“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.” Scott Gottlieb, M.D., Commissioner of Food and Drugs

The Commissioner of Food and Drugs Scott Gottlieb summarized the latest work the FDA is doing to implement the Produce Safety Rule mandated by the FDA Food Safety Modernization Act (FSMA) in a letter addressed to the National Association of State Departments of Agriculture (NASDA).

In the spirit of open communication between NASDA, FDA, and the states implementing the policies, he laid out the latest updates from the FDA related to the Produce Safety Rule and:

  • Rulemaking
  • Implementation Preparedness
  • Partnership Building

You can read his entire letter here.

In summary, this is what he had to say…


The Definition of “Farm”

To address concerns expressed by NASDA and the farming community about whether and when packing houses, terminal markets, and other entities conducting farm-related activities are required to comply with the preventive controls or produce rules, the FDA is reconsidering the definition of a “farm” as used in the FSMA regulations.

They agree that there is a need for additional clarification and, so, are actively working on proposing a draft rule to include edits to the farm definition.

Agricultural Water

The Produce Safety Alliance hosted a summit this past February on agricultural water standards — focusing on how agricultural water is an important and challenging area that should be addressed by Produce Safety Rule requirements.

In response to frank conversations about the challenges presented by the current requirements in the Produce Safety Rule, the FDA is currently collecting information through on-farm visits and meetings with stakeholders about on-farm conditions and water systems. They are hoping to learn more about the diverse ways water is used and to ensure that practical and effective standards are applied to all farming operations.

Biological Soil Amendments of Animal Origin (BSAAOs)

FDA is working toward creating a framework for evaluating the safe use of untreated BSAAOs (such as raw manure) on farms. They just concluded a major research initiative involving the United States Department of Agriculture’s (USDA) Agricultural Research Service and several state universities to develop a multi-year, seasonal, and regional dataset involving the persistence of pathogenic E. coli and Salmonella in the growing environment.

Produce Guidance

The FDA is continuing to develop the draft guidance for the Produce Safety Rule. They expect to release it for public comment in the near future. 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.

Domestic-Foreign Parity

To ensure that food imported from abroad is as safe as that produced domestically, the FSMA’s Foreign Supplier Verification Programs (FSVP) was implemented.

In addition to FDA inspections of foreign facilities, they have conducted hundreds of inspections under the FSVP final rule since the first compliance date in May 2017. As more FSVP compliance dates roll out, they are continuing to build their FSVP importer inventory.

Implementation Preparedness


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.

FDA has conducted 6 of 7 produce regulator training sessions planned for 2018 and is on-target for reaching the NASDA-informed number of state regulators that need training to be ready for initiation of inspections in 2019.

They are also offering 2 virtual training programs this fiscal year. One, entitled “Produce Inspections for Regulators Virtual Produce Tour,” was posted on YouTube in June. A second webinar will be available by September 30 entitled “An Overview of the Produce Inspections Training Curriculum for Extension Service Agents.”

On-Farm Readiness Review (OFRR) Visits

To help farmers assess how prepared they are to comply with the Produce Safety Rule, NASDA (in collaboration with the FDA) has invested significant resources into developing and implementing OFRR visits. These voluntary reviews begin this summer.

Inspectional Documentation and Dispute Mitigation and Resolution Procedures

Recently, FDA and NASDA have worked toward ensuring objectivity and consistency for produce inspections as well as ways to handle disagreements between regulatory agencies conducting produce inspections. They have made progress on both initiatives.

For produce inspections, FDA and NASDA have been working on alternatives to the traditional 483 inspectional observation form. They would like to try out a produce-specific inspectional form that recognizes the unique issues associated with produce farm inspections.

Also, FDA and NASDA have held extensive discussions on Dispute Mitigation and Resolution Procedures. The FDA has recently received a final round of feedback from NASDA on their draft procedures — they expect to finalize those shortly.

Building On Partnerships

Partnership with States

46 states and 1 territory receive technical support and funding to help states implement produce safety programs — including outreach, education, identifying inventories of covered farms, and preparing for the initial inspections of large farms in 2019. They 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 the Office of Regulatory Affairs Office of Partnerships for assistance with the application process.

FDA/USDA Formal Agreement

On June 5th, FDA formally recognized the USDA’s Harmonized Good Agricultural Practices (H-GAPs) Program as aligned with the FDA Produce Safety Rule in an effort to help farmers meet requirements as efficiently as possible.

In Summary

“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.” Scott Gottlieb, M.D., Commissioner of Food and Drugs

While NASDA and FDA are leading the implementation of the Produce Safety Rule, it is up to you as a food industry professional to understand the trends and findings from the FDA’s FSVP inspections and apply them to your processes to remain compliant—normally an excruciatingly difficult task to accomplish.

As Scott Gottlieb said, “Food safety needs to be priority number one…”

About the Author

Patty Harvey, a nationally recognized food expert and speaker, is the Food Product Manager at Govzilla. Patty joins Govzilla from PL Harvey Consulting, LLC where she continues to consult for the world’s top food companies.

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