9 replies to this topic

[JSwenPDX]

I'm trying, I really am: Browsing the FDA available content, reading posts here, attending FSMA update sessions in my area, checking for webinars...

 

Is anyone else waiting for the CFR to be updated to take action on any of this? It seems like a whole lot of wasted energy to worry about staying ahead of something so slow moving which will surely have ample guidance and implementation time provided. (Background: I am at a USDA/FDA facility with SQF Level 2 certification.)

 

So my question: FSMA Prep? Really?

 

*Not judging - looking for a convincing argument against waiting.

 

Thanks!

 

J

 

 

[MWidra]

My suspicion is that the draft version that was published in the Federal Register with revisions last September will be the final version and will be published into the CFR on or about August 31, 2015 as required by the consent decree with the court.  Right now, they are probably frantically training inspectors (as they said they would be doing) so that inspections that would be performed after that would be using the new regs.  There have been no notices of changes to those revised rules, so I think they are now cast in stone.

 

http://www.lexology....7c-2527e2020657

 

My guess is that they are waiting because some sites have not yet been visited under the old regs this year (ours has not, and I got the hint that they need to get this done by the end of August) and they want to get that done before they start on the new regs.  But that's just my personal opinion, and it may not be correct.

 

Have no fear, FSMA is coming.

 

Martha

[Setanta]

I don't doubt that FSMA is coming, I remain doubtful that if I am SQF level II (or any GFSI cert) that I will need to do much to align with FSMA.   I could be wrong...but I don't see any US gov't thing being more strict.  Think of all the failures, and all of the inspections that they'd have to deal with.

[ladytygrr]

I don't doubt that FSMA is coming, I remain doubtful that if I am SQF level II (or any GFSI cert) that I will need to do much to align with FSMA.   I could be wrong...but I don't see any US gov't thing being more strict.  Think of all the failures, and all of the inspections that they'd have to deal with.

 

Our company is working with a Food Safety consultant with over 30 years in the business (it's through a university in our state and is free of charge - they provide support to entrepreneurial food companies) and she basically confirmed what Setanta said. If you have GFSI certification or have established programs that align with GFSI requirements, you're most likely NOT going to have to worry.

 

I certainly breathed a sigh of relief on that! 

[3esa]

At times I feel like they're way behind schedule though.

 

I've been job searching here and there and have seen FDA jobs for FSMA related activities (inspectors, guidance document writers).  Even recently I saw a few.

[Charles.C]

The FDA Food Safety Modernization Act (FSMA), the most sweeping reform of our food safety laws in more than 70 years, was signed into law by President Obama on January 4, 2011. It aims to ensure the U.S. food supply is safe by shifting the focus from responding to contamination to preventing it.

 

http://www.fda.gov/F...egulation/FSMA/

 

2016 ?

http://www.foodsafet...t/#.VdT9UrK0v2Q

[MWidra]

http://www.fda.gov/F...egulation/FSMA/

 

2016 ?

http://www.foodsafet...t/#.VdT9UrK0v2Q

 

In case you were not aware, fiscal year 2016 starts in October of 2015 for the US government.  The FDA's funding request, if Congress gets off their lazy seats and works on it, will help cover the additional personnel and costs associated with the Human Food Safety portion (the part that is supposed to go into effect at the end of August) and the Foreign Supplier Verification Program ( due to start October 31, 2015).

 

That FSVP is going to be very important for anyone who sells food to the US, because it places a greater burden on foreign suppliers for proof of food safety than domestic suppliers.

 

Martha

[Setanta]

Since it is August 20th already, I doubt anything is going to pass this year, let alone require any action this year.

[MWidra]

Since it is August 20th already, I doubt anything is going to pass this year, let alone require any action this year.

The Federal Register publication of the revised rules came out last year.  The comment period for that has been over for a long time.  There is nothing more that the FDA needs to do except publish the final rule into the Federal Register and instructing the CFR to be modified.  That would take effect immediately since there has been ample opportunities for public comment.  Right now, the FDA is working on the support programs for the FSVP which is due to go into effect in October.  So they are pretty much done with the Human Food portion of FSMA.  The entire FSMA law is a phased implementation, everything is not going into effect at the same time.

 

Because they were sued by the Center for Food Safety to implement FSMA, and because they entered into a consent decree with the court, it would be difficult to change the Human Food implementation date significantly, because then they could be pulled back into court for contempt.  There is nothing that the Judicial Branch of the government likes more than to make the other branches squirm.  And the Judicial Branch has the final say in everything.

 

I believe that FSMA will probably be delayed by a short time, maybe mid September.  But they may surprise me.  The FDA cannot hire new people until October 1, if they get their budget.  And they don't do most of the inspecting themselves, the states do it under contract to the FDA.  But if all the sites gets visited before August 31, then they have until the end of the year to visit again.

 

Martha

[mgourley]

I believe that FSMA will probably be delayed by a short time, maybe mid September.  But they may surprise me.  The FDA cannot hire new people until October 1, if they get their budget.  And they don't do most of the inspecting themselves, the states do it under contract to the FDA.  But if all the sites gets visited before August 31, then they have until the end of the year to visit again.

 

Martha

 

And this assumes that all the contracted state inspectors have been trained. 

 

Marshall