FSMA Fridays: The Food Defense Rule (Part Two Of Three)
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.
In FSMA Fridays: The Food Defense Rule, Part One, Barbara Levin of Safety Chain and the Acheson Group panel discussed who the food defense rule applies, the major concerns the FDA is trying to address by implementing the rule. Additionally, the group discussed what needs to be done as far as creating effective vulnerability assessments, process steps, and mitigation strategies with in the food defense rule. Here, in FSMA Fridays: The Food Defense Rule, Part Two, the team explores food defense even further, speaking about 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.
Melanie, we’re sitting here using words like CAPA (Cooperative and Preventative Actions) and monitoring and verification. These are the same things that we’ve spoken about with about preventative controls for human foods. So, it feels kind of like food safety, but it’s different. What are the similarities and what are the differences between preventive controls for human food and food defense rules?
Melanie: Great observation and great catch, Barbara. You know, as you sit here listening to David, and for those of you who dialed into the preventive controls FSMA Friday, we’re probably thinking, “Boy, a lot of this sounds really familiar. This sounds like a food safety plan. This sounds like identifying my hazards, and putting preventive controls in place, and monitoring those hazards, and putting corrective actions in place.” Right? It sounds a lot like going around that wheel that, at least we, as the Acheson Group, have built around your food safety plan.
This food defense rule is very similar, so you’re probably like, “Hmm, what’s the difference?” Well, there are some differences, but there are a lot of similarities, but knowing where those differences lie is very critical, I think, and very important. Also, playing on the similarities and not reinventing the wheel is equally as relevant.
So, some of the differences, just to point out, while both the preventive control rule and the food defense rule require you, as David mentioned and pointed out, to verify your controls are working, in the food defense rule there is no need to validate that your mitigation strategies are effective like you do need to do in the preventive controls rule for human foods. Also, if you’re doing your own vulnerability assessments versus outsourcing it, you do need to have someone who knows what they are doing, and David mentioned all the steps you need that you need to go through in order to perform your own vulnerability assessment. But, it doesn’t call for, in the codified rule, this qualified individual concept or credential, like the preventive controls rule does.
Another important distinction is there’s no assumption that the food that you produce is automatically adulterated if it’s produced of a mitigation strategy that’s out of whack. Like it is assumed under the preventive controls rule. Let me just explain a bit. Under the preventive controls rule, if you set a preventive controls parameter to control a risk that’s reasonably likely to occur, and you produce food that is produced outside that preventative control — it’s out of whack, it’s out of parameter, it’s out of compliance. That food is produced and goes out the door. It’s automatically presumed to be adulterated unless you can prove otherwise. So the burden of proof falls on you as a manufacturer to prove out that it’s not adulterated. The food defense rule does not have that high a burden on you. You are not automatically presumed to have adulterated food if your mitigation strategy on food defense is out of whack. So those are some, I think, critical distinctions that we’ve gleaned under this rule, Barbara.
Thanks, Melanie. David, you started to mention this a little bit before when we were talking about validation, and I think this is probably on everybody’s mind. How does a company know if their approach is effective? Is it possible to gauge this out? You know, an international event or an intentional alteration or a terrorist attack on the food supply?
David: It’s one of those things that it’s a very rare, thankfully, event. We’ve had a couple historically where somebody deliberately attacked a food supply for political gain or something else. As Melanie said, there isn’t a need to validate the system, but there’s a need to have them in place and show that you’re monitoring them. For example, if you’ve got a video surveillance camera in a place and you’re saying, “This is the way we’re going to control a potential access risk,” then that video camera has to be working. But we don’t have to try to sneak a maybe terrorist in there and show that they can’t break the seals. I think the FDA recognizes, but doesn’t state it, that if somebody is determined to do this, I mean literally determined to do this, it’s going to be really hard to stop them. That’s my view of this.
You cannot seal a facility up to the point that this becomes impossible because you wouldn’t be able to make food, and nobody else could get in there. But, they do expect us to kind of go through this due diligence process and understand where our risks are, put controls in place, and, as we’ve been saying, track them and monitor them, and make sure that they’re working. So, if we have controlled access make sure those systems are working, if we have video surveillance, likewise. If we put locks on bulk tanks, make sure that they’re effective and that they’re not left off, it’s going to be impossible to show that it’s truly effective without challenging the system, and they’re not suggesting that, thankfully.
In a variety of places this is true; when they’re asking for comment they want comment back on this rule, which, I plan to go off on just a little bit of a tangent here. When this rule was put out, the FDA was basically saying, “We’re not quite sure how to position this one.” We’ve got deliberate attack terrorism in here. We’ve taken economic motivation out. We’re not including tampering. As Melanie said, we’re excluding farms except dairy farms because there’s the milk challenge, the milk risk. We need comment. We need feedback from the private sector on what makes sense, what’s doable, what’s economically viable. So they really are asking for a lot of comment on this one, and it wouldn’t surprise me if the comment section stretched out a little bit on this one, especially if people start to say, “Hey guys, we need a bit more time to think about that.” Given, as I said in my opening comments that this rule is not going to go final until basically spring 2016. So we’ve got a long time on this one. It’s a little bit of a sleeper, unless you really stop to think about it. So I certainly urge everyone listening to this, look at it — look at this one carefully. Think about it, and give comment to the FDA. It’s going to help shape this into a doable and economically feasible program.
Melanie, David touched on this a little bit. Economically motivated adulteration is not included, and I guess the question is, “Why wasn’t it included?” If you’ve read some of the blogs, people think this is obviously intentional, and that this could be more prevalent than maybe the terrorist attacks on the food supply. What are your thoughts?
Melanie: You know, David and I have had many a conversation about this one Barbara, and I think it surprised a lot of industries that this topic fell outside the scope of this rule. The FDA kicked the topic of economically motivated adulteration over to the final preventive controls rule, and I know that David has some very distinct opinions on this particular topic, so I think I’m going to do my colleague and boss a favor and kick it over to him to chime in.
David: Thanks, Melanie. , I have given this one a lot of thought, and I was a little surprised that they didn’t include it here. I can sort of understand why they didn’t, because they said this is about terrorism, as we’ve said. It’s about trying to do a lot of harm to a lot of people. Typically, economically motivated adulteration, or EMA, it doesn’t do that. Although, we saw a pretty bad situation with melamine, both in the United States with pets, and in China with young children, so we know it can happen.
What worries me about this one, and this is one where maybe the food defense rule is not a place to comment on it, but I comment on it anyway, because there’s something the FDA needs to hear. As Melanie and the agency have said, ““We are going to put this in the preventive control rule.” So my read of that is back to where we’re trying to look at a potential risk supplies, and a risk reasonably likely to occur. We look at it through an EMA, an economically motivated adulteration plan. What does that mean? Is it fair to say that president has been set with using chemicals like melamine in foods where you’re measuring quality by protein content? If that’s the case, then do we need to set up controls as part of our food safety plan, preventive controls, to control that risk? I’m mean, that’s an obvious example that everybody’s familiar with.
So, if you’re going to have to check for melamine, then do you need to check for every other high nitrogen-containing chemical in a food where you’ve got lots of nitrogen when you’re measuring protein? But then where does the next one come? You know, we’ve seen a few episodes in various parts of the world of economically motivated adulteration. So where does president kick in terms that it shifts from a potential to a reasonably likely to occur event? Then how do you control it? In the context of this, this could require a lot of testing for a lot of compounds in incoming ingredients with probably a pretty low hit rate and a questionable impact on humans unless there’s some confirmation that we haven’t thought of. So, I think this is going to land somewhere, and the reason I hoped it would be in food defense is because I think the bar is a little lower on that one, but it, as I said, has been kicked to the preventive controls.
Despite that, let’s not sit and wait. Let’s just be thinking about some of the challenges on this, and collect comments and put comments in now on that aspect because this one could be economically fairly significant, I think if the scope of it isn’t limited. I appreciate the opportunity, Melanie and Barbara, for extending on that one.
In FSMA Fridays: The Food Defense Rule Part Three, Levin will invite the pod/webcast’s audience to ask questions regarding FSMA’s food defense rule. The Acheson Group’s David Acheson and Melanie Neumann will address questions regarding exemptions that may or may not be granted to dairy farms, retail establishments, and facilities producing alcoholic beverages. Additionally, what defines an exemption, the FDA’s food defense plan building tool, and other questions regarding FSMA’s food defense rule will be explored. Stay tuned.
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Miss Part One of the series? Click here to check it out.