When Albany Law School Professor Tim Lytton attended the 2015 Food Safety Summit in Baltimore nearly two weeks ago, he could sense something, however faintly, among the crowd of food industry professionals: nervousness. For decades, he said, the public has been anxious about the safety of our food system. From the Jack in the Box E. coli outbreak in 1993 to the spinach E. coli outbreak of 2006, and massive outbreaks and recalls from peanut butter, cookie dough, and myriad other products in the years following, consumers have spent decades wondering about the safety of their food. http://www.dreamstime.com/stock-photo-decorative-scales-justice-courtroom-image20405420Of course, the food industry is also concerned about food safety, but recent developments are making food safety an even larger concern for food companies. Accountability has extended to the top executives, and companies are more concerned than ever about the risk of litigation and the need to properly manage and document every part of their operation. Much of that paradigm shift relates to the Food Safety Modernization Act (FSMA), a federal law enacted in 2011 that promised the most sweeping reform to the U.S. food system in more than 70 years. Key parts of the law are scheduled to finally go into effect over the coming year, and they’re intended to transition the nation’s food safety strategy from reactive — responding to recalls and outbreaks — to one that’s much more proactive and preventive. “Part of what FSMA’s doing is spreading some of that anxiety about food safety from the public onto the producers,” said Lytton, an author specializing in tort litigation and industry regulation who is currently writing a book on the U.S. food safety system. “You’re starting to hear from the industry not just a discussion about risk management, but a general responsibility about food safety — creating a culture of food safety that’s partly an anxiety about food safety.” Food producers have long felt the pain of outbreaks and recalls, not just from a financial and brand-damaging perspective, but from the risk of litigation. Since at least the Jack in the Box outbreak in 1993, food companies linked to outbreaks have often come to face lawsuits from those who fall seriously ill or who lose loved ones to foodborne illness. For decades, however, many food companies have escaped litigation because they’re simply never caught. Recent advancements in technology are beginning to change the landscape, but currently, less than 10 percent of foodborne illnesses are ever traced back to a specific food product. In the coming years, new technologies such as whole-genome sequencing will result in a greater number of illnesses being traced back to products. Combine that with more stringent record-keeping and supply chain verification requirements coming down the pipe with FSMA, and you’ll be seeing a higher percentage outbreaks and illnesses connected to food products over time, said Dave Gombas, senior vice president of food safety and technology at the United Fresh Produce Association. When it comes to fresh produce, Gombas said, the stakes can feel especially high. For one, fruits and vegetables don’t have the benefit of a cooking “kill step” for bacteria that’s afforded to so many other types of foods. “People are becoming more conscious of their vulnerability,” he said. “Fortune favors the prepared. Those folks who are more conscientious are going to be exposed to less risk.” One of the most important things to prepare for is the risk of recall, Gombas said. Even if they feel they’re doing everything right, recalls can be impossible to predict. “Recalls happen and you don’t have to do anything wrong,” Gombas said. “Being prepared is the difference between a painful recall and a very painful recall.” Lytton agreed, saying that the most prepared companies have figured out an insurance plan. “I think that adequate liability insurance and recall insurance is essential to the survival of a company,” Lytton added. That said, plenty of food producers are feeling well-prepared for FSMA implementation. Members of California’s Leafy Green Marketing Association (LGMA), for example, already abide by standards that are generally stricter than FSMA, given what’s known so far about the upcoming final rules, said CEO Scott Horsfall. “Based on our experience, I’m confident that farmers will find it easier to comply than they may think,” Horsfall said. But elsewhere in the industry, some companies are still not feeling confident about their preparedness for FSMA, assuming they’ve taken the first step of pulling their head out of the sand and accepting that it’s coming, said Dave Theno, CEO of food safety consultancy firm Gray Dog Partners and former vice president of food safety at Jack in the Box. While Theno said that most of his clients are prepared for FSMA, some companies are feeling intimidated particularly by the prospect of validating and documenting their processes. Under FSMA’s preventive controls rules, for example, companies will be required to verify the effectiveness of their safety protocols. “There are a ton of people out there that aren’t doing bad things, but haven’t validated what they do,” Theno said. “They have no idea if their processes are exact or not.” Assuming that FDA can fully fund enforcement of FSMA — the agency is asking Congress for an additional $109.5 million — Theno and others hope that the agency uses the first few years after enactment as a sort of learning period for both the industry and the agency. Both the industry and FDA need time to ease into the age of FSMA regulations, Theno said. One way companies can better prepare for all of FSMA’s regulations is by embracing traceability technology, said Tejas Bhatt, program director for the Global Food Traceability Center at the Institute of Food Technologists. Traceability and record-keeping are the foundations on which all other aspects of FSMA compliance are built, Bhatt said. By tracking each end of the supply chain, companies can easily stay accountable in the eyes of FDA. “You cannot solve a problem that you’re unaware of,” Bhatt said. “Without traceability, you don’t have a way to know what could go wrong with your supply.” Thankfully, Bhatt said, FDA has given companies a large amount of leeway in how they choose to trace their supply chains and validate their processes, allowing companies to choose the best options and tools for their needs. Given that, he sees smaller companies having unique opportunities to quickly adapt to the new landscape of food safety regulation. But the bottom line is that companies need to adapt if they’re not already ahead of the curve. Under FSMA, record-keeping is king. “To the agency or any other stakeholder, if it’s not documented, it didn’t happen,” said Melanie Neumann, executive vice president and chief financial officer for The Acheson Group, a food safety consultancy firm. “The biggest step-up for industry needs to happen with record-keeping.” In some ways, FSMA is simply memorializing into law what the best food safety practitioners have been doing for years, Neumann added. For the most part, companies have slowly been accepting that coming into compliance with FSMA will not only help consumers, but it will help protect their brands as well. Yes, the law is costly, Neumann said. Yes, it’s burdensome. But compared to the promised benefits of reduced recalls and outbreaks, the changes are worth it, she said. “When you really look at all of its component parts and all of its net results,” Neumann said, “consumers win, brand reputation wins, and it really becomes the ultimate risk-management tool where all the stakeholders win.”