Still a Jungle
In an environment of drug-resistant pathogens and “pink slime,” why do the food industry and government place the onus for safety on consumers?
More troubling still is the fact that although Barbara Kowalcyk has dedicated her life to fixing the system, her tireless work on a package of reforms dubbed “Kevin’s Law” has been stymied by our politics. In 2010, Congress sought to address our food-safety problems by passing the Food Safety Modernization Act (FSMA). The legislation gave the FDA the authority to order mandatory recalls (previously, food recalls were only voluntary), conduct more frequent inspections, and exercise greater powers over imported foods—all good things. But while the FSMA represents a real achievement, it is still inadequate to the challenges we face and, sadly, tragedies like Kevin’s are likely to happen again. This is because the FSMA fails to address some of the most severe risks of our modern food system.
Antibiotic use in animal production vividly illustrates how industry practices threaten human health, and how government action can be painfully slow in response. Animals consume 80 percent of antibiotics in the United States, mostly in low doses that increase the quantity and speed of meat production. A preponderance of scientific evidence has shown that the routine use of antibiotics in otherwise healthy animals results in drug-resistant strains of bacteria that render these lifesaving drugs less effective in treating human disease. The FDA has been slow to act on the issue despite the World Health Organization, the U.S. GAO, the Institute of Medicine, and the National Research Council each recommending stricter rules on antibiotic use, including a ban of certain antimicrobials in animal production. In fact, the FDA itself considered a ban on penicillin and tetracycline in animals as early as 1977, but abandoned its efforts without holding a single hearing due to opposition in Congress.
Until recently, the FDA remained largely on the sidelines despite mounting evidence about the dangers of antibiotic resistance. In 2005, the FDA banned fluoroquinolones, a powerful class of antibiotics that includes the drug Cipro, because of the widespread development of antibiotic-resistant Campylobacter in poultry. In early 2012, the FDA banned most uses of cephalosporin, another class of antibiotics, for similar reasons. More recently, after a lawsuit was filed by several environmental and consumer groups, a federal magistrate judge ordered the FDA to complete its review of penicillin and tetracycline begun 35 years ago. Then, in April 2012, the FDA issued final guidance to industry on what it calls the “judicious use” of antimicrobial drugs in animals.
Although the FDA now recognizes that giving antibiotics to healthy animals simply to increase production poses real threats to human health, these new rules are unlikely to have any real effect on industry practice. This is because rather than ban widespread use of antibiotics in animal production, the FDA instead provided a set of guidelines that will allow industry to continue the practice, including on healthy animals, so long as it is considered a preventive measure and is conducted under the supervision of a veterinarian. In other words, the FDA expects industry to regulate itself. Recent studies leave the wisdom of the FDA strategy very much in doubt. Researchers at Johns Hopkins University recently found traces of several banned substances in feather meal (a byproduct of the chicken industry), including the same class of antibiotics the FDA banned from use back in 2005.
Nor does the FSMA address the gaps in oversight caused by our fragmented food-safety rules. For instance, although the new act gives the FDA the power to issue a mandatory recall, it leaves the power of the USDA, which oversees food-safety activities in slaughterhouses or other meat-production facilities, untouched. Moreover, efforts to give the USDA the same recall authority now enjoyed by the FDA have met with stiff resistance by the food industry. With Republican control of at least one chamber of Congress likely to continue past the 2012 elections, these and other legislative solutions will likely remain out of reach in the near to medium term.
Even the law’s achievements are in question, given the current fiscal and political climate. In June 2011, the Republican-controlled House passed an agricultural appropriations bill that cut $87 million from the FDA food-safety budget and reduced funding for USDA food-safety programs as well. Georgia Representative Jack Kingston, who chairs the House agricultural appropriations subcommittee, justified the cuts by arguing that the U.S. food supply was “99.99 percent safe.” A Senate bill restored the cuts and in November 2011 Congress passed a conference report that increased food-safety spending by almost $50 million—still well short of the $287 million requested by the Obama Administration. Funding problems aside, full implementation of the law will require the FDA to issue more than 50 new rules and guidance documents over the next several years, a daunting task under the best of circumstances. A Republican victory in the 2012 presidential election and a changing of the guard at the FDA would likely slow or stop some of these rules from going into force.
Clearly, government policy has not kept pace with the emergence of more dangerous pathogens or the changing patterns of production and consumption that multiply and magnify our exposure to risk. The reason, not surprisingly, is political. The food industry enjoys tremendous influence over the way government regulates food safety. A revolving door allows former congressional staffers and government officials to move easily between government and industry throughout their careers. A thickened layer of presidential appointees in the executive branch provides a valuable point of re-entry for individuals with industry experience, who then oversee rules and regulations that affect their former employers. Campaign contributions keep the machine well oiled, guaranteeing industry access to Congress and the executive branch. Finally, well-financed legal teams allow the industry to initiate and, more importantly, sustain long and complicated legal challenges to policies that might improve food safety but could add costs or increase industry exposure to liability.
Bureaucrats must share some of the blame as well. Because reducing administrative duplication and overlap would take power and resources away from the many departments and agencies with a finger in the food-safety pie, the bureaucracy has been resistant to reform. In 2005, the GAO issued a report reviewing seven high-income countries (Canada, Denmark, Germany, Ireland, the Netherlands, New Zealand, and the United Kingdom) that had consolidated food-safety authority in a single agency, finding that all seven experienced improved performance, reduced gaps in oversight, and improved accountability and transparency. In their response to the report, the USDA and the Department of Health and Human Services discounted the experiences of other countries, arguing instead that food-safety goals are “better advanced through enhanced interagency coordination rather than through the development of legislation to create a single food agency.”
With so many agencies involved, holding someone accountable when things go wrong is extremely difficult. This partly explains why government and industry place so much emphasis on the role and responsibilities of American consumers in food safety. The government site FoodSafety.gov instructs consumers to “clean, separate, cook, and chill” their food “to help keep your family safe from food poisoning.” Although household hygiene is important, these simple steps cannot protect consumers from the most virulent microbial pathogens. Kevin Kowalcyk died because of an invisible killer that our system failed to stop, not because his mother failed to keep a clean kitchen. Framing the food-safety issue as one of individual behavior rather than as a systemic risk shifts responsibility away from industry and government and places it squarely on the individual.
Fixing food safety in the United States requires action on two levels. On one level, we need a reform agenda that lays out the legislative and administrative changes that can solve the problems we’ve identified. But broad reform will require something bigger than a policy program. To change our food-safety system, we need to change the way we talk and think about the issue. This will require reframing food safety so that Americans insist government and industry play their proper role in managing risk.
Although many advocates and the GAO have called for the creation of a single food-safety agency with cabinet-level status, centralizing authority is not a panacea for food-safety risks. Consider the cautionary tale of the Department of Homeland Security (DHS). Consolidating agencies with multiple missions into a single entity can actually reduce the capacity of the bureaucracy to act effectively. This is one unfortunate lesson of FEMA, which experienced a loss of morale and the departure of many old hands when the mission of the agency shifted from disaster relief to anti-terrorism after being absorbed into DHS. Nothing quite so vast is being considered in the case of food safety, nor is the creation of a new, stand-alone agency in the realm of political possibility right now. Nevertheless, we can still reduce the duplication and overlap of our current system by improving the division of labor among various agencies with food-safety responsibilities.
One way to think about this challenge is by distinguishing between risk assessment and risk management. Currently we have multiple agencies doing both: The FDA and USDA each employ their own staffs of scientists to assess the risks of various pathogens, as well as separate teams of inspectors to monitor slaughterhouses and production facilities for compliance with government standards. A smarter alternative would concentrate risk-assessment and risk-management functions separately in those parts of the government that can do the job best. For instance, the USDA already has more than 7,000 inspectors and compliance officers located throughout the country whose presence on site is required for slaughterhouses and production facilities to operate. By contrast, the FDA employs only 2,500 inspectors and other field staff to monitor domestic and imported food. Even if fully funded, the FSMA would only increase FDA staff size to just over 3,000, with almost half of the growth in staff going to import inspections.
Moving all inspection functions to the Food Safety Inspection Service in USDA could eliminate some of the duplication and gaps that have plagued food safety. Meanwhile, the FDA could focus its energies on risk assessment by becoming the nation’s premier source of scientific research on foodborne pathogens and how to address them. This focus on risk assessment better accords with the historic mission of the FDA in drug regulation, where the emphasis has been on pre-market approval and evaluation rather than post-market monitoring.
Skeptics will argue that any reconfigured food-safety system will cost money that’s difficult to come by in an age of austerity. Yet the combined USDA and FDA food-safety budget is just over $2 billion a year, or less than one-tenth of 1 percent of federal outlays. Given that the human cost of foodborne illness is estimated at $75 billion a year (higher if we include the product losses to industry from recalls), even a modest increase in our commitment to food safety would appear to be a good value. Others will rightly question whether the USDA can effectively protect the nation’s health when an important mission of the department is to promote the commercial interests of agriculture, including the food industry.
This is a legitimate concern. However, a departmental reorganization in 1995 separated marketing and food-safety functions at the USDA and created a new under secretary for food safety with responsibility for FSIS alone. One consequence of this reorganization is that food-safety issues now enjoy a more prominent place within the USDA bureaucracy; by contrast, food-safety concerns in the FDA must compete for resources within an agency primarily concerned with drug regulation in one of the largest departments in the federal government, Health and Human Services.
Politics and Persuasion
However, moving inspection authority to the USDA, the FDA, or some new stand-alone agency will not by itself improve food safety. So long as the political obstacles to reform remain in place, government will suffer from inadequate resources and limited powers to meet the risks of an industrial food system. Real reform requires that food-safety advocates take their case to the public, increase awareness about the risks we face every day, and reframe the issue so that it is government and industry that bear chief responsibility for foodborne illness, not consumers.
The unfortunate fact is that few of us really want to know what we eat. However, the success of books and films like Fast Food Nation and Food, Inc. suggests that when consumers do peek behind the veil of shrink-wrapped meat, they take notice. For example, between 2004 and 2008, the percentage of respondents to a Gallup poll who said they had “a great deal” of confidence in the federal government to ensure the safety of the U.S. food supply declined from 31 percent to 15 percent. Over the same period, those who said they had “not much” confidence or “none at all” in how government handles food safety increased from 14 percent to 29 percent. This suggests an opening for advocates to reframe the food-safety issue in a manner than can mobilize consumers.
In the case of food safety, the dominant frame is that consumers are responsible for the safety of their own food. This view is reinforced in various ways, from the mundane notion that consumers can protect themselves by keeping a clean kitchen to the claims of the food industry, enshrined in legal doctrine, that naturally occurring bacteria like salmonella are beyond the reach of government regulators. Foodborne illness, in this view, is an unfortunate but unavoidable feature of the world we live in.
To challenge this outlook, advocates must highlight the contradictions between the fiction of accidental illness and the reality of a broken system. People do not become ill because they failed to take certain precautions when handling their food. People become ill because they are exposed to risks that they cannot control, risks that are multiplied by the practices of the food industry and magnified by the shortcomings of the regulatory system.
What is needed, in short, is a shift in thinking. Up until the 1960s, car accidents were generally believed to be the result of drivers’ bad behavior. The publication of Unsafe at Any Speed revealed that some fatalities were not only avoidable but that manufacturers actually resisted making safety improvements to their cars.
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