Overview of the Food Safety Modernization Act
So with this act, there’s 50 new rules. These are the focus areas that they kinda focus on, and I’m going through each one of them in the next couple of slides. With the Food Safety Modernization Act and with the rules that came with it, it’s more about prevention, it’s not so much reaction. So with a lot of the other rules that happened in between time, HACCP (Hazard Analysis and Critical Control Points) rule and standards were set about midway in the 90s, and that was all about reacting to if something happened, then what was your reaction to it. And so now, we’re working on standards that will cause you to think about your practice ahead of time, and work on how to prevent certain accidents and outbreaks to happen. As far as manufacturing, preventative control is mandatory now both in human foods and animal foods. You have to have one person trained as a preventative control individual in your facility that will then turn around and train everyone at your facility itself. Also, and this is what Joe is going to talk about later, is the Produce Safety Rule. And he’ll tell you all the standards with that, so I don’t wanna steal his thunder. So even with that one person in your area, or in your company, has to be trained. Another thing that we were talking about as we were getting ready for training this month is that the training goes with the person and not with the company. So if that person ends up leaving your company, that means you have to get someone else trained. But it’s all about preventing intentional contamination, so making you think ahead. I’m an instructor for classes on campus as well, for me — and I watched a lot of my students last spring — I said, you have to think ahead. Of all the things that we’ve taught you up to now — a lot of them were seniors — you have to take the time to think about what effect could happen in the future. A lot of them left last spring preventative control training so wherever they ended up going, it was an asset to that company. It also mandates inspections, or increase the frequency of of inspections of your facility. These are probably more than likely unannounced visits. I know that when a lot of things started moving forward with produce, the FDA could show up at any time. We can’t tell you when they’re showing up. If you hear they’re in the area, they may come see you. You also have to have full access for them to your records. And we’ll talk about how important record-keeping is on this next slide. And also you have to have some mandatory testing of your product through accredited laboratories. They’re all throughout the states, I don’t know if we’re going to start doing anything on campus but if we cannot do the testing for you, we know those who can do it for you. As far as responding is a part of this rule, there are now mandatory recalls. There is a big component of the preventative controls that’s focusing on allergens. So I think for a lot of people it was voluntary before. But now, and I’ve noticed that too when I actually took the preventative controls training, that every day there was a new, Hey, they have to recall this because it has this particular allergen in it. And I think to myself sometimes, Don’t they know that peanuts … that something has peanut something in it? But a part of the rule is that you have to say, you can’t say should, must, or something… There’s a way in the rule that you cannot say, you have to say that it does contain this, it was produced, we know that it was produced in a facility that also has peanuts in it, or any of the other allergens that were that are associated with food allergens. As far as…traceability is another thing. With you guys being in local food you know that the consumers want to know where their product came from who was all involved in the processing of their food and with me especially working with cottage food producers and start-up companies, they like to get to know who made their products. And so the larger industries are working on this as well, they made that a part of the rule as well. Keeping track of where the food came from and how you can track it back all the way to the table. That’s also helpful as far as recalls go. Also keeping additional record-keeping for high-risk products. So record-keeping, we’ll probably exhaust it to death in the trainings that we do. Even when you take certain trainings, there’s whole sections, they talk about record-keeping, they give you examples back of sheets to use, so you have to make sure that you, when you work with these companies let them know that they have to keep great and neat records over time. Imports of foods, we’ll talk about the numbers of imports in the United States. We now have to hold them accountable as well. There’s a high number of imports that come into the United States, so they will have to have the proper testing, they have to have the proper certifications, everything before they enter their foods here into the US. The same way that it is done for domestic food through the United States. And they can be denied entry into the United States. And at the same time, they wanted this rule also to enhance partnerships. Not so many people working into their own areas. So now the inspectors are now talking to us, or right now there is a grant for us with the Produce Safety Alliance, we’re working hand in hand one on one with IDALS, with this training, and so that’s one partnership that has been developed here in the state. So who does this rule affect? So the very very small food operations are not impacted as much with this rule. So those who sell within the past three years less than $500,000 are not impacted right now for this rule. As well as those who have end-use consumers that are restaurants, retail facilities and sell directly to consumers, so farmers market people, not as much of these rules do they have to follow. There are certain parts that they will have to follow but they don’t have to follow the complete rule itself. Other exemptions are those who have to do HACCP, so Hazard Analysis and Critical Points. That’s mostly associated with seafood, juice and some meats. As well as some low-acid foods, so even this summer, DIA, Department of Inspections and Appeals, had — not kombucha, sauerkraut or something like that. They still have to maintain HACCP plans. As well as those who are producing dietary supplements and certain alcoholic beverages. We did a presentation for the wine group this summer, and they were smaller wines, we told them that they did not have to follow all the rules, but they did have to train their employees and keep proper records. Same thing for them, even though they don’t have to follow all of the rules, if the FDA shows up, they have to be ready. We’re working on having fact sheets and materials for everyone, so they can know what standards they have to follow. Other exemptions are, those raw agriculture products that are other than fruits and vegetables. So grains, and they’re warehoused in elevators. And also the holding spaces for effective storage. They’re not affected by this rule as well. So who does it affect? So in school, we use this as a kind of way to separate the two. There are some food products that are under the regulation of the Food and Drug Administration and there are some that are under USDA. So FDA, that’s for the dietary supplements, your bottled water, your food additives, infant formula, and non-USDA products. So that doesn’t tell you too much, does it? But we’ll give you more definition as we go. So the FDA is responsible for a large percentage of the food supply. And 15 percent of that has been imported into the US, and it’s estimated that 60 percent of those food products are fruits and vegetables, and they are imported in. So, consumers want fresh produce all year round, so the only way we can get it all year round is if we’re getting it from other places. And then they are responsible for about 1 percent of all the imported foods in the US. So beef and other food products are imported in as well. For the USDA, how we differentiate it is that meat is often associated with the USDA. Cattle swine, horses, mules… ew… are all regulated by the FDA. Egg products are also regulated by the USDA and processed eggs, so your liquid eggs are under that rule and frozen eggs as well. Also, and I remember when my co-advisor, we were teaching a farm to table class, kept bringing up that pepperoni pizza fell under USDA. So even though it only contains a small percentage of meat, it falls under the USDA. Am I saying it wrong? I’m saying USDA. In my mind, that’s what I’m saying. As well as beef sandwiches, hot dogs, corn dogs, chicken sandwiches, chicken noodle soup, all of that falls under that area. As far as the USDA, they regulate products that are 3 percent or less of meat, so I guess where that pepperoni pizza falls under, and less than 2 percent of cooked meat, and 30 percent of tallows and meat extracts. And then products that are less than 2 percent of poultry, 10 percent of skins, shelled eggs and processing plants such as those who are preparing eggs for sale. They also regulate animal food, so we’re going to talk about why this is important with the rules. So there are six different rules we’re going to talk about so foods that are for livestock and domestic animals. So when we talk about the rules, these are not all of them, but these are the six that are pertaining towards that we’re going to just cover today, and that are important in food production. So preventative control for human and animal foods are for those who generate, process, manufacture or pack foods. And they have to register with the FDA under the Bioterrorism Act. Not farms or retail establishments fall under this rule. And it applies for both domestic and imported foods. And there are some exemptions and modifications, like I said with the wine. When we spoke to them this summer, we said, you have to register for the Bioterrorism Act, as well as you have to do two additional things that were associated with the rule. As far as human food, as far as domestic and foreign manufacturers, they have to register under the Food, Drug, and Cosmetics Act and follow the regulations of Current Good Manufacturing Practices, so when I was in school there was just Good Manufacturing Practices, but with this new rule, there are other things added on, so now it’s called the Current Good Manufacturing Practices. As far as establishing and implementing hazard analysis and risk-based predictions of human foods. And animal foods, they have to do the same thing. Everyone loves their animals, they will get upset with us if something happens to the animals, so the same things we do for us, we have to do for them. We have to register, we have to follow Current Good Manufacturing Practices, and it requires you to do a risk analysis. Teresa: Can I just add on real quick, something I learned through all this is the preventive control where it will affect global food is it may or may not affect food hubs, depending on their size and what they do. It does affect your dairy processors. They fall under preventive controls. So they’re having to think about, you know a lot of them had HACCP and now they have to shift to Preventive Controls to be current with the law. So, Food Safety Verification Program, this is strengthening the oversight of imported foods, it’s a requirement for them to perform risk-based activities. And in the United States, that’s used in a manner that provides a public health protection of their domestic products. So this is all about the imported foods, so the same thing that goes for domestic foods also goes for imported foods. Food Defense — focus on the mitigations and strengthen protection of foods against intentional adulteration. So like I said, even with allergens. If you don’t readily work on identifying those allergens, that could be an intentional adulteration of the food item, because you have not recognized it. So it could fall under that area. And this is required for both domestic and foreign facilities, and it is to prevent a large harm to the consumers as a whole. Sanitary transportation — so a lot of people don’t think about this. So yes, we have to make sure that the product is grown safely on the farm, have to make sure that it’s processed safely, but then you also have to make sure that it’s safe during transportation. So that’s why there are so many refrigerated trucks. That’s why certain trucks look a certain way or are sealed off in a certain way. So they even have rules that are required to that, and that’s requiring that the food is safe through transportation. I think even one of my colleagues is working on campus on some kind of sanitation and transportation research as it’s related to packaging as well. So it’s becoming a big topic in our area. So this is both for human and animal foods and like I said, it’s covering mostly sanitation. So Joe is going to talk about Produce Safety, so I just highlighted it as one of the six, but he’s going to talk about it. Both Dr. Angela Shaw and Dr. Jim Dickson are over the Preventive Control and FSMA training. Dr. Shaw does preventive control in human foods. We won’t be having that training here this fall but we will be having trainings next spring. And I don’t know about animals, I know that they had one this summer sometime. So the persons that you should get in contact are those, about FSMA and about the training. I think one reason why Dr. Dickson is not here is that he’s out performing an audit that’s probably associated with this. Joe, it’s your turn. Tag, you’re it! And I’ll be back. I have a wrap-up.