Civil Law

– COMMENTARY –

“Like getting the rug pulled out from under us.” That’s how some farmers react when hearing about the FDA’s sudden and unexpected change in food safety requirements for the use of agricultural water before harvesting a crop. 

The original compliance date was January 2022, but the Food and Drug Administration has delayed it.

Because agricultural water can be a major pathway for pathogens, the Food Safety Modernization Act’s produce ag-water rule originally established microbial quality standards for agricultural water, including irrigation water. 

These original requirements were for water that comes into contact with certain produce, namely fruits and vegetables such as strawberries and lettuce that are typically eaten raw. Crops that are cooked before eating aren’t affected by this because cooking involves a kill step — heating the food to temperatures high enough to kill pathogens. This includes pasteurized fruit and vegetable juices.

The FDA has clarified that the proposed rule only applies if the agricultural water contacts the harvestable portion of a crop. It does not apply to water applied during or after harvest. That water must still meet specific microbial standards.

As part of this, FDA points out that it is important to keep in mind that there may be other water use that requires microbial compliance, such as the water used to make up fertilizers or other crop treatments.

The feedback that the FDA received on its original version was that these microbial standards, which included numerical criteria for pre-harvest microbial water quality, may be too complex for growers to understand, translate, and implement.

In response to these concerns, the FDA considered how it might simplify the water standards in an attempt to reach a balance that decreases regulatory burdens on growers, whenever appropriate, while at the same time keeping consumers safe.

The good news is that “the FDA apparently listened and has made changes many have asked for,” said Ramkrishnan Balasubramania, executive director of Florida Organic Growers, in a webinar produced for growers. “The microbial water quality profile and water testing frequency, these are gone right from the get-go,” he said. “This is very welcome.”

Bottomline, if finalized, the revised rule would replace the pre-harvest microbial quality standards and testing requirements with requirements for growers to conduct pre-harvest agricultural water assessments once annually, which do not necessarily include testing, — and whenever a change occurs that increases the likelihood that a known or reasonably foreseeable hazard will be introduced into or onto harvestable parts of produce or food contact surfaces.

As part of their pre-harvest agricultural water assessments, produce farms covered by the rule would be required to evaluate certain factors, such as the location of the farm’s water source, the way the crop, or crops, are irrigated, and the frequency of environmental conditions such as heavy rains that could impact water quality and therefore jeopardize produce safety.

The proposed rule contains information about what farmers will need to assess and what to do if they bump into problems or make changes to their operations. For example, what they should do if they switch from well water to surface water from streams, lakes and rivers, among other sources. Or if their neighbor begins running livestock on adjoining land. It also includes ways to deal with these problems.

Balasubramania, meanwhile, pointed out that the growers will need some guidance, tools, and even funding to comply with the rule. The FDA says it plans to help with that.

For a quick background, the act’s Produce Safety rule establishes, for the first time, science-based minimum standards for the safe growing, harvesting, packing, and holding of fruits and vegetables grown for human consumption. As such, the rule is part of the agency’s ongoing efforts to implement the Food Safety Modernization Act, which was signed into law in 2011.

Not a slam dunk
Not everyone thinks that FDA’s decision in favor of having growers assess and solve their problems is a silver bullet.

“One of the biggest issues so far is that we don’t have a final rule on what the water rule is going to be, just a vague impression of where they’re going,” said Keith Schneider, food safety professor at the University of Florida. “The idea of whether it’s better or not really depends on what that final ruling ultimately turns out to be.”

Even so, he thinks the farmers would love not having to test their water, but that the new scheme would have them become risk assessors. 

“It’s much easier to take a water sample than it is to learn risk assessment,” he said. “The bigger question now is whether or not individuals can perform an adequate risk assessment to determine how to handle their irrigation water. I do believe you will have more confusion and frustration only because the paradigm has changed again.”

Some warn this will entail a long learning curve.

As for how important it is to get this right, Schneider said that if you don’t, “you can end up getting people sick, and no one wants that.”

“Conversely,” he said, “if you make it too restrictive you might discourage farmers and end up driving production outside the borders of the U.S., which is what we also don’t want.”

Click here to see a Florida Organic Growers podcast on the FDA’s ag water rule.

Brandon Roozen, executive director of the Western Washington Agricultural Association said he worries that “one grower’s self-assessment might not be so thorough as another grower’s and that could leave buyers wondering exactly whom to trust.”

Yet at the same time, he appreciates the FDA’s desire to keep things flexible and not take a one-size-fits-all approach, especially considering how diverse agriculture across the country is.

“It’s good to have some wiggle room for local conditions,” he said. “But food safety can’t be compromised.”

During public hearings, some growers and ag associations took a different tack altogether, saying that the removal of required testing would be a drawback and that the rule should be more strongly encouraged or even required under certain circumstances.

Meanwhile, except for the section in the Food Safety Modernization Act dealing with ag water, all of the other sections of the act have been finalized.

The delay is not surprising since water is so important both to farming and to food safety. As Schneider was quick to point out: “Water has the biggest potential to turn small problems into large problems.”

What’s a grower to do?
Getting the pre-harvest ag water rule to where it is now — proposed, then revised, and not yet finalized — has been a long haul, about 5 years. And it’s not there yet, especially since the FDA says the actual compliance date has not yet been set. 

However, an agency spokesperson did say the FDA is moving ahead on finalizing the proposed rule. The projected publication date is October 2023.

The spokesperson also said that stakeholders will have the opportunity to comment on the compliance dates, but not the proposed rule, when they’re announced. Given how long this has taken already, some food safety experts don’t expect it to happen soon. 

Meanwhile, the FDA will be exercising what the agency refers to as “enforcement discretion” until the final new rule passes.

Until then, growers are encouraged to abide by the original proposed rule, which was based on microbial standards. 

“That one’s still in place, and everyone is supposed to be doing what it requires,” said Schneider. “But the biggest ambiguity right now is if and how the FDA will be enforcing it.”

(To sign up for a free subscription to Food Safety News, click here)

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