FDA’s Warning Shot For Leafy Greens
On April 6, the Food and Drug Administration fired an unmistakable warning shot at the leafy greens industry. I hope it will serve as a call to urgent action that gets to the root of the problem of the persistent presence of dangerous E. coli in the growing environment for leafy greens and other fresh produce.
Carefully using the regulatory language in its produce safety rule (21 CFR 112.11) and citing the recurring nature of the E. coli hazard in the Salinas and Santa Maria growing area, FDA declared the recurring strain implicated in the 2020 outbreak to be a “reasonably foreseeable hazard,” which FDA attributed to the presence of cattle on land adjacent to growing fields.
This finding seems obvious and shouldn’t be surprising. The surprise, however, is that FDA used regulatory language to express its finding and spelled out the implications: farms covered by the FSMA produce safety rules “are required to implement science and risk-based preventive measures” to minimize the risk of serious illness or death from the E. coli hazard.
Make no mistake, however, FDA’s message is aimed not only at farms but at every entity involved in the commercial production, processing, and sale of leafy greens coming from the California Central Coast Growing Region. The message is that, without effective preventive measures, such leafy greens are in violation of federal food safety regulatory standards.
I do not anticipate FDA taking judicial action to enforce its April 6 finding, absent egregious practices or clear negligence in a particular leafy green growing situation. I do see, however, a heightened sense of urgency at FDA and frustration that efforts to date have not solved the leafy greens safety problem. I share that frustration.
Fifteen years ago, the disastrous spinach outbreak caused by E. coli O157:H7 was linked by the Centers for Disease Control and Prevention (CDC) to run-off from nearby grazing land. Since then, we’ve had outbreak after outbreak associated with E. coli in leafy greens and other fresh produce. And the outbreaks are just the tip of the public health iceberg. The federal government estimates that 60 percent of all food-related E. coli O157:H7 illnesses are associated with fresh produce. The vast majority of these illnesses are not part of an identified outbreak.
The E. coli outbreaks and illnesses persist despite a lot of hard work by a lot of people in the leafy greens industry, researchers, the California Department of Food and Agriculture (CDFA), the FDA and its federal partners. Stop Foodborne Illness, the organization of illness victims and their families whose board I co-chair, works with the California LGMA on the common cause of strengthening food safety culture in the leafy green industry. We also advise the Leafy Greens Safety Coalition, a group of leading retailers working to strengthen safety practices. I have participated in the California Agricultural Neighbors Workgroup convened by CDFA Secretary Karen Ross. So, I know serious people are at work on the problem.
What then is the urgent call to action? What do consumers expect of the leafy greens industry, especially those individuals and families who know first-hand the devastating human impact E. coli infections can have? What does the public health demand?
At one level, the answer to all three questions is the same. The leafy greens industry and all those across the leafy greens supply chain and in government should be doing urgently everything they reasonably can to minimize the now well-known risk posed by E. coli O157:H7. According to FDA, the law requires no less. Certainly, this includes prevention measures within the leafy greens production system, such as strict implementation of rigorous water quality and irrigation standards, improved compost management, sanitation of harvesting equipment, and pre-harvest test-and-hold programs.
But the prevention strategy must go deeper. Modern food safety best practices dictate that prevention should begin at the root of the problem. As long as leafy greens are grown outdoors in the vicinity of cattle operations, I believe the food safety problem will persist until the shedding by cattle and the release of dangerous E. coli into the environment is minimized at its source. Effective vaccines are available. Changed feeding practices have promise. Perhaps containment measures can reduce risk.
The experts need to determine what combination of measures works best, but it is clear that no responsible food manufacturer would today deem it acceptable to produce food in an environment in which dangerous bacteria are being released or are present on a sustained basis. The same principle should apply to leafy greens and other fresh produce grown outdoors.
The important difference, of course, is that the leafy greens producer has no direct control over the source of the hazard. And the cattle producer isn’t responsible for where leafy greens are grown. That is why FDA Deputy Commissioner Frank Yiannas calls for “industry leadership and collaboration among growers, processors, retailers, state partners and the broader agricultural community,” including cattle producers.
I am glad FDA is sounding the alarm, but I know from experience that the kind of leadership and collaboration that is urgently needed is easier said than done in an industry and government structure that is notoriously fragmented and often works in silos. And the obstacles to solving the problem are not just technical. They include the need for creative solutions on such matters as who pays for interventions needed in cattle production to make leafy greens safe.
But too much is at stake for all concerned to let such obstacles stand in the way. Now is the time for leaders from all across the commercial value chain and government to act together, with greater urgency, to get to the root of the problem and prevent it.
Mike Taylor
About the author: Mike Taylor is co-chair of the board of the non-profit consumer advocacy group Stop Foodborne Illness, which is a 25-year-old group supporting and representing foodborne illness victims and their families in efforts to keep other people from getting sick. Before that Taylor served as FDA’s Deputy Commissioner for Foods and Veterinary Medicine from 2010 to mid-2016. His first tour in government began as a staff attorney at FDA, where he worked on seafood safety and nutrition labels. Later Taylor worked for USDA’s Food Safety and Inspection Service, where he became acting under secretary for food safety. Taylor was the government official who, after the deadly 1992-93 Jack in the Box hamburger outbreak, ruled that the pathogen E. coli O157:H7 is an adulterant in meat. Taylor also practiced law in the private sector.
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