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Poll: Do you have a Functional Food Defense Plan? (94 member(s) have cast votes)

Do you have a Functional Food Defense Plan?

  1. Yes (52 votes [55.32%])

    Percentage of vote: 55.32%

  2. No (42 votes [44.68%])

    Percentage of vote: 44.68%

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#1 Simon

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Posted 25 May 2015 - 07:08 PM

A food defense plan is a system that works to protect food products from intentional adulteration or tampering. It's a basic requirement of food safety management systems to have a food defense plan in place, but just how many of our plans are truly functional and not just a set of policies and procedures gathering dust on a shelf…the existence and requirements of which are unknown to most of the employees. 

 

Or perhaps your food defense plan is full adopted, well designed, practical, efficient and effective and you feel confident and comfortable your business is protected.

 

Please vote one way or the other and let’s discuss what it means to have a fully functional food defense plan.

 

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Simon


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#2 Charles.C

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Posted 25 May 2015 - 08:01 PM

Hi Simon,

 

Do you wish to include activities probably classifed as "Food Fraud" within your "Food Defence" ?

 

Globally the terminologies are confused with respect to safety/non-safety/adulteration issues. And similarly in BRC as far as i can see.

 

I could expand the above comment but I anticipate you will choose Yes regardless so no wish to confuse unduly. :smile:


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#3 Dimitis

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Posted 26 May 2015 - 03:17 PM

Hi Simon,

 

Is it mandatory to have Food Defense Plan in EU also? I though it was USA only. 


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#4 MWidra

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Posted 26 May 2015 - 05:47 PM

Hi Simon,

 

Do you wish to include activities probably classifed as "Food Fraud" within your "Food Defence" ?

 

Globally the terminologies are confused with respect to safety/non-safety/adulteration issues. And similarly in BRC as far as i can see.

 

I could expand the above comment but I anticipate you will choose Yes regardless so no wish to confuse unduly. :smile:

This is how these terms are considered in the US:

 

Food Fraud is normally applied to ingredients/materials.  It's the risk of one material being substituted for another.  Like horsemeat in beef.  Basically, it answers the question of how much do you trust your suppliers.

 

Food Defense is applied to your facility, or transportation system.  Its focus is preventing some type of terrorist or otherwise deranged individual (someone with a grudge against the company comes to mind) from adulterating the food.  That thought grew out of the post-911 concerns that also spawned the Patriot Act here.  It is more about cameras and fences than about chain of custody.

 

In Issue 7, BRC places food defense in the Site Standards, Section 4, subsection 4.2, Security.  That's the same section as the prerequisite programs.  It places Product Authenticity (subsection 5.4) in Section 5, Product Control.  Since that is a new topic in this issue of BRC, it had no place in Issue 6.  Security was in Section 4 in Issue 6.

 

I'm in the middle of preparing our compliance manual to move to BRC, so I'm kind of immersed in this.

 

They are distinct entities here, though that may not be the case in other countries.  I think we need to keep them separate, myself.

 

Martha


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#5 Charles.C

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Posted 26 May 2015 - 06:21 PM

Hi Martha,

 

This was the thinking which (rightly or wrongly)  led to my query -

 

(1) Food defence “appears” to be reserved for (intentionally) safety related activities within its definition.

(2) Food fraud  “appears” to be reserved for (intentionally) non–safety related activities within its definition.

 

Adulteration (in BRC’s viewpoint) appears to nominally be in (2).

 

However, obviously, activities classifiable as in (2) may often ultimately end up in (1), eg melamine. Or not, eg horsemeat.

 

Food defence - Procedures adopted to assure the safety of raw materials and products from malicious contamination or theft.

 

Adulteration The addition of an undeclared material into a food item for economic gain.

 

Food fraud - Fraudulent and intentional substitution, dilution or addition to a product or raw material, or misrepresentation of the product or material, for the purpose of financial gain, by increasing the apparent value of the product or reducing the cost of its production.

 

In USA I suspect ‘adulteration” is not defined as with respect to economic gain but more with respect to “wholesomeness” and/or “safety”

 

http://www.foodsafetymagazine.com/magazine-archive1/augustseptember-2014/economically-motivated-adulteration-broadening-the-focus-to-food-fraud/


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#6 Simon

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Posted 26 May 2015 - 06:44 PM

Hi Simon,

 

Do you wish to include activities probably classifed as "Food Fraud" within your "Food Defence" ?

 

Globally the terminologies are confused with respect to safety/non-safety/adulteration issues. And similarly in BRC as far as i can see.

 

I could expand the above comment but I anticipate you will choose Yes regardless so no wish to confuse unduly. :smile:

 

See Martha's definition.

 

 

Hi Simon,

 

Is it mandatory to have Food Defense Plan in EU also? I though it was USA only. 

 

Depends what you mean by mandatory.  Not legally no, but a requirement of food safety standards that apply to large parts of the food chain and a wise thing to do anyhow.


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#7 MWidra

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Posted 26 May 2015 - 06:48 PM

Charles, it depends on whose definition of "Adulteration" you use.  As far at the FDA is concerned, it's the change of a food or drug that conforms to the FDA standards to one that does not.  It does not matter if that is through intentional adding of an adulterant, or if it occurs through the activities of bacteria, or if the label is not correct, or if it occurs through an act of God.  Any food/drug that is not compliant with 21 CFR is adulterated.

 

Someone can adulterate a wholesome food material in your facility deliberately.  We protect against that using Food Defense.  It defends our products from the actions of others on our site.

 

Someone can represent their food as something that it is not and try to sell it to you.  We protect against that by initiating a process to select suppliers who do not sell fraudulent food materials.  That is what your Food Fraud plan would prevent, and all of the adulteration occurs outside of your site.

 

The definition of fraud:

A false representation of a matter of fact—whether by words or by conduct, by false or misleading allegations, or by concealment of what should have been disclosed—that deceives and is intended to deceive another so that the individual will act upon it to her or his legal injury.

 

Someone has to lie about a matter of fact for there to be fraud.  Food fraud involves a falsification of a matter of fact about food.  You can defend against food fraud by screening your suppliers better, or checking their material before buying, but it always involves a pre-purchase issue.  Food defense involves keeping the bad guys away from your product so they don't muck with it.

 

Martha


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"...everything can be taken from a man but one thing:  the last of the human freedoms--to choose one's attitude in any given set of circumstances, to choose one's own way."  Viktor E. Frankl

 

"Life's like a movie, write your own ending."  The Muppets


#8 lcsandberg

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Posted 26 May 2015 - 07:19 PM

In my experience, companies are not interested in spending the money to live and breath food defense.


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#9 Charles.C

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Posted 26 May 2015 - 08:03 PM

Charles, it depends on whose definition of "Adulteration" you use.  As far at the FDA is concerned, it's the change of a food or drug that conforms to the FDA standards to one that does not.  It does not matter if that is through intentional adding of an adulterant, or if it occurs through the activities of bacteria, or if the label is not correct, or if it occurs through an act of God.  Any food/drug that is not compliant with 21 CFR is adulterated.

The FDA's definition is up to them of course.

 

 (the definition is rumoured to be an effective lever in combination with the the Voluntary Recall Policy for  products whose defects  are in a  HACCP grey area).

 

My only current reservation was that the terminologies in use are liable to be differently interpreted according to location. Not an unusual phenomenon of course.

 

I guess BRC have started the (private) ball rolling.

 

I also noticed that FSMA got into the act 12 months ago -

 

http://www.fda.gov/F...A/ucm378628.htm


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#10 MWidra

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Posted 26 May 2015 - 08:47 PM

Food Defense was put into the proposed FSMA (which is a statute and not an agency) regulations to remain compliant with the Bioterrorism Act of 2002, which was passed in response to 9-11.  Food facilities have been required to register under that legislation since 2002, and food importers are required to notify the FDA of impending food imports under that law as well.  The FDA had the power to close down any facility that showed the potential of introducing dangerous food materials that could cause death or serious illness to the public.  Up until FSMA, it was the only power that the FDA had been granted by Congress, which is why recalls here were not ordered by the FDA but were voluntary.  It took until 2011 for Congress to grant the FDA the power to recall food.  They could cite and prosecute manufacturers after the fact, but they could not recall.  It is a testament to the good will of the food industry in the US that most manufacturers felt their civic duty to protect the public and the food supply, and would recall/withdraw products willingly.

 

Few people in other parts of the world realize that, they have felt that the FDA was ducking its responsibility.  But they only recently had the power.  They still cannot use it until regulations are lawfully adopted to set up the parameters that will trigger it and the mechanisms that they will use.

 

In the US, an executive agency cannot take an action unless it is specifically granted that power by the Congress (separation of powers), without letting people know what they will be subjected to (fair notice), without giving the stakeholders the opportunity to speak (due process), and without giving people a reasonable amount of time to comply before enforcement (no ex post facto law).  It's part of that Constitution thingy we have here.  :)

 

Martha


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"Life's like a movie, write your own ending."  The Muppets


#11 Charles.C

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Posted 26 May 2015 - 09:33 PM

Hi Martha,

 

So do you think that the FDA/FSMA would regard the horsemeat scandal as within the scope of the Defence Plan ?

 

(This maybe should strictly be a separate topic but it connects to my initial post[s])


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#12 MWidra

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Posted 26 May 2015 - 10:01 PM

Hi Martha,

 

So do you think that the FDA/FSMA would regard the horsemeat scandal as within the scope of the Defence Plan ?

No.  That would totally be under the USDA.  The FDA does not regulate meat.

 

The USDA would not consider that a food defense issue, but it is adulterated because the label is not a correct representation of the contents.  It defrauds the public.

 

It's also illegal by several state statutes to sell horsemeat for human consumption, though it is not banned by the United States government.  Many states ban the slaughter of horses.  The USDA is barred by a funding bill from inspecting horse meat slaughtered here, so even if they could be slaughtered, the meat could not be sold or exported because it has no inspection certification.  So the horsemeat content would be another legal issue depending on where it was to be sold.

 

Confused yet, lol?

 

Martha


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"...everything can be taken from a man but one thing:  the last of the human freedoms--to choose one's attitude in any given set of circumstances, to choose one's own way."  Viktor E. Frankl

 

"Life's like a movie, write your own ending."  The Muppets


#13 Charles.C

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Posted 26 May 2015 - 10:15 PM

So how about if the scandal was for a product within the FDA's jurisdiction ?


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#14 Charles.C

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Posted 27 May 2015 - 12:39 AM

Hi Martha,

 

After some digging,

As of early 2014, the answer to my (US) query, I think, would have been predicted as Yes (with caveats), for example this AIB summary –

Attached File  fiz1 - UnboxingFSMA.pdf   349.31KB   79 downloads

 

But, currently, I think the answer to my query is simply – Nobody knows,  because the final rules have yet to be published. The deadlines for various aspects vary between  August 2015 and May 2016 –

http://agfdablog.com...implementation/

 

FWIW, one (updating)  approx. to  official  “thinking”  seems to be here –

http://www.fda.gov/F...cm247559.htm#FD

 

A quite informative (2015) visual comparison of  the inter-relationships between food fraud/defence/safety from various contexts, eg GFSI is here –

Attached File  fiz2 - Food fraud,defence,safety.pdf   1.72MB   168 downloads

 

Note -  IFSQN webinars are available on both Food Fraud and FSMA (see webinar archive).

 

The above link (currently) defines Food Defense as -

 

Food Defense is the effort to protect the food supply against intentional contamination due to sabotage, terrorism, counterfeiting, or other illegal, intentionally harmful means. Potential contaminants include biological, chemical and radiological hazards that are generally not found in foods or their production environment. Food defense differs from food safety, which is the effort to prevent unintentional contamination of food products by agents reasonably likely to occur in the food supply (e.g., E. coli, Salmonella, Listeria).


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#15 Simon

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Posted 27 May 2015 - 07:38 AM

Of course the definition of food defense is important because if we don't clearly understand what it is then we certainly cannot have a fully functioning plan. 

 

That said the main purpose of this poll is to find out if members feel they have a fully functioning food defense plan and perhaps to list out what they have in it and how it works.

 

The poll so far has 8 answering NO and 2 YES, so maybe those that already voted can say why they feel they do or they don't have a functioning plan.

 

The idea is maybe we can build up a framework of best practice and practical ideas, problems and solutions to problems.

 

Can we proceed on this basis please. :smile:

 

Thanks,
Simon


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#16 mgourley

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Posted 27 May 2015 - 09:44 AM

Food Defense is really fairly simple. You do a threat vulnerability assessment, you put assets and/or procedures in place to mitigate the risks and then you challenge and monitor the system to see whether it is effective. 

I'll go through some mitigation strategies. By no means a complete list, of course.

 

1. Perimeter Defense

- Fencing

- exterior doors should be sturdy and always locked when not in use

- Employee entrances should be secured by cipher locks, swipe cards or the like.

- All exterior bulk tanks, etc. should be securely locked (no cheap locks)

- CCTV in place to monitor things

 

2. Shipping and Receiving

- Robust policies/procedures in place

- Incoming and outgoing shipments should be inspected for signs of intentional tampering or contamination.

- Incoming raw material deliveries are scheduled. Trucks are not allowed to just "show up".

- In a perfect world, driver identification would be checked against a photo provided by the trucking company.

- Access to shipping/receiving areas are controlled and monitored. Delivery drivers are kept outside the building, or in holding pens inside the building.

 

3. Mail handling

- Mail is not handled in production, storage or shipping areas.

 

4. Interior Defense Measures

- As a result of threat assessment, vulnerable areas are identified, and access to these areas are restricted and monitored. (CCTV).

- Establish a key registry. All door keys need to be identified, who has them, how many there are, etc.

- Unexpected changes in inventory needs to be reported and investigated.

- Suspicious packages need to be immediately reported.

- Access to all raw materials, finished products and packaging are restricted to authorized personnel.

- Storage areas are monitored on a regular basis.

- Chemicals and hazardous materials are locked in access controlled areas when not in use.

- Maintain an up to date inventory of chemicals and any hazardous materials.

- Access to IT infrastructure is restricted.

 

5. Personnel Defense Measures

- Background checks for prospective employees.

- ID cards or swipe cards required

- Any company supplied locker or storage area should spot checked on a random basis.

- Uniforms or other identifying clothing should be worn

- Be aware of any disgruntled employees. They are the most likely to commit intentional adulteration.

 

6. Non-Employee Defense Measures

- Non-Employees are required to follow all company policies. Short training session is preferred prior to entry into production, storage or shipping areas.

- Non-Employees are escorted while in the facility and not allowed access to restricted areas, unless their reason for visiting require access.

- Non-Employees are identified with badges, distinctive clothing, hair coverings, etc.

- Logs of Non-Employee arrival and departure are maintained.

 

7. Training

- Food Defense awareness training is provided to all employees.

- Specific training is provided to employees based upon their duties and responsibilities.

- Training should address access control measures and access to restricted areas.

- All employees are trained to report any suspicious activity.

- Employees that answer phones will be trained to respond to threats directed towards the facility, people, products or the brand of the company.

 

8. Investigation

- Any unusual activity/situation will be investigated by authorized and trained employees.

- All customer complaints will be investigated and resolved within seven days of complaint receipt.

 

9. Challenging the System

- Contract with third party and conduct an assessment where the third party actively tries to enter your facility and access restricted areas.

- Conduct in depth internal audits of the program.

- Place "suspicious packages" in restricted areas. Find out if employees report them.

 

10. Monitoring the system.

- Internal audits of the policies/procedures that make up the system.

- GMP audits should include checking the mitigation strategies that are in place.

 

 

I'm sure there are plenty more, and of course your plan will be totally dependent upon the size and location of your facility, what products you produce, who your employees are, what level of risk you determine you have and how much money is willing to be spent.

 

Marshall


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Posted 27 May 2015 - 10:04 AM

Hi Marshall,

 

I deduce you answered  Yes for the poll.

 

May i ask if the item (intentional adulteration) currently listed as FD.2 by FDA  was included in yr Food Defense Plan ?

(Of course, if you're within USDA's jurisdiction, this topic may have a different significance, auto-No perhaps?)


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#18 MWidra

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Posted 27 May 2015 - 10:47 AM

Food Defense is really fairly simple. You do a threat vulnerability assessment, you put assets and/or procedures in place to mitigate the risks and then you challenge and monitor the system to see whether it is effective. 

I'll go through some mitigation strategies. By no means a complete list, of course.

 

1. Perimeter Defense

- Fencing

- exterior doors should be sturdy and always locked when not in use

- Employee entrances should be secured by cipher locks, swipe cards or the like.

- All exterior bulk tanks, etc. should be securely locked (no cheap locks)

- CCTV in place to monitor things

 

2. Shipping and Receiving

- Robust policies/procedures in place

- Incoming and outgoing shipments should be inspected for signs of intentional tampering or contamination.

- Incoming raw material deliveries are scheduled. Trucks are not allowed to just "show up".

- In a perfect world, driver identification would be checked against a photo provided by the trucking company.

- Access to shipping/receiving areas are controlled and monitored. Delivery drivers are kept outside the building, or in holding pens inside the building.

 

3. Mail handling

- Mail is not handled in production, storage or shipping areas.

 

4. Interior Defense Measures

- As a result of threat assessment, vulnerable areas are identified, and access to these areas are restricted and monitored. (CCTV).

- Establish a key registry. All door keys need to be identified, who has them, how many there are, etc.

- Unexpected changes in inventory needs to be reported and investigated.

- Suspicious packages need to be immediately reported.

- Access to all raw materials, finished products and packaging are restricted to authorized personnel.

- Storage areas are monitored on a regular basis.

- Chemicals and hazardous materials are locked in access controlled areas when not in use.

- Maintain an up to date inventory of chemicals and any hazardous materials.

- Access to IT infrastructure is restricted.

 

5. Personnel Defense Measures

- Background checks for prospective employees.

- ID cards or swipe cards required

- Any company supplied locker or storage area should spot checked on a random basis.

- Uniforms or other identifying clothing should be worn

- Be aware of any disgruntled employees. They are the most likely to commit intentional adulteration.

 

6. Non-Employee Defense Measures

- Non-Employees are required to follow all company policies. Short training session is preferred prior to entry into production, storage or shipping areas.

- Non-Employees are escorted while in the facility and not allowed access to restricted areas, unless their reason for visiting require access.

- Non-Employees are identified with badges, distinctive clothing, hair coverings, etc.

- Logs of Non-Employee arrival and departure are maintained.

 

7. Training

- Food Defense awareness training is provided to all employees.

- Specific training is provided to employees based upon their duties and responsibilities.

- Training should address access control measures and access to restricted areas.

- All employees are trained to report any suspicious activity.

- Employees that answer phones will be trained to respond to threats directed towards the facility, people, products or the brand of the company.

 

8. Investigation

- Any unusual activity/situation will be investigated by authorized and trained employees.

- All customer complaints will be investigated and resolved within seven days of complaint receipt.

 

9. Challenging the System

- Contract with third party and conduct an assessment where the third party actively tries to enter your facility and access restricted areas.

- Conduct in depth internal audits of the program.

- Place "suspicious packages" in restricted areas. Find out if employees report them.

 

10. Monitoring the system.

- Internal audits of the policies/procedures that make up the system.

- GMP audits should include checking the mitigation strategies that are in place.

 

 

I'm sure there are plenty more, and of course your plan will be totally dependent upon the size and location of your facility, what products you produce, who your employees are, what level of risk you determine you have and how much money is willing to be spent.

 

Marshall

An outstanding summary.

 

For the US members who want to lay out a compliant Food Defense Plan, you can use The FDA's Food Defense Plan Builder.  There are training videos on how to use it.  Here is the plan builder site on the FDA site, with links to everything you need to make a solid plan.  It is a very comprehensive process, and it requires you to make risk assessments for all those categories of threats.

 

There is a FAQ section below the links, and I encourage people to check them out.  It really does answer a lot of questions about food safety and the plan builder.

 

http://www.fda.gov/F.../ucm349888.htm 

 

The definition of Food Defense on this page is the current official definition, so this is what the plan builder addresses.

 

"Food Defense is the effort to protect the food supply against intentional contamination due to sabotage, terrorism, counterfeiting, or other illegal, intentionally harmful means. Potential contaminants include biological, chemical and radiological hazards that are generally not found in foods or their production environment. "

 

Martha


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"...everything can be taken from a man but one thing:  the last of the human freedoms--to choose one's attitude in any given set of circumstances, to choose one's own way."  Viktor E. Frankl

 

"Life's like a movie, write your own ending."  The Muppets


#19 MWidra

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Posted 27 May 2015 - 10:49 AM

*There is a FAQ section below the links, and I encourage people to check them out.  It really does answer a lot of questions about food SECURITY and the plan builder."

 

Sorry, it's early in the morning here.  Please excuse the error.


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"...everything can be taken from a man but one thing:  the last of the human freedoms--to choose one's attitude in any given set of circumstances, to choose one's own way."  Viktor E. Frankl

 

"Life's like a movie, write your own ending."  The Muppets


#20 mgourley

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Posted 27 May 2015 - 11:57 AM

Charles,

 

Yes, intentional adulteration is specifically addressed in the plan. That's what a Food Defense plan is designed to mitigate.

Martha has the FDA's definition listed above.

 

Marshall


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#21 Charles.C

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Posted 27 May 2015 - 05:26 PM

Hi Marshall,

 

Thanks for the above and yr encyclopedic earlier post.

 

I'm getting confused by all these terminologies. :doh:   I meant to ask regarding  EMA , not IA. (EMA is apparently equatable  to the "Food Fraud" of Europe).

 

As i understand EMA is currently (due its [nominally] non-harmful intention)  not in the Food Defence Plan's Scope, ie is located as per attachment below.

Attached File  GMA Comments on Economically Motivated Adulteration Supplemental.pdf   95.77KB   68 downloads

  


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Kind Regards,

 

Charles.C


#22 esquef

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Posted 27 May 2015 - 05:52 PM

For what it's worth here's a Food Defense Plan Builder provided for free by the FDA:

 

http://www.accessdat.../fdplanbuilder/

 

The resulting comprehensive Food Defense/Site Safety plan that it generated was deemed acceptable by our SQF auditor and has been received well by our customer base as well.


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#23 Simon

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Posted 28 May 2015 - 01:17 PM

Great list Marshall and thanks for the link esquef.

Hopefully be of help to those members without a good plan.

 

Regards,
Simon


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#24 BigLou21972

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Posted 29 May 2015 - 03:41 PM

We use the FDA Plan Builder and we love it. Basically you just put in your info and it builds the plan for you. Very structured and detailed.   :sleazy:

                                                                                                                                                                                                                                     Lewis


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#25 mgourley

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Posted 29 May 2015 - 10:40 PM

Many have mentioned the FDA plan builder. I wholeheartedly endorse it as well.

It's really a no brainer to use it, especially if you are in the USA, to comply with FSMA.

One would assume that there is not much a FDA auditor could complain about if your food defense program is based on a tool the FDA has released.

 

Marshall


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