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Is it wise to change our HACCP Plan to a HARPC?


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#1 HappyCoin

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Posted 06 November 2014 - 03:52 PM

We will soon be starting the annual review of our HACCP Plan and with the rumors floating that FSMA is right around the corner .... would it be wise to change our HACCP Plan to a HARPC?  Has anybody starting doing this yet? 

 

Thank You for the help!!


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#2 RG3

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Posted 06 November 2014 - 05:52 PM

Keep in mind that if you are required to be HACCP compliant you are not required to be HARPC compliant.


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#3 Mike Green

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Posted 06 November 2014 - 08:24 PM

Keep in mind that if you are required to be HACCP compliant you are not required to be HARPC compliant.

 

from the HARPC website

 

 

 

 Is anyone exempt from HARPC?
There are 6 major categories of food facilities that are exempt from HARPC. The first major exemption relates to food companies under the exclusive jurisdiction of the U.S. Department of Agriculture (those handling, processing, shipping meat, poultry, pork, eggs, etc.). The second major exemption is for companies that are subject to FDA’s new Standards for Produce Safety authorities, which were also created by FSMA. This exemption applies to farms, cooperatives, growers, harvesters and other companies handling raw fresh fruits and vegetables. The third major exemption applies to facilities that are subject to and comply with FDA’s seafood and juice HACCP regulations.  The fourth, more limited exemption, involves low acid and acidifed canned food processors, but only as the regulatory controls govern and control certain aspects of microbiological contamination (e.g., botulism). The fifth group of exempt companies includes those defined as “small” or “very small” businesses. FDA is required to define these terms by regulation.  Sixth and last, and very similar to the immediately previous exemption, is the group of companies with a previous 3-year average product value of less than $500,000.  FDA may also, by future regulations, exempt facilities that solely produce food for animals, store raw agricultural commodities (other than fruits and vegetables) intended for further processing or that store packaged foods that are not exposed to the environment.

 

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I may sound like a complete idiot...but actually there are a couple of bits missing

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#4 MWidra

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Posted 06 November 2014 - 08:38 PM

The main difference between HACCP and HARPC that I see a stated emphasis on prevention.  Our HACCP/Food Safety plan is prevention oriented and is getting more so, and would fulfill the requirements that are in the proposed FSMA.

 

I think that the HARPC system was set up because most facilities were only required to operate using cGMP.  So they were not familiar with the risk analysis thought process and the need for monitoring of points where there is a risk of problems.  So maybe HARPC is HACCP for cGMP people.  The HACCP facilities are exempt maybe because they already are compliant for all intents and purposes.

 

We've been beefing up our HACCP plan all along, so I think that it's ready to fulfill the HARPC requirements within our HACCP plan.

 

The beauty of most US regulations is that they are performance based standards.  That means that, except for a small subset, you can become compliant with the regulation in what ever way you want, as long as you accomplish the goal.  For example, it tells you that your hazard analysis must be risk based, and what hazards to consider, but it does not tell you how to assess the risk.

 

So, if your HACCP plan fulfills the requirements of the FSMA, you can call it what you like, you will be in compliance.  :thumbup:

 

Martha


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#5 Snookie

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Posted 06 November 2014 - 08:45 PM

Caveat:  I have done some reading on this and still need to do more.......that being said, this to me is a "a rose by any other name..." and political.  From what I read a properly done HACCP plan will do the same thing as a HARPC, but think the key to this political.  On HARPC website under frequently asked questions it says the following: 

 

HACCP (Hazard Analysis and Critical Control Point) is the FDA’s regulatory predecessor to FSMA’s statutory HARPC.  HACCP is a very similar hazard control system, but only applies to seafood and juice processors.  HARPC applies to all food facilities subject to FDA registration except those covered by and in compliance with HACCP (and a few other significant exemptions discussed below). Another significant difference is that seafood and juice HACCP were created by FDA regulation – not by federal statute. HARPC was created by an amendment to the Food Drug and Cosmetic Act, specifically, the Food Safety Modernization Act (FSMA). Although arguments could be made that seafood and juice HACCP are unconstitutional, in that they were created by a federal agency and not by the federal legislative process, those arguments do not exist for HARPC.

 

So FMSA created HARPC to sidestep all the legal issues, and but some teeth behind it. 


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#6 MWidra

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Posted 06 November 2014 - 09:05 PM

Caveat:  I have done some reading on this and still need to do more.......that being said, this to me is a "a rose by any other name..." and political.  From what I read a properly done HACCP plan will do the same thing as a HARPC, but think the key to this political.  On HARPC website under frequently asked questions it says the following: 

 

HACCP (Hazard Analysis and Critical Control Point) is the FDA’s regulatory predecessor to FSMA’s statutory HARPC.  HACCP is a very similar hazard control system, but only applies to seafood and juice processors.  HARPC applies to all food facilities subject to FDA registration except those covered by and in compliance with HACCP (and a few other significant exemptions discussed below). Another significant difference is that seafood and juice HACCP were created by FDA regulation – not by federal statute. HARPC was created by an amendment to the Food Drug and Cosmetic Act, specifically, the Food Safety Modernization Act (FSMA). Although arguments could be made that seafood and juice HACCP are unconstitutional, in that they were created by a federal agency and not by the federal legislative process, those arguments do not exist for HARPC.

 

So FMSA created HARPC to sidestep all the legal issues, and but some teeth behind it. 

The Caveat on that web site, which is HARPC.com, is that this is from a consulting firm that wants to sell you a HARPC plan of their making.

 

If you search on the FDA website, you get no hits for HARPC, but you do for HACCP.  I just read the text of the proposed law in the hazard analysis section, and it has a description of what you need to accomplish, but it does not call it HARPC.

 

Just follow the final  regs, when they come out, there is a year to implement, and you should be fine.  :shades:

 

Martha


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#7 RG3

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Posted 06 November 2014 - 11:27 PM

Except they want you to add Radiological as part of the Hazards.


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#8 Snookie

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Posted 07 November 2014 - 12:03 AM

Except they want you to add Radiological as part of the Hazards.

 

Crazy just crazy! 

 

But then

 

The Caveat on that web site, which is HARPC.com, is that this is from a consulting firm that wants to sell you a HARPC plan of their making.

 

If you search on the FDA website, you get no hits for HARPC, but you do for HACCP.  I just read the text of the proposed law in the hazard analysis section, and it has a description of what you need to accomplish, but it does not call it HARPC.

 

Just follow the final  regs, when they come out, there is a year to implement, and you should be fine.  :shades:

 

Martha

 I caught that it is a consulting firm that owns the website, and I agree with Martha, wait until final regs come out. 


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#9 MWidra

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Posted 07 November 2014 - 03:13 AM

Except they want you to add Radiological as part of the Hazards.

True, but it's easy to add one more line to your risk assessments, especially since that should be mostly negligable, unless we are getting raw materials from Bikini Atoll.   :o

 

Martha


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#10 HappyCoin

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Posted 07 November 2014 - 01:57 PM

Thank You for all of the information that has been passed along.  I believe that we will wait until final regualtions come out.

 

Thanks Again


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#11 Snookie

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Posted 07 November 2014 - 05:50 PM

True, but it's easy to add one more line to your risk assessments, especially since that should be mostly negligable, unless we are getting raw materials from Bikini Atoll.   :o

 

Martha

 

Not necessarily true.  Have friends who work in the radiological sciences.  You would be surprised at the amount of background radiation on the planet and where it goes.  But that does not mean its a problem.  But since so many don't understand it, it will cause too much stress to prevent non-existent safety issues.   


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#12 MWidra

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Posted 10 November 2014 - 01:57 PM

Not necessarily true.  Have friends who work in the radiological sciences.  You would be surprised at the amount of background radiation on the planet and where it goes.  But that does not mean its a problem.  But since so many don't understand it, it will cause too much stress to prevent non-existent safety issues.   

Yes, but you have to remember that the important consideration for radiological risk is only if the radiation would be above the normal background radiation.  And the limit of exposure for the general public is much higher than for radiological workers, which your friends would be concerned about.  Like the mercury levels in fish in a particular lake or stream, any area with higher radioactivity would be known and available for quick research.

 

Just a slightly off topic trivia, there was a lot of glassware and dishes that was produced in the 1930s and 40s using uranium as a pigment.  It gives a particular orange color to ceramics and green to glass.  It is not considered harmful to have it sitting around, since most of the radiation is absorbed by the air within about an inch or so, and it's low energy alpha particles.  But the uranium or other heavy metals can leach off into food if it is used for storage or for acidic foods.  It's fun to see it glow in the dark (actually under black light), in the case of the glass.  :off_topic:

 

http://en.wikipedia....i/Uranium_glass

 

http://en.wikipedia....sta_(dinnerware)

 

This is from a former RSO (radiation safety officer) for a biotech firm.

 

Martha


Edited by MWidra, 10 November 2014 - 02:03 PM.

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#13 Snookie

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Posted 10 November 2014 - 05:31 PM

True, but it's easy to add one more line to your risk assessments, especially since that should be mostly negligable, unless we are getting raw materials from Bikini Atoll.   :o

 

Martha

 

Except how many companies have tested for this and can assure that it is within normal limits. 

 

 

Yes, but you have to remember that the important consideration for radiological risk is only if the radiation would be above the normal background radiation.  And the limit of exposure for the general public is much higher than for radiological workers, which your friends would be concerned about.  Like the mercury levels in fish in a particular lake or stream, any area with higher radioactivity would be known and available for quick research.

 

Yes, but again how many are testing for this and this would not be cheap and this would not be a procedure done at most labs.   I don't know about you but food is pricey enough without adding additional costs that may not be value added. 

 

Note to self:  Open new count lab, could be big bucks..


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#14 MWidra

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Posted 10 November 2014 - 07:03 PM

Except how many companies have tested for this and can assure that it is within normal limits. 

 

 

 

Yes, but again how many are testing for this and this would not be cheap and this would not be a procedure done at most labs.   I don't know about you but food is pricey enough without adding additional costs that may not be value added. 

 

Note to self:  Open new count lab, could be big bucks..

The EPA, the USDA and the FDA monitor radiation levels the best that I can ascertain.  The EPA monitors the levels in precipitation, drinking water and air.  The FDA monitors imported food.  I think that the USDA monitors meat and dairy products.  Between all of them, the data has been gathered for how much radiation is usually around in regions of the country or world and how much is being found in food products.  We don't have to monitor for it ourselves.

 

But...getting to that data is not super easy nor is it easy to interpret.  But I think it is not insurmountable.  So here are some ways I see to perform the risk assessment:

  1. The FDA would block any food that is being imported that is unsafe (remember, all imported cargo is tested for radioactivity as part of our Homeland Security initiative), if your raw materials are imported.  So there is a low risk there for imported food materials, since the FDA will be doing the testing.
  2. For raw materials from domestic sources, you may need to check the EPA data on the location where the material is produced to see if there are elevated environmental radiation levels.  The environment will be the source of the contamination of the material.  If the area is not considered to be a high radiation area, then your risk assessment could state that the risk is low because of EPA monitoring.  You may want to check each year to see if the levels have changed, but I think that the EPA would be placing bans on food production in contaminated areas.
  3. If you are irradiating your own products as a microbiological control measure, that could be a real source of risk due to the presence of radioactive materials on site, and you would need to consider how to control the possibility of contamination due to a breaking of the sealed source.  For that you would need to have a protocol in place.

People in the US are terrified of radiation, so there have been a lot of controls put in place for that risk.

 

Setting up a rad lab is expensive, but not prohibitively so.  I would use liquid scintillation counting of samples.  I seem to remember that a new counter costs about $60,000 and you would need someone to prep the samples and run the counts.  That is a lot of money, but it's not a huge price tag if you have paid for something to irradiate your products which is more expensive.  The only time I would consider it to be necessary would be if you are irradiating your product on site, and you then would be doing a monitoring program anyway.

 

I really think that the risk assessment is easy unless you are irradiating your product, and then it is still pretty straightforward.  But that's my $0.02.

 

Martha


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#15 ChocoTiger

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Posted 02 March 2015 - 10:24 PM

I listened to a webinar about moving from HACCP to HARPC, and asked a question about the similarity between the Food Safety Plan required by HARPC, and the Food Safety Plan required by SQF.  The answer given was that the 2 are very similar/aligned, with very few gaps between them.  Being SQF Level 2 (Module 2 & 11) puts a facility in a good place, according to the panel in the webinar.  There's a lot of talk about Risk Assessment, and the use of "Significant" instead of "Reasonably likely to occur".  I had to do a really in-depth, step-by-step Risk Analysis of my HACCP Plans for the SQF Level 2 Audit at my facility, which seems to also be required.  I think a combination of the SQF Food Safety Plan, a HACCP Plan Risk Assessment, and the HACCP Plan itself should fulfill the requirements of HARPC.


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#16 Simon

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Posted 03 March 2015 - 07:06 AM

I asked our webinar speaker from NSF the other week if a business has for example GFSI certification and a fully functioning and effective HACCP plan then will it be evolution or revolution to get to HARPC.  He said mostly some terminology differences, also need to consider radiological hazards (and that could be literally a one liner if N/A) and beefed up a little on food defense.  If you already have a strong food defense program as part of your FSMS then you should be ok.  So evolution..


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#17 Mr. Incognito

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Posted 03 March 2015 - 01:45 PM

We, as a company, are not doing a damn thing with this steaming pile of garbage until it's set law and the actual regulations are out.


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#18 Mr. Incognito

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Posted 03 March 2015 - 01:45 PM

We, as a company, are not doing a damn thing with this steaming pile of garbage until it's set law and the actual regulations are out.


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#19 Snookie

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Posted 03 March 2015 - 04:47 PM

We, as a company, are not doing a damn thing with this steaming pile of garbage until it's set law and the actual regulations are out.

 

 

AMEN & AMEN!!


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#20 MWidra

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Posted 17 March 2015 - 02:07 PM

For those who want to get a White Paper on incorporating the FSMA requirements into your current plans, SGS has offered one free.

 

http://www.foodquali.../view/1053634/2

 

Martha


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