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FDA requiring allergen control to be a CCP

FDA Allergens CCP

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#1 RG3

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Posted 01 June 2015 - 07:24 PM

Hello All,

 

   I have a question about Allergens being a CCP. I have the FDA at my facility and they are reviewing my programs. Amongst everything they are looking over my HACCP. They found it curious that I had pulled allergens out of the regular Risk Analysis and made it it's own risk analysis as requested by an SQF auditor. Then they had asked me why I don't have allergens as a CCP. I said I have it as a pre-requisite. I have a non controllable allergen "FISH" and I have seasonings that are never opened that have allergens. 

    I showed them all of the controls I have upon receipt and a label verification before it leaves the facility, all the different signage I have, the storage area dedicated to allergens, scheduling, etc. etc. etc. Can someone please let me know how to combat this question or validate their reason for Allergens to be a CCP?


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#2 Charles.C

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Posted 01 June 2015 - 09:12 PM

Hello All,

 

   I have a question about Allergens being a CCP. I have the FDA at my facility and they are reviewing my programs. Amongst everything they are looking over my HACCP. They found it curious that I had pulled allergens out of the regular Risk Analysis and made it it's own risk analysis as requested by an SQF auditor. Then they had asked me why I don't have allergens as a CCP. I said I have it as a pre-requisite. I have a non controllable allergen "FISH" and I have seasonings that are never opened that have allergens. 

    I showed them all of the controls I have upon receipt and a label verification before it leaves the facility, all the different signage I have, the storage area dedicated to allergens, scheduling, etc. etc. etc. Can someone please let me know how to combat this question or validate their reason for Allergens to be a CCP?

 

Hi RG3,

 

Maybe it's  just a question of haccp "viewpoint", more precisely the FDA's viewpoint.

 

You didn't mention yr specific product but here is one (2011) FDA example for CCP handling of allergen hazards in seafood.

 

Attached File  allergen CCP.pdf   126.98KB   120 downloads

 

I assume the FDA-validation of the CCP could be "by definition" although "Labelling" as a control measure seems OK to me.

 

Other viewpoints use Prerequisites as you mention.


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#3 mgourley

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Posted 01 June 2015 - 09:26 PM

Interesting question. Maybe because of this?

 

If they are considering PRP's to be "controls" at a certain processing step, then it makes sense.

 

However, you can't have a HACCP Plan without first having PRP's. 

 

By their logic, and decision tree (which is just a scaled down CODEX tree), any control you have in place would necessarily be a CCP.

 

Maybe you can get them to further explain their thinking on this.

 

Marshall


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#4 Charles.C

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Posted 01 June 2015 - 09:32 PM

Interesting question. Maybe because of this?

 

If they are considering PRP's to be "controls" at a certain processing step, then it makes sense.

 

However, you can't have a HACCP Plan without first having PRP's. 

 

By their logic, and decision tree (which is just a scaled down CODEX tree), any control you have in place would necessarily be a CCP.

 

Maybe you can get them to further explain their thinking on this.

 

Marshall

 

It's possible FDA interpret PRPs as SSOPs in this specific instance.


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#5 mgourley

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Posted 01 June 2015 - 09:55 PM

Charles,

 

I suppose it's possible. It's interesting because I have never heard of this questioning before.

I guess it might be specific to fish, but I don't see how. Allergens are allergens and allergen control programs are allergen control programs.

 

Marshall


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#6 Charles.C

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Posted 02 June 2015 - 07:30 AM

Hi Marshall,

 

You're right. The FDA Seafood approach to haccp was (ca 1990s) envisaged as a (uniquely?) Prescriptive System. And (based on their manual) maintained up to, at least, 2011, eg -

 

Attached File  hazard menu.png   98.25KB   0 downloads

 

The Prerequisite concept of FDA (Seafood) and FSIS also seems to have been, at least originally, quite well aligned,eg

 

Attached File  HACCP Prerequisites, FSIS vs FDA vs NACMCF vs Codex.pdf   34.29KB   70 downloads

 

(prob. late 90s)

 

Currently, the (Global) scope of "PRPs" has obviously expanded from SSOPs in many texts, eg ISO/GFSI. But for FDA and FSIS? This general look suggests a real hotch-potch and for terminologies also. :smile:

 

http://edis.ifas.ufl.edu/fs138


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#7 The Director

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Posted 02 June 2015 - 11:14 AM

If in doubt, I always find it useful when faced by the possibility of a step being a CCP (what is the process step in your case, anyway), to ask

"What is the critical limit which separates safe from potentially unsafe".  Allergens are particularly difficult to define in this respect.

 

As I have said in response to other HACCP questions, auditors should be concerned with whether the controls are suitable to prevent sale of unsafe food, not the labels and acronyms which are attached to process steps. You reach that conclusion by good risk assessments and good controls.  The HACCP revie, if done correctly,  shows you have not left any gaps

 

The Director


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#8 Ekivlen

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Posted 02 June 2015 - 03:14 PM

Much like the way a FSIS/USDA inspector's head would short-circuit if you validated a control program for lethality temperatures and cooling for proteins, so too does an FDA's inspector's brain with allergen control programs as a pre-req. Much is similar in the context of the justification - the public health risk is so great and such a multitude of non-conformances have occurred.

They've just dug their heels in and not budged.

I eventually relinquished on this one. The pre-req. program we had in place was so well maintained that we made the decision as a food safety team to establish it as a CCP.

What was the final resolve?


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#9 Charles.C

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Posted 02 June 2015 - 03:34 PM

If in doubt, I always find it useful when faced by the possibility of a step being a CCP (what is the process step in your case, anyway), to ask

"What is the critical limit which separates safe from potentially unsafe".  Allergens are particularly difficult to define in this respect.

 

As I have said in response to other HACCP questions, auditors should be concerned with whether the controls are suitable to prevent sale of unsafe food, not the labels and acronyms which are attached to process steps. You reach that conclusion by good risk assessments and good controls.  The HACCP revie, if done correctly,  shows you have not left any gaps

 

The Director

 

Yes but auditors are obliged to use Standards as their reference for compliance. Don't blame the Messenger ?

 

And then came OPRPs. :smile:


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#10 moskito

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Posted 04 June 2015 - 07:31 AM

Hi RG3

 

 

in this question for me the decision is dependent on whether you use claims (e.g. gluten-free etc) or not.

 

IFS/BRC auditors: we have created a allergen class in HACCP and doing hazard analyis as for others. If we can not avoid cross contact due to measures (raw material or supplier selection, cleaning etc.) labelling is the measure of choice (even more with inhomogeneous distributed particulate allergens than homogeneous distributed allergens).

Allergens and allergenmanagement will be covered by some of our PrPs.

 

 

Rgds

moskito


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#11 Charles.C

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Posted 04 June 2015 - 07:44 AM

Hi RG3

 

 

in this question for me the decision is dependent on whether you use claims (e.g. gluten-free etc) or not.

 

IFS/BRC auditors: we have created a allergen class in HACCP and doing hazard analyis as for others. If we can not avoid cross contact due to measures (raw material or supplier selection, cleaning etc.) labelling is the measure of choice (even more with inhomogeneous distributed particulate allergens than homogeneous distributed allergens).

Allergens and allergenmanagement will be covered by some of our PrPs.

 

 

Rgds

moskito

 

hi moskito,

 

Regulatory supercedes Private.


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Charles.C


#12 RG3

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Posted 04 June 2015 - 03:15 PM

When I had asked why they think Allergen control should be a CCP? What training or literature did they receive that information? They told me "FDA training". I simply said I don't agree with it needing to be a CCP because I have all the proper controls in place and I made my decision tree and have it as a pre-req. Then I said I'll take it into consideration and ask the experts, so I immediately started to type away here on IFSQN. They are reviewing my paperwork and I won't get my verdict until Friday.

 

Marshall, if I followed what you have in that link, I agree that everything would be a CCP. That link is what is in Seafood HACCP.

 

For The Director they didn't see any GAP's in the HA they just sort of mentioned that Allergen control should be a CCP, I was able to demonstrate control, so their rebuttal was then why not just make it a CCP. I do see how they make it a CCP in Seafood HACCP Chapter 19.

 

Ekivlen the final resolve is not until tomorrow Friday. They took some homework with them to review.


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#13 The Director

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Posted 04 June 2015 - 03:53 PM

Good luck with the feedback.

I confess here that I am not overly familiar with seafood HACCPs specifically, nor the workings of the FDA as we have a slightly different approach here in the UK, but I hope I do understand the workings of HACCP after nearly 30 years use of the technique.

I have read up a little in the FDA publication  "Fish and Fishery Products Hazards and Controls Guidance  Fourth Edition –  APRIL 2011"

I hope this is the appropriate document, and my is it a good read!!!

May I refer you to Chapter 19, p 356

 

Labelling controls that are designed to ensure that any major food allergen that is present in a food is declared on the label are the most effective means of controlling this hazard. However,such controls are not suitable to prevent the unintentional introduction of allergenic proteins from foods that contain these allergens into foods that are not intended to contain them, through cross­ contact (e.g., use of common equipment, improper production scheduling, or improper use of rework material). Unintentional introduction of allergenic proteins should be controlled through rigorous process controls, either as part of a prerequisite program or as part of the Hazard Analysis Critical Control Point (HACCP) program itself.

 

I have underlined what is to me the appropriate permission to control allergens by the PRPs

 

Let us know how you get on

Best regards

 

The Director

 

 

 

 


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#14 RG3

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Posted 04 June 2015 - 04:31 PM

LoL I love it!!! It is by the way written by the FDA. She wrote it down on her notes when she asked again "Can you tell me why again you don't have it as a CCP?" and I replied "Because I have it as a prerequisite program." And I saw her write it down.

 

:thumbup: IFSQN

 

I don't know how I overlooked that part. Thank you "The Director"


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#15 Charles.C

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Posted 04 June 2015 - 07:44 PM

Hi Director,

 

Slightly selective extracting perhaps -

 

Unintentional introduction of allergenic proteins should be controlled through rigorous process controls, either as part of a prerequisite program or as part of the Hazard Analysis Critical Control Point (HACCP) program itself. The Fish and Fishery Products regulation, 21 CFR 123 (called the Seafood HACCP Regulation in this guidance document), requires such a regime.

 

The F.Guide opinion (in 2011) apparently requires  FDA to modify 21CFR 123, their Final Rule. That should certainly give FDA some food for thought. :smile:

 

The reality of course is that Allergen Control has probably been (randomly?) handled via either Prerequisites or CCPs since the time of the 1995 Regulation above (correction - actually more likely to be post 1997).  "Critical" washing steps in the process to prevent allergenic cross-contamination are also currently being regarded as "classic" OPRPs.

 

Life would maybe be easier if everyone referenced ISO 22002-1 ?


Edited by Charles.C, 05 June 2015 - 10:52 AM.
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#16 Charles.C

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Posted 05 June 2015 - 10:45 AM

Addendum

 

Hi RG3/Director

 

It seems highly unlikely that the FDA will not have encountered the current interpretative disagreement before. If so a quoted precedent will probably be shortly forthcoming. Their Compliance Guides are probably being pored over at this moment. :smile:

 

It is interesting to scan the 1995 Final Rule (attached below) for "allergen". There are no hits.

 “Allergens” are also not mentioned anywhere in Ch.19 of the F. Guide’s 1st ed (1996) issued to parallel the Final Rule.

 

Attached File  Fish and Fishery Products - Final Rule.pdf   876.9KB   44 downloads

 

As far as Prerequisites goes (aka SSOP from FDA’s POV at that time) the details within the document illustrate the then-existing argument as to whether Sanitation should be haccp handled by CCPs or not. By 1997, the NACMCF (afaik the basis of FDA’s thinking) clearly favoured Prerequiste programs (although not specifically defining allergen control as such), eg –

http://www.fda.gov/F...06801.htm#app-a

 

There are IMO 2 hazard scenarios involved here as far as allergens are concerned –

 

(a) the hazard to a consumer from a fish-X product regarding it’s intrinsic possession of an allergenic fish protein (does it?) or other X constituent allergenic proteins,

(b) the hazard from cross-contamination from this fish-X product/its process  to other products which do not contain the fish allergen.

 

The Fishery Guide’s “not suitable”  comment seemingly refers to (b). I infer it considers that (a) should be a CCP and controlled by labelling.

Unfortunately, from the Guides POV, there is (at least in 2011) no relevant supporting content within the Final Rule to enable the F.Guide to “upgrade” its "not suitable" opinion into a stated action.

 

I deduce from RG3's posts that the (Prerequisite?), allergen control  Program (including labelling control) covers both (a) and (b) ?

 

From an FDA POV, it is interesting to note that The Guide is literally that. Some extracts from the Intro. -

 

(i) FDA announced its adoption of final regulations to ensure the safe and sanitary processing of fish and fishery products in the Federal Register of December 18, 1995 (60 FR 65096) (hereinafter referred to as the Seafood HACCP Regulation).

 

(ii) This guidance is also intended to serve as a tool to be used by federal and state regulatory officials in the evaluation of HACCP plans for fish and fishery product.

 

(iii) FDA’s guidance documents, including this  guidance, do not establish legally enforceable  responsibilities. Instead, guidance describe the  Agency’s current thinking on a topic and should  be viewed only as recommendations, unless specific regulatory or statutory requirements are  cited.

 

(iv) Processors may choose to use other control strategies, as long as they comply with the requirements of the applicable food safety laws and regulations. However, processors that chose to use other control strategies (e.g., critical limits) should scientifically establish their adequacy.

 

It’s an interesting thread.


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#17 Ekivlen

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Posted 05 June 2015 - 04:23 PM

This song-and-dance came up in a state Ag and Markets audit I had a few years ago. The state auditors also were contracted as FDA auditors from time to time.

I fought the fight about why I had not assigned a critical control point at storage due to the fact that I had an outsourced security company (and paid good money to do so) monitoring storage temperatures in all of the freezers and coolers. Time/temp parameters were set and if they were exceeded (over and under) we received an alarm call to the admin office during business hours and to a phone tree during off hours. We ran a quarterly test in which we spiked the holding vessel temperatures for the set time to verify that the alarm panel would alert. Since the thermometers were fixed to the cooler (with silicone), we companion verified monthly with a weekly calibrated thermometer.

We went back and forth. Them adamant that a critical control point was necessary, me adamant that there was zero food safety risk as long as the pre-requisite program was validated and verified at the established frequencies. The final resolve, entertainingly, was that they relinquished that the PRP was adequate to maintain food safety. However, they warned me that they could walk out to the parking lot, change into an FDA uniform, come back in the facility, and I would have been cited as not having a CCP at this stage. I was not entertained...


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#18 jtrue

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Posted 20 July 2015 - 07:41 PM

Hi RG3... I just stumbled upon this entry while browsing the forums. I had this exact same scenario happen at our facility. We used the prerequisite program defense as well and fortunately it worked and we didn't have to make any changes. 

 

Did that defense work for you? I don't see the outcome 


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