The FDA's New Food Safety Rules Won't Accomplish Much

More regulation for very little return.


Credit: Jellaluna / photo on flickr

Earlier this week 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—was data 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 a lowball, suggested 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.

The visit by the Chinese delegation coincided with the Food and Drug Administration's (FDA) release this 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 this month, 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 that are 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 the 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 one percent of total foodborne illness cases, while the higher end would result in a 2.6 percent reduction. As I've noted previously, this is no lowball estimate. It's the 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 the 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, the 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 the CDC. "Over 80 percent of outbreaks involved food prepared in commercial settings, such as restaurants, delis, or catering businesses."

But the FDA doesn't regulate food preparation or handling in restaurants and hospitals. That job is left to states, counties, and cities. That means the FDA has no impact at all on the leading source of foodborne illness.

What's more, the FDA also doesn't regulate meats like 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 the FDA, is responsible for ensuring the safety of the nation's meat supply.

So if the 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 the 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 the 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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  1. “But the FDA doesn’t regulate food preparation or handling in restaurants and hospitals. That job is left to states, counties, and cities. That means the FDA has no impact at all on the leading source of foodborne illness.”

    Unfortunately, the FDA provides significant guidance to states and localities and the impact is significant. Many institutional foodservice programs are now required to implement HACCP. Training requirements, complex food handling requirements, and NSF-certification of equipment regulations are practiced in many states – the result is exceedingly high start-up costs for new restaurants and obviously significant on-going opertational costs/burden.

    The National Restaurant Association champions these efforts and benefits financially via operation of the ServSafe program; ditto NSF.

  2. I thought that most cases were caused at home do to improper handling and cooking? I know that the ,mostly ,elimination of home canning ,refidgeration and ways to preserve food by food companies reduced food illness by large amouts in the 20 century.

  3. 125,000 hospitalizations and 3,000 deaths annually from food-borne illness, but 48 million infections?

    I’d say that we are already doing damn good with our food supply, even if 47.5 million people get the hershey squirts.

    1. I’m sure that # is projected from some assumptions. It’s like, how often do you get diarrhea (which maybe they measure by sales of loperamide or something), & then assume a certain percentage of that is caused by bio agents.

  4. So, once again spending more on Big Brother’s oversight does little but increase our taxes. What a surprise. Wash your hands, wash your food, enjoy life. Don’t support more ineffective “governing”. Sounds like a good plan to me.

  5. In 1905 it was China that urged the US to enact truth-in-labeling so that customs agents there could distinguish pharmaceutical preparations from morphine Mickey Finns concocted to knock out crying babies. China’s boycott packed enough clout to help Teddy Roosevelt push the Pure Food and Drug Law of 1906 through the Senate. Soon, Mrs Winslow’s Soothing Syrup in the Sears Catalog was finally labeled “poison,” as in the English packaging. This two-page antifraud enactment became effective in 1907 and–with considerable help from Southern prohibitionism–caused a short depression the approach of which sparked the Panic of 1907. Overall, it was a beneficial measure to curtail counterfeiting, fraud and poisoning. Local authorities back then did the rest. State governments today are too busy militarizing police and robbing citizens under the cloak of federal asset-forfeiture provisions to waste time on consumer protection. Americans were reminded, in 2007, what happens when a society establishes criminals-by-right and looters by-law?men who use force to seize the wealth of disarmed victims. The Chinese learned that in 1949.

  6. Well you have to have some sort of excuse to rob the taxpayer. It doesn’t really have to be a good excuse, after all, this is a nation where we think preventing even the slightest possible injury is worth any amount of your money and liberty.

    1. Regulators have to justify their existence. They do this by crafting ever-more regulations. Effectiveness is kinda beside-the-point.

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