Improving Federal Oversight of Food Safety
The Department of Health and Human Services (HHS), the U.S. Department of Agriculture (USDA), and the Office of Management and Budget (OMB) have taken some positive steps since the 2015 high-risk update to address fragmentation in the federal food safety oversight system. For example, HHS and USDA have continued and expanded collaboration on specific food safety issues, and HHS has updated its strategic plan to address interagency coordination on food safety. However, additional steps are needed to address the system’s fragmentation and remove this issue from the High-Risk List.
For more than four decades, we have reported on the fragmented federal food safety oversight system, which has caused inconsistent oversight, ineffective coordination, and inefficient use of resources. We added federal food safety oversight to the High-Risk List in 2007 because of risks to the economy, to public health, and to safety. A 2011 estimate by the Centers for Disease Control and Prevention (CDC)—its most recent estimate—indicates that, as a result of foodborne illness, roughly 1 in 6 Americans (48 million people) gets sick each year, 128,000 are hospitalized, and 3,000 die. CDC data also show that the number of reported multistate foodborne illness outbreaks is increasing. This is notable because although multistate outbreaks make up a small proportion of total outbreaks, they affect greater numbers of people. For example, according to CDC data, 3 percent of reported outbreaks from 2010 to 2014 were multistate, but these outbreaks were associated with 11 percent of illnesses, 34 percent of hospitalizations, and 56 percent of deaths. CDC cites several potential contributors to the increase in reported multistate outbreaks, including greater centralization of food processing practices, wider food distribution, and improved detection and investigation methods.
Most who get sick from a foodborne illness will recover without any lasting effects; however, some individuals may suffer long-term health effects, such as kidney failure, chronic arthritis, or nerve damage. For example, according to CDC data, each year in the United States an estimated 1.3 million people are affected by an infection with the foodborne pathogen Campylobacter. Of these, approximately 1 in 1,000 develop Guillain-Barré syndrome, a disorder in which a person’s immune system attacks the body’s own nerves. Researchers have also linked exposure to E. coli, Salmonella, and other foodborne pathogens to a long-term risk of developing Crohn’s disease, a chronic inflammatory bowel disease. According to a May 2015 estimate from USDA’s Economic Research Service, the most common 15 foodborne pathogens together impose an economic burden related to foodborne illnesses, hospitalizations, and deaths in the United States of over $15.5 billion annually. That same year, researchers at HHS’s Food and Drug Administration (FDA) estimated health costs associated with foodborne illness at about $36 billion annually.
In addition to the human health toll, foodborne illness outbreaks can impose high costs to industry from food recalls. An October 2011 study published by the Grocery Manufacturers Association (GMA), in partnership with Covington & Burling LLP and Ernst & Young, estimated the cost of food recalls. The study surveyed 36 GMA member companies and found that more than half had been affected by a product recall in the prior 5 years. For companies that had faced a recall in the past 5 years, 48 percent estimated the financial impact to be less than $9 million; 29 percent, from $10 million to $29 million; and 23 percent, $30 million or more. Based on the survey results, the four largest costs that companies face as a result of a recall are business interruption or lost profits; recall execution costs, such as destroying and replacing recalled products; liability risk; and company or brand reputation damage.
As we reported in December 2014, three major trends create food safety challenges. First, a substantial and increasing portion of the U.S. food supply is imported, which stretches the federal government’s ability to ensure the safety of these foods. Second, consumers are eating more raw and minimally processed foods, which in general are more susceptible to foodborne pathogens. Third, segments of the population that are particularly susceptible to foodborne illnesses, such as older adults and immune-compromised individuals, are growing.
The safety and quality of the U.S. food supply, both domestic and imported, are governed by a highly complex system stemming from at least 30 federal laws that are collectively administered by 16 federal agencies. The federal agencies with primary responsibility for food safety oversight are USDA’s Food Safety and Inspection Service (FSIS) and FDA. FSIS is responsible for the safety of meat, poultry, processed egg products, and catfish. FDA is responsible for virtually all other food. As we reported in May 2016, the federal food safety oversight system is supplemented by states, localities, tribes, and territories, which may have their own laws and agencies to address the safety and quality of food.
 GAO, High-Risk Series: An Update, GAO-07-310 (Washington, D.C.: January 2007).
 Economic burden measures the impact of disease on the welfare of all individuals in a society—also referred to as welfare loss. Economists measure the economic burden of a disease as the sum of the willingness to pay by all individuals in society to reduce its incidence or likelihood.
 Differences between the estimates may be explained by the number of identified pathogens included, whether or not unidentified causes of foodborne illness are included, and analytical methods used for developing the estimate.
 GAO, Federal Food Safety Oversight: Additional Actions Needed to Improve Planning and Collaboration, GAO-15-180 (Washington, D.C.: Dec. 18, 2014).
 As a result of 2008 Farm Bill provisions amending the Federal Meat Inspection Act, regulatory responsibility for catfish inspection fell to FSIS in December 2015, when FSIS issued final regulations for a mandatory catfish examination and inspection program. The program regulations became effective in March 2016. 80 Fed. Reg. 75,590 (Dec. 2, 2015).
 GAO, Food Safety: FDA Coordinating with Stakeholders on New Rules but Challenges Remain and Greater Tribal Consultation Needed, GAO-16-425 (Washington, D.C.: May 19, 2016).
HHS, USDA, and OMB have taken some positive steps since the 2015 high-risk update to address fragmentation in the federal food safety oversight system—including in relation to crosscutting requirements for individual strategic and performance planning documents and collaboration on specific food safety issues—but they have not addressed our March 2011 recommendation for a government-wide plan and Congress has not acted on our December 2014 matters for it to consider for government-wide planning and leadership. We continue to believe that these actions are important to federal food safety oversight efforts. A framework for addressing these actions could be provided through development and implementation of a national strategy for food safety oversight. Food safety and government performance experts who participated in a 2-day meeting that we, with the assistance of the National Academies of Sciences, Engineering, and Medicine (National Academies), convened in June 2016 stated that there is a compelling need for such a strategy to provide a framework for strengthening the federal food safety oversight system and addressing fragmentation.
Developing a national strategy for food safety oversight could also provide a framework for addressing our March 2011 recommendation for a government-wide plan and our December 2014 matters for Congress to consider for government-wide planning and leadership. In addition, developing and implementing a national strategy could provide a framework for addressing criteria for removing food safety from the High-Risk List. Such a strategy could also include actions consistent with our prior suggestion that Congress may wish to assess the need for comprehensive, uniform, risk-based food safety legislation or amendment of FDA’s and USDA’s existing authorities.
 GAO, Food Safety: A National Strategy Is Needed to Address Fragmentation in Federal Oversight, GAO-17-74 (Washington, D.C.: Jan. 13, 2017).
To address capacity constraints for addressing fragmentation in federal oversight of food safety and to guide corrective actions and monitor progress, Congress should consider directing OMB to develop a government-wide performance plan for food safety and formalizing the Food Safety Working Group (FSWG) through statute. To provide building blocks toward OMB’s development of a government-wide performance plan for food safety, USDA should implement our priority recommendation to continue building upon its efforts to implement the GPRA Modernization Act of 2010 (GPRAMA) requirements to address crosscutting food safety efforts in its strategic and performance planning documents, which HHS has already done. These actions should provide federal food safety agencies with vehicles to demonstrate strong commitment to, top leadership support for, and progress in implementing corrective measures to address fragmentation in federal oversight of food safety. These actions could also be addressed through development and implementation of a national strategy for food safety oversight, which could thereby address criteria for removing food safety oversight from the High-Risk List. In addition, such a strategy could include actions consistent with our prior suggestion that Congress may wish to assess the need for comprehensive, uniform, risk-based food safety legislation or amendment of FDA’s and USDA’s existing authorities. If, over the next several years, weaknesses in the food safety system persist, Congress should also consider commissioning a detailed analysis of alternative organizational structures for food safety.
 Pub. L. No. 111-352, 124 Stat. 3866 (2011). GPRAMA amended provisions of the Government Performance and Results Act of 1993 (GPRA), Pub. L. No. 103-62, 107 Stat. 285.
GAO-17-74: Published: Jan 13, 2017. Publicly Released: Feb 13, 2017.
Since 2014, the Department of Health and Human Services' (HHS) Food and Drug Administration (FDA) and the U.S. Department of Agriculture's (USDA) Food Safety and Inspection Service (FSIS), the federal agencies with primary responsibility for food safety oversight, have taken some actions to address fragmentation in the federal food safety oversight system, and HHS has updated its strategic plan to...
GAO-16-425: Published: May 19, 2016. Publicly Released: May 19, 2016.
The Food and Drug Administration (FDA) took numerous steps to ensure meaningful and timely input from nonfederal officials during development of the FDA Food Safety Modernization Act (FSMA)-mandated rules on produce, human food, and animal food but did not fully meet its tribal consultation responsibilities. Among other things, FDA—an agency within the Department of Health and Human Services (HH...
GAO-15-180: Published: Dec 18, 2014. Publicly Released: Dec 18, 2014.
The Department of Health and Human Services (HHS) and the U.S. Department of Agriculture (USDA) have taken steps to implement GPRA Modernization Act of 2010 (GPRAMA) requirements but could more fully address crosscutting food safety efforts. For example, GPRAMA requires agencies to describe in their strategic and performance planning how they are working with other agencies to achieve their goals...
GAO-11-289: Published: Mar 18, 2011. Publicly Released: Mar 18, 2011.
For more than a decade, GAO has reported on the fragmented nature of federal food safety oversight and how it results in inconsistent oversight, ineffective coordination, and inefficient use of resources. In 2007, GAO added this issue to its high-risk list. In March 2009, the President established the Food Safety Working Group (FSWG) to coordinate federal efforts and establish food safety goals to...
GAO-07-310: Published: Jan 31, 2007. Publicly Released: Jan 31, 2007.
GAO's audits and evaluations identify federal programs and operations that, in some cases, are high risk due to their greater vulnerabilities to fraud, waste, abuse, and mismanagement. In recent years, GAO also has identified high-risk areas to focus on the need for broad-based transformations to address major economy, efficiency, or effectiveness challenges. Since 1990, GAO has periodically repor...