6 replies to this topic

[MWidra]

Next batch of FSMA rules submitted to the Federal Register for publication. It takes a few days, so they will be out very soon. FDA is keeping to the schedule given by the court. their news release says " The FDA has submitted the final produce safety, foreign supplier verification and third party accreditation rules to the Federal Register for publication."

 

Martha

[Simon]

Thanks for the update Martha.

[MWidra]

And the rules were published in the Federal Register today.

 

Link to the FDA page on the FSVP (Foreign Supplier Verification Program):

 

http://www.fda.gov/F...ovdelivery#key 

 

Link to the Produce Safety Standards:

 

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

 

LInk to Webinars on these and the Third Party Auditors Standards:

 

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

 

The webinars in the series have been excellent, and worth looking at, either live or afterwards.

 

Martha

[Simon]

Thanks for keeping members up to date on the FSMA, much appreciated.

 

Can you sum up the FSMA in a paragraph? If not I'll watch the webinars.

 

Regards,

Simon

[MWidra]

Thanks for keeping members up to date on the FSMA, much appreciated.

 

Can you sum up the FSMA in a paragraph? If not I'll watch the webinars.

 

Regards,

Simon

Actually, FSMA is not hard to understand if you are already GFSI or working on it.  If you are used to the "old way" of FDA food regulation, it is a shock.

 

If I were to summarize FSMA as I see it, but I'm not an expert, I would list some critical points:

 

1. It's taking HACCP to a higher level.

2. Instead of Critical Control Points, were you find spots where you can control a hazard, it involves the broader thought of Preventive (not preventative) Controls

3. These PCs are based on RISK as well as the hazard, and you have to do a risk-based hazard assessment of your entire process, including hazards that raw materials would bring in.  That is slightly different than your HACCP hazard assessment.

4. If you cannot initiate a PC to control for a hazard that has a reasonable risk, then you have to either make sure that your suppliers or your customers are controlling that hazard, and that you verify that fact, or you notify your customers that your food is not controlled for that hazard.  This, of course, is not permitted for RTE foods.

5. The Human Food Preventive Controls does not apply to produce or farms or anyone who is covered by some specific programs.  You would need to check for the exemptions to see if you are not covered by the Preventive Controls rules.

6. Animal foods are now being regulated to a similar standard as human food.

7. You are required to assess the hazards that raw materials from foreign suppliers could bring into your process, using a risk-based assessment.  If any are significant, and cannot be controlled in your process, you must verify that they are being controlled by the supplier.  Foreign suppliers are being held to a higher standard than domestic suppliers.

 

This is a huge simplification of the rules, but you get the idea that the philosophy has changed from the "react to adulterations" procedures to "prevent adulteration" procedures.  If you are GFSI, you are probably about 90% FSMA ready, and your program will only need some tweaking.  At least that's what the webinars are saying.

 

There are some groups doing FSMA webinars, many in concert with The Acheson Group (TAG), who are consultants.  I would check out any webinars available where TAG is presenting, the person who usually presents is a food safety attorney and knows the law very well.

 

And, please, read the fact sheets on the FDA site and look for the guidance documents when they come out after January.  You can sign up for FSMA updates on the FDA site, there is an entire page and section on FSMA there.

 

Large companies have one year to comply, smaller ones 2 years, and some others 3 years.  Check that out as well.

 

Martha

[Simon]

Brilliant Martha...very helpful.

 

Thanks,

Simon

[usfresh]

Thank you for this info! 
Really helpful!