FDA issued a proposed rule September 13, 2017, that would extend the compliance dates for agricultural water requirements in the Produce Safety Rule, giving the agency four years to reconsider the water standards to ensure that they are feasible.
FDA Commissioner Scott Gottlieb hinted at a possible “course correction” in relation to the water standards, in a presentation last month at the National Association of State Departments of Agriculture annual meeting in New Orleans.
The agency has gotten the message from stakeholders that the microbial quality standards for agricultural water are “too complicated, and in some cases too costly, to be effectively implemented,” he said.
Under the proposed rule, the earliest non-sprout compliance date for the water standards won’t be until January 2022.
In another announcement, Gottlieb said the planned 2018 produce inspections by states under agency-funded cooperative agreements will not begin until spring 2019. He urged the states to use the 2018 cooperative agreement funding for On-Farm Readiness Reviews — voluntary farm visits by a team of state officials, cooperative extension agents, and FDA produce experts, to give farmers an assessment of their “readiness” to meet the new requirements.
NASDA and FDA have already pilot-tested On-Farm Readiness Reviews in six states, and they are planning to roll out the program nationally this fall.
A NASDA-FDA working group formed to work on plans for training state and federal inspectors recently piloted a regulator training course. The agency has four regulator training courses planned for 2018, Gottlieb said. “We’re committed to offering more training courses before the start of inspections to ensure we train inspectors to meet these needs,” he said.
The agency is also growing its Produce Safety Network of FDA produce safety experts located across the country.
FDA is still working on “a rather large guidance document” on the Produce Safety Rule and Gottlieb said he is aware there is “some frustration that this guidance has not come out yet.” He said the agency now expects to publish the draft guidance early next year.
Gottlieb also noted concerns raised regarding the use of traditional Form 483 reports to document regulatory issues during produce inspections. The agency is “planning to explore additional ways of communicating our concerns about what we observe during produce inspections,” he said.
In response to requests from stakeholders, the agency also has listed eight additional water testing methodsas equivalent to the method incorporated by reference (Method 1603) in the Produce Safety Rule and it and intends to add other methods to the list as they are identified, he said.
Finding the correct balance between food safety and real-world irrigation practices when growing produce, domestic and foreign, has presented FDA with significant regulatory challenges. The extension in the dates for compliance with agricultural water requirements gives the agency more time to accomplish internal produce rule preparations, and allows produce growers more time to adjust irrigation practices if they prove to be needed.
Posted in Foods, FSMA Perspective and tagged Charles Breen.