This article was co-authored by David Plunkett. Both Klein and Plunkett work on food safety issues at the Center for Science in the Public Interest. As stakeholders begin wading in to the proposed food safety rules released by FDA this month, it is inevitable that some critics will begin cherry picking issues and holding them up as proof positive that the rules—and the entire Food Safety Modernization Act—are doomed to fail.  That’s the position taken by Baylen Linnekin in an Opinion piece recently published on Food Safety News calling the proposals “pathetic” and “outrageous” (The FDA’s Pathetic Food Safety Proposal).  But Linnekin overlooks much of FSMA’s value in his attempt to discredit the rules. One of the key elements—indeed, the central element—of FSMA was the paradigm shift that turned FDA from a reactive agency to a preventive one.  While Linnekin sees that shift as agency overreach, most stakeholders view it as a needed and overdue change in food regulation, which has too often focused narrowly on the problems identified in the most recent outbreak.  Many of those who worked on the law saw the focus on prevention as a fundamental shift in the way the FDA does business, and spent years crafting a law that maximized the benefits of prevention within the boundaries of realistic implementation. Linnekin says that “big business, academia, public health, the media, and government” were a “predictable” group of supporters.  Ironically, Linnekin fails to see exactly how unpredictable such a coalition was.  It is highly unusual for consumer advocates and industry groups, for example, to advocate together for the passage of reform—and yet that’s exactly what happened with FSMA.  Not because, as Linnekin suggests, the law’s impact will be “minimal,” but instead because all the stakeholders recognized just how badly reform was needed. While there are many opinions on the new law and the proposed regulations, Linnekin’s attacks on the new law are too overt to pass over – it misses entirely the public health benefits that could result in three to five years from now. Consumers, and for that matter farmers and food producers of all sizes, need to celebrate passage of the Food Safety Modernization and here’s why. Foodborne illness is a serious national problem that deserves serious solutions.  The Centers for Disease Control estimate that 48 million people suffer a foodborne illnesses each year.  Of those, almost 128,000 require hospitalization and 3,000 die prematurely.  It is estimated these illnesses cost American consumers an aggregate $78 billion each year in healthcare expenses, lost productivity, reduced quality of life and loss of life. Nationwide outbreaks and food recalls serve as regular reminders that Linnekin’s contention that food safety can be taken care of by conscientious farmers and food producers and eagle-eyed food-safety lawyers is just wishful thinking. Because symptoms may develop days and many meals after the exposure, it is difficult for consumers to connect the disease to its specific cause.  That makes it difficult for eagle-eyed lawyers to win cases.  In fact, less than one-third of foodborne disease lawsuits that survive to jury trial result in a finding for the plaintiff. Outbreaks tend to be an exception to the rule, because when many people get sick from a single food product, state public health officials can sometimes find the source.  However, outbreaks have a down side for the industry.  Consumers lose confidence in foods associated with outbreaks, and that has consequences for businesses producing similar foods. The conscientious farmers and food producers Linnekin mentions; they’re on the side of wanting regulation. Why?  The outbreak of E. coli O157:H7 associated with bagged spinach in 2007 was traced to a single farm field, yet loss of consumer confidence cost the raw spinach industry $350 million in lost sales over the first year alone.  The Peanut Corporation of America outbreak in 2008-09 cost all peanut farmers $1 billion in lost sales.  Meanwhile, major peanut brands saw sales decline and spent millions of dollars on advertising to protect their brand even though they were not implicated in the outbreak.  These losses were driving factors in why businesses as well as consumers came together to support the Food Safety Modernization Act. When Congress passed and the President signed FSMA, it was to bring our principal national food safety program into line with 21^st century knowledge about how to manage disease through prevention.  It revised an antiquated law that focused on responding to problems after the fact instead of requiring adoption of modern prevention approaches already widely used by many food companies.  In fact the goal of FSMA is to create a level-playing field, so companies using these approaches aren’t undersold by those who cut corners on safety. No law will eliminate all causes of foodborne illness.  But following Linnekin’s logic would be like deciding it is hopeless to bail out a sinking boat because the ocean is too deep.  In fact, every illness averted saves that consumer from a debilitating illness that invariably leads to days lost from work or caring for family members, and can sometimes lead to hospitalization and occasionally death. What about the costs?  Using better food safety systems in food plants and preventing illnesses is literally spending pennies to save dollars: $500 million of cost for implementing reasonable safety measures could help avert $3 BILLION in cost imposed on consumers.  And these costs include health care costs and lost wages.  But the real driver for consumers, who overwhelmingly supported the passage and implementation of FSMA, is the strong desire to avoid the pain and suffering caused by these illnesses, which are easily averted with better control systems. Linnekin even cited research by the Center for Science in the Public interest in his argument that asserted that inspections declined, as did foodborne illness, as documented in the FoodNet program of the Centers for Disease Control and Prevention.  But the data actually show something quite different:  dropping rates of illness were largely associated with pathogens commonly found in meat and poultry, not FDA-regulated products.  That nuance is extremely important, since the rates began dropping with the implementation of HACCP in those products 10 years ago.  What the data actually shows is that instituting similar reforms at FDA—such as requiring preventive controls for farms and food processors—could send rates of bacteria in those foods falling as well. Linnekin’s evaluation is not wholly without merit.  It is important to analyze tools, like FoodNet, to ensure they can measure the effectiveness of the new FDA food safety program.  Additionally, his complaint that FDA will inspect high-risk facilities maybe twice in the decade illustrates that while much can be achieved with FSMA, that inspection rate hardly seems adequate.  FDA could improve its record on enforcement, though admittedly there are some hopeful signs. Finally, there remains a problem of resources that Congress should resolve.  How much money is needed?  That’s an issue for another debate, but consider this: Last year the government spent more money looking for microbes on Mars than it spent looking for them in our food.  Asking whether we have our priorities right when it comes to funding food safety at FDA would be a good place to start the discussion. During periods of change, particularly after lengthy periods of inaction, some skepticism is to be expected.  It’s not unreasonable for stakeholders to ask FDA how it intends to accomplish some of the goals set forth in FSMA—and in particular to wonder how these precarious fiscal times will treat public health.  But it’s unreasonable to draw premature conclusions as the rulemaking process begins.  FSMA may not be a perfect vehicle for prevention, and FDA may not have all of the tools it needs to do the work of the law, but the intention to protect public health is unquestionably there.  Critics of the process would do well to engage in making the regulations as protective and effective as possible, rather than tearing down efforts to move forward with food safety reform. Pictured: Mangoes imported from Mexico, photo courtesy of FDA.