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TAG September 22, 2018 0 Comments

In the July FSMA Fridays session, TAG Founder and Owner David Acheson discussed where we are with FSMA today. There have been a lot of updates on FSMA from FDA, but the agency did announce that it is publishing three guidance documents on the IA rule. The first, which we discussed in a recent newsletter, was pretty extensive, and if you are subject to the rule, it does provide some helpful guidance. FDA has not stated when the other two guidances will emerge. Though the updates may be few, there are still a lot of questions swirling around the industry related to FSMA and compliance. Following are some of the top questions – and answers. 1. The next big rule to hit is Intentional Adulteration (IA) in July 2019. What do you see the industry doing to prepare for that? The last of the big seven rules of FSMA, IA is in some ways the simplest and in some ways the most difficult because it focuses on the industry looking at their processes and making determinations around intentional adulteration – as relates to mass casualties. It’s not about tampering or economically motivated adulteration (which is in the Preventive Controls rule), it focuses on terrorism. So the guidance nicely lays out where in the plant could someone do that. There are lots of potential places, but it’s important to look at it through lens of widespread public harm. That is, a single event in facility – one thing in one place that would contaminate a lot of servings. The industry is struggling with how to approach this, without locking, barring, and sealing every possible place of harm. But with compliance due in 2019, you have 12 months to figure out – and TAG has tools to help. It’s also important to note that the rule only applies to registered firms – domestic or foreign – with sales over $10 million. 2. What should food companies be doing now that most of the compliance deadlines are past? 

With facilities having completed the basics – they have written FSP, have trained people, etc. – we’re hearing the PCQIs saying – now what? Corporate feels it’s done, so what should we be doing now? My response: Don’t relax. The purpose of FSMA’s preventive approach is to assess risk and build programs to control that risk. That was done; that’s what compliance was about. Now it’s about showing FDA that you are following your programs: with monitoring, ongoing verification, corrective action, reanalyzing, and updating your programs. It’s no longer about just putting controls in place – it’s now about doing it. So moving from creation to maintenance and execution is the next big hurdle. 3. What are we seeing from regulators in the way of enforcement for FSMA? 

From what we are seeing with our clients, there is a mix, there is a lot of inconsistency and variation among regulators and districts. That said, there is definitely a shift from educate to regulate. A year ago, FDA focused on educate then regulate with about a 95%/5% split. Now we’re seeing a focus on regulate with maybe a little educate, and it’s rapidly moving to full-bore regulation with a focus on “You should know what to do.” And we are seeing FSMA knowledgeable inspectors, with some are using heavy sticks. For example, I’ve seen 483s issued for lack of FSVP, and inspectors are definitely looking for and at your validation studies. 4. What is FDA focused on currently from a regulatory perspective? 2018 has been a year of fairly complicated, ongoing, highly visible and reputation-damaging outbreaks – the likes of which we haven’t seen in a while (e.g., romaine). So FDA has gotten very focused on putting out fires. Additionally, they are leveraging more and more their lab testing and genetic technologies, such as whole genome sequencing (WGS). Though I don’t have a crystal ball, my expectation is that they also will start to have a stronger focus on product tracking. I’ve drawn parallels in recent newsletters of the 2018 romaine outbreak with the 2006 spinach outbreak. There are similar numbers ill and died. The leafy greens agreement has done a lot, but we are still in the same situation. So I wouldn’t be surprised if FDA starts pushing traceability. 5. Has FSMA impacted the rate of “swabathons” from FDA? No, not that I’ve seen. Swabathons are alive and well. FDA is continuing to use them and leverage them, but they are not FSMA derived – they were happening before FSMA, are being driven somewhat by concerns of outbreaks, and are prevalent and impactful. For example, an ice cream producer stated that his facility has had three swabathons in the last year. He got through each without them finding anything, but it’s evident that this was driven by the Listeria findings in other ice cream facilities. FDA see swabathons as yielding good risk-based value, and I won’t be surprised if the agency gets resources to do more. 6. How is whole genome sequencing playing into FSMA enforcement and FDA actions? This is related to swabathons and use of WGS and it is becoming a frequently used tool by FDA, as well as state public health reg and CDC, to link illnesses and situations with specific food products or facilities. So in relation to swabathons – if FDA finds a Salmonella or Lm in your plant, even if it doesn’t match anything in the current database, it goes into the database and it stays there – and a small number are being matched up through WGS. Some of the challenges of WGS are related to what a match means and how much pushback is there when match isn’t perfect. While it is an indicator that there may be a link, it is just a starting point. If there is a match from your food or facility, the regulator will show up. But don’t see it as a threat, you are not necessarily responsible for the illness, there are still lots of questions to be answered – e.g., did any of them actually eat your food? Does the timing connect? If you are in such a situation, reach out to us. We deal with one just about every week, and that shows that it is being heavily used. So … should you use it? There’s not a right or wrong on that one; it’s what you feel is right. But you definitely don’t want to be found with resident strain by FDA and you not know about it. 7. Is random testing for pathogens by a third party still a good standard for small animal food companies, or should we look at in-house pathogen testing? To me, random testing implies that it’s not statistically validated, so it tells you nothing. Overall, I am not a big fan of finished product testing as a means to control risk, so I don’t think random testing is a way forward. But if you are going to use it as a preventive control, be sure to read that section of FSMA because it has some pretty specific requirements. Additionally, if you are doing any zone 1 or finished product testing, hold the product before you ship. The Acheson Group continues to monitor the latest on FSMA, and guides clients throughout the food supply chain on ensuring compliance.  Have a question about FSMA? Need assistance with FSMA compliance or gap assessments? Contact TAG today. About The Acheson Group (TAG) Led by Former FDA Associate Commissioner for Foods Dr. David Acheson, TAG is a food safety consulting group that provides guidance and expertise worldwide for companies throughout the food supply chain. With in-depth industry knowledge combined with real-world experience, TAG’s team of food safety experts help companies more effectively mitigate risk, improve operational efficiencies, and ensure regulatory and standards compliance. Learn more at:


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