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In the spring of 2019, FDA began routine Produce Safety Rule (PSR) inspections of larger farms and orchards, with small farm inspections to begin in the spring of 2020. To determine what these food producers should expect when FDA comes knocking on the farmstead door, what the agency is seeing thus far, and how it all impacts the downstream food chain, including food processors and manufacturers, QA asked FDA Commissioner of Food Policy & Response Frank Yiannas about his farm-visit experiences and impressions. Following are his responses:

1. This spring, you began Produce Safety Rule inspections of larger farms and orchards. In general, what are you finding — both positive practices and continuing opportunities?

FDA and our state partners began routine inspections this year at large farms. Routine inspections for sprout operations began prior to that time. FDA has started conducting routine inspections of foreign farms while the vast majority of domestic Produce Safety Rule (PSR) inspections are conducted by our state partners under the State Cooperative Agreement Program (CAPs). Some routine state and FDA inspections are only just beginning because the produce harvest season for those farms only just started. While it’s too soon to provide trends because of the limited pool of inspectional data that FDA and state partners have collected so far, we’re off to a good start doing work that has never been done before.

FDA Commissioner of Food Policy & Response Frank Yiannas (left, gesturing) observes and discusses agricultural water treatment on a California farm.
Photo courtesy frank Yiannas

2. FDA has said its initial goal in PSR inspections is to be educational and collaborative, while still ensuring compliance and food safety. What does this mean?

At FDA, we’re committed to prevention. Our inspection teams are trained to help farmers understand the PSR requirements and provide them with reference materials to facilitate that understanding. The collaborative mindset also means that our inspection teams will engage with the farmers to understand the farm operations and will evaluate the overall food safety impacts of the farm practices, taking a big-picture approach that considers how different parts of the operation intersect and impact each other. While collaboration and education are important, when we see a condition or practice that could introduce hazards into produce, we will take appropriate action to help ensure the condition or practice is addressed.

We delayed the start of routine large-farm inspections until this spring in part because more time was needed to help ensure that produce farmers have the training and information they needed to comply with the Produce Safety Rule. During that time, we worked to help provide access to training; we published a draft guidance; and we collaborated with the National Association of State Departments of Agriculture on the development of On-Farm Readiness Reviews. These voluntary reviews help farmers assess how ready they are to comply with the rule.

Just as with the first round of routine inspections for other rules established by the FDA Food Safety Modernization Act, such as the Preventive Controls for Human Food, the Preventive Controls for Animal Food, and the Foreign Supplier Verification Program, we understand that this may be new territory for food producers. That is why we continue to focus on education and technical assistance during these initial inspections.

3. You have noted that treatment of surface water used for irrigation is catching on. Can you discuss what you’ve seen?

On a recent trip to California, we had an opportunity to observe treatment of agricultural water used for overhead sprinkler irrigation of leafy greens to meet a new requirement of the California Leafy Greens Marketing Agreement (LGMA). On this visit to an organic farm we watched agricultural water being treated in accordance with LGMA requirements for overhead sprinkler irrigation for leafy greens seed germination. We also observed the irrigation crews carefully verifying treatment parameters at the terminus of the irrigation system, to help ensure that the treatment is delivered in an effective manner throughout the overhead sprinkler irrigation system. In addition, we saw similar water treatment equipment on other fields and farms.

4. Following those observations, you stated, “If more firms take measures like this, we will make surface water even safer.” Please explain.

Observing firsthand how growers are using a risk-based approach to evaluate, monitor, and control for contamination in agricultural water to prevent contamination of their fruit and vegetable crops is a game-changer. We have observed a variety of different approaches on farms, and FDA has long said that growers have a range of viable options to consider when addressing agricultural water safety issues, based on the practices and conditions specific to their farms. In some circumstances other options, such as changing the timing or manner of water application, may be more feasible than the option to treat water.

Whatever option they choose, farmers are increasingly taking proactive measures like these to help further strengthen food safety culture on their farms, which is ultimately a win for consumers.

5. How are your on-farm and industry group visits being used in FDA’s continuing look at the microbial water quality and testing standards of the rule? Any updates on this?

During the period of the agricultural water compliance date extension for covered produce other than sprouts, FDA has been pursuing a rigorous stakeholder engagement plan. One aspect of that plan has been more than 200 educational farm visits since 2017, which have helped to further refine our understanding of the myriad of variations in agricultural water sources and uses. The farm tours have included representatives from government agencies, academia, and the produce industry, along with farmers whose farms are covered by the PSR. We also have engaged with technical experts from both the public and private sectors on matters such as water microbiology and water systems. These experiences help to inform our work on the produce rule’s agricultural water provisions as we diligently pursue solutions to further reduce the regulatory burden or increase flexibility while continuing to protect public health.

Growers have a range of viable options when addressing agricultural water safety issues, based on the practices and conditions of their farms.
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6. How does all this impact food processors and manufacturers; i.e., what should be required of their produce suppliers, and what will FDA be looking for in produce supplies when inspecting these facilities?

Under the FSMA preventive controls and foreign supplier verification rules, processors and importers have the responsibility to assess their supply chain, unless a future step in the manufacturing process will apply necessary controls. When evaluating processors and importers, FDA will review the supply chain controls to determine that the processors and importers are meeting their requirements and have the necessary programs in place. Since produce is often processed without a cook step, having supply chain or importer controls in place is very important to ensure the safety of processed or imported produce.

7. What else is important for the food industry to understand in this area?

It’s important for the food industry to understand that FDA is committed to the partnership that has grown and evolved since FSMA was first signed into law. FDA leaders have visited farms and facilities all over the country, and we have all been impressed with the dedication we’ve seen among farmers to the nation’s rich tradition of farming and to the health and well-being of the customers who trust them to provide safe foods.

In the speeches I’ve given since joining FDA, I always close with this thought: “I’ve learned from working with FDA from the other side of the fence that there’s a lot industry can do to advance food safety. And there’s a lot government can do to advance food safety. But what is crystal clear to me, having now been on both sides of that fence with some influential organizations, is that there’s so much more we can do together.

“Whether you’re in the private or public sector, whether you’re at the state or Federal level, we’re all working for the same boss — consumers — so let’s work together to keep their food safe. They’re counting on us to do so.”

The author is Editor of QA magazine. She can be reached at llupo@gie.net.