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How It All Began: The History of FSMA
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In this episode, we’re joined by Kristin Esch from the FDA and Produce Safety Technicians Allissa Conley and Morgan Anderson as they dive into the history and purpose of the FSMA Produce Safety Rule. They discuss how it all started, why food safety is so important, and the benefits of a proactive versus reactive approach to produce safety.
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Transcript
Introduction to the Podcast
00:00:00
Speaker
Hello and welcome to the Agri-Food Safety Produce Bytes podcast, where we discuss all things produce safety and dive into the rules and regulations surrounding the Food Safety Modernization Act Produce Safety Rule.
00:00:13
Speaker
Hello,
Meet the Produce Safety Technicians
00:00:14
Speaker
everyone. My name is Morgan Anderson. I'm a produce safety technician based out of the Ottawa Conservation District. But I service um eight other counties all the way towards the Lansing area. um And I'll pass it to Alyssa to introduce herself. My name is Alyssa Conley. I am the produce safety technician based out of the Newaygo Conservation District. I serve 13 counties in West Central Michigan. And I'm excited for this podcast today.
Role of FDA in Produce Safety
00:00:41
Speaker
We're going to be kind of doing a background deep dive into the produce safety rule. And we have the pleasure of having Kristen Esch on our call today. And I'll let her introduce herself a little more.
00:00:52
Speaker
Hi everybody, my name is Kristin Esch and I am with the FDA. I predominantly work in the North Central region. There's 12 states that I cover, but I also do work across the nation and and internationally.
Understanding the Produce Safety Rule
00:01:05
Speaker
My job is mainly to focus on education and outreach to farmers, industry, educators, and in and regulatory staff ah regarding the produce safety rule.
00:01:18
Speaker
Thank you, Kristin. We wanted this podcast because the theme of this newsletter for this month through the Michigan on Farm Produce Safety Team um is how and why does the produce safety rule apply to me? And so we want, like Alyssa said, to take a deep dive into the importance of the produce safety rule and how it came to be. um So Kristin, do you want to kind of start us off with how the creation of the Food Safety Modernization Act and the Produce Safety Rule came to be?
00:01:45
Speaker
So Congress enacted FISMA, the Food Safety Modernization Act, in response to dramatic changes in the in the global food system and understanding of foodborne illnesses and its consequences. So that included the realization that preventable foodborne illness is both a significant public health problem and a threat to the economic well-being of the food system.
00:02:11
Speaker
So the Produce Safety Rule was established as part of the Food Safety Modernization Act passed in 2011, which mandated that the FDA create specific regulations for the growing, harvesting, packing, and holding of produce. Essentially, this set the first federal standards for safe production and handling of fruits and vegetables to minimize foodborne illnesses associated with fresh produce.
00:02:40
Speaker
This marked a significant shift from reaction to contamination to proactively preventing it, which has never happened before in the produce realm.
Historical Outbreaks and Lessons Learned
00:02:52
Speaker
Yeah, and i I have two cases, examples. Before the FSMA and produce safety rule, one was um E. coli in Spanish 2006. There was 200 people as like hot cases. And then in 2011 with a cantaloupe farm and there was 147 case count with Listeria. And those numbers, as most of us probably know, are maybe even under reported because some people may have gotten sick and didn't go to the hospital or get tested and have it be reported.
00:03:22
Speaker
um So I think that kind of just emphasizes once again, Kristen, what you're saying about the importance of the proactive versus reactive, especially in an expanding food system.
00:03:33
Speaker
Yeah, and Morgan, also due to the short shelf life of produce, there's a lot of outbreaks that we usually can't identify because you know produce moves quickly throughout our our food system. So it's it's easier for us to identify ah potential problems before they happen than it is to identify what happened afterwards.
00:03:59
Speaker
Yeah, so Morgan, you kind of spoke on some of the historic outbreaks. Kristen, do you have any information on maybe some newer outbreaks or kind of updated stats on what's going on with food safety currently?
Flexibility and Challenges of the Produce Safety Rule
00:04:13
Speaker
Yeah, in 2022, produce was identified in 37% of reported illnesses. And as Morgan alluded to earlier, reported illnesses, it's what is reported. So we all know that, you know, sometimes we get sick, um we don't necessarily go to the doctor.
00:04:33
Speaker
We don't necessarily contact our local health department. So I think a lot of people are like that. And I think that that's very underrepresented. um And since 2011, there's been 60 identifiable pathogenic outbreaks.
00:04:52
Speaker
they wearing produce That's kind of crazy. And like you said, it's underreported. um I saw something from the CDC that they estimate that foodborne illness causes annually, just per year, 48 million illnesses, 128,000 hospitalizations and 3,000 deaths. But of course, if produce is 37% of that, that's a pretty big number there. And I think one of the benefits of a proactive approach also offers some flexibility within the produce safety rule. Christian, do you want to speak to some of that flexibility within the rule itself and why that's there?
00:05:28
Speaker
Yeah, so the produce safety role was developed to cover all types of farms, which is a ah difficult feat if you think about it, because every farming system has its own way of doing things. And even if you're ah harvesting the same type of commodity, each farm is going to grow, harvest, pack and hold those commodities differently. So it's the produce safety will was developed to allow for the flexibility for each farm to be able to continue farming in the way that works best for them, both economically and efficiently, but does set some minimum standards to help protect public health.
00:06:12
Speaker
Yeah, and I think that's one of the pros and the cons sometimes because sometimes growers want a certain answer like tell me what I need to do and I'll do it and it's not always as black and white as that. um But there's a reason like you said every farm is different and there's no way to have a very prescriptive one pathway for every farm to meet the produce safety rule. um I think that's kind of reflected in the new Ag irrigation water rule and that's more flexible and it's not as prescriptive with just the meaning of certain testing requirement and stuff like that. So I i also grew up on a farm um and I think that
00:06:49
Speaker
It's really hard for people to see their farm differently when they're doing it every day. um So it's nice to have a flexible produce safety rule and resources in the state of Michigan, but every state to kind of have to navigate this flexibility when the produce safety rule and see their farm in a different light of what maybe they could do better and maybe what they're already doing really well.
Economic and Safety Benefits of Proactive Measures
00:07:08
Speaker
I think too, we mentioned the benefit of the proactive approach in keeping people from getting sick, but also as a farm, you're thinking of your business. So it is also a way to help you save money, right? If you're taking these approaches now to help yourself, that could help you from a potential recall that could be even more costly than implementing a food safety practice on the farm. So I like that part of it as well. Yeah. And I think that sometimes when ah folks, they they feel like, well, maybe I haven't gotten anybody sick through the practices on my farm. My produce has never gotten anybody sick. And that's most likely true. But as we talked about earlier, there's a lot of people that don't report. So we may not know. And and and I think that every farm, every farm wants to do things right. they Nobody wants to get anybody sick, right? So the Produce Safety Rule is just providing some minimum federal standards
00:08:08
Speaker
that will help provide farmers with a way to continue that and allow for them to grow, harvest, pack, and hold safe produce. Absolutely. What are some hurdles you had to overcome, whether it's how you're making sure that everyone across the US, but even within states, is implementing the produce safety rule uniformly? What are some hurdles you think with just in the creation of the produce safety rule and the implementation of it?
Consistency in Safety Standards Application
00:08:37
Speaker
Yeah, so it's a big task when you do have a rule that's not so so black and white to have farmers and inspectors, regulatory staff, be as consistent as possible when it comes to the implementation of the rule. So we have a a few things that that we do. Of course, we've got, you know, some fact sheets that people can look at and you can find those at the FDA website.
00:09:01
Speaker
We've also worked on ah developing workshops. So we've worked with industry and states to put together ah workshops and materials for workshops so that every state has the same materials and is providing the same information.
00:09:19
Speaker
When they're doing workshops for let's say cleaning and sanitizing or for egg water systems, maybe for use of biological soil amendments of animal origin or common terms for that would be like manure, fish meal, those kind of things. So we have developed some of those workshops.
00:09:39
Speaker
We also have a national calibration program that is developed to work with state regulatory as well as FDA regulatory staff to go out and ah watch them conduct an inspection and to see how they are implementing and interpreting the rule.
00:10:00
Speaker
And so that program is available to states and FDA regulatory staff if they choose to participate in the calibration program. Yeah, it sounds like there's lots of training opportunities to be on farm, but also with other professionals, which I think is always um a plus to learn from other people and what they've seen. I was in a training once with people from California and they're talking about avocado like orchards and how they're growing on hills and the nature of that. And I thought that was, I never thought about you know an avocado growing system. so We don't have that here in Michigan. So um I personally appreciate trainings of other professionals to learn from them and how they are seeing things, even though it's a completely different farming system, which is just speaks once again to the flexibility of the produce safety rule for that reason.
00:10:49
Speaker
I think one thing that I hear a lot in the field is some frustration with growers about just the different food safety audits and schemes and why there are different options for them. And so I'm curious that kind of goes back to a little bit of the history of the produce safety rule and how gaps maybe predated the produce safety rule and if you would be able to speak to that and maybe some of the differences there.
Inspections vs. Third-Party Audits
00:11:13
Speaker
Sure. So audits, like you said, were developed quite a long time ago and there are third party audits where somebody comes onto the farm and they have a list of things that they have to go through. Usually the farmer has to pay for these audits and they're kind of like a points-based system. So
00:11:35
Speaker
There's certain things that a farm can choose not to do on that list of identified items and it's okay, they'll still pass their audit. Also, audits don't look at the whole farm. Audits only look at the particular commodity and it that the buyer is buying. that So if the buyer requires an audit on your strawberries, but you're also growing apples, the auditor will only look at your strawberry production area and your strawberry packing area. well It will not look at anything to do with apples. However, the the produce safety rule wants to look at your whole farm because you're also selling those apples. And if you're selling whole fresh uncut apples,
00:12:21
Speaker
that's going to be covered under the produce safety rule. So we want to make sure that how you're handling your strawberries and your apples are both safe. So we don't just look at, or the produce safety rule doesn't just look at one commodity. It's also not fee-based. It is a a federally mandated law and it is an inspection. So there's a difference between an audit and an inspection. Then we want to make sure that we use those terms correctly because I think Part of that is where we we find some of the confusion, but audits again are going to be something that the buyers require, whereas an inspection is federally mandated and it's it's something that all farms that sell fresh uncut produce have to go through.
00:13:08
Speaker
Yeah, I didn't know that gaps predated the purchase data, which makes sense because there probably was some liability that the buyers, grocers, et cetera, needed from the farms to make sure that what they were getting was also safe before they even got it. That was something that actually came up in surf safe training that I took a couple of weeks ago was before you even bring it into your restaurant or your retail space, make sure you're getting it from verified producers. And I was like, Oh, that's really interesting way to put it. Um, cause I'm working with the people.
00:13:36
Speaker
growing that food. And I can see why from the other end, why they wanted to show some kind of credibility for growing safe food. So yeah, thank you for bringing that up. That was something I always wondered about was that kind of history there. Yeah. And I think I've been doing, I did it prior to this job. I did inspections for many years. And it's very interesting, you know, how when, when you're doing something,
00:14:00
Speaker
All of us do it. When you've been doing something, you have a routine and you've been doing it for so many years at this farm, you know, for generations. It's just how you run your farm. It's a, it's a routine that you have. And it's interesting when you do have somebody come on the farm, whether it's an audit or an inspector, they see things differently and they're, we're there to help, right? We're, we're not looking as a gotcha. It's a there to.
00:14:29
Speaker
help. And we'll see something that maybe you've been doing for many years that if you tweaked it a little bit, it it would help with preventing possibly preventing some contamination. So I think it's always good to have an extra set of eyes regardless of what you're doing. I think it always helps kind of get outside of your normal routine and and help you think of things in in a different way.
Support and Preparation for Farmers
00:14:56
Speaker
We're very lucky to have photo safety folks in the conservation district because you are there as confidential, no fee, you can come on, you can take a look and it's there's no pressure there, right? So you guys can get on the farm and and at least just at a minimum have ah have a chat with them and take a look at some things.
00:15:18
Speaker
and have that second set of eyes come and take a look and see what you're doing. and don't I don't think that that's ever a bad thing to have somebody just somebody else come in and take a look. That's what I was gonna say. Thanks for the shout out.
00:15:31
Speaker
Yeah, it's definitely very rewarding to be able to go on farm knowing that that's our role and be able to help maybe someone who's new to farming that's nervous about their inspection, or maybe it's been their three to five year window and they're wanting help. So it always is nice to be able to provide them with that help when they need it. And also you guys help with farm readiness reviews as well. Still, is that correct?
00:15:55
Speaker
We do so that on-farm readiness review is usually at your local technician with a MSU extension. and We go out to the farm together and work through your on-farm readiness review. And then we can also be invited to an inspection by a grower if they um want a little extra support during that day as well, which is awesome.
00:16:13
Speaker
I do want to do a shout out to the fact of having somebody else at your inspection, because sometimes farmers can be nervous during an inspection and not hear everything. And that way you'll have somebody else there that's able to um help you remember a everything that was said.
00:16:34
Speaker
And B, maybe um interpret some of of the language, the the government language that may have been used. So I think it's always great to have somebody else there while the inspection is happening. I agree. Yeah. And I, I've been on some inspections where we use it in our everyday language and the food safety role of like cover produce and the, the farmers like It's covered by a real if it's like, no, that's not what we mean. It means it's covered. It's regulated by the produce safety rule. And so kind of taking a step back. So it's nice to have more eyes and ears on your farm during the inspection, just for that reason. Cause yeah, things that we say, sometimes we don't think about what it means out of context of produce safety world for sure. But yeah, so I've heard my interviews, like Alyssa mentioned, it's kind of gets you ready. The wheels greased for, um, your inspection with the Michigan department of ag in rural development.
00:17:28
Speaker
We mostly go around and see and witness the practices that you're doing, because that's what an inspection will do. um We do ask for some records, so it has some records to make sure that the records the inspectors will be asking for you will have or will at least mention them if we we don't look at them. um Just to make sure that all your I's are dotted and T's are crossed to kind of make the farm more at ease. And sometimes it's nice to be like, let's see where you're pointing that out in the rule. Let's talk about it. So then the grower itself can also understand where some of those questions are coming from and why they're being asked on an inspection.
00:18:01
Speaker
Yeah, I think, too, a really good resource that comes with doing it on Farm Readiness Review is actually that book you get at the end. It has a column with the produce safety rule language, like the federal language, and more of plain language that's easier for all of us to understand. And then it also gives you ways to comply with the rule. So I think that's also a really nice resource that growers can take advantage of to really help them out and feel more prepared for an inspection.
00:18:31
Speaker
Just to kind of round it out, what we were starting to talk about at the beginning there is that a reactive management of foodborne illnesses is all about reacting to problems as they arise.
Conclusion and Resources
00:18:44
Speaker
Proactive management on the other hand is about anticipating problems and taking steps to prevent them from happening in the first place, which is what we're all trying to do, right? So by shifting to a proactive approach,
00:18:57
Speaker
We can limit the number of outbreaks, therefore reducing the occurrences of produce-related illnesses and deaths, which is what we all want as a collective produce community. absolutely prevention is key
00:19:14
Speaker
Thanks to anything referenced in this episode are provided in our show notes, which can be accessed on the website at C-A-N-R dot M-S-U dot E-D-U slash agri-food underscore safety. Thank you to everyone for listening, and don't forget to tune in next month for another episode of our Produce Bites podcast.