The Food and Drug Administration on Thursday announced a long-awaited final rule imposing requirements on farmers for ensuring that agricultural water doesn't contaminate produce with dangerous pathogens.
The regulations implement some pre-harvest agricultural water requirements for covered produce that were required under the Food Safety Modernization Act that was signed into law in 2011. Notably, the final rule drops microbial criteria and testing requirements for the water growers use to irrigate crops and instead lays out a comprehensive pre-harvest assessment of the water that farmers must do.
The pre-harvest assessment includes an evaluation of the location of the water source, type of delivery system and protection against contamination. The assessment also looks at the application of water, environmental conditions like heavy rain, impacts from adjacent land use and other factors.
Farms are required to annually assess their pre-harvest agricultural water or whenever a significant change occurs or whenever a condition likely to introduce a hazard is identified.
Under the new standards producers must also implement effective mitigation practices within specific timelines based on the findings of their assessments. Hazards related to activities on nearby land uses are subject to expedited mitigation.
Animal grazing or the presence of livestock near a produce farm or its water source has been a major cause of foodborne outbreaks in produce.
“These revised requirements reflect recent science, findings from investigations of several produce-related outbreaks, and feedback from a variety of stakeholders,” FDA wrote in a constituent update. “These revisions will more comprehensively address a known route of microbial contamination that can lead to preventable foodborne illness.”
The rule also sets compliance dates under the new requirements. Very small farms have two years and nine months after the effective date of the final rule. Small farms have one year and nine months, while all other farms have nine months.
It does not alter the existing requirements for agricultural water for sprouts or for harvest and post-harvest activities.
The agency plans to partner with state regulators, educators, the National Association of State Departments of Agriculture and the Produce Safety Alliance to provide training to local partners in order to implement these changes.
The rule, released Thursday, will be published in the Federal Register on Monday.
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The Leafy Green Products Handler Marketing Agreement said in a statement that it is currently reviewing the rule and will provide more information next week.
"The LGMA organizations in Arizona and California welcome FDA’s final agricultural water rule," the organization wrote in an email. "As leading food safety organizations, we have prioritized the safety of agriculture water since our founding in 2007."
Sonia Salas, associate vice president of science at Western Growers Association, applauded the flexibilities for growers in the final rule. However, she said there’s still concern with implementation, and how the agency will conduct outreach and support farms.
“I feel there are going to be challenges with implementation,” Salas said. “In the context of doing a risk assessment, that’s a smart way of approaching that risk. It's just that there is a need for education and training, especially for many that haven’t done that.”
International Fresh Produce Association celebrated the final rule and said it is less "overly complex" than the original proposal with realistic guidelines for growers.
Consumer organizations expressed mixed reactions to the finalized version, particularly how closely it aligns with the 2022 proposals.
Specifically, the agency did not provide more concrete guidance on the agricultural water standards, said Thomas Gremillion, director of food policy at Consumer Federation of America.
“The lack of enforceable, prescriptive standards in the rule raises a significant concern that many food safety hazards will evade remediation if not detection,” Gremillion said in an email.
Additionally, CFA hoped FDA would incorporate validated microbial testing under the required water assessments and that growers must treat water in certain high-risk situations, like when using surface water in overhead irrigation systems right before harvest. The final version does not appear to include these changes.
Still, Gremillion said he is optimistic the overall rule will provide new protections for consumers and “foster a culture of food safety among growers.”
As each agricultural water system has some variability, it’s difficult to create a standardized rule. The final standards include flexibility so each individual farm can structure their water safety system to fit their needs, said James Kincheloe, food safety campaign manager at the Center for Science in the Public Interest.
While consumer groups acknowledged some flexibility was necessary in the final rule, Kincheloe said it’s important to ensure there’s not too much leeway for the industry as that can lead to less consumer protection.
“We will be closely scrutinizing the final rule and the implementation of that final rule to ensure that even with the flexibility of the rule that produce water is being protected by scientifically supported methods,” Kincheloe said. “Because there's, there's a chance that things might fall through the cracks or there could be holes in the rule, or if he's not perfectly implemented.”
