FDA delays some safety requirements for produce under FSMA to make them less complicated, costly
Speaking to attendees at the annual conference for the National Association of State Departments of Agriculture (NASDA) in New Orleans, FDA Commissioner Scott Gottlieb recognized that “agricultural water can be a major conduit of the pathogens that contaminate produce,” such as those that lead 2006 E. coli outbreak in bagged spinach that sickened 200 people nationwide and killed three.
But, he added, some of the well-intended microbial quality standards for agricultural water in the Produce Safety Rule are “too complicated, and in some cases too costly, to be effectively implemented.”
As such, he said, FDA wants to extend the compliance dates for agricultural water requirements for produce other than sprouts by at least two years and as much as four years – making the earliest non-sprout compliance date January 2022 instead of the original Jan. 28, 2018 deadline. Sprouts will remain subject to their original compliance dates because of their unique vulnerability to contamination, according to FDA.
This delay will give FDA and those affected by the rule “time, over the next four years, to hammer out the most effective and practical approach for agricultural water,” Gottlieb said.
FDA seeks input from stakeholders
To do this, Gottlieb outlined steps that FDA and stakeholders will take in the coming years, the first of which will be gathering additional information from stakeholders about how they use water to ensure the standards are practical and effective.
One way FDA will do this is by hosting early next year a summit on agricultural water quality and testing, similar to the one it held on biological soil amendments earlier this year.
“Additionally, our cadre of Produce Safety Network experts across the country will help us gain first-hand information on the practices and conditions that will inform our next steps. We’ll work closely with the farming community, state and tribal leaders and our counterparts at USDA to make this work,” Gottlieb said.
FDA expands water testing methods
FDA also will update allowable water testing methods that are equivalent to the reference method in the Produce Safety Rule, Gottlieb said. These will include the eight additional testing methods from EPA that FDA listed in a recent letter to Western Growers, according to the agency.
State inspections delayed
In addition, the agency will delay state inspections related to its State Produce Implementation Cooperative Agreement Program, which currently supports 43 states with more than $30 million to develop produce safety programs, Gottlieb said.
“While our original intent was for states to begin inspections during 2018 to be consistent with the January 2018 compliance dates for larger farmers, I’m announcing today that we’re change course. 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 the states establish strong produce regulatory programs before inspections begin. We agree. So, FDA is modifying the approach outlined in the cooperative agreements,” and routine inspections won’t begin until spring 2019, he said.
This extra time also will give FDA time to educate, train and expand its On-Farm Readiness Reviews, which are voluntary farm visits by state officials, FDA produce experts and others to help farmers understand their state of readiness to meet the new requirements.
So far these reviews are in six states, but Gottlieb said FDA plans to roll them out nationally this fall.
“Our experience indicates that these will be an influential tool for helping farmers and regulators have the regulatory clarity they are looking for,” he said.
Additional training for inspectors, regulators on the horizon
Relatedly, FDA will use the compliance extension period to train state and federal inspectors and regulators.
Gottlieb said FDA currently has four inspector trainings planned, but will offer more before inspections begin to ensure all inspectors are properly trained.
“Additionally, the Produce Safety Network is also putting together a Technical Assistance Network for Regulators” that “will let state regulators working in the field get answers to questions as they come up to speed on the standards, and as they eventually perform inspections,” Gottlieb said.
To further help regulators and inspectors, FDA will release a long-awaited guidance document on the Produce Safety Rule, Gottlieb said. And while he failed to set a specific release date, he said FDA understands the industry frustration that this guidance is not published yet.
He also pointed to the recently released Small Entity Compliance Guide for produce, noting: “This, in addition to the preamble of the rule, has valuable information for all stakeholders, though the SECG is particularly geared towards the needs of small farmers.”
While Gottlieb is committed to making FSMA work in the long run for produce, he also recognized that there are other concerns about FSMA beyond produce and he reassured the group that FDA is working to address them as well.
“I know there are other concerns related to the various FSMA rules, not just produce. These include topics like parity between domestic and imported foods and the definition of a ‘farm.’ Recent conversations have also shown us that we need to provide greater clarity to our regulatory partners in a number of areas related to the other FSMA rules,” he said.
As such, Gottlieb said he is convening a group of senior FDA and NASDA leaders to meet regularly under the leadership of deputy commissioner Stephen Ostroff and associate commissioner Mel Plaisier.