On-Farm Readiness Reviews Support Farmers as They Safeguard Produce

By: Scott Gottlieb, M.D., and Stephen Ostroff, M.D.

Dr. Scott Gottlieb, Commissioner of the U.S. Food and Drug Administration

Scott Gottlieb, M.D., Commissioner of the U.S. Food and Drug Administration

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.

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.

FDA Commissioner Scott Gottlieb, right, talks with farmer Gary Willis in Hood River, Oregon.

FDA Commissioner Scott Gottlieb, right, talks with farmer Gary Willis in Hood River, Oregon.

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.

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.

FDA Deputy Commissioner Stephen Ostroff, left, with farmer Brent Jackson in Autryville, North Carolina.

FDA Deputy Commissioner Stephen Ostroff, left, with farmer Brent Jackson in Autryville, North Carolina.

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.

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 ofrr@nasda.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.

Follow Commissioner Gottlieb on Twitter @SGottliebFDA

FDA-State Partnership Propels FSMA Implementation

By: Michael R. Taylor and Stephen Ostroff, M.D.

Ever since the FDA Food Safety Modernization Act (FSMA) was enacted in 2011, we’ve said that successful implementation is not possible without a meaningful partnership between FDA and its counterparts in state government. This is especially critical in the new area of produce safety regulation.

Michael R. Taylor

Michael R. Taylor, FDA’s Deputy Commissioner for Foods and Veterinary Medicine

After years of rulemaking – of planning, discussing and revising – this partnership is no longer just an aspiration. Instead, it’s evolving into a real union of public health and regulatory colleagues at the state and federal levels who together are taking concrete steps to make the produce safety protections envisioned by FSMA a reality.

An example of this forward movement is a conference we both attended on March 22 in Orlando, Florida, where the National Association of State Departments of Agriculture (NASDA) unveiled its proposed framework for state participation in the implementation of FDA’s new produce safety rule. This rule—for the first time—establishes enforceable federal safety standards for the production and harvesting of produce on farms.

In 2014, FDA entered into a five-year cooperative agreement with NASDA to work with state partners to collaboratively plan implementation of the produce rule. The NASDA framework will help guide and inform states that are working to develop a state produce safety regulatory program that is aligned with the FSMA rule.

The NASDA framework was developed with the active involvement of 24 state departments of agriculture and five national public health organizations. Key areas addressed include education and compliance, information sharing, regulator training, accessing laboratory resources, technical assistance, and infrastructure.

Stephen Ostroff, M.D.

Stephen Ostroff, M.D., formerly FDA’s Acting Commissioner, will be succeeding Mr. Taylor as Deputy Commissioner on June 1

All 50 states were represented at the Orlando meeting to review and discuss the proposed framework, which is intended by NASDA to be a living document that can be refined and improved over time as experience is gained with implementation of the produce safety rule. The level of alignment and energy among participants at the conference – which included 46 agriculture departments and 19 public health departments – was inspiring and demonstrates that we are very much on the right path toward a sustained partnership with our state colleagues.

The states have always been clear in conversations with us, and we have been clear in conversations with Congress, that federal funding is necessary for the work ahead. State agriculture and public health personnel are the ones who have built relationships with and knowledge of local farming communities and practices and can often deliver oversight most efficiently. But almost all states will have to build produce safety programs largely or completely from scratch. We want to rely on them, not only to deliver education and technical assistance, but also to provide ongoing compliance support and oversight.

But this requires resources.

The President’s Fiscal Year 2017 budget request includes $11.3 million in new funds for the National Integrated Food Safety System. We have been building this system to fully integrate the more than 3,000 state, local and tribal government agencies involved in food safety in FDA’s work to meet the FSMA mandate. The FY 2017 funding, which Congress is considering, will be used primarily to support state produce safety programs through cooperative agreements and grants.

The FY 2017 funding builds upon resources for states that Congress provided for FSMA implementation in FY 2016. Earlier this month we took an important step toward distributing these funds – $19 million – to support state produce safety programs by soliciting applications for cooperative agreements with state regulatory agencies. These funds will make an important down payment on the capacity states need to be our full FSMA partners in produce safety. The FY 2017 funding request recognizes that more will be needed – both next year and beyond — to realize this goal.

There is a great diversity in where states are right now in planning and developing their produce safety programs. Some may already have developed multi-tiered plans and are ready to begin implementing. Others may just be starting to consider what’s ahead. This program is designed to give states the support they need at whatever stage they’re in.

Our goal is to get the initial funding to a number of states before the end of this fiscal year.

This has been a long road. But we are gaining real momentum toward the ultimate goal of having a food safety system in place in which government agencies at all levels are working in partnership with each other – and collaboratively with farmers – to ensure that we are doing everything we can to prevent or reduce the risk of foodborne illness. Safe and widely available produce is good for consumers, good for public health, and good for growers. That’s why we’re all in this together.

Michael R. Taylor is FDA’s Deputy Commissioner for Foods and Veterinary Medicine; Stephen Ostroff, M.D., formerly FDA’s Acting Commissioner, will be succeeding Mr. Taylor as Deputy Commissioner on June 1.