How to add Economically Motivated Hazards into HACCP Plan to comply with FSMA?

I'm trying to modify my HACCP plan to comply with FSMA. I got stuck when tried to insert economically motivated hazards in the processing steps. If someone can share with me a template, or provide me a link on integrating  HACCP plan with FSMA, it would be a great help.

Thanks

Charmila   

I'm trying to modify my HACCP plan to comply with FSMA. I got stuck when tried to insert economically motivated hazards in the processing steps. If someone can share with me a template, or provide me a link on integrating  HACCP plan with FSMA, it would be a great help.

 

Thanks

Charmila   

Not personally involved with FSMA but I anticipate that the answer to yr EMA query is - Not recommended.

After all, one is for Safety, the other is Not (at least by intention).

These are in our food defense plan and ingredient hazard analysis. For economically motivated  - one would be your ingredients so testing ingredients, using reputable suppliers, etc. Honey, seafood, olive oil are just a few examples of ingredients that have been known to be adulterated - using cheaper ingredients than the real thing. Spices are another one. 

Also - https://www.cfsanapp...egies/index.cfm. 

BRC now requires Food Fraud to be included in the HACCP plan (in addition to having a VACCP or equivalent plan for it) - if it's a useful reference point then you can get a free copy of the standard here: https://www.brcgsboo...ue-8/c-24/p-414

Nonetheless I very much share the same view as Charles, i.e. that HACCP is best kept focussed on HACCP, and having to incorporate both EMA and food defence elements into the HACCP plan to jump through BRC's hoops has only reinforced that view!

Hi all, 

I agree that food safety plans and food fraud prevention plans should be kept separate, but what the OP wants to do is correct.  Under FSMA, hazards to food safety that could arise from economically motivated adulteration (EMA) MUST be included when doing the hazard analysis part of the food safety plan.  So, for example, if you are doing a hazard analysis on cashew nut pieces for pesto manufacturing you might consider these hazards: 

• salmonella
• aflatoxins
• stones

Hazards like the ones listed above would be present due to accidental contamination.

Under the FSMA rules and guidelines, when doing your hazard analysis, you must consider hazards that are present due to accidental contamination and ALSO hazards that might be present due to purposeful (economically motivated) contamination.  The FDA guidelines are clear about this.  An example would be peanut protein - a hazard - that could be present due to food fraud (peanuts are cheaper than cashew nuts).  When peanut pieces are fraudulently added to cashew pieces it is economically motivated adulteration (EMA) and it would pose a hazard to consumers.  FSMA says clearly that the peanut protein hazard (EMA) should be addressed within the HACCP plan (in the hazard analysis part). 

That is how EMA fits into HACCP plans under FSMA.  It's completely different to food fraud prevention programs (sometimes called VACCP plans), which should be separate to HACCP plans.   

Btw there have been multiple recalls for peanut proteins in cashew nut pesto all around the world in recent months, so that is a hazard worth including in your food safety hazard analysis! 

Hi all, 

 

I agree that food safety plans and food fraud prevention plans should be kept separate, but what the OP wants to do is correct.  Under FSMA, hazards to food safety that could arise from economically motivated adulteration (EMA) MUST be included when doing the hazard analysis part of the food safety plan.  So, for example, if you are doing a hazard analysis on cashew nut pieces for pesto manufacturing you might consider these hazards: 

• salmonella
• aflatoxins
• stones

Hazards like the ones listed above would be present due to accidental contamination.

 

Under the FSMA rules and guidelines, when doing your hazard analysis, you must consider hazards that are present due to accidental contamination and ALSO hazards that might be present due to purposeful (economically motivated) contamination.  The FDA guidelines are clear about this.  An example would be peanut protein - a hazard - that could be present due to food fraud (peanuts are cheaper than cashew nuts).  When peanut pieces are fraudulently added to cashew pieces it is economically motivated adulteration (EMA) and it would pose a hazard to consumers.  FSMA says clearly that the peanut protein hazard (EMA) should be addressed within the HACCP plan (in the hazard analysis part). 

 

That is how EMA fits into HACCP plans under FSMA.  It's completely different to food fraud prevention programs (sometimes called VACCP plans), which should be separate to HACCP plans.   

 

Btw there have been multiple recalls for peanut proteins in cashew nut pesto all around the world in recent months, so that is a hazard worth including in your food safety hazard analysis! 

Hi Karen,

Ths for yr input.

FSMA is not my area of expertise but TBH I found the above confusing.

I noted this comment in a related link -

For each possible adulterant, make a note of whether it could be hazardous to human health if present in the food.  As an example, olive oil is commonly adulterated with (non-olive) vegetable oils.  That type of adulteration is unlikely to be hazardous and as such it would not require a preventive control.

https://www.foodfrau...zards-from-ema/

Can you provide a FSMA link which categorically  states that non-safety related hazards which may be linked to EMA must be included in a harpc/(FSMA)food safety plan ? Sounds like a recipe for writing an Encyclopedia.

( IIRC, for raw materials, SQF specifically exclude non-safety (FF) hazards whereas BRC include. )

If the economically related substitution results in a potential food safety risk, then yes, it should go into HACCP but think about it, if you use chilli powder, I bet you've already got Sudan dyes in there?  So you've already got yourself covered.

Just put something into your scope saying that "economically related substitution will be considered where a food safety risk could result from this activity" then cross reference to your vulnerability / VACCP and food defence plans for other economically motivated attacks.

If the economically related substitution results in a potential food safety risk, then yes, it should go into HACCP but think about it, if you use chilli powder, I bet you've already got Sudan dyes in there?  So you've already got yourself covered.

 

Just put something into your scope saying that "economically related substitution will be considered where a food safety risk could result from this activity" then cross reference to your vulnerability / VACCP and food defence plans for other economically motivated attacks.

Hi GMO,

Are you talking about FSMA or is this just a personal generic opinion ?

Hi Karen,

 

Ths for yr input.

 

FSMA is not my area of expertise but TBH I found the above confusing.

 

I noted this comment in a related link -

 

 

Can you provide a FSMA link which categorically  states that non-safety related hazards which may be linked to EMA must be included in a harpc/(FSMA)food safety plan ? Sounds like a recipe for writing an Encyclopedia.

 

( IIRC, for raw materials, SQF specifically exclude non-safety (FF) hazards whereas BRC include. )

It's spelled out the best in food defense under intentional adulteration. Many people including myself will put this portion into the ingredient hazard analysis because then you're not repeating yourself by having two ingredient hazard analyses. Then in that portion of the your food defense, you reference the ingredient hazard analysis.

https://www.fda.gov/.../98085/download

It's spelled out the best in food defense under intentional adulteration. Many people including myself will put this portion into the ingredient hazard analysis because then you're not repeating yourself by having two ingredient hazard analyses. Then in that portion of the your food defense, you reference the ingredient hazard analysis.

 

https://www.fda.gov/.../98085/download

Hi kfromNE,

Thks for attachment.

TBH I thought the "food defence" portion is driven by conceptually different "hazards" as compared to the Food Safety Plan/"Preventive Controls".

I noticed in yr attachment this comment -

While acts of intentional adulteration may [include?] many other forms, including acts of disgruntled employees or economically motivated adulteration, the goal of this rule is to prevent acts intended to cause wide-scale harm. Economic adulteration is addressed in the final preventive controls rules for human and animal foods.

I deduce the above refers to 2 (or more) different rules.

As I understood, Post 5 implied that the ^^^ "blue"  bit somehow provides for a separation of EMA-related hazards into safety/non-safety entities with the former entering the FS Plan. (similar to SQF)

I guess one needs to study the Rules.

Hi Karen,

 

Ths for yr input.

 

FSMA is not my area of expertise but TBH I found the above confusing.

 

I noted this comment in a related link -

 

 

Can you provide a FSMA link which categorically  states that non-safety related hazards which may be linked to EMA must be included in a harpc/(FSMA)food safety plan ? Sounds like a recipe for writing an Encyclopedia.

 

( IIRC, for raw materials, SQF specifically exclude non-safety (FF) hazards whereas BRC include. )

Sorry to confuse you, Charles,

I agree non-safety related EMA doesn't need full consideration in a food safety plan.  But how do we know if a certain type of EMA could create a food safety hazard unless we do a hazard analysis?

In the olive oil example you provided, the hazard analysis process would identify that sunflower oil adulteration could occur, then decide it isn't a food safety risk.  So it doesn't need a control.  In the peanut/cashew example you would identify the hazard, then determine that such adulteration could cause a food safety risk, so it does need a control. 

Here is the FDA guidance which requires such:

3.4.1.6 Chemical hazards that may be intentionally introduced for purposes of economic gain

The PCHF requirements specify that you must consider, as part of your hazard identification, known or reasonably foreseeable hazards that may be intentionally introduced for purposes of economic gain (21 CFR 117.130(b)(2)(iii)).

https://www.fda.gov/.../99558/download

Karen

Sorry to confuse you, Charles,

 

I agree non-safety related EMA doesn't need full consideration in a food safety plan.  But how do we know if a certain type of EMA could create a food safety hazard unless we do a hazard analysis?

 

In the olive oil example you provided, the hazard analysis process would identify that sunflower oil adulteration could occur, then decide it isn't a food safety risk.  So it doesn't need a control.  In the peanut/cashew example you would identify the hazard, then determine that such adulteration could cause a food safety risk, so it does need a control. 

 

Here is the FDA guidance which requires such:

3.4.1.6 Chemical hazards that may be intentionally introduced for purposes of economic gain

The PCHF requirements specify that you must consider, as part of your hazard identification, known or reasonably foreseeable hazards that may be intentionally introduced for purposes of economic gain (21 CFR 117.130(b)(2)(iii)).

https://www.fda.gov/.../99558/download

 

Karen

Hi Karen,

Thks for the links. Jogged my memory as to the appearance of EMA in the FSPCA manual. Sadly, this important aspect is omitted (since presumably redundant) in the otherwise impressive example of a FSMA compliant Plan in the FSPCA's Appendix.

I suppose the OP's FSMA difficulty is hardly surprising since haccp/EMA(FSMA) are derived from disparate origins, ie accidental contamination/safety vs  intentional adulteration/non-safety>safety.

I noticed these 2 vaguely related  GFSI/FSMA comments -

While both programs [VACCP/TACCP] have been adopted by the Global Food Safety Initiative (GFSI) in Europe, neither have been formally accepted by the US Food and Drug Administration (FDA). The Food Safety Modernization Act (FSMA) includes the Mitigation Strategies to Protect Food Against Intentional Adulteration Rule but this focuses only on public health concerns. Adulteration that does not present a risk to food safety is outside of the scope of the FSMA Rules.

https://globalfoodsa...the-difference/

And yet it is necessary to implement EMA within FSMA !

Similarly, in a GFSI context, approximating EMA to VACCP, and food defense to TACCP -

 

QA. How can TACCP and VACCP integrate with FSMA to add value?

Sklare. It’s not really a question of integrating with FSMA any more than HACCP integrating with FSMA. They are tools to help to support a FSMA compliance program. TACCP and VACCP complement HACCP. TACCP and VACCP are designed to mitigate the vulnerabilities involved in acts of intentional contamination which HACCP is not.

As far as FSMA is concerned, they are tools that can be used to satisfy requirements of FSMA such as food defense and intentional adulteration. The additional value they could provide is that they will help satisfy the requirements of FSMA and go beyond them.

https://www.qualitya...ty-and-quality/

No surprise IMO that the OP got stuck with a "square peg".

PS - here is one suggested response to the OP's query -

 haccp plus EMA.pdf   115.74KB   92 downloads

Thank you all for your input.

Charmila