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Draft of the Preventive Controls Guidance Document Available

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#1 MWidra

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Posted 24 August 2016 - 09:25 PM

The FDA has published a draft of the guidance document for the HARPC for Human Foods.  It is available at the link below.  They have opened a comment period, so this is just the draft.  At the bottom of the page, there is a place for you to download the document.  It is 185 pages long, so I won't upload the file here.

 

http://www.fda.gov/F...rce=govdelivery

 

 

Martha


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#2 Charles.C

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Posted 25 August 2016 - 02:29 AM

The FDA has published a draft of the guidance document for the HARPC for Human Foods.  It is available at the link below.  They have opened a comment period, so this is just the draft.  At the bottom of the page, there is a place for you to download the document.  It is 185 pages long, so I won't upload the file here.

 

http://www.fda.gov/F...rce=govdelivery

 

 

Martha

 

Hi Martha,

 

Many Thks for the info.

 

A few comments -

 

Regarding yr OP, afaik (= based on post/thread below) the terminology HARPC has now been abandoned. Officially or not is unclear to me. It certainly does not seem to appear in the primary link of OP or any of its active attachments.

http://www.ifsqn.com...al/#entry104808

 

i scanned the issued Chapters. Impressive, wide-scoped, material but, for me, seems (so far) to have one immediate critical defect - zero worked examples (cf the FDA's previous practical  "magnum opus" - HACCP Fishery Guide,2011).

 

Presumably substantial overlap with the FSPCA manual. I noted various xreferences.

 

I am still trying to find an unambiguous answer (ie Yes/No) to one simple, FSMA, question - Is one permitted under FSMA to submit a "Food Safety Plan"  which makes use of  (named) CCPs ? (I note that the linked document carefully mentions (Pg 11)  "You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations." Hmmmm.)


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Charles.C


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#3 MWidra

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Posted 25 August 2016 - 03:48 AM

Hi Martha,

 

Many Thks for the info.

 

A few comments -

 

Regarding yr OP, afaik (= based on post/thread below) the terminology HARPC has now been abandoned. Officially or not is unclear to me. It certainly does not seem to appear in the primary link of OP or any of its active attachments.

http://www.ifsqn.com...al/#entry104808

 

i scanned the issued Chapters. Impressive, wide-scoped, material but, for me, seems to have one immediate critical defect - zero worked examples (cf the FDA's previous practical  "magnum opus" - HACCP Fishery Guide,2011).

 

Presumably substantial overlap with the FSPCA manual. I noted various xreferences.

 

I am still trying to find an unambiguous answer (ie Yes/No) to one simple, FSMA, question - Is one permitted under FSMA to submit a "Food Safety Plan"  which makes use of  (named) CCPs ? (I note that the linked document carefully mentions (Pg 11)  "You can use an alternative approach if it satisfies the requirements of the applicable statutes and regulations." Hmmmm.)

Charles, FDA really never used the term HARPC officially, it has been promulgated by the people who have written about it.  That's why you don't see it in the guidance document.

 

The FSPCA material was derived from the Human Preventive Controls regulations, so the xreferences are to be expected.

 

You never submit a food safety plan to the FDA.  People don't realize that.  It's not like a certification where they initially approve your plan, it's just the law.  So you don't ever send it to the FDA, but you need it set up for when they appear out of nowhere.  The day they show up at your site, you show an inspector what you do, and they determine if it meets the requirements of their regulations.  You can make a Human Preventive Controls plan, to make it easy so it's all in one place, but you don't have to.  If you have a food safety plan which is almost but not quite compliant, and can produce evidence that you follow the regulations with supplemental plans, it is OK.  This was clearly stated at the public meeting at the time of the publication of the Preventive Controls regulations.  The recording of that meeting is on the FDA site.  

In general, most US regulations are performance based compliance, you are fine as long as you get to where you are supposed to be.  How you get there is up to you.  There are some regulations which are standard based, which means that you need to follow a specific manner to achieve the compliance.  They will spell out the exact things you need to do.  An example is the nutritional label, that is standard based compliance.  Most of the Human Preventive Controls are performance based, so it does not cause an undue burden on a company.  I know this is different from many other countries in the world, but we value our individuality.  As long as it comes out right in the end, we can do it how we want.   ;)

 

Martha


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#4 Charles.C

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Posted 25 August 2016 - 06:27 AM

Hi Martha,

 

Thks.

 

I think the implication was that everyone should now stop using harpc. Hence my interest. The implicit guidance competitor, FSP, sounds feeble IMO.

 

I appreciate yr comment about submittance. IIRC the Final Seafood Rule had the same effective implementation technique.

 

I deduce you believe that the textual use of  "CCP" within a harpc/fsp will be unobjectionable to FDA. 


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Charles.C


#5 Simon

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Posted 25 August 2016 - 06:37 AM

Thanks for the clarifications Martha.

 

You may want to check the latest two article on the site: http://www.ifsqn.com...html/_/articles

 

If you have BRC/FSSC you won't be a million miles away and fundamentally you should have an effective FSMS that is keeping your products safe.

 

Cheers,

Simon


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#6 Charles.C

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Posted 25 August 2016 - 07:57 AM

Thanks for the clarifications Martha.

 

You may want to check the latest two article on the site: http://www.ifsqn.com...html/_/articles

 

If you have BRC/FSSC you won't be a million miles away and fundamentally you should have an effective FSMS that is keeping your products safe.

 

Cheers,

Simon

 

Sadly, the key link on the BRC website ("Click here") seems to be inactive to my browser (re-tried one week later, ditto, link seems abandoned).

 

http://www.brcglobal...px#.V76jmF43kyR

 

I have to say that the concept (by virtue of being GFSI recognized) of being able to "by-pass" all the innovative FS contributions developed by the FDA/laid out in the FSPCA manual over the last 2-3 years is somewhat mind-boggling (apparently even including the PQSI !) .

 

There will surely be a catch somewhere.

 

The interesting part for many factories will perhaps be as to how much of the BRC7 standard can also be neglected. Salsa ?


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Charles.C


#7 mgourley

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Posted 25 August 2016 - 08:38 AM

My quibble would be the items that are (coming soon).

 

Seems to me that's where the meat of the guidance will be found.

 

Marshall


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#8 Charles.C

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Posted 25 August 2016 - 03:54 PM

JFInterest, here is an SQF/FSMA comparison Report/Table presumably "equivalent" to the BRC one mentioned above (I daresay the report was previously posted on the forum). Note that this is dated 2015 and for the scope defined in the report. (The timing of the BRC comparison (similarly sourced) is unmentioned on website).  

The Report is detailed (93 Pgs) and in places illuminating but seems to more focus on how SQF's own content is echoed/matched by text in the FSMA Rules. I would have thought the reverse presentation would ultimately be the critical one.

 

Possibly relevant to some of the above posts, i noted this final paragraph/caveat -

 

As noted being compliant with SQF level 2 will place a facility in a significant positive position
for Human Preventive Control Rule compliance.  However, it is important to note that FDA will
likely still want to see a HARPC focused food safety plan
. This will obviously refer heavily to all
that is the SQF material, but planning on how to address a FDA inspector’s question “Please
show me your food safety plan” is a good idea.  So be ready to have some type of overarching
document that pulls together all the various aspects of a food safety plan, referring to all your
SQF compliance information, is a good way to prepare.

(Note the usage of "HARPC" as a differentiating tool, perhaps to soon be replaced by "FSMA" ?)

 

Attached File  SQF (Lvl2) - FSMA Comparison Model, October 2015.pdf   1.3MB   110 downloads


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Charles.C


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#9 Charles.C

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Posted 01 September 2016 - 04:08 AM

JFI again, i noticed this (maybe speculative) comment regarding CCPs in HARPC (dec2015/jan 2016). The recently (unseen by me) issued BRC - FSMA/ compatible(?) FS Standard may also clarify the situation (albeit FSMA-HARPC Guidance documentation seems still at Draft Stage ?)

 

HACCP vs. HARPC
HARPC is similar to HACCP in that it points out a need for control when there is a significant hazard.[1] Both HARPC and HACCP are risk assessments, but they differ, slightly, in how significant hazards are addressed. Classic HACCP employs a CCP whenever there is a significant hazard; however, HARPC recognizes that there might be a program, such as handwashing, that is used as a control for a significant hazard but may not have parameters like a traditional CCP. Because some of these programs do not have parameters, HARPC requests additional documentation for them, which a CCP also requires, such as monitoring, corrective action and verification. Under HARPC, a preventive control is a control measure that prevents or minimizes a significant hazard. Since a CCP meets the definition of what is a preventive control under HARPC, a company may continue using CCPs within their plan.[1]

 

(NB - minimizes is a return to CCP-concepts given up around 2 decades ago !)

http://www.foodsafet...od-safety-plan/


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#10 Charles.C

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Posted 04 September 2016 - 11:23 AM

Hi All,

 

i daresay people directly FSMA involved are familiar with the current (ongoing) article linked below but if otherwise it makes fascinating reading IMO as to some of the HARPC problems indicated above and in a parallel baking thread (No.27549) -

 

https://foodsafetyte...ntive-controls/

 

I particularly noted the 2016 contributions dated May16, June01, June15.

 

i had also not realised the potential harpc difficulties where existing iso 22000 schemes are concerned, ie due the notorious OPRP.


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Charles.C






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