(This article was posted here on Nov. 21, 2015, and is reposted with permission from the author.) In mid-November, I spent two days lecturing to a group of visiting food-safety regulators from China’s Hubei province. I shared a great deal of current and historical food safety facts with them. The data that really stunned these food-safety regulators — to the extent that they asked me three times, through my translator, if the numbers I cited were correct — were on the number of cases of foodborne illness in the United States each year. Every year, about 48 million Americans are sickened by foodborne illness, according to the Centers for Disease Control (CDC) data I cited. This results in 125,000 hospitalizations and 3,000 deaths. It’s not that foodborne illness isn’t a problem in China. After all, a 2007 estimate, considered lowball, suggested that 300 million Chinese are sickened by foodborne illnesses each year. It’s just that the Chinese had traveled here to learn because their country is attempting to emulate our food-safety system. And the numbers I cited shocked them. FDAinspector_406The visit by the Chinese delegation coincided with the Food and Drug Administration’s (FDA) release this past month of the second of two key Food Safety Modernization Act (FSMA) rules that I’ve long argued won’t make our food safer. The data the FDA cites in those rules may shock you. The final produce rule, released in November, estimates that it will help in “averting approximately 331,964 illnesses per year” that are attributable to contaminated fruits and vegetables. The final good manufacturing practice (GMP) rule, released earlier this year, estimates that it covers foods responsible for 903,000 out of the 48 million total U.S. cases of foodborne illness each year. The agency estimates that it need only prevent about 156,500 of those 903,000 illnesses for the GMP rule to be cost-effective. The math on these final rules is basic and clear. Together, according to FDA’s own estimates, the GMP and produce rules can reduce foodborne illnesses by between 488,464 and 1.23 million cases. Those aren’t exactly groundbreaking numbers. In fact, the lower end would result in a combined reduction of 1 percent of total foodborne illness cases, while the higher end would result in a 2.6-percent reduction. As I’ve previously noted, this is no lowball estimate. It’s FDA’s own best-case scenario for the effectiveness of these rules. This is a small sliver of an already tiny slice of the foodborne illness pie. Why so small? The impact of FSMA is so low because — despite the fact that FDA proudly regulates roughly 80 percent of the food in America — the foods it regulates are responsible for a startlingly low percentage of foodborne illnesses. Put another way, FDA regulations can’t touch the most likely sources of foodborne illness. For example, norovirus causes 58 percent of all foodborne illnesses. That makes norovirus the leading cause of foodborne illness in this country. It’s caused in large part by improper food-handling practices. “Sick food handlers specifically caused 53 percent of the foodborne norovirus outbreaks by contaminating food and may have contributed to another 29 percent of the outbreaks,” reports CDC. “Over 80 percent of outbreaks involved food prepared in commercial settings, such as restaurants, delis, or catering businesses.” But FDA doesn’t regulate food preparation or handling in restaurants and hospitals. That job is left to states, counties, and cities. That means FDA has no impact at all on the leading source of foodborne illness. What’s more, FDA also doesn’t regulate meats, such as beef, pork, and poultry, which are responsible for another 22 percent of foodborne illnesses. The U.S. Department of Agriculture’s Food Safety and Inspection Service, rather than FDA, is responsible for ensuring the safety of the nation’s meat supply. So, if FDA regulations don’t speak to the most common cause of foodborne illness in America, and they don’t cover meats, what’s left? After all, norovirus and foods regulated by USDA account for four out of every five cases of foodborne illness in America (58 percent and 22 percent, respectively). That means that FDA regulations could prevent, at best, only one out of every five cases, or up to 9.6 million cases of foodborne illness. But the key FSMA rules show nowhere near even that sort of impact. This is why I’ve blasted FDA for arguing for years now that foodborne illness is a largely preventable problem and that more FDA enforcement authority and a bigger budget are keys to solving the problem of foodborne illness. They’re not. And the agency and its supporters need to own up to this fact.

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