FDA has announced that it has worked with the Environmental Protection Agency (EPA) to update the protocol for the development and registration of treatments for pre-harvest agricultural water to remove Listeria monocytogenes from the organism test panel.

FDA says that this change is being made because pilot studies have found that sanitizer treatments that will likely be effective for E. coli and Salmonella may be different from those that are most effective for L. monocytogenes. This is likely due to the physical characteristics of E. coli and Salmonella being distinctly different from those of L. monocytogenes. In light of recent outbreaks of Shiga toxin-producing E. coli (STEC) and Salmonella linked to produce, FDA and EPA agreed and decided to move forward with removing this pathogen from the panel.

“We expect that doing so will facilitate the registration of antimicrobial treatments against STECs (and other E. coli) and Salmonella in pre-harvest agricultural water, the availability of which will be a significant resource for farms to protect their crops against these pathogens,” FDA said in a statement. “While we are removing L. monocytogenes from the protocol at this time, companies may opt to continue testing against L. monocytogenes for inclusion in their registration with EPA.

Recent outbreaks of foodborne illness associated with the consumption of romaine lettuce and other leafy greens have highlighted the need for a viable option for treating agricultural water against foodborne pathogens.

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Since organizing in 2007, the California Leafy Green Marketing Agreement (LGMA) has pledged to protect public health, assure safe leafy greens, and instill confidence in its food safety programs.

Scott Horsfall, LGMA’s CEO, says that the organization has enacted a list of food safety practices that are implemented on leafy greens farms and verified through government audit. These important safety measures were derived through working with university and industry scientists, food safety experts, government officials, farmers, shippers, and processors.

In August 2020, the LGMA approved more than 50 updates to these required food safety practices for the farming of leafy greens, all unanimously approved by the board. “These changes deal with water, sanitation, and equipment, and the LGMA has appointed special committees looking at adjacent lands to see if there are things that need to be done to put further practices in place in those areas,” Horsfall tells Food Quality & Safety.

One of the most notable updates involves the adoption of requirements that ensure the safety of water used during overhead application of pesticides and crop protection materials.

According to April Ward, LGMA’s marketing director, any water from open sources, including a canal or reservoir, applied via overhead application must be treated to eliminate pathogens during the 21 days prior to harvest. This updates what was agreed upon last year.

Additionally, the board approved enhancements to monitoring requirements for water used in farming leafy greens to ensure that regular water quality tests are conducted and that samples are collected throughout the irrigation systems used in leafy greens fields.

Another enhancement to the old rules, Ward says, was minimizing the risk of furrow irrigation water from coming into contact with any edible portion of a leafy greens plant.

There are also updated best practices for cleaning harvest equipment, containers, tools, and bathroom facilities in and near leafy greens fields and new language designed to prevent the cut end of leafy greens product from coming into contact with the ground during harvest.

It’s now up to the California Department of Food and Agriculture to incorporate these regulations into its food safety checklists used by government auditors to verify that these updated practices are properly followed on farms.

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On July 30, FDA announced a new protocol for the development and registration of antimicrobial treatments for pre-harvest agricultural water, such as the water used in farm irrigation systems. The protocol was developed through a collaboration with the U.S. Environmental Protection Agency (EPA).

Companies can now use data developed under this protocol to support EPA registration of products that can treat agricultural water against foodborne bacteria, which could provide farmers with a useful tool to help protect the safety of produce intended for consumers, such as romaine lettuce and other leafy greens.

EPA’s approval of this protocol allows for companies to develop data on the effectiveness of their products in inactivating foodborne bacteria, such as E. coli or Salmonella, in preharvest agricultural water. Companies may use the data developed to support registration of new treatment products, or amendments to current products’ labels, for use against microbial contamination in pre-harvest agricultural water.

Recent outbreaks of foodborne illness associated with the consumption of romaine lettuce and other leafy greens have highlighted the need for a viable option for treating agricultural water against foodborne pathogens. While farmers are not required to treat their agricultural water, these treatments could be a valuable tool to help farmers protect the safety of their produce. There currently are no registered antimicrobial treatment products that are authorized for use on agricultural fields, or for treatment of irrigation water systems or ponds. This protocol is an important step toward addressing this lack of available treatments for preharvest agricultural water.

FDA intends to release a proposed rule in late 2020 to revise certain agricultural water requirements in the Produce Safety Rule and to address practical implementation challenges while protecting public health.

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As FDA issued a rule in March that finalized its extension of the Food Safety Modernization Act Produce Safety Rule (PSR) compliance dates, researchers at Cornell University’s Produce Safety Alliance are working to simplify the process of compliance with agricultural water standards. In a paper published in mid-February, the Produce Safety Alliance—a partnership between Cornell, the FDA, and USDA—reflected on the national water summit it held last winter in Covington, Ky., to better understand agricultural water implementation challenges for both growers and FDA. At issue in last year’s discussion was Subpart E of the PSR, which deals with agricultural water, and above all the most pressing subject for many has been the cost of testing water according to PSR demands.

Don Stoeckel, PhD, Midwest regional extension associate, Produce Safety Alliance, is one of the authors of the paper, which concluded by calling for training, outreach, and technical assistance for farmers, and increased transparency from FDA. He tells Food Quality & Safety that the details are important: With the cost of a single water test ranging from $30 to $60, not counting the time to collect the sample, transport it to the lab, evaluate test results, and maintain records, he says a year’s worth of tests can easily add up in the hundreds or thousands of dollars for an individual farm. However, he stresses that we still know so little about agricultural water safety that the benefits of such testing are uncertain.

The Complexity of Water

“There is little by way of direct evidence that [EPA] standards [for recreational water, to which FDA’s standards are similar] have the same link to public health when applied to consuming irrigated produce,” Dr. Stoeckel says. “EPA established a scientific basis for their criteria from illness resulting from incidental ingestion of swimming-beach water. In other words, EPA has science to show that the standards help know when water is safe enough to swim in, but FDA does not have much science to show that the same standards help know when water is safe enough to irrigate with.”

Though there is plenty of proof that the quality of agricultural water affects the safety of produce, Dr. Stoeckel says, “To my knowledge, epidemiological data to correlate any water quality parameter with public health outcomes is lacking. Without such underlying data, science-based quantitative standards are more difficult to support.”

The reason for both the compliance-date extension and the water summit last year were simple: Water is complex, and agricultural water is even more complicated. FDA said March 18 that compliance-date extensions were necessary “to address questions about the practical implementation of compliance with certain provisions and to consider how we might further reduce the regulatory burden or increase flexibility while continuing to protect public health.”

Betsy Bihn, PhD, senior extension associate and director, Produce Safety Alliance, and another of the paper’s authors, added, in a press release, “The United States is a big place with many different water sources and systems.”

Complying with Requirements

One of the key results from the water summit, comments Dr. Stoeckel, was the conclusion that “meeting PSR water requirements, as currently written, is a concern in terms of cost and value to risk assessment.”

Dr. Stoeckel specifies that the costs of testing simply added up to far more than the benefits to produce safety, particularly considering that to date, scientists and regulators have not been able to make a quantitative link between more expensive sampling and management acting on sample results and reduced food safety risk.

“We generally agree that less fecal material and other contamination on produce means less risk to public health,” Dr. Stoeckel says. “However, it is very difficult to propose action levels/standards based on generic E. coli concentration or other measurements.”

Dr. Stoeckel is quick to say that water with fecal contamination is bad for produce safety, and that fact will not change.

“The main things that may change,” he says, “are how that fecal contamination is measured, and what steps are taken to protect produce safety based on the level of fecal contamination. Good Agricultural Practices call for analysis of generic E. coli in water used for fresh produce to detect fecal contamination, and farmers should continue that type of testing to help understand the quality of their water.”

Farmers are adaptable, and Dr. Stoeckel has no doubt they will be able to adapt to and meet requirements necessary to produce safe and healthy food. However, farmers need to understand the changes FDA is implementing and the reasoning behind them—which is why it was important to discuss and simplify the rule.

“All of us will benefit from plain language […] from FDA to explain compliance strategies for any new requirements,” he says. “Given sufficient time, and support (education, financial, infrastructure), the farms will be able to meet the requirements.”

The next steps will be FDA’s. The federal agency came away from the meeting last year with information from stakeholders across the industry about their needs, and Dr. Stoeckel says he trusts FDA will build on that knowledge to “re-evaluate and possibly alter the requirements of Subpart E.”

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The year 2018 was a hard time for romaine lettuce. Two massive, multistate E. coli outbreaks associated with leafy greens occurred (even extending into Canada), sickening hundreds of people and killing at least five. But as the outbreaks wound down, the culprit appeared even more difficult to control than leafy greens: It was a matter of contaminated agricultural water. And while the puzzle of making agricultural water safe has challenged food safety experts for a long time, the 2018 outbreaks introduced the question to the general public, many of whom now joined in asking, “How do we ensure the water used to irrigate fresh fruit and vegetables is safe?”

“Both the spring and fall outbreaks were devastating to the leafy greens industries,” says Jennifer McEntire, PhD, vice president of food safety and technology for United Fresh Produce Association in Washington, D.C. “In both cases, it appears that there is an environmental source of the pathogen. This is a new type of challenge in that it’s not about preventing an occurrence at a single point in time—it requires a revaluation of the system. Agricultural water has always been recognized as a risk and has always been managed.”

Luke LaBorde, PhD, professor of food science at Penn State’s College of Agricultural Sciences, concurs, underlining that the safety of agricultural water has always been notoriously hard to control.

“Especially,” he tells Food Quality & Safety, “if you’re using surface water from streams and irrigation ditches and things like that—it can change very suddenly. It can take some contamination upstream, what they call ‘point contamination,’ and spread it over wide distances, sometimes unexpectedly. In the case of the romaine outbreaks in Yuma, Arizona, it’s thought that there were irrigation ditches used for their produce farms that ran adjacent to animal-holding facilities. Now, we’ve known for a long time that that’s not a good idea. But still it happens.”

This contradiction is at the crux of agricultural water safety, Dr. LaBorde says. Though many farms know what approach they should be taking, they can be limited in their ability to implement them by financial concerns and other challenges like a lack of control over how neighboring farms handle waste.

“It’s tough, because people are slow to change their whole operation,” he says. “There are all sorts of things people can do, like keeping the animal facilities farther away and watching for drainage and run-off, but if it’s not your property, it’s kind of hard to control what other people do.”

Yet Rebecca Ozeran and Brooke Latack, livestock advisors at University of California Cooperative Extension, note that industry has hardly been inactive on the issue of agricultural water safety—particularly not the leafy greens industry.

“The food safety community has long been aware of the risks of water contamination, and water quality has not been ignored in food safety practices,” Ozeran and Latack jointly explained in an email to Food Quality & Safety. “Most leafy greens growers in the U.S. (producing about 95 percent of our lettuce) are already certified by the Leafy Greens Marketing Agreement, which […] regularly audits food safety practices at all certified operations. But there are inherent risks of contamination from eating any food produced in an open system. It is not feasible to grow all our crops in sterile, enclosed environments. Although operations can and do follow many practices to reduce the risks of food contamination and foodborne illness, the risks will never completely disappear. Even the best possible regulations and management will never achieve permanent zero percent contamination.”

Sampling Falls Short

The overarching problem, says Dr. LaBorde, is that regardless of regulation, some producers will inevitably end up facing situations they couldn’t have predicted. Existing regulations demand sampling and provide metrics for microorganisms, particularly (the largely harmless) generic E. coli, a good indicator of fecal contamination that can signal pathogenic E. coli or Salmonella. Even when sampling water according to regulations, a facility may miss pathogens.

“Taking some samples periodically is just not going to catch unexpected situations,” Dr. LaBorde says. “You can’t ask people to do more unless there are some assurances that what they are actually doing is going to have a public benefit. This E. coli sampling, for instance, sometimes it works, sometimes it predicts, sometimes it doesn’t. But all the studies that have come out say it’s a very poor predictor of human pathogens in water.”

Phyllis Posy, vice president, strategic services and regulatory affairs, for UV-water-treatment firm Atlantium Technologies, agrees. “Taking a sample is just that—an indication of that time and place,” she says. “How many folks are going to sample right after the rain stops, or when the temperature is coldest or warmest? We don’t catch the extremes and that may be when the contamination is measurable.”

Compounding the problem, says Dr. LaBorde, is the likelihood that sampling will miss contaminated silt in a reservoir or ditch. In the case of the Yuma E. coli outbreak, he recalls, “Some people say it might have been silt at the bottom of a ditch that was stirred up. Bacteria can attach to silt, so you may not have picked them up in the water itself. But if that silt or sediment is upset by mixing and flowing, then it can get into the irrigation system and onto the produce.”

Ozeran and Latack also note the difference between surface-water quality and the presence of pathogens in water sediment. While changes to weather can change the constitution of surface water, “sediment that collects at the bottom of a reservoir, canal, or stream tends to have higher concentrations of bacteria than the water itself. With a rainstorm causing hillside runoff or flooding, sediment and the bacteria living there can become suspended in the water. Turbid water after a storm therefore may have a higher concentration of bacteria than it had before the storm.”

While Ozeran and Latack encourage sampling as frequently as possible, and recording general site conditions while sampling (such as whether a flock of birds has recently been in the reservoir) in order to be informed about conditions affecting water quality, they acknowledge that available technology doesn’t allow constant monitoring, making constant measures for the moment impossible.

United Fresh’s Dr. McEntire puts it even more bluntly: “The bottom line is that there is no good testing protocol.”

Drinking Water Is Not Irrigation Water

Dr. LaBorde says a foundational problem with discussions about water safety is that standards applied to drinking water are not applied to irrigation water, with good reason. Initial approaches to E. coli were based on incidences of sudden contamination such as a baby’s diaper in a small lake, which is difficult to apply to irrigation.

“Transferring [an approach grounded in public health epidemiology] over to water that gets on a plant, that’s different to your exposure when you’re swimming and your mouth is open and you’re gulping water,” Dr. LaBorde adds. He notes that research on this subject is ongoing, with researchers trying to improve the means of quickly identifying fecal contamination. “But it’s very frustrating for everybody because the systems just aren’t that good right now, and while there is a lot of research to improve that, it takes time. I don’t think there is a good answer right now. The thinking has been, ‘Well this is good enough for now.’ We’ve got to do something.”

Meanwhile, says Posy, it’s unwise to attempt to apply EPA drinking water standards to irrigation due to volume alone. She stresses that EPA has zero responsibility to oversee agricultural water, since its domain is limited to drinking water.

“If you use [drinking water] for something else—say a company uses it as an ingredient or a processing aid—you can’t rely on EPA drinking water rules since the risk assessment on which those rules are based is for a household use of drinking water at less than one illness for 10,000 exposures,” says Posy. “But a household won’t have 10,000 exposures for about two to three years; a food plant will have 10,000 exposures the first day of the month!”

Is Treatment an Option?

Approaches to treating water differ, but for most the principal sticking point for irrigation water treatment is the price. Daniel Snow, PhD, lab director of the University of Nebraska’s Water Sciences Laboratory, argues, “I think monitoring and understanding impacts to irrigation water quality is clearly important, but treatment will be extremely difficult and prohibitively expensive in comparison to monitoring and treating drinking water.”

The difference, says Dr. LaBorde, is the massive volume of water used for irrigation—much of it turbid and full of organic matter.

“It’s not like you can put some chlorine in a bucket of water,” Dr. LaBorde says. “This is thousands and thousands of gallons. But some people have done that: They’ve had systems that run irrigation water through large pellets of chlorine, and it comes out treated. But chlorine isn’t a very good sanitizer for high turbidity water.”

The other question, he notes, is whether treatment is actually practical. Trying to imagine how much sanitizing agent one would need to treat the water for a major leafy-greens farm, Dr. LaBorde comments it simply costs too much, though such an approach might be workable in smaller farms that would not have to invest as much as a major operator to treat the volume of their irrigation water.

“Some people are actually shifting away from surface water and going to well water,” Dr. LaBorde says. “In theory it’s quite a bit less risky because if it’s a good well and it’s maintained, it’s not exposed to the surface and unexpected events and flooding.” Yet wells—which demand access to a potable aquifer—are not always available, Dr. LaBorde notes, while “out in California, they have had a drought. Those wells are getting low, and there’s only so much water.”

Posy, however, believes there is a role for treatment to play in agricultural water safety. “Since chemicals can have disinfection by-products and require serious control to make sure they do not have impact on the produce itself, I’m a fan of UV disinfection,” she says. “Even if you overdose the water, there’s no negative impact downstream. Watering cycles are not 24/7—we need to get smarter about how to employ treatments that are well controlled and portable as well as remotely controlled. There are systems available that treat water by measuring the real-time quality of the water and using only the dose needed, when needed. Integrated reporting means that the machine tracks key parameters and tells you when you need to pay attention. The key is to use validated systems, not just ‘check-the-box’ systems.”

Best Pathogen Practices

There are simply no easy solutions to the questions surrounding irrigation water safety, says the University of Nebraska’s Dr. Snow.

“At the very least, we might consider developing programs to evaluate irrigation water safety in areas with intensive food crop production,” he says, adding, “Regulation is seldom an efficient means for solving complex problems. If regulations governing irrigation water quality are being considered, there should be sound science supporting the type of monitoring and controls to be implemented.”

This is what concerns Dr. LaBorde as well. Above all, he says, we simply don’t know very much about irrigation safety, and many of the practices we’ve attempted to put into place for reducing pathogens are very expensive but may not be proven to reduce contamination risks. For smaller operators, shelling out for testing procedures they’re not even sure will keep their produce safe is a source of resentment.

Dr. LaBorde says, “It always comes back to: ‘Are you really sure that it’s the best way to be certain the water is safe for its purpose?’”

We may not have very many answers right now, but the shortest route to better practices is discussion, says Posy. “There is a real disconnect between the food safety community and the water safety community, both on the government and food processor/supplier/grower sides,” she says. “There’s even less dialogue on the discharge/recharge side. We need more dialogue and forums.”

For Ozeran, getting irrigation safety right comes down to developing high-level policy that balances scientific evidence, industry capacity, and pre-existing practices in the industries in question.

“For instance, if an industry is already implementing the best available practices but still experiencing food contamination,” she says, “then we need to support additional research to identify better ways to reduce contamination risks. If new policies cannot be implemented, or lack scientific support, then those policies will not improve food safety.”

The Food Safety Modernization Act carries with it a set of regulations pertaining to produce and agricultural water, but for Dr. McEntire it’s important to remember those regulations reflect minimal standards for a marketplace that has internal requirements generally exceeding those demanded by regulation, and often more frequently inspected.

“Most growers are subject to one or more annual food safety audits that include requirements around agricultural water,” says Dr. McEntire. “In California and Arizona, most producers are part of the Leafy Greens Marketing Agreements. Those water testing requirements go above and beyond the requirements in the Produce Safety Rule.”

Dr. LaBorde considers various factors that come into play, such as the increasing public appetite for raw produce, as well as the practice of irrigating with overhead sprayers, which douse produce in water.

“There are lower risk types of application methods such as drip or burrow irrigation,” he says, “which can be designed such that it wouldn’t contact the crop, reducing a lot of risk. That’s possible in very large farms. A lot of people who use drip irrigation here in Pennsylvania are small- or medium-size farms.”

Dr. LaBorde is also paying attention to studies on time-before-harvest, which aim to determine whether leaving produce in the sun will kill off enough pathogens to get produce down to safe levels. “That’s not always practical either because sometimes you have to water the crop just before harvest.”

He’s open to any new ideas about irrigation safety, but that openness is tempered by a clear understanding of how many factors come into play in trying to keep agricultural water safe. Dr. LaBorde—and many others—are as quick to dismiss silver-bullet thinking with real-world challenges.

The problem with irrigation safety, Dr. LaBorde concludes, is, “There aren’t a lot of easy answers.”

The post Agricultural Water Safety appeared first on Food Quality & Safety.

FDA issues a rule to finalize the new compliance dates for the agricultural water requirements in the Food Safety Modernization Act Produce Safety Rule.

Larger farms are now required to comply with the agricultural water requirements by Jan. 26, 2022, while small farms have until Jan. 26, 2023 and very small farms until Jan. 26, 2024. This rule does not change the compliance dates for sprout operations.

These compliance dates have been extended while the FDA considers how best to protect public health while addressing widespread concerns about the complexity of the agricultural water requirements and the practicality of implementing them across a wide variety of farms, water sources, and uses. The FDA intends to use this time to work with stakeholders to address these concerns.

According to a statement released from FDA Commissioner Scott Gottlieb, MD, (who is scheduled to resign from his position next month) and Deputy Commissioner Frank Yiannas, “Ultimately, we’ll implement requirements that are modern, efficient, rigorous, and achievable. We remain firmly committed to science-based requirements directed to agricultural water to minimize the risk to public health. We look forward to continued engagement with stakeholders in the coming months as we further consider the path forward on agricultural water.”

While this rule extends the compliance dates for the agricultural water provisions, produce remains subject to the other provisions of the Produce Safety Rule and the adulteration provisions of the Federal Food, Drug and Cosmetic Act.

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The Homer C. Thompson Vegetable Research Farm, Freeville, N.Y., utilizes an irrigation pump that pulls water from Fall Creek for use in irrigation and vegetable production.

Consumer preferences for fresh rather than processed produce and vegetables over the past 20 years are causing government regulators and scientists to direct more research toward assuring water used in agriculture is clean.

If pathogens are detected, a farmer may stop using water from a particular source, for example using well water instead of surface water, Dr. LaBorde says. Or, the farmer can treat the water with sanitizer or change watering to a drip irrigation system where only the roots and not the plant leaves are exposed to water.

Municipal water is the safest, followed by ground water in wells. Surface water in canals and streams is subject to fouling by wildlife. The main risks for produce are runoff, the water source, and animal droppings. So while surface water can be used in a drip irrigation system, for example, it may not be good for washing produce after harvest, when well or spring water is best, says Dr. LaBorde.

Farmers also need to be aware of what is upstream from them. For instance, they need to be aware if a new dairy operation has been set up or if a summer home with a faulty septic system is back in use.

AI and Algorithms

Martin Wiedmann, PhD, Gellert Family Professor in Food Safety at Cornell University in Ithaca, New York, is taking a high-tech approach to managing surface water use and to identify when water is at increased risk of having pathogens. He and his colleagues are developing algorithms and mathematical approaches to minimize risks.

Field associates using a multi-parameter YSI probe to work on a tailwater study for the University of California, Davis, Division of Agriculture and Natural Resources.

Managing surface water is a hot issue, says Dr. Wiedmann.

“One day the water at a certain point may be pathogen free and the next, it may not,” he explains. “The effect of rain can depend on what the land upstream looks like, whether it has farms or weekend houses with old, failing septic systems. So the water may be okay Monday through Friday, but not Saturday or Sunday.”

Dr. Wiedmann is using a GPS map to characterize what is happening upstream from a farm to predict higher or lower risk and to help farmers decide when to treat water or use an alternative source.

He says the FSMA rules are generic, but his approach is precision agriculture based on algorithms and using artificial intelligence to make predictions about water quality in specific areas on specific days.

“FSMA is one size fits all,” he says. “This [ours] is a better way to manage water quality. We’ll take precision agriculture to precision food safety at the field level.”

In the western United States, water conservation also figures into the picture. Researchers at the University of California, Davis, are studying the quality of tailwater, irrigation runoff from a field into a reservoir or pond, for reuse in pre-irrigation and germination.

“It’s very rare to detect pathogens in tailwater,” says Michael Cahn, PhD, farm advisor, irrigation and water resources at UC Davis’ Division of Agriculture and Natural Resources in Salinas, California. His group has been testing five reservoirs and ponds in the Salinas Valley over the past year to evaluate the food safety risks of using tailwater for irrigating leafy green crops using conventional irrigation and production practices. They checked the chemical, physical, and microbiological characteristics of tailwater and well water, looking at nutrients, pH, salinity, dissolved organic carbon, E. coli, coliform bacteria, and Salmonella.

They found that tailwater from the fields did not present more risk than well water despite containing more nutrients and dissolved organic compounds. The group also discovered that generic E. coli survived longer in well water than in tailwater. The survival of pathogenic E. coli and Salmonella in soil and on lettuce leaves was similar for tailwater and well water. Their final report will be published by the Center for Produce Safety.

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