The food safety system in America is broken. Each year, 76 million Americans get sick, 325,000 are hospitalized and 5,000 die from food-borne hazards in the U.S., according to the Centers for Disease Control and Prevention. Since September 2006, a number of nationwide outbreaks and recalls have exposed gaping holes in the safety net guarding U.S. consumers from contaminated food.
Spinach contaminated with a deadly strain of E. coli, peanut butter with Salmonella, pet food with toxic chemicals, botulism in canned chili that remained on store shelves weeks after initial recall, 22 million pounds of ground beef recalled because of E. coli contamination — each of these tragedies have demonstrated a different problem with our system of regulating the food supply.
The impact of these outbreaks has been devastating. After the 2006 outbreaks, consumers’ confidence in the food they purchase at restaurants and grocery stores declined 16 percent, according to the annual survey of the Food Marketing Institute. USA Today reported in July 2007 that 83 percent of shoppers were concerned about food from China, and 61 percent about food from Mexico.
The food industry has felt the impact of declining confidence as spinach farmers experienced a loss of $350 million after the September 2006 outbreak.
Cost provides another measure for assessing the need for action on food-borne illnesses. The U.S. Department of Agriculture’s Economic Research Service estimated the economic costs of hospitalizations, lost productivity and death from the five most common pathogens at $6.9 billion in 2000. The greatest percentage of this cost is from premature death, which occurs primarily in people over 65 for Salmonella and children under 5 for E. coli. The elderly, people with compromised immune systems, pregnant women, children and infants are most at risk of serious illness from food-borne disease. Many pathogens, including Salmonella and E. coli, can lead to chronic illness and reduced life expectancy.
IN 2007, the Government Accountability Office designated food safety as a high-risk federal government program. Agriculture, including all food production, constitutes about 13 percent of gross domestic product and is the largest industry and employer in the U.S.
Yet inadequate funding and confusion caused by the way 100-year-old food safety laws and their accompanying bureaucracies have evolved hamper federal food safety efforts.
Federal food expenditures are not distributed evenly across all the high-risk foods, but instead are concentrated on meat and poultry products regulated by the USDA. Historically, while the USDA regulates one-fifth of the food supply causing 27 percent of outbreaks, its food safety appropriations have been twice that given to the Food and Drug Administration. Increased appropriations starting in 2008 have begun to address this disparity, but the FDA’s funding still lags the USDA’s.
The USDA has the resources to inspect meat and poultry plants daily, as required by law. In contrast, the FDA, which regulates 80 percent of the food supply, inspects food facilities it oversees on average just once every 10 years. The FDA’s food program as of 2007 had a current funding shortfall of $135 million, which an FDA budget official described as equivalent to a 24 percent budget cut.
Overall consumer confidence in the FDA has plummeted. A Gallup Poll has documented that confidence in the FDA’s ability to ensure the safety of the food supply fell 11 percent between 2001 and 2008. Polling after last fall’s Peanut Corporation of America outbreak found only half of Americans believe the government does a good job of enforcing the nation’s food laws.
Outbreaks are a symptom of an agency overwhelmed by responsibility, but that lacks the staff and resources to function effectively. The FDA responds to crisis after crisis rather than preventing them. FDA funding shortfalls reached a critical level by 2007, leaving the agency with fewer inspectors even as their workload continued to increase.
By 2006, inspections conducted by the FDA had declined 81 percent from 1972 levels. The number of FDA field staff declined 12 percent between 2003 and 2006, as federal inspections fell 32 percent. With budget increases in 2008 and 2009, the agency is beginning to rebuild, but adding inspectors alone will not solve the FDA’s problems.
The food safety system is also fragmented among 12 federal agencies that share responsibility for regulating food. This results in a chaotic and inefficient system. The three main agencies divide duties as follows: the USDA inspects meat and poultry; the FDA oversees the safety of all other foods; and the Environmental Protection Agency sets tolerances for pesticides in food.
This regulatory system proves confusing, wasteful and highly ineffective. For example:
-- A frozen cheese pizza is subject to inspection by the FDA, which usually inspects the average food manufacturing facility only once every 10 years. A frozen pepperoni pizza falls under jurisdiction of the USDA, which performs almost daily inspections.
-- Imported foods are treated differently depending on whether they are regulated by the FDA or the USDA. While the USDA approves all foreign meat and poultry plants that want to export to the U.S., the FDA cannot even visit the foreign food processors that are linked to outbreaks of illness in this country without the invitation of the foreign government.
-- Lettuce and other leafy greens have caused outbreaks from strains of E. coli and Salmonella previously associated with meats. Although USDA inspectors visit farms, they do not inspect the crops for safety. The FDA, the food safety agency most likely to regulate the safety of leafy greens, does not inspect the farm unless there is an outbreak of illness. Fresh vegetables of all kinds fall through a huge crack in the U.S. food safety system.
AT THE HEART of the FDA’s problems is an antiquated statute that is out of step with modern food safety regulation. The Federal Food, Drug and Cosmetic Act sets up a reactive structure in which the agency is truly empowered only when food is found to be adulterated or misbranded. This is very different from the Federal Meat Inspection Act, for example, which requires government inspectors to approve every meat or poultry carcass before it can be sold. The FDA has authority to implement improvements under the Federal Food, Drug and Cosmetic Act and the Public Health Service Act, but neither law gives the agency clear mandates from farm-to-table when it comes to food safety.
Recent events are signaling that the time for reform is now. Congress appears ready to adopt a modern regulatory oversight program and fund it adequately to fulfill its mission. The FDA Amendments Act of 2007 includes a Sense of Congress stating this intent. The Senate and House have held numerous hearings on food safety. The emergence of coalitions of traditionally estranged consumer and industry organizations, such as the Alliance for a Stronger FDA, gives Congress a unique opportunity to appeal to many constituencies as it rebuilds the agency.
To fix the FDA, Congress must adopt legislation that addresses deficiencies in 11 critical areas by establishing:
-- Process controls implemented by industry. The safety and security of the food supply requires an integrated, systemwide approach to preventing food-borne illness, with oversight by federal food safety agencies. Food contamination can be prevented by using programs of quality assurance and preventive process control, such as Hazard Analysis and Critical Control Points (HAACP), that are developed by individual companies. These programs are already widely used, and they can be incorporated into food production systems at all levels.
-- Performance standards set by the FDA. Congress should require the FDA to set performance standards based on best-available science on hazards linked to specific food products and other public health considerations. Standards also can be used to ensure that food is produced in a sanitary manner that limits the likelihood of contamination by pathogens, chemicals or even physical hazards such as glass and metal. The HAACP and performance-standard approaches would focus food safety activities on prevention and would permit more efficient and effective government oversight through analysis of records as well as visual and laboratory inspection.
-- More frequent inspection schedules. The FDA must have congressionally mandated authority to create a system of risk-based inspection, based on the type of food handled and the processes used. Under this system, food establishments would receive an inspection classification or rating based on public health considerations and scientific evidence to determine the frequency and timing of inspections. All facilities now regulated by the FDA should be subject to a mandatory inspection frequency, with higher risk facilities inspected much more often (e.g. daily, monthly or quarterly). This system of inspection would allow for the best use of government resources while still providing safety checks along the entire farm-to-fork continuum.
-- Better import controls. The FDA must have authority to establish a system under which governments or foreign food establishments seeking to export food to the U.S. can certify their food safety system. This certification should demonstrate that the food being shipped to the U.S. meets standards of food safety, inspection, labeling and consumer protection that is at least equivalent to foods produced in this country.
-- Stronger research and education programs. The FDA and industry must improve techniques to monitor and inspect food and develop efficient and sensitive methods for detecting contaminants and reducing harmful pathogens. Educational programs that promote better understanding and practice of proper food-safety techniques, such as thoroughly washing hands and cooking foods to proper temperatures, could significantly reduce food-borne illness. Programs also are needed to help health professionals improve their diagnosis and treatment of food-related illness and to advise individuals at special risk.
-- An on-farm food safety mandate. The FDA should require all growers and processors to keep a written food safety plan based on the principles of preventive process control and designed by the farmer to address the specific environmental conditions on the farm. It also should develop specific, standardized and enforceable criteria for use by the farmers for such items as water quality, manure use and management, and worker sanitation. Processors must mark packaging to ensure easy trace-back when fruits and vegetables are implicated in an outbreak. Package markings must be specific enough to extend all the way back to the farm(s) of origin. The FDA, states and/or buyers also should audit written plans at least once per growing season.
-- Mandatory recall authority. Mandatory recall authority for the FDA would ensure that recalled foods are removed from the market more quickly and effectively.
-- Trace-back systems. The FDA needs the authority to identify the source of foods that pose health hazards to consumers. The ability to trace a contaminated product back to the source of production would allow the agency to conduct more rapid and thorough investigations, and would allow producers to identify more precisely the source of a problem. It could help narrow the scope of recalls by more quickly identifying the specific plant or country of origin.
-- Administrative detention authority. If an FDA inspector has reason to believe a domestic or imported food is unsafe, adulterated or misbranded, the agency must have authority to detain the food for a reasonable time. If it is determined the detained food cannot be brought in compliance with food safety requirements, the FDA should be able to condemn the food.
-- Authority to issue civil penalties. Food companies must be subject to civil and criminal penalties for violating food safety laws. Today, the FDA must pursue a criminal prosecution when it finds a violation because the agency doesn’t have the authority to assess civil fines. The cost and difficulty of mounting a criminal prosecution makes it more likely food companies will get away with some violations.
-- Protection of whistleblowers. Employees must be protected from the threat of being fired, demoted, suspended or harassed as a result of providing information or assisting in the investigation of a violation of food safety law. Whistleblower protection could have helped prevent illnesses and deaths that resulted from the Peanut Corporation of America outbreak. One story reported that employees who knew of unsanitary conditions at the plant kept quiet because they “wanted to keep their jobs.”
KEY U.S. FOOD safety laws are a century old and were not designed to deal with modern issues such as escalating imports, bioterrorism or tainted produce. The last several years have demonstrated the need for enhanced national security, and the recent outbreaks serve as a reminder that much more must be done to protect the food supply. Comprehensive reform should draw from these recommendations.
Change is hard, but it has been done abroad. The U.K. reformed its food safety program to establish a single Food Standards Agency in 1999. That agency has proved effective in reducing the incidence of food-borne illness and building public confidence. Food-borne illnesses declined 18 percent within the first three years of the new agency, with a reduction from 37 percent to 6 percent in the occurrence of eggs and poultry infected with Salmonella. The change came after food scares in the 1990s led all sides to recognize the need for change, and that realization built the momentum needed to reach a workable compromise. The U.S. is at the same nexus of crisis and consensus, and the momentum for reform is building.
Caroline Smith DeWaal is director of the food safety program for the Center for Science in the Public Interest and co-author of “Is Our Food Safe? A Consumer’s Guide to Protecting Your Health and the Environment.” David W. Plunkett is a senior staff attorney with the food safety program at the CSPI, and has more than 20 years experience working with legislatures at the state and federal level. This report was adapted from their white paper, “Building a Modern Food Safety System for FDA Regulated Foods.”