FDA has signed a consent decree in federal court agreeing to create a list of high-risk foods and publish a proposed rule establishing industry recordkeeping and traceability requirements by September 2020, with a final rule to be issued by November 2022.
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The consent decree, signed in the U.S. District Court for Northern California in June, settled a lawsuit brought in October 2018 against FDA and the Department of Health and Human Services by two consumer advocacy groups. In their complaint, the Center for Food Safety (CFS) and the Center for Environmental Health argued that FDA had violated the Food Safety Modernization Act (FSMA) by failing to publish a high-risk foods list by January 2012 and proposed recordkeeping requirements for facilities that manufacture, process, pack, or hold those foods by January 2013.
The settlement was made without admission or denial of the allegations, with both sides agreeing that “resolution of this matter without further litigation is in the best interest of the parties and the public.”
“This is a major victory for public health,” said Ryan Talbott, CFS staff attorney in a statement. “FDA has sat on its hands for years, neglecting to make these high-risk designations, while outbreaks caused by Salmonella, E. coli, and other pathogens have sickened and killed people. This settlement ensures FDA will finally take these much-needed actions to reduce the threat of foodborne illness.”
“After years of stalling, FDA can no longer delay enacting the FSMA high-risk food regulations,” added Jaydee Hanson, CFS policy director. “FDA needs to designate what these high-risk foods are and how they should be reported so that we can build a safer food system that prevents as many of these foodborne illness outbreaks as possible.”
Earlier, in May 2018, nine major consumer and food safety groups urged FDA “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.” 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 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.
Minefield for Food Industry?
Many food safety experts and consumer groups applauded FDA’s decision to finally move forward on designating a high-risk foods list and proposing rules to mitigate their hazards. But others worry that the effort might have unintended consequences.
“Creating a list of high-risk foods may appear to some to be a great idea, but I am not a big fan of this approach,” explains David Acheson, MD, former associate FDA commissioner for foods and founder and CEO of The Acheson Group.
“Be careful what you ask for in terms of putting industry into compliance for high-risk foods,” Dr. Acheson tells Food Quality & Safety. “In some ways, it could be a minefield for the food industry. As we have learned, any food can become high risk if you don’t grow, produce, transport, or sell it with appropriate food safety controls. I worry that industry will spend too much time trying to navigate from the high-risk to the ‘low-risk’ list,” he wrote in a recent blog post.
If that were to happen, it would likely be driven to some extent by the degree of “demonization” of high-risk foods. “I hope that consumer groups and others providing opinions do not lose sight that any food, if not grown/manufactured/transported/sold with appropriate food safety controls, can be high risk,” Dr. Acheson emphasizes.
Enacted in January 2011, FSMA requires a range of preventive measures to reduce foodborne hazards, including the designation of high-risk foods that are more susceptible to being a source for foodborne illness outbreaks and additional reporting requirements for them.
FSMA Section 204(d)(2) gave the agency one year to compile the list and two years to propose enhanced recordkeeping requirements. FDA has been working on the matter even while grappling 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.
FDA delayed routine farm inspections until spring 2019 to allow more time for guidance, training, technical assistance, and planning. The agency continues to methodically work through such contentious issues as agricultural water testing and the safe use of raw manure on crops, especially in light of recent E. coli O157:H7 contamination of romaine lettuce linked to untreated on-farm reservoirs and runoff from concentrated animal feeding operations.
Despite missing the two high-risk food designation deadlines, FDA in 2014 did publish a draft methodology for identifying such foods and opened a docket for public comments. And as required by FSMA, FDA completed two product tracing pilot projects in conjunction with the nonprofit Institute of Food Technologists.
Currently, the Bioterrorism 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 imposes certain recordkeeping requirements on covered farms, traceability coding is not one of them. Any new high-risk food recordkeeping rules that FDA develops will be in addition to these requirements.
Growing Burden of Illness
An estimated 48 million people in the U.S. become ill from foodborne diseases each year, according to CDC. Approximately 128,000 are hospitalized and 3,000 die every year based on exposure to pathogens present in the food supply. The annual cost to the U.S. economy in medical bills and productivity losses is more than $93 billion, according to a 2015 study.
The incidence of foodborne infections increased in 2018 compared to 2015-17, according to CDC’s Foodborne Diseases Active Surveillance Network (FoodNet) report, released in April. Surveillance from labs in 10 states confirmed that more than 25,600 infections, nearly 5,900 hospitalizations, and 120 deaths were caused by eight enteric pathogens commonly transmitted through food.
As in previous years, Campylobacter was the most prevalent, being responsible for 9,723 illnesses, 1,811 hospitalizations, and 30 deaths. This was followed by Salmonella with 9,084 illnesses, 2,416 hospitalizations, and 36 deaths. Campylobacter is commonly associated with consumption of raw or undercooked poultry and meat, while Salmonella is an issue in many types of food, including eggs, meat, poultry, fruits, vegetables, spices, and nuts.
Nationwide, the actual number of cases is much greater. This is because FoodNet collects data from public health departments in only 10 states, covering just 15 percent of the U.S. population.
Making a List
FDA’s draft methodology for designating high-risk foods lists several factors the agency might consider. These include the food’s known safety risks, including its history and severity of illnesses; its potential risk for microbial or chemical contamination given its nature or production processes; the point in manufacturing where contamination is most likely to occur, and steps needed to reduce it; and the food’s likely or known severity, including health and economic impacts.
Dr. Acheson draws particular attention to the fact that, for the high-risk designation, FDA might consider not only the food but the manufacturing process points at which contamination is most likely to occur. He urges FDA to consider feedback it received from its proposed 2014 designation of high-risk foods.
The Produce Marketing Association (PMA) noted in its comments that it would be “patently unfair that [food companies] that have implemented robust preventive controls be burdened with additional tracing requirements due to the industry segment as a whole being designated a ‘high-risk’ food category.”
For example, FDA should evaluate facilities that manufacture, process, pack, or hold raw agricultural commodities in a manner different from low-acid canned food facilities, wrote James R. Gorny, PhD, vice president, PMA. “A one-size-fits-all approach to evaluating food risk will likely prove difficult, overestimating risk for some foods while underestimating risk for other food categories,” he said.
In its comments, United Fresh argued that “high risk” and the need for traceability are not connected.
“The need to trace implicated foods back to the source of contamination and forward to all other potentially contaminated foods can occur in any commodity, regardless of prior linkage to foodborne
outbreaks,” wrote David Gombas, PhD, senior vice president, United Fresh.
“Further, requiring enhanced recordkeeping will not make ‘high-risk’ foods safe, only potentially better assure their traceability in the event of a recall or outbreak, as would be necessary for any food regardless of calculated risk,” Dr. Gombas added. Accordingly, “it is unnecessary for FDA to designate a food as ‘high risk’ in order to require adequate and accurate recordkeeping to enable traceability.”
According to the consent decree, FDA can extend the court-imposed deadlines only if the plaintiffs (the Center for Food Safety and the Center for Environmental Health) agree. If agreement cannot be reached, FDA can petition the court for extension of time but it needs to demonstrate “good cause and/or exceptional circumstances,” with the burden resting on FDA.
“FDA has a large and complex job in front of it, which is most likely why it has taken so long” to compile a list of high-risk foods, Dr. Acheson says. “I also suspect that FDA has not seen this as a great public health tool and so has not given it priority. But I hope that FDA is able to leverage this for the minor gains it will give us and not create a two tier structure for food that will create potential complacency in the low-risk category.”