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FDA proposes changes to agricultural water rule

USDA irrigation at Leafy Greens farm
Conventional sprinkler irrigation at Leafy Greens, operated by farmer Tom Heess, in the Salinas Valley, Calif.
FMSA Produce Safety Rule revised to change certain pre-harvest agricultural water requirements for covered produce.

Recent foodborne illness outbreaks have been linked to agricultural water upstream. In an effort to enhance the safety of produce, the U.S. Food and Drug Administration issued a proposed rule that requires farms to conduct comprehensive assessments to help them identify and mitigate hazards in water used to grow produce.

“There have been far too many foodborne illness outbreaks possibly linked to pre-harvest agricultural water in recent years, including water coming from lands nearby produce farms,” explains Frank Yiannas, FDA Deputy Commissioner for Food Policy and Response.

This is the latest step in the agency’s implementation of the FDA Food Safety Modernization Act, and it proposes to replace some of the existing requirements for agricultural water in the Produce Safety Rule.

“If finalized, we’re confident this proposal would result in fewer outbreaks in the U.S. related to produce, protecting public health and saving lives,” adds Yiannas.

The proposed rule, if finalized, would change certain pre-harvest agricultural water requirements for produce and farms subject to the PSR, other than sprouts operations. Key provisions in the proposed rule include a requirement for farms to manage their agricultural water quality based on the results of a comprehensive systems assessment that is adaptable to the wide variety of water sources and uses and future scientific advancements. 

It also calls for an annual assessment by farms of their pre-harvest agricultural water to identify any conditions likely to introduce hazards into, or onto, covered produce or food contact surfaces. Based on these assessments, farms would then determine whether corrective or mitigation measures are reasonably necessary to reduce the potential for contamination. The assessment would include an evaluation of the farm’s water system, agricultural water use practices, crop characteristics, environmental conditions and other relevant factors, such as the results of any testing conducted to inform the assessment. 

The revisions add a requirement that farms implement expedited mitigation measures for hazards related to certain activities associated with adjacent and nearby lands, to protect the quality of the water used on produce. This is being included following several recent outbreak investigations on produce that revealed potential routes of contamination including activities and conditions, such as animal grazing and the presence of livestock and wildlife on land adjacent to, or near, produce farms or their water sources. 

The update also removes certain testing requirements for pre-harvest agricultural water and replacing them with the agricultural water assessments identified above. The proposed revisions are intended to address stakeholder concerns about complexity and practical implementation challenges while protecting public health. 

Stakeholders respond

National Association of State Departments of Agriculture CEO Ted McKinney expressed the organization’s appreciation for FDA’s leadership on the proposed changes.

Seven years ago, NASDA developed the NASDA Model Produce Safety Implementation Framework for states to use as a roadmap to implement the Produce Safety Rule. Forty-seven states have developed cooperative programs consistent with the framework. NASDA has also developed an On-Farm Readiness Review process, in conjunction with FDA and Land Grant University Extension services, to offer a voluntary, non-regulatory opportunity to assess a farm’s readiness for FSMA compliance.

“For years, NASDA has worked with the nation’s state produce safety programs to build uniform and consistent regulatory programs from the ground up, as we know the safety of our food and water is vital to everyone,” McKinney says. “NASDA looks forward to sustaining its work with FDA to develop educational tools to assist farmers in complying with the rule once it is finalized and we’ve reviewed all the details.”
NASDA encourages everyone to review the proposed rule and make comments to the Federal Register.

Eric Deeble, National Sustainable Agriculture Coalition policy director, says NSAC has been working to ensure that important food safety guidelines for farmers are sufficiently simple, flexible and centered on risk.

“We are closely reviewing FDA’s newly released proposed Agricultural Water Standard rules now. It is our hope that the proposed agricultural water assessment approach will allow farms to individually assess their risks and tailor mitigation methods to each farm,” Deeble says. “Upon initial review, we appreciate the agency’s move away from the previous rule, which was too focused on a set number of tests and a testing regimen that would have resulted in significant and disproportionate costs to small, diversified farm operations.” 

Deeble adds, “At its core, this rule continues to place the burden of assessment and mitigation of hazards solely on fruit and vegetable farmers. Problems with agricultural water quality need to be addressed at a societal and systemic level, instead of expecting farm by farm enforcement to correct a problem that originates upstream. The Coalition also remains concerned about the rule’s encouragement of chemically treated water and the potential environmental impact of this element of the rule.”

TAGS: Livestock
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