion.

Cheers.

[Charles.C]

Dear abhagat,

I’m no lawyer or in the USA but I suspect the logical query is whether the item X is considered to be adulterated within the context of (current) text such as –

Microbiological contamination and adulteration
The fact that a food is contaminated with pathogens (harmful microorganisms such as bacteria, viruses, or protozoa) may, or may not, render it adulterated. Generally, for ready-to-eat foods, the presence of pathogens will render the food adulterated. For example, the presence of Salmonella on fresh fruits or vegetables or in ready-to-eat meat or poultry products (such as luncheon meats) will render those products adulterated.
For meat and poultry products, which are regulated by USDA, the rules are more complicated. Ready-to-eat meat and poultry products contaminated with pathogens, such as Salmonella or Listeria monocytogenes, are adulterated. (Note that hotdogs are considered ready-to-eat products.) For raw meat or poultry products, the presence of pathogens will not always render a product adulterated (because raw meat and poultry products are intended to be cooked, and proper cooking should kill pathogens). Raw poultry contaminated with Salmonella is not adulterated. However, USDA's Food Safety and Inspection Service (FSIS) has ruled that raw meat or poultry products contaminated with E. coli O157:H7 are adulterated. This is because normal cooking methods may not reduce E. coli O157:H7 below infectious levels. E. coli O157:H7 is the only pathogen that is considered an adulterant when present in raw meat or poultry products.

http://en.wikipedia.org/wiki/Adulterated_food

(I guess that assuming product X is processed within a regulatory approved facility, it will officially be categorised as a RTE, non-RTE, etc product, regardless of any labelling variations ?)

I guess that if product X is considered to be adulterated, the capability to be further merchandised is regulatory controlled. As per the above comment regarding pathogenic E.coli, it is possible that alternative labelling of the form you suggested might not be an appropriate option.

Or are you simply saying that you disagree with the scientific content of existing regulations as illustrated in extract above ? If so, please elaborate.

Rgds / Charles.C

PS – I did a little Googling regarding yr earlier Rich example but could not find any clear statement as to whether the products involved were categorised as RTE or not ? Can you clarify / supply a link?

[abhagat]

Hello Charles,

Thank you for continuing the conversation.

To be succinct, there are some products on the recall listthat are ready to cook.

In context to RTC for USA:

1. USDAis never going to sample them for routine testing

2. Productmay contain some uncooked ingredients



So it can contain O121 however the validated cookingprocess is supposed to make the product safe.

You are bringing in some very interesting quotes/informationthat is making this conversation progress on a scientific/regulatory fact baseddiscussion.

For example: “E. coli O157:H7 is the only pathogen that is considered anadulterant when present in raw meat or poultry products.” So when does thegovernment start considering O121 as an adulterant for a RTC product. I thinkthe time is ripe with this recall.



“(I guessthat assuming product X is processed within a regulatory approved facility, itwill officially be categorised as a RTE, non-RTE, etc product, regardless ofany labelling variations ?)”:

This istrue for Rich Foods. Products were produced in a regulatory approved facilityand the implicated products are non-RTE.<br style="mso-special-character: line-break;"><br style="mso-special-character: line-break;">

“alternativelabelling of the form you suggested might not be an appropriate option”

Once again this is a RTC food, expected to contain certainpathogens and the only exception being O157, because the government has not YETmade the other big 6 illegal. So I am not disagreeing with the scientific content of existingregulations as illustrated in the quote posted by you.

I am not able toattach pics of the products involved in the recall. I will type in the links:

http://dailysavings....-rich-products/

http://www.walmart.c...s-7-oz/20880828

One of them is under FDA jurisdiction and the other is USDA.

[Charles.C]

Dear abhagat,

Thks for links and comments.

Regarding Rich Recall, it appears that the source of contamination with O121 is as yet unknown. The 2 latest updates (April 4, 5) I saw are –

http://www.fda.gov/S...s/ucm346633.htm
http://www.fda.gov/F...s/ucm345768.htm

The distribution of the event is illustrated here –
http://www.examiner....break-15-states

I noticed this description applied to initial suspect batch –

Rich Products Corporation, a Buffalo, NY firm, is recalling approximately 196,222 pounds of frozen chicken quesadilla and various other heat treated, not fully cooked frozen mini meals and snack items.

http://www.fsis.usda.gov/fsis_Recalls/

I guess the above implies non-RTE as you noted.

E. coli O157:H7 is the only pathogen that is considered an adulterant when present in raw meat or poultry products.

Actually Wiki looks in need of updating since the group of pathogenic E.coli strains (including O121) known as Big Six seemingly became (FSIS) categorised as adulterants if detected in meat after June4, 2012.
http://www.foodsafet.../02/new-e-coli/

Rgds / Charles.C

[Marshenko]

Charles is correct regarding the STECs, one can reference FSIS Notices 07-13, 29-12, 40-12 as well as USDA News Release No. 0171.12 and Federal Register Vol. 76, No. 182: http://www.fsis.usda...s/2010-0023.pdf

[abhagat]

HelloCharles,

You areright the source is unknown, mainly due to the vast list of products implicatedin the recall, in the name of food safety. I am hopeful details will emerge.

I don’t writethat a lot but actually Wiki might be right. Big six are not a UNIVERSAL adulterantyet!

“On June 4, 2012,the FSIS implemented a sampling and testing program for beef trimmings only.”

“At a later date, FSIS laboratories willimplement non-O157 STEC testing in other sampling programs. FSIS will issueboth a Federal Register notice and an FSIS Notice reflecting thesechanges before FSIS begins testing these additional raw beef products for thesix non-O157 STECs.”

“FSIS is expected to expand the testingprogram in 2013 to include other cuts of beef as well as other meats.”

Thecountdown is on…

Thanks forthe links.

[Charles.C]

Dear abhagat,

This is a kind of footnote since it seemed to me that one particular aspect of previous posts required a little more explanation. As illustrated earlier, the FSIS designation of pathogenic E.coli O157 as an adulterant in NRTE foods (in contrast to Salmonella) was based on the stated inability to “eliminate” any such contamination on cooking, as per my Wiki extract. I found this statement slightly surprising so i have done a little more digging into the background science.

It is, I think, invariably the case that E.coli O157 and other E.coli "Big Six" strains have been accepted as more difficult to eliminate than Salmonella.
However a look into the history around the original decision as to bestow “adulterant” status reveals that the difficulty was also significantly linked to the tendency of Americans to prefer “undercooked” meat products, eg hamburgers.
A, perhaps, somewhat dramatized version of the 1994 O157 decision is here –

 ss1 - Looking Back_ The Story Behind Banning E. Coli O157_H7 _ Food Safety News.pdf   128.78KB   18 downloads

Now, the “Big Six” E.coli strains have been added to the adulterant classification.

A review detailing the sources, routes of infection and tabulated incidents associated with non-O157 strains of E.coli is in this 2010 White paper –

 ss2 - e.coli white paper NonO157 STEC.pdf   265.48KB   9 downloads

A (2012) FSIS risk profile detailing the scientific justification of the original FSIS decision and its expansion to the “Big Six” is here –

 ss3 - e.coli risk profile Non O157 STEC.pdf   1.02MB   10 downloads

A representative extract from ss3 is –

The study demonstrated that cooking steaks from non-intact primals inoculated with high levels of E. coli O157:H7 and non-O157 STEC to internal temperatures of 120 to 160°F was insufficient to eliminate the contamination. While the relatively high inoculation levels (3.5 or 6 log microorganisms/g) are unlikely to be representative of typical contamination levels, reductions in non-O157 STEC and E. coli O157:H7 log microorganisms/g levels at most of the cooking temperatures and steak thicknesses was comparable. Thus, typical or traditional cooking (defined as an internal temperature of 120 to 160˚F) of non-intact steaks contaminated with non-O157 STEC may result in the consumption of contaminated product after typical or traditional cooking, as has been shown for E. coli O157:H7 (Laine et al., 2005)

The following 2007 document which compares the UK / US cooking procedures for burgers with respect to the fate of E.coli O157 also makes rather fascinating reading IMO -

 ss5 - safe cooking of burgers.pdf   179.88KB   23 downloads

It might also be worth adding that the existence of two organisations, FDA and USDA , controlling different food products and, seemingly, with occasionally differing viewpoints may have had some influence on the FSIS position. For example this 2011 document –

 ss4 - The FDA considers any disease-causing strain of E. coli in food to be illegal. What is FSIS's Position.pdf   145.13KB   9 downloads

I also noticed that the operational implementation of FSIs's (pathogenic) E.coli control scheme has recently been expanded –

The U.S. Department of Agriculture’s (USDA’s) Food Safety and Inspection Service (FSIS) has announced that, as of February 8, 2013, it will require producers of non-intact raw beef and all ready-to-eat products containing meat and poultry to hold shipments until they pass agency testing for foodborne pathogens. FSIS announced its plan to implement this policy in April 2011.
In the past, FSIS’s practice has apparently been “to allow products tested for adulterants to bear the mark of inspection, and to enter commerce, even when test results have not been received.” FSIS had asked, but not required, official establishments to maintain control of products tested for adulterants pending test results. According to FSIS, “because establishments, including official import inspection establishments, were not consistently maintaining control of product, despite FSIS’s request that they do so, adulterated product was entering commerce.” FSIS has reportedly stated that if the new requirement had been in place between 2007 through 2010, 49 of the 251 meat, poultry and processed egg product recalls that occurred during that time could have been prevented.

http://www.lexology....2c-c7d6f7d96868

Rgds / Charles.C

PS – have not seen any recent documents published on the cause of the Rich outbreak.

PPS - Here is an additional viewpoint on the overall topic -

 ss6 - Ready to Cook Frozen Meals With E. coli Can Be Very, Very Dangerous.pdf   241.27KB   39 downloads
Especially note the last line. True or not ?.

[abhagat]

Hello Charles,

 

Thanks for continuing to contribute great references for this topic. I accessed the subject today because I am still personally interested in this. As you would have noticed the outbreak has done little to catch anyone’s attention to make a meaningful policy change other than bloggers, famous attorneys (read Marler Clark) and getting Rich Foods into the annals of recalls.

 

Agreed. E. coli O157:H7 is difficult to eliminate but ‘inability to eliminate’ is wrong. You can destroy E. coli O157:H7 using validated cooking on even non-intact beef products. The law says “FSIS is clarifying that additional raw beef products contaminated with E. coli O157:H7 will be considered adulterated unless they are further processed to destroy the pathogen.” Which basically is the right thing and one of the smarter laws. Also according to the labeling guidelines any NRTE food is required to have instructions for ‘cooking thoroughly’. Supplier/Manufacturer need to know their worst case scenarios here!

Non O157s are not any difficult to eliminate than O157s.

 

Big six has been added to adulterant but like I wrote before – for non intact meat only (trimming and ground): “On June 4, 2012,the FSIS implemented a sampling and testing program for beef trimmings only.”  You have attached whitepapers and risk analysis which does not mean it is a law yet.

But once again if you can ‘cook it out’ and prove it you that you have further processed to destroy it, you are allowed to do it. To remain focused on the topic of Rich Foods recall, if the cooking process at customers end within the limitations of safe handling instructions was working and nobody got sick this would not have been a recall. You don’t eat a frozen pizza.  

 

Reference ss3 is a classic case of showboating data. First of the author wants to go with a 6 log bacterial contamination. Great. Like the author admits it is an insane amount of contamination. Nevertheless, in 2005 Liane could not destroy it but then Duffy comes along in 2006 and gives you a decimal reduction time of 10 min at 131F. Makes you think ooh that’s dangerous. But guess what appendix A says cook at 131F for 89 min for a 6.5 log reduction of Salmonella. Now is your O157 more hardy than Salmonella or less  

 

Every USDA plant follows Appendix A and nobody gets sick. This is the gap that we often see between academia and industry.

The last quote that you have is more of a maintaining control of product in case the product is found positive during routine monitoring by USDA. Traditionally companies ‘voluntarily’ held their product when USDA was testing it but lately USDA mandatorily wants you to hold product until negative results are received by one of their regional laboratories. This was a notice provided to all companies under USDA jurisdiction back in Feb. 2013.

 

Finally, back to Rich Foods recall. The investigations seem to be on, so far no clue about the source of contamination.

By the way, ss6, classic Bill Marler article, flashy headline and acting as if he is the savior of customers and wants to protect them from the big evil Food manufacturers. Although I agree with the last statement of his. You cannot tell consumers to JUST cook the shit (technically E. coli) out of something, that’s just bad PR on part of the company. But again practically you may eat chocolate chips or cookie dough but chances are you are not going to attempt to eat frozen pizza. In summary understanding your worse case scenario is what risk assessment is all about. If your worse case scenario does not have any pathogen survivors you are most likely not going to make anyone sick.

 

Thank you once again for all the interesting articles Charles.

 

Regards,

 

Arpan.

[Charles.C]

Dear abhagat,

 

Big six has been added to adulterant but like I wrote before – for non intact meat only (trimming and ground): “On June 4, 2012,the FSIS implemented a sampling and testing program for beef trimmings only.”  You have attached whitepapers and risk analysis which does not mean it is a law yet.

 

My posted text/link contained this sub-link which I omitted since the linked document is lengthy and I was nervous that the post was already excessively protracted.

 

http://www.gpo.gov/f.../2012-29516.pdf

 

The sub-link does appear to be a legal notice of implementation (?) but as to whether it has actually been operationally implemented for the items mentioned within (or others) I have absolutely no idea. You can see poultry is mentioned but not in a definitive way as far as I could (quickly) see. I didn’t attempt an exhaustive search for any later documents countermanding (or modifying) the notification but such may exist also. The B6 story has already been going for at least 2 years so anything’s possible.

 

Rgds / Charles.C

 

PS any links to further info. on current situation from anyone are welcome of course

[abhagat]

Hello Charles,

 

Yes the sub-link provided by you is a legal notice of implementation; however is a hold-release policy notice. Also, once again not a blanket rule. Covering only non-intact beef or beef intended for non-intact purposes as far as non-O157 STECs are concerned. In fact there is a quote that reads:

 

“In addition, FSIS did not consider non-O157 STEC in the benefits and costs analysis. In June 2012, FSIS began testing for six non-O157 STEC in raw beef manufacturing trimmings. Although FSIS anticipates additional public health benefits will accrue as a result of establishments maintaining control of such products tested by FSIS until negative results for non-O157 STEC become available, there is not enough data to accurately estimate benefits at this time.”

 

So zero tolerance of Listeria monocytogenes is cost justified but this still does not meet the cost-benefit criteria ?

 

What is the B6 story you were referring to? Could you please provide a link?

 

Also, as far as FSIS is concerned if you can ‘cook it out’ and prove it you that you have further processed to destroy the pathogen of concern, you are allowed to put it on the retail shelves.

 

Thank you. 

[Charles.C]

Hello Charles,

 

Yes the sub-link provided by you is a legal notice of implementation; however is a hold-release policy notice. Also, once again not a blanket rule. Covering only non-intact beef or beef intended for non-intact purposes as far as non-O157 STECs are concerned. In fact there is a quote that reads:

 

“In addition, FSIS did not consider non-O157 STEC in the benefits and costs analysis. In June 2012, FSIS began testing for six non-O157 STEC in raw beef manufacturing trimmings. Although FSIS anticipates additional public health benefits will accrue as a result of establishments maintaining control of such products tested by FSIS until negative results for non-O157 STEC become available, there is not enough data to accurately estimate benefits at this time.”

 

So zero tolerance of Listeria monocytogenes is cost justified but this still does not meet the cost-benefit criteria ?

 

What is the B6 story you were referring to? Could you please provide a link?

 

Also, as far as FSIS is concerned if you can ‘cook it out’ and prove it you that you have further processed to destroy the pathogen of concern, you are allowed to put it on the retail shelves.

 

Thank you. 

 

Dear abhagat,

 

I admire yr willingness to slog through all the textual details .

 

I might add that one of the references  I previously attached did, from memory,  mention that poultry had not (then) been significantly linked with the Big Six. However since this product is, I believe,  specifically within FSIS’s “responsibility”  the eventual (sampling) result can perhaps be predicted ?

 

What is the B6 story you were referring to? Could you please provide a link?

 

Sorry, poor English shorthand, B6 = Big Six.

 

Also, as far as FSIS is concerned if you can ‘cook it out’ and prove it you that you have further processed to destroy the pathogen of concern, you are allowed to put it on the retail shelves

 

I anticipate that the consequences with respect to the product “eating” quality and financially incurred charges  may well be ruinous ? And the fear of a "sampling error" perhaps?

 

Rgds / Charles.C

[abhagat]

Thank you Charles.

 

I have incentive that someone is willing to have an interaction about one of the topics that is of great interest to me makes all the reading worthwhile!

 

Back to the topic on the big six, it is understandable that the big six have been associated with beef since poultry has traditionally been troubled by Salmonella. Kind of like oranges:Salmonella::Apple: E.coli. So FSIS has focused just on beef for the big six. Also, a matter of perspective; if you are not trying to find big six in Poultry the data will show up as “not being a significant risk in poultry”.

 

Yeah the big six outbreaks can be traced back up to at least 10 years but they have been popular lately only for the past two years, after FSIS brought them into the limelight.

 

In your final statements you do bring up an interesting topic. In my experience, FSIS allows the practice of ‘reaching lethality’. This is accomplished using validated cooking procedures and disclaimers provided to the raw beef vendors. This is covered under E. coli process control standards and supported by Appendix A of FSIS. So as long as you prove using regulatory standards there are virtually no financial risks involved.

 

The sampling comes at a stage where your environmental tests have forced you to believe with ‘reasonable probability’ New term coined by FDA   that the product is adulterated and you have no choice but to do an extensive sampling, statistically acceptable to regulatory agencies involved and in the US there is zero tolerance for L. monocytogenes, but that is an all-together different topic.

 

Regards.

 

Arpan.

[Charles.C]

Dear abhagat,

 

 

Back to the topic on the big six, it is understandable that the big six have been associated with beef since poultry has traditionally been troubled by Salmonella. Kind of like oranges:Salmonella::Apple: E.coli. So FSIS has focused just on beef for the big six. Also, a matter of perspective; if you are not trying to find big six in Poultry the data will show up as “not being a significant risk in poultry”.

Yeah the big six outbreaks can be traced back up to at least 10 years but they have been popular lately only for the past two years, after FSIS brought them into the limelight.

 

 

Well, I guess Jack in the Box plus known US factors such as consumer undercooking did provide some beef focus. Just like Asian Influenza is still doing for chicken. From memory, E.coli O157 is also not commonly associated with chickens unless from cross-contamination.

It is also possible of course that,  historically,  knowledge / handling capabilities / technical limitations were (are) involved. Most strains of E.coli are harmless. E.coli O157 is itself still a relatively “new” pathogen. It could be considered that the “limelight” factor is a praiseworthy objective from a public health POV.

 

In your final statements you do bring up an interesting topic. In my experience, FSIS allows the practice of ‘reaching lethality’. This is accomplished using validated cooking procedures and disclaimers provided to the raw beef vendors. This is covered under E. coli process control standards and supported by Appendix A of FSIS. So as long as you prove using regulatory standards there are virtually no financial risks involved.

 

Interesting. Are the relevant re-processing requirements /  lot microbiological verification procedure documented / accessible ?

 

The sampling comes at a stage where your environmental tests have forced you to believe with ‘reasonable probability’ New term coined by FDA   that the product is adulterated and you have no choice but to do an extensive sampling, statistically acceptable to regulatory agencies involved and in the US there is zero tolerance for L. monocytogenes, but that is an all-together different topic.

 

I’m sure you are aware of the sampling limitations for zero-tolerant pathogens in foods.  I wouldn’t know if FSIS is dis-similar procedurally to FDA in cases such as being discussed in this thread but for the latter organisation (unless something has recently changed), factors such as  potential risk to brand name,  analytical / reprocessing / repacking costs IMEX have traditionally been likely to result in the product being removed from commercialization in the USA. This is not a purely US characteristic  of course, some other locations can be even more Regulatory demanding.

 

I am surprised at the lack of recent official feedback  on the Rich farm case, latest (May10) update AFAIK,  - A total of 35 individuals infected with the outbreak strain of STEC O121 have been reported from 19 states.

 

http://www.ecoliblog... (E. coli Blog)

 

 

Rgds / Charles.C

[abhagat]

Hello Charles,

 

In my opinion, E. coli O157:H7 is less prevalent in Poultry than beef mainly because Campylobacter and Salmonella dominate their guts. Definitely, the historic data and handling have their fair share of contribution in the pathogen presence in meats and poultry. I am not sure what do you mean by technical limitations though.

 

You are right most strains of E. coli are harmless but the fact is that they are still a widely accepted marker of contaminated food or water. Calling E. coli O157:H7 a relatively new pathogen is so 1982 J. Just like L. monocytogenes. However now the ‘limelight' is on the next generation of the big non O157 STECs and I agree that it is praiseworthy for public health and safety.   

 

Please see attached article on ‘re-cycling’ contaminated meat.

http://www.foodsafetynews.com/2009/11/e-coli-contaminated-meat-recycled/

 

As far as lot microbiological verification procedures and sampling are concerned FSIS has done a better job than FDA and published a very detailed document last year:

http://www.fsis.usda.gov/PDF/Controlling_LM_RTE_guideline_0912.pdf

check out chapter 4, page 6.

 

FSIS does 'appear' to have more strict zero tolerance policy than FDA especially when we refer to L. monocytogenes but when it comes to reality many companies will go for the zero tolerance regardless of whether they are alternative 2 or 3 to err on the side of caution and prevent public health risk. You are absolutely right, in the name of brand reputation, analytical, re-processing capability mainly due to the nature of the product and repacking costs involved, the contaminated RTE products most likely would end up in the landfill. I am not surprised this is not a purely US characteristic. But I doubt any other region of the world would be more demanding than “less than 0.04 cfu/g” J

 

Yes, the Rich Farms investigation has not proceeded beyond the link that you posted, and is surprising, especially since the story is now close to two months old. One of the big hurdles with the investigation seems to be the large number of skus (31) involved , spanning all kind of meats and poultry products. By the time this becomes clear we will definitely have a much better understanding on O121 though especially if they find the organism 'living' in the plant in Georgia!

 

Thank you.

[Charles.C]

Dear abhagat,

 

Calling E. coli O157:H7 a relatively new pathogen is so 1982

 

Well, Salmonella was cultured / proposed to be a pathogenic bacterium in 1885

 

 

I am not sure what do you mean by technical limitations though.

 

 

I was thinking of the microbiology, for example compare  the BAM / MLG procedures for E.coli O157, etc to that of generic E.coli.

 

Thks for the two links. I have great respect for the technical capabilities of both FSIS and FDA. However the lengthy document attached does contain some distinctly questionable statements. Some  –

 

………. Salmonella is considered an indicator of lethality for Lm

 (Pg 2.28,  4-8)

 

Most food residue and all microbes are rich in ATP ……………

(2.49)

 

…….lots having the calculated mean concentrations or greater will be rejected with at least 95% confidence.  Each of these plans achieves assurance that Lm is present at <1 in the sample size.

(Pg 4.6)

 

The IT document also has a few interesting (in some cases repetitively) debatables also –

 

“An E. coli contaminated beef product must not be distributed until it has been processed into a ready-to-eat product,” the regulations say.

 

“Even though cooking it to 165 degrees makes it sterile,” said ……………..

 

But I doubt any other region of the world would be more demanding than “less than 0.04 cfu/g”

 

<  0.02 cfu/g is also quite popular.

and composites ?

 

Getting rather OT .

 

Rgds / Charles.C

[abhagat]

^{Hello Charles,}

 

^{Thks for the two links. I have great respect for the technical capabilities of both FSIS and FDA. However the lengthy document attached does contain some distinctly questionable statements. Some  –}

 ^{FSIS and FDA have a lot of resources but that does not make them immune to mistakes!}

 

^{………. Salmonella is considered an indicator of lethality for Lm}

 ^{(Pg 2.28,  4-8)}

 ^{I think you will find research papers for and against this statement. Traditionally Salmonella has been considered hardier that L. monocytogenes and E. coli O157:H7}

 

^{Most food residue and all microbes are rich in ATP ……………}

^(2.49)

^{Not trying to defend this statement for the sake of it but technically microbes are indeed rich in ATP and even a food that is commercially sterile is not free of microbes (think spoilage), especially when the food is on an equipment surface where it provides a nutrient source, where usually ATP tests are conducted.}

 

^{…….lots having the calculated mean concentrations or greater will be rejected with at least 95% confidence.  Each of these plans achieves assurance that Lm is present at <1 in the sample size.}

^{I don’t see any errors in these statements. These have been validated by ICMSF and have been published in several peer-reviewed journals. Researchers from several countries have validated this.}

 

^{(Pg 4.6)}

 

^{The IT document also has a few interesting (in some cases repetitively) debatables also –}

 

^{“An E. coli contaminated beef product must not be distributed until it has been processed into a ready-to-eat product,” the regulations say.}

 ^{Like I have mentioned several times before, USDA allows reprocessing and sale of a ‘contaminated’ product as long as you reach lethality using validated cooking.}

 

^{“Even though cooking it to 165 degrees makes it sterile,” said ……………..}

 ^{Calling it sterile is where I will draw the line at that, even if the statement comes from the chairman of the National Joint Council of Food Inspection!}

 

^Quote

^{But I doubt any other region of the world would be more demanding than “less than 0.04 cfu/g”}

 

^{<  0.02 cfu/g is also quite popular.}

^{and composites ?}

^{You can make it as tight as possible. In US, as allowed by USDA, for Listeria monocytogenes you can go up to < 0.008 cfu/g and for E. coli O157:H7 in beef you can go as low as < 0.003 cfu/g, as specified standards for absent.}

^{Composites are not allowed in US, at least for RTE food product samples to be tested for Listeria monocytogenes.}

 

Cheers,

 

Arpan.

[Charles.C]

Dear abhagat,

 

^{Hello Charles,}

 

^{Thks for the two links. I have great respect for the technical capabilities of both FSIS and FDA. However the lengthy document attached does contain some distinctly questionable statements. Some  –}

 ^{FSIS and FDA have a lot of resources but that does not make them immune to mistakes!}

Or to amendments ?. i think one reason was maybe that a large proportion of the relevant document (itself huge) was actually reiterated from the previous version. Have a look at the listed reference dates. Updating is a problem for all of us.

 

 

^{………. Salmonella is considered an indicator of lethality for Lm}

 ^{(Pg 2.28,  4-8)}

 ^{I think you will find research papers for and against this statement. Traditionally Salmonella has been considered hardier that L. monocytogenes and E. coli O157:H7}

^{Maybe compare the typical (6D) theorised / approved cooking times for meats based on L.mono / Salmonella respectively ?}

^{Indirectly related to the Hamburger story also I believe.}

^{Actually I had thought that the US logic was fundamentally based more on epidemiological data which demonstrate that health - related incidents related to Salmonella far exceed L.monocytogenes ?  E.coli O157's recognition was maybe related to the Jack in the Box episode and the (perceived) Ostrich attitudes of manufacturers? (An analogous but differently caused incident sadly occurred in UK also).}

 

^{Most food residue and all microbes are rich in ATP ……………}

^(2.49)

^{Not trying to defend this statement for the sake of it but technically microbes are indeed rich in ATP and even a food that is commercially sterile is not free of microbes (think spoilage), especially when the food is on an equipment surface where it provides a nutrient source, where usually ATP tests are conducted.}

^{Published documents indicate large variations in ATP between bacterial species.}

 

^{…….lots having the calculated mean concentrations or greater will be rejected with at least 95% confidence.  Each of these plans achieves assurance that Lm is present at <1 in the sample size.}

^{I don’t see any errors in these statements. These have been validated by ICMSF and have been published in several peer-reviewed journals. Researchers from several countries have validated this.}

^{I'm no statistician but there are long-standing arguments (eg Frequentist / Bayesian) over the statistical validity of  such  statements. The subtleties involved probably represent nit-picking to the users of the conclusions but such is life in the fast lane. It could be argued that the plans are more a support for HACCP. .}

 

^{(Pg 4.6)}

 

^{The IT document also has a few interesting (in some cases repetitively) debatables also –}

 

^{“An E. coli contaminated beef product must not be distributed until it has been processed into a ready-to-eat product,” the regulations say.}

 ^{Like I have mentioned several times before, USDA allows reprocessing and sale of a ‘contaminated’ product as long as you reach lethality using validated cooking.}

^{My point was that "E.coli" is not even a definitive pathogen  as stated above. The article has numerous errors.}

 

^{“Even though cooking it to 165 degrees makes it sterile,” said ……………..}

 ^{Calling it sterile is where I will draw the line at that, even if the statement comes from the chairman of the National Joint Council of Food Inspection!}

 

^Quote

^{But I doubt any other region of the world would be more demanding than “less than 0.04 cfu/g”}

 

^{<  0.02 cfu/g is also quite popular.}

^{and composites ?}

^{You can make it as tight as possible. In US, as allowed by USDA, for Listeria monocytogenes you can go up to < 0.008 cfu/g and for E. coli O157:H7 in beef you can go as low as < 0.003 cfu/g, as specified standards for absent.}

^{Composites are not allowed in US, at least for RTE food product samples to be tested for Listeria monocytogenes.}

^{The (meaningful) limits are also related to detection abilities / sensitivities / specificities Unfortunately the associated maths can get  quite unpleasant (to me anyway), especially where pooling is involved.}

 

 

Rgds as usual / Charles.C

[abhagat]

Or to amendments ?. i think one reason was maybe that a large proportion of the relevant document (itself huge) was actually reiterated from the previous version. Have a look at the listed reference dates. Updating is a problem for all of us.

I am sorry I still don’t agree, they have done a good job of putting in a lot of recent references from 2011, 2010, 2009, etc. which is definitely good research and a great upgrade to the previous version. I have used it extensively but zero tolerance trumps everything when rubber meets the road.
 

Maybe compare the typical (6D) theorised / implemented cooking times for meats based on L.mono / Salmonella respectively ? Indirectly related to the Hamburger story also.

Yes, absolutely, we aim for > 6 log reduction of Salmonella. Hamburger story is relatively new compared to 6D reduction which is based on heat resistance of Salmonellae in reeference to water activity as well as inoculation studies in beef.
 

I'm sorry but published documents indicate large variations in ATP between bacterial species.

 The argument is not on the variation in ATP between bacterial species but the fact that ATP can be used as an indirect indicator of the presence of them, and has been effective in early detection of biofilms as well.
 

I'm no statistician but there are long-standing arguments (eg Frequentist / Bayesian) over the statistical validity of  such  statements. The subtleties involved probably represent nit-picking to the users of the conclusions but such is life in the fast lane .

I am not well versed in statistics either but if you have ever had the need to sample products you will have to do that based on statistics accepted by the International community or your federal requirements. And nothing trumps ICMSF. You can argue about it but unless the regulations change you are probably not going to convince lawyers or inspectors if you choose an alternate route.
 

My point was that "E.coli" is not even a definitive pathogen  as stated above. The article has numerous errors.

 
According to me, there are two reasons for this: As more and more non-O157s are incorporated into the testing module, small companies will not have the resources to test for each individually.  And secondly E. coli has remained and continues to be the indicator organism for fecal contamination and
 

The (meaningful) limits are also related to detection abilities / sensitivities / specificities Unfortunately the associated maths can get  quite unpleasant (to me anyway), especially where pooling is involved.

Absolutely, detection limits, sensitivities and specificities are fixed for a specific procedure but you can stretch the limits by increasing your sample size. For the same reason as suggested by you, compositing for product testing is not allowed in US.