The Food and Drug Administration's long-awaited produce safety regulations move in the direction the industry was already following to prevent contamination from irrigation water. But consumer groups say the agency may have gone too far to appease producer concerns.
The new rule published May 6 is aimed at preventing food pathogen outbreaks by assessing and tracking agricultural water.
The updated regulations offer more flexibility for growers, notably by doing away with microbial water quality criteria and testing requirements, which consumer groups had pushed as an accountability measure.
Instead of tests, FDA will require a comprehensive pre-harvest assessment of the water source, which will have to include an evaluation of the site of the water source, the type of delivery system, and how the system is protected against contamination. It also will have to address how water is applied, environmental conditions like heavy rain, impacts from adjacent land use, and other factors.
Farms are required to assess their pre-harvest agricultural water annually, or whenever a significant change occurs or a condition likely to introduce a hazard is identified.
Under the new standards, producers also must 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. In the rule, however, FDA says, "We acknowledge the longstanding colocation of animals and plant food production systems in agriculture and note that this rule does not prohibit the presence of animals on or near a farm, nor does it establish requirements or responsibilities for entities other than farms covered by the rule."
A previous proposal would have required microbial testing, and there could not be any detectable E. coli in 100 milliliters of agricultural water. That proposal, however, received significant pushback from the industry as not conducive to farms of different sizes or truly predictive of water contamination, said Michael Hansen, senior staff scientist at Consumer Reports.
The final version does not mandate testing for agricultural water used for irrigation but does retain mandatory testing of any water that contacts produce during or after harvest.
A pre-harvest water assessment is a more holistic approach, which Hansen applauded. He is concerned about what accountability measures will ensure farms are properly assessing their systems.
While it makes sense for farms to accurately track and assess agricultural water quality to prevent any economic impact from a recall, Hansen noted it’s difficult and rare for an outbreak to be traced back to an individual food source.
Without microbial testing requirements, Hansen said he doubts there will be any significant decrease in outbreaks. “It is proper to take a more holistic approach, but I just think that there should be verification steps,” he said.
The switch to the pre-harvest assessment system removes a “one-size fits all” approach and adds flexibility for growers, industry advocates say. Instead of focusing on water testing and meeting certain levels, the new pre-harvest assessment pushes growers to consider what happens at adjacent farms and the “totality of their system,” said Natalie Dyenson, chief regulatory and food safety officer at the International Fresh Produce Association.
Natalie Dyenson, chief regulatory and food safety officer at IFPA
“We realize that it's not just what happens within your farm any more,” she said. “You have to think about your farm, and then what's adjacent and what's nearby and what are those impacts?”
Growers and the industry were already moving to implement practices similar to the pre-harvest water assessment, Dyenson said. The leafy greens industry, for example, has already included such practices so the guidelines should not be a "heavy lift" for anyone in the industry, she said.
Some advocates are still waiting to see how FDA will implement the rule, with some concerned about increased subjectivity in the final rule.
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One provision in the final rule replaces some requirements in the proposed rule to allow alternative mitigation measures, but it is not clear how growers should assess and define these, said Sonia Salas, associate vice president of science with Western Growers Association.
“I would think alignment is key, and education, to make sure the implementation is done correctly,” Salas said.
The rule will not be a challenge for all types of farms, as some have already transitioned to water quality assessments, Salas said. But it’s unclear how everyone in a range of types of sizes of farms will be trained and how inspectors will be taught to verify the assessments.
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 the changes. Advocates said the agency has discussed hosting webinars and providing additional guidance ahead of compliance dates.
Overall, consumer groups viewed the final rule as a positive step toward updating an out-of-date and important set of regulations, but also had concerns about implementation.
The proposed rule was a bit too strict and complicated, said Thomas Gremillion, director of food policy at Consumer Federation of America, but the pendulum swung too far in the opposite direction in the final rule, which he said offers too little guidance.
Gremillion said it seems as if FDA did not want to overburden growers with the rule. However, for smaller farms without a food safety team or the ability to invest in a plan specific to their farm, a lack of prescriptive and definitive rules may have relieved some compliance burdens, he said.
“It's almost like the growers have to go and become food safety experts to comply with this rule,” Gremillion said. “I know that's not anyone's intent and so hopefully, they're able to make this more implementable.”
Consumer groups also are worried how anticipated reductions to state and local inspectors will affect the food safety system. In recent years, FDA has been able to supplement state inspection programs, but with a tighter budget the agency has begun warning states to expect less funding in 2025.
State programs are already struggling and underfunded, groups previously told Agri-Pulse, and reduced funding could have a dramatic impact.
Gremillion said he hopes Congress will either fully fund state inspections or include a line item in appropriations legislation designated for these programs.
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