FDA proposes pushing back FSMA produce water standards


FDA proposes pushing back FSMA produce water standards


By Helena Bottemiller Evich


09/12/2017 11:12 AM EDT


The FDA wants to give farmers and states more time to help the agency rework the new water standards for produce, one of the most controversial parts of the Food Safety Modernization Act regulations.


The agency announced Tuesday a proposed extension of compliance deadlines on the produce water standards of anywhere from two to four years, depending on the size of the operation.


The water standards, finalized in 2015, are aimed at keeping deadly pathogens, like E.coli O157:H7, out of water used to grow crops by enhancing testing and monitoring efforts. But the standards have been intensely criticized by growers who argue the requirements are onerous and extremely difficult to understand.


The FDA also said Tuesday it will delay routine state inspections on the produce safety rule until the spring of 2019.


"While our original intent was for states to begin inspections during 2018, to be consistent with the January 2018 compliance dates for larger farms, I'm announcing today that we're changing course," FDA Commissioner Scott Gottlieb told the National Association of State Departments of Agriculture meeting in New Orleans Tuesday morning, according to prepared remarks obtained by POLITICO. "We've heard very clearly from farmers and other stakeholders, including NASDA, that more time is necessary to ensure farmers have the training and information needed to comply and that states establish strong produce regulatory programs before inspections begin."


Gottlieb acknowledged the agency's approach to water standards was simply too complicated and "in some cases" too costly. "We agree that FDA needs to take another look at our approach, given these concerns," he said, according to his remarks. "There's a consensus that agricultural water can be a major conduit of the pathogens that contaminate produce. To make FSMA work for the long run, it's important we have a workable approach to water."


The proposed extension of compliance deadlines for water would allow the agency more time to simplify the standards to make them more workable for growers. In effect, the earliest compliance date for produce growers would be moved to January 2022. (Sprout growers still would have to meet earlier deadlines.)


Gottlieb also acknowledged that postponing routine inspections in the second year of the cooperative agreements could affect state budgets and compliance plans, and advised states that FDA's Office of Regulatory Affairs would provide information on how these can be reworked.


The water standards, as they stand now, include testing requirements that vary depending on the type of water a farmer uses, including untreated surface water, untreated groundwater and public water. For farms using untreated surface water that comes into contact with produce, for example, a grower would need to perform an initial survey of the water, collecting at least 20 tested samples, to determine what's known as a "microbial water quality profile." The process is complicated and requires a lot of math.


Gottlieb said the agency will do plenty of outreach to educate producers on the standards to improve the process of streamlining them, including by participating in a summit focused on agricultural water quality and testing.


"We want to learn more about the diverse ways that water is being used in farms across the country so that we have standards that will work for everyone, and won't be overly burdensome to growers," Gottlieb said, according to the remarks. "We need to make sure this new framework is practical and workable."


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