Sep 14, 2017
FDA delays parts of FSMA rollout, seeks input on water regulations

The FDA is proposing changes to how it will implement provisions of the Produce Safety Rule of the Food Safety Modernization Act (FSMA) in the coming years, including delaying some rules and asking for more public input.

At the National Association for State Departments of Agriculture annual meeting in New Orleans Sept. 12, FDA Commissioner Scott Gottlieb announced that FSMA won’t work unless the agency takes new steps to address the challenges that have become increasingly apparent since the produce rule became final in November of 2015.

“The truth is, there are things we’ve done well in getting this rule ready for prime-time,” he said. “But there are also things that may require a course correction.”

Specifically, Gottlieb announced changes to the compliance dates for the ag water section of the rule as well as new testing methods that will be allowed. In addition, he announced a delay before on-farm routine inspections would begin and that education would take place before those inspections are implemented.

For the agricultural water provisions of the FSMA Produce Safety Rule, the FDA issued a proposed rule that, if finalized, would extend the compliance dates for ag water by an additional two to four years for produce other than sprouts.

While producers might sigh in relief at the additional time, Jim Gorny

vice president of food safety and technology for the Produce Marketing Association, said the more notable development is that the proposed extension is meant to provide FDA with the opportunity to review and revise the FSMA Produce Safety Rule agricultural water standards.

“It’s not about the delay,” he said. “It’s all about the FDA being open to another policy course.”

FDA’s proposed new dates for agricultural water compliance dates.

  • Large farms – January 26, 2022
  • Small farms – January 26, 2023
  • Very small farms – January 26, 2024

The proposed rule is open for public comment for 60 days and the FDA doesn’t plan to enforce the agricultural water requirements for produce, other than sprouts, while the new rules are being considered. The FDA will also be convening an agricultural water summit early next year while gathering input from stakeholders as how the agency should possibly change the current FSMA Produce Safety Rule agricultural water provisions.

Gorny said producers have had three main concerns when it came to ag water: what analytes (chemical compounds) would be tested for, how often they would be tested and what testing methods would be allowed.

The FDA announced and posted on its website a list of eight additional agricultural testing methods that will be allowed under the FSMA produce safety rule. That still leaves the other two concerns to be hammered out.

Gottlieb said that farmers and state agriculture officials consistently told the FDA that the microbial quality standards for agricultural water are too complicated, and in some cases too costly, to be effectively implemented.

“We hear your concerns. We take them seriously,” he said. “That’s why we announced our intention to explore ways to simplify our approach to make compliance less burdensome and less costly, while still being protective of public health.”

Gorny said that it has been clear for some time that the FDA was listening effectively and the new and encouraging development is that the agency is now starting to act on the concerns they’ve been collecting.

The FDA also committed to taking steps to making sure that regulations are consistently applied across the country. That included ensuring state level inspectors receive the training they need before conducting inspections. Gottlieb said while the largest farms are still expected to be in compliance by January of next year, routine expectations won’t begin until January of 2019.

“I’m committed to taking a comprehensive approach to ensuring that industry and regulatory partners have the tools they need to implement FSMA,” Gottlieb said. “I’m talking about training, technical assistance, and guidance documents to make our expectations clear.”

CEO of the Leafy Green Products Handler Marketing Agreement, Scott Horsfall, said producers, farmers and distributors need to have those guidance documents in hand before they are held to the new FSMA guidelines.

“The biggest need is that FDA has to promulgate written guidance to FSMA, and that hasn’t been forthcoming,” he said.

Gottlieb said that other concerns include the definition of a “farm” according to the new FSMA rules, which dictates if an operation is governed by produce safety rules or preventative control rules.

Also a new tool to help operations, called On-Farm Readiness Reviews, has been announced. The on-the-ground assessments not only provide regulators and producers an assessment of what an operation need to do to be ready to comply with FSAM rules, but they educate extension agents as well. Gorny said that’s important because extension agents are often who provide producers with the advice to overcome the real-world problems they face.

A full transcript of Gottlieb’s comments can be found here.

Gottlieb in his comments, and Gorny in his analysis, both agreed that the changes were not about delaying the FSMA but making the roll-out more successful.

“I believe deeply in the protections enabled by FSMA,” Gottlieb said. “I support its goals. My aim is to make sure we take smart steps to make the law viable.”

Summary of changes (compiled by PMA)

Agricultural Water Compliance Dates:  Earlier today (9/12/17) FDA issued a proposed rule that, if finalized, would extend the compliance dates for the agricultural water provisions of the FSMA Produce Safety Rule by an additional two to four years for produce other than sprouts.  The proposed extension is meant to provide FDA with the opportunity to review and revise the FSMA Produce Safety Rule agricultural water standards based on upcoming stakeholder input to ensure that these standards enhance public health and are feasible and practicable for farmers to implement. FDA’s new, proposed agricultural water compliance date for the largest farms is January 26, 2022. Small farms and very small farms would have until January 26, 2023 and January 26, 2024, respectively. This proposed rule is open for public comment for 60 days.  Importantly FDA does not intend to take action to enforce the agricultural water requirements for produce, other than sprouts, while the rulemaking process is underway.  FDA will also be convening an agricultural water summit early next year as well as soliciting input from stakeholders as how the agency should consider amending the current FSMA Produce Safety Rule agricultural water provisions.

Testing Methods:  The FDA announced and posted on its website a list of eight additional agricultural testing methods that the FDA has determined to be equivalent to the required method specified in the FSMA produce Safety rule.

Produce Farm Inspections:  Dr. Gottlieb also announced that FDA and their State partners will follow through on their promise to educate before and during inspections and as such FDA and States will not begin assessing FDA Produce Safety Rule compliance, with the non-water requirements until Spring 2019. However, farms will still be expected to meet all produce safety requirements set by the rule for produce other than sprouts, except those related to agricultural water, by their original compliance dates. This means January 2018 for the largest produce farms.  The FDA and their State partners will use this time to expand the availability of education outreach opportunities called On-Farm Readiness Reviews that have been piloted in six states. On-Farm Readiness Reviews are conducted by a team of state officials, cooperative extension agents, and FDA produce experts that provide farmers with an assessment of their “readiness” to meet the new FSMA Produce Safety rule requirements.

— Scott Stuntz, contributing editor


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