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FSMA Preventive Controls Rule

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#1 Ryan M.

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Posted 19 December 2016 - 03:11 PM

The Global Food Safety Resources website has a few good articles on the FSMA and some of the rules.  A good overview for those who are unfamiliar with FSMA.

 

The Food Safety Modernization Act (FSMA) - An Overview

 

FSMA Preventive Controls Rule

 

FSMA Foreign Supplier Verification Act

 

FSMA Produce Rule

 

I hope you find this helpful.

 

Ryan


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#2 rpp_k

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Posted 22 December 2016 - 01:02 AM

Thank you very much (>_<)b


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#3 MDG

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Posted 22 December 2016 - 03:01 AM

Thank you.


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#4 Charles.C

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Posted 22 December 2016 - 04:42 AM

Hi Ryan,

 

Interesting stuff, thks although i suspect the details are less simple than perhaps implied.

 

Not my area fortunately but I query some of the content, eg states some businesses required to comply preventive controls rule by September 17, 2015 + 1 yr, ie already.  Are the FDA  already actively approving Businesses' submitted HARPC documents ? Just Curious.

 

I get the impression that the (haccp) details of how to determine Preventive Controls are still under debate in spite of things like PCQI training courses being in full motion.

 

I have been waiting with interest to see the methodology for the FDA's proposed Risk-based List of Foods  (classified into High/Low risk etc) for maybe 1-2 years now. Still unreleased afaik ? (a table of Risk-assessed Farm activities was released in Draft a long time ago and may be finalised in the Farm Final Document mentioned/linked).


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Kind Regards,

 

Charles.C


#5 Ryan M.

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Posted 23 December 2016 - 03:25 AM

For large businesses it is required. Those businesses must have a PCQI person available and have a food safety plan written in terms of the HARPC process. You don't submit the plan to regulators, but rather you must have it documented, available, and have he supporting records to show the inspectors.

Determining preventive controls are based on the risk assessment of your hazard analaysis. The real difference is the hazard analysis takes it as the perspective of no controls in place, e.g. You don't consider pasteurization during the hazard analysis and risk asssessment. However, the hazards should be reasonably likely to occur. So, for fluid dairy in a tanker foreign material such as wood would not be considered a hazard because it is not likely to occur.

The FDA will have some types of products/processes defaulted as high or low risk, but a lot of them will be based on their inspection of your food safety plan, your process and your facility. So while a product or process may be considered high risk, if the facility and he management of that risk is sufficient in the eyes of the inspector the risk could be considered low.

This is new to the inspectors so it will be a learning curve. Honestly it wll probably take another 5 to 10 years before before it becomes a natural process. By hen the next big and best food safety regulation will be along.


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#6 Charles.C

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Posted 23 December 2016 - 06:40 AM

Hi Ryan,

 

Thks for above.

 

I think maybe you missed the thrust of my RA comments. A specific list has been FDA-promised with the (then) proposed RA methodology already drafted. Eons ago.

For Fresh Produce a massive RA using a potentially "similar" technique has been done and the results published (and attached on this forum).

I'm not criticising the delay since I  anticipate that any general quantitative approach (not MRA oriented) will be a slog. But this list, as i understood, was intended to be a fundamental crutch for the entire New System. Maybe it's already being quietly "shelved". (Like Brexit ?)

 

I have somewhat avoided the FSMA topics since my background reading seemed to have concluded that currently, the "learning curve" is a mess and everyone is going to see various oddities come to light as intimated in yr previous post. The extracts attached in this post seemed to crystallise recent progress and their source thread seems to me (a non-USA observer) to contain "cutting-edge" evaluations -

 

http://www.ifsqn.com...ce/#entry107725

 

The non-submitting procedure you refer is, I think, identical to that employed by FDA for their seafood haccp pioneering introduction. It tended to mute/divert  direct public confrontations. I liked parts of the PCQI manual very much indeed but it also IMO totally avoids some basic nitty-gritty, real-life situations as has been discussed here previously. It also, IIRC, appeared inconsistent with some of the specific RA requirements as defined in the CFR rules. Certain of these divergences have been noted/published and also discussed on this forum. Afaik, no subsequent instructional revisions have been made but i may be out of touch.

 

Frankly, I am still unsure if this is not all "Much Ado About Nothing" from a purely RA POV.


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Kind Regards,

 

Charles.C






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