August 7, 2018

FDA releases update on rollout of Produce Safety Rule

Food and Drug Administration (FDA) Commissioner Scott Gottlieb has reached out to state agricultural commissioners, secretaries and directors to update them on progress made on issues related to implementation of the Produce Safety Rule mandated by the Food Safety Modernization Act (FSMA).

Gottlieb said at the National Association of State Departments of Agriculture (NASDA) annual meeting that he’s committed to communicating with state agriculture leaders about the ongoing work that is taking place to successfully implement the produce rule.

As part of communication, he released a letter with updates on rule-making and implementation preparedness.

The letter addressed multiple areas of interest including rules around agricultural water and documentation around inspections.

Agricultural water

Gottlieb said in February FDA joined a summit hosted by the Produce Safety Alliance on the agricultural water standards. Discussion focused on how agricultural water is an important and challenging area and he said there were frank conversations about the challenges presented by the current requirements in the Produce Safety Rule. Alternate water testing and management strategies were discussed.

“We are currently collecting information about on-farm conditions and water systems,” Gottlieb said. “During this NASDA process, we are engaging with stakeholders through on-farm visits and other meetings to learn more about the diverse ways water is used and to ensure that the standards will be as practical and effective as possible for all farming operations.”

Produce guidance

  FDA continues to develop the draft guidance for the Produce Safety Rule and anticipates that it will be released for public comment in the near future.

“I know this guidance is long awaited, especially with inspections around this rule scheduled to begin in 2019,” Gottlieb said. “To accommodate growing practices that vary by region and commodity, a great deal of flexibility was built into the rule, and there are different approaches that farms can take to meet the requirements.”

In the draft guidance, he said, FDA will explore some of these approaches by discussing and demonstrating how they might be implemented.

Documentation and dispute resolution

Recently, FDA and NASDA have worked to explore new ways of ensuring objectivity and consistency for produce inspections as well as ways to handle disagreements between regulatory agencies conducting these inspections. Gottlieb said progress has been made.

“For produce inspections, FDA and NASDA have been working on alternatives to the traditional 483 inspectional observation form,” he said. “The idea is to pilot a produce-specific NASDA inspectional form that recognizes the unique issues associated with produce farm inspections. It holds promise as a tool for both helping farmers understand what is being examined in an inspection and promoting consistency among inspections by providing a structured format that closely tracks the Produce Safety Rule provisions.”

FDA is working with NASDA to finalize this alternative form in the near future.

“While it is our hope that a produce-specific inspectional form may reduce the likelihood that incorrect or extraneous information is recorded – and our training efforts have aimed at reducing the chance that will happen – we also want to be prepared for the rare possibility that this does occur,” Gottlieb said.

In particular, he said FDA wants mechanisms to quickly resolve any disagreements between agencies with produce safety regulatory authority. The agency recently received a final round of feedback from NASDA on its draft procedures, and said it expects to finalize these shortly.


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