FSMA - Sanitary Transportation

Hello,

The company I work for manufactures seasoning blends and we also sell single ingredient spices.  I believe the proposed rule deadline for FDA to finalize for FSMA - Sanitary Transportation is March 31, 2016.

My question pertaining to that section is the reference to exceptions to the general rule.  FDA website lists Shelf stable food completely enclosed in a container as an exception which I believe we fall under.  With our product storage at ambient temp, sealed packaging (sealed plastic containers or sealed plastic bags shipped in a box), and if these two aspects are maintained these will not become unsafe throughout it's storage life.  In my admittedly sometimes challenged mind, this would make the risk low for adulteration during transport.  I am just running this past all you Quality gurus to see if you agree we would be exempt from this part.

And if I am wrong, set me straight!

As always, thanks for the valued guidance

P.S. The company passed it's first GMP audit at both locations last month.  We are now continuing working toward SQF Level II certification.

Qkel, I few questions to pontificate on too if you have not already

Are these blends or spices very expensive and/or easily substituted with something else?

Are your trucks company owned or different for every load?

How many loads do you send in a month or year?

How about a trailer seal program? 

Are they always full loads, or LTLs?

How many stop points does the load make before it reaches the final customer?

Is it sold to a broker, then to a customer?

I am sure I am missing some good ones...

But you are correct IMO from a packaging and temp stand point you are low risk

G

G, thanks for replying to my inquiry.

I totally understand why you pose the questions and appreciate that you have.

I have been already tossing most of those around.  Our transportation options are not singular and are customer types are varied.

It's going to take a hazard analysis to make sure we make the right determination for ourselves.

I guess what I am trying to determine is are we meeting the criteria of the exception.  The FDA only states shelf stable food completely enclosed in a container.  In my opinion, that statement is not as specific as it could be.

And one other tidbit.  On my original post above, I mentioned passing the first GMP audit.  I want to thank everyone on this forum.  Without this resource and your very much appreciated suggestions and guidance, I truly think I would have lost my mind.  I was so focused for the past couple of years bringing Quality up to where it needed to be to even have the audit, at times, I was wondering what the heck I got myself into.  I do have to say, I have a wonderful Quality team that has developed fully over the last year from one to five total that has made all the difference in the world.  The Quality Supervisor alone has made a huge impact with his efforts.  When I started, they thought one person could do Quality and SQF.  Now everyone from management down are coming along quite nicely to understand what it's going to take to get to this next level.  Trust me, we still have snafus back to the olden days, but the buy-in has improved and made all the difference in the world to move from being reactive to proactive. 

All that's great and all, but for this old quality gal, you all made the most difference in my little neck of the woods.  So thanks!

O the government will always be a vague as possible.  Multiple carries, customers, and LTLs complicate your shipping.  So maybe get some those above mentioned staff together and see if as a team you can say you feel your loads are safe or where you need small improvements.  If you can back up your statement of "we are low risk" because of X, Y & 1, 2 you will be fine.

Food safety is one big elephant and you are eating the same way most of us do, 1 bite at a time.  In due time you will have a robust program, after all getting the whole team paddling in the correct direction is the biggest hurdle.

Fight on!!

G