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FSMA: Smoothing the Transition

How technology can help with FSMA compliance
AT-Final

Ruiz Sales’ investment in technology has also been sizeable, but the return on investment is worth the cost. In the long run, Ruiz posits, the end result is almost always a more efficient and effective operation. “These are the kinds of benefits that can keep a company successful for many years, even in the face of massive changes like FSMA.”

Smaller fruit growers in the Northwest have told Borton’s Leavitt that the increase in FSMA and other regulations could drive them out of business. But for bigger companies like Borton (which recently merged with Chelan Fresh of Chelan, WA), FSMA creates opportunities—specifically, smaller growers who can’t afford to run their own tests to prepare for an FDA audit can turn to Borton and use the company’s in-house labs.

Leavitt also hopes that getting the government’s seal of approval will help further protect the integrity of Washington brands and generate new business for companies that meet or exceed FSMA demands. “Right now, it seems awfully burdensome and expensive,” he admits, “but we hope to get more steady business from the Walmarts and the Costcos of the world. They want a homogenous, consistent product and we want the market to have the safest, best fruit possible.”

Conclusion
Adapting to FSMA and its new regulatory era has not been easy for many companies, up and down the fresh fruit and vegetable supply chain. And with a number of produce-specific details yet to be ironed out, challenges remain. The good news is the hard choices companies are making now, including all the time and money invested in technology and other upgrades, will ensure they’re FSMA compliant and provide plenty of benefits down the road, from faster, more efficient processes to safer product.

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In 2011, when then-President Barack Obama signed the Food Safety Modernization Act (FSMA) into law, it radically changed the food safety landscape for U.S. producers and importers of fresh fruits and vegetables.

Food safety compliance is no longer driven solely by self-interest on the part of produce buyers and sellers looking to avoid the potentially catastrophic effects of a sudden outbreak—compliance now has the force of law behind it. Six years after its passage, the industry-specific guidelines of FSMA are still being hammered out. But produce companies have gotten a head start, adopting new technologies to navigate the evolving regulatory landscape.

Compliance Drives Innovation
Wood’s Produce Company, a distributor based in Meadows of Dan, VA, took food safety seriously long before FSMA became law. But FSMA did help the company take its food safety program to a whole new level says Doug Turner, Wood’s food safety director.

All of the company’s documentation and recordkeeping are now online, and every pallet shipped from its warehouse can be traced through customized Sage Pro software—not only when and where it was shipped, but the employee who picked it as well. “Traceability, from where we were to where we are now—is amazing,” extols Turner.

When it became clear to Yakima, WA’s Borton & Sons, Inc. that FSMA was going to become a reality, food safety and compliance director Jeremy Leavitt became certified by the U.S. Food and Drug Administration (FDA) as a lead trainer, enabling him to train not only Borton’s employees but its grower partners as well.

Borton & Sons also made significant upgrades to its packing shed to meet new requirements. Leavitt says the company can now do aerobic plate counts, listeria, and other food safety testing at its in-house lab, instead of relying on a third party. And once the FDA finishes expected tweaks to FSMA water regulations, Borton & Sons expects to create its own water-testing lab.

In addition, the grower-shipper has made other changes to meet the needs of the new regulatory era. Leavitt explains that the company used to run swab-based tests in its facility each quarter; now, tests are conducted every week. And to better prepare for recalls, Borton has hired a public relations firm, bought more recall-specific insurance, and installed software upgrades to more easily track lab results in real time. “The whole idea is to mitigate risks,” explains Leavitt. “With the government involved now, there are a lot more potential risks.”

Mike Dodson, president and chief executive officer of Lotpath, Inc. in Fresno, CA, says many of Lotpath’s fresh produce customers have repurposed the company’s quality control software for food safety applications to meet FSMA requirements. A California table grape grower-shipper uses Lotpath’s Quality mobile app to track food safety criteria from the cleanliness of drinking water and washwater to whether hairnets are being used. Inspired by such customer-generated uses of its software, Lotpath is now considering developing its own food safety-specific products.

The most important technological change FSMA has brought to Nogales, AZ shipper Ruiz Sales is in the way shipments are tracked, shares company president Richard Ruiz. Global trade item number (GTIN) and Databar systems can track every lime Ruiz Sales ships—from the field to the consumer’s table.

Ruiz Sales has also invested in new machinery and tools to help stay in compliance with FSMA requirements.

The company’s eight-lane Orb-Tek machine stickers all product to customer specifications in a way that meets FSMA mandates while also being cost effective. “Without the machine, the ability to provide traceability at the level of individual fruit would be expensive and difficult, as we would have to hand-sticker all of our products,” Ruiz explains.

Another change in the industry due to FSMA, Ruiz notes, has been a sizable increase in online ordering, tracking, and database management. Ruiz has invested in all three to stay on top of the vast amount of data necessary to meet FSMA requirements. “Such platforms allow us to digitally track our produce from the farm to our retail and wholesale customers,” Ruiz says. “We’re also able to better keep track of accounts payables, receivables, and all of our other expenses with ease, which helps us make good decisions.”

Preventive Controls
The new emphasis on preventive controls has been a boon for Wood’s Produce. As Turner sees it, the best way to fight food safety-related problems is with prevention—to do everything possible to keep such incidents from happening in the first place.

Wood’s drivers have traditionally relied on a mounted light to determine whether a truck’s refrigerated unit was operating. But such a simple red light/green light system is no longer acceptable in the FSMA era. Even if the green light is on, the product inside may not be at the temperature needed to ensure cold chain viability, so the company is in the process of upgrading all of its trucks.

The importance of FSMA and other food safety protocols hit home recently for Wood’s Produce, after the company sent a load of distressed watermelons to the county landfill. Before the melons could be properly disposed of, they were stolen and ended up at one of Wood’s customers. Yet because of its advanced traceability capabilities, the company was able to clearly show the movement of the melons and prove its innocence to officials investigating the crime.

Investments Pose Challenges
For Borton’s Leavitt, becoming an FDA-certified lead trainer in FSMA regulations wasn’t easy, and the demands it has made on his time have been significant. Training growers can take a few days out of his work week, but the potential costs of no training far outweigh the headaches that come with it.

Another challenge for Borton has been to understand exactly how FSMA regulations apply to the company and its growers. For instance, Leavitt initially assumed Borton fell under FSMA’s Produce rule. Now, because of the company’s processing capabilities, he thinks it’s more likely to be under the law’s Preventive Controls rule. “If and when the FDA shows up, people need to understand the rule,” he says.

In addition to ensuring their own compliance, produce companies like Borton also are working hard to change FSMA itself, so it more accurately reflects the industry.

Leavitt, who serves on food safety committees for the Northwest Horticulture Council and U.S. Apple Association, is working with other officials to convince the FDA to make FSMA water testing more flexible. Current regulation is based on California Leafy Greens Marketing Agreement requirements. Leavitt believes these requirements are too onerous for growers of apples and other tree fruit, which are far less susceptible to disease than lettuce and leafy greens. Fortunately, the agency announced earlier this year it would take another look at FSMA water regulations.

As fluent in food safety as Wood’s Produce already was, meeting FSMA requirements did not come without its share of challenges, Turner says. One example is the Act’s language or legalese, which he says made it difficult to understand. Fortunately for Wood’s Produce, Safe Quality Food Institute materials provided crucial assistance in translating FSMA into language they could understand. “They helped us figure out where we met or exceeded requirements,” he shares. “I didn’t have to lay awake at night thinking about failing an FDA audit.”

Finding The Right Tools
Of the many challenges posed by food safety, figuring out how best to comply with FSMA and food safety protocols demanded by customers is significant. When Lotpath asked clients what kind of food safety software products they’d like to see on the market, Dodson says many requested a program capable of juggling several protocols at once.

So in addition to helping companies navigate FSMA and other requirements, Dodson says a new Lotpath food safety-specific software product could give companies the ability to do their own audits in advance of a formal audit from the FDA or a third party.

Many of the upgrades related to meeting FSMA standards require large upfront investments, says Ruiz. Database tools, automated platforms, and machines for stickering, packing, and sorting are among the more expensive. But this is nothing compared to the cost of a food safety outbreak. “No matter how expensive an upgrade,” he emphasizes, “it’s never more expensive than food that makes consumers sick or worse.”

Benefits Outweigh Risks
Meeting FSMA and other food safety requirements has certainly come at a price. Turner says sealing its building, protecting against rodent infiltration and water leaks, training its 35-member staff, and upgrading software and other technology has not been inexpensive. But these investments will pay dividends for years to come. “We can now sell to anyone in the world,” he points out. “In the future, this will only help us. We had to do it—and it’s a good investment.”

Ruiz Sales’ investment in technology has also been sizeable, but the return on investment is worth the cost. In the long run, Ruiz posits, the end result is almost always a more efficient and effective operation. “These are the kinds of benefits that can keep a company successful for many years, even in the face of massive changes like FSMA.”

Smaller fruit growers in the Northwest have told Borton’s Leavitt that the increase in FSMA and other regulations could drive them out of business. But for bigger companies like Borton (which recently merged with Chelan Fresh of Chelan, WA), FSMA creates opportunities—specifically, smaller growers who can’t afford to run their own tests to prepare for an FDA audit can turn to Borton and use the company’s in-house labs.

Leavitt also hopes that getting the government’s seal of approval will help further protect the integrity of Washington brands and generate new business for companies that meet or exceed FSMA demands. “Right now, it seems awfully burdensome and expensive,” he admits, “but we hope to get more steady business from the Walmarts and the Costcos of the world. They want a homogenous, consistent product and we want the market to have the safest, best fruit possible.”

Conclusion
Adapting to FSMA and its new regulatory era has not been easy for many companies, up and down the fresh fruit and vegetable supply chain. And with a number of produce-specific details yet to be ironed out, challenges remain. The good news is the hard choices companies are making now, including all the time and money invested in technology and other upgrades, will ensure they’re FSMA compliant and provide plenty of benefits down the road, from faster, more efficient processes to safer product.

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Andy Nelson, a Kansas-based writer and editor, has more than 20 years of experience in journalism and custom media.