At a Glance:
- Learn what regulators require today regarding traceability.
- Gain insights into the implications of new regulations.
- Learn what regulators may require in the near future.
- Identify exactly what areas will be impacted and what will be expected of you.
- Prepare for change with a recommended step-by-step approach.
Welcome everyone to today’s Thought Leadership Webinar titled, FSMA Update: Food Plans that Comply with New Rules, led by Dr. David Acheson. This is the first in our new webinar series focused on what food companies need to know about the new proposed rules that has stemmed from the Food Safety Modernization Act, along with what they can do to prepare for compliance.
My name is Jon Cowan, I’m the Senior Account Manager of Food Solutions at Plex Systems. Plex organizes these educational webinars at no charge to our attendees. We are presenting some of the industry’s leading experts on regulatory compliance and related processing issues.
This is an extension of our mission to help food and beverage processors implement best practices in processing operations and regulatory compliance. We’re happy to have the chance to share best practices with a wider audience.
As I mentioned, our speaker today is Dr. David Acheson. Dr. Acheson has led several of our most popular webinars in the past. His impressive background in the industry includes roles as an associate professor at Tufts University, the Chief Medical Officer at the FDA’s Center for Food Safety and Applied Nutrition, and the FDA’s Associate Commissioner for Foods. And the most recent FDA position, Dr. Acheson provided agency wide leadership roles for all food issues, including health promotion and nutrition.
Today, as Managing Director for Food and Import Safety at Leavitt Partners, he leads that organization in working with multinational clients, from farm to retail, to address food safety and food defense challenges. Dr. Acheson, with that, I’ll turn things over to you for today’s presentation.
|Dr. David Acheson||
Thank you, Jon, appreciate the introduction, and welcome everybody to today’s webinar. As Jon says, we’re going to talk about the Food Safety Modernization Act, focusing on food plans, and the proposed preventive control rules, which I’m sure many of you, if not all of you, are aware of.
What I want to talk about is that beginning with the key provisions, what’s this about, what are the components of a food safety plan? So, how should we begin to approach this given that these are proposed rules, they’re not final? And I want to make the point right out of the gate that all companies who don’t have to develop food safety plans need to start thinking about that today and not waiting until we have a final rule. Looking a little bit about on the impacts of this on the food industry, and then sort of focusing on how technology can actually help you prepare for this.
Food Safety Modernization Act signed into law January 2011, so over two years ago. As you’re all aware, it is a huge change to the way we approach foods, food safety, and it reflects an integrated global system’s approach. So this is really FDA looking at global risk for food, FDA regulated food, as impacts the American consumer.
So if there is a heavy, heavy focus on import controls, as well as domestic controls. And it is a fundamental shift from reactive agency to one focused on prevention. And I think that is a key way to be thinking about this.
So as we move forward from here, the first question is, who is covered? Who has to develop a food safety plan? Who does these preventive controls apply to? Am I in or am I out? Remembering that these are proposed rules, they’re not final rules – some components of it are likely to change. This part of who is in may change a little bit, but not in any major way, I don’t believe.
The first question, in terms of, “Do I need to pay attention to this?” is to ask yourself a question. “Am I required to register with FDA under the Bioterrorism Act, section 415 of the Food, Drug, and Cosmetic Act. This is not a new part, this is not, this is not FSMA, this is back to 2005 in relation to the requirements to register. And if you’re required to register, then, pay attention, because you may be in or you may be out. As a reminder, registration is those who manufacture, process, pack or hold human food.
So, this speaks to anybody who is a warehouse, or a distribution center, a manufacturer, or a processor. But within those there are some exceptions. It does apply to both domestic and imported companies that have to be registered. But as I have mentioned, there are various exemptions, so let’s talk about those.
The first exemption, and remember that this is exemptions for the preventive control rule. This does not exempt you from the whole of the FSMA law, we’re just talking preventive controls. If you are already required to do juice and seafood under the old HAACP rules, then you are exempt.
Farms are exempt, although the definition of farms have gotten somewhat complicated. But essentially, if you are a farm growing raw agricultural products, your exempt from this rule, but you would likely have to comply with the produce rule, depending on how big your farm is. If you are under the low-acid canned food rules, particularly for Botulism or microorganisms, you’re exempt. But other aspects of controls, like, [chemical] and physical risks are not exempt from LACF facilities CPMG manufacturers are exempt from this part of the rule because they’re already controlled by good manufacturing practice requirements.
Warehouses are a mixed bag. Warehouses and distribution centers are required to register, but the way the rule is currently written, not all warehouses would need to provide with the preventive control rules. So essentially, warehouses are exempt unless they store fruits and vegetables other foods that require time temperature control, to control microbial growth.
So in other words, if you are a warehouse in which you have got tomatoes, lettuce, and other fresh-cut produce, perhaps, and at the same time also have got canned goods, packaged goods that are dry and don’t require time temperature control. My interpretation of the law of the proposed rule of today, is that you would need to have a food safety plan around the time temperature control for the fresh produce items that require that, but not everything else.
The warehouses are little bit of a gray zone and there are questions on this. There was recently a public meeting held by FDA where it was clearly a request to better definitions of these issues around warehouses, but that’s the current interpretation. And I think the intent from FDA is that if you are warehouse and you are handling dry goods, the risks are small, really small, and thus, you don’t need preventive control plants around those. But if you are handling fruits and vegetables and fresh-cut and that type of thing, then there clearly is a risk and you do need a plan around that.
There’s also some exemptions in relation to the size of your business. If you’re a small business, very small business, then you are exempt, or have modified requirements.
So, you’ve got to register, you’ve looked at the list, you’re not exempt. What do I do next? Well this slide summarizes the flow that you should be thinking about.
Think about, at the top of the circle, I need to do a hazard analysis. I’m going to talk about each one of these boxes in more detail in the subsequent slides, so, step one, hazard analysis. And I’m sure you’re all thinking, “Well, I’ve got a HAACP plan. Isn’t that what I need to do?” Well, yes you do, but my view is it needs to go beyond that, and I’ll explain what I mean by that in just a second.
Once you have done your hazard analysis, you then need to institute preventive controls for those hazards that are reasonably likely to occur. You’ve got to monitor those controls to make sure that they are working, you have to establish corrective actions. And if you need to institute a corrective action, and obviously, you should do that, you need ongoing verification that the process is working, and a periodic reanalysis of this whole system.
If anything changes, if you change your production lines, if you change your suppliers, something in the system changes, then you need to make sure that the plan is reflective of that change. And if nothing changes, you need to do a reanalysis every two years in anyway to create a new food safety plan – this is what the FDA is proposing.
So we start with the hazard analysis, we established what do we need to control, we’ve monitored it, we’ve got corrective actions, we’re verifying it’s working, we’ve got a periodic reanalysis. And probably the most important point of this slide is the piece in the middle that says “Documentation”.
All this needs to be written down, and the records need to be kept on an ongoing basis to make sure that the system is working, that the corrective actions are appropriate, and that is all documented. The old adage, “If you didn’t write it down, you didn’t do it” is becoming much more of a reality today with the Food and Drug Administration.
This slide is taken from one of the FDA presentations, and it summarizes, essentially, what’s required around all of this. And they expect those who have to comply with this part of the Food Safety Modernization Act to have process control, to have food allergen control, to have sanitation controls and to have a recall plan. Those are the four major elements that the FDA expects companies to have.
The systems have to be verified that they’re working, which means that there’s got to be appropriate validation. Those systems have to be calibrated. Are they working the way they’re supposed to? And then ongoing review of records.
So with that, let’s jump into a polling question. As you can see here on the slide, we’ve got a question. Which of these best describes where you are with HAACP plans? A series of answers there, so just pick one, and give your answers and we’ll come back to this once we have some answers in.
So, we’re now moving to the top of my circle and we’re going to talk about hazard analysis, and there’s a process associated with this. The process here is, step one, identify all the potential hazards associated with each type of food you manufacture.
So what does this mean? You need to be thinking about potential hazards, developing a list of things that could occur, and this is about for each type of food you manufacture. So if you’re manufacturing five or six different types of food, you’ve got to be thinking about five or six different types of lists. Once you develop the potential hazards, and you’ve got to be thinking about biological, chemical, physical, and for the first time, radiological.
All right, we’ve got some answers up here, and clearly the predominate answer here is number C, “We have a HAACP plan and regularly collect critical data on paper.” So, it’s good that we’ve got most of the people, the participants have got a HAACP plan. It’s interesting that most of it is on paper.
We’ve got, essentially, the next is that we’ve got to continually monitoring using electronic data collection linking to trend analysis, which is kind of state-of-the-art thinking. So that’s good that we’ve got almost a quarter of the participants doing that.
Half of the participants have a plan and they’re regularly collecting the data, but it’s paper driven, so, that always creates the challenge. And the good news is we don’t have very many who don’t have a plan or their plan is a set up for data collection. As you can see, my theme here is what you’ve got a plan in place we need to find ways to be able to capture this data on an ongoing basis.
Let me go back to my hazard analysis, the biological, chemical, physical, and radiological. Many of you will be thinking, “Well, what’s this radiological? What’s that all about?” And there have been some instances of radiological contamination because of the contamination of groundwater, and that’s what FDA’s thinking.
There’s also, obviously, there was the tsunami in Japan and now I think that probably triggered this thinking some more, but I think the control there is that there’s an expectation that you will check to make sure that any of the water you’re using in processing is not from an area that has natural levels of high radioactivity. This part of FSMA does not include intentional, food defense is going to be a later, subsequent rule. So as you’re thinking to your hazard analysis there’s no need to be thinking about terrorism and deliberate; that will come subsequently.
So we’ve got our potential list, we’ve thought about the different groups, and then down to my fourth bullet, “Determine if each hazard is reasonably likely to occur.” Looking at the severity of the illness, the foreseeable use of the food. What’s that mean? It means is it going to be eaten by anybody compromised, elderly, children and so on, because the risk, the severity, the potential risk may change depending on who’s consuming the food.
If it’s reasonably likely to occur, then you’ve got to identify and implement appropriate preventive controls; process controls, environmental controls, and allergen controls. And, essentially, these have got to be sufficient to assure that the food isn’t adulterated.
“Now isn’t this just straight HAACP?”, I’m sure many of you are thinking. In my view is, not quite, let me explain why. If we take a concrete example, simple example, like, somebody who is posting peanuts, making peanut butter. We’ve got a classic system where we have a raw product coming in. It is roasted it, obviously, the roaster is a Critical Control Point, into the temperature, the belt speed, the nut depth have to be appropriate. And those are important parameters, we’ve identified a hazard reasonably likely to occur, salmonella, we’ve got a Control Point, great.
Once the nuts are roasted, they then get to ground, and then they go into a jar for the final product. Between the roaster, and the line, and going into the jar, the FDA is going to expects you to think, a hazard that’s reasonably likely to occur is the environmental contaminants such as salmonella. And that has to be controlled.
So, here we’re sort of getting a little away from conventional HAACP because typically environmental contamination like that doesn’t fall drastically into HAACP because you can’t readily define a Critical Control Point. Yet, it is a hazard, it’s reasonably likely to occur, and has to be controlled.
So hopefully you’re getting a drift here that this is about preventive controls related to hazards that are reasonably likely to occur, and it’s not just a crisp, old-fashioned, conventional Critical Control Point thinking around HAACP.
So, we’ve got to identify the parameters needed to control a hazard, and as I’ve said, it’s not necessarily always the same as a CCP, you’ve got to show these controls work. You can use published studies, you can use independent scientifically valid studies; my belief is you can do your own studies so long as it’s scientifically valid. And you’ve got to have a recall plan as part of this preventive control system. This is a new requirement. Most companies have a recall plan, but now as part of your food safety plan, you need to have one documented. So that’s a change.
Once we’ve done all this, we’ve set of our systems, we have to monitor that things are going according to plan, so we need to establish and implement written procedures to monitor each one of these preventive controls. So this is beginning to put together your food safety plan. We’ve got our potential risks, we’ve been through them, and we’ve categorized them into those reasonably likely to occur.
Why that is likely, we’ve got our, “Here’s how we’re going to control it”, it’s all written into your plan. And the plan it’s got, here’s how we’re going to monitor each preventive control, here’s how it’s going to give us an early warning. It’s going to allow us to correct a deviation before it becomes a problem, and it’s going to allow for corrective action.
Now, the FDA has said in the proposed rules that this monitoring needs to be frequent enough to provide an assurance that the control’s working. Is it consistent? And this could be continuous monitoring, but it doesn’t have to be. Obviously, from our previously polling question, some are doing continuous monitoring, and it’s clearly a great way to go. If you’re not, it’s not required, but it’s one way to go.
Under the monitoring, you’ve got to keep the records. And the FDA has said, again, in the proposed rule, but they want people to make these observations in specific measurements, not just a checklist.
Well what does that mean? Well, my interpretation of that means, back to my roasting example, they expect you to document the temperature, and the belt speed and the nut depth of that roaster if that was a role and important preventive controls. Not just simply to have a checklist where the QA manager goes around, looks at the parameters, and just check the box. “Yep, check. We’re all in spec.” They actually want the observations and specific measurements. And as I mentioned before, if you don’t write it down, it didn’t happen.
So now we’ve got our monitoring. Things are not always going to go according to plan, we need a corrective action. So the FDA expects you to have thought about corrective actions.
What might go wrong? Well, back to my nut example. What might go wrong is the capacity to maintain temperature falls below a certain critical level, so the preventive control is no longer working. What are we going to do? When that happens, we will do this. You know, it may say, “Well, we’re going to put them all in landfill.” Or you may say, “Well, we’ll redirect them and put them back through the roaster.”
Either way, there’s something written into your food safety plan about a corrective action, “Here’s what we’re going to do.” So that when your monitoring activity detects a deviation, you take the corrective action that you’ve prescribed and you write it down. And obviously, to my third bullet here, the corrective action has to assure that the food affected by the deviation has been evaluated for safety.
There’s an assumption, in my nut example, that any food that has fallen below that preventive control level for the kill step, the roaster step, is adulterated. We have to assume is adulterated until you have proved it otherwise, and that could be that you put it back to the roaster having corrected the problem. So corrective action’s going to be an important piece to this.
What about the verification? Making sure everything’s working according to plan. I talk a little bit about validation, that the adequacy of preventive controls; make sure that they are doing what you believe they are supposed to be doing. Verify that you are implementing. There is interesting language in the preventive control proposed rule about the food safety plan and the preventive controls have to be validated by a qualified individual.
The FDA is going to provide more information on what they mean by a qualified individual, but it’s essentially somebody who is trained either through having attended courses of appropriate level, and FDA hasn’t yet quite defined what that means. Or they’re qualified to experience, and I think we need better understanding of exactly what FDA means by a qualified individual. But it’s clear they expect somebody who knows what they’re doing to be overseeing all of this.
And that doesn’t have to be somebody in-house. As I’ve mentioned, this verification has to show that the records are completed, the deviations are recorded, the corrective actions are all done, and it’s all got to be documented. As you can see here, there’s a very heavy theme of documentation, record-keeping.
Okay, speaking of documentation and record-keeping, polling question two. How do you store your records now? Two simple choices here, electronic, paper, or not much. So, poll away and we’ll see what we get.
So continuing this theme of record-keeping requirements, we obviously, as I’ve already mentioned, the FDA is looking for actual observations, or continuous, and they’ve stated it has to be made concurrently with the activity. Well what’s that mean? Well that means, to me, is that you can’t just simply go around, and a day later, gather all the information. It has to be concurrent with the activity. So in my roasting, it has to be real-time, essentially. As I’ve already said, it has to contain the actual values.
It can be paper or it can be electronic, the FDA doesn’t say which it has to be, you can use either. One interesting thing that has crept in to this proposed rule is that if you do use electronic record-keeping, the FDA is proposing to make it subject to something called 21 CFR Part 11. And 21 CFR Part 11 is something that’s been used by FDA in the devices and medical products areas for a long time. Essentially, it’s a requirement to ensure that electronic records are accurate, and that the signature on them is appropriate, so it’s really, essentially, making sure that electronic records are robust.
Some question whether this is going to stay in there, but for now, it’s in there. So it’s going to be important as we move down this road for anybody keeping electronic records if this stays and that they understand what this is about.
So our answers to the polling questions is, the majority of people are either on paper or electronically on a server. Slightly more on paper. We’ve got, what is it? 57% on paper, 40% electronically. There’s nobody who’s not keep the records, so that’s good. And we have very small, couple of percentage, who are actually using Cloud-based systems.
So the good news is, we’ve got lots of people keeping records, and as you’re hopefully beginning to understand, the record-keeping requirements are going to get amped up here. There’s going to be more of it, there’s going to be more need to it. So I think we will see people shifting towards looking for electronic, technological solutions to solve some of these challenges.
So, our records, whether they’re paper or electronic, have got to be maintained for two years. The FDA says that six months of these have to be available on-site. Well what does that mean? Does that mean they’ve got to be physically stacked up in a corner somewhere? No, I don’t think so. What that means is that you can have them on a server, you can print them out if they want them, I believe, just as long as you can get them with a click of a mouse from a terminal in the facility, you are good to go.
What this is saying is you cannot do is, just store them all at corporate and say “It’s going to take us two days to get them.” And this is driven by previous challenges the FDA has had; when they go into a facility, ask for records, and they’ve been told, “Well, everything’s off-site at corporate. It’s going to take us two or three days to get it.”
They’re basically saying, with these rules, you’ve got to have them right there, and at least six months of them have got to be available at the time of request by FDA. And generally, once they’re beyond two years old, you can get rid of them, but they’ve got to maintain records for at least two years.
So, as we move on thinking about this, circling back here, we’ve got, essentially, the hazard analysis we talked about, the preventive controls, looking at all your risks, controlling those ones, the monitoring, the corrective actions, the verification that everything’s working, periodic reanalysis, and this ongoing documentation and record-keeping.
The timing on this, the proposed rule is out, obviously. We have until May 16th to provide comments on the proposed rule. Once the comments are in, and I don’t rule out the likelihood that the comment period will get extended, it may well get extended. Let’s assume that it’s not extended, and by mid May the comments are in an FDA goes into deliberation to make the final rule. It will be at least a year, I believe, before we see a final rule, and more likely longer than that.
Because the FDA is also pulling out rules on produce, and on foreign supplier verification, and third-party audits, and preventive controls for animal foods, and they want to try to pull all this together. I think that we’re looking at least a year out.
Once the rule is final, there’s different timing, if you’re a very small business, you’re going to have three years to comply. And interestingly, the FDA is asking for some comment on how to define a very small business. They’re saying it could be $250,000 annual revenues, or it could be $500,000, or $1 million. If you’re a small business, which they define as 500 people, you’ve got two years, and everybody else is one year. So we’re going to have at least a year once the final rule is out even if you’re a big player.
Obviously, one message here is, “Oh, we’ve got plenty of time, we can relax.” I don’t subscribe to that, and I don’t subscribe to that because most of this thinking is actually just good best practice thinking to protect the brand. That’s an important part of what this is about. Some of the record-keeping, I agree, maybe a little onerous, maybe a bit beyond the way you want to go for brand protection. But the essential preventive control, strategy thinking, environmental control, allergens, and having a good recall plan, is just good business.
Okay, let’s move on to our third polling question. Now that we’ve talked about FSMA, let’s just see where people feel are in relation to their readiness. So this is about which of these situations best describes your readiness for FSMA compliance? All the way from, “We’re fully prepared and ready to go,” right down to, “We’re confused on how to approach the changes and are looking for a place to start,” and a variety of things in the middle. So take a look at these and let’s see where people think they are today.
So, let’s assume that not everybody on the call feels they’re 100% there. What should you be doing? How should you be approaching this? And this slide really gets my thinking on how to prepare. The first thing that you would do is you want a team. And remember that these food safety plans that we’ve talked about are done on a per facility basis. You cannot develop a food safety plan at corporate and use it throughout the whole chain of your manufacturing process facilities. Each plan needs to be facility specific, and within that, each food has to have a specific plan.
Now, obviously there’s overlaps, there’s areas that are going to be very similar, but nevertheless, there is an expectation that each facility and each type of food will have had a separate thought process. So, you need a team, you need people who understand processing we need people who understand the regs, you need people who understand the requirements.
So, obviously, spending time to understand how these regs apply to you isn’t going to be important. Do you qualify for any exemptions? Then assess how far you are from being compliant. How close are you to being on ready with the things that we’ve just been talking about. You do a Gap analysis, look at your risk controls through a HAACP lens and the SOPs that you’ve got.
Look at your environmental program look at your allergen control program. If you have a recall plan, would it work? So you begin to put this together, you’re assessing the systems here, on developing your food safety plan.
We talked a lot about records, so look at your record-keeping system. And as you’re starting to think about your preventive controls, are you capturing the key data to document the process control? So I’m back to my roasting example. Are you capturing those key data elements? Are you capturing the temperatures, and the belt speeds, and the nut depth, if those are all key elements? What data documentation do you have to say, “Well, salmonella is a risk reasonably likely to occur in our processing environment, and are ready to eat environment. How are we controlling that? Are we capturing the key data elements to document that we are controlling that risk?”
And, obviously, can technology help you to do this efficiently, reduce efforts, simplification, save costs? And more importantly, or as importantly, look to help you trend the data. So you identify problems earlier and to institute corrective actions, which is precisely what FDA is wanting you to do.
Look at your training program. I haven’t talked much about training, but training is an integral part of what FDA expects companies to do. Do you have a training program? Is it robust? Looking at how you are addressing your corrective actions. How are you capturing those today? Have you thought about them? Have you got them in a good place?
Obviously, technology can help you get there, it will help you collect and organize documents, it can help you manage the plans and CAPAs, it can track histories, it obviously can achieve the traceability requirements, which again, we haven’t talked about specifically in this webinar because we’re talking about preventive controls and food safety plans.
Interestingly, for some of you who may not be aware, just yesterday, the FDA released the latest thinking on product tracking requirements because the pilot study that was undertaken by the Institute of Food Technology was released yesterday, and it has a whole series of recommendations from that group. But fundamentally, FSMA has not changed the traceability requirements in terms of the one up, one back.
Obviously, the ability to use technology to conduct audits, and mock recalls and make sure that the program is working. And relying on a single source for data, information’s real-time, less room for human error, as we’ve said earlier. And obviously linking barcode technology to speed up the processing steps and capturing some of those key data elements that’s going to keep you out of trouble. Or if you do have trouble, you keep the problem narrowed, it’s tight, and you get onto it very quickly and control a very quickly, which once again, is key for protecting the brand.
I want to finish up with just some common questions that I’ve heard over the last month talking about FSMA, and possibly set the scene for some other questions or preempt some that maybe people have had. I’ve touched on this. “I have a HAACP plan. Does that mean I’m all set?” Well, hopefully you’re seeing is it puts you in a very good place, but it doesn’t make you quite right yet.
The preventive control requirements are written as risk based preventive controls. It doesn’t say in the proposed rule, “You need a HAACP plan.” And there is a subtle difference, and I think, I hope, that my example of a nut roasting example, where, yeah, the roasting part clearly falls into conventional HAACP. The environmental control for salmonella is not conventional HAACP. So it does go beyond just straight HAACP plan thinking.
“Does my food safety plan have to have a defined format?” No it doesn’t. The FDA has made it pretty clear, you can put this together any which way you want so long as those key elements are covered. That you’ve done your hazard analysis, you’ve identified your preventive controls, you’re monitoring, you’re verifying the system’s working, you’ve got reanalysis, you’ve got corrective actions, and you are collecting the data. How you do it- the FDA isn’t prescriptive, and I don’t think they will be. And I don’t think they should be.
Next question, “What should I do about my supply chain? Should that be part of my food safety plan?” This is a topic that came up frequently, interestingly, Congress gave FDA the authority to require manufacturers and processes to control the risk in their supply chain. FDA could have put that in the proposed rule, but they did not – they chose not to.
My view of this is that, remember, this is proposed rule, and I suspect the final rule is going to have some elements in it, of an expectation that manufacturers and processes and those who have to follow these preventive control rules, will have some process to control upstream supply chain. Not quite clear how far that will go, but we all know that’s the risk. It’s repeatedly a risk – there’s been many instances where a supply chain is a risk. So once again, I’m back to controlling your supply chain, understanding your supply chain risk, is an important part of best practice.
It isn’t in the proposed rule, I suspect it will come back into the proposed rule, but my view is that there are times when you control the upstream risk, that’s part of your preventive control strategy. You’re using an ingredient that you’re not cooking, somebody else is cooking, so you control that risk by making sure that your supplier is doing what they’re supposed to. That’s the logic that I see here.
What’s the FDA really looking for in a food safety plan? Well, that’s a pretty general question. Hopefully, I’ve provided some granularity of what they’re looking for around the thinking process and the components of it. But what they’re really looking for, reading in between the lines, is that you understand where risk is in your facility when you are controlling it. Is your culture right?
Have you got your ducks lined up in terms of proper thinking around preventive control strategies? And while writing a plan, it could be onerous, it could be difficult, it could be complicated, it could be time-consuming, to me that is vital 10% of the lift here the FDA is expecting you to do. Yes, you’ve got to have a plan, yes, you got to be able to show them the written plan if they come in and ask for it.
But what really matters and what the agency’s really looking for, are you implementing it? Are you finding those problems? Are you stopping things in instituting corrective actions before there’s problems? Do you have an environmental control program that is working?
So it’s much more about applying these preventive controls that the agency’s really interested in, than just simply having a nice binder with a fancy plan in it. It’s much more about the application, and the implementation of that plan than just simply writing it.
So in summary, it’s really is about risk based thinking and risk based controls. Looking very broadly – and my view is, starting in your upstream supply chain, going right through to your facility conventional HAACP, SOPs, environmentals, allergens, etcetera.
I’ve already said, these are proposed rules. I don’t think much of this is going to change. There will be some changes. It is time to take some action now. Start thinking about how you do this. Do you have your FSMA team? Do you know where you’re going? Begin thinking about it. Get a program in each one of your facilities to address FSMA.
There is this major shift towards documentation, so start to ask yourself questions, “Are we good with that? Where are our gaps, where our problems, where our holes? How can we make this more efficient?” And think about letting technology do some of the heavy lifting for you in that regard because I think it can and I think it can be very helpful. There’s certainly going to be an expectation that stuff is captured, information’s captured, data is captured, corrective actions are captured.
And I think technology can go a long way to helping you protect the brand because you’re looking at trends and getting out front, that are not just safety, but quality as well. The two things can go hand-in-hand in many of these systems.
So with that, Jon, the presentation is complete, and I’d be more than happy to address any questions either related to some of the few that I asked at the end and try to answer, or others. So, let me hand back to you, and open up with some questions.
Great, great. Thank you Dr. Acheson, and thanks for definitely, a great presentation. You’ve certainly have given us a lot to think about and I suspect you’ve raised a lot of questions in the process. So let’s begin our Q&A session, we do have about 10 to 15 minutes or so set aside to answer any of your questions. We’ve had some come through already to the Q&A panel, and we would like some more. If you’ve got your questions, please feel free to submit them through the Q&A panel on the right side of your screen.
The first one that’s come through, Dr. Acheson, is in relation to the USDA and how do USDA governed plants fit into the Act?
Great question. This Act, Food Safety Modernization Act, is exclusively focused on FDA facilities. It does not have any impact to changes on the meat Acts, the poultry Acts, the egg Acts, so there is no impact on the USDA food safety inspection service components of food safety, or meat, poultry, egg inspections.
Where there is an impact is in facilities which are regulated by both regulatory agencies. Manufacturers, processors who have both the USDA in there and also making FDA regulated products. And I say is impacted there because it’s unclear exactly how this is going to fit together.
This is a question that came up to me just, actually, earlier this week, in the context of, we have to have a HAACP for USDA were this the facility that makes sandwiches, meat sandwiches and is regulated by USDA. And they obviously have to have a HAACP plan for the FSIS inspector who’s in there.
And because they are doing other things in the facility that are FDA regulated, they make salads, and they make soups, and they make a variety of other things, they’re now saying, “Well, we’ve got to have a food safety plan. “Will, the USDA HAACP plan work for FDA? And my view is, no, because they’re actually a little different in the way that I’ve tried to describe.
So we’re going to end up with this slightly challenging situation where the company that is actually dual regulated may end up having to have to completely different sets of food safety documents; one for FDA and one for USDA. Which isn’t quite the same as the question is — Does it have an impact on USDA regulated facilities? What the answer’s clearly no, it doesn’t. But if you are USDA regulated facility and you’ve got FDA in there as well, it’s probably going to create a bit of extra burden.
A further extension to that thought, Jon, is as you look at the way FDA is going with some of their new requirements, it wouldn’t surprise me at some point down the road to see USDA pick up on some of these and actually make them a requirement and USDA regulated facilities as well. But so far, I haven’t actually seen that moving forward. But I think in the future we may see some of these things morph over into USDA regulatory requirements. But that’s probably years off and we should be worrying about it too much today. So, it’s a good question.
|Jon||Great. I’ve got several more questions to have come in, Dr. Acheson. The next one is, “What would you envision as possible preventative controls for the environmental contamination scenario you quoted earlier, being the salmonella in roasted peanuts?”|
My view of that is, obviously, you need appropriate sanitation controls and that ready-to-eat area. And this means that you have got sanitation plans, you’ve got systems that have got appropriate cleanup, washing down, sanitation, whatever is needed within the context of the facility and everywhere is different, the challenges are different. If it’s dry versus a wet facility, obviously, the sanitation cleaning is entirely different.
My view is that you document that you have done it, and that you make it very clear that the documentation is in your food safety plan implementation strategy. There’s an interesting point around the monitoring of an environmental control program. The Food Safety Modernization Act proposed rule does not have a requirement to monitor environmental controls.
It doesn’t have a requirement in there to say, “Well, I need to test my environment for the presence of pathogens or indicator organisms.” My personal view is that I don’t think you can have environmental control program and have a high level of assurance that it’s effective without some level of monitoring, that’s just my personal view. The FDA has not required that in the proposed rule. This is another area where I think they may in the final because, to me, there’s a bit of a disconnect.
So, within that, what am I saying? Is you build your sanitation program, and let’s assume that you know what you’re doing, or if you haven’t, you’ve got somebody to help you do it. What monitoring am I talking about? I’m talking about heavy monitoring in zone two, three, and four.
I’m not personally thinking the FDA is going to drive you to be monitoring in zone one, particularly if you have a food that’s going to show a shelf life, it doesn’t make financial sense, it doesn’t make business sense. And my belief is that if you have got a really good handle on zone two, looking for, say, mysterious species if that’s what is the concern, or salmonella, depending on the type of facility that you’ve got. And FDA callout both of those microbes in the proposed rule as hazards that need to be assessed, and then controlled if they reasonably likely to occur in a ready-to-eat area.
So I think robust sanitation plans, lots of documentation around that to show that you’re doing it on a regular basis per the prescriptive plan, and a level of monitoring in zone two, three, and four. Or possibly some indicators on zone ones; I don’t think there’s any expectation of pathogens on zone ones, to show that your environmental control program is indeed working. So that’s my approach to how one would institute that.
And I think the final comment on that, Jon, is I think you will see much more coming out in relation to specifics like this when we have the guidance documents that are being currently developed relation to this proposed rule, which will be more commodity specific. The proposed rule covers all FDA regulated products with those exemptions I talked about. The guidance documents will drive down into specific areas.
Great. I think this next question is somewhat related to your response there, too, “Do you think environmental monitoring will be required or expected even for raw product manufacturers who do not have a kill step Critical Control Point?”
Well, I personally answer that. My view of that is I think the FDA are likely to require it to some level. Personal view is, it’s a best practice. If you’ve got a sanitation program and you need to control that risk, then you need to be monitoring to show that you’re controlling that risk.
Heavy, heavy focus on ready-to-eat. The question was, obviously, had a raw focus to it. I personally don’t think that that’s particularly helpful in the raw area. You know, you kind of expect to find some of these agents in the raw area, but you don’t want to find them in zone two and a ready-to-eat area.
So if you’re a raw facility doing something to the product and then shipping it off to somebody else who is going to then further process it to have a microbiological kill step, then my view is that spending a lot of time a monitoring the environment isn’t good use of resources. There’s always exceptions to what I’ve just said, and that’s clearly a very sweeping statement, but, to me, that is the public health and scientific logic around controlling environmental risk. It really is all about preventing it getting into the food once it is a ready-to-eat product.
Great, and I think this next question kind of maybe correlates there as well, and that’s, “Can you comment on the application of FSMA to seed and grain facilities?”
Seed and grain facilities fall, really, under produce rules and are largely exempt. There are a lot of details and exemptions in the produce rule, not the one we’ve been talking about. This is preventive controls we’ve been talking about.
The produce rule, in terms of exemptions, are grain facilities, and I think, pretty much across the board, they are exempt. Seeds, likewise, depending on, yeah, theoretically, if they are seeds that are ultimately going to be consumed by humans, as some seeds are, and that would be different without further processing if they don’t further process.
So many of those are exempt, particularly, the grains. Some seeds will fall into nuts. I think, nuts and seeds are required, depending on what you do with them. Seeds is pretty broad, if a seed is going to be turned into something that you put on a salad, that’s a whole different use of a seed than the seed is going to be put in the dirt to grow a crop.
If it’s the latter, then I think there’s no requirements. If it’s the former, then there will be preventive control requirements if it’s going to be, essentially, the ready-to-eat seed, much like a nut.
Okay. So there’s a question that came in about getting specific to their environment, “My facility packs blueberries, or, you know, just an agricultural product, which are then frozen. It’s very simple, there are no Critical Control Points. Will that still be acceptable?”
Yeah, yeah. Like I said, I don’t think you have to have Critical Control Points. A facility that’s processing blueberries, even if it’s as simple as you’re getting them to come in, and whatever you’re doing to them – separating them, getting the twigs and sticks, the leaves out. Maybe there’s some quality checks and some handling, they’re frozen. There are potential risks in a facility like that that the FDA will expect you to identify and to control. Does that constitute Critical Control Points?
No. I mean, that’s really kind of one of the things I’ve been trying to emphasize is, that if you can’t identify a CCP in your process, that doesn’t mean you don’t need a food safety plan because there are components in a food safety plan that’s got from CCP-like thinking, and I believe some non-CCP-like thinking. And that’s an example where you may not have any CCPs, but you still need some preventive control strategy with the product that is some essentially, leaving your facility in a ready-to-eat form, in terms of identifying and controlling risk.
That’s the logic of this. But as I said, that doesn’t necessarily constitute a classic CCP type approach.
Okay, great, moving on. Next question. Clarification. There’s some importers and distributors that are registered with FDA.
|Jon||Would they still need to develop a food safety plan under the Food Safety Modernization Act because they are not a manufacturer?|
No, the registration around the food safety plan is manufacturers, processes, warehouses, and distributors. So if you are a manufacturer or processor and you were required to register because you’re manufacturing or processing a food that is going into interstate commerce in the United States, then, yes, you would need to have a food safety plan. Unless you’re an exemption, like, dietary supplement, or seafood, or a juice, or a low-acid canned food type thing.
So, if you are an importer who’s registered, you’re going to have all of that and a series of headaches, and there’s going to be foreign supply and verification, which is not what we’re talking about here.
But the importers themselves won’t need to do this because they’re not a manufacturing processor. Similarly, if it’s a distributor or a warehouse somewhere, then those distributor warehouse exemptions will kick in. If it’s a product that needs time/temperature control for microbial risk, then, yes, you’ve got to do something, if it’s dry goods, then, no. That’s the current interpretation of the rules.
And it doesn’t matter whether you’re situated domestically in the United States or somewhere outside of the United States, if you fall into that category, where you are manufacturing a product that is coming into the US, and so, you’re thus currently required to register, it would apply.
Just to add another layer to that, Jon, is if I’m manufacturing a product, say, I’m in Vietnam, I’m manufacturing an ingredient that is being shipped to another part of Vietnam, or to China, or to Brazil. And then I’m manufacturing, using that ingredient to manufacture a subsequent product that I am then shipping into the United States. So we’ve got an ingredient manufacturer in Vietnam, we’ve got a secondary manufacturer in Brazil.
The Brazilian company is shipping into the US – they have to be registered. They’re a manufacturing facility, they need to be registered. The ingredient supplier in Vietnam does not. They are one step back. This isn’t FSMA requirement, it’s for Bioterrorism Act requirements.
So if that Vietnamese ingredient producer is simply manufacturing ingredients that are being shipped to another party that is not a direct importer into the US, then they don’t have to register. It will be the secondary manufacturer whose making product shipped into the US that would need to register.
So those registration requirements didn’t shift in FSMA. There’s a few tweaks around farms which I’m not going to get into, but, essentially, manufacturers and processors didn’t shift.
Okay. There’s quite a few questions that have come in on, you know, what impacts me specifically. So a couple of them that have come up are vegetable canneries, and dog food, pet treat manufacturers. How do they fit into this plan?
If you’ve LACF, low-acid canned food exemptions, then take a look at that part, particularly, for microbiological hazards. As I’ve said, you’d be exempt, for other hazards, you wouldn’t. Under the animal food part, pet foods and animal foods, there’s going to be a parallel rule released that’s going to look, I think, somewhat similar to this one.
This is preventive controls for human food. There’s a parallel rule that is currently sitting under review in the White House on preventive controls of animal foods. That will cover the pet food and the animal food aspects of what you need to do. So we don’t have a lot of insight on that one yet.
But I think it’s safe to assume that it’s going to look somewhat like this one. They will expect you to have identified and control risks reasonably likely to occur in that environment. And obviously, for pet foods, there is this crossover between illnesses in animals and illnesses in humans who are handling the pet food.
And we’re seeing, obviously, recurring incidents where pet foods are being recalled because they contain salmonella. And while, yeah, there’s some concern about the animals, there’s also concern about the human handling that food. So, what we’ve talked about, to be really black-and-white, what we’ve talked about, on this call, is preventive control for human food.
But there is a parallel rule in the works that will deal with preventive controls on pet foods. So that may be a subject for a subsequent webinar. But right now don’t have a lot of insights into what that looks like, but assume it’s going to look somewhat like this.
Okay. And I missed one in there, too, “Wineries – are they included or excluded from these proposed rules?”
|Dr. Acheson||Alcoholic beverages are out. They’re out.|
Okay. All right, we’ve got time for just maybe one or two more questions. We’ve had a lot of great questions come in, we appreciate it and we’ll try to get to most of them. If we can’t answer it on today’s call, we’ll certainly follow up with you and try to get your specific questions answered. One of the last ones was, “I see no difference between the requirements of paper or electronic records, 21 CFR Part 11, in terms of the need for it to be accurate, authentic, the integrity or context, and need for timeliness. Could you comment on that?”
I think that’s an accurate statement. Yeah, the FDA is silent on whether it should be paper or electronic. They’re certainly not mandating electronic. And I think that’s absolutely right, they’ve got to be correct, and accurate, and timely, and appropriate, and meet the needs in the rule.
Whether they are scraps of paper in filing cabinets or they’re all nicely stashed somewhere in a Cloud – it doesn’t matter. The FDA’s agnostic as to what that is. I think that what’s going to be important here for businesses as they realize that their recordkeeping requirements are going to go up. What is the most cost-effective way to meet that requirement?
And then, within that, how can we, then, leverage all this new record-keeping into improving quality, and trending things in the facility, getting out in front, making better use of our inventory, so that there are returns on investment for the use of the technology that go beyond simple compliance? But the simple answer to the question is, no, it doesn’t matter. You can do it all on paper if you want to – you’re just going to probably have to buy a bunch of new filing cabinets to make it happen.
All right, and I think we’ll probably make this our last, or next to last question, “How do you envision the pending sanitation transportation of food proposed rule to be incorporated into the preventative control rules for exempt facilities?”
Well there is a whole another rule does in the works, I don’t think it’s going to be out anytime soon, around sanitation, sanitary transportation of foods. There’s definitely a bit of an expectation in these preventive control requirements. That when it’s time/temperature controls needed, and transportation is somehow linked into that, that you’d be thinking about that in the context of this preventive control thinking.
It sounds like the question was in relation to an exempt facility? I think if it’s exempt, it’s exempt. Probably the ultimate answer to that question is going to be there once we see what the FDA’s putting out there for proposed sanitary transportation rules, and we don’t have those yet.
Like I said, there are other components of this Act that are missing, and they will all integrate because in a supply chain, part of is going to be on a truck, or in a ship, or in a plane. And we’re controlling the risk while the food is moving around is obviously an important part of maintaining overall control in certain situations. It doesn’t matter if it’s dry goods, necessarily, but it may matter a lot if they’re goods that are subject to abuse that could lead to microbial growth.
So, that’s a bit of a gray area right now, and I think we’ll get a better insight to be able to answer that question more thoroughly once we see the sanitary transportation rules. So, not a very good answer, but that seems to be, it’s still some questions around that one that I don’t have total clarity on because we’re still waiting for some rules.
Yeah. Well, I think we’re up against the end of the hour, here, so, I want to thank everyone for attending today’s session. There were some questions about whether or not we could get access to this session. Again, you’ll see on this final slide where you can come to the plex.com/fsma resource center and check out future webinars that we’re doing. We’ll certainly have Dr. Acheson on again.
As these proposed rules continue to flesh out from the FDA, we’ll be right on top of them – Plex will be hosting a webinar series for you explaining those rules. And then following up with those seminars, a means of showing you how technology can be applied to help you meet a lot of these different mandates, and that’s exactly what Plex Systems does.
So, please go on our website, there’s a lot of great information up there as well as a recording of this webinar session. So we thank you again, we thank you Dr. Acheson for a great presentation. We hope you all found today’s session worthwhile.
And, you know, as a final note, in a couple of moments you’ll see a survey pop up with a few questions. We do ask that everybody participate in that survey – it really helps give us some feedback on what you found effective, as well as giving you a means to give us some future topics to discuss on future webinars. So we appreciate that input as well. Thank you all, again, and we look forward to seeing on the next webinar series.