In the last month of 2021, the Food and Drug Administration (FDA) announced they would postpone the Food Safety Modernization Act’s (FSMA) Produce Safety Rule (PSR) water compliance requirements, subpart E, which was set to begin in January 2022. The FDA intends to exercise enforcement discretion for the agricultural water requirements for covered produce while proposing changes to the current water requirements.
Industry Pushes Back
FDA held public meetings on the initial water requirements and had great pushback from farms throughout the U.S. and internationally, given the vast uses and practices of agricultural water for hundreds of commodities and regions. The proposed revisions are intended to address stakeholder concerns about complexity and practical implementation challenges by replacing certain pre-harvest agricultural water testing requirements with provisions for comprehensive pre-harvest agricultural water assessments. The intent of the assessment is to help farms to identify potential sources of contamination and effectively manage their water.
The proposed water requirements eliminate the necessity of the Microbial Water Quality Profile (MWQP), which consisted of a rolling four-year dataset of water testing results. The water testing frequency varied based on the water source for ground water or surface water sources. FDA received a great deal of pushback on the mandatory testing due to its perceived costs and challenges it presented. With the new proposed rule, water testing could be one element of a mitigation strategy if the grower chooses to include testing as part of their strategy, but they are no longer obligated to do so.
The proposed agricultural water assessments would offer flexibility for farms to evaluate a range of factors that impact pre-harvest agricultural water quality, using a systems-based approach. The farm has the ability to determine which mitigation strategies will work to address the issue based off their current situation on the farm and not a universal testing mandate.
FDA’s new approach to water assessment versus water testing is in line with the PSR current requirements for cleaning and sanitizing of equipment and tools, allowing the farm to evaluate their practices and determine the best cleaning methods, procedures, frequency and/or mitigation measures to ensure a safe food environment. The new risk-based approach to determine corrective actions or mitigation measures for agricultural water resembles the same principals of Hazard Analysis Critical Control Point (HACCP).
The proposed rule would revise subpart E of the FDA Food Safety Modernization Act’s Produce Safety Rule to change certain pre-harvest agricultural water requirements for covered produce other than sprouts. 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 (“agricultural water assessment”) that is adaptable to the wide variety of water sources and uses and future scientific advancements.
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.
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 like animal grazing and the presence of livestock and wildlife on land adjacent to, or near, produce farms or their water sources.
The removal of certain testing requirements for pre-harvest agricultural water and replacing them with the agricultural water assessments. The proposed revisions are intended to address stakeholder concerns about complexity and practical implementation challenges while protecting public health.
The goal of the FDA is to complete the compliance date rulemaking as quickly as possible. The FDA will be allowing for written comments through April 5, 2022 and will listen to stakeholder comments at two virtual public meetings to be held in February 2022.