September 11, 2018
By: Scott Gottlieb, M.D., and Stephen Ostroff, M.D.
FDA Commissioner Scott Gottlieb, MD
We know how important it is to get produce safety right. Taking steps to prevent contamination of produce is the primary purpose of the Food Safety Modernization Act’s (FSMA) Produce Safety Rule. The FDA is committed to making sure that the standards designed to minimize the risk of contamination are workable, and that farmers have the information and tools needed to effectively implement them.
One of the resources now available to farmers is the On-Farm Readiness Review (OFRR) program. The National Association of State Departments of Agriculture (NASDA) created this program in collaboration with the FDA. On-Farm Readiness Reviews provide farmers real-time feedback on their current operations and facilities. These reviews can help farmers address any areas in need of improvement before a regulatory inspection takes place in the future. Working together, the aim is to improve the safety of the food supply while still maintaining a vibrant agriculture sector.
As part of this program for advance, readiness reviews, food safety professionals conduct voluntary, non-regulatory visits to farms and packinghouses. Their goal is to observe current practices and provide feedback on how those practices can be strengthened to better align with regulatory expectations. These reviews are not inspections. There are no written reports or paperwork associated with these visits.
Stephen Ostroff, M.D.
FDA’s Deputy Commissioner for Foods and Veterinary Medicine
Many states are using the cooperative agreement funds that they received from the FDA to support the program. When the FDA announced that regulatory inspections would be delayed until next year, we encouraged our state partners to redirect some of the funds they had initially planned for inspections to these activities. We have spent much time visiting with farmers and collaborating with them on a shared mission of food safety. We know that the farming community wants to be in compliance with food safety laws. Together, we see great value in helping farms strengthen their practices. The idea is to take steps now to make sure all farmers are ready for the implementation of FSMA’s inspections.
While market-driven, on-farm audits may not be new to produce farmers, FSMA-mandated inspections will be new. The readiness reviews give farmers an opportunity to get individualized feedback from food safety professionals before inspections begin next year. We visited farms on opposite coasts this summer to observe reviews and talk to farmers directly about the progress they’ve made and the challenges they foresee.
And the FDA is committed to continuing to work with farmers to address remaining issues.
The Oregon Department of Agriculture and NASDA organized one of our visits. It was to the Willis Family farm in Hood River, Oregon. On this trip, Alexis Taylor, the director of the Oregon Department of Agriculture; Bob Ehart, the NASDA senior policy and science advisor; and several other local farmers, accompanied us. Our FDA team included colleagues from FDA’s Produce Safety Network, who are regionally stationed around the country. These FDA colleagues are a tremendous asset to support the states, farmers, and other stakeholders in understanding and implementing the Produce Safety Rule.
FDA Commissioner Scott Gottlieb, right, talks with farmer Gary Willis in Hood River, Oregon.
The team began the review by explaining the OFRR process and walking through which parts of the Produce Safety Rule were relevant for farmer Gary Willis’ operations. They also discussed his established recordkeeping practices and the trainings he has already completed, both of which are helpful in meeting rule requirements. The tour of the farm had the feel of a guided conversation to better understand practices Mr. Willis has in place for equipment and facility maintenance, worker health and safety, and maintaining restroom and hand washing facilities. We also learned about the farm’s harvesting methods and irrigation system. This time spent with Mr. Willis was invaluable, and his commitment to food safety was clear. We are grateful for his invitation to us to join the visit. By the end of the review, Mr. Willis and his fellow farmers had a better understanding of what to expect during an inspection as well as a firmer grasp of how to meet the Produce Safety Rule requirements.
A second visit was to the Jackson Farming Company in North Carolina. This visit gave us another opportunity to personally see the value of these reviews. Here the OFRR focused on worker hygiene and training, along with food packing and storage. The North Carolina Department of Agriculture and Consumer Services, NASDA, North Carolina State University, and the North Carolina Farm Bureau organized this OFRR tour. We were joined by North Carolina Agriculture Commissioner Steve Troxler to meet farm owner Brent Jackson, his son Rodney, and his food safety team.
At the farm, we observed the steps they’re taking to ensure workers are properly trained on their jobs, and don’t contaminate produce; steps to identify workers who are sick and shouldn’t be around produce; the access to hand washing and bathroom facilities; and when gloves, aprons and other barrier protections are used. We also walked through the packing operation as the season’s last cantaloupes came in from the field and saw how they were unloaded, cleaned, sorted, packed, cooled and stored.
FDA Deputy Commissioner Stephen Ostroff, left, with farmer Brent Jackson in Autryville, North Carolina.
Throughout this visit, we saw firsthand the benefit of the continuous dialogue, interaction and information sharing between the OFRR team and farm staff. Both parties were fully engaged in talking through the requirements and determining whether the farm appears to be meeting the standards or how processes can be improved to ensure they’re met. The fact that farm staff had been through the Produce Safety Alliance training before our visit helped them understand the process of the review and major components of the FSMA rule. It made for an efficient and effective visit.
Our time spent with these family farmers only deepened our appreciation for the hardworking American farming community, and affirmed the value of state, NASDA, and FDA efforts to make the OFRR program and other training and technical assistance available. During the final day of the visit to North Carolina, the FDA also had the opportunity to participate in Agriculture Commissioner Troxler’s 14th annual Food Safety Symposium. More than 300 people from around the state attended this gathering. The event focused on the Produce Safety Rule. It provided a valuable educational opportunity for the state’s farming community. It was encouraging to see so many North Carolinians at the event and such significant interest and enthusiasm throughout the farming community regarding food safety.
It’s reassuring to see how useful OFRR visits can be in helping farmers understand what to expect in working with us to help ensure the safety of the fruits and vegetables we serve our families. We encourage farmers to take advantage of these reviews. Interested farmers should first attend a Produce Safety Alliance (PSA) training course (or equivalent). Upcoming training courses are listed on the PSA website. Once trained, farmers should contact their state Department of Agriculture (or the Department of Health in Alaska and Indiana). Farmers can also contact NASDA at firstname.lastname@example.org for more information.
Scott Gottlieb, M.D. is the Commissioner of the U.S. Food and Drug Administration; Stephen Ostroff, M.D., is FDA’s Deputy Commissioner for Foods and Veterinary Medicine.