In response to recent multistate outbreaks of pathogenic E. coli O157:H7 infections linked to romaine lettuce and leafy greens, nine prominent consumer and food safety groups have urged FDA to designate produce, particularly leafy greens, as a high-risk food category and to implement long-overdue Food Safety Modernization Act (FSMA) traceability requirements for them by the end of this year.
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Explore This IssueOctober/November 2018
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But that seems unlikely to happen, as FDA is continuing to take its time. Section 204 of the FSMA, enacted in January 2011, gave the agency one year to compile a list of high-risk foods and two years to propose enhanced recordkeeping requirements for them. FDA, however, is still working on the list even as it grapples with new challenges, such as implementing the produce safety rule, particularly the inspection of farms and other facilities that grow, harvest, pack, and hold fruits and vegetables for human consumption.
The FSMA final produce safety rule (Standards for the Growing, Harvesting, Packing, and Holding of Produce for Human Consumption) went into effect in January 2016 and compliance began in January 2018 for large farms (having more than $500,000 in average annual sales). Smaller farms have until January 2019 or January 2020 to comply, depending on their annual sales. (FSMA has exemptions for very small farms, farms that only sell raw produce locally, such as at farmers markets, and those that grow crops for further processing, such as tomatoes for canned tomato sauce.)
“The FDA is committed to making sure that the standards designed to minimize the risk of contaminations are workable, and that farmers have the information and tools needed to effectively implement them,” wrote FDA Commissioner Scott Gottlieb, MD, and Deputy Commissioner Stephen Ostroff, MD, in a September blog posting.
Accordingly, FDA has delayed routine farm inspections until spring 2019 to allow more time for guidance, training, technical assistance, and planning. The agency is also methodically working through such contentious issues as agricultural water testing and the safe use of raw manure on crops.
“We urge you to designate produce, including leafy greens, as a high-risk food category and propose regulations that will enhance product tracing for produce in the event of an outbreak,” nine major consumer and food safety groups urged FDA Commissioner Gottlieb in May. Among the groups signing the six-page letter were the Center for Science in the Public Interest, Consumers Union, Food & Water Watch, The Pew Charitable Trusts, and the Consumer Federation of America.
Noting that retailers now can trace the origin of certain produce shipments in mere seconds using blockchain and other advanced technologies, “it is no longer acceptable that the FDA has no means to swiftly determine where a bag of lettuce was grown or packaged,” the groups wrote.
In 2014, FDA published a draft methodology for identifying high-risk foods and opened a docket for public comments. The methodology remains unfinalized. “Such a lengthy and resource-intensive process for identifying high-risk foods is at odds with the one- and two-year timeline that Congress set out in FSMA,” the groups wrote, noting that produce, especially leafy greens, is “clearly” high-risk. An FDA spokesperson says the agency “has spent the years since the passage of FSMA developing and implementing rules that transform our food safety system from being reactive to preventive.”
The Bioterrorism Preparedness and Response Act of 2002 requires businesses in the food supply chain to maintain rudimentary one-step-forward, one-step-back traceability records. But farms are exempt from that rule. And while the produce safety rule does impose certain recordkeeping requirements on covered farms, traceability coding is not one of them.
As required by FSMA, FDA has completed two product tracing pilot projects in conjunction with the nonprofit Institute of Food Technologists (IFT). Based on IFT’s findings and recommendations, FDA in 2016 submitted a report to Congress with its own recommendations, the implementation of which the agency said “will be resource-dependent.”
While some recommendations are being implemented, the high-risk foods list and traceability mechanisms are not. “Without effective traceability, neither the agency nor industry can begin to address these challenges and prevent future outbreaks,” the food safety and consumer groups wrote.
High-Risk Leafy Greens
Between 2009 and 2013, fresh produce was responsible for more than 58 percent of all foodborne illnesses due to Listeria monocytogenes, 51 percent of E. coli O157, 46 percent of Salmonella, and 33 percent of Campylobacter, according to a recent report from the Interagency Food Safety Analytics Collaboration.
This year has seen several multistate produce-related food safety outbreaks. Most prominently, an E. coli outbreak linked to romaine lettuce from the Yuma, Ariz., growing region sickened 210 people in 36 states, with 96 hospitalizations and five deaths. No specific farms, packing, or distribution facilities have been implicated. In June, FDA officials told a meeting of the Leafy Greens Food Safety Task Force, an ad hoc industry/government group, that canal water contaminated with manure from a nearby large cattle feeding operation may have been the source.
The Yuma romaine lettuce outbreak was not related to an earlier multistate outbreak of E. coli O157:H7 infections linked to leafy greens in the U.S. and romaine lettuce in Canada. That outbreak was associated with a different DNA fingerprint of the bacterium. Among the 21 people affected by that outbreak, nine were hospitalized and one died. The Public Health Agency of Canada identified romaine lettuce as the source of their infections, while U.S. investigators suggested a variety of leafy greens, but could not identify a specific type.
Also during the summer, more than 500 people became infected with the Cyclospora cayetanensis parasite after consuming salads from McDonald’s restaurants in 16 states. For this outbreak investigation, FDA used a new, real-time PCR detection method. Cyclospora is generally transmitted through feces-contaminated food and water. FDA investigated distribution and supplier information for romaine and carrots but results were inconclusive.
Separately, 250 laboratory-confirmed cases of Cyclospora infection were reported among people who ate pre-packaged Del Monte vegetable trays purchased from convenience stores in the Upper Midwest. As in the other cases, FDA’s traceback investigation did not identify a single source or potential point of contamination.
FDA’s long delay in issuing the high-risk food list and traceability requirements under FSMA Section 204 “is untenable in light of the recent unsolved outbreaks,” the food safety and consumer groups wrote. As David Acheson, MD, former FDA associate commissioner for foods and president and CEO of The Acheson Group, puts it, “Our tracking systems still don’t work. They take much too long and are too imprecise.”
Dr. Acheson is concerned that the leafy greens industry, particularly the romaine lettuce sector, will suffer in sales much as spinach did after a massive E. coli outbreak in 2006 that sickened more than 300 people and killed three. Similarly, a Salmonella outbreak from salsa in 2008 was initially blamed on tomatoes, but eventually linked to peppers from Mexico.
“Because it took so long to trace the contamination and determine peppers as the actual culprit, the tomato industry was ravaged as consumers began avoiding tomatoes altogether based on advice from states and FDA,” Dr. Acheson says. The scare ended up costing the tomato industry hundreds of millions of dollars in lost sales.
Growing and shipping records, when they exist, are often handwritten and the types of information they contain can vary from company to company. Traceback becomes even more difficult when a single production lot of bagged salad may contain romaine and other leafy greens from multiple ranches.
“Better recordkeeping at businesses producing and distributing the nation’s food would increase the speed and effectiveness of outbreak investigations and recalls,” says Sandra Eskin, food safety project director at The Pew Charitable Trusts. “FDA can and should spur these improvements.”
The produce industry, of course, has not been waiting for FDA and has launched a number of initiatives to tackle the traceability conundrum. For example, following a series of nationwide E. coli outbreaks in 2006 from produce, California farmers and industry groups established the California Leafy Greens Marketing Agreement (LGMA). LGMA provides a mechanism for verifying that farmers follow established food safety practices for lettuce, spinach, and other leafy greens. Member companies sell and ship produce only from farmers who comply with LGMA-accepted food safety practices, including mandatory USDA audits and state inspections.
The Produce Traceability Initiative (PTI), sponsored by the Canadian Produce Marketing Association, GS1 US, the Produce Marketing Association, and the United Fresh Produce Association, aims to help drive voluntary whole-chain traceability by using GS1 protocols to identify products, locations, and transactions, and using advanced electronic data management standards, such as blockchain technology.
PTI estimates that about 60 percent of produce cases currently carry PTI labels with GS1-issued company prefixes and 14-digit Global Trade Item Numbers in machine-readable barcodes. (Some of the shipments of contaminated Yuma romaine lettuce did carry barcodes, but these apparently were not scanned through the distribution system.)
Meanwhile, FDA is providing $32.5 million in funding to 46 state agriculture departments to help implement the FSMA produce safety rule. The grants are for education and outreach programming and for compliance and enforcement. As part of the effort, the National Association of State Departments of Agriculture has developed a Model Produce Safety Implementation Framework for states to consider.
“When you consider how much fresh produce is consumed every day, much without any type of kill step, one has to applaud the produce industry in keeping the vast amount of produce really safe,” says Dr. Acheson.
But he urges vigilance. “We all need to take lessons from all the outbreaks regardless of the implicated source and work together to continue to improve traceability, to limit the impact of any contamination at any point in the chain, to protect consumers, and protect the industry as a whole,” Dr. Acheson says.