Baylen Linnekin | Food Safety News

FDA’s New Food Safety Rules Won’t Accomplish Much

Baylen Linnekin — Tue, 01 Dec 2015 06:02:50 +0000

(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. The 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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Could a Single Food-Safety Agency be the Answer?

Baylen Linnekin — Mon, 09 Feb 2015 06:02:22 +0000

(This article by Baylen J. Linnekin was published here on Feb. 7, 2015, and is reposted with permission. He is executive director of the Keep Food Legal Foundation and an adjunct professor at George Mason University Law School, where he teaches Food Law & Policy.) This week, with little fanfare, the Obama administration released a proposed 2016 budget that would dramatically remake FDA and USDA. The plan would strip each agency of its extensive food-safety oversight responsibilities and hand them over to a new food-safety agency to be housed within the Department of Health and Human Services. The plan would be a big loss for FDA — an agency within HHS — which saw its food-safety budget and staff increase, thanks to passage of the Food Safety Modernization Act in 2011. It was likely no coincidence that Margaret Hamburg, who has served as FDA commissioner for the past six years, announced this past week that she was leaving the agency. At the cabinet level, the proposal can be seen as a mixed bag. It’s a big win for HHS, where the new agency would reside. But HHS’s gains mean that USDA would likely lose all of its food-safety budget and staff. It’s unclear at this point if the proposal has legs. I expect much will ride on two factors. First, will big players within the regulated industries support the measure? Second, will the Obama administration pitch the idea to the GOP-dominated Congress as a cost-cutting measure, or, alternately, as a take-it-or-leave-it regulatory buildup? The answer to all these questions remains to be seen. “[T]he devil is in the details,” wrote Marion Nestle, who commonly supports increased food-safety regulations, of the Obama administration’s proposal. While I disagree with Nestle about the manifest need for more regulations — which often cost hundreds of millions of dollars, but make our food no safer — I do agree with her call to wait for more details. I said as much during an appearance on HuffPost Live this past week. While we wait, there are several factors to consider that will help to determine whether creating a single food-safety agency would benefit the ones who matter: consumers and taxpayers. One key issue is the problems caused by current regulatory overlap. No case better illustrates this overlap — and the serious food-safety issues it raises — than the 2010 recall of more than 300 million eggs. While FDA regulates eggs in the shell — the kind you purchase by the dozen — USDA is in charge of grading the eggs. As I wrote in recounting the egg recall in a 2012 law-review article, this overlap meant that USDA’s egg graders, who were on site at the offending egg-laying facility and saw its filthy conditions firsthand, ignored their key food-safety responsibilities because they saw the safety of the eggs as FDA’s problem. (FDA might inspect such facilities once every few years.) “Yet the presence of these egg graders at the laying facility did nothing to ensure the eggs were safe — in spite of the graders’ duty,” I wrote in the article. “The egg graders’ presence and oversight merely offered a false veneer of safety — a facade that made food less safe.” A related problem is the differing standards imposed by USDA and FDA regulations on similar products. The egg case illustrates but one example. Frozen cheese pizzas sold at your local grocer are regulated by FDA, for example, while the same manufacturer’s frozen pepperoni pizzas are regulated by USDA. USDA requires all food labels to be pre-approved by the agency before the food may be marketed and sold. On the other hand, FDA has no such requirement. That means if you were to put one piece of pepperoni on a FDA-regulated frozen cheese pizza, it would be subject both to label pre-approval requirements and USDA regulations. Another key issue is the same that arose during FDA’s FSMA rulemaking process. Simply put, FDA crafted inane and costly rules for regulating agricultural producers that demonstrated — charitably — how little agricultural expertise the agency possesses. There’s no reason to believe that FDA’s parent department, HHS, possesses such expertise either. Who would lead this new food-safety agency within HHS? Noted food-safety litigator Bill Marler nominated himself for the job. Agricultural and restaurant interests might chafe at the idea of Marler, who has won civil suits against them for food-safety violations. Other food producers, such as grocery food makers, would no doubt balk at other potential choices for the job. What would the removal of food-safety oversight from FDA mean for the agency’s ban on the interstate shipment of raw milk? Recall that the ban came into being in the late 1980s, thanks to a court decision that is based solely on FDA data. Could a new challenge to the ban argue that since FDA no longer plays a role in food safety, there is no longer a legal basis for the ban? Calls for some unitary food authority are nothing new. Nestle notes food-safety advocates have urged the federal government to consolidate its food-safety authority for decades. Other big ideas for big new government action have also appeared from time to time. In 2008, New York Times columnist Nick Kristof urged the Obama administration to scrap USDA and FDA altogether in favor of a “Department of Food.” More recently, fellow Times food columnists Mark Bittman and Michael Pollan called for the creation of a national food policy. (Interestingly, neither piece focuses on food safety.) If a new federal food-safety agency would help eliminate redundancies in staffing and inefficiencies in budgeting while establishing simpler, uniform requirements, then the new agency might earn — and even deserve — widespread support. But if such an agency would not save consumers and taxpayers money, wouldn’t make our food safer, would put those with little expertise in charge of key regulations, and would double down on existing FDA and HHS campaigns targeting everything from caffeine to soda to trans fats and salt, then this proposal is rightly dead in the water.

Is Foodborne Illness on the Rise?

Baylen Linnekin — Mon, 19 Jan 2015 06:02:43 +0000

(This article by Baylen J. Linnekin was published here on Jan. 17, 2015, and is reposted with permission. He is executive director of the Keep Food Legal Foundation and an adjunct professor at George Mason University Law School, where he teaches Food Law & Policy.) The past few weeks have seen what may be an unprecedented number of headlines around the world pertaining to foodborne illness. A number of these illnesses have proven fatal. In Mozambique, beer allegedly tainted with crocodile bile killed dozens at a wedding. It’s unclear at this point how the bile did — or even could — make its way into the beer. (It’s also not clear that crocodile bile is poisonous.) In India, more than two-dozen people are dead and at least 100 people are ill, some severely, after consuming homemade liquor containing deadly methyl alcohol during a cricket match. Elsewhere in India, four members of a family died after dining at a restaurant to celebrate a holiday. In California, a batch of drug-laced sweet bread from a Santa Ana bakery has sickened more than 40 people. And listeria-tainted apples, which authorities say are linked to a California producer, have killed three. Despite this news and the prevalence of Buzzfeed-worthy foodborne illness headlines, the domestic food supply is still remarkably safe — and among the safest in the world. CDC data indicate that foodborne illness is not on the rise in the United States. Agency data from 2013 show only one statistically significant increase in illnesses caused by various pathogens (vibrio), while showing statistically significant decreases in illnesses caused by two key pathogens — listeria and salmonella. But is the overall safety of our food supply enough to warn off regulations? What, if anything, is the government’s proper role in preventing foodborne illness and punishing food adulteration? I think the federal government should have the authority to order adulterated products off the market and to punish (with fines, arrest, or both) those who sell food that sickens others. While I’m often a critic of FDA regulations — particularly those pertaining to food safety — it turns out that my own beliefs here mirror FDA rules currently in place. It may surprise you to learn that FDA only recently was given the power to order food recalls. Scholars and advocates pushed for years for Congress to grant FDA the power to order recalls of food that is adulterated and harmful — something that finally came to fruition in the otherwise awful Food Safety Modernization Act (FSMA). Again, I’m a big supporter of FDA having such power. “Giving the FDA mandatory recall authority, as the [FSMA] did, is an important tool for forcing foods that have been found to be a definitive hazard off the market,” I wrote last year. FDA’s power to punish those who adulterate food and cause harm has been in place far longer. That’s a good thing — particularly if the culprit does so intentionally. FDA clearly deserves some of the credit for the safety of our food supply. But, as I noted in recent FSMA comments I submitted to FDA on behalf of Keep Food Legal Foundation (the nonprofit I lead), that’s but a small piece of the puzzle. “The FDA can’t wash the hands of every eater and cook in the country,” I wrote. And it can’t prevent bad actors from intentionally poisoning food — as may have recently happened in India, Mozambique, and California. That’s why the private sector’s role is so important. The safety of our food supply is a testament to the men and women who make our food — and to the companies that employ them. It’s also thanks to the lawyers who sue those people and companies when they do harm. Thanks to splashy headlines and a handful of truly appalling recent cases, foodborne illness may appear to be on the rise. Thankfully, that’s not the case. What’s more, data and the combined efforts of the public and private sectors make it clear that the tools are in place to push back against foodborne illness.

The FDA's Pathetic Food Safety Proposal

Baylen Linnekin — Mon, 21 Jan 2013 08:18:38 +0000

This article was originally published in Reason on January 19. Earlier this month the FDA released drafts of two highly anticipated food-safety rules. The agency has billed the proposed regulations as key tools for implementing the Food Safety Modernization Act (FSMA), the biggest FDA food-safety update in more than seven decades, which President Obama signed into law in January 2011. The new rules would cost about half a billion dollars per year. The cost of FSMA will be borne by farmers and food producers of all sizes. The FDA estimates the FSMA will cost America’s small farms about $13,000 each per year. Larger farms — much more capable of bearing the costs — will be out about $30,000 per year. Other food producers are likely to face varying fees. But will the proposed rules make America’s food supply — already quite safe and getting safer thanks to conscientious farmers, producers, and sellers of all sizes, vigilant watchdog groups, and eagle-eyed food-safety lawyers — any safer? Before its passage, the FSMA had its predictable supporters in big business, academia, public health, the media, and government. Another camp — one in which I was a charter member — argued against adopting the rules because they were likely to be costly and ineffective. For examaple, in a Northeastern University Law Journal article published last year, “The Food Safety Fallacy,” I argued that the FSMA would increase the FDA’s power and budget but questioned whether the new law would have any impact on food safety. Now that I’ve seen the key rules the agency has proposed to implement the FSMA, the facts appear to support my contention. How can I be so confident? In pushing for passage of the law, the FDA and its supporters billed the law as a necessary solution to a problem of great magnitude. Indeed, some 48 million Americans suffer from some form of foodborne illness each year — a figure the FDA cites at several of its FSMA web pages. The agency claims the FSMA will “better protect public health by strengthening the food safety system” and helping to eliminate the “largely preventable” problem of foodborne illnesses. But if we can largely prevent foodborne illness, we won’t have the new FSMA regulations to thank. In truth, the law’s real impact on food safety will be minimal. The FSMA would permit the FDA to hire about 2,000 new food-safety inspectors in order to increase the frequency of food-safety inspections. Specifically, the proposed rules would require that “[a]ll high-risk domestic facilities must be inspected within five years of enactment and no less than every three years, thereafter.” Given that the FSMA rules are just now open to public comment and won’t be final for another year or two, this translates into a likely total of exactly two inspections of what the FDA refers to as the most “high-risk domestic facilities” over the next decade. How’s that for impact? Even if these inspections were to take place more than once in a blue moon, just how effective at preventing foodborne illness are FDA inspections? Not very. The Center for Science in the Public Interest, for example, notes that FDA food safety inspections dropped by 47 percent between 2003 and 2006. During that same period, according to CDC data, rates of infection from bacteria like listeria were flat, and below traditional averages. This reflects what the CDC has reported — that despite the misconception that cases of foodborne illnesses are mushrooming, there has been a general “downward trend in foodborne infections.” That’s no thanks to the FDA. “Even when it does uncover health violations at food-processing plants,” wrote Barry Estabrook in Mother Jones in November, “the FDA takes enforcement action in only about half of the cases and almost never imposes fines.” In other words, foodborne illness cases have been decreasing without the FSMA, fewer FDA inspections over a period of several years did not translate into any detectable difference in cases of foodborne illness, and even FDA inspections that uncover violations rarely translate into perceptible agency action. But if the impact of the proposed FSMA rules seems scant in light of these facts, consider the utterly feeble effect these rules would have on the 48 million cases of foodborne illness under the FDA’s own best-case scenario: A four-percent reduction in cases of foodborne illness. “The new rules could prevent nearly two million illnesses annually, according to the FDA,” wrote the Philadelphia Inquirer in an editorial supporting adoption of the proposed rules. Indeed, the data estimates come straight from the FDA. In other words, the proposed rules — if implemented to absolute perfection — would only reduce incidences of foodborne illness from 48,000,000 a year to 46,000,000 a year. Remember, this is the same agency that claims its FSMA is a key tool to help eliminate the “largely preventable” problem of foodborne illnesses. Outrageous. Critics of my argument might contend that these are just the first of several regulations the FDA will propose in order to implement the FSMA. That’s true. But while there are still three “FSMA Provisions in the Works,” they appear to be even less impactful than the expensive and pathetic rules proposed this month. Two rules “in the works” apply solely to imported foods — which are responsible for just a tiny percentage of foodborne illness cases. Another would “enhance” the “capacities” of foreign and domestic food-safety agencies at the federal, state, and local levels — which is agency-speak for things like training and technical assistance, white papers, guidance documents, conferences, and the like. So anyone waiting for future FSMA rules to provide more bang for their buck is likely to be even more disappointed with the next set of proposed rules. “I’m really not confident — doing the math, based on the FDA’s figures,” I said in a television appearance to discuss the rules last week, “that there’s going to be the sort of impact that the FDA’s promising.” That was last week. The more I learn about and reflect on the proposed regulations — which number more than 1,000 pages in length — the more I want Congress and the FDA to stop trying to do as much as possible in the area of food safety. Rather, I want the agency — which can by its own most optimistic estimates achieve very little, and at great cost — to focus on doing (and wasting) as little as necessary.