 Well, hi everybody. Welcome to our Wednesday weekly webinar. I am not Julie Gardner-Obbinson. Unfortunately, you're stuck with me today. I'm Scott Swanson. I'm a media specialist with ad communication. Today's speaker is going to be Kim Koch. But first, I want to do a quick reminder of our other upcoming webinars, April 12th. Next week will be Esther McGinnis on the spotted wing Drosophila. April 19th, Dr. Cliff Hall on how to cam low and high acid foods. And then our final one will be on the 26th with Todd Wyman introducing youth to gardening. And one other reminder, if for some reason you weren't, you had to leave early or something happened collaborate and you locked up and you wanted to watch it. Or if you know somebody else who wants to watch these, we are all being recorded. And we're uploading them to YouTube and then putting them on the field of fork website. And just next to the next to the topic, you'll see it says watch the recording and then it takes you to YouTube to watch it. So I feel the logistics real quick about the collaborate screen that we're looking at. If you have any questions, please type them down in the chat pod there in the lower left corner. You can type them in as we go. We'll keep in track of them. But we'll also have time at the end for some questions and answers. And then of course, the old special plea from Julie. Make sure you fill out the survey. It's a short survey you'll receive in your email at the end of the webinar. And there are some neat prizes for you to entice you to fill out that survey. And now on to today's presentation. Our speaker today is Dr. Kim Koch. He has served as the NCI feed center manager for 27 years. In addition to his responsibilities on campus, he also has served as a consultant for the U.S. Grains Council, the U.S. Soybean Export Council, Land O'Lakes International, the Chinese Ministry of Agriculture, and the State of North Dakota. In the past three years, he has also been very involved with the Food Safety Modernization Act, serving on the International Subcommittee's trainer network, where he is a trainer of trainers and a lead instructor for human and animal food compliance. Dr. Koch is actually at a hotel in Kansas City right now attending a pet food conference and a trade show. So we thank him for taking some time and joining us today. Go ahead, Dr. Koch, your turn. All right. Well, thanks, Scott, and I'd like to welcome everybody to the webinar. This is the first webinar. Well, it's not the first webinar I've done, but it's one of the first ones. So if I start talking too fast, please, you know, raise your hand and yell at me or something. So today we're going to talk about FISMA, the Food Safety Modernization Act, and will it impact your business? And if you are a small to medium-sized food producer of animal food or of human food, you probably know the answer to this, and it is yes, unfortunately. And most of us feel like we are over-regulated anyway, but this is just another one of those things we have to do. So these are the history of the food laws or the dates of the food laws that are currently on the books in the United States, and they date from 1906 when we had the Peer of Food and Drug Act enacted. The Federal Food and Drug and Cosmetic Act was enacted in 1938, and that is the basis of all food law in the United States. It's been continually updated. Some of those updates would have occurred in 1958. How many of you remember September 11, 2001? And one of the immediate after-effects of that was the Bioterrorism Preparedness and Response Act of 2002. That was the first time that FDA took it upon itself to ask food manufacturers, both human and animal, to register themselves. And so every food producing entity, every ingredient supplier, those types of things were and are required to register with FDA. It's a free process. Somehow you forgot to register. It's not a big deal. You just go to the FDA website, and there's a place where you register. Currently, we are all required to re-register every two years on even years. There was the Amendment Act in 2007, which is just more of a bookkeeping thing than anything. I don't think anybody even really knows what it is. And then in 2011, the Food Safety Modernization Act, or FSMA, or FSMA, depending upon which side of the fence you're on. If you think it's a good thing, you call it FSMA. If you're sort of opposed to it, you call it FSMA because, oh, it's just going to add more burden to me. And FDA considers FSMA to be the most speaking reform of our food safety laws in 70 years. And it is quite involved. So you probably ask yourself, well, what the heck? Why do we need FSMA? We have the safest food supply in the world anyway. Why do we need, does anything else need to be done? Now, here's some facts that you can read. I mean, there are 48 million people in America that get sick each year from food-borne pathogens. And of those people, 3,000 die. Actually, one dying is a big deal. 3,000 is a really big deal. Our food supply has become much more high-tech and complex. This number of 15 percent of our food being imported, that's probably a little low. It's probably higher than that. And it's probably going to continue to be growing as time goes along. We have more food in our marketplace now, and it's different from what it used to be years before. We have new food, new hazards in our foods, and how many people with its fat that you can get E. coli and flour, even though we all probably know that it's been there for a long, long time. But yet it didn't become a big deal until last year when General Mills had to recall 13 million pounds of flour in his recall because of E. coli that made people sick. Or a more recent recall has been sunflower kernels that had the stereo monocytogeness contamination. Well, nobody in their wildest dreams ever thought you would find the stereo monocytogeness on sunflower kernels. And yet it happened and it resulted in probably the largest food recall in history. So in the month of February, if you have nothing better to do with your time, it's always fun to go to the FDA website and look at the recalls. Well, in the month of February, there are 43 of them. 18 of them were the result of the stereo monocytogeness and cheese. And I'm sure all of you have heard of the company Sargenta. Well, it was their products that were impacted by this. And so it happens to everybody. These are some examples of outbreaks that have occurred in the past. The big one, of course, that everybody remembers was the peanuts, the peanut butter, peanut product from 2008, 2009. It was an early big deal. Nine people died. The Peanut Corporation of America who was responsible for this was heavily fined and their CEO and their, and his wife and one other person were sentenced to jail. The CEO, that 30 years his wife, I think, got 20 and the third person was serving 12 to 15. So this food safety is a big deal. And FDA under Fizman now has authority. They are able to prosecute you much more easily than they were before. There was an example in England where we had botched lizards and hazelnut yogurt. And then in the United States, most of our recalls are due to undeclared allergens. And so usually what happens is you're making something and you do not put the proper label on it. Or somebody on your line doesn't change the labels that are going on the product even though the product changed. So it's extremely important that you have accurate labeling to prevent allergen cross contact because allergens are a big deal and they do make people sick and they can kill people. So inside the FISMA Act, there are seven rules. And most of what we're going to talk about today are going to be the top two that show the preventive controls for animal and human food. We're going to skip producers produce safety because that is sort of a different topic. The foreign supplier verification program does fit into both preventive controls for animal food as well as human food. If you've never heard of the sanitary transportation of human and animal food rule, you need to go to the FDA website and read their guidance document because it takes effect tomorrow. So if you transport or load human or animal food, this takes effect tomorrow. You have to be in compliance with this. Probably the biggest thing with it is making sure if you ship bulk ingredients in either hopper trucks or hopper rail cars, that the cars are clean, that they are physically clean inside, that you can verify that you looked inside the car, car is empty. That may mean you have to take a picture of it. But you need to have proof. Yes, this car is empty. If the car has something in it, then you have to clean it. You have to set whatever that is aside and say what it is you're going to do with it and then proceed to say, okay, now the car is clean. I can use it. If you're using containers, that means you must look inside your container. If you're shipping food in bulk or in tote bags or in even paper bags and you are shipping food, it needs to be a food grade container. I hear stories all the time about we're not getting food grade containers, we're getting something else. The previous load was scrap iron and they didn't take all of it out. So now we've got to take the scrap iron out, wash the inside of the container, perhaps sanitize it before we can use it. It adds costs to what we're trying to do. It adds time to what we're trying to do and it's just a real problem. But that's just the way it is. We will not talk about number six or number seven. Number six is yet to even be really written. And number seven is only intended for food items that would be easily tampered with. And what we assume that to be is liquids. So like milk, anything you could shoot or put an agent into easily, you need to have a program in place that says how you're going to keep that from happening. So the goal of SHISMA isn't really to make life difficult for us food producers. But it is to help us prevent food problems rather than responding to food problems because always before we've always just responded, something happened and we took action. Under this law we're supposed to take action before something happens. So these are the two rules. Twenty-one, I should explain, CFR stands for Code of Federal Regulations. Every rule law in the United States is in the Code of Federal Regulations. The book is probably close to seven feet high if you printed it all out and stood it on its end. So 21 CFR part 117 is the current good manufacturing practice hazard analysis and risk-based prevention control for human food. It has seven subparts, A3G. 21 CFR part 507 is basically the same rule it is just for animal food. It has some minor differences from the human food and it only has six subparts. If you really want to entertain yourself you can download either one of these rules from the FDA website. Put them on your night stand and if you have trouble doing the sleep at night start reading. It's probably going to put you to sleep. So the big question everybody has is, well, who's covered? Let me list. And here's the easy answer. Facilities that manufacture, process, pack or hold. Human food which is 117.1 or animal food which is 507.1. So in general it's all those facilities that are required to register with the FDA under section 415 of the FDNC Act which is the 2002 Bioterrorism and Response Act. Please note farms are not required or not covered by this rule. So farms are not covered by this rule. Retail food establishments are not covered by this rule. Other rules apply to retail food. It applies to both domestic as well as imported food. There are some exemptions and modified requirements. So we're going to look at an exemption. So it's what is called a qualified facility. It's explained in CFR 21 117.5A and CFR 21 507.5A. These are very small businesses. You can read the rest of the million dollars in total sales. Plus the value of any food that's held without sale. And then the other, what the other example here is food sales averaging less than $500,000 per year during the last three years. Sales must be the qualified end users which is customers, you and I, consumers, restaurants, et cetera. And so they're exempt from the hazard analysis and the risk-based preventing control which is in the rule. It doesn't mean they're exempt from the manufacturing practices. They may in fact still have to be cognizant or aware of that fact that they may need to comply with good manufacturing practices. So this is another exemption. So if you're making food that's subject to hazard, so seafood or juice or low acid canned food, please note the fault, low acid canned food regulations. Dietary supplements are covered under something else and alcoholic beverages are exempt. So here's some other ones. This one is what's known as the raw agricultural commodity. So it's a facility such as a warehouse that only stores unexposed package food. I'm sorry, I skipped that ahead of myself. I apologize. This one is about warehouses. So you have a warehouse and trucks bring you packaged food on pallets. They offload. They sit in your warehouse. Then you take those pallets, put them into another truck and they leave. Unless it requires refrigeration, you do not have to follow the preventive controls. That doesn't affect you. If on the other hand you are working with food that requires refrigeration, then you have to have your preventive controls in place and you must use monitoring and verification and good manufacturing practices that apply to you. So this is the grain storage facilities such as grain elevators and warehouses that only store raw agricultural commodities, other than fruits and vegetables. If you're storing fruits and vegetables, you're not exempt. If all you're doing is storing grain, you may be exempt. So that's that. But having said that, I'm going to qualify it just a little bit and say, so you're a country elevator, farmers bring you grain in their trucks, you unload it, you put it in your facility. You don't do anything with it and then a train comes and you load it on a train and it goes somewhere else. You would be exempt. But if, on the other hand, you took this grain and you cleaned it and you took those screenings or cleanings and you processed them or just even sold them on into the marketplace, you would not be exempt because that would be considered a process. Even though it's often considered, oh, well, cleaning is just part of the deal. Well, I'm sorry, but it's not just part of the deal. So it's the rack exemption where agriculture come out of the exemption. So you are just a holding or transportation of our agricultural commodities. It's not a new exemption that's been around. The GMPs are going to apply to packaging and packing and holding. There are some things you can do to make you compliant under the rule. And again, this is all sort of subject to interpretation. I'm not a legal expert, so I can't really tell you are you or are you not exempt? It sort of depends. And then there's the farm-related exemptions. So an example of this would be, okay, the MCI female is exempt because we are considered by definition to be part of a farm. And so therefore we are not subject to this law, which we were all very happy to learn. That was the case. And then you've got some certain other things you can do that you could be considered exempt under. Best thing to do is just simply go to FDA and ask, well, this is the situation. Am I exempt? And let them tell you yes or no. I will tell you that sometimes it can take upwards of three to six weeks to get your answer. Part of that's because FDA is understaffed and they just don't have the people to answer your question in a timely manner or in a manner they would like to answer it. They're doing the best they can. So when does FISMA start? Well, actually FISMA has already started for certain groups, no food manufacturing facilities. So if you were a larger company, if you had more than 500 employees and you were a human food production facility, you had been in compliance since September 16th of 2016. If you were a large animal food producing facility with more than 500 and full-time equivalent employees, now on September the 19th of 2016, you had to comply only with the GMP part of the rule. And then in September 18th of 2017, then the preventive controls, you have to be compliant with preventive controls. So the thing about GMPs is they're just, they're called good manufacturing practices. They are fairly self-explanatory. They aren't really ever written down anywhere. It's just that you are supposed to be doing things in a manner that would lead to the production of safe food. And it's usually a visual type thing. So if you look and you see a very, very clean operation, then you might just sort of assume, even though you should never assume anything, that everything is okay. If you see a situation where there are bugs or where there is evidence of pest presence, you might consider, oh, this could be bad. And a little aside here on the food side, a month and a half ago, a company in Oklahoma that produces a frozen chicken product had their chicken in bags inside of cardboard boxes stacked on pallets wrapped with plastic in their warehouse, in their cold warehouse. And an inspector happened to walk through and noticed that there were mouse droppings all over the place. And he said, I'm sorry, this is unacceptable. I'm closing this facility down as of right now. I need to have all of the product that you have produced since you can prove, to show, you have to show me when the last time was your pest control people were here. They ended up bringing back almost 90 tons of frozen chicken because this, you know, there were mouse droppings on the floor, on some of the packaging, and it's evidence that they're very easily could have been adulteration of the product. So we continue down here, produce safety takes place in 2018. The foreign supplier verification program would start this year in May. A little bit about foreign supplier verification. If you import an ingredient or a product from a foreign supplier, and they are not a registered FDA facility, then you as the importer must take it upon yourself to show that these people produce their food under conditions that would make render it safe underneath FSMA. So they have to have a hazard analysis in place. They have to have a preventive controls plan in place. Basically, they just have, you have to show that they are doing everything that they formally would do if they were compliant, if they were a registered FDA facility. Now, if they are a registered FDA facility, you don't need to go through this because they are, of course, producing safe food. Sanitary transport takes place tomorrow. And then the food defense business start until 2019. So this is general. This is big companies. Anybody with more than 500 full-time equivalent people. So most of us aren't big companies. Most of us fall into this small business, medium-sized business. So here again, we have the human at the top here. So less than 500 full-time equivalents. Your compliance date is September the 18th of this year. You must be in compliance with FSMA with the preventive controls. If you're a small animal food producer who has less than 500 full-time equivalents, on September the 18th of this year, you only have to be in compliance with CMPs. And it's September the 17th, 2018, for the preventive controls. Produce safety. Here again, we've got these dollar values, less than 500,000 in produce and sales. That means you're going to have, you will be compliant in 2019 in January. Foreign supply verification doesn't apply. Third party predation doesn't apply. Sanitary transport does apply. And food defense does not. So this is very small business compliance dates. So and you must meet the applicable definition of being a very small business. And the definitions are actually a lot larger than they're showing here. They are in the rule. You can go and look at the rule. There are also guidance documents that were published by FDA that are available on their website that will also help explain this. So human food, again, we're looking at September the 18th, 2017. So this is less than a million in sales and the market value of food manufactured process packed and filled without sale. For animal food, excuse me, it's 2018 by the CMPs. 19 for the preventive controls. Produce safety. If you're less than 250,000, you're delayed all the way out to 2020. Again, the Foreign Supplier Verification Program really doesn't impact you. The compliance date is 17, but it doesn't really have anything to do with you. Third party accreditation doesn't apply. Sanitary transport probably does not apply. But if it does, then it would be, it starts tomorrow and then food defense doesn't really apply. So I mentioned this food safety plan that everybody needs to have underneath the preventive control part of the law. It's a written document that's kept on-site. It does incorporate a hazard analysis. That just means you look at all the potential hazards that may be in the ingredients that you are bringing into your plant to make your products and those hazards that may be on your products as it leaves your plant. And what it is you're going to do to assure that they are under control. And the food safety system is just making this work. It's the outcome of implementing your food safety plan. And that side of things kind of straightforward and then we get to being a little more complicated. So in a food safety plan, the things in the yellow box are absolutely required. They are written, they are encodified language in the rule. So you must have a written hazard analysis. It must be on-site. If you don't identify any hazards, that's, it still needs to be there. You just need to say, I didn't find any hazards. I don't expect any hazards. These are the reasons why I don't expect any hazards. If you find a hazard, then you must have a preventive control. The preventive control can be a process control such as heat. That's the one always everybody thinks, oh yeah, we're going to, this stuff is going to be cooked. It's going to be heat treated. It will kill anything. It can be a food allergen control. And actually a food allergen control can be as simple as just changing the labels on your product according to what it is that's in your product. So if you make something that has eggs in it, the egg is the allergen. So you put on your label, it contains eggs or if it contains milk, it contains milk. So if you've got products that are made on your line, some of them have eggs and some of them don't have eggs and you forget to change your labels, then you could be, you've violated your process control. So that would be a bad thing. It could be a sanitation control. So that means you've identified something that has to be dealt with by sanitizing. So you may have, this is when your biological pathogens come into play. This is when lysotheria monothotogeness comes into play or E. coli. So you are actually sanitizing food contact surfaces with some type of a liquid or a spray or something that's going to render those particular pathogens dead. It could be a supply chain process control, which means you're not going to control it. You're going to make the people who are supplying you control it. And most of us who are trainers would say, well, good luck with that because you're trying to push something upstream that people aren't really going to be happy about. And then there's this other. And other is never explained. Other can be almost anything that controls a hazard. That is not a process control. It is not a food allergen control, a sanitation control or a supply chain control. And then if you have one preventative control, then you must have a recall plan. And then you have to have procedures for monitoring what you're going to do if you have to take a corrective action and then how you're going to verify everything. Those are required. The ones on the right that say useful, they are useful, but they should almost always be there. You should be able to have in your food plan, your food safety plan, you should have a statement that says, this is what we make and this is how we make it. This is our food safety team and have their names there. The flow diagram, this is how we do what we do. This is where we have preventive controls in place if we're using preventive control. It's helpful for you because you cannot do a hazard analysis unless you actually understand what it is you're making and where you may or may not be at risk. So in the rule there are these qualifications of individuals who manufacture processed pack of food. And this is actually written in the rule. This is codified language. So everybody that works in your plant needs to have training in the principles of food hygiene and food safety. They also need to have training in personal hygiene and why it is important to food safety. Those have to be recorded. So you have to have some process in place for all of your employees sit down either individually or collectively and either watch a video, a PowerPoint, or listen to some person like myself tell them about food safety and personal hygiene and why that is important to food manufacturing. And then write down the date they took the training, have them sign it, and keep that in your record book. Because that is the only record you are required to have in your good manufacturing practices. If you don't have it, inspectors are not going to be happy. And then there's this individual who's known as a preventive controls qualified individual. Now this person can do, there's two ways you can become one of these. You could either take a class in which you are taught the concepts and the tools that you use to do a risk analysis and then to write your food safety plan. And so the course that I teach is the one that's the standardized curriculum that's recognized by the FDA that's adequate. Or if you happen to be a PhD food microbiologist with 25 years of experience, you would probably qualify as a preventive controls qualified individual. We would sort of expect that you understand the nature of what it is you're trying to do. You understand what a hazard is, you'd understand how you could control it. A person does not have to be an employee of yours. He or she can be an external consultant. Training has to be documented and they have to be kept in the records as long as the employee is there. So preventive controls qualified individuals are extremely important people. Usually when we start telling them what it is they are going to have to do, most of them want to leave the class and say I'm sorry I didn't realize that's what I was signing up for. And this is what they do. They have to oversee or perform the preparation of the food safety plan which means they have to do the hazard analysis. They have to do validation of preventive controls if you're using preventive controls. And there's some other things with 90 days. Don't worry about the 90 days that will be explained to you if you went to training. They have to review records. So everything we do is recorded. All actions. So if you're monitoring the temperature of your roaster oven because you're making, I don't know, roasted sunflowers and you have to have them to a certain temperature to assure yourself that you've managed to kill any of the pathogens that might be on the sunflowers. And you record that temperature every so often, either visually and manually reading a thermometer or you've got an automatic system that takes the temperature constantly. And there's an alert shoe if there's a problem. It goes under temperature. And so you have these little charts and every time you do one of these recordings, you write, the person doing it says yes at 9 a.m., the temperature was, I initial, and you initial it. And then at the end of seven working days, your PCQI comes by and checks to make sure that you have checked all your boxes. Actually, it's better if the PCQI can come by every day to make sure that you've checked all your boxes because then you don't find yourself in a situation where, uh-oh, look at this. On Tuesday, we had an out of compliance reading but nobody noticed it and we didn't get an in-compliance reading until Thursday. So all the product we made from whatever time it was on Tuesday until whatever time it was on Thursday needs to be called back. Hopefully, it hasn't left your control, but it may have. So that's why we try to keep this seven working days that suggest that it's in the rule. It's better if it's a little more often than that. Then you need to reanalyze your food safety plan at least every three years. It's better to do it more often. And also, if you have another compliance situation, you have to initiate a corrective control and you need to do that all within 90 days. So there is this Food Safety Modernization Act Technical Assistance Network. So if you have a scientific or a technical question you'd like to ask, you can actually ask this group that's at the Illinois Institute of Technology, which is in Chicago. And inside of that is the IFSH is the International Food Safety and Health Organization. And the Alliance is the Food Safety Preventive Controls Alliance. So anything that's a scientific or a technical question send it to these people. If it is a regulation or a policy question, that is, well, I do this, in my exempt, send it to FDA. And like I said, they will answer. It may take longer than you would like, than you would think it should take, but they will answer. So I mentioned this, the Food Safety Preventive Controls Alliance, which is actually the people who read the curriculum that I teach. It was a public-private partnership that was funded by the FDA. And our mission is to develop outreach and training and technical assistance to assist the regulated industry in complying with FISMA. The curriculum that we have is the standardized curriculum that was recognized by FDA. Successfully completing the courses is one way to make the requirements of being the Preventive Controls Qualified Individual. This is the contact information for the FSPCA. The easy thing to do is to just Google FSPCA. It's the first thing that comes up. And that's their homepage. And on the homepage, there are links to a whole variety of helpful sources of information. And I would encourage you to look at that. You know, this is, we also have what's known as the FSPCA community. Anybody can become part of the community. All you have to do is go on and create an account. It's free. So you get resources and knowledge articles. You can find lists of when we have courses that are scheduled. And you can get technical assistance. It's a fairly easy website to navigate. And with that, I'd like to thank you. I hope I did not talk too quickly. If you have questions other than regulatory and interpretation questions, I can try to answer them. So one of the things that a lot of people sometimes wonder about is okay, I'm an ethanol producer and I have what's known as distiller's grains. And I sell those to guys who make animal feed. Do I have to be, does this apply to me? And the answer is yes. You're selling an ingredient that's going to be used to make animal feed. So yes, you are. You must be compliant with this rule. So then the next question they always have is, well, I don't have any hazards. And the response is, well, yes, you do because corn has mycotoxins. Typically, it can have afotoxin as a percentage. It is a hazard. Do you do anything in your process that controls afotoxin? The answer is no. So you don't really have anything that you can do in an ethanol production facility that's going to control afotoxin. So you have to declare, or at least make the people aware to buy your distiller's grains that, oh, by the way, this is the afotoxin that this is carrying. And those people are going to say, oh, okay, thank you very much. I wish I didn't have to deal with this. But now I have to come up with a way to try to negate that. And what happens is we negate it. We don't ever really negate it. We just dilute it. So we make it less hazardous by blending. So that's one thing. So ethanol plants definitely need to be in compliance. If you're a flower miller and you're selling flower to the food industry, human food industry, but you're also selling wheat mids and other things to the animal food industry. So do I need to be both? Do I have to have PCQIs that are both human and animal food? And the answer would be no. Mostly what you're doing is selling to the human food side. You just fall under the human food. You fall under 117. And as long as you keep your wheat midlings and your brand and things like that in safe storage conditions, or under conditions that would cause them to be considered to be safe, you can sell them to the animal food people. And it won't make any difference. You can go to animal food production. So you do not need to be compliant with both. Well, I'm still not seeing any questions down there, Kim. So I think we'll stop the recording. And if anybody else still throws them down there, I guess you can still go ahead and answer it. But if not, I'm going to stop.