Revamping Federal Oversight of Food Safety
The fragmented federal oversight of food safety has caused inconsistent oversight, ineffective coordination, and inefficient use of resources. The 2010 nationwide recall of more than 500 million eggs because of Salmonella contamination highlights this fragmentation. Several agencies have different roles and responsibilities in the egg production system, including the Food and Drug Administration (FDA) and the U.S. Department of Agricultures (USDA) Food Safety Inspection Service (FSIS), USDAs Agricultural Marketing Service, and USDAs Animal and Plant Health Inspection Service. Three major trends also create food safety challenges: (1) a substantial and increasing portion of the U.S. food supply is imported, (2) consumers are eating more raw and minimally processed foods, and (3) growing segments of the population are increasingly susceptible to foodborne illnesses.
New food safety legislation, the FDA Food Safety Modernization Act (FSMA), which was signed into law in January 2011, strengthens a major part of the food safety system. It shifts the focus of FDA regulators from responding to contamination to preventing it, according to FDA, and expands FDAs oversight authority. While FSMA has several provisions that require interagency collaboration on food safety oversight, it does not apply to the federal food safety system as a whole or address USDAs authorities, which remain separate and distinct from FDAs. Whats more, because FSMA is not yet fully implemented and a number of the regulations required under the law are still under development or review, it is too early to understand in depth the impact of the law on federal oversight of food safety.
 FDA has developed two draft rulesone on produce safety and the other on preventive controls for human foodwhich were issued in January 2013 and at the time of GAOs report were available for public comment. Other FSMA-related rules are still under development.
GAO recommended that one of the actions to help reduce fragmentation was for the President to reconvene the Council on Food Safety. The President demonstrated strong commitment and top leadership support by establishing the Food Safety Working Group in 2009 to coordinate federal efforts and develop goals to make food safe. The working group is co-chaired by the Secretaries of Health and Human Services and Agriculture and includes officials from many federal agencies, including FDA and USDA. Through the working group, federal agencies have taken steps designed to increase collaboration in some areas that cross regulatory jurisdictionsin particular, improving produce safety, reducing Salmonella contamination, and developing food safety performance measures. In the case of Salmonella, for example, USDA officials told us that staff from USDA and FDA communicated on a regular basis to coordinate efforts to develop their respective agencies goals, as they are closely intertwined. Both agencies set goals to reduce illness from Salmonella within their own areas of egg safety jurisdiction by the end of 2011. According to the USDA officials, USDA and FDA coordinated on ensuring that the goals complemented one another, utilized the same datasets, and covered the same time period so that the agencies measure their progress consistently. Whats more, because FDA has not yet fully implemented the regulations required by FSMA, it is too early to understand in depth the impact of the law on federal oversight of food safety.
While such actions are encouraging, they are first steps. The agencies have not developed a government-wide performance plan for food safety that includes results-oriented goals and performance measures and information about resources. Such a plan is particularly important in an era, such as the present, of tight federal budgets. When GAO added food safety to the High Risk List in 2007, it said that what remains to be done is to develop a government-wide performance plan that is mission-based, has a results orientation, and provides a cross-agency perspective. Such a plan could be used to guide corrective actions for addressing fragmentation and monitoring progress by the 15 federal agencies that collectively administer at least 30 food-related laws. Without a government-wide plan, decision makers do not have a comprehensive picture of the federal governments performance on food safety.
Food safety oversight remains fragmented in several areas. The primary food safety agencies are FSIS, which is responsible for ensuring the safety of meat, poultry, and processed egg products, and FDA, which is responsible for ensuring the safety of virtually all other food.
GAO has also reported that food safety oversight is fragmented in the following areas:
- As GAO reported in August 2011, there is no centralized coordination to monitor the federal governments overall progress in implementing the nations food and agriculture defense policy, established in Homeland Security Presidential Directive-9 (HSPD-9). HSPD-9 assigns more than nine federal agencies various responsibilities to enhance the nations preparedness for food and agriculture emergencies. Without centralized oversight, however, the federal government cannot ensure that these nine agencies efforts are coordinated to overcome fragmentation, efficiently use scarce funds, and promote the overall effectiveness of the federal government. GAO recommended that the Homeland Security Council direct the National Security Staff to establish an interagency process that would oversee agencies implementation of HSPD-9 and that the Department of Homeland Security resume its efforts to coordinate agencies overall HSPD-9 implementation efforts. The Department of Homeland Security (DHS) generally agreed with GAOs recommendation, and the National Security Staff stated that it agreed that a review of HSPD-9 is appropriate and that they would look for an opportunity to do so. DHS and NSS officials told us that they have taken some steps to address these recommendations; however, the recommendations have not yet been fully implemented.
- Fragmentation occurs in coordinating messages about recalls of food products during multistate outbreaks of foodborne illnesses. In these cases, many agencies, including FDA, USDA, DHS, the Centers for Disease Control and Prevention, and state and local governments, play a role in responding to these events. In July 2012, GAO reported that FDA had not implemented recommendations previously made by other entities, such as the Institute of Medicine, to help address challenges in advising the public about food recalls and food borne illness outbreaks. GAO recommended that FDA implement these recommendations, which included (1) developing a coordinated plan for crisis communications with other federal agencies and (2) consulting with USDA on lessons learned in advising consumers about recalls to determine whether any of USDAs practices may be feasible at FDA, as consistent with applicable law. The Department of Health and Human Services, FDAs parent agency, neither agreed nor disagreed with the recommendations in the report but stated that it and FDA will explore each recommendation as they consider how to implement the recall provisions of FSMA. The Department of Health and Human Services also indicated that FDA is working with DHSs National Incident Management System to improve interagency efforts during incidents and that FDA will continue to work with USDA to gain insight and determine whether any of USDAs current practices may be feasible at FDA. These actions, if appropriately implemented, could help address GAOs recommendations.
- Provisions of the Food, Conservation, and Energy Act of 2008 (Farm Bill) that assigned FSIS responsibility for issuing final regulations to carry out a catfish examination and inspection program would result in duplication of federal programs and cost taxpayers millions of dollars annually without enhancing the safety of catfish intended for human consumption. Specifically, FDA has traditionally overseen the safety of all seafood, including catfish, but the Farm Bill assigned regulatory responsibility for catfish inspection to USDA once USDA issues final regulations for a mandatory catfish examination and inspection program. Under its proposed program, FSIS would conduct continuous inspections of domestic catfish processing. As GAO reported in May 2012, if FSIS were to implement its proposed catfish inspection program, responsibility for overseeing seafood safety would be further divided and would duplicate existing federal programs at an additional cost. First, the FSIS program would require implementation of hazard analysis plans that are essentially the same as FDAs hazard analysis requirements for seafood. (FDA would still inspect all other types of seafood). Second, as many as three agenciesFDA, FSIS, and the National Marine Fisheries Servicecould inspect facilities that process both catfish and other types of seafood. Both FDA and the National Marine Fisheries Service officials stated that continuous inspection will not improve catfish safety and is counter to the use of FDAs hazard analysis requirements, in which systems are most efficiently monitored periodically rather than daily. Third, under FSMA, FDA has an opportunity to enhance the safety of all imported seafoodincluding catfishand avoid the duplication of effort and cost that would result from FSISs implementation of its proposed program. To enhance the effectiveness of the food safety system for catfish and avoid duplication of effort and cost, GAO suggested that Congress consider repealing provisions of the Farm Bill that assigned USDA responsibility for examining and inspecting catfish and for creating a catfish inspection program. Congress has not taken such action.
GAO is monitoring the agencies progress by following up on all these recommendations.
The executive branch should develop a government-wide performance plan that includes results-oriented goals and performance measures and a discussion of strategies and resources in order to guide corrective actions and monitor progress. The Working Group should continue to facilitate coordination between the food safety agencies. While FSMA expands FDAs oversight authority in many areas, it does not apply to the entire federal food safety system. Congress should continue to monitor the success of the Working Group and of FSMA. If, over the next several years, the Working Group does not provide sustained leadership, and if FSMAs prevention-based approach does not successfully address weaknesses in the food safety system, Congress may wish to assess the need for comprehensive, uniform, risk-based food safety legislation or amend FDAs and USDAs existing authoritiesrecognizing that tight budgets may constrain far-reaching actions for the foreseeable future. Congress should also consider commissioning a detailed analysis of alternative organizational structures for food safety. Finally, Congress should consider repealing provisions of the Farm Bill that assigned USDA responsibility for examining and inspecting catfish and for creating a catfish inspection program.