The Food Safety Modernization Act of 2011 was the largest legislative overhaul and expansion to safeguard the U.S. food supply since the 1930s. For the first time in Food and Drug Administration (FDA) history, the new law mandated enforceable standards to prevent bacteria (including E. coli, salmonella and listeria) from contaminating fruit and vegetables headed to market. Consistent with the pace of prior regulatory oversight, it took years to establish a monitoring framework for essential measures that would make up the Produce Safety Rule, such as worker training, health and hygiene, quality of agricultural water, and sanitation of equipment and buildings. Meanwhile, as the FDA sought to address health risks from “growing, harvesting, packing, or holding” a long list of fresh produce from apples to zucchini, there have continued to be numerous multistate outbreaks of foodborne illnesses.
The most recent food related health crisis was last week’s spate of a virulent strain of food poisoning, Salmonella adelaide, that affected at least 60 people throughout the Midwest who ate watermelon, honeydew or cantaloupe from Walmart, Costco, Whole Foods, Trader Joe’s and other outlets. The widespread digestive distress (diarrhea, fever, and abdominal cramps) triggered a massive recall of pre-cut melons by Caito Foods, an Indianapolis-based subsidiary of one the country’s biggest food distributors, SpartanNash. In five states, between April 30 and May 28, 2018, the Centers for Disease Control reported, consumers as young as 1 and as old as 97 became ill from melon traced back to Caito. At least 31 people have been hospitalized.
Though the grocery industry has seen other strains of salmonella cause outbreaks related to melons previously, the Produce Marketing Association says “this is the first time we have detected Salmonella adelaide and melons.”
Although proposed safety standards for cultivating and packaging produce for human consumption had been drafted by 2013, a nearly year-long public comment period led to a “more flexible and less burdensome” version, and after more months of public comment the produce rule was finally finalized in November 2015. The root of the regulation is aimed primarily at reducing contamination from the water used in farming.
However, a recent but little-noticed report (below) by the Government Accountability Office (GAO), which tracked the slow march from intention to action, shows that the FDA regulation meant to cut back on fruit and vegetable salmonella outbreaks does not yet require companies to comply with the guidelines.
As produce producers adjust to the new standards, they have been given a very generous preparation period to educate themselves on exemptions, definitions and restrictions. Implementation has been postponed twice (the FDA now expects to begin inspection in 2019), slowed by a statutory requirement that the agency provide an ongoing mechanism to “evaluate and respond to business concerns.”
The GAO lists a number of prominent cases of produce-borne poisoning in recent years to make its case for the importance of the regulation: "...beginning in the summer of 2017, a Salmonella outbreak linked to imported papayas sickened more than 200 people in 23 states and killed one, according to the Centers for Disease Control and Prevention; in 2011, 147 people fell ill and 33 died as a result of eating cantaloupes contaminated with Listeria. Other produce-related outbreaks in recent years have involved cucumbers, hot peppers, alfalfa sprouts, bean sprouts, and packaged salads."
"Because produce is often consumed raw, without processing to reduce or eliminate contaminants, preventing contamination is key to ensuring safe consumption," the GAO added.
If the rule were in effect, it may not have prevented the pre-cut melon outbreak, but could certainly reduce the number of Americans poisoned each year—if companies are ever required to comply.