16 replies to this topic

[ShannonH]

OK- So here is the situation.  I have been informed and rightly so by our SQF consultant that our HACCP plan is poorly written and contains a lot of info that does not pertain to us.  So, we are assembling our HACCP team and getting them all trained in before we tackle revamping our plan.  My main question is this, in following the Codex decision tree the last question is "Will a subsequent process step eliminate or reduce occurence to an acceptable level?"  We manufacture ONLY frozen raw bread and bun doughs.  They must all be baked by the consumer.  Since cooking will eliminate occurance of such things as Salmonella do we still need to include storage temperatures as a CCP or would they simply be a CP.  I understand we do not want to say, "Hey, they have to cook it so who cares what we do!" but I do not want to overthink this either.  Thoughts?  Thanks!

[SQF1188]

First off, you can't assume the customer is going to cook your product to time and temperature standards for killing bacteria. The consumer baking step is out of your control so I'd say your answer to "will a subsequent process step eliminate or reduce occurrence to an acceptable level" is NO. The product you release must be validated as safe. Meat companies can't go selling hamburger contaminated with E. coli and assume the customer will cook the product as directed and take no liability for food safety.

[Mr. Incognito]

Not exactly true.

 

Food manufacturers are not liable, by the government, for people not properly handling their food as directed by the manufacturer.

 

If your product description sheet directly states that the product is not ready to eat and you communicate that properly to the next step or consumer, depending on your product use, then you are not legally liable.  However anyone can sue anyone and you never know what a judge will do in the end.

 

So what do you need to do?  If you are selling to a distributor who is selling to the consumer then it HAS to be on the packaging how to properly cook the food and that it should not be eaten without properly cooking by the direction.

If you are selling to a company that is going to cook it (let say you sell frozen doughnuts to a doughnut shop) then you should have it in your specification sheet and on the case they buy from you... generally.

 

I don't know your product stream and packaging with more information I could steer you into a more clear explanation. 

 

This whole thing is part of "intended use" of a product.

 

Of course your product has to tell people how to keep it stored properly as well "Freeze until time to cook/eat" and "Refrigerate left overs" etc. those kinds of things.

 

As an example:  If you buy milk with a use by date of 1/1/14 and decide to drink it on 12/1/14 is it's the company's fault that you got sick and died?  No you drank it 12 months after the use by date... and you died because of Darwinism.

[Charles.C]

Dear Shannon,

 

I cannot vouch for Baking industry or SQF but yr basic "to be cooked" query is certainly not unique in general HACCP.

 

I assume yr storage acceptably maintains an appropriately low temperature.

 

I recently posed an almost equivalent scenario at link below where the (FDA-validatable) answer was NO (CCP).  After using it, never had an auditorial challenge. (In much earlier HACCP literature, answer was YES). You might say it represents a "haccp compromise/evolution". But with legislatory CCPs as exist in USA, one never knows for sure.

 

http://www.ifsqn.com...ge-2#entry77227

 

Rgds / Charles.C

[SQF1188]

I wouldn't worry as much about getting sued as much as ramifications for a recall if product was ever traced back to the company. Look at the cookie dough recall back in 2009 and subsequent years. No one is getting sued but companies are losing big money recalling product because they can't guarantee it as safe even though it's labeled and a "ready to bake" product with warnings of raw egg, salmonella, etc.(The cookie recalls have mostly been from E.coli in flour that hasn't gone through a kill step) With FSMA coming into play soon the FDA will gladly recall your product if you can't guarantee food safety (they are going to have the power to recall product now). Better to be safe and have the kill steps in place for your ingredients(most likely your first CCP) and then have storage temperatures as a control because the risk was eliminated in prior kill steps.

 

I do agree with Mr. Incognito that you may not be liable from a getting sued perspective and if you're selling to a company that is cooking your product you can make them sign a letter guaranteeing they've cooked the product to specification and must be able to prove that.

[BillC]

I come down somewhere in the middle on this one.  The cookie dough analogy is helpful.  I ate raw cookie dough, with raw eggs, as a child (and fortunately for me I dodged Darwin) and lots of people undoubtedly still do.  It's delicious.  So the risk from uncontrolled pathogen growth shouldn't be just ignored.  Raw bread dough I expect is not so delicious, but I haven't tried your product.

 

So the question becomes do we know about the end use of this product?  Is it eaten by elderly and immunocompromised; is it sold to hospitals? Is it likely to be undercooked. - example microwave pizza pockets cooked by teenaged boys after school - what would be the likely outcome if it were under-cooked or eaten raw in a way that could be reasonably forseen?  In your case, how much growth can you expect in your product if temperature controls fail, and what is the residual risk for what you can reasonably expect in product abuse?

 

My gut feeling is storage is a(n important) control point but not a CCP - but I don't know enough about your particular product use and to fully judge. Labeling is part of the picture, but not all of it. 

[Charles.C]

Dear Shannon,

 

Not that I'm promoting a particular system but you might consider a look at the innovatory Risk Assessment flow chart  provided within BRC's Global Food Standard.

 

This enables a decision as to the risk status of Production Areas for a wide range of food processes, eg with/without thermal stages.

 

And here are a few more documents which you may find of interest –

 

 Kraft Codex Tree.pdf   22.13KB   174 downloads

(cf original Codex) (esp.note Qs.3 and 4 in current context)

 

http://www.foodsafet...g-instructions/

 

http://askfsis.custh...ested/1/p/0/c/0

(not dough-related, just to illustrate the legal possibilities)

 

Rgds / Charles.C

 

PS - added later - I should add that personally I have never used Codex trees or variants thereof, particularly due to the possibility of confusion over their implementation / interpretation. (Another recent version which somewhat reverses the PRPs  insertion in above example is the Campden Tree, eg  -

 

http://www.ifsqn.com...ing/#entry56969

[Charles.C]

I wouldn't worry as much about getting sued as much as ramifications for a recall if product was ever traced back to the company. Look at the cookie dough recall back in 2009 and subsequent years. No one is getting sued but companies are losing big money recalling product because they can't guarantee it as safe even though it's labeled and a "ready to bake" product with warnings of raw egg, salmonella, etc.(The cookie recalls have mostly been from E.coli in flour that hasn't gone through a kill step) With FSMA coming into play soon the FDA will gladly recall your product if you can't guarantee food safety (they are going to have the power to recall product now). Better to be safe and have the kill steps in place for your ingredients(most likely your first CCP) and then have storage temperatures as a control because the risk was eliminated in prior kill steps.

 

I do agree with Mr. Incognito that you may not be liable from a getting sued perspective and if you're selling to a company that is cooking your product you can make them sign a letter guaranteeing they've cooked the product to specification and must be able to prove that.

 

they can't guarantee it as safe

 

(slightly dough OT)

 

I don't quite understand yr logic. Are you saying that the manufacturer must guarantee that all frozen, NRTE, raw retail product is free of "significant" pathogens at point-of-sale?. I suspect this would (currently) delete several meat / poultry industries.

 

Do the USDA / FDA implement microbiological specifications, eg generic E.coli/Salmonella/E.coli O157/Campylobacter/ L.mono for retail, frozen raw meat / poultry products, to be cooked, baked, etc by the consumer ?. If not, why not ? If Yes, can you elaborate (link?) a little ?

( I believe that some testing is done, eg for E.coli O157, due the fact that some US consumers deliberately undercook the product, i guess that could generate a consumer CCP, if a control measure exists.)

 

I seem to remember something called  the "Pathogen Reduction Scheme" ca 1998.

http://www.fsis.usda...nd/bkbeyond.htm

 

Rgds / Charles.C

[Mr. Incognito]

Look... consumers are idiots.  To prove this I'll illustrate a point from when I worked in pasta.

 

We had customers call in and complain that they cooked their pasta for X minutes like the box said and it never got soft...  Let me explain to you that these cook times are tested and are correct.  They are never wrong.  We also cooked each lot of pasta we made every day and graded them.  The best thing we could figure is that they put a pot of cold water on the stove, threw in the pasta, turned on the burner, set a timer, and drained it.  Some people are so stupid they don't know that you have to BOIL the water before you put the pasta in...  (ok "stupid" may be too harsh... but not in my mind).

 

So.  No matter what product you make someone is going to prepare it wrong.  There is no question about it.  You have to have your PRPs implemented to try to control any further contamination than the product ingredients may have started with.  You can test those ingredients if you really want to but some products always have an inherent risk of different issues.

[Charles.C]

Dear Mr.Inc.,

 

Unfortunately illogical consumer practices (from a safety POV) can also lead to some interesting consequences on (regulatory) manufacturing control systems, eg  -

 

http://askfsis.custh...E. coli O157:H7

 

Clearly, this illogical (from a safety POV) practice has manufacturing HACCP implications, ie the raw finished product is perhaps more accurately categorized as "partially"  RTE. Of course, it further emphasizes the significance of labelling instructions (producer disclaimer required?).

 

Hopefully US dough consumers do not exhibit analogous "gourmet" tendencies ?

 

Charles.C

[Mr. Incognito]

I had a friend, friend being an extremely loose term, who used to order raw meat products from a Denny's we used to go to (a chain restaurant in the U.S.).  They actually had him sign weavers that if he got sick or died they weren't liable.  He had to write on it that he wanted it rare.  People know the risks but they don't want to be responsible when they get sick. 

[SQF1188]

(slightly dough OT)

 

I don't quite understand yr logic. Are you saying that the manufacturer must guarantee that all frozen, NRTE, raw retail product is free of "significant" pathogens at point-of-sale?. I suspect this would (currently) delete several meat / poultry industries.

 

Do the USDA / FDA implement microbiological specifications, eg generic E.coli/Salmonella/E.coli O157/Campylobacter/ L.mono for retail, frozen raw meat / poultry products, to be cooked, baked, etc by the consumer ?. If not, why not ? If Yes, can you elaborate (link?) a little ?

( I believe that some testing is done, eg for E.coli O157, due the fact that some US consumers deliberately undercook the product, i guess that could generate a consumer CCP, if a control measure exists.)

 

I seem to remember something called  the "Pathogen Reduction Scheme" ca 1998.

http://www.fsis.usda...nd/bkbeyond.htm

 

Rgds / Charles.C

 

Meat/Poultry industries are set to standards that are acceptable as far as salmonella, e coli, and other bacterial loads. They have to put forth a product that is in an acceptable range because they know the product use isn't always fully cooked. I don't know what frozen NRTE product would fall under but I'd assume there's possibility of misuse and if it was my product that would concern me.

 

 I think we're getting a little away from the question here as initially we were talking about whether "a subsequent process step will eliminate or reduce the hazard" and my logic is that if the consumer baking step is the process step that addresses your hazard I'd say that's the reason an auditor wanted to see rewriting of a HACCP Plan.

[R. U. Cereus]

I am glad this discussion started because I have found myself facing a similar dilemma with a pot pie process. I have microbiology degree and a few years of experience in the flour milling industry, so I am very aware of how dirty flour is.

 

Using the standard HACCP risk analysis matrix, raw flour could create a CCP due to the fact that it is a raw material that can and does contain Salmonella. Consequence could be "Food Recall" and based on pot pie history, this is a "Known to Occur", or at least a "Could Occur". Even if I want to unwillingly take a leap of faith and expect the customer to not abuse the product and to cook it to temp, that "Could Occur" still puts me at a CCP.

 

The only method of "control" I can think of involves storing the flour under frozen conditions to mitigate any potential growth of present pathogenic organisms. Not that this will necessarily kill anything.

[fgjuadi]

Will a subsequent process step eliminate or reduce occurence to an acceptable level?"  We manufacture ONLY frozen raw bread   They must all be baked by the consumer.

 

 

I agree with dbloomstrand - this is a question of your process and acceptable levels of contaminants.  You determine what the acceptable level of contaminant is.  You can set levels which are acceptable if the product is later cooked.  You want to be careful not to discount all hazards - some pathogens are very harmful, and if there is a risk a consumer will misuse your product, you need to consider that risk, and determine what an acceptable level of control is.  I think (?) raw eggs in dough are the worst for Salmonella, so maybe your control is to only use pasteurized eggs.

 

As far as the consumer goes, in your HACCP worksheets, you generally will have an area for target consumer and intended use (are babies or the elderly consuming this product?  Is it marketed to young children? Is it RTE?  etc) .  You can list undercooking / consumer misuse as a micro hazard.  I would think a reasonable control is to put cooking instructions or a "Cook before consuming" warning  on the packaging.   Your HACCP team determines that the current labeling is sufficient to control the product.   

 

Again, I agree with Incognito - Consumer are morons & you never know what they'll do.  I'm even a moron about eating RTE batter when I'm baking.  Cuz I like to lick the bowl.  And the spatula.  And the blender thingys.  And it feels better when I do it than when normal people do it because I know how BAD it is, like a guy in a band that rides a motorcycle, and has tattoos. I'm gonna have a 10lb bucket of raw cookie dough & a shirtless, mohawked, gun totin' fella for lunch, because I'm an American. 

Edited by magenta_majors, 28 August 2014 - 07:31 PM.

[Charles.C]

Dear All,

 

I rather suspect that  detection of Salmonella or E.coli O157 in any official sampling of the raw dough taken at point of sale would reveal a Nil tolerance as the acceptable level. Quite willing to be proven wrong though.

 

@Shannon -

Since cooking will eliminate occurance of such things as Salmonella do we still need to include storage temperatures as a CCP or would they simply be a CP.

 

To address above query, I assume you are not suggesting storage is a beneficial step due to freezing being able to eliminate or acceptably reduce the microbial level of pathogens. It doesn’t, not in the "short" term anyway.

 

Accordingly i presume you regard cold storage as a potential hazard due to the possibility of microbial pathogen growth. IMO, assuming yr cold storage maintains a temperature of, say <=(-)18degC at the core of yr product [max. maybe (-)12degC]  the likelihood of growth is presumably negligible. So there is no significant risk.

To put it another way, from a microbial POV, the typical result of cold storage  is to maintain the status quo after freezing.

 

 Rgds / Charles.C

[TAN85]

I could be completely wrong here, but it's a learning curve ..... I would be inclined to say that the cooking process - although it would eliminate pathogens etc, is out of your "jurisdiction" so to say, and your responsibility ends at the point of dispatch, so that stage does not apply to your controls/operation.  Therefore, you still need to prove that the measures you are taking do in fact control contamination (regardless of what happens to the end product once it leaves your warehouse).  Also, pathogenic contamination isn't the only risk involved, you'd have physical/chemical etc .... I mean if a piece of glass got into the flour used to make the dough, or inadequate storage resulted in bacterial growth ... those are all things you would be taking into consideration. So then your reply to the last HACCP question would determine if it became a CP or CCP ......

[Charles.C]

I could be completely wrong here, but it's a learning curve ..... I would be inclined to say that the cooking process - although it would eliminate pathogens etc, is out of your "jurisdiction" so to say, and your responsibility ends at the point of dispatch, so that stage does not apply to your controls/operation.  Therefore, you still need to prove that the measures you are taking do in fact control contamination (regardless of what happens to the end product once it leaves your warehouse).  Also, pathogenic contamination isn't the only risk involved, you'd have physical/chemical etc .... I mean if a piece of glass got into the flour used to make the dough, or inadequate storage resulted in bacterial growth ... those are all things you would be taking into consideration. So then your reply to the last HACCP question would determine if it became a CP or CCP ......

Dear Tan,

 

Thks yr input. There are indeed a variety of opinions in the literature as to how a hazard analysis RA should be carried out.

It is also apparent that consumers occasionally choose to ignore labelling instructions and thereby place themselves at risk. (The event where manufacturers provide an incorrect label is probably far more frequent and is a major contributor to recall statistics, especially in respect to allergens).

 

My own haccp RA preference is to include an assumption that the typical consumer does follow labelling statements. Accordingly I enclose one example ilustrating this logic within hazard analysis methodology (not for dough).

 

 03seafood.pdf   88.12KB   141 downloads

 

It might be added that as mentioned in an earlier post, the dough process offers an alternative option to use pre-heat-treated raw material so as to “compensate” for consumers ignoring the labelled cooking instructions and eating raw dough. In the case of the dough recall of 2009, this change appears to have been eventually implemented.

 

Rgds / Charles.C