FDA Update on FSMA’s Produce Safety Rule

On July 31, a letter about the progress made thus far on the Produce Safety Rule mandated by the U.S. Food and Drug Administration’s (FDA’s) Food Safety Modernization Act (FSMA) was published by FDA Commissioner Scott Gottlieb. The letter was specifically targeted toward state agricultural commissioners, secretaries, and directors, emphasizing that he is committed to communicating with state agriculture leaders about the ongoing work that is taking place to successfully implement the produce rule.

The letter covers updates in the areas of rule-making and implementation preparedness. Below are a few excerpts that specifically relate to the Produce Safety Rule, and food safety in general.

Rulemaking-related Update: Agricultural Water
In February, we joined a very successful summit, hosted by the Produce Safety Alliance, on the agricultural water standards. There were hundreds of participants at the summit in Covington, Kentucky, and 28 satellite locations across the country. Discussion focused on how agricultural water is an important and challenging area that should be addressed by Produce Safety Rule requirements. There were frank conversations about the challenges presented by the current requirements in the Produce Safety Rule, and alternate water testing and management strategies were discussed. Feedback from these discussions will help inform further dialogue with stakeholders and other next steps on these important issues. We are currently collecting information about on-farm conditions and water systems. During this 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. We aim to be as transparent as possible moving forward, and we remain committed to protecting public health while implementing rules that are workable across the diversity of the food industry.

Rulemaking-related Update: Produce Guidance
We continue to develop the draft guidance for the Produce Safety Rule and anticipate that it will be released for public comment in the near future.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. 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 this draft guidance, FDA will explore some of these approaches by discussing and demonstrating how they might be implemented. FDA has also committed to holding four public meetings around the country, where stakeholders will have the opportunity to publicly discuss the document. We intend to announce those dates soon via a notice in the Federal Register.

Implementation Preparedness: Training
There has been progress on Produce Safety Rule training for 2018. Through the Produce Safety Alliance training, almost 600 grower training courses have been conducted domestically and internationally. Through these programs more than 14,000 farmers have been trained. Domestically, 49 train-the-trainer courses have been held in 30 states, with more than 1,500 trainers trained. Internationally, 246 international grower trainings have been held in 14 different countries that trained 5,988 farmers.

FDA’s regulator training has also been a key focus. We have conducted six of seven produce regulator training sessions planned for 2018, and we remain on-target for reaching the National Association of State Departments of Agriculture (NASDA)-informed number of state regulators that need training to be ready for initiation of inspections in 2019. FDA continues to work with NASDA on enhancements to the regulator training, which will be evaluated and updated as the inspection, compliance, and enforcement documents are reviewed within the Agency. We are also offering two virtual training programs this fiscal year. One, entitled “Produce Inspections for Regulators Virtual Produce Tour,” was posted on YouTube in June. The video is intended for produce inspectors, regulators, growers, extension agents, and others interested in produce inspections conducted in accordance with the Produce Safety Rule. A second webinar will be available by September 30 entitled “An Overview of the Produce Inspections Training Curriculum for Extension Service Agents.”

Implementation Preparedness: On-Farm Readiness Review (OFRR) Visits
NASDA, in collaboration with FDA, has invested significant resources into developing and implementing OFRR visits to help farmers assess how prepared they are to comply with the Produce Safety Rule. These voluntary On-Farm Readiness Reviews are beginning this summer. There are 14 OFRR training sessions being completed, and states are working to set up mechanisms for farms to request OFRRs. I applaud NASDA’s education efforts and encourage states to continue working with NASDA staff on these activities.

Implementation Preparedness: Inspectional Documentation and Dispute Mitigation and Resolution Procedures
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 produce inspections. After exploring options extensively, we have made progress on both initiatives.

For produce inspections, FDA and NASDA have been working on alternatives to the traditional 483 inspectional observation form. The idea is to pilot a produce-specific 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. In particular, we want mechanisms to quickly resolve any disagreements between agencies with produce safety regulatory authority. That is why FDA and NASDA have held extensive discussions on Dispute Mitigation and Resolution Procedures. In our most recent conversations, we have been able to reach agreement on a path forward for avoiding the use of strikethroughs when correcting documents. We recently received a final round of feedback from NASDA on our draft procedures, and expect to finalize these shortly.

FDA’s expectation is that dispute resolution between FDA and state regulatory bodies will be rarely needed because the vast majority of produce inspections will be conducted by states and because of the mitigation steps we have committed to for the small number of inspections we will perform. Nevertheless, we feel we are now taking an important step to finalize the Dispute Mitigation and Resolution Procedures in a way that addresses NASDA concerns.

Building on Partnerships: Partnership with States
Most states are well on the way to implementing produce safety programs, including outreach, education, identifying inventories of covered farms, and preparing for the initial inspections of large farms in 2019. In recent years, FDA has provided technical support and funding to help states build the infrastructure for these new programs, and earlier this month, we announced new cooperative agreements with three additional states as well as renewed agreements with states already taking part in cooperative agreements. This brings us to a total of 46 states and one territory participating. We welcome remaining states that have not applied for cooperative agreements (or those that would like to expand their cooperative agreements to Competition B funding) to contact our Office of Regulatory Affair’s Office of Partnerships for assistance with the application process.

Building on Partnerships: FDA/USDA Formal Agreement
On June 5th, we formally recognized the USDA’s Harmonized Good Agricultural Practices (H-GAPs) Program as aligned with the FDA Produce Safety Rule. Produce growers have repeatedly expressed concerns about facing multiple market access audits from produce buyers and now additional inspections for compliance with the Produce Safety Rule. While this recognition does not exempt farms covered by the Produce Safety Rule from state or federal inspections, it is intended to help farmers meet the requirements as efficiently as possible.

FDA takes our responsibility for assuring the safety of the food supply seriously, and food safety is one of my highest priorities as Commissioner. While the United States has one of the safest food supplies in the world, recent outbreaks continue to highlight the all-too-real consequences of foodborne illness, and the need to ensure that the goals of FSMA are fully achieved. Our goal, through better communication, smart regulation, and enhanced use of technology, is to shift our food system from one that reacts to problems to one that prevents them from happening in the first place. Food safety needs to be priority number one from the farm to table. I know you all share this goal and that together we are leading the implementation of this critical food safety program.