W-A-A-A-A-Y Too Long

This FSMA thing actually coming to fruition is just taking way too long.  They are still considering proposals.  I read something yesterday that said they think that things might start moving in 2017.  The Act was signed in 2011.


And now the Fed wants to get involved (tax) the internet or it’s users?  They are already trying to or controlling health care.


These guys are too much.




FDA – Gone

Sen. Dick Durbin and Rep. Rosa DeLauro have introduced a bill in Congress that would establish a single, independent federal food safety agency.  Food safety oversight is currently split up among 15 agencies.  Durbin and DeLauro want to create the “Food Safety Administration”.


If this passes, in our opinion, this will further prolong real enforcement of FSMA.  Heck, it’s already been 4 years and nothing has happened!






FSMA (Food Safety Modernization Act) now requires that all facilities that holds, prepares, packs, warehouses, distributes, manufactures, bottles, cans, etc foods have a HACCP plan or food safety plan.


If you haven’t, start on yours today.  This is a must.



FDA in 2015?

They will probably still be finalizing their proposed rules.  So taking an educated guess that there will  not be a lot of audits.  We recommend that you be ready for them in the later half of 2016.

*  You should have programs set up for all of your preventive controls.

*  You should monitor your programs and your supply chains’ programs.

*  You should have a program for your corrective actions.

*  You should have a program that is easily accessible for your documents.

*  You should have an environmental monitoring (mentioned in this blog earlier) program.

*  You should have a mock audit for all of the above.




111 Folks Sick

111 people are stricken with salmonella from eating beans sprouts.


But my question is, since bean sprouts are hard to clean and really can’t be cooked if you like them on a sandwich, what do you do?  Just not eat them?




Getting Ready for FDA

The first thing we recommend that you do is hire or assign an individual who understands the Food Defense rule, HACCP, preventive controls rule, has been through a GFSI audit, and knows who is in your supply chain.


With this knowledge, that individual should be getting you prepared for the next visit by FDA.




Tattle Tale

Remember that because of FSMA, FDA may make it mandatory for us as auditors to call FDA if we see a non-conformance in your plant.


You may want to voice your concern regarding this with FDA.





Do It Now.

You may want to consider becoming GFSI certified before your current customers ask you to.  For most it’s about a 7-8 month process.


And when you do become certified, it’s a great marketing tool for future prospects.






Are You High Risk or Non High Risk?

Under FSMA, FDA is saying that they are going to be inspecting high risk food companies once every 3 years and non high risk food companies once every 5 years.  One criteria for placing your firm in the high risk category is if you have had past problems like a recall.


So first of all you have to find out what category your company is in.  Our recommendation is not to call them but to find out on your own.


But the frequency of inspections seems curious to me.  If FDA is trying to ramp up this big huge program, it seems strange to me that they are only going to be inspecting some facilities once every 5 years.  Back in the 70’s and 80’s, we knew food processors that were being audited at a minimum of once per year.