FSMA & The Dietary Supplement Industry

To submit questions, use the webinar sidebar menu. You'll select the questions tab, you'll type in your answer and then hit the enter key on your keyboard. Then at the end of the presentation we will address questions. So I'll give a quick overview of Eurofins. Eurofins is driven by our mission to contribute to global health by offering the highest quality testing, training, auditing and consulting services. We strive to listen to our customers and not simply meet, but exceed their expectations. Our footprint is global, with 35,000 staff and 400 laboratories across 44 countries, and a portfolio of over 150,000 analytical methods. Eurofins provides a unique range of analytical testing services to pharmaceutical, food, environmental, and consumer products industries and to governments. Now, I will pass off to Larisa.

Larisa: Good morning. Thank you everyone for joining us today. It sounds like we have quite a few of you on the line. I am Larisa Pavlick, with United Natural Products Alliance. And United Natural Products Alliance is a trade association. We represent over 100 dietary supplement and natural products companies. We have companies that are in the spaces of raw materials, suppliers, contract manufacturers, manufacturers that are making their own brands. We have some brand owners that have ... managing the needs of using contract manufacturing service and in-house services. And we have service providers including, laboratories. Eurofins is one of our members. And that's fantastic. We are really thankful to have you guys. Then we also provide services including training, education, to help the industry understand the new regulations and how they impact your business and specifically how they impact your business in the dietary supplement sector. Next slide.

Genevieve: Okay, so now we're going to have a few questions to learn more about you, the audience. So I will put up the questions and you can submit your answers. Okay. This first question; rate yourself. Do you think you and your facility are fully compliant and have received training, somewhere in the process of moving into compliance, aware of FSMA but are completely lost and need training, or you're unaware of FSMA and the changes. We'll keep this open for a few more seconds. Okay, I'm going to close the poll now. It looks like most people are somewhere in the process of moving into compliance. One more question. Do you have PCI? We'll keep this poll open for a few seconds. Okay, great. It looks like the majority do have PCI. Now I will pass back to Larisa to continue her presentation.

Larisa: Thank you. Okay, here we go. We, as I said, are gonna talk about Food Safety Modernization Act. And most of you will hear that referred to as FSMA. It's really great news to see that we have 63% of the audience that has PCQI certificates. That's fantastic. If you've heard this presentation or something very similar to it, just be patient. I promise I'm gonna add some new tidbits all the way through, so that you'll have some new information to work with regarding this and how it affects you and your business.The Food Safety Modernization Act is a new act that was passed by President Obama. It was signed in 2011. With that, FDA was tasked with modernizing the food safety system to ensure that FDA was no longer working with reacting to food outbreaks and emergencies, but rather moving it to a preventative system. With that we have seven new rules. I've listed all of them here on the slide. We're only gonna cover three of them today, which I feel have the biggest impact to our industry, the dietary supplement world.

Preventative controls for human foods and produce safety rules. We're gonna touch on that just a little bit. Then foreign supplier verification programs. Some of the other rules include the preventive controls rule for animal food, sanitary transport and intentional adulteration, and third party accreditation. One of those pieces that you might want to be interested in is accredited third party certification. There's several different ways that the FDA wants you to use this area. But one of them that might be important to you is voluntary qualified importer program. This would help you to improve or expedite products that you may be importing from overseas. But we're not gonna cover that today, I just wanted to raise that to your attention.

The Food Safety Modernization Act, this is a quote that I've pulled from the FDA website, and it says that it, "enables FDA to better protect public health by strengthening the food safety system. It enables FDA to focus more on preventing food safety problems rather than relying primarily on reacting to the problems after they occur." I was working with the FDA immediately before joining UNPA. I was an investigator for the Denver district office, conducting investigations at dietary supplement facilities and some food facilities. We spent a lot of our time and effort, and energy on reacting to all these outbreaks and emergencies. Once we walk through this a little bit, I hope that this really starts to make sense to you and it lays the groundwork for some systems that we probably already had in place. But just developing a documentation system to demonstrate that we have the ability to evaluate our products, evaluate our raw materials, and understand where the hazards are reasonably likely to occur. Then we would introduce those preventive systems to reduce or eliminate those hazards from happening in the first place.

The biggest piece I wanted to show you here, is the Food Safety Modernization Act. Modernization is really one of the key words, along with prevention, that you're gonna hear throughout my slides. FSMA. One of the biggest intentional adulterations in food history has been the melamine. I'm sure many of you that are listening have heard, or were involved in this outbreak. There were over 150 brands of pet products that were impacted. The dairy industry was dramatically impacted, as were many of our ingredients that were being measured for protein. This was the incident in China where they found that melamine was being intentionally added to milk holding facilities to increase that protein content in that product, so that the materials would appear to be more valuable through that intentional adulteration. This is one of those emergencies that happened immediately prior and during the development of this rule.

If we take you to our industry specifically, this is an article that I found and FDA is aware of as well, but this is salmonella that occurs specifically in dietary supplement products. This was a powdered dietary supplement and it was a recall of over 40,000 pounds of this dietary ingredient, due to a contamination of salmonella. One of the things that I wanna stress to all of you, is that within our industry salmonella is one of our biggest concerns. Salmonella can survive in dry environments for a significant amount of time. It doesn't reproduce in that environment because it needs the moisture. So when I was an investigator, when we were doing environmental swabbing, we would look for environments that had the potential to be both wet and dry. 'Cause salmonella when it's exposed to the moisture has the ability to reproduce, but in a dry environment it'll just survive and it'll maintain in that environment. Most of our dry powders, which is a majority of our ingredients, fall into that category.

When we look at CDC data, there's also a significant amount of salmonella outbreaks that have occurred immediately prior to the passage of the Food Safety Modernization Act. If you look at this list here, there's a lot of different types of products that are shown. Alfalfa sprouts is typically in a wet environment. Pistachios would be dry, peanut butter is a very low moisture food because it has so much oil. But there's a lot of outbreaks and emergencies and we've had a lot of news related to PCA and the outbreaks related to the salmonella there. Looking in 2008, we have some raw produce, which is usually from agricultural waters. Rice and wheat, those are dry environments. Then the cantaloupes, again we had cantaloupes which were contaminated during the washing process through some facility contamination of equipment.

These are areas that we all need to think about. Again, with FSMA we're looking at what types of processing do you have. What types of raw materials are you using, and where are the raw materials sourced to really understand what are the risks and hazards that you need to be controlling for in your processing. Here's another example that was published in November of 2017. With FSMA, you have to consider all hazards reasonably likely to occur. Unfortunately, radiological hazards are something that has been in the news, the FDA is aware of. This is something that depending on the country of origin, you really need to consider if this is a hazard that's reasonably likely to occur in your products.

Here, the romaine lettuce. This is a very recent outbreak and emergency. This information was pulled from a news source, but I could have shown you some of the CDC data. This trace back I believe is complete, but they've pretty much isolated that this is from an agricultural water contamination. So due to the contaminated water being spread onto the plants, that pathogen was surviving on the surface of those plants. Then after it was harvested and provided to the consumer, consumers became ill because it survived those transport and harvesting steps. There was no step specifically introduced to reduce or eliminate that hazard. I only bring this example to you, because in our industry, we have a lot of botanically derived ingredients. With botanically derived ingredients we need to consider whether or not this would be something to need to be managed.

Here's a slide related to FDA. I'm sure you've had enough examples, but this is really showing immediately after the passage of FSMA, which was 2011, these are the outbreaks and emergencies that the FDA was responding to. If you notice at the top, it says they've evaluated more than 575 potential foodborne illnesses. These examples here on the table show that there's an average of 23 outbreaks that the FDA is investigating a year. At two a month that's a lot of resources and a lot of time. But the one thing that's coming out of this, is that there's 900 recommendations for preventive activities. So although this slide shows data that's after the signing of this rule, and really before it's been implemented, because most of the companies should have started implementation around 2015, hopefully we'll see this will become lower and we'll have less outbreaks and emergencies.

But the FDA is tracking and trending what are those outbreaks and emergencies, how could those be prevented from happening again. Let's look at the name. This is the full name here in red. Current Good Manufacturing Practice, Hazard Analysis, and Risk-based Preventive Controls for Human Food. It's now found in 21 CFR Part 117. What I want you to notice is that there's really three significant portions of this rule. There's the current good manufacturing practice, hazard analysis, and then the preventive controls. We're gonna talk about each of those specifically. But I want you to also be aware that you're probably gonna see this written and talked about by FDA and other regulatory bodies. And in the literature you'll see it often by its acronym and you'll see different acronyms. Most often you'll probably hear it referred to as the Preventive Controls Rule.

FSMA, what is it specifically? This is a quote again from the FDA. "It's intended to ensure that we have safe manufacturing, processing, packaging and holding of food products for consumption in the United States." Over time, this is the largest shift in food regulations in over 70 years. That was 1938 when we had the Food, Drug and Cosmetic Act. As all of you know, there has been a lot of changes since 1938. We have a lot of new techniques and a lot of technologies to help us to understand what are the concerns and how do we prevent them.

If you look at the slide here, it shows you the progression of microbiology. Moving from 1938 we were at the end of the observation era. We were looking at organisms through microscopes, but not really understanding the science behind it. Then we started plating them on potatoes and then we moved into Petri dishes and standard methods. Now we have full genome sequencing where we can look at an outbreak and emergency, and we can take specimens from a person that became ill. We can study those and isolate the pathogenic bacteria and look at a food product that is suspect and we can match it to exactly what food products may have caused the illness. Then trace it back to the manufacturing environment through environmental swabbing. So there's a lot of new technologies that make us all able to do a much better job, and understand how to reduce and eliminate these hazards.

The applicability of the preventive controls rule applies to all companies that are selling food products. Remember, in the United States, food products include dietary supplements. They're under the same umbrella in the FDA's regulatory environment. Food, including raw materials. Raw materials both used in food and the raw materials used in dietary supplements. Remember, FDA put those all in the same basket under the food umbrella. With this diagram you're seeing a bulk container of fish oil. Depending on the intended use, is how you're gonna be regulated by FDA. We'll get into a couple areas that make it a little bit wishy washy, but for the most part, most ingredients are going to be classified as a food product like I have demonstrated here, showing the salad oil.

Anything that is distributed with a nutrition facts panel in our industry, would be covered by this rule. So any shakes, nutritional powders, green ... Sometimes you'll see bars or gummies. The bummer for most of us is, I've used a pretty bleak slide here showing a ticking time bomb. Almost all of you should be in compliance with this rule. Most of the members at United Natural Products Alliance have already reached their compliance dates. Most of our industry, based on my experience as an investigator, has already reached the compliance dates. Only the very small companies have a little bit more time, and that's not very much time. They only have until September of 2018 to be in compliance with the preventive controls rules.

Here's an index that shows you all of the subparts of the new rule. Those that I have grayed out, it's not that they're not important, but they're really administrative sections. Only a few of you would probably fall into this area. For a qualified facility is a very small facility. You'll have a little bit different expectations, and this is how FDA would withdraw those exemptions. Then under modified requirements, the one I'd like to have you notice, is if you're using cold storage for safety, that section may apply to you. But all of the other sections that are shown in black would apply to all companies who are manufacturing, distributing, or selling a food product. We're gonna go over some of the differences for supplements in a little bit further down.

If you're a dietary supplement; meaning that you are selling finished product, you are exempt from two sections. One of the biggest challenges I've had over the last two years of presenting on this topic, is that many companies will come to me and they'll say, "I'm a dietary supplement company, I'm exempt." Well, the facts are you are not exempt. You're only exempt from two sections, so you really need to pay attention and understand the remainder of the slides to really grasp what those expectations are of you so that you can be prepared during your next audit. You're exempt from Subpart C, which is the hazard analysis and preventive controls section and also Subpart G, which is the supply chain program. But you're only exempt if you're fully compliant with Part 11, which is our dietary supplement GMPs and serious adverse events reporting. With 21 CFR Part 111, that means that you have written, established and implemented specifications. And remember, our specifications must include identity, purity, strength, and composition. And you have to identify all potential contaminants. Then the next step is, we're also going to verify that those have been met. That's what makes us outside of the preventive controls rule, 'cause we're already taking that on ourselves by being compliant with our 111.

If you are a food product, or if you are selling dietary ingredients, you need to be aware that the dietary supplement GMPs are changing. You previously were regulated under 21 CFR Part 110, which is the good manufacturing practices for foods. But as all these compliance dates are reached, you will now be required to be compliant with 21 CFR Part 117, Subpart B is where you're gonna find the GMPs. That means as of September, the GMPs will be different and you need to be aware of those expectations. Some of the major shifts and changes are allergens. We'll talk about that in a little bit, but allergens must be addressed. And you also have shifted from some of those things that were listed in 110 that might have been under a should, meaning it was suggested, have either been changed to a shall meaning it's required, or they have been removed from the regulation.

We've talked about GMPs being the first part of the name. Now we're gonna talk about hazards and hazard analysis. Hazards mean that any biological, chemical, including radiological, or a physical agent that has the potential to cause illness or injury to the consumer. Some of those examples will be your raw materials. Where is it grown, how is it harvested, how is it stored? You have to look at the manufacturing process. What type of processes are being used and what kind of hazards would be introduced through that process? Do we need to consider cutting, grinding, milling steps that would possibly introduce some metal fragments. Do you use glass jars and packaging? So we maybe have to consider glass hazards.

How about employees? What does your hygiene program look like? Do you have training and education around disease and illness, and do you offer time off for employees so that they're able to stay away from work when they're sick, rather than coming in? Do you monitor your environment to ensure that you don't have any pathogens that are surviving in the environment, that are living in the cracks and crevices along the floor? Do you have wet and dry environments? Do you have sanitizers, are you using your detergents appropriately? Then economic adulteration. Do you have any potential for intentional adulteration? We're talking pharmaceuticals, or substitutions, deletions. Any of that has to be considered when you're talking about hazards in the dietary supplement product.

Here's a couple more examples when we talk about adulteration in our industry. This is from 2013. Actually I worked on this case while I was at the FDA in the Denver district. We had a large amount of tumeric that was coming in during that time that was testing very high for lead. We did have hospitalizations, I don't believe there were any deaths at that time. But there were a lot of people that were implicated during this time. Then how about dyes? A lot of our products in the dietary supplement industry are impacted with dyes. That may be something that you need to consider when you're looking at the hazards for your dietary supplement ingredients, and creating food safety plans.

How about kratom? That's been all over the news lately and it really makes us look terrible as an industry. But kratom is not a legal dietary supplement ingredient. FDA has issued import alerts over the last couple years that are related to kratom. I know some of our trade association partners also have disagreements whether this should be a legal ingredient or not. But at the moment it is currently not a legal ingredient. There is an import alert issued in 2012 and in 2014 for kratom containing dietary supplements or bulk ingredients. What we experienced last year, the reason I bring it up, is not because of the kratom topic, but because of the salmonella. This again shows an example of the botanically derived ingredients and a salmonella contamination. Many of our ingredients that we use in our industry are botanically derived and salmonella has the potential to be in the product and survive the manufacturing environment. This case specifically has 199 cases. The map there in the middle shows you how many states were impacted. Almost every state in the United States has been impacted. The colors there show you the number of people that became ill. The darker colors meaning more people and the lighter colors showing that one to five people became ill. If it's white it means that they weren't impacted. But there were 50 hospitalizations from the kratom incident. So something we should consider in our industry for other botanically derived ingredients.

Then if we look at dietary supplement recalls, in our industry we had several recent recalls. This is from the FDA website, but two of them are from unapproved new drugs. Which is pretty common from an investigator standpoint. If we're looking at male performance products, weight loss products, sport supplements, we're always looking for some potential for contamination in those ingredients. And you should be too, as an ingredient supplier, a raw material manufacturer, or a brand owner. Then you also have to look at the allergens. Allergens are pretty big news for FDA. They spent a lot of time and effort and emphasis, especially with FSMA, to understand where allergens are present and are they being labeled appropriately. Here we have a probiotic and it's the same company that has had two recalls to unmarked allergens.

Hazards, we've already identified what a potential hazard is; biological, chemical or physical. If we're talking about a preventive control, we're talking about a hazard that is known or reasonably foreseeable, we've talked about some of those examples that we've seen in the news. It's identified by a person that has knowledge about the manufacturing process, packaging or holding of the food. And that in absence of the preventive control, the hazard would cause an illness or injury, or would be reasonably likely to cause an illness or injury. So the PC or the preventive control is introduced to reduce or eliminate the hazard from occurring.

Now as we look back at that index specific to our industry, I have put the green text here to show you what's different for supplements. Although we're exempt from C and G, we are not exempt from Subpart A, and there's very specific training requirements that are mentioned in 117.4. It includes a preventive control qualified individual. It looks like we have about 40% of the people on this call that are not yet a PCQI or don't have one on their staff. This is something that's very important to you and Gary's gonna talk about it in a bit.

If you are a dietary supplement, you still must be compliant with Subpart B. There's very specific text related to allergen and allergen prevention. That's something all of us need to be aware of in this industry. Then Subpart F is where we have training records and other records that are applicable to us in our industry. Again, I'm ignoring those sections in gray, but if you fall into those areas it's something you may need to take a look at. Here is your very quick touch on the produce rule. The reason I bring up the produce rule, is that many of our ingredients, again botanically derived ingredients, may fall under the produce rule. This is another quote from the FDA. It's, "Produce means any fruit, vegetable, including mixed or intact fruits and vegetables, including mushrooms, sprouts, peanuts, tree nuts or herbs." We're gonna go into it a little bit more deeply, but this is a lot of text. I'm not expecting you to read it and I'm not gonna read the whole thing. But I bolded the areas that I think are most important. Under the produce rule, produce that is used in the production of spices, ingredients of dietary supplements, may be eligible for an exemption. But then look down towards the bottom. If it receives commercial processing that is adequate to reduce the presence of microorganisms of public health significance. That would be your salmonella or your listeria. Depending if you're talking a wet or a dry environment. Most of our dietary supplement ingredients need to be considered under the produce rule because do you have a manufacturing step that reduces or eliminates a microbiological hazard that's reasonably likely to occur?

The produce rule is saying if you don't have that in place, you will have steps during harvest, and manufacturing, and growing that will reduce or eliminate the microbiological hazards from being introduced in the first place. So it's managing your agricultural water and talking about your environment and some other factors. Foreign supplier verification program is taking us one step further. Again, this is the third rule under FSMA that we're gonna touch on today. But foreign supplier verification programs applies to anyone importing ingredients or finished goods from outside of the United States for distribution into the United States food market. The final rule requires that importers perform certain risk-based activities to verify that the food imported into the United States has been produced in a manner that meets applicable food safety standards.

What does that mean? That means if you are importing foods from other places in the world, you have to ensure that your supplier if you're importing a dietary supplement, are meeting the expectations of 111. If you're importing a dietary supplement ingredient, you're going to verify that that supplier is meeting the expectations of 117. If you're importing a produce, you would understand the produce rules and make sure they were applying all of those rules. Same with juice, seafood, canned foods. Any of those other food products, all of them would have to make sure they're meeting applicable food safety standards. What is the applicability? To us in our industry, it goes back to dietary ingredients, raw materials used in dietary supplements. Those would all be under the foreign supplier verification program and the preventive controls rule. Dietary supplements are also covered, meaning finished goods. Something in a tablet, capsule, powder form, finished dosage form. Or something in a bottle or package. Then again, any food product marketed with a nutritional facts panel.

The foreign supplier verification program, if you go through the training and if you study the rules, it applies to the importer. Who in the United States is receiving those goods as they cross over the border? Who owns the product, who is issued a purchase order for that product? Who is taking responsibility for that product to ensure that it's meeting those food safety standards? Here's your requirements. If you are identifying yourself as a food FSVP importer, and that's gonna be some new language that you're gonna see on your importation forms and on those electronic portals, it is saying that you are verifying that your foreign suppliers are producing food imported into the United States in a manner that meets the expectations of the food safety standards. You're also gonna take the responsibility and state that that food is not adulterated and that it's not mis-branded. When we're talking about mis-branding on this rule, we're talking about allergens specifically.

More bad news is, the compliance dates for this rule have also already passed. I have grayed out most of the compliance dates on this slide because again, only the very small companies have a little bit more time to move into compliance. In a nutshell, the U.S. companies are required to verify and qualify their foreign suppliers, and Gary's gonna talk about it a little bit of the verification activities. Because it's very specific in this rule. FSVP must also be conducted by a qualified individual. Just like a preventative control qualified individual, you must have somebody that's classified as a qualified individual who can implement this rule and manage this program on site.

FSVP rule works in tandem with the preventative controls rules, so that's good news. They're not asking you to duplicate your processes or go through extra steps. They're saying that they work together, but one thing is you have to have a unique importer identification number. Without that importer identification number on your importation portals, you are going to flag yourself, or could potentially flag yourselves for your audit. There is a drop down menu on the import portal that is going to give you the option of saying unknown. When you use that unknown drop down box, you may be contacted by FDA, because they're going to ... You're basically identifying yourselves as not being aware of this rule, the foreign supplier verification program.

Here's a guidance document that we're not gonna have time to go over today. I'm putting it in the slide deck because I want you to go back to it if you need any questions answered regarding the unique identifier and how to go through that process. This is a quote that I pulled off I think was the FDA website. But just please understand that the DUNS number has been identified. A DUNS number is free of charge. I know just like the facility registrations, a lot of companies pop up out of nowhere and you can find them through Google searches that they offer to do your facility registrations for you. Please don't pay for these services, you can register for free online for your facility registration. You can also get a DUNS number for free.Specific requirements for dietary supplement companies can be found under 1.511. When I looked at this, I was really breaking it into to several subcategories. We looked at it and found that there's different categories depending on the type of operations that you have. Are you or are your customers required to establish specifications for components and labels? And are you required to verify them? That's really where you'll see the differences on these rules.

Under the foreign supplier verification program there's 13 sections. If you look down below in the table, I've divided it into those three sectors or subcategories as I call them. We've developed some training tools that we use during our courses and with that, we show you for a manufacturer specifically, what types of training and processes do you have to have in place. With FSVP, you have to have five to seven of those 13 subparts. If you are a raw material distributor who's selling to a manufacturer, you have four to six different sections that you might need to be compliant with. Then the largest impact would be for those finished products that are coming from overseas as a finished good. Meaning in a tablet, capsule, finished dosage form. It could be bottled or in bulk, but you would have to have eight to 10 of those sections that you would need to be compliant with.

Our next foreign supplier verification training will be in September. It's being held in Sandy, Utah. Here's one of my favorite quotes from a very wise man, Charles Darwin. "It is not the strongest of the species that survives, nor the most intelligent that survives. It is the one that's most adaptable to change." I hope that you have a brief look into the new expectations under FSMA and that you're ready to make the next step. If you need any help, please let us know.

There's your summary. I want you to take away that this is about prevention, it's about proactive steps. It's scientifically based, it's looking at tracking and trending, and history. It's looking at risk-based activities. What do you need to do next? You're next step if you haven't done so already, is obtain training to get you to understand the new rules. Being the preventive controls rule, the foreign supplier rule, and then if that produce rule applies to you. I thank you for your time. I hope you have a fantastic day, and I'm gonna pass it over to Gary.

Gary: All right. Well thanks Larisa. That was fantastic. Appreciate that, great. And certainly let me say that Eurofins, we are very excited to be a part of the UNPA. And working with you on this project and many other opportunities for us to work together in the future. We're very excited about that. I wanted to pick up from Larisa's great job and talk a little bit about some of those verification activities for the dietary supplements in regard to FSMA. One of the things that Larisa mentioned was training. Again, a lot of these slides are right out of the FSMA rules, so 60% of you who've been through the PCQI training may recognize some of these. But for those of you who don't, and a couple of things to point out, because dietary supplements has got what we call modified requirements, some parts of the rule apply, some parts don't, it can be quite confusing. So Larisa did a great job in clarifying that for us.

But one part is training. Now 117.4 talks about the qualified individual, and Larisa mentioned that. What does that mean? Basically what that means, is that you have to have a system by which you have people who are assigned a task, be whatever it is. Driving a fork truck, running the packaging machine, whatever. You have to show that they are qualified to do the task that you've asked them to do through training, experience, education. What process do you have in place to basically justify I've now assigned this person this task, here's why they are qualified to do it. It could be running your foreign supply verification program, it could be running your fork truck, it could be running your filling machine, it could be doing any of the tasks within the manufacturing of the product that you making. You must have a system for qualified individuals. Everyone in the facility must have food hygiene and food safety training, and records must be maintained.

Now for those of you who are in the finished product dietary supplements rule, you're thinking, "Well, we're exempt from that." Well, no you're not. This is actually under Part B, so this is under the GMPs. The training on food hygiene, the training on food safety, the qualified individuals in the facility, this applies to you even if you're exempt to portions of the rule. You have to have these types of activities and these records in place. The other, Larisa talked about the preventive control qualified individual, PCQI. There are two means by which you can get recognized as a PCQI, and it is each facility's responsibility to define who is their preventive control qualified individual. One way you can do it is through attending the training course, which I'm gonna talk about in just a second. Or you can get qualified through job experience. Again, the definition of the PCQI; a qualified individual who has successfully completed training in the development and application of risk-based preventive controls, at least equivalent to that received under a standardized curriculum recognized as adequate by the FDA. Now, who is that? Standardized curriculum recognized as adequate by the FDA. There's only one right now, and you see the certificate there on your screen. You see the FSPCA, the Food Safety Preventive Control Alliance. That curriculum is the only curriculum that is recognized as equivalent by the FDA. That certificate that you see there on the screen, your PCQI has got to basically have one of those.

You say, "Well, wait a minute. You can get job qualified through job experience to develop and apply a food safety system. So I don't need the training because I've been doing this for five years." Well, I will tell you, I have posed this question to the FDA on multiple occasions, and they have stated that there is no defining criteria for what qualifies a person through job experience. So I asked the question, I said, "Okay, well I've been through 50 HACCP classes, and I've been in food safety for 30 years. Would I be a PCQI?" And they said, "No, because you don't have training on preventive controls." Essentially, the preventive control training is required to be a PCQI. It doesn't explicitly say that, but that's for all and practical purposes that is the truth. You have to have the PCQI training, the FSMA training from FSPCA to be recognized as a preventive control qualified individual. And your certificate should look just like the one you see on the screen. If it doesn't, it's not authentic.

We've talked a lot about the PCQI. What do they have to do? The rule's pretty specific on what they have to do. They have to prepare your food safety plan. Now, this is Part C, which Larisa talked about some folks it applies, some folks it doesn't. This is the preventive control portion of the rule, preparation of a food safety plan. You have to have a food safety plan if Part C applies to you. If you're a ingredient supplier, if you're anyone other than those who are under 111, you must have a food safety plan, and I'll talk more about that in just a minute. But that food safety plan must be developed by the preventive control qualified individual.

Validation of the preventive controls. I'll talk more about that in just a minute. But basically that must be under the purview or supervision of the PCQI. Determine if we don't have to do validation. Review of records within seven days. This is some of the ones that some folks get the most heartburn about. Basically what that means is, all records created under the food safety plan. Things like your monitoring records, corrective actions, anything. Calibration records, verification records, any of those types of records would have to be reviewed within seven days of their creation. If you produced some monitoring records on Monday, the preventive control qualified individual must have reviewed those records by the next Monday. Basically every record under the food safety plan has to have two signatures. It has to have a monitor, who's a qualified individual, because they're qualified to do the task you're asking them to do. And you have to have someone who's the preventive control qualified individual. Two separate initials or signatures must be on every record that comes out of the food safety plan.

The last requirement of the preventive control qualified individual, is they must reanalyze the food safety plan at least every three years, or when there's significant changes. When significant changes or at least every three years. We can't have a food safety plan that's more than three years old. Now, note that this individual, this PCQI does not have to be an employee of the facility. You can hire a consultant to play this role for you, you can hire someone who's not an employee of the facility. You just have to have someone who's identified, and they have to have their training certificate available within your food safety plan so when FDA comes in and says, "Who's your PCQI?", you can say it's Bob and here's Bob's training certificate.

Now, for those 36% of you who aren't preventive controls or haven't identified a preventive control qualified individual yet, just wanted to give you a quick example and a note as well. If you are in a facility that actually produces ingredients for human dietary supplements, as well as animal supplements, in Eurofins we do a lot of activity with the animal supplement world as well. There are two separate training courses. So you need to be advised that there are two separate training courses. The human food rule has a separate training course, and the animal food rule has a separate training course. And they are not mutually recognizable, meaning if you've taken the human food, you're good for animal, and animal you're good for human, no. If you actually do both, if you manufacture both human food ingredients and animal food ingredients, you actually have to take both classes.

They're both from the FSPCA, they are different. We do teach both, and you see there on the screen that there's hopefully one coming to your area soon. We'd certainly love to see you there. Notice also that we have these international. Larisa talked about the foreign supplier verification program. Those folks who are exporting into the United States must identify a PCQI as well. They have to comply with the rule, just like you do. Just like anyone here in the U.S. has to comply, anyone whose international has to comply as well. So therefore, we're offering and many folks are offering these FSMA classes internationally. We've been in Chili, we've been in Taiwan, we've been in France, we've been in Brussels, we've been in the U.K., Mexico, Canada. A lot of folks who are importing into the U.S. don't have PCQIs identified yet and they need to get them. So we're getting a lot more requests for these international courses now.

Last thing I wanna say about training, is for the produce rule Larisa mentioned, that there is a separate produce class as well. The produce class is mandatory, it's a one day class for those in the produce industry, who are growing those botanical ingredients for dietary supplements. The one day produce food safety training class is required as part of the compliance of the rule. So again, we can certainly help you find produce classes if you're in need of a produce food safety FSMA class as well.

Now, a question that I get asked a lot of times is, "I have a HACCP plan so I'm good with FSMA, right?" And the answer unfortunately is no. It's a good start, but the HACCP plan in of itself does not make sure that you're in compliance with FSMA. Basically, when you're moving from HACCP, which is our traditional food safety management, to the preventive controls. What is your HACCP plan today, just transitions over to your process preventive control. That's pretty easy, you don't have to change anything, nothing changes at all. But as Larisa talked about in 117, now we have allergen controls that are part of the GMPs. So if you have an allergen in your facility and Part C of the rule applies to you, you must have an allergen preventive control. This may have been your allergen control plan previously, but now it's required to be an allergen preventive control. If you have an allergen preventive control, you have to have a sanitation preventive control to address the changeover from allergens to non-allergens.

You also have to have a sanitation preventive control if you have a ready to eat food that has a chance for contamination prior to packaging. Larisa talked about those salmonella issues, we're gonna talk more about that in just a minute from the environment. But if you've got that product has been through a lethal process and we haven't put it in a package, and it has exposure to the environment, and there's a risk for environmental contamination, I must have a sanitation preventive control. Which previously may have been my sanitation standard operating procedures. My SSOPs. Now it must be a sanitation preventive control. Larisa talked a little bit about the supplier approval program, or supplier preventive control. Who's applicable, who's not. Certainly for those ingredient folks, for everybody who 111 doesn't apply, you have to have that supplier preventive control when the supplier is applying a control on your behalf to address a hazard. If a supplier's cooking it, if the supplier's irradiating it, if the supplier's doing something to destroy a pathogen or control a pathogen on your behalf, you must have a supplier preventive control program in place. Previously, this may have been your supplier approval program, or your supplier monitoring program. Now again, it's gonna transition to a supplier preventive control.

And if you have any of these preventive controls defined in your food safety plan, you must have a recall preventive control as well. Which previously may have been your recall or your withdraw program. I wanna real briefly talk about verification versus validation. That's a big question. We get a lot of questions, what's the difference, verification, validation? Validation, again you see the official text there from the rule. In my simple mind I try to say, "Okay, well basically validation is proving that whatever we're doing will control the hazard. Prove that it works." Through literature review, through scientific study, through regulation, through whatever. There's a lot of different ways that you can validate. Now the only preventive control that requires validation, is the process preventive control, or in the old vernacular our critical control points, our CCPs. Those require validation, nothing else under FSMA requires validation.

Verification is are you doing what you say you're gonna do. If you said you're gonna monitor once a week, are you doing it? If you said you're gonna take the temperature once an hour, are you doing it? If you said you're gonna cook it to 145 degrees, are you doing it? It's are you doing what you say you're doing. That's verification. Now, FSMA adds a lot of verification activities on to our requirements. One of them is environmental monitoring. Now again, if you have to have a sanitation preventive control, if you have ... Larisa was talking to us about the salmonella in dry products. And we know through experience, many years of experience, that if we've got salmonella in dry, finished products, the majority of the time it's coming from the environment of the facility. Larisa talked about the swabbing that FDA does. FDA's did swab-a-thons as we all know.

Part of the rule, and this is the only place in the rule where testing is actually required. If you've got one of those sanitation preventive controls, if you've got a ready to eat product that has a risk for environmental contamination prior to packaging, FDA will expect that you will be doing environmental monitoring as a verification activity. If you're a dry environment, it's got to be salmonella. You have to identify the test organism, and that organism is expected to be the pathogen of interest. When you have to do environmental monitoring, and again in those ready to eat food environments you have to, it must be scientifically valid. You must identify which organism you're sampling for, what's your sampling plan, what's your locations to be sampled. What's your frequency for sampling, what tests are you gonna be doing. Is it a PCR, is it a BAX, is it an ELISA, whatever. What laboratory is conducting the testing, and obviously what's your corrective action if you find a result that you don't like. All that must be documented in your food safety plan as part of verification.

Now I'll spend the rest of my few minutes here on supplier verification. This could be the foreign supplier verification rule, those verification activities that have to be done for FSVP. Or for those folks who do have to have a supplier verification program, a supplier preventive control, you have to have these verification activities as well. The key here is that that supplier themselves cannot do their own verification. They can't do a questionnaire, they can't do an internal audit and send it to you and say, "Steve, we meet FSMA, we're good." You have to either do it yourself, they can provide a third party independent audit for you. They can provide testing, they can provide certificate of analysis, but the supplier themselves cannot just fill out a questionnaire, cannot just fill out their own audit form and send it to you and say that they're in compliance with FSMA. But the key with supplier verification is, the key intent there is, is the supplier meeting the rule? Is the supplier meeting the sections of the rule which apply to them? Be that B, or C, or G, whichever parts of the rule apply to them, are they in compliance? Do they have a PCQI, have they got the preventive controls, have they validated them, are they doing their verification activities?

You have the requirement now to go onsite and verify that your suppliers, be it international or domestic, are meeting the rule. Again, those verification activities, what are they? An onsite audit that needs to be done at least annually by a qualified auditor. We'll talk more about that in a minute. Sampling and testing done by the supplier with an outside laboratory, or by the receiving facility. You can review the supplier's food safety records, which is required as part certainly within foreign supplier verification program as well. So really those are the only three activities that fall under verification activities as appropriate defined by FDA. Onsite auditing, sampling and testing, or review of their food safety records.

Now, what is the onsite audit requirements? When do we have to do an onsite audit? If that supplier is addressing a serious hazard for you, on your behalf, you must have an onsite audit, again which documents the before use of the raw material, and at least annually thereafter. That onsite audit must show they are meeting the preventive control rule. That's what the audit has to show, has to show they're meeting, they're in compliance with the rule. You can try to do some exceptions or exemptions, but basically annual audits is now what FDA is requiring for supplier verification when serious hazards are being controlled by the supplier. The onsite audits must be done by a qualified auditor. Now if you look at the rule, who's a qualified auditor? The FDA talks about an agent of a certification body, or a government employee. Really, if you look at the definition of qualified auditor, it's anyone who's got experience and training, or anyone who has been trained as an auditor, or experience in auditing. So experience in auditing, or trained as an auditor, those folks would be qualified. And again, you have to have their document, their paperwork to show why they're qualified. Part of what they do obviously, is verify that the HACCP or food safety plan again, meets the rule.

Last slide here, we talk about sampling and testing as part of verification activities. Again, product sampling not required. It's recommended, but not required as part of verification. But if you do it, you have to make sure it's done in an outside lab, it can be done by the supplier or done by the receiving facility. Can be communicated through a certificate of analysis. Methods must be defined and appropriate, and you must have appropriate references as well. So you can use indicator tests for verification, you can use pathogen tests for verification. If you get a certificate of analysis now for salmonella in your raw materials, that certainly can be used as part of your supplier verification activities as well. Coliforms and dietary supplement powders or whatnot, certainly can be an appropriate verification activity as well.

That's it. I appreciate your time. Again, as the vice president of food safety services, I oversee our training, consulting, a fully accredited certification body where we can execute all those GFSI standards, as well as first and second party audit. I really appreciate your time. Looks like we may have hopefully a few questions, but appreciate your attention and everybody have a great afternoon. I'll turn it back over to Genevieve.

Genevieve: All right. Thank you Gary. Now we're gonna answer a few questions from attendees. First question. Who has the responsibility to comply with FSMA? The company who manufactures the product, or the company who owns the product?

Gary: All right, I'll grab that one Larisa and you can add in if you want. Thanks, Genevieve, it's a great question. And there's a lot of confusion because sometimes it's like, "Okay, well I'm making this product for my customer. It's in their package, it's in their brand. They're telling me what suppliers I have to use, they're telling me what ingredients I have to buy. So therefore it's their product, it's not even mine." FSMA's very clear, the responsibility for compliance to the rule lies with the manufacturer. They don't really care who owns it, they only care who's manufacturing it. So if you are a supplier, you are a facility under the rule if you are manufacturing, changing the nature, holding or handling the product. The fact that you don't own it, the fact that you're manufacturing it for somebody else, FSMA doesn't care. If you're manufacturing it, you're required to be in compliance.

Larisa: That's a good answer Gary. Genevieve, I'd like to just expand on that. As a former investigator from the FDA, if you look at some of the history of warning letters this year, you'll see the agency's perspective, or what I interpret as the agency's perspective. A lot of warning letters have been issued to brand owners stating that if they're using a contract manufacturer, that you still have the obligation to ensure that that product meets quality and specification standards that are defined in the regulations. Because as a brand owner who has their name on the label, whether it says manufactured for, manufactured by, or distributed by, it does give you the ultimate responsibility to ensure that that product meets U.S. food safety expectations.

Gary: Yeah, that's a great point Larisa. I mean, obviously if your brand's on it you wanna make sure it's in compliance. And if your brand's on it you wanna make sure there's no interruption in that supply chain and your manufacturer or the co-manufacturers are meeting the rule. I would just add one more thing. Many times for a manufacturer, the question is, "Okay, well I'm not picking these suppliers. I'm not picking these ingredients, my customer is." But the rule's very clear. You still must do those supplier verification activities, even if you're being told who you have to buy from. You still have the ownership, you still have to have the onus on you to be responsible to make sure they meet those supplier verification activities.

Now, it can be very nasty if you find out those suppliers are not meeting their activities that they should be doing. Then you gotta go back to that customer and have a difficult conversation. But you can't just wash your hands and say, "Well, they're not my suppliers, they're my customers'." No, if they're sending you ingredients, they're your suppliers.

Genevieve: All right. Well thank you. One last question. Does FSVP training replace PCQI certification? Or do you need both?

Gary: Actually Larisa can speak to that as well.

Larisa: Go ahead Gary.

Gary: Yeah, you definitely need both. The PCQI training is required to identify and qualify that individual to be a preventive control qualified individual. Now, so that's for all intents, purposes mandatory. The FSVP training is not mandatory, but it is certainly one key step to qualifying a person to be able to manage your foreign supplier verification program. The FSVP training again, is not as I guess mandatory as the PCQI. And they are not the same, they are independent. If you're a PCQI who is the importer responsible for managing your FSVP program as Larisa talked about, you may need both. One teaches you how to manage your preventive controls and build your food safety plan. One teaches you how to manage and verify your foreign supplier verification program. They are two different classes, dealing with two different rules.

Genevieve: All right. Well, thank you Gary and Larisa. That wraps up our Q&A and our webinar. I want to remind everyone that a recording of this webinar, along with a copy of the slides will be available within two business days. And the questions that didn't get answered during our Q&A session will be followed up with. Thank you everyone for attending.

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