If there is a law of public policy effectiveness, it is that structure and function are co-dependent variables. What this means in plain English is that large organizations can do well only what they were designed to do in the first place. If the environment changes but the structure of an organization does not, then the organization will inevitably fail to produce the outcomes for which it exists. Eventually, the people who depend on, are affected by, and pay for those outcomes will notice the problem and press the appropriate authorities to fix it.Most often, those authorities will seek to address concerns first through administrative actions—changes in regulations, responsibilities within the organization and budget levels. They will steer away from changes in the substance of underlying law, and, most important, they will avoid altering the structure of the organization itself. Those changes are far more challenging, both conceptually and politically, and they invite outside forces to the table. Palliative fixes usually don’t work for long, however, and the problems recur. This general narrative of bureaucratic inertia distills perfectly into the story of America’s food safety system today. The environment has changed radically, but the substance of the law and structure of the system have not. Tinkerers have tweaked policies and budgets but left alone the real problems, which have grown larger with every new outbreak of E. coli or Salmonella. Congress is now close to completing a major reform of the food safety provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA). The House passed a bill in July 2009, and the Senate is due, as of this writing, to act within the next few weeks. The bill under consideration is important but limited in its ambitions. It does nothing to improve the safety of meat and poultry products, which are inherently high-risk foods, and it does nothing to rationalize the chaotic food safety organizational structure. As a result, the money we allocate for food safety will not be used as effectively as it could be, communication and coordination will remain scattered, special interest lobbies will be able to focus their efforts more effectively, and the feudal organization of both the Executive and Legislative pieces of the system will continue to reinforce each other. Predicting the result of this is simple: More people will get sick and die from diseases that are almost entirely preventable. Figuring out how to fix the problem requires some understanding of the Byzantine muddle of law and structure that we call a food safety system. What follows is a primer on the problem. What Has Changed
We presume that a scientifically and technologically advanced society will figure out how to reduce the number of times that food intended to nourish body and soul ends up causing illness and death instead. Somehow, this presumption fails when it comes to the food industry and the U.S. government. The U.S. Centers for Disease Control and Prevention (CDC) estimates that each year there are multiple millions of cases of food-borne illnesses in the United States, hundreds of thousands of hospitalizations and about 5,000 deaths.1 On average, an American dies from a food-borne illness every two hours. Last spring the CDC reported that its FoodNet program, which tracks illnesses on an annual basis, showed no progress in four years in reducing the number of illnesses caused by major pathogens. A recent Ohio State University study projected the annual total economic cost of food-borne illness caused by all pathogens at $150 billion.2Food-borne illness continues to plague us because there have been major changes in the environment in which food safety programs operate, but few changes in the programs themselves. The first environmental change concerns the way most of our food is grown, processed and consumed. Fifty years ago that all happened within a relatively small area and short period of time. If someone made an error, it affected a relatively small number of people. Today most of the food Americans eat is grown by larger and fewer domestic farms or imported from other countries, processed by a handful of large companies that distribute it across the nation through thousands of retail outlets. Thus the kinds of food safety failures that were once merely local or regional now have the capacity to become national or international events. Take hamburgers: Ground-beef consumption has increased dramatically over the past several decades as the result of both greater affluence and the growth of “fast food.” Ground beef is versatile. Supermarket butchers used to create “hamburger meat” by grinding together pieces of meat and fat left over when they prepared a steak or roast. Today, companies specialize in making frozen ground beef patties both for supermarkets and fast-food chains. They combine the thick layer of external fat cut from carcasses of cattle that were “grain-finished” on feedlots with meat from old dairy cows or frozen blocks of extra lean beef imported from New Zealand and Australia, where cattle are raised and slaughtered specifically for this market. Each patty may contain meat from a hundred different animals. Meat from just one seriously contaminated steer can infect thousands of mass-produced hamburger patties and make dozens of people sick. And hamburgers are just one example of this problem. A single contaminated ingredient in a multi-ingredient food like salsa or dry cereal can produce the same results. Second, eating habits have changed. An increasing amount of food is now turned into partially prepared or ready-to-eat products that save time for busy families and the large and growing population of people living alone. Each additional processing step provides another point where food can be contaminated. At the same time, a growing movement encourages people to “eat locally” and support area farmers. Food grown and consumed locally may taste better, it may be more energy efficient and it may help to build a sense of community, but so far, at least, there are no data to support the contention that it is less likely than mass-produced food to be contaminated with pathogens. However, smaller lots and limited distribution do constrain the number of people put at risk. Americans are also eating more fresh, uncooked fruits and vegetables. Between 1991 and 2006, fresh fruit consumption rose 12.9 percent and fresh vegetable consumption, excluding potatoes, rose 29.5 percent. While this trend improves nutrition, it also increases food-safety risks because, by definition, raw produce has not been subjected to enough heat to kill pathogens. Bacterial, viral and parasitic enteric pathogens from human or animal intestines may contaminate the products either in the field or at any step between harvest and consumption. National and international distribution increases the problem. A major portion of the leafy greens consumed in the United States, from large farms in California and Arizona, are trimmed-bagged and shipped across the country. Contaminated fresh-bagged lettuce and spinach, fresh sprouts, berries and unpasteurized juices have all been vectors for large outbreaks of food-borne illness. In 2006, an outbreak traced to fresh-bagged spinach contaminated with E. coli O157:H7 from California caused nearly 200 people in 26 states to become ill. Three of them died. Cryptosporidium, a parasite, and Salmonella bacteria on vegetables, fruits and berries, especially from Mexico and Latin America but also from California, have caused outbreaks of illness in the United States. The third way our eating habits have changed is that we now consume much more imported food. We get off-season produce from Mexico and Latin America and seafood from China and several Southeast Asian countries. Shrimp and fish from these countries are often raised, fed and transported in ways that result in their containing high levels of filth, heavy metal (mercury), and other dangerous substances. But the retail price is cheap and the market is growing. The numbers tell the food-import story. From 1997 to 2007, U.S. imports of agricultural and seafood products from all countries increased 35 percent. By 2005, nearly 15 percent of the overall volume of food consumed in the United States was imported. Today, that number is between 18 and 23 percent, including 84 percent of all the fish and shellfish, 43 percent of all non-citrus fresh fruits and 54 percent of all tree nuts. As of January 2009, 367,600 facilities in 180 foreign countries had registered with the Food and Drug Administration (FDA) to export food to the United States. There are more than 150,000 foreign processing companies actually shipping to the United States. These imports are responsible for approximately half of the foods associated with food-borne illness. The FDA has had essentially an open door policy for imported food. Any foreign company can ship food to the United States if it registers with the FDA and notifies the agency when it is shipping products. The FDA inspects only 1 percent of imported food at dock. Even with such a porous safety net, the FDA catches a fair bit of bad stuff on its way into the country. A Congressional Research Service compilation of data on food shipments refused entry by the FDA during the 2007 and 2008 fiscal years found that vegetables, seafood and products containing them topped the lists of imports denied entry. Fruit and vegetable products from the Dominican Republic, Mexico and elsewhere in Latin American and the Caribbean were frequently refused entry because of high pesticide residues and bacterial contamination. In June 2007, the FDA detained imports of farm-raised seafood from China because of the possibility they were contaminated with unapproved drug residues. In late 2008, it blocked dairy products from China until importers could prove they were not contaminated with melamine, a toxic chemical intentionally added to milk to increase measured protein levels. The same chemical was implicated in the recall of large amounts of pet food and in infant formula in China, a series of scandals that, uncharacteristically for that country, made big headlines. What Hasn’t Changed
Despite these epochal changes in the way we eat, the nation’s food safety system has changed very little. The major U.S. food safety laws—the FFDCA, the Federal Meat Inspection Act, the Poultry Products Inspection Act and the Egg Products Inspection Act—all have their roots in the Pure Food and Drug Act and the Meat Inspection Act, both signed into law by President Theodore Roosevelt on June 30, 1906. The last major revision of the food portions of the FFDCA was passed seventy years ago. Some elements of the current Federal Meat Inspection Act and the Poultry Products Inspection Act date back to the turn of the 20th century and were last rewritten more than forty years ago.Our legislative stasis has left us today with a deeply fractured inspection system. The Government Accountability Office has identified a dozen different agencies that play a role in administering some 35 separate laws affecting food safety, but the primary responsibility for preventing food-borne disease rests with the two agencies. The FDA, which is part of the Department of Health and Human Services (HHS), is responsible for most food (about 80 percent) and all drugs and related devices; the Food Safety and Inspection Service (FSIS) within the U.S. Department of Agriculture (USDA) is responsible for inspecting meat, poultry and, more recently, farmed catfish.3 The other major part of the system is the CDC, also part of HHS, which monitors, identifies and investigates food-borne disease problems and works with Federal, state and local agencies and other institutions to develop and evaluate methods of controlling food-borne disease. The CDC’s FoodNet active surveillance system is the core of the analysis of the incidence and causes of food-borne disease. FoodNet documents the cases of illness caused by nine major food-borne pathogens, including the seven most common: Salmonella, E. coli O157:H7, Campylobacter, Listeria, Vibrio vulnificus, Norwalk virus and Shigella. The CDC also counts “outbreaks”—instances when a laboratory sample verifies that two or more people got sick from eating the same food from the same source. But most food related diseases don’t occur in outbreaks; they’re “sporadic”—isolated cases in which one lonely soul experiences abdominal cramps, vomiting, diarrhea and other symptoms of gastro-intestinal infection. The CDC is also responsible for what may be the most important change in food-safety regulation in recent history, developing and deploying the capacity to use the DNA of various pathogen subtypes to connect illnesses caused by the same food but separated by many miles. It is a major contribution to food safety. Suddenly, mild-mannered CDC scientists have been transformed into Muhammad Ali, taunting food-borne pathogens that they can run, but they can’t hide. DNA fingerprinting is a major epidemiological asset. It is possible that the number of people who got sick in the past was substantially higher, or lower, than the current rates, but there was no way to connect the illnesses. Now there is. DNA fingerprinting has also unquestionably had an enormous influence on the public’s perception of food-borne illness because high-profile recalls have been increased as a result. Beyond the FDA, the FSIS and the CDC, state and local governments also have major responsibilities for food safety, but variations in local laws and resources affect the consistency of their efforts. A chart of the U.S. food safety system is so extravagantly convoluted it would put Rube Goldberg to shame. Consistent with the nature of organizations, the food safety agencies have tried to adjust to changing conditions by altering inspection protocols and other policies within the limits of existing law. Changes made by regulatory action alone are highly susceptible to court challenges. Neither key food safety agency had sought a basic revision of its charter to enable it to address current problems until the Obama Administration endorsed the current FDA modernization effort. Better late than never, for the bureaucratic subcultures within both the FDA and the USDA have developed several age-related illnesses. Let’s first look at problems within the FDA. The FDA is the nation’s primary food-safety agency, responsible for ensuring that domestic and imported food products (except the aforementioned meat, poultry, farm-raised catfish and processed egg products) are safe, nutritious, wholesome and accurately labeled. It oversees some 44,000 U.S. food manufacturers, plus more than 100,000 other registered domestic food facilities and warehouses, plus the previously noted 150,000 foreign food processors. With few exceptions, the FDA only conducts actual inspections of domestic food facilities about once a decade. There are historical and political reasons for the mismatch between the FDA’s mandate and what it actually does. The word “food” comes first in the FDA’s title, but it has in recent history taken a back seat to the agency’s responsibility to regulate the rapidly expanding drug and medical device industries. Most FDA Commissioners have had a background in drug-related issues and have had little familiarity with or interest in food safety. Doctors Margaret Hamburg and Joshua Sharfstein, the FDA’s current Commissioner and Principal Deputy Commissioner, respectively, both pediatricians with experience running big city health departments, have reputations as hard-charging agents of change, but in their first year at the FDA they have closely followed the counsel of career FDA staff. Within this drug-centric, bureaucratic subculture prestige has generally attached to positions dealing with drugs, devices and biologics. On the food side of the FDA, approving new food additives, determining appropriate use of antibiotics or hormones in food animals, and even nutrition labeling have been more valued positions. In addition to being intellectually stimulating, such work was more likely to lead to opportunities for rewarding work outside of government if the scientist wanted to leave. Until the scope of the problem was publicized by large outbreaks, food-borne illness was regarded by the agency, the regulated industry and, frankly, the public as just a bellyache. Congress exacerbated the tilt toward funding drug and device activities at the expense of food by amending the Food and Drug Act to require the FDA to collect user fees for the approval of new drugs and devices. However, the user-fee provisions kick in only if the agency maintains a stipulated level of budget resources allocated to these functions. With agency appropriations held relatively flat for most of the past twenty years, user fees were responsible for most new funds. Food safety, on the other hand, commanded no user fees. Thus, when budgets flattened during the Clinton and Bush Administrations it’s no surprise that FDA money was allocated to support drug and device activities that leveraged user fees, keeping the overall level of revenues available higher than it would otherwise have been. In addition, while drug and device makers needed FDA staff and funding to approve new products, food processors weren’t eager to lobby Congress for more money to increase oversight of their food safety protocols. This also contributed to less attention paid to food safety issues, and helps explain why food-safety activities at the FDA have been scattered, with no high-level leadership focused on them. Inspections are managed by the office of Regulatory Affairs and the same staff conducts inspections for all regulated products. Congress requires that companies manufacturing Class II drugs and devices be inspected every two years, but there is presently no required frequency for food safety inspections. As funds were squeezed, food inspections declined. The Food Safety and Inspection Service (FSIS) within the USDA is the Rodney Dangerfield of the health and safety regulatory world. It gets no respect in part because it is located in the Department of Agriculture rather than a health agency, and because much of its staff is assigned to the not especially glamorous task of monitoring meat and poultry production lines. Although the FSIS continues to administer an archaic law, there have been major efforts to use adjusted regulations to modernize its activities. The old laws have some of the attributes that most experts view as essential to a modern food safety system. Meat and poultry inspection is a preventive program; inspectors have to visit every plant at least once a day to assure products meet safety standards. Since 2000, all meat and poultry plants have been required to have process controls; the FDA has applied such controls only to seafood and fresh juices. The FSIS has also instituted performance standards to assure a company’s controls work as intended, though the standards are not based on public health data and enforcement power is lacking. The FDA has not established a wide spectrum of performance standards. The FSIS also protects consumers from unsafe imported meat and poultry: Before a company can send its products to the United States, FSIS personnel must find that the exporting country’s food safety program is equivalent to the U.S. program. There is extensive port inspection. The FDA has no comparable authority, has not sought it, and rejected it when it was proposed on its behalf. The FSIS program is adequately funded and staffed because plants cannot slaughter animals or ship processed food until a USDA inspector has approved it. The fiscal year 2011 budget is more than $1.16 billion, most of it from appropriated funds, some of it from user fees. The FSIS has a staff of 9,700. Most are on-site meat and poultry inspectors. However, it also employs more than a thousand veterinarians and more than 300 enforcement officers professionally trained in Hazard Analysis and Critical Control Point plans (HACCP) programs. The Government Accountability Office (GAO) and others argue that the FSIS gets too much money considering it regulates only 20 percent of the food supply. This is a surprising position considering that the GAO has generally supported allocating resources according to risk, not quantities inspected, and most of the meat and poultry products the FSIS regulates are inherently high risk, while many FDA-regulated foods are far less susceptible to contamination. The USDA also commands high-level policy leadership. The Under Secretary for Food Safety at the USDA is the highest-ranking food safety official in government, outranking the FDA Commissioner. The office was established by Congress to isolate food safety from the USDA’s agriculture-promotion activities. Congress acted after Vice President Gore’s “Re-inventing Government” project proposed moving meat and poultry inspection to the FDA. Congress rejected the proposal and Gore never pursued it. But all is not well with the FSIS. Like the FDA, it still lacks and very much needs the authority to enforce preventive controls and performance standards, to allocate resources according to risk, and to provide for mandatory recall and fees for companies that require extra inspection. But the regulated industry opposes such legislation, and passing it would require proponents to sell it to the agriculture committees, venues that are far less friendly to food-safety reform than the health committees where FDA reform legislation has been considered. The result is that the FSIS’s history provides a particularly clear example of a regulator using “work-arounds” of an archaic law to do its job, since it fears that opening its charter up to Congress might result in a situation worse than the status quo. As for the larger question of structure, whereas a single food-safety agency would provide a superior, more logical approach to food safety, separating the FSIS from other USDA functions has at least addressed the most immediate inherent conflict-of-interest problems that come with having the program in the USDA. Things could be, and have been, worse. The Political Landscape
Now things may even get better. Three years ago the FDA’s fortunes stopped dropping. Democrats took back control of Congress and have been more sympathetic to funding regulatory agencies in general. A series of large, national food-borne illness outbreaks, most traced back to FDA-regulated foods, shook public confidence in the ability of government to protect safety of the food supply. The FDA’s major stakeholders and leaders decided change was essential to protect their own interests as well as those of the public.The outbreaks showed how lax the FDA was on food safety. Although under consideration for a decade, there was no final safety guidance for produce growers when the 2006 spinach outbreak occurred. The FDA had never inspected the Peanut Corporation of America, the firm responsible for the biggest food recall in history. In 2007, the GAO listed the nation’s food safety system as “at risk of failure.” Shortly after the 2008 election, it included food safety as one of the priority areas that needed presidential and congressional action in their first year in office. As a result of all this, there have been steady increases in overall FDA budgets, especially for food safety, during the past three years. In fiscal year 2008 Congress increased the total funding for FDA food activities by $127 million. In fiscal year 2009 Congress added an additional $141.5 million. Both increases were directed at providing more inspections. President Obama responded with more than just money. In March 2009, he devoted a Saturday address to food safety, announcing the appointment of new FDA leaders, promising new FDA food-safety funding and endorsing a very limited change in the administrative structure at the FDA. In addition he created a White House Food Safety Working Group, chaired by the Secretaries of Agriculture and HHS, to coordinate the various Federal food safety activities. He later endorsed the House version of the FDA food-safety modernization act. On food-safety organizational structure, however, the President punted, opting for the least change possible—just a small re-organization of the food safety programs within the FDA. He rejected proposals to create a single food safety agency—hence the aforementioned White House Food Safety Working Group. The President also rejected proposals to create a separate Food Safety Administration within HHS, leaving the drug device and tobacco functions to carry the FDA monogram as the Federal Drug Administration. A Food Safety Administration would have given food functions truly equal standing with drugs and devices. Not doing it creates the risk that, with the FDA launching the new tobacco control program, food will once again be shortchanged. Nevertheless, the Obama plan does bring together FDA food-safety programs under the leadership of a new deputy commissioner, Michael R. Taylor. Taylor is a leading proponent of stronger food safety programs and restructuring. Just as important, the pending law should do some good. If it passes without substantial weakening, the FDA reform legislation will provide the opportunity for major improvements in food safety. The new law will give the FDA, for the first time in its history, a specific mandate to prevent food-borne illness instead of just cleaning up after the fact. It may provide a funding mechanism for it, as well. The House bill requires each facility to pay an annual registration fee of $500. The fee will be suspended if appropriated funds don’t remain above a set level. Both bills, House and Senate, require food processors to establish process controls, to set performance standards, to impose fees on errant or inept plants that absorb unusual agency resources, and to require the recall of contaminated food. Both provide the FDA major new powers to assure the safety of imported foods. There are weaknesses in the legislation, however. While inspection frequencies are increased, only high-risk plants will be visited annually. The FDA leadership is also pushing for escape hatches that let them reduce inspections if they do not get all of the funding they request. Worse, the legislation is limited to the FDA; it does not address at all weaknesses in the FSIS program. Neither does the bill address the structural contradiction embodied by the U.S. Trade Representative’s office (USTR). The Trade Representative is charged with keeping our doors open to goods from other countries so that theirs will be open to our products. This includes countries whose safety standards are neither stringent nor enforced. With all due respect to the virtues of free trade, it should not come at the expense of exposing Americans to shrimp and catfish fed human waste or contaminated with mercury. We want to sell agricultural products to the Chinese but not at the expense of finding that our food comes with a helping of melamine. A posting on the U.S. Trade Representative website announces that that office participates actively in the White House Food Safety Working Group to ensure that trade obligations are met. The site makes no comment about protecting public health, and the problem posed by the USTR in this regard is not theoretical. USTR staff have persuaded the Office of Management and Budget to hold up the implementation of a new law requiring the FSIS to assure the safety of farm-raised catfish because the rule would require the Vietnamese to meet U.S. safety standards, and it has pushed Congress and the USDA to permit the importation of chicken processed in China though China has not demonstrated that its safety provisions are equivalent to ours. In both cases the USTR has sought actively to diminish food-safety standards in the name of free trade. Despite these limitations, it would still be a good thing if the law passed, and it would be better if it passed quickly, before special interests can destroy it with self-interested amendments. (Small farmers and “locavores” have already declared war on the bill’s efforts to regulate the safety of produce “on-farm”, for example.) The biggest challenge, however, will lie with the FDA itself. It is by no means clear that the FDA will want to implement this law to its fullest potential, as consistent with congressional intent. Career staff have shown little enthusiasm in the past for taking up new responsibilities. They just don’t believe that, over the long term, the agency and Congress will allocate funds for them to carry out all the responsibilities. It will fall to the present Commissioner, Margaret Hamburg, to implement the law if it is passed. At present, it’s not clear she will do so. In testimony and speeches she has served notice that she does not share the view of Congress, advocates or victims that increased Federal inspections are essential, and she’s fond of repeating the meaningless phrase, “You can’t inspect safety into food.” Moreover, the new law, if passed in its current form, phases into force in different time periods. Some of the provisions do not have implementation deadlines, meaning it’s likely they will never be implemented unless the Commissioner pushes very hard to do so. Beyond the FDA, the President’s seeming dismissal of the importance of the meat and poultry inspection program is troubling. Not only did he not propose changes to the meat and poultry inspection program, he waited until December 2009 to name an Under Secretary for Food Safety. The office has been vacant since the Bush Administration appointee left in September 2008.4 In the absence of clear policy and leadership from a new Administration, career civil servants keep doing what they were doing before. In this case that means pursuing policies advanced by President Bush and his supporters in the meat and poultry industry that favor industry and place consumers at greater risk. Pathogens associated with meat and poultry, Campylobacter and Salmonella, in particular, continue to cause illnesses, and the Department failed to meet its self-imposed deadline for issuing new performance standards. It is impossible to know the intent of the Administration with regard to meat and poultry safety. Lack of action on FSIS issues may signal that the Obama Administration intends to celebrate passage of the new FDA food safety reform law, declare victory over food-borne illness and move on to other subjects. That would almost surely leave the Administration vulnerable to serious criticism after each ensuing meat or poultry-related outbreak. The victims of food-borne illness and their families who came to Washington to lobby for quick passage of the FDA reform legislation are not screamers and shouters of the variety who encircled the Capitol to voice their rage about health care reform. But they and millions of other Americans do feel passionately that, as the President said last year, ensuring the safety of the food supply is a basic function of government. They want the President, the Congress, the FDA and other government officials to put that responsibility first. Millions of lives depend on it.
2Robert L. Scharf, “The Costs from Food-borne Illness in the U.S.”, Pew Produce Safety Project, Georgetown University, March 3, 2010.
3Distressed by reports of filth and veterinary drug residues in catfish imported from Southeast Asia and of the FDA’s lax inspection program, Congress in 2008 moved jurisdiction for the safety of imported catfish from the FDA to the Food Safety and Inspection Service in the USDA.
4The nominee for Under Secretary is Elisabeth Hagen. She has been at the agency for three years, moving up quickly through the ranks to a political appointee position. She was previously in private medical practice.