FSMA Fridays: The Food Defense Rule (Part One Of Three)
Safety Chain’s Barbara Levin discusses FSMA’s Food Defense rule with the Founder and CEO of the Acheson Group, Dr. David Acheson and Melanie Neumann, the Acheson Group’s CFO and VP.
On the last Friday of every month, Barbara Levin of Safety Chain, a leading provider of food safety and quality assurance automation and compliance solutions, hosts FSMA Fridays™, the leading online forum for the food and beverage community to learn the latest information about the FDA’s Food Safety Modernization Act (FSMA). Featuring Dr. David Acheson, the popular monthly interactive pod/webcast is sponsored by SafetyChain Software and The Acheson Group. In the most recent installment, the panel discusses the Food Defense rule. This is a transcript of the February 28 pod/webcast. The only items not included in this article are warm-up conversations and segues in the discussion.
Barbara Levin: Welcome. We’re very excited about today’s topic, the food defense rule. I’m Barbara Levin; I’ll be your host today. We’re very excited to welcome our FSMA Fridays team; we’ve got Dr. David Acheson and Melanie Newman with us today. So, as always, David and Melanie, welcome. David and Melanie are coming to us live from the GFSI (Global Food Safety Initiative) conference in Anaheim, CA. David is speaking this morning so we’re going to jump right into it so we don’t make you late for your session. Before we jump into food defense, what’s the latest and greatest from the FDA?
Dr. David Acheson, Found and CEO of the Acheson Group: The biggest update is the announcement by the FDA that they’ve come to an agreement with the legal entities and consumer groups around deadlines. So, very briefly, and we’ll talk about these more as we move forward with FSMA Fridays, but it looks like we’re going to have preventive control rules, human and animal foods, no later than August 30, 2015, as the final rule. Now remember that compliance with these rules comes 12 months later. So, preventive controls, August 30, 2015, which kicks it to summer 2016 for implementation. Then we have a series coming out in Oct 2015, as finals, and that’s going to be the farm supply verification program. The produce standards are released third party — that’ll be August 31, 2015, and then sanitary transport is going to be final in March 2016, and the food defense one in 2016.
So what we’re about to talk about today is actually the one with longest lead time, which is probably a good thing because I think there are some things in here that, as we’ll discuss, that the FDA is asking questions about. So the good news/bad news is that we now look like we’ve got seconds down final roll dates, which basically translates into we know when we’re going to have to step up to the plate and have this stuff done. So, things are moving.
Things are moving. Thanks, David. So with that, Melanie, let’s jump right to you. There have been a lot of questions about this rule. Melanie, who does it apply to? What’s the real concern the FDA’s trying to address and have they or how have they made it worth-based?
Melanie Neumann, CFO and VP of the Acheson Group: Great questions, Barbara. I think there are just a lot of surprises with this rule to be honest with you. The goal of the food defense rule, according to the FDA, is focused on terrorism and public harm. So the goal of this rule is to look for places to put controls in place where terrorists can put bad stuff in to cause bad things to happen and to cause harm. We’re focusing on places like bulk mixers and bulk liquid tanks. We’re focusing on bigger companies and bigger brands. So this rule isn’t focusing on the small guys, it’s not focusing on small farms for example, and we’re not focusing on, say tampering. So, to get back to your question, Barbara, who does it apply to? The rule applies to manufacturers and processors of human food with sales over $10 million.
We’re not focusing on animal food, we’re not focusing on places that store and hold food, unless they are storing bulk liquids. We’re not focusing on farms, unless we’re talking about dairy farms that are producing milk, because again, we’re going back to those bigger places or places of highest rift ergo bulk liquids where terrorists are looking to kill or hurt people or cause that greatest public impact. That single point of attack, and that’s where the FDA has made this rift-based. The FDA’s felt like we really needed to focus on terrorists and mass casualties. So this rule is the single point of attack based. That’s why the small farms are not a good target unless it’s dairy-based milk producing farms, and the big brands are the point of attack here and the big companies over $10 million.
David, let’s get back to you. We’ve discussed many times, these dates are not actually as far away as they seem when it comes to what companies have to do to get ready for compliance. So, if you fall into one of these categories that Melanie just described, what do you need to do as far as vulnerability assessment, process steps, and mitigation strategies?
David: Yeah, it is this, “What have I got to do?” question that’s obviously everybody’s thinking about. Like already, I get to defense and now basically nicely articulated this is about mass casualty, and that’s what the FDA is focused on. So, what you have to do? There are a number of steps that the agency lays out in the purposed rule. As it goes through these, you’ll see that there are a few parallels here to some other things we’ve talked about.
Number one, you assemble a food defense team. Who in the business knows about food defense? Who do you need to tap into for expertise on that? Think about the possible agents and the process whereby an agent could be added to one of your foods in the way Melanie described — bulk liquids and bulk mixers. . It is getting to the point where you need to sort of be looking at it with a lens, such as, “Alright, I’ve got a little vile or a pot of bad agent, bad chemical. Where might I put that? I’ll add it to food — a bulk liquid tank or a bulk mixer or rework — that could wind up in large quantities of food that could subsequently be consumed and lead to a terrorist event.”
So we’re thinking about the agents, to some extent. We’re thinking about where they may be added, and accessibility. This is an important point because that then spins into, “What are my actionable steps? I’ve identified where I’ve got some vulnerabilities. So, as we talk through this, what are my vulnerabilities, where are my vulnerabilities?” thinking through the lens of bulk liquids and bulk mixing. Then it becomes, “How do I stop that? How do I mitigate that?” That can be tough, as It sort of gets into systems of limiting access and surveillance and education and training and those sorts of things.
The rule is calling for monitoring of this system and appropriate corrective actions when you see something that isn’t appropriate, and verifying that the system is doing what it’s supposed to do. It doesn’t require validation, in other words, you don’t have to validate your food defense plans, thankfully. It does call for training. Thinking through the risks, how to control them, where they are, making sure they are documented in a food defense plan, continually monitoring it, creating a corrective action plan, and making sure people know what they’re doing are all part of this training. So, that’s in essence what focal will need to do.
In FSMA Fridays: The Food Defense Rule Part Two, Levin will and the Acheson Group’s Melanie Neumann and Dr. David Acheson dive deeper into food defense. Topics that will be discussed include the similarities and differences between preventative controls for human food and the food defense rule, how to know if a company’s approach to food defense will be effective, and why economically motivated food adulteration is not included in the FDA’s rule on food defense.
If you would like to attend FSMA Fridays, registration is free at www.fsmafridays.com. FSMA Fridays is a registered trademark of SafetyChain Software.