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Fresh Take
Understanding 7 Major Food Safety Modernization Act (FSMA) Rules
Dr. Michelle Danyluk, Professor and Extension Specialist in the Food Science and Human Nutrition Department at University of Florida, provides insight into 7 major FSMA rules that farmers need to know.
Dr. Michelle Danyluk clarifies the relationship between the Food and Drug Administration and the Food Safety Modernization Act (FSMA), highlights proposed legislation yet to be finalized, and provides insight into 7 major FSMA rules including:
1. Produce Safety Rule
2. Foreign Supplier Verification Program (FSVP)
3. Sanitary Transportation Rule
4. Protection Against Intentional Adulteration
5. Accredited Third-party Certification
6. Preventive Controls Rules for Human and Animal Food
7. Voluntary Qualified Importer Program (VQIP)
Resources:
Learn more about food safety and upcoming events and webinars on our website: https://foginfo.org/food-safety-for-producers/
Learn more about FSMA on the U.S. Food and Drug Administration Website:
https://www.fda.gov/food/guidance-regulation-food-and-dietary-supplements/food-safety-modernization-act-fsma
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Welcome to Florida Organic Growers podcast series Food Safety for Farmers. A project funded by the USDA National Institute of Food and Agriculture Food Safety Outreach Program, our podcast provides information on food safety topics that farmers can use to better understand how to comply with the Food Safety Modernization Act regulations. Thanks for tuning in regulations.
Speaker 2:Thanks for tuning in. Hello everyone, Thank you so much again for tuning in to our Road to Safe and Healthy Food Project podcast series. We're very happy to have Michelle Danilock with us today. Michelle is a professor and extension specialist with the Food Science and Human Nutrition Department at the University of Florida. Hi, Michelle.
Speaker 3:Hey, jc, great to be here.
Speaker 2:Today we're going to be talking about the Food and Drug Administration, fda, and the Food Safety Modernization Act rules, which is something that a lot of our farmers are probably either familiar with or they hear these acronyms all the time. So we wanted to take a little bit of time right now to maybe understand what is the relationship between the FDA and the Food Safety Modernization Act, or FISMA as it's often known.
Speaker 3:Yeah for sure. So the food safety modernization act was signed into law back in 2011. So 11 years ago now, almost. And if you can remember back from your high school or maybe middle school civics classes, right, acts are what get passed, and then out of acts come different specific rules that propose different sorts of different, different things for whatever the act is written about. So the Food Safety Modernization Act really was a bipartisan effort that was put forward to modernize the way foods are regulated within the United States.
Speaker 3:The way foods are regulated within the United States and I should caveat that by saying not meat and poultry products they had their own regulation that came out in 1996 that really dealt with meat and poultry. So here we're talking about all the other types of food that don't fall under that 1996 regulation for meat and poultry, the meat and poultry, and it really is the first new food safety regulation that we've had within the United States to cover all our foods except meat and poultry Since back in the early 1900s. We haven't had a modernization of the way we regulate food since that time Again, with the exception of meat and poultry and seafood, and then there was also a juice rule that came into effect in about 20 years ago, in the early 2000s. So it was a huge effort that was assigned to FDA to really modernize the way we look at food safety within the United States to make it proactive instead of reactive.
Speaker 3:Historically our food safety regulations, again from over 100 years ago, have been very reactive in nature. So it was really to be proactive, so that everybody was trying to prevent these outbreaks of foodborne disease instead of just reacting to them when they happened. And so out of the Food Safety Modernization Act, which we call FISMA I think much to the chagrin of FDA or the early chagrin of FDA we got really seven different rules out of that, out of that, out of that act, and that I think we're going to chat through a little bit today. Some of those rules are still proposed. They're not final, but we'll talk through what we've got and what's missing.
Speaker 2:Absolutely. And so, yes, you mentioned and I was going to ask or confirm with you that right now we are talking about seven rules, and one of the rules that I understand is sort of one that maybe our farmers are familiar with is the produce safety rule.
Speaker 3:Yeah, so the produce safety rule is sort of what we think about as the first time ever that farmers and that the farming community has really been regulated by the federal government in terms of food safety. So it's a groundbreaking effort in terms of it's really the first time that we've looked at federal standards for food safety all the way back in that growing environment on the farm.
Speaker 2:And then the other rule that I have heard but don't really know a whole lot about is the foreign supplier verification program. What is that?
Speaker 3:Yeah, so that is another one of the FISMA laws and I think we should go back and touch a little bit more on the produce safety reg. But I think it's great. Yeah, but it's great to touch on foreign supplier verification first, because I know a lot of our growers in the United States are worried that importers of fresh fruits and vegetables are not being held to the same high food safety standards that they are, and so the Foreign Supplier Verification Act is the way that FDA is holding those importers to make sure that produce and other food products imported to the United States meet the high requirements of the produce safety rule.
Speaker 2:That's a little bit like us here at Florida. Organic Growers can sort of relate in terms of organic foods. We know what the certified organic farmers here in the States you know have to comply with, and then the question sometimes is well, what about people who want to sell you know banana, organic bananas coming from overseas? You know they can trust that in order for that product to come into the States, it has to comply with and go through the same process that farmers here in the country have to comply with and they get inspected. And so my understanding is, as you pointed out, that that also applies for stuff that's coming out of the country.
Speaker 3:Yep, absolutely, yeah, absolutely Exactly and in an exactly similar way. And so we circle back around to the produce safety rule. This, this rule really applies to farms growing fresh fruits and vegetables meant for human consumption, um, and so I'll tell you, fda has some interesting definitions of what they call fresh fruits and vegetables, and they, they have a list of products that are not frequently consumed raw. And so it's interesting, right, because and I will tell you that this list has evolved over time and I think will continue to evolve, because you know there's a lot of different produce out there, right, and you know. So you think about somebody growing some of these Asian green vegetables, right? And I'm sure you've got folks on your call growing them.
Speaker 3:Well, I can tell you, fda probably has not heard of all the different types of fruits and vegetables that the growers listening to this call are growing.
Speaker 3:So they're still evolving that list of rarely consumed raw, but they've also exempt from the rule, um, growers that are really small, um, so those, those folks are exempt from the rule, and then also exempt from the rule are, um, somebody that's growing fruits or vegetables that are going into processing, so if it's going into something like freezing or it's going into a can, or if it's going into make make juice, then those are exempt from the produce safety rule as well.
Speaker 3:But otherwise, growers growing fresh fruits and vegetables are covered by this rule and, again, it's the first time there's been a federal rule to cover their activities. And I'll tell you, one of the things I like the most about the way that FDA has put this rule together is that they have realized that they, as FDA, can't enforce it. So they're working closely with their state collaborators and those states are the ones actually doing the inspections, which I think is really good for our growers, right. Which I think is really good for our growers right, because we know that, like here in Florida, the folks at the Department of Agriculture here in Florida have a really great understanding of what's going on in Florida and what the farms here should look like, and don't expect them to look like something else.
Speaker 2:So I think that's very, very important and thanks for, you know, sort of clarifying that. So we've talked also about this. You know again, the foreign supplier verification program and stuff coming, you know, from overseas. Is there anything else that maybe farmers should know about that in?
Speaker 3:terms of you know what that really means. Yeah, yeah, it's interesting what that really means. So there's a lot of aspects covered in the produce safety rule. Right, it applies to growers and it talks about really five main areas worker training and worker health and hygiene, soil amendments of animal origin, intrusion of wildlife and other animals, water use and cleaning and sanitizing. Right, are there really five sort of focus areas of what the produce safety rule looks at? What the preventive control rule does is it requires anyone who is the importer of fresh fruits and vegetables or, like I said, any food commodity, to really make sure that the foods that they're importing meet those same requirements as were in the produce safety rule, and I think it's really interesting because it puts that onus on understanding and ensuring the food safety in the produce safety rule or other rules.
Speaker 3:And what I think is so interesting about this is when you think about the way a lot of produce is imported right, it's imported by brokers, right? Brokers who might never actually see or touch the product, yeah, or brokers who've maybe never visited the farm that they're importing the product from, but this rule puts the onus on them now to be able to prove that it's met that same safety minimum. So I think there's a ton of work that needs to be done in that import community to make sure that they are actually doing this. And I know this is the foreign supplier verification rule is one of those rules where we have seen a lot of FDA activity in terms of inspection and regulation, and it's one that I think we will continue to see activity on, because it really is out there as the rule that puts on the importer here in the US the onus of proving that that food from overseas has been produced to the same standard as our domestically sourced food.
Speaker 2:So what about? Because it sort of leads me to think whether we're talking about, you know, importers, or the way that the food that is coming from overseas gets here, or even here in the country, and the, I guess, the transportation. Is there anything about transportation or rules when it comes to the way that produce is moving from one place to the next?
Speaker 3:Yeah, so you've hit it right on the head, jc. There is another rule out there called the sanitary transportation rule, and this rule looks at the risk posed to food products from how it's being transported. Now, I think important for our transportation from a field to a packing house. That activity of transportation is covered in the produce safety rule here. What we're talking about really is that transportation sort of once our product is ready to go to market, all the way through the chain until it gets to its location. So we're talking about the container ships that might be bringing produce in from overseas, we're talking about those reefer units that might be moving produce across the country to different operations, and it requires that those folks that are doing that transportation uphold the application of risk-based preventive controls for hazards during that transport.
Speaker 3:And so I'll tell you, historically, the reason that this came out was due to some some allergen concerns and some other concerns, especially when you look at tanker trucks and difficulty of transporting liquid, liquid food products and cleaning those inside of the tanker trucks. Yeah, that's sort of where, historically, how I like to think about it. But it really does go beyond that because it requires those folks, the transporters, to comply with transport standards and that includes things like proper temperature, right, keeping the temperature, the right temperature, so you're not getting folks switching off the refrigeration in their trucks if it costs too much money. We're looking at sanitary operation and really cleaning out those vehicles and making sure that they are not a source of contamination. And, like I said, it applies to the motor, it applies to rail, it sort of applies to a lot of different ways of shipping product. It doesn't apply, unfortunately, to the actual physical ship or the air transportation, but it does require a bunch of different standards Again, really making sure that these equipments are properly maintained and cleaned and sanitized and cleaned and sanitized.
Speaker 2:I was going to ask does that mean that there's got to be some sort of records or evidence to show and that you know actually get audited or inspected or requested?
Speaker 3:Yeah, it does require proper record keeping for any sort of cleaning or sanitizing, for the training of the folks doing that, monitoring forms again for things like cleaning and sanitation and temperature. Those are all required by this rule, I will say. The law also requires food businesses to submit to FDA's authority if they want to do an on-site visual inspection, especially if there's been some sort of a report of some sort of a problem with the business For your growers. I do want to highlight one other thing. Produce is an interesting commodity, right, because we often think about food being sealed in some sort of a packaging, but for a lot of produce those boxes are vented, right, we've got vents in our boxes or in our packaging, and so there's a lot of questions and there's a lot of research being done right now on what the risks of produce are specifically related to those vents in the packaging, which I just find very interesting.
Speaker 2:Well, there's that I think sometimes about. You know, because it's all about, in my opinion, you know, as a consumer, trusting what I'm buying, but when you know whether it's the packaging or how it is that I'm getting that product, is there anything in the rule that sort of addresses whether it's either intentional excuse me alteration or things that can happen to food as it either is being transported or as it gets to that end user?
Speaker 3:Yeah, jc, you segued perfectly into another rule that FISMA addresses, and so another rule under the Food Safety Modernization Act is what's called the intentional adulteration rule, or the AI rule is what is commonly referred to, and what that rule has to do with really has to do with food defense and preventing or coming up with a plan to keep food from being intentionally adulterated. And so you know intentional adulteration are really fancy legal words. What that really means is is somebody like coming in and purposefully putting something into your food product to make other people sick, whether it be a chemical toxin or or a bacteria or or something else into your food product to make other people sick, whether it be a chemical toxin or or a bacteria or or something else, into your product? Um, and there are a couple of. There's a classic example of how, um, of how something can be intentionally adulterated and and sort of the. The best case example happened out in State where a cult group was trying to influence a local election, and so they went and put salmonella all over a salad bar in a restaurant, trying to make a lot of people sick. Yeah, and so all those people who became sick then couldn't vote in the election and their preferred candidate could be elected. So there are examples of this.
Speaker 3:Certainly, post 9-11, we saw a lot of FDA interest in this area.
Speaker 3:Right, because you could I mean you could see a terrorist, this being a possible way for a terrorist to again make a lot of people sick. Yeah, especially if we talk about maybe not the bacterial toxins or bacterial pathogens, but if we talk about, like, some of the chemical or bacterial toxins or chemical contaminants. Right, you put something like that into a water supply or into a milk supply with wide distribution, you can make an awful lot of folks sick. So you know, the FD, this is the one. I think that for me, is like CSI foodborne outbreak, where we, you know, talk about really some bad actor going in and intentionally making products sick, and so really, this whole regulation requires people to build a food defense plan. Now I will say this this is not required by farms. This is really about food manufacturing companies and they have to build their own plans and use that strategic document to address how they're going to prevent the potential of right, intentional adulteration or a bad actor intentionally adding something into their, into their food product as a as a terrorism activity.
Speaker 2:What about something that I that I'm sort of wondering who is doing in those cases that we want to make sure that people are compliant and whether you know certification is required Third party, I guess what I'm getting at is third party certification, and I can sort of maybe make a comparison of who does the certification for organic farms. They're accredited third-party organizations that know exactly what the regulation requires. Is there such a thing when it comes to the rules, and is that part of the rules?
Speaker 3:Yeah, so that is a part of the rule. It's that there's a whole nother rule on that and it's called the accredited third-party certification and it's a voluntary program. So, unlike those other rules that are not voluntary, third party accreditation is a voluntary program. But it's exactly what you said. It really is a program where companies or individuals can be accredited to be a third party auditor. This is really important when we talk back to that foreign supplier verification or FSVP rule, because the program is really targeted at accrediting third-party auditors so they can go and do the inspection of third-party of those foreign facilities for the importers. So it's very much like you just talked about for organic foods. Again, it really is trying to make sure we have those auditors out there who understand the rules that they are auditing to to really again make sure that food coming into the US is very safe.
Speaker 2:So I think that's one, two, three, four, I think, five rules. What is another rule that perhaps we haven't discussed yet?
Speaker 3:Yeah.
Speaker 3:So there's a couple rules that we haven't discussed yet and those both fall under the sort of large category of preventive controls rules. And so preventive controls rules really took the voluntary HACCP or the voluntary hazard analysis, critical control point regulations or requirements for buyers and sort of put them on steroids and put them into all food manufacturing facilities. Again, with a few exceptions, but really most large food manufacturers in the United States and importing into the United States now fall under these rules called the preventive controls rules, and there's one for human food, there's one for animal food. So we'll talk about human food, so we'll talk about human food first and we'll talk about animal food after. Yeah, but so what those rules did is they really took again those HACCP principles and brought in a bunch of other things into the rules.
Speaker 3:So companies that do have a preventive control plan, they need to do a hazard analysis where they look at all the potential hazards that could be in their food product, not only looking for biological, physical and chemical hazards, but within that chemical hazard class we also have to include radiological hazards, and that really came through from sort of the nuclear meltdown at Fukushima over in Japan and the potential for radioactive material to get into our food. Then, like a HACCP they have to do, after they identify hazards and do a hazard analysis, they have to put in preventive controls and they bucket preventive controls into four different categories of preventive controls that have to be maintained. They have what they call process preventive controls. Those are preventive controls in the process where you have to, you know, make sure you're system is operating the way you think it should be operating. So whether that's maintaining sanitizer level in a dump tank or heat treating to a certain time and temperature standard, those fall under process preventive controls.
Speaker 3:They have something called allergen preventive controls and that really is to prevent something from being mislabeled with the wrong allergen information in it, so really focused around labeling and cleaning and sanitizing. They have something called sanitation preventive controls and this is really to prevent environmental pathogens from getting onto products from a food facility. And then they've got something called supply chain preventive controls, which are what you put in place if somebody else along your supply chain is going to control a hazard for you. So it really builds out this very comprehensive food safety program. It also requires everybody falling under the preventive control rule for human food have a really comprehensive recall plan to make sure that those products can be recalled appropriately if there is need for a recall. So it really does build out a very, very comprehensive food safety plan for those within the manufacturing sector.
Speaker 2:And I think we're down to the last rule and, if I'm not mistaken, is that one that is related to importers. And you know we were talking before as we're going down through the, through the rules, the foreign supply verification program, but is there, is that last rule related to that?
Speaker 3:Yeah, so the voluntary qualified importer program is really linked back into that foreign supplier verification program that we talked about above, and what it is is a fee-based program so that foreign food facilities that intend to import their products to this company can become registered and verified, so that it really speeds up a process of inspection and evaluation of their products coming into the US, whether they be for food or animal consumption coming into the US, whether they be for food or animal consumption.
Speaker 2:Okay, so, michelle, you've shared some, I mean a really good summary of these seven rules, but one thing that I was hoping maybe we can, you know, discuss in the time that we have left. I understand that there are more, if not new, proposed regulations. If ESMA has some new regulations, can you maybe give us a little bit of a summary or oversight of what that is?
Speaker 3:Yeah, there are a number of them out there.
Speaker 3:Probably the one that the listeners to this might have heard the most about is the, the food traceability program.
Speaker 3:You know, and I think I think I talked a little bit when we talked about the preventive control rule, about recalls I think traceability is a huge issue within within food in general and I think especially within within produce, where we've got perishable commodities, um, one of the one of the things that that rule that rule is really sort of bringing itself together to do, is really help people or require people to have very good traceability um of of their products.
Speaker 3:And so Frankie Honest, who's a deputy commissioner over at FDA, used to work at Walmart before he moved over to FDA, and a story that he's fond of telling is that one day he asked his team at Walmart to tell him where the mangoes in his package of fresh cut mangoes came from. And I won't, I won't tell you the whole story, but, okay, needless to say, they couldn't do it very well or very easily, right? And and I think that's true with a lot of fresh produce, right, we have co-mingling, yeah, label each individual produce item, and so really, what they're working on in this traceability rule is to come up with a better way to be able to better be able to do trace back and accountability when we've got a food safety issue, and I do think that's a really great, great thing for it.
Speaker 2:I certainly do want to know. You know where my mangoes came from. That's a good story. I'm actually now curious of what the full story is, but you know, I certainly think that our farmers are going to benefit from. You know some of the information, or all of the information that you've shared with us today. Is there things that you recommend to our listeners when it comes to these rules and the topics that we've covered today and how to find out more?
Speaker 3:Yeah, I mean, I think the number one thing to do is just do your best to stay informed and I think, whether that's working like organizations with fog or reaching out to folks at extension at the universities, find a way to stay engaged in the rule. And I think one of the ways to do that is to engage with FDA. They have a community listserv that if you do email, you can sign up for, and they will probably more often than anyone wants to send you an email about different updates that are going on in these different rules. If you're wondering or curious about which of those rules might affect you, again reaching out to University Extension or FOG or to FDA as well, there's decision trees available on the website to help see if a rule applies to you.
Speaker 3:And, yeah, just asking out and asking us for help, we do try to keep folks as up-to-date as possible when new rule information come out, when things change. I mean, like we mentioned at the very beginning, a lot of these rules are very, very new. Implementation and inspections are in their very early days, and so we're seeing evolution of them all as folks get more comfortable with them and we figure out how to make them work on all different types of operations. So I think keeping in touch, keeping up to date, doing what you can, listening to podcasts like this, listening to other educational content, is great, and then reaching out as much as you need with specialized questions about your individual operations is always encouraged.
Speaker 2:Yeah, and we certainly appreciate experts like you taking the time to talk to us and to our farmers, our listeners. We really, really appreciate the time you've spent today with us to clarify and provide information about the FDA and the food safety monitoring section at Rules. Michelle, thank you so much. Yeah, my pleasure, and we invite everyone to continue to tune in to our future episodes. We'll go over more information to help you understand food safety. Don't forget to check our website for new podcast episodes and updates and upcoming webinars. Please also check us out. Sign up to receive updates through our mailing list and feel free to also submit questions on our website. Thank you so much.
Speaker 1:Thank you for tuning in. Visit our Food Safety for Farmers podcast page on our website, wwwfoginfoorg, to find more information about episodes and webinars. Subscribe to our email list for updates and submit any questions you may have about food safety.