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March FSMA Fridays - Supply Chain Controls - How Preventive Controls for Human Food & FSVP Fit Together

Posted on April 24, 2018 by Brian Sharp

March FSMA Fridays - Preventive Controls and FSVPAs FSMA compliance date ticks closer, the dialog continues on FSMA Fridays. In our March 2016 session, Dr. David Acheson and Rolando Gonzalez with The Acheson Group was on hand to share the latest FSMA updates and provide additional insights on supply chain controls and how the preventive controls for human foods and the foreign supply verification program fit together.  This topic was derived from the TAG / SafetyChain FSMA readiness survey – as an area that the industry needed further insights on.  This survey report is now available, and can be accessed here.

Here are a few select highlights from our March session – to hear the complete session recording – access here.

Latest FSMA updates from Dr. Acheson:

  • With Mike Taylor leaving the Food and Drug Administration, Dr. Acheson response to whether his departure would have an impact on timelines, changes to FSMA:

I think Mike deserves a lot of kudos for having driven the regulations through and got us to this point. The person who is taking over for him, Dr. Steve Ostroff, is now in charge of what I think is totally the hardest part of this, which is driving it through to the execution and truly implementing the changes. So, I think we’ll see some changes, and of course, remember it’s an election year, as like how can we forget, and that also slows everything down.

  • Still in holding pattern waiting for guidance documents. As a result, a lot of companies will have to move forward without the guidance documents and interpret the rules the best they can.
  • More money going into different components of FSMA; about 25 million into training focused on produce. Then announced that that is slightly being focused on training the states on how to interpret the produce rule and inspect that which inspect farms in relation to that.  
  • Many training programs now in place that are coming out for the PCQIs (Preventive Control Qualified Individuals). Still expecting training programs like the PCQI to be coming out on the produce, and ultimately on foreign supply verification program.
  • Sanitary transport rule is due out end of month – the April FSMA Fridays session is due to cover this final rule.

Why supply chain controls matter

As shared by Mr. Gonzalez: Food safety events in the recent past have generated significant media attention and resolve a pretty much increased concern over the food supply in general. We can probably all think about examples of issues that have been brought about by suppliers both domestically and those who provide us food and ingredients from overseas of course. We’ve seen product recalls offer regulations, new industry standards, with no question that they’re all impacting the food and beverage supply chains, pretty much worldwide.

With a supply chain that is getting increasingly complex and globalized, the situation is definitely not likely to get any easier, so we’ve seen some of these high profile cases of food safety outbreaks, with substantial economic consequences, last sales, recalls, compensation costs, damaged reputations, and ultimately putting some of these companies out of business.  So, by implementing controls within their supply chain, businesses can improve this ability into their upstream sources.

In that way determine whether their system is, and the solutions that they have in place are sufficient to comply with the new rules and regulations, respond to the, pretty much ever-evolving consumer habits and demands, and also protect their brands from the potentially damaging impact of a recall, perhaps an outbreak of food-borne illness. It also helps sufficient companies such responsive and proactive entities in mitigating risk and protecting public health. So, it’s definitely a good idea. That’s why supply chain controls truly matter and companies should definitely pay attention to that.

How FSMA evolved with regard to supply chain regulatory requirements

Abbreviated version of what Dr. Acheson shared:  As a food company, wherever you are in the supply chain, whether you are on a farm, or manufacturer, or a distributor or food service retail, one of the most frequent calls, and maybe the most frequent calls, other than labeling issues with allergens, is when you get that phone call from one of your suppliers saying, “We just realized we shipped you something that’s causing a problem.”

We’ve seen a number of situations where supply chain controls have caused fairly massive, broad, high consequence recalls, and we said before that the Peanut Corporation of America, example was a big driver.

Those of you who think back to PCA, that recall, in fact, there were several from a couple of plants, triggered up close to 4,000 other recalls of people in the downstream supply chain who'd received this product, and that was massive.  The recall started in January and continued through to July; it just kept going on and on and on, and I think this got congress to say, “We need to make sure that food companies take responsibility from a regulatory perspective of their suppliers.”

So it was really because of that and because of other situations where we’d seen recalls that had got pretty broad because there was a failure to control supply chain risk that this went into the statute and basically the statute said, “Okay FDA, you’ve got the authority to require supply chain controls.”

Again, those of you who remember back to the first version of the preventive control rule. It was actually silent on supply chain control. We talked about that on FSMA Fridays, and I think we all anticipated it would go in the final rule, and sure enough it did. It’s recognition that the FDA is saying to all of us, “You need to pay attention to your suppliers.”

The way FSMA further evolved was when the original proposed rules came out, as I said, the preventive control rule was silent on supply chain, but the foreign supply verification program (FSVP) was not. The FSVP basically said, "If you’re an importer of food, you need to do the due diligence on your suppliers; you need to assess the risks, you need to make sure that the suppliers are controlling those risks or somebody you’re selling the product to is controlling those risks."

There was a big discrepancy between essentially the burdens on imported versus domestic between the two rules. In the final rules, that has all got flushed out.  Essentially, the burden is now the same. If you are importing food, there’s requirements for you to do due diligence on your suppliers just as much as it is as if you’re sourcing the food from the neighboring state or down the street. So, FSMA has evolved from essentially recognition that this is an area that needs regulatory oversight, which was what was in the statute.

Preventive control rule and FSVP essentially covers the whole system. It doesn’t impact farms and it doesn’t impact retail and food service, but importers and registered farms has got a big focus on supply chain controls and regulatory requirements, and this is a big change. That’s very new. So, it has evolved, and where we’ve landed is (supply chain controls) is not just for brand protection. It’s now a regulatory requirement..

There were quite a few other informative topics explored during this FSMA Fridays session as well including:

  • What the FSMA preventive control rule require
  • The foreign supplier verification program requirement review
  • Who has to comply with Preventive Controls vs. FSVP rule

Plus audience questions addressed during the March session included:

  • “How do you document if a supplier doesn’t have to comply with the PC rule, but you still have to comply?”
  • “Can the importer of record request access to their supplier’s food safety plans?”

To hear the complete FSMA Fridays session recording - (only 30 minutes long and lots of informative information!) – access here.

And be sure to join us on April 29 for our next FSMA Fridays – where we will be discussing the final Sanitary Transport Rule.  More info and sign-up @:  www.FSMAFridays.com