Federal Food Safety and Security System: Fundamental Restructuring Is Needed to Address Fragmentation and Overlap
Published: 2004-03-30T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: The safety of the U.S. food supply is governed by a highly complex system of more than 30 laws administered by 12 agencies. In light of the recent focus on government reorganization, it is time to ask whether the current system can effectively and efficiently respond to today's challenges. At the request of the Subcommittee on Civil Service and Agency Organization, we reviewed and summarized our work on the safety and security of the food supply regarding (1) the fragmented legal and organizational structure of the federal food safety system, (2) the consequences of overlapping and inconsistent inspection and enforcement, and (3) options for consolidating food safety functions.
section_title: What GAO Found
paragraphs: As we have stated in numerous reports and testimonies, the federal food safety system is not the product of strategic design. Rather, it emerged piecemeal, over many decades, typically in response to particular health threats or economic crises. The result is a fragmented legal and organizational structure that gives responsibility for specific food commodities to different agencies and provides them with significantly different authorities and responsibilities. The existing food safety statutes create fragmented jurisdictions between the two principal food safety agencies, the Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA). As a result, there are inconsistencies in the frequency of the agencies' inspections of food facilities and the enforcement authorities available to these agencies. In short, which agency has jurisdiction to regulate various food products, the regulatory authorities they have available to them, and how frequently they inspect food facilities is determined by disparate statutes or by administrative agreement between the two agencies, without strategic design as to how to best protect public health. In many instances, food processing facilities are inspected by both FDA and USDA. Furthermore, federal food safety efforts are based on statutory requirements, not risk. For example, funding for USDA and FDA is not proportionate to the amount of food products each agency regulates, to the level of public consumption of those foods, or to the frequency of foodborne illnesses associated with food products. A federal food safety system with diffused and overlapping lines of authority and responsibility cannot effectively and efficiently accomplish its mission and meet new food safety challenges. These challenges are more pressing today as we face emerging threats such as mad cow disease and the potential for deliberate contamination of our food supply through bioterrorism. Therefore, fundamental changes are needed. First, there is a need to overhaul existing food safety legislation to make it uniform, consistent, and risk based. Second, consolidation of food safety agencies under a single independent agency or a single department is needed to improve the effectiveness and efficiency of the current federal food safety system. Integrating the overlapping responsibilities for food safety into a single agency or department can create synergy and economies of scale, as well as provide more focused and efficient efforts to protect the nation's food supply.

section_title: Letter
paragraphs: I am pleased to be here today before the Committee on Government  Reform’s Subcommittee on Civil Service and Agency Organization to  discuss the Subcommittee’s interest in streamlining the federal  government. Today, I will discuss our work on the federal food safety  system and whether its current design provides sufficient protection for  consumers while ensuring logical and effective use of scarce government  resources. In recent testimony before this Subcommittee, the Chairman of  the National Commission on the Public Service, Mr. Paul Volcker,  recommended that government programs that are designed to achieve  similar outcomes be combined into one agency and that agencies with  similar or related missions be combined into large departments that  encourage cooperation, achieve economies of scale in management, and  facilitate responsiveness to political leadership. He noted that important  health and safety protections fail when responsibility for regulation is  dispersed among several departments, as is the case with our federal food  safety system.
At GAO we concur with this view. In his September 2003 testimony, the  Comptroller General stressed the importance of beginning to take steps to  achieve fundamental reorganization of the federal government into a  limited number of mission-related executive departments. His testimony  pointed out that redundant, unfocused, and uncoordinated programs  waste scarce resources, confuse and frustrate program customers, and  limit overall program effectiveness. Based on GAO’s substantive body of  work on the federal food safety system and as we have testified in the  past, we believe that overhauling existing food safety statutes,  consolidating food safety agencies under a single independent agency or a  single department, and streamlining inspection and enforcement efforts  would improve the effectiveness and efficiency of the current federal food  safety system.
While the food supply is generally safe, each year tens of millions of  Americans become ill and thousands die from eating unsafe food. The  federal government spends about $1.3 billion annually to ensure the safety  of domestic and imported foods, and estimates that the costs associated  with foodborne illnesses are about $7 billion, including medical costs and  productivity losses from missed work. As we have stated in previous  reports and testimonies, the nation’s food safety system is a patchwork  structure that hampers efforts to address the risks of inadvertent or  deliberate food contamination. Fundamental changes are needed to  correct deficiencies in the system, reduce overlap and duplication, and  ensure a safer food supply. In summary, a system with diffused and  overlapping lines of authority and responsibility cannot effectively and  efficiently accomplish its mission and meet new food safety challenges.  These challenges are more pressing today as we face emerging threats  associated with diseases like bovine spongiform encephalopathy (BSE),  better known as mad cow disease, and the potential for the deliberate  contamination of our food supply through bioterrorism.
My testimony today provides an overview of the government’s fragmented  food safety system, the consequences of overlapping and inconsistent  inspection and enforcement, and options for consolidating food safety  functions. I will also provide a brief overview of the agencies’ roles in  addressing the emerging threat of a bioterrorism act against the nation’s  food supply and for protecting the U.S. from mad cow disease. This  testimony draws upon our wide-ranging, ongoing, and completed work on  food safety and upon completed work and previous testimonies on issues  related to government organization and transformation. We used updated  data on agency expenditures and numbers of employees and  establishments that we obtained from the agencies. We used consumer  expenditures data from the Bureau of Labor Statistics (BLS) and analyzed  foodborne illness outbreaks data from the Centers for Disease Control and  Prevention (CDC). To assess the reliability of these data, we reviewed  existing documentation about the data and the systems that produced  them and interviewed agency officials knowledgeable about the data; we  determined that the data were sufficiently reliable for the purposes of this  testimony. We conducted our work in accordance with generally accepted  government auditing standards.
subsections: section_title: Background
paragraphs: The safety and quality of the U.S. food supply is governed by a highly  complex system that is based on more than 30 laws and administered by  12 agencies. In addition, there are over 50 interagency agreements to  govern the combined food safety oversight responsibilities of the various  agencies. The federal system is supplemented by the states, which have  their own statutes, regulations, and agencies for regulating and inspecting  the safety and quality of food products. The United States Department of  Agriculture (USDA) and the Food and Drug Administration (FDA), within  the Department of Health and Human Services (HHS), have most of the  regulatory responsibilities for ensuring the safety of the nation’s food  supply and account for most federal food safety spending. Under the  Federal Meat Inspection Act, the Poultry Products Inspection Act, and the  Egg Products Inspection Act, USDA is responsible for the safety of meat,  poultry, and certain egg products. FDA, under the Federal Food, Drug, and  Cosmetic Act, and the Public Health Service Act, regulates all other foods,  including whole (or shell) eggs, seafood, milk, grain products, and fruits  and vegetables. Appendix I summarizes the agencies’ responsibilities.
Existing statutes give the agencies different regulatory and enforcement  authorities. For example, food products under FDA’s jurisdiction may be  marketed without the agency’s prior approval. On the other hand, food  products under USDA’s jurisdiction must generally be inspected and  approved as meeting federal standards before being sold to the public.  Although recent legislative changes have strengthened FDA’s enforcement  authorities, the division of inspection authorities and other food safety  responsibilities has not changed.
As we have reported, USDA traditionally had more comprehensive  enforcement authority than FDA; however, the Public Health Security and  Bioterrorism Preparedness and Response Act of 2002 has granted FDA  additional enforcement authorities that are similar to USDA’s. For  example, FDA can now require all food processors to register with the  agency so that they can be inspected. FDA can also temporarily detain  food products when there is credible evidence that the products present a  threat of serious adverse health consequences, and FDA can require that  entities such as the manufacturers, processors, and receivers of imported  foods keep records to allow FDA to identify the immediate previous  source and the immediate subsequent recipients of food, including its  packaging. This record keeping authority is designed to help FDA track  foods in the event of future health emergencies, such as terrorism-related  contamination. In addition, FDA now has the authority to require advance  notice of imported food shipments under its jurisdiction. Despite the  additional enforcement authorities recently granted to FDA, important  differences between the agencies’ inspection and enforcement authorities  remain.
Finally, in addition to their established food safety and quality  responsibilities, following the events of September 11, 2001, the federal  agencies began to address the potential for deliberate contamination of  agriculture and food products. In 2001, by Executive Order, the President  added the food industries to the list of critical infrastructure sectors that  need protection from possible terrorist attack. As a result of this Executive  Order, the Homeland Security Act of 2002 establishing the Department of  Homeland Security, and subsequent Presidential Directives, the  Department of Homeland Security provides overall direction on how to  protect the U.S. food supply from deliberate contamination. The Public  Health Security and Bioterrorism Preparedness and Response Act also  included numerous provisions to strengthen and enhance food safety and  security.
section_title: Fragmented System Hampers the Efficiency and Effectiveness of Food Safety Efforts
paragraphs: As we have stated in numerous reports and testimonies, the fragmented  federal food safety system is not the product of strategic design. Rather, it  emerged piecemeal, over many decades, typically in response to particular  health threats or economic crises. In short, what authorities agencies have  to enforce food safety regulations, which agency has jurisdiction to  regulate what food products, and how frequently they inspect food  facilities is determined by the legislation that governs each agency, or by  administrative agreement between the two agencies, without strategic  design as to how to best protect public health. It is important to  understand that the origin of this problem is historical and, for the most  part, grounded in the federal laws governing food safety. We and other  organizations, including the National Academies, have issued many  reports detailing problems with the federal food safety system and have  made numerous recommendations for change. While many of these  recommendations have been acted upon, problems in the food safety  system persist, largely because food safety responsibilities are still divided  among agencies that continue to operate under different laws and  regulations. As a result there is fragmentation, inconsistency, and overlap  in the federal food safety system. These problems are manifested in  numerous ways as discussed below.
Federal agencies have overlapping oversight responsibilities.
Agency jurisdictions either assigned by law over time or determined by  agency agreements result in overlapping oversight of single food products.
For example, which agency is responsible for ensuring the safety of frozen  pizzas depends on whether or not pepperoni is used as a topping. Figure 1  shows the agencies involved in regulating the safety of frozen pizza.
In other instances, such as canned soups, it is the amount of a particular  ingredient contained in the food product that governs whether it is subject  to FDA or USDA inspection. As a result, canned soup producers are also  subject to overlapping jurisdiction by the two food safety agencies.
Overlap and duplication result in inefficient use of inspection  resources. Food processing establishments may be inspected by more  than one federal agency because they process foods that are regulated  under different federal laws or because they participate in voluntary  inspection programs. As of February 2004, FDA’s records show that there  are about 2,000 food processing facilities in the United States that may  handle foods regulated by both FDA and USDA because their products  include a variety of ingredients. Multi-ingredient products that are  regulated by both FDA and USDA include pizza, canned soups, and  sandwiches. GAO found that 514 of the 8,653 FDA inspections conducted  in six states between October 1987 and March 1991, duplicated those of  other federal agencies. For example, FSIS had five inspectors assigned full  time to a plant that processed soups containing meat or poultry, yet FDA  inspected the same plant because it also processed soups that did not  contain meat or poultry. Thus, rather than having the full-time inspectors  assigned to the plant conduct inspections for all the plant’s products,  additional inspectors from another agency were required to conduct  separate inspections of products as a result of the different ingredients  contained in the product.
Moreover, there is also inefficient use of federal inspection resources  dedicated to overseeing the safety of seafood products. FDA has  responsibility for ensuring the safety of domestic and imported seafood  products. However, as we reported in January 2004, the NOAA Seafood  Inspection Program also provides fee-for-service safety, sanitation, and/or  product inspections for approximately 2,500 foreign and domestic firms  annually. Thus, both FDA and NOAA’s programs duplicate inspections of  seafood firms. To make more efficient use of federal inspection resources,  we have recommended that FDA work toward developing a memorandum  of understanding that leverages NOAA’s Seafood Inspection Program  resources to augment FDA’s inspection capabilities.
Federal agencies’ different authorities result in inconsistent  inspection and enforcement. Despite the additional enforcement  authorities granted to FDA by the Public Health Security and Bioterrorism  Preparedness and Response Act of 2002, differences between the agencies’  inspection and enforcement authorities remain. For example, when FSIS  inspectors observe serious noncompliance with USDA’s food safety  regulations, they have the authority to immediately withdraw their  inspection services. This effectively stops plant operations because a  USDA inspector must be present and food products under USDA’s  jurisdiction generally must be inspected and approved as meeting federal  standards before being sold to the public. This ensures more timely  correction of problems that could affect the safety of meat and poultry  products. In contrast, food products under FDA’s jurisdiction may be  marketed without the agency’s prior approval. Thus, while FDA may  temporarily detain food products when there is credible evidence that the  products present a threat of serious adverse health consequences, FDA  currently has no authority comparable with USDA’s allowing it to stop  plant operations. As a result, problems identified during FDA inspections  may take longer to correct.
Federal agencies’ different authorities to oversee imported foods  also result in inconsistent efforts to ensure safety. A significant  amount of the food we consume is imported; yet, as we have testified in  the past, the same fragmented structure and inconsistent regulatory  approach is being used to ensure the safety of imported foods. For  example, more than three-quarters of the seafood Americans consume is  imported from an estimated 13,000 foreign suppliers in about 160 different  countries. As we have reported, however, FDA’s system for ensuring the  safety of imported seafood does not sufficiently protect consumers. For  example, the agency inspected about 100 of roughly 13,000 foreign firms in  2002 and tested slightly over 1 percent of imported seafood products. In  January 2004, we reported that despite some improvements, FDA is still  able to inspect only a small proportion of U.S. seafood importers and visit  few seafood firms overseas yearly. As we have previously recommended, a  better alternative would be to strengthen FDA’s ability to ensure the safety  of imported foods by requiring that all food eligible for importation to the  United States be produced under equivalent food safety systems. USDA  has such authority. In fact, USDA is legally required to review  certifications made by other countries that their meat and poultry food  safety systems ensure compliance with U.S. standards and USDA must  also conduct on-site inspections before those products can be exported to  the United States. At this time, 37 countries are approved to export meat  and poultry products to the United States.
Frequency of inspections is not based on risk. Under current law,  USDA inspectors maintain continuous inspection at slaughter facilities  and examine each slaughtered meat and poultry carcass. They also visit  each processing plant at least once during each operating day. For foods  under FDA jurisdiction, however, federal law does not mandate the  frequency of inspections. The differences in inspection frequencies are, at  times, quite arbitrary, as in the case of jointly regulated food products. For  example, as we testified in 2001, federal responsibilities for regulating the  production and processing of a packaged ham and cheese sandwich  depends on whether the sandwich is made with one or two slices of bread,  not on the risk associated with its ingredients. As a result, facilities that  produce closed-faced sandwiches are inspected on average once every 5  years by FDA, whereas facilities that produce open-faced sandwiches are  inspected daily by FSIS.
Federal expenditures are not based on the volume of foods  regulated, consumed, or their risk of foodborne illness. FDA and  FSIS food safety efforts are based on the respective legislation governing  their operation. As a result, expenditures for food safety activities are  disproportionate to the amount of food products each agency regulates  and to the level of public consumption of those food products. FDA is  responsible for ensuring the safety of approximately 79 percent of the  foods Americans consume annually, while its budget represented only 40  percent ($508 million) of the approximately $1.3 billion spent on food  safety oversight during fiscal year 2003. In contrast, FSIS inspects  approximately 21 percent of the foods Americans consume annually, while  its food safety budget represented 60 percent ($756 million) of the federal  expenditures for food safety in 2003. Figure 2 shows the imbalance  between the dollar amounts that the agencies spend on food safety  activities and the volume of foods Americans consume annually.
Perhaps more importantly, the agencies’ food safety expenditures are  disproportionate to the percentage of foodborne illnesses linked to the  food products they regulate. For example, according to foodborne illness  data compiled by the CDC, USDA-regulated foods account for about 32  percent of reported foodborne outbreaks with known sources. Conversely,  FDA-regulated foods account for about 68 percent of these outbreaks.  (See fig. 3.) Yet, USDA’s food safety expenditures are about 49 percent  more than FDA’s.
Finally, as figure 4 shows, FSIS has 9,170 employees that are, by law,  responsible for daily oversight of approximately 6,464 meat, poultry, and  egg product plants. FDA has roughly 1,900 food inspection employees  who, among other things, inspect about 57,000 food establishments.
Overlaps in egg safety responsibility compromise safety.
Overlapping responsibilities have resulted in extensive delays in the  development of a comprehensive regulatory strategy to ensure egg safety.  As we have reported, no single federal agency has overall responsibility  for the policies and activities needed to ensure the safety and quality of  eggs and egg products. Figure 5 shows the overlapping responsibilities of  multiple agencies involved in overseeing the production, processing, and  transportation of eggs and egg products.
As shown in figure 5, FDA has the primary responsibility for the safe  production and processing of eggs still in the shell (known by industry as  shell eggs), whereas FSIS has the responsibility for food safety at the  processing plants where eggs are broken to create egg products. Despite  FSIS and FDA attempts to coordinate their efforts on egg safety, more  than 10 years have passed since the problem of bacterial contamination of  intact shell eggs was first identified, and a comprehensive safety strategy  has yet to be implemented. Agency representatives serving on the  President’s Council on Food Safety developed an Egg Safety Action Plan in  2000 and identified egg safety as one component of food safety that  warranted immediate federal, interagency action. As of March 2004,  comprehensive regulations to implement the actions the agencies  identified in the Action Plan have not been published.
Claims of health benefits for foods may be treated inconsistently  by different federal agencies. Overlaps also exist in the area of health  benefit claims associated with certain foods and dietary supplements.  FDA, USDA, and the Federal Trade Commission (FTC) share  responsibility for determining what types of health benefit claims are  allowed on product labels and in advertisements. The varying statutory  requirements among the agencies can lead to inconsistencies in labeling  and advertisements. As a result, the use of certain health benefit claims on  a product might be denied by one agency but allowed by another. For  example, the FTC may allow a health claim in an advertisement as long as  it meets the requirements of the Federal Trade Commission Act, even if  FDA has not approved it for use on a label. Similarly, USDA reviews  requests to use health claims on a case-by-case basis, regardless of  whether or not FDA has approved them. Thus, consumers face a confusing  array of claims, which may lead them to make inappropriate dietary  choices.
Multiple agencies must respond when serious food safety  challenges emerge. Inconsistent food safety authorities result in the need  for multiple agencies to respond to emerging food safety challenges. This  was illustrated recently with regard to ensuring that animal feed is free of  diseases, such as bovine spongiform encephalopathy (BSE), or mad cow  disease. A fatal human variant of the disease is linked to eating beef from  cattle infected with BSE. As we reported in 2002, four federal agencies are  responsible for overseeing the many imported and domestic products that  pose a risk of BSE. One, the U.S. Customs and Border Protection, screens  all goods entering the United States to enforce its laws and the laws of 40  other agencies. The second, USDA’s Animal and Plant Health Inspection  Service (APHIS), protects livestock from animal diseases by monitoring  the health of domestic and imported livestock. The third, USDA’s FSIS,  monitors the safety of imported and domestically produced meat and, at  slaughterhouses, tests animals prior to slaughter to determine if they are  free of disease and safe for human consumption. Finally, FDA monitors  the safety of animal feed—animals contract BSE through feed that  contains protein derived from the remains of diseased animals. During the  recent discovery of an infected cow in Washington state, FDA investigated  facilities that might have handled byproducts from the infected animal to  make animal feed. Figure 6 illustrates the fragmentation in the agencies’  authorities.
When we issued our report in 2002, BSE had not been found in U.S. cattle.  However, we found a number of weaknesses in import controls. Because  of those weaknesses and the disease’s long incubation period—up to 8  years—we concluded that BSE might be silently incubating somewhere in  the United States. Then, in May 2003, an infected cow was found in  Canada, and in December 2003, another was found in the state of  Washington. USDA’s Animal and Plant Health Inspection Service operates  the surveillance program that found the infected U.S. cow, while FDA  must ensure that the disease cannot spread by enforcing an animal feed  ban that prohibits the use of cattle brains and spinal tissue, among other  things, in cattle feed. With regard to the meat from the BSE-infected  animal found in Washington state, FSIS conducted a recall of meat  distributed in markets in six states. Both USDA and FDA have reported  that meat from the cow was not used in FDA-regulated foods. However,  had the meat been used, for example, in canned soups that contained less  than 2 percent meat, FDA—not FSIS—would have been responsible for  working with companies to recall those foods. (As app. II shows, the  agencies’ oversight responsibilities for food products vary depending on  the amount of beef or poultry content.) Neither FDA nor USDA has  authority under existing food safety laws to require a company to recall  food products. Both agencies work informally with companies to  encourage them to initiate a recall, but our ongoing work shows that each  agency has different approaches and procedures. This can be confusing to  food processors involved in a recall. Overlapping responsibilities in  responding to mad cow disease highlight the challenges that government  and industry face when responding to the need to remove contaminated  food products from the market. As part of work currently underway, we  are looking at USDA and FDA food recalls—including USDA’s oversight of  the BSE-related recall and FDA’s oversight of the feed ban. We are also  monitoring both USDA’s and FDA’s BSE-response activities.
There are undoubtedly other federal food safety activities where overlap  and duplication may occur. For example, in the areas of food safety  research, public outreach, or both FDA, and USDA’s Economic Research  Service, FSIS and the Cooperative State Research, Education and  Extension Service have all received funding to develop food safety-related  educational materials for the public. In addition, responsibility for  regulating genetically modified foods is shared among FDA, USDA, and  the Environmental Protection Agency (EPA). However, we have not yet  examined the extent to which these and other areas of overlap and  duplication impact the efficiency of the food safety system.
section_title: Emerging Terrorist Threats Highlight the Need to Reorganize the Federal Food Safety System
paragraphs: The fragmented legal and organizational structures of the federal food  safety system are now further challenged by the realization that American  farms and food are vulnerable to potential attack and deliberate  contamination. As we recently reported in a statement for the record  before the Senate Committee on Governmental Affairs, bioterrorist  attacks could be directed at many different targets in the farm-to-table  continuum, including crops, livestock, food products in the processing and  distribution chain, wholesale and retail facilities, storage facilities,  transportation, and food and agriculture research laboratories. Experts  believe that terrorists would attack livestock and crops if their primary  intent were to cause severe economic dislocation. Terrorists could decide  to contaminate finished food products if their motive were to harm  humans. Both FDA and USDA have taken steps to protect the food supply  against a terrorist attack, but it is, for the most part, the current food  safety system that the nation must depend on to prevent and respond to  bioterrorist acts against our food supply.
For example, in February 2003, we reported that FDA and USDA  determined that their existing statutes empower them to enforce food  safety, but do not provide them with clear authority to regulate all aspects  of security at food-processing facilities. Neither agency feels that it has  authority to require processors to adopt physical facility security measures  such as installing fences, alarms, or outside lighting. Each agency,  independently of one another, developed and published guidelines that  food processors may voluntarily adopt to help them identify security  measures and mitigate the risk of deliberate contamination at their  production facilities. However, while food inspectors were instructed to  be vigilant, they have not been asked to enforce, monitor, or document  their actions regarding the extent to which security measures are being  adopted. As a result, neither FDA nor USDA can fully assess the extent to  which food processors are following the security guidelines that the  agencies developed. Officials note, however, that they have taken many  steps to address deliberate food contamination. Both agencies have  distributed food security information to food processors under their  jurisdictions and are cochairing the Food Emergency Response Network,  which integrates the nation’s laboratory infrastructure for the detection of  threat agents in food at the local, state, and federal levels. Among other  things, USDA established the Office of Food Security and Emergency  Preparedness, enhanced security at food safety laboratories, and trained  employees in preparedness activities. Similarly, FDA revised emergency  response plans and conducted training for all staff, as well as participated  in various emergency response exercises at FDA’s Center for Food Safety  and Applied Nutrition.
Another GAO report documented vulnerabilities in federal efforts to  prevent dangerous animal diseases from entering the United States. Our  2002 report on foot-and-mouth disease concluded that because of the  sheer magnitude of international passengers and cargo that enters this  country daily, completely preventing the entry of foot-and-mouth disease  may not be feasible. During the 2001 outbreak of food-and-mouth disease  in Europe, poor communication between USDA and Customs officials  caused delays in carrying out inspections of international passengers and  cargo arriving from disease-affected countries.
section_title: Fundamental Changes Needed to Improve Effectiveness and Efficiency of the Federal Food Safety System
paragraphs: To address the problems I have just outlined, a fundamental  transformation of the current food safety system is necessary. As the  Comptroller General has testified, there are no easy answers to the  challenges federal departments and agencies face in transforming  themselves. Changes, such as revamping the U.S. food safety system, will  require a process that involves key congressional stakeholders and  administration officials as well as others, ranging from food processors to  consumers. There are different opinions about the best organizational  model for food safety, but there is widespread national and international  recognition of the need for uniform laws and the consolidation of food  safety activities.
Establishing a single food safety agency responsible for administering a  uniform set of laws would offer the most logical approach to resolving  long-standing problems with the current system, addressing emerging  threats to food safety, and ensuring a safer food supply. This would ensure  that food safety issues are addressed comprehensively by better  preventing contamination throughout the entire food cycle—from the  production and transportation of foods through their processing and sale  until their eventual consumption by consumers. In our view, integrating  the overlapping and duplicative responsibilities for food safety into a  single agency or department can create synergy and economies of scale  that would provide for more focused and efficient efforts to protect the  nation’s food supply. A second option would be to consolidate all food  safety inspection activities, but not other activities, under an existing  department, such as USDA or HHS. Other measures have not proven  successful. For example, the Farm Security and Rural Investment Act of  2002 mandated the creation of a 15-member Food Safety Commission  charged with making specific recommendations to improve the U.S. food  safety system and delivering a report to the President and the Congress  within a year. The Congress has thus far not provided funding for the  commission.
Simply choosing an organizational structure will not be sufficient,  however. For the nation’s food safety system to be successful, it will also  be necessary to reform the current patchwork of food safety legislation  and make it uniform, consistent, and risk-based. As table 1 shows, five of  eight former senior food safety officials with whom we discussed the  matter in preparation for this testimony concur with this view.
Three officials had different views on the best approach to address  problems with the current food safety system. Joseph Levitt, director of  the FDA’s Center for Food Safety and Applied Nutrition from 1998 to 2003,  recommends that the existing agencies be fully funded. Thomas Billy,  administrator of USDA’s FSIS from 1996 to 2001 and director of FDA’s  Office of Seafood between 1990 and 1994, believes that no changes should  take place until a presidential commission evaluates the problems,  identifies the alternatives, and recommends a specific approach and  strategy for consolidating food safety programs. However, Mr. Billy  supports incremental legislative steps to fix current shortcomings. Finally,  Caren Wilcox, USDA’s deputy under secretary for Food Safety from 1997  to 2001, believes that creating a single food safety agency would be  advisable, but only under certain circumstances.
In 1998, the National Academies similarly recommended modifying the  federal statutory framework for food safety to avoid fragmentation and to  enable the creation and enforcement of risk-based standards. Moreover,  our 1999 report on the experiences of countries that were then  consolidating their food safety systems indicated that foreign officials are  expecting long-term benefits in terms of savings and food safety. Five  countries—Canada, Denmark, Great Britain, Ireland, and New Zealand— have each consolidated their food safety responsibilities under a single  agency. For example, New Zealand’s Food Safety Authority was created in  July 2002 to reduce inconsistencies and lack of coordination in food safety  management by two separate agencies—the Ministry of Health and the  Ministry of Agriculture and Forestry. The new authority anticipates an  effective use of scarce resources and a reduction in duplication of effort.
section_title: Conclusions
paragraphs: In conclusion, given the risks posed by new threats to the food supply, be  they inadvertent or deliberate, we can no longer afford inefficient,  inconsistent, and overlapping programs and operations in the food safety  system. It is time to ask whether a system that developed in a piecemeal  fashion in response to specific problems as they arose over the course of  several decades can efficiently and effectively respond to today’s  challenges. We believe that creating a single food safety agency to  administer a uniform, risk-based inspection system is the most effective  way for the federal government to resolve long-standing problems, address  emerging food safety issues, and better ensure the safety of the nation’s  food supply. This integration can create synergy and economies of scale,  and provide more focused and efficient efforts to protect the nation’s food  supply.
The National Academies and the President’s Council on Food Safety have  reported that comprehensive, uniform, and risk-based food safety  legislation is needed to provide the foundation for a consolidated food  safety system. We recognize that consolidating federal responsibilities for  food safety into a single agency or department is a complex process.  Numerous details, of course, would have to be worked out. However, it is  essential that the fundamental decision to create more uniform standards  and a single food safety agency to uphold them is made and the process  for resolving outstanding technical issues is initiated.
section_title: Matters for Congressional Consideration
paragraphs: To provide more efficient, consistent, and effective federal oversight of the  nation’s food supply, we suggest that the Congress consider    enacting comprehensive, uniform, and risk-based food safety legislation    establishing a single, independent food safety agency at the Cabinet level.
If the Congress does not opt for an entire reorganization of the food safety  system, we suggest that as an alternative interim option it consider    modifying existing laws to designate one current agency as the lead  agency for all food safety inspection matters.
Madam Chairwoman, this completes my prepared statement. I would be  pleased to respond to any questions that you or other Members of the  Committee may have at this time.
section_title: Contacts and Staff Acknowledgments
paragraphs: For further information about this testimony, please contact Lawrence J.  Dyckman, Director, Natural Resources and Environment, (202) 512-3841.  Maria Cristina Gobin, Katheryn Summers Hubbell, Kelli Ann Walther,   Amy Webbink, and John Delicath made key contributions to this  statement.
section_title: Appendix I: Federal Agencies’ Food Safety Responsibilities
paragraphs: Food and Drug Administration (FDA)
Centers for Disease Control and Prevention  (CDC)
Animal and Plant Health Inspection Service  (APHIS)
Agricultural Marketing Service (AMS)
Agricultural Research Service (ARS)
National Oceanic and Atmospheric  Administration (NOAA)
Collecting revenues and enforcing various Customs  laws.
section_title: Appendix II: Differences in Inspection Frequency of Manufacturers of Similar Products
paragraphs: Beans with bacon (2 percent or more bacon)
Pork and beans (no limit on amount of pork)
section_title: Appendix III: Related GAO Products
paragraphs: Food Safety: FDA’s Imported Seafood Safety Program Shows Some  Progress, but Further Improvements Are Needed. GAO-04-246.  Washington, D.C.: January 30, 2004.
Bioterrorism: A Threat to Agriculture and the Food Supply.   GAO-04-259T. Washington, D.C.: November 19, 2003.
Combating Bioterrorism: Actions Needed to Improve Security at Plum  Island Animal Disease Center. GAO-03-847. Washington, D.C.: September  19, 2003.
Results-Oriented Government: Shaping the Government to Meet 21st  Century Challenges.GAO-03-1168T. Washington, D.C.: September 17, 2003.
School Meal Programs: Few Instances of Foodborne Outbreaks Reported,  but Opportunities Exist to Enhance Outbreak Data and Food Safety  Practices. GAO-03-530. Washington, D.C.: May 9, 2003.
Agricultural Conservation: Survey Results on USDA’s Implementation of  Food Security Act Compliance Provisions. GAO-03-492SP. Washington,  D.C.: April 21, 2003.
Food-Processing Security: Voluntary Efforts Are Under Way, but Federal  Agencies Cannot Fully Assess Their Implementation. GAO-03-342.  Washington, D.C.: February 14, 2003.
Meat and Poultry: Better USDA Oversight and Enforcement of Safety  Rules Needed to Reduce Risk of Foodborne Illnesses. GAO-02-902.  Washington, D.C.: August 30, 2002.
Foot and Mouth Disease: To Protect U.S. Livestock, USDA Must Remain  Vigilant and Resolve Outstanding Issues. GAO-02-808. Washington,  D.C.: July 26, 2002.
Genetically Modified Foods: Experts View Regimen of Safety Tests as  Adequate, but FDA’s Evaluation Process Could Be Enhanced.   GAO-02-566. Washington, D.C.: May 23, 2002.
Food Safety: Continued Vigilance Needed to Ensure Safety of School  Meals.GAO-02-669T. Washington, D.C.: April 30, 2002.
Mad Cow Disease: Improvements in the Animal Feed Ban and Other  Regulatory Areas Would Strengthen U.S. Prevention Efforts. GAO-02-183.  Washington, D.C.: January 25, 2002.
Food Safety: Weaknesses in Meat and Poultry Inspection Pilot Should Be  Addressed Before Implementation. GAO-02-59. Washington, D.C.:  December 17, 2001.
Food Safety and Security: Fundamental Changes Needed to Ensure Safe  Food.GAO-02-47T. Washington, D.C.: October 10, 2001.
Food Safety: CDC Is Working to Address Limitations in Several of Its  Foodborne Disease Surveillance Systems. GAO-01-973. Washington, D.C.:  September 7, 2001.
Food Safety: Overview of Federal and State Expenditures. GAO-01-177.  Washington, D.C.: February 20, 2001.
Food Safety: Federal Oversight of Seafood Does Not Sufficiently Protect  Consumers. GAO-01-204. Washington, D.C.: January 31, 2001.
Food Safety: Actions Needed by USDA and FDA to Ensure That  Companies Promptly Carry Out Recalls. GAO/RCED-00-195. Washington,  D.C.: August 17, 2000.
Food Safety: Improvements Needed in Overseeing the Safety of Dietary  Supplements and “Functional Foods.” GAO/RCED-00-156. Washington,  D.C.: July 11, 2000.
School Meal Programs: Few Outbreaks of Foodborne Illness Reported.  GAO/RCED-00-53. Washington, D.C.: February 22, 2000.
Meat and Poultry: Improved Oversight and Training Will Strengthen  New Food Safety System. GAO/RCED-00-16. Washington, D.C.: December  8, 1999.
Food Safety: Agencies Should Further Test Plans for Responding to  Deliberate Contamination. GAO/RCED-00-3. Washington, D.C.: October  27, 1999.
Food Safety: U.S. Needs a Single Agency to Administer a Unified, Risk- Based Inspection System. GAO/T-RCED-99-256. Washington, D.C.: August  4, 1999.
Food Safety: U.S. Lacks a Consistent Farm-to-Table Approach to Egg  Safety. GAO/RCED-99-184. Washington, D.C.: July 1, 1999.
Food Safety: Experiences of Four Countries in Consolidating Their Food  Safety Systems. GAO/RCED-99-80. Washington, D.C.: April 20, 1999.
Food Safety: Opportunities to Redirect Federal Resources and Funds  Can Enhance Effectiveness. GAO/RCED-98-224. Washington, D.C.:  August 6, 1998.
Food Safety: Federal Efforts to Ensure Imported Food Safety Are  Inconsistent and Unreliable. GAO/T-RCED-98-191. Washington, D.C.:  May 14, 1998.
Food Safety: Federal Efforts to Ensure the Safety of Imported Foods Are  Inconsistent and Unreliable. GAO/RCED-98-103. Washington, D.C.: April  30, 1998.
Food Safety: Agencies’ Handling of a Dioxin Incident Caused Hardships  for Some Producers and Processors. GAO/RCED-98-104. Washington,  D.C.: April 10, 1998.
Food Safety: Fundamental Changes Needed to Improve Food  Safety. GAO/RCED-97-249R. Washington, D.C.: September 9, 1997.
Food Safety: Information on Foodborne Illnesses. GAO/RCED-96-96.  Washington, D.C.: May 8, 1996.
Food Safety: Changes Needed to Minimize Unsafe Chemicals in Food.  GAO/RCED-94-192. Washington, D.C.: September 26, 1994.
Food Safety: A Unified, Risk-Based Food Safety System Needed. GAO/T- RCED-94-223. Washington, D.C.: May 25, 1994.
Food Safety: Risk-Based Inspections and Microbial Monitoring Needed  for Meat and Poultry. GAO/RCED-94-110. Washington, D.C.: May 19,  1994.
Food Safety and Quality: Uniform, Risk-Based Inspection System  Needed to Ensure Safe Food Supply. GAO/RCED-92-152. Washington,  D.C.: June 26, 1992.
Food Safety and Quality: Salmonella Control Efforts Show Need for More  Coordination. GAO/RCED-92-69. Washington, D.C.: April 21, 1992.
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