Agrifood Safety Produce Bites

Understanding the Proposed Water Rule

February 04, 2022 Michigan On-Farm Produce Safety
Agrifood Safety Produce Bites
Understanding the Proposed Water Rule
Show Notes Transcript

The FDA recently proposed changes to the FSMA Produce Safety Rule Agricultural Water Rule requirements. In this episode, Phil Tocco, Food Safety Educator with Michigan State University Extension, and Annalisa Hultberg, Food Safety Educator with the University of Minnesota, discuss the proposed changes to the rule and provide guidance on how to submit comments.

Comments can be written and faxed to the FDA at 301-827-6870 or mailed to:

Division of Dockets Management (HFA-305)
Food and Drug Administration
5630 Fishers Lane, Room 1061
Rockville, MD 20852

To read more about the rule or if you would like to comment on the proposed rule, you may do so at FSMA Proposed Rule on Agricultural Water.

Comments must be submitted by April 5, 2022.

Additional Resources:

Agricultural Water Proposed Rule Fact Sheet


Funding for this podcast was made possible in part by the Food and Drug Administration through grant PAR-16-137. The views expressed in the posted materials do not necessarily reflect the official policies of the Department of Health and Human Services, nor does any mention of trade names, commercial practices or organization imply endorsement by the United States Government.

Alison Work:

Hello, and welcome to the agrifood safety produce bites podcast, where we discuss all things produce safety, and dive into the rules and regulations surrounding the Food Safety Modernization Act Produce Safety Rule.

Phil Tocco:

I'm Phil Tocco. I'm with Michigan State University Extension. I'm based in Jackson County, but I cover the entire state with respect to on-farm produce safety.

Annalisa Hultberg:

Thanks for having me today. It's great to be here. My name is Annalisa Hultberg, and I'm a statewide Extension Educator in food safety at the University of Minnesota.

Phil Tocco:

So, I'm just curious, you know, you've been doing food safety for a long time and so you probably were around when the current rule was put into place. I'm curious what issues your growers had with the current rule as it is that would make FDA want to go back to the drawing board in the first place?

Annalisa Hultberg:

Yeah, I mean, you know, we've all been doing the the trainings and really providing a lot of education about the current rule, and it required a pretty deep understanding of math and an understanding of data and being able to read and understand water tests and to quantify them. You know, it was a it was kind of a lot for our growers to understand. How about you, Phil?

Phil Tocco:

Well, so I know, some of our growers, the issues were that they were drawing from multiple water sources, like maybe the same stream but drawing at three different points in the stream, things like that. And the way the current rule worked is you'd have to treat each of those draw points as a separate source. So I can see where some people would have some problems with that.

Annalisa Hultberg:

Yes, yep. For sure. I would agree. I think, you know, it also didn't specify that, kind of a deeper look and understanding, taking a step back and thinking about the factors on farm that might affect the quality of your water. That wasn't explicit in the rule as written. So, you know, from FDA's perspective, from what we have, based on what they've said and what they've written, they wanted to move away from just relying on that water test as a way to understand the quality of your water solely based on that quantified tests, and those criteria and move more towards a deeper understanding and thinking about all of the factors that might affect the quality of that water, and then doing something about it.

Phil Tocco:

I'm wondering, so is the test dead, or is water testing still allowed in some parts of the rule?

Annalisa Hultberg:

It's certainly my understanding that it's allowed. I think it's not required. But as a verification, practice to understand if the measures that you've taken to fix whatever hazard might be present, I certainly would hope that testing would still be a part of that, because it really is a great way to understand the quality of your water. In Minnesota, we use a lot of groundwater. We're lucky to have good, deep, pretty protected, relatively clean aquifers, and understanding their quality, you know, an annual test, in terms of GAPs, we say, you know, an annual test. If nothing changes, you're good to go. But I certainly will continue to say, regardless of any regulation, that that is a great idea to continue to understand if their wellhead is cracked or some sort of infiltration is getting into that groundwater, I still think testing is still an important part of that. It's just not required in terms of the rigid frequency, but it's still a verification practice. Would you agree with that?

Phil Tocco:

I think so. I think the reports of water testing's demise have been greatly exaggerated.

Annalisa Hultberg:

Yes, it's just a lot more, there's a lot more flexibility and it seems to be a lot less rigid and prescriptive.

Phil Tocco:

So it's not prescriptive. What other differences do you see?

Annalisa Hultberg:

Well, maybe first we could say the things that haven't changed. So I think it's important to say that this proposal is all about pre harvest water. We're not talking, there are no proposed changes to the post harvest water quality criteria, so that post harvest water still has to be no detectable generic e coli in a 100 ml sample for post harvest and harvest use. So we were only talking about that pre harvest. I think that's pretty important. That's one of the first things, as I've been talking about this with growers that people are like, hold on, are we talking about post harvest? Because that water still needs to be drinkable.

Phil Tocco:

Right. Absolutely. And just for the record, we're talking about water that either touches the harvestable portion of the crop, or we're talking about water, like post harvest, touches the crop, or touches a direct food contact surface.

Annalisa Hultberg:

Yep, it still has to meet that definition of agricultural water. So it seems that the biggest change here is that the proposal really replaces that pre harvest, for the pre harvest water that Microbial Water Quality Profile, and that sampling regime with a systems based assessment of the quality of your water. So we're stepping away from just quantitative test results to looking at your entire water system, which might be quite a bit more broad and vague, and require quite a bit more thinking perhaps on the growers perspective.

Phil Tocco:

So with the MWQP, or the Microbial Water Quality Profile, it sounds like FDA set a standard and everybody had to meet the standard. So sort of the burden of proof for whether or not your water was clean enough was on the FDA. And now with this Ag Water Assessment and this qualitative assessment of water, instead of that burden of proof being on the FDA, all of a sudden now, a grower needs to accept the responsibility for whether or not their water is safe. Is that a fair characterization?

Annalisa Hultberg:

Yes, although I think in the current rule, it's still the grower's prerogative to ensure that their water is safe for it's intended use.

Phil Tocco:

I didn't mean that part so much as the grower wouldn't have had to prove that by meeting the Microbial Water Quality Profile, that it was safe. If they met the MWQP, FDA basically established that as being sort of safe, whereas now, a grower has to take a lot more responsibility.

Annalisa Hultberg:

Yeah, and that involves a lot more thinking. Less math, but a lot more thinking about the factors that go into making your water system safer.

Phil Tocco:

So then this Ag Water Assessment, I mean, what are some of the key components of the water assessment?

Annalisa Hultberg:

Yeah, so it seems like this Ag Water Assessment is kind of the key part of this proposed water rule. So a farmer would conduct this ag-wa if the water meets the definition of agricultural water. That is first and foremost. It needs to be conducted annually, or when something changes substantially, and it has to be written. So, I mean, the way I'm reading it is it is just a thorough assessment of the factors that might cause your water to be contaminated. And then at the end of this ag water assessment, you have a determination about the quality of your water, and what you might need to do.

Phil Tocco:

Okay, that makes sense.

Annalisa Hultberg:

So, the FDA has laid out, in their written document so far, has laid out kind of five categories of factors that the farm has to assess as a part of this Ag Water Assessment. Do you want to walk through those?

Phil Tocco:

I can totally do that. So the first one is really talking about the water system in general. So where it is, and whether or not it's a groundwater source or surface water source, and then the type of the distribution system you've got in place and how protected that water system is. It's a lot like parts of the annual water system inspection in the rule is, as it's currently written, but it doesn't stop there, it keeps going. So then we've got Ag Water practices, which is really how the water is applied. What other things were included in that Ag Water Assessment?

Annalisa Hultberg:

So, you mentioned what the Ag Water System is, about the location and then the type of distribution system, and then how you get it to the crop, so the application method. Also the crop characteristics, so how likely is it that if there was pathogens in that water, how likely is it that it might adhere to the surface or would it be internalized or sucked in to the actual cellular structure of that crop? So that surface adhesion is going to be greater in things like bumpy rind cantaloupe, as opposed to an egg plant, you know, just think about those bumps, so, like, the type of the crop. And then environmental conditions, so thinking through what the conditions are during the growing of that specific crop. So are you getting a lot of heavy rain events? How is your humidity? That can affect how those pathogens are adhering or if those pathogens are desiccating the field and going with. Air temperatures, and then sun and kind of UV exposure. We know that pathogens can dry up in the field and that has been shown to happen.

Phil Tocco:

This doesn't strike me as a something you can do in five minutes, either. I mean, it sounds like I know the FDA gave some estimates that basically a small farm, this is going to take an hour to do, and like a large farm, it might take as many as nine hours to complete.

Annalisa Hultberg:

Yeah, that's what I read from the FDA as well. And I mean, if you think about it, depending on the size of the farm, I believe it could take more time. I mean, you're really being asked to think quite carefully and potentially gather data from quite a few sources. This, I mean, because if you think through these kind of four things that we just mentioned, this might be information that you have on hand. You know the rind of your melon. But also if we're, you know, if this proposal is saying that you need to look upstream and think about all of the upstream uses, and think about weather patterns, this might be information that you gather from a number of sources, and that definitely might take some time. They also spell out that you will need to reassess if there are significant changes. So they don't exactly spell out what that means, what a significant change would be, but you would, this is definitely not thought to be a static thing that you do once a year, check off, and then don't do it again for another year.

Phil Tocco:

So it sounds like to me, not only is there a time commitment, but then you've got to do something with the information. So you basically, it's basically in three buckets, if you will. Good to go, or you found some things that need to be fixed, or it's unsafe for use. Would that be a fair characterization?

Annalisa Hultberg:

Yeah, I think that is how they spelled it out there. Either it is, there's no risk present, and you're okay to go. It would be interesting to me how you would prove that, so to speak. So that might be a comment people could say is, do I just say I never saw a risk to my water system for the entire year? You still would need to go down all of those categories that we mentioned previously, and kind of describe how your risks could be very low, or the risks are present but you're kind of not sure if they're going to impact the immediate quality of the water and therefore this kind of a longer term fix, or there's immediate presence, a risk presence and you have to stop that use immediately and make changes.

Phil Tocco:

So I'm interested in that middle category. It sounded like, basically, whenever there, whenever you think that poop is in your water, you've got a certain timeline to do the fixes. And then if there's a situation where there's not, where you don't think poop is in your water, you may have a longer timeline to do the fixes.

Annalisa Hultberg:

Yeah, that is how I also read that, I mean, which, which makes sense. I would like to see some examples of what exactly they mean by an immediate foreseeable hazard. But I feel like if you saw literal poop in the water that you were pumping from to irrigate with that would be a reason for you to discontinue use immediately.

Phil Tocco:

Absolutely. So then, I'm curious from your read what you came up with, with respect to ways of once you've got the determination, if there's risks present, and they're not sure if they're impacting the quality of water, what sort of mitigations would you do?

Annalisa Hultberg:

Yeah, so they kind of break it down into two categories of you have mitigation measures, or you have corrective measures, and mitigation measures are those longer term things that you're going to change and it might be a longer term fix, but that corrective measure is something that needs to be changed within the same season because the hazard that you're fixing, it poses a more of an immediate threat. So some of the suggestions are making modifications. This might be repairs, this might be building fences on your property or adjacent property. It's important to note that this rule really does mention in a few places that these hazards might be present on adjacent property. It might not just be your land. And that is really important to note, as we make comments, that it might be difficult for you to assess what those hazards are in your neighbor's property, but also important because they might pose a threat to that water. So it is actually important to note those.

Phil Tocco:

Not only is it important to try and figure out your neighbor's property, but I mean, I could see a grower having an issue trying to talk to a neighbor about fixing some of this stuff, too.

Annalisa Hultberg:

Yes, neighborly relations can be challenging, so this might add to that mix.

Phil Tocco:

So one of the things that they're also proposing is this die off of at least four days. In the current rule, one of the corrective measures is to apply up to a four day die off and that will reduce the microbial counts. It's essentially two log, so it basically moves that decimal point number of of bacteria count by two decimal places over, and they're proposing at least four days between the last irrigation event and the time to harvest. It makes sense, and I'm grateful that they're allowing that as a fix. It's hard to figure out how you would assess die off if you don't know what you start with, and I think that's something I struggle with. And I'm sure, I'm sure in the final rule, FDA is going to give us some guidance on how to deal with that.

Annalisa Hultberg:

Yeah, I think it's worth noting that it is not a cure all for potentially dangerous levels of bacteria in our water. You know, it's so it is a, an option that they've laid out here does the science really support that that is a Get Out of Jail Free card, for example? You know, I don't know that that science does support that.

Phil Tocco:

The good news is it sounds like one of the mitigations, they also talk about is switching to drip irrigation, which not only does that reduce the risk, but it exempts you from doing any other Ag Water assessments again. So it's kind of cool. It's like, you know, if I switch from overhead irrigation to drip, I then really get out of jail free as it were.

Annalisa Hultberg:

But you know, switching to drip, I would say just from a GAPs perspective, stepping away from regulation, I would say that's a much better option, because it truly does reduce your risk, because the water isn't touching the edible portion, assuming that the system is set up so that there isn't holes in your drip tape and it is suddenly an overhead sprinkler.

Phil Tocco:

Just to reinforce I think that's the biggest thing about this rule is it really makes the grower really focus on risk reduction and the risks. What are my risks, and then how do I reduce those risks? And so you're absolutely right, that all of the GAPs stuff that folks have learned about water, they're going to need it. They're going to need every every ounce of that and plus, so.

Annalisa Hultberg:

Yeah. Yeah. And I will say just for plant health, in addition, you know, there's a lot of benefits. I know that that setting up drip can be expensive and a difficult, system wise a lot of infrastructure to deal with, but we know that from a disease reduction standpoint, they can also have a lot of other benefits as well. So then they also mention treating the water in accordance with the Produce Safety Rule, the current Produce Safety Rule.

Phil Tocco:

It's kind of expensive, isn't it?

Annalisa Hultberg:

Not something that that growers necessarily would do in Minnesota. I don't know, how about you, Phil?

Phil Tocco:

Some growers, I think, in Michigan, would treat their water and some already do. But certainly, broad scale treatment of water is really tough. And some experts have said that just because you're treating water to bring down something like E coli numbers, doesn't mean that you're going to kill all the baddies and there's some baddies that really aren't controlled by things like chlorine. So you've got to worry about that too.

Annalisa Hultberg:

Exactly. So yeah, they do lay out some options, and I think that I personally would like to see some more options laid out and hopefully folks aren't using something like the die off and just perhaps thinking, well, I don't need to do any sort of an Ag Water Assessment, because I'm just going to do a very brief Ag Water Assessment and then use die off and not really think about the quality of my water, because that would be not really in the spirit of the rule or in risk reduction.

Phil Tocco:

So when only so when does a person not have to do an Ag Water Assessment?

Annalisa Hultberg:

So it's my understanding that if the water source meets postharvest ag water requirements, you don't have to do that ag water assessment. So basically, if that's untreated groundwater that has no detectable generic e coli in that 100 mil sample, it meets that postharvest requirements, and you don't need to conduct that Ag Water Assessment. Or if it's municipal water, if it's from a public water system that has been tested and treated, then you also don't need to do that Ag Water Assessment. The one last thing to note, though, is that you still have to do that inspection of your water distribution systems, as the current rule lays out. So that's kind of an inspection of your distribution lines, your well, that stands. So this would be in addition to that, and a much more holistic look at your water systems on your property and in your adjacent properties, kind of beyond that inspection of your physical infrastructure. Is that your understanding, Phil?

Phil Tocco:

I think so. Yeah, absolutely. Cool. So in light of all of this, what should a grower do at this point for this season coming up?

Annalisa Hultberg:

Well, so we know that this is a proposed rule and the comment period doesn't close until April 5 of 2022. So the rule as written right now stands and enforcement discretion is my understanding still stands as well.

Phil Tocco:

Yeah. So basically, nobody should go out and make changes based on this stuff. And the other thing I think is important to reinforce is the fact that you know, neither you or I are lawyers, so this should not constitute legal advice I guess is what I was gonna say.

Annalisa Hultberg:

Right. And also, I think it's really important to remember that this is a proposal. Nothing in this rule is final. So we should not be making any changes based on something that's not final, I think what we should do right now is read enough of the rule to understand it. Understand what an Ag Water Assessment is, and what you would do with it, you know. I think one maybe good way to think about it is picture your farm and picture yourself doing an Ag Water Assessment about all of your water system. Look at the FDA factsheet. They have a pretty decent factsheet, that it's only three pages and it really kind of, it has a couple of tables that really lay out what the Ag Water Assessment is. Picture doing it on your farm, picture writing it, picture when you would have to redo it, when when you would have to do a reassessment, and then picture making all those records, because this is an additional record, and then make comments to the FDA about what is clear to you in that process and what is not clear.

Phil Tocco:

Yeah, it makes definitely makes good sense. They'll be able to say whether or not it's doable or not and if it isn't doable, then, you know, FDA needs to hear about it.

Annalisa Hultberg:

For sure. I really think the FDA needs to hear about this. Phil and I were both around as the Produce Safety Rule in its current form was initially, you know, proposed and the rulemaking that initial rulemaking process was in place, and we were really asking for folks to go and read it and make comments and I know that that is a time commitment. That's a really big time commitment. So we don't say it lightly. But this is kind of the one and only chance we get this very formal sort of docket process that the FDA has that looks kind of overwhelming and formal. It is really their one and only process to gather those thoughts. So if you read it and then you have a statement just as simple as "I don't understand what a significant change would be that would make me have to redo my Ag Water Assessment", you know, if it's as simple as that, that might be a great statement. I guarantee other folks are probably thinking it if you are. Any other thoughts that you have on how to make good comments, Phil? I know you wrote a nice blog piece about this.

Phil Tocco:

Sure. Be constructive, don't tear the institution down. If you've got a specific question about a part of the rule, there's usually these things called provision numbers that accompany every one of the statements, so definitely give them a provision number, and relate whatever the provision is back to your farm activities. And then explain to them why what they're proposing isn't doable, given what you are, what you currently have going on your farm, and then follow it up potentially with some way that they could fix it, where it would become doable.

Annalisa Hultberg:

I think that's really, really good advice Phil, because the FDA is only able to make rules based on the information that they know, and they aren't farmers. So they really rely on you to give specifics to your operation and say, in my operation, this would take this much time and therefore cost this much and would be difficult, or, you know, this part really makes sense to me and I applaud you for doing XYZ. Totally fine to do too. But don't think that you need to be a water quality expert or microbiologist at all, the main thing that they want to know is how would it affect you and your bottom line? I and I, let's take them at their word. They keep on saying they want people to make comments, so let's do that.

Phil Tocco:

Let's give it to him. Yeah, absolutely. And I think the other thing to realize is that this podcast should not be your only source of information, you know, reach out to your local Extension educator that does produce safety. If you have service providers that do produce safety, reach out to them to ask questions, but yeah, definitely don't make this the only mechanism that you're learning about. Thanks for talking to me about this, Annalisa.

Annalisa Hultberg:

Yeah, thank you, Phil. I think this is really good and hopefully it helps people just kind of wrap their head around it. I know it's a lot to take in, so thanks for your help with getting this information out.

Alison Work:

Links to anything referenced in this episode are provided in our show notes, which can be accessed on the website at canr.msu.edu/agrifood_safety. Thank you to everyone for listening and don't forget to tune in next month for another episode of our produce bites podcast.