Food Safety: A National Strategy Is Needed to Address Fragmentation in Federal Oversight
Published: 2017-01-13T00:00:00

Fast Facts:
Although the U.S. food supply is generally considered safe, foodborne illness remains a costly, common public health problem.
The safety and quality of the food supply is governed by a system administered by 16 federal agencies. For example, one agency regulates frozen cheese pizzas, another agency regulates frozen pizzas with meat, and additional agencies regulate components of both.
Food safety and government performance experts agree that there is a need to develop a national strategy to provide a framework for strengthening this system. We recommend that the Executive Office of the President lead the effort to develop such a strategy.

Highlights:
section_title: Why GAO Did This Study
paragraphs: Although the U.S. food supply is generally considered safe, foodborne illness remains a common, costly, yet largely preventable public health problem. The safety and quality of food involves 16 federal agencies. For more than 4 decades, GAO has reported on the fragmented federal food safety oversight system. Because of potential risks to the economy and to public health and safety, food safety has remained on GAO's list of high-risk areas since 2007.
GAO was asked to examine efforts toward and options for addressing fragmentation in the federal food safety oversight system. This report (1) describes the actions HHS, USDA, and OMB have taken since 2014 to address fragmentation and evaluates the extent to which these agencies have addressed two prior GAO recommendations for government-wide planning and (2) assesses actions that food safety and other experts suggest are needed to improve the federal food safety oversight system. GAO convened an expert meeting, reviewed agency documents, and interviewed agency officials.
section_title: What GAO Found
paragraphs: 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 address interagency coordination on food safety. However, USDA has not yet fully implemented GAO's December 2014 recommendation that it describe interagency collaboration on food safety in its strategic and performance planning documents. In addition, the Office of Management and Budget (OMB) has not addressed GAO's March 2011 recommendation to develop a government-wide plan for the federal food safety oversight system.
At a 2-day meeting GAO hosted in June 2016, 19 food safety and other experts agreed that there is a compelling need to develop a national strategy to address ongoing fragmentation and improve the federal food safety oversight system. This is consistent with a prior GAO finding that complex interagency and intergovernmental efforts can benefit from developing a national strategy. The experts identified the following key elements of such a strategy:
Purpose: The starting point for a national strategy includes defining the problem, developing a mission statement, and identifying goals.
Leadership: The national strategy should establish sustained leadership at the highest level of the administration with authority to implement the strategy and be accountable for its progress. The strategy also needs to identify roles and responsibilities and involve all stakeholders.
Resources: The national strategy should identify staffing and funding requirements and the sources of funding for its implementation.
Monitoring: The national strategy should establish milestones that specify time frames, baselines, and metrics to monitor progress. The strategy should be sufficiently flexible to incorporate changes identified through monitoring and evaluation of progress.
Actions: In addition to long-term actions, the national strategy should include short-term actions to gain traction in improving the food safety system. Actions should focus on preventing, rather than reacting to, outbreaks of foodborne illnesses.
These elements are consistent with characteristics GAO has previously identified as desirable in national strategies. Past efforts to develop high-level strategic planning for food safety have depended on leadership from the Executive Office of the President (EOP). By developing a national strategy to guide the federal food safety oversight system and address ongoing fragmentation, the EOP, in consultation with relevant federal agencies and other stakeholders, could provide a framework for making organizational and resource decisions. Among other things, such a strategy also could provide a framework for addressing GAO's recommendation for a government-wide plan and for removing food safety oversight from GAO's High-Risk List.
section_title: What GAO Recommends
paragraphs: GAO recommends that the appropriate entities within the EOP, in consultation with stakeholders, develop a national strategy to guide the federal food safety oversight system and address ongoing fragmentation. HHS, OMB, and the Domestic Policy Council did not comment on the recommendation. USDA disagreed with the need for a national strategy but cited factors to consider should changes be proposed. GAO believes the recommendation should be implemented.

section_title: Letter
paragraphs: Although the U.S. food supply is generally considered safe, foodborne  illness remains a common, costly, yet largely preventable public health  problem. 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 the U.S. Department of  Agriculture’s (USDA) 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 the  Department of Health and Human Services’ (HHS) 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 on 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. Of the companies that had faced a recall in the past 5  years, 48 percent estimated their financial impact to be less than $9  million; 29 percent, from $10 million to $29 million; and 23 percent, $30  million or more. According to 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 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. In all, more than  3,000 nonfederal agencies perform the great majority of government food  safety activities. Among other things, these agencies investigate and  contain illness outbreaks; conduct illness surveillance and monitor the  food supply for contamination; inspect restaurants, grocery stores, and  food processing plants; and take regulatory action to remove unsafe or  unsanitary products from the market.
For more than 4 decades, we have reported on the fragmented federal  food safety oversight system. In January 2007, because of risks to the economy and to public health and safety, we added the federal oversight  of food safety to our list of areas at high risk for fraud, waste, abuse, and  mismanagement, or most in need of transformation. In March 2011, we  recommended that the Office of Management and Budget (OMB), in  consultation with the federal agencies having food safety responsibilities,  develop a government-wide performance plan for food safety. In  December 2014, we recommended that USDA and HHS more fully  describe in their strategic and performance planning documents how they  are working with other agencies to achieve their food-safety-related goals  and objectives. In our February 2015 High-Risk Update, we reported  that these recommendations had not been implemented.
You asked us to examine efforts toward and options for addressing  fragmentation in the federal food safety oversight system. This report (1)  describes the actions HHS, USDA, and OMB have taken since 2014 to  address fragmentation in the federal food safety oversight system and  evaluates the extent to which the three agencies have addressed our two  previous recommendations for government-wide planning and (2)  assesses actions that food safety and other experts suggest are needed  to improve the federal food safety oversight system.
To address our first objective, we reviewed documents and interviewed  officials from HHS, USDA, and OMB on the actions the agencies have  taken since our December 2014 report and the effect of these actions on  addressing fragmentation in the federal food safety oversight system. To  address our second objective, in June 2016, with the assistance of the  National Academies of Sciences, Engineering, and Medicine (National  Academies), we convened a 2-day GAO meeting of experts to discuss  fragmentation in the U.S. federal food safety oversight system and  suggest actions to improve the system. Through discussions with  National Academies staff and our subject matter experts, we selected  food safety and government performance experts on the basis of the  relevance of their knowledge; their prominence in the public discourse on  food safety issues; and their diversity of experience working in food  safety, such as through prior experience working for FDA, CDC, or USDA  or current experience working for the food industry. We started by  categorizing the types of expertise we needed, such as detailed  knowledge pertaining to (1) the organization and structure of the current  federal food safety oversight system, including recent efforts to enhance  collaboration among food safety agencies; (2) public organizational  structure and performance or organizational transformation; and (3) other  countries’ recent efforts to restructure their food safety oversight  systems. We developed an initial list of potential participants. We further  developed this list through a literature review, recommendations from  food safety experts, and recommendations from our subject matter  experts. Nineteen experts representing a range of expertise and interests  participated in the meeting. The experts included officials who had  formerly worked on food safety at senior levels in the federal government  as well as representatives from food-related industries, nongovernmental  research organizations, state agencies, foreign food safety agencies,  academia, and advocacy groups. (See app. I for a list of these experts  and their affiliations.) In addition to convening the meeting, we  interviewed additional food safety and other experts, including a recently  retired senior FSIS official. We also reviewed relevant laws; regulations;  our prior reports; reports from the National Academies; and other relevant  documents, such as the 2001 Food Safety Strategic Plan produced by the  President’s Council on Food Safety.
We conducted this performance audit from November 2015 to January  2017 in accordance with generally accepted government auditing  standards. Those standards require that we plan and perform the audit to  obtain sufficient, appropriate evidence to provide a reasonable basis for  our findings and conclusions based on our audit objectives. We believe  that the evidence obtained provides a reasonable basis for our findings  and conclusions based on our audit objectives.
subsections: section_title: Background
paragraphs: This section discusses the federal oversight of food safety, past reviews  of the federal food safety oversight system, and the status of federal  efforts to address criteria for removing oversight of food safety from our  High-Risk List.
subsections: section_title: Federal Oversight of Food Safety
paragraphs: Of the 16 federal agencies that collectively administer at least 30 federal  laws governing food safety and quality, FDA and FSIS have primary  responsibility for food safety oversight. Table 1 summarizes the food  safety responsibilities of all 16 agencies.
As we said earlier, for more than 4 decades, we have reported on the  fragmented nature of federal food safety oversight. For example, in our  past work, we described how FDA is generally responsible for ensuring  that eggs in their shells (referred to as shell eggs) are safe, wholesome,  and properly labeled; FSIS is responsible for the safety of eggs  processed into egg products; USDA’s Agricultural Marketing Service  (AMS) sets quality and grade standards for shell eggs, such as Grade A;  USDA’s Animal and Plant Health Inspection Service (APHIS) manages  the program that helps ensure laying hens are free from Salmonella at  birth; and FDA oversees the safety of the feed that hens eat. In addition,  we reported that FDA has primary responsibility for regulating  manufacturers of frozen cheese pizzas, FSIS has primary responsibility  for regulating manufacturers of frozen pizzas with meat, and multiple  additional federal agencies play roles in regulating the components of  either type of pizza. Similarly, we have noted that FSIS inspects  manufacturers of packaged open-face meat or poultry sandwiches (i.e.,  those with one slice of bread), but FDA inspects manufacturers of  packaged closed-face meat or poultry sandwiches (i.e., those with two  slices of bread). However, establishments producing closed-faced meat  or poultry sandwiches intended for export to Canada can be inspected for  Hazard Analysis and Critical Control Point (HACCP) compliance by FSIS  under a voluntary inspection program, and samples collected by FSIS will  be tested for certain pathogens by AMS.
section_title: Past Reviews of the Federal Food Safety Oversight System
paragraphs: In an August 1998 report, the National Academies concluded that the  fragmented federal food safety oversight system was not well-equipped to  meet emerging challenges. In response to the academies’ report, the  President established a Council on Food Safety later that year and  charged it with developing a comprehensive strategic plan for federal food  safety activities, among other things. The council’s Food Safety Strategic  Plan, released on January 19, 2001, recognized the need for a  comprehensive food safety statute and concluded that the organizational  structure of the food safety system makes it more difficult to achieve  future improvements in efficiency, efficacy, and allocation of resources  based on risk. In October 2001, we recommended that USDA, HHS, and  the Assistant to the President for Science and Technology, as joint chairs  of the President’s Council on Food Safety, reconvene the council, which  had disbanded earlier that year, to facilitate interagency coordination on  food safety regulation and programs.
In our prior work, we have also identified options for reducing  fragmentation and overlap in food safety oversight, including alternative  organizational structures. These options include establishing a single food  safety agency, a food safety inspection agency, a data collection and  risk analysis center, and a coordination mechanism led by a central  chair. We also suggested that Congress might wish to assess the need  for comprehensive, uniform, risk-based food safety legislation or to  amend FDA’s and USDA’s existing authorities. (For descriptions of  selected options, see app. II.)
When we added the federal oversight of food safety to our list of high-risk  areas in January 2007, we found that a challenge for the 21st century  was to find a way for federal agencies with food safety responsibilities to  integrate the myriad food safety programs and strategically manage their  portfolios to promote the safety and integrity of the nation’s food supply.  We noted that we had detailed problems with the fragmented federal food  safety oversight system and had found that the system had caused  inconsistent oversight, ineffective coordination, and inefficient use of  resources. We stated that Congress and the executive branch could and  should create the environment needed to look across the activities of  individual programs within specific agencies and toward the goals that the  federal government is trying to achieve. To that end, in the January 2007  High-Risk Update, we reported that we had recommended that a  mechanism be put in place to facilitate interagency coordination on food  safety regulations and programs. We also suggested that Congress and  the executive branch work together to develop a government-wide  performance plan for food safety.
A number of actions have been taken since we added federal oversight of  food safety to our High-Risk List in 2007. In March 2009, the President  established the Food Safety Working Group (FSWG) to coordinate  federal efforts and develop goals to make food safer. In January 2011,  the FDA Food Safety Modernization Act (FSMA) was enacted,  representing the largest expansion and overhaul of U.S. food safety  authorities since the 1930s. Also in January 2011, the statutory  framework for performance management in the federal government,  originally set out in the Government Performance and Results Act of 1993  (GPRA), was updated by the GPRA Modernization Act of 2010  (GPRAMA). GPRAMA adds new requirements for addressing  crosscutting efforts in federal strategic and performance planning that  help drive collaboration and address fragmentation. For example,  GPRAMA requires agencies’ strategic plans and performance plans to  contain a description of how the agencies are working with other agencies  to achieve their goals and objectives. GPRAMA requirements apply at the  departmental or agency level, not to organizational components.
In March 2011, we recommended that OMB, in consultation with the  federal agencies having food safety responsibilities, develop an annually  updated government-wide performance plan for food safety. We stated  that a performance plan offers a framework to help ensure agencies’  goals are complementary and mutually reinforcing and to help provide a  comprehensive picture of the federal government’s performance on food  safety. Furthermore, we stated that such a plan could assist decision  makers in balancing trade-offs and comparing performance when  resource allocation and restructuring decisions are made. In December  2014, because OMB had not taken action to develop a government-wide  performance plan for food safety and the FSWG was no longer meeting,  we suggested matters for Congress to consider, including (1) directing  OMB to develop a government-wide performance plan for food safety that  includes results-oriented goals and performance measures and a  discussion of strategies and resources and (2) formalizing the FSWG  through statute to help ensure sustained leadership across food safety  agencies over time. Congress has not taken action.
We found that FDA and FSIS were involved in numerous mechanisms to  facilitate interagency coordination on food safety; however, the  mechanisms focused on specific issues and none provided for broad- based, centralized collaboration. As of September 2016, federal oversight  of food safety remained on our High-Risk List. Table 2 shows nine  selected collaborative mechanisms involving FDA and FSIS, as reported  in December 2014.
section_title: Status of Federal Efforts to Address Criteria for Removing Oversight of Food Safety from Our High-Risk List
paragraphs: We have identified five criteria, all of which must be fully met for an area  to be removed from our High-Risk List. In our February 2015 High-Risk  Update, we found that for federal oversight of food safety, three of the  criteria had been partially met, and two had not been met (see table 3).
Our assessment of whether the criteria were met focused largely on  efforts Congress and the executive branch had made toward developing  a government-wide performance plan for food safety and establishing a  centralized mechanism for broad-based collaboration, such as the  FSWG. In our February 2015 High-Risk Update, we noted that, with the  enactment of GPRAMA in January 2011, Congress and the executive  branch demonstrated leadership commitment to improving collaboration  across the federal government. We also noted that HHS and USDA had  taken steps toward our December 2014 recommendation to implement  GPRAMA’s crosscutting requirements for their food safety efforts but  could more fully address crosscutting food safety efforts in their individual  strategic and performance planning documents and thereby provide  building blocks toward implementing our March 2011 recommendation  that OMB develop a government-wide performance plan on food safety.  However, as of February 2015, OMB had not taken action on our  recommendation to develop such a plan. In addition, we noted that the  President had demonstrated leadership commitment and progress by  establishing the FSWG to coordinate federal efforts and develop goals to  make food safer. However, as of February 2015, the working group was  no longer meeting, and nothing had taken its place. Federal food safety  agencies also have the capacity to participate in a centralized,  collaborative mechanism on food safety—like the FSWG—but  congressional action would be required to formalize such a mechanism  through statute.
section_title: HHS and USDA Have Taken Some Actions Since 2014 to Address Fragmentation, but USDA and OMB Have Not Fully Addressed the Need for Government-Wide Planning
paragraphs: HHS and USDA have taken some actions since 2014 to address  fragmentation in the federal food safety oversight system, and OMB has  focused on implementing FSMA, but USDA’s and OMB’s actions have not  fully addressed our two recommendations for government-wide planning.  Since 2014, 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. OMB has focused its  efforts on working with agencies to facilitate implementation of FSMA.  The facilitation, collaboration, and updates are positive steps, but USDA’s  and OMB’s actions do not fully address our two recommendations for  government-wide planning.
subsections: section_title: Since 2014, HHS and USDA Have Enhanced Collaboration, and HHS Has Updated Its Strategic Plan to Address Crosscutting Food Safety Issues
paragraphs: The two agencies with primary responsibility for food safety within HHS  and USDA—FDA and FSIS, respectively—continue to use the nine  collaborative mechanisms that we reported on in December 2014, all of  which focus on specific issues. For example, FDA and FSIS continue to  collaborate with CDC through the Interagency Food Safety Analytics  Collaboration to improve estimates of the most common sources of  foodborne illnesses. According to CDC’s website, the three agencies  teamed up to create this collaboration. Its goal is to improve coordination  of federal food safety analytic efforts and address crosscutting priorities  for food safety data collection, analysis, and use. FSIS and FDA also  serve as the co-lead organizations for the food safety topic area under  Healthy People 2020, a national health promotion and disease prevention  initiative that provides 10-year national objectives for improving the health  of all Americans and includes 42 topic areas. The food safety topic area  has six objectives related to the goal of reducing foodborne illnesses in  the United States, such as reducing infections caused by key pathogens  transmitted commonly through food and increasing the proportion of  consumers who follow key food safety practices. According to USDA  officials, Healthy People 2020 informs their agency goals and their work  with CDC and FDA.
In addition, over the past 2 years, FDA and FSIS have developed one  new collaborative mechanism, according to FDA and FSIS officials. The  mechanism, called the Interagency Collaboration on Genomics and Food  Safety (Gen-FS), also includes CDC and the National Institutes of Health  (NIH). Gen-FS focuses on sequencing the complete DNA of pathogens  for surveillance, detection and investigation of outbreaks, and antibiotic  resistance for pathogens causing intestinal illnesses transmitted by food  and other routes, according to FSIS officials. The Gen-FS steering  committee meets monthly to discuss harmonization of training, laboratory  methodologies, and data access and analysis, according to FDA officials.
Furthermore, FDA officials said that implementing FSMA has been the  agency’s major food safety focus over the past 2 years, and FDA is  partnering with nongovernmental stakeholders, state and local  governments, and federal agencies to ensure FSMA’s successful  implementation. Under FSMA, FDA is responsible for more than 50  regulations, guidelines, and studies. This includes seven foundational  rules. Table 4 provides additional information on the foundational rules.
For example, FDA issued the final FSMA rule on produce, one of the  foundational FSMA rules, in November 2015. The rule establishes  science-based minimum standards for the safe growing, harvesting,  packing, and holding of produce, meaning fruits and vegetables grown for  human consumption. To develop the rule, which went into effect on  January 26, 2016, FDA officials said they worked directly with farmers,  which required a significant amount of collaboration with USDA and the  states. In addition, these officials said they worked with the  Environmental Protection Agency (EPA) on water quality and safety  aspects of the produce rule, with the Department of Homeland Security  on the intentional adulteration rule, and with the Department of  Transportation on the sanitary transportation rule. Furthermore, in May  2016, we found that FDA had taken numerous steps to ensure  meaningful and timely input from nonfederal officials during development  of the FSMA-mandated rules on produce, human food, and animal food  but did not fully meet its tribal consultation responsibilities.
OMB staff told us that their main food safety-related focus since 2014 has  been on meeting with agencies to oversee FSMA implementation. OMB  staff stated that they meet with FDA and FSIS officials via conference  calls on a regular basis to discuss the implementation of FSMA, as well  as the agencies’ budgets, regulations, and food safety issues more  broadly. These meetings occur at times separately and at times with both  FDA and FSIS officials present, according to OMB staff. These staff also  said that they work on an agency-specific basis, helping agencies  develop agency-specific performance plans, talking to agencies about  how to improve performance, and working with agencies to collaborate on  FSMA implementation.
In December 2014, we found that HHS and USDA did not fully address  crosscutting food safety efforts in their individual strategic and  performance planning documents and that doing so could help provide a  comprehensive picture of the federal government’s performance on food  safety. We recommended that both HHS and USDA more fully describe  how they are working with other agencies to achieve food-safety-related  goals in their strategic and performance planning documents, as required  by GPRAMA, and the agencies agreed with our recommendation. Since  then, in taking steps to update its strategic and performance planning  documents to better address crosscutting food safety efforts, HHS  implemented our recommendation. Specifically, in February 2015, HHS  updated its strategic plan to more fully describe how it is working with  other agencies to achieve its food-safety-related goals and objectives.  Among other things, HHS described its collaboration with USDA, EPA,  and others through collaborative mechanisms such as the National  Antimicrobial Resistance Monitoring System, the Partnership for Food  Protection (PFP), and the Food Emergency Response Network.  However, USDA has not fully implemented our recommendation,  although it has taken some steps toward doing so. For example, FSIS  included more information on crosscutting food safety efforts in its fiscal  year 2017-2021 strategic plan and in its draft fiscal year 2017 annual plan  than it did in its prior strategic and annual plans. In its fiscal year 2017- 2021 strategic plan, it included a list of collaborations, and the draft fiscal  year 2017 annual plan includes a section on enhancing collaboration with  partners. In addition, FSIS officials told us that FSIS is partnering with  CDC, FDA, and NIH on the HHS agency priority goal to reduce foodborne  illness caused by Listeria. The priority goal includes (1) sequencing the  complete DNA of Listeria strains to improve the detection and  investigation of Listeria outbreaks and (2) FDA and FSIS jointly reporting  on their activities to reduce Listeria at various points across the food  supply chain. USDA plans to include information on interagency  collaboration in its next strategic plan, according to USDA officials.
section_title: OMB’s Efforts Since 2014 Do Not Address Our Recommendation for a Government-Wide Plan
paragraphs: As noted above, HHS’s and USDA’s efforts since 2014 are positive steps  toward government-wide planning, but OMB has not addressed our  recommendation for a government-wide plan for the federal food safety  oversight system. Without an annually updated government-wide  performance plan for food safety that includes results-oriented goals,  performance measures, and a discussion of strategies and resources,  which we recommended to OMB in March 2011, Congress, program  managers, and other decision makers are hampered in their ability to  identify agencies and programs addressing similar missions and to set  priorities, allocate resources, and restructure federal efforts, as needed,  to achieve long-term goals. Also, without such a plan, federal food  safety efforts are not clear and transparent to the public.
OMB staff told us that they were not aware of any current plans to  develop a government-wide performance plan for food safety. OMB staff  said that OMB works on an agency-specific basis, providing input on  agencies’ performance plans and offering suggestions on how to improve  performance. However, agencies’ individual performance plans alone do  not provide the integrated perspective on federal food safety performance  necessary to guide congressional and executive-branch decision making  and inform the public about what federal agencies are doing to ensure  food safety. A government-wide performance plan would provide a  coordinated action plan for food safety and a plan for monitoring and  measuring agencies’ activities. We continue to believe that a government- wide plan is important for federal food safety oversight efforts.
section_title: Food Safety and Other Experts Suggested That a National Strategy Is Needed to Improve the Federal Food Safety Oversight System
paragraphs: Food safety and government performance experts identified the  development and implementation of a national strategy for food safety as  a first step toward improving the federal food safety oversight system.  Experts identified examples of negative effects that continue to occur as a  result of fragmentation in the federal food safety oversight system. These  experts agreed that there is a compelling need to develop a national  strategy to provide a framework for strengthening that system and  addressing fragmentation and described five key elements that should be  included in such a strategy. Developing a national strategy for food safety  oversight could also provide a framework for addressing our March 2011  recommendation for a government-wide plan, our December 2014  matters for Congress to consider for leadership and planning, and criteria  for removing federal food safety oversight from the High-Risk List.
subsections: section_title: Food Safety and Government Performance Experts Cited Negative Effects of Fragmentation in the Federal Food Safety Oversight System
paragraphs: During the 2-day meeting we hosted with the assistance of the National  Academies, food safety and government performance experts cited  examples of the negative effects that continue to occur as a result of  fragmentation in the federal food safety oversight system. These  examples further illustrate negative effects we have highlighted in our  past work, including our 2015 High-Risk Update. For example, experts  noted that FDA and FSIS have different statutory authorities. One expert  noted that the two agencies’ statutory authorities result in two  fundamentally different approaches to inspections. FDA’s authority  requires a risk-based approach, in which inspection rates vary depending  on the level of risk associated with a food product. FSIS’s authority, in  contrast, directs the agency to examine the carcasses and parts of  covered animal species and all processed food products before they  enter the food supply. Because of these differences, an expert raised  questions about the proper allocation of resources based on risk.
Commenting on the food safety system more broadly, several experts  noted that the allocation of resources is not necessarily connected to the  risk of foodborne illness. For example, one expert noted that at the  federal level, FSIS and FDA receive close to the same amount of funding  for food safety oversight but that FSIS is responsible for the safety of 20  percent of the food supply, and FDA is responsible for ensuring the safety  of 80 percent of it. Furthermore, because FSIS must meet continuous  inspection requirements, it may be allocating too many resources to  inspecting low-risk food processing facilities that produce foods that do  not pose substantial threats to public health, according to another  expert. For example, the expert highlighted the differences in resource  allocation by comparing inspection rates at facilities producing cheese  and pepperoni pizzas. A production line at the facility producing cheese  pizza, which is regulated by FDA, may be inspected once every 5 years.  On the other hand, a production line producing pepperoni pizza, which is  regulated by FSIS, is inspected daily. The expert said the risk of  foodborne pathogens related to both types of pizza is low because the  pizzas are cooked. While raw meat is a high-risk food, meat that is  thoroughly cooked, such as pepperoni on pizza, does not pose the same  level of risk because the process of cooking eliminates existing  pathogens.
section_title: Experts Agreed That There Is a Compelling Need to Develop a National Food Safety Strategy and Identified Its Key Elements
paragraphs: The 19 experts attending our 2-day meeting agreed that there is a  compelling need to develop a national strategy to provide a framework for  strengthening the federal food safety oversight system and addressing  fragmentation. The experts identified and described five key elements  that should be included in a national strategy for food safety oversight.  These five key elements follow.
Purpose: The starting point for developing a national strategy  includes defining the problem, developing a mission statement, and  identifying goals.
Leadership: The national strategy should establish sustained  leadership to achieve progress in food safety oversight. The  leadership should reside at the highest level of the administration and  needs to have authority to implement the national strategy and be  accountable for its progress. The strategy also needs to identify roles  and responsibilities for implementing the national strategy and involve  all stakeholders, including federal, tribal, state, and local government  agencies; industry; consumer groups; academia; and key  congressional committees.
Resources: The national strategy should identify staffing and funding  requirements and the sources of funding for implementing the  strategy.
Monitoring: The national strategy should establish milestones that  specify time frames, baselines, and metrics to monitor progress. The  national strategy should be sufficiently flexible to incorporate changes  identified through monitoring and evaluation of progress.
Actions: In addition to long-term actions, the national strategy should  include short-term actions, such as improving training for food safety  officials, to gain traction on improving the food safety system. Actions  should focus on preventing, rather than reacting to, outbreaks of  foodborne illnesses. For example, several experts mentioned  modifying the statutes that FSIS implements, such as the Federal  Meat Inspection Act and the Poultry Improvement Act, to align the  authorities of USDA with the Federal Food, Drug, and Cosmetic Act,  as amended by FSMA, which outlines FDA’s responsibilities. This  could help ensure a consistent approach across food commodities.  See appendix III for a list of actions identified by the experts that could  be considered for inclusion in a national strategy for food safety  oversight.
The experts’ call for a national strategy for food safety oversight is  consistent with our past work on national strategies. We found that  complex interagency and intergovernmental efforts, which could include  food safety, can benefit from developing a national strategy and  establishing a focal point with sufficient time, responsibility, authority and  resources to lead the effort. For example, in August 2007, we reported  on another area involving significant coordination and collaboration  across all levels of government, as well as the private sector: preparing  for and responding to an influenza pandemic. We found that, as part of  its efforts to address the potential threat of an influenza pandemic, the  executive branch had developed a National Strategy for Pandemic  Influenza and an associated implementation plan and had started working  toward completing the plan’s action items. In February 2004, we reported  that national strategies themselves are not endpoints, but rather, starting  points, and, as with any strategic planning effort, implementation is the  key.
The five key elements of a national strategy identified by the experts are  also consistent with characteristics we have identified as desirable in a  national strategy. In our February 2004 report, we found that national  strategies are not required, either by executive or legislative mandate, to  address a single, consistent set of characteristics. However, on the  basis of a review of numerous sources, we identified six desirable  characteristics to aid responsible parties in further developing and  implementing national strategies. Table 5 lists and describes the six  desirable characteristics and shows how the elements of a national  strategy for food safety oversight identified by experts align with the six  desirable characteristics.
Although the experts did not specify which entity should lead the national  strategy, past efforts to develop high-level strategic planning for food  safety have depended on leadership from entities within the Executive  Office of the President (EOP), such as the Domestic Policy Council  (DPC), the Office of Science and Technology Policy (OSTP), and OMB.  For example, the President’s Council on Food Safety was co-chaired by  OSTP, along with HHS and USDA, and involved staff and officials from  OMB and the DPC among others. Similarly, the FSWG was led by USDA  and HHS and was convened by the DPC. OMB staff and FDA officials  stated that a national strategy for improving food safety could be  beneficial. However, FDA officials cautioned that timing would be an  important consideration given that FDA is focused on FSMA  implementation. FSIS officials said that they would defer to OMB  regarding questions on the potential benefit of a national strategy for food  safety. OMB staff said that OMB relies on direction from the  administration to determine national priorities.
Entities within the EOP also play a leadership role in other ongoing  strategies that require cross-agency collaboration. For example, since  December 2013, OSTP and the National Security Council have led a  multi-agency effort, including HHS and USDA, to develop the National  Strategy for Combating Antibiotic-Resistant Bacteria, with a goal of  preventing, detecting, and controlling outbreaks of antibiotic-resistant  pathogens. In addition, OMB has established a cross-agency priority  goal of improving science, technology, engineering, and mathematics  education. Since May 2013, OSTP has taken a lead role, along with the  National Science Foundation, in working with multiple agencies to  implement a 5-year strategic plan. By developing a national strategy to  guide the nation’s efforts to improve the federal food safety oversight  system and address ongoing fragmentation, the appropriate entities  within the EOP, in consultation with relevant federal agencies and other  stakeholders, could provide a comprehensive framework for considering  organizational changes and making resource decisions.
section_title: A National Strategy Could Provide a Framework for Addressing Our Recommendation for a Government-Wide Plan, Our Matters for Congress to Consider for Leadership and Planning, and Criteria for Removing Federal Food Safety Oversight from Our High-Risk List
paragraphs: Developing a national strategy for food safety oversight, as suggested by  the experts, could provide a framework for addressing our March 2011  recommendation for a government-wide plan and our December 2014  matters for congressional consideration for leadership and government- wide planning. As we mentioned previously, we have found that complex  interagency and intergovernmental efforts can benefit from developing a  national strategy and establishing a focal point with sufficient time,  responsibility, authority, and resources to lead the effort. The national  strategy, as described by the experts and possessing the desirable  characteristics described in our past work, could fulfill the intent behind  our March 2011 recommendation for OMB to develop a government-wide  performance plan for food safety. Such a strategy could include all of  the elements of a government-wide performance plan for federal food  safety oversight, such as government-wide goals and performance  indicators. In addition to addressing our recommendation for a  government-wide plan, to the extent that a national strategy for food  safety oversight establishes sustained leadership for the issue, it could  fulfill the intent behind our December 2014 matter for Congress to  consider formalizing the FSWG through statute to help ensure sustained  leadership across food safety agencies over time.
In addition, developing and implementing a national strategy could  provide a framework for addressing the five criteria for removing federal  food safety oversight from our High-Risk List. As discussed previously,  experts agreed that a national strategy should include sustained  leadership, which could address the criterion for leadership commitment.  In addition, the national strategy, by including information on resource  requirements, actions, and milestones and metrics to monitor progress,  could also meet our criteria for capacity, an action plan, and monitoring,  respectively. Finally, depending on its contents, a national strategy could  demonstrate progress in implementing corrective measures, the final  criterion for removing federal food safety oversight from our High-Risk  List.
section_title: Conclusions
paragraphs: Since 2014, the primary federal agencies responsible for ensuring a safe  food supply—FDA and FSIS—have taken actions to address  fragmentation in the federal food safety oversight system. However, food  safety and government performance experts who participated in the  meeting we convened cited examples of the negative effects that  continue to occur as a result of fragmentation in the federal food safety  oversight system and generally agreed that there is a need for a national  food safety strategy. These examples further illustrate negative effects  that we have highlighted in our past work. The experts identified five key  elements that should be included in such a strategy: stating the purpose,  establishing sustained leadership, identifying resource requirements,  monitoring progress, and including actions for gaining traction. These  elements are consistent with characteristics that we have identified as  desirable in a national strategy. By developing a national strategy to guide  the nation’s efforts to improve the federal food safety oversight system  and address ongoing fragmentation, the appropriate entities within the  EOP, in consultation with relevant federal agencies and other  stakeholders, could provide a comprehensive framework for considering  organizational changes and making resource decisions. Experts identified  the following stakeholders as key contributors to a national strategy for  food safety: federal, tribal, state, and local government agencies; industry;  consumer groups; academia; and key congressional committees. Such a  national strategy also could provide a framework for addressing our  recommendation for a government-wide plan, our matters for Congress to  consider for leadership and planning, and criteria for removing federal  food safety oversight from our High-Risk List.
section_title: Recommendation for Executive Action
paragraphs: To guide the nation’s efforts to improve the federal food safety oversight  system and address ongoing fragmentation, we recommend that the  appropriate entities within the EOP, in consultation with relevant federal  agencies and other stakeholders, develop a national strategy that states  the purpose of the strategy, establishes high-level sustained leadership,  identifies resource requirements, monitors progress, and identifies short-  and long-term actions to improve the food safety oversight system.
section_title: Agency Comments and Our Evaluation
paragraphs: We provided a draft of this report to HHS, USDA, OMB, and DPC for their  review and comment. In written comments, HHS did not comment on our  recommendation to the EOP. USDA disagreed with the need for a  national strategy but cited factors to consider should changes be  proposed. USDA also discussed several points related to the report’s  findings. HHS’s and USDA’s written comments are reproduced in  appendixes IV and V, respectively. In addition, HHS and USDA provided  technical corrections, which we incorporated as appropriate. Also,  according to an e-mail from the Special Assistant to the President of the  EOP, OMB and DPC did not have comments on the draft report.
To guide the nation’s efforts to improve the federal food safety oversight  system and address ongoing fragmentation, we recommended that the  appropriate entities within the EOP, in consultation with relevant federal  agencies and other stakeholders, develop a national strategy that states  the purpose of the strategy, established high-level sustained leadership,  identifies resource requirements, monitors progress, and identifies short-  and long-term actions to improve the food safety oversight system. USDA  stated that it is not yet convinced that developing and implementing a  national strategy would result in significantly different outcomes in  protecting public health by preventing foodborne illness with its partners.  However, USDA also noted that, should major changes to the federal  food safety system be proposed, it is imperative that they are data-driven,  well-designed, collaborative, and ultimately, continue to enable the United  States to have the safest food supply in the world. Even with USDA’s  reservations, we continue to believe that a national strategy would  provide a comprehensive framework for considering organizational  changes and resource decisions to improve the federal food safety  oversight system.
USDA made a number of other comments related to the report’s findings.  First, USDA stated the report does not appear to explain or acknowledge  the depth and breadth of key federal agency efforts and activities to work  together within the bounds of existing statutory authorities, particularly  across FSIS, FDA, CDC, and other federal food safety partners. In  addition, USDA said that the report appears to significantly underestimate  the complexity of modifying statutes that FSIS and FDA currently  implement with the intent of better alignment. Related to acknowledging  the depth and breadth of key federal efforts and activities, in our  December 2014 report, we identified and described numerous  collaborative mechanisms involving FDA and FSIS to highlight these  positive efforts, and for this report, we requested information on any  additional collaborative mechanisms developed since 2014, which we  included. However, we found and continue to believe that these  mechanisms focus on specific issues and do not provide for broad-based,  centralized collaboration that would allow FDA, FSIS, and other agencies  to look across their individual food safety programs and determine how  they all contribute to federal food safety goals. Related to underestimating  the complexity of modifying statutes that FSIS and FDA currently  implement, we discuss modifying statutes as an example of the numerous  actions that experts identified could be considered for inclusion in a  national strategy for food safety oversight. We envision that ultimately it  will be up to the stakeholders participating in such a strategy to decide  which actions to pursue.
Second, USDA stated that FSIS continues to strongly disagree with the  draft report in that it undervalues and diminishes the many collaborative  mechanisms that are in place among FSIS and FDA, as well as with CDC  and other federal and non-federal food safety and public health partners.  In addition, FSIS said that the characterizations of all collaborations as  “narrow” and “specific,” and the implication that broad-based collaboration  does not occur through FSIS’s deeply integrated engagement, is  inaccurate. Further, USDA stated that the implication that the  collaborations are not well-targeted or sufficient appears to reflect a lack  of understanding of how agencies with food safety/public health  responsibilities operate in sync with each other. USDA also stated that  FSIS’s activities with FDA, CDC, and other food safety partners are  strategic, highly outcome- and mission-driven, and fully address the  GPRAMA crosscutting requirements for federal strategic and  performance planning that help drive collaboration and address  fragmentation. USDA stated that it is important to note that we did not  present or provide any evidence for any area where sufficient  collaboration does not occur. As we said earlier, we found and continue to  believe that these collaborative mechanisms focus on specific issues and  do not provide for broad-based, centralized collaboration that would allow  FDA, FSIS, and other agencies to look across their individual food safety  programs and determine how they all contribute to federal food safety  goals.
Third, USDA stated that it appreciated that our report attempts to  recognize new collaborations since 2014; however, it does not include  three of four new collaborations on which FSIS provided testimonial or  written information to us—the HHS agency priority goal for foodborne  Listeria monocytogenes illnesses interagency effort, PFP, and the One  Health Initiative. Related to the HHS agency priority goal, in the report, we  stated that FSIS officials told us that FSIS is partnering with CDC, FDA,  and NIH on the HHS agency priority goal to reduce foodborne illness  caused by Listeria. PFP and the One Health Initiative were established  prior to 2014; however, in the report, we did discuss PFP in the context of  presenting examples of collaborative mechanisms involving FDA and  FSIS that we reported on in December 2014 and collaborative  mechanisms described by HHS in its updated strategic plan.
Fourth, USDA stated that our report indicates that USDA has not fully  implemented our prior recommendation to address crosscutting food  safety efforts in its strategic and performance planning documents,  because USDA, at the department level, did not alter its just-published  fiscal year 2014-2018 strategic plan to mention food safety collaboration  across USDA’s large, broad, multi-agency portfolio. USDA stated that  FSIS believes our continued focus on USDA not editing and reissuing its  departmental strategic plan to include such reference to be misplaced.  Further, USDA stated that food safety collaboration is addressed in the  USDA fiscal year 2014-2018 strategic plan’s key food safety illness  indicator, which directly reflects FSIS’s broad, long-standing collaborative  activity with FDA and CDC associated with Healthy People, and in FSIS’s  fiscal year 2011-2016 and fiscal year 2017-2021 strategic plans. In our  December 2014 report, we stated that GPRAMA requires agencies to  include in their strategic plan a description of how they are working with  other agencies to achieve their goals and objectives. In addition, we  stated that GPRAMA does not apply to organizational components of  agencies. Instead, agencies are expected to work with their components  to implement GPRAMA requirements in a manner that is most useful to  the whole organization. In December 2014, we found several relevant  crosscutting efforts that were not identified in USDA’s fiscal year 2014- 2018 strategic plan, and recommended that USDA more fully describe in  its strategic and performance planning documents how it is working with  other agencies to achieve its food-safety-related goals and objectives. In  December 2014, USDA concurred with our recommendation, and USDA  plans to include information on interagency collaboration in its next  strategic plan, according to USDA officials.
Fifth, USDA stated that it is concerned about the implication that many of  the possible actions to include in a national strategy do not require  congressional approval and can be taken by executive branch agencies  without such approval; USDA stated that they cannot. In addition, USDA  stated that while the recommendation for executive action is quite  general, the specifics, as outlined in appendix III of our report, appear far  too prescriptive for us to typically recommend, and place disproportionate  value on expert opinion rather than on data-driven analysis. Further,  USDA stated that we appear to place importance on expert opinions,  including citing many statements that were factually incorrect or  misrepresented in a prior draft, and some of whose testimonial  statements we removed. This included statements that implicitly  supported assertions that FDA’s statutory authorities could be appropriate  to apply to the products that FSIS regulates. USDA stated that no data,  study, or evidence supports this approach as being more protective of  public health and prevention of foodborne illness. USDA also stated that it  continues to be concerned about our selective and dominant use of  expert opinion studies to support its findings. In addition, USDA stated  that we cite certain prior studies and panels from 1998, 2001, and more  recently, yet other studies, such as one in 2002 by a White House- established Policy Coordinating Committee, concluded that the goals of  the Administration were better advanced through enhanced interagency  coordination rather than through, for example, the development of  legislation to create a single food safety agency. Related to USDA’s  concerns about the actions listed in appendix III requiring congressional  approval and appearing too prescriptive, the purpose of the appendix was  to present a list of actions identified by the experts that could be  considered for inclusion in a national strategy for food safety. As we  stated earlier, we envision that ultimately it will be up to the stakeholders  participating in such a strategy to decide which actions to pursue. Related  to USDA’s concern about the apparent importance we place on expert  opinions and our use of expert opinion studies to support our findings, we  selected food safety and government performance experts on the basis of  the relevance of their knowledge; their prominence in the public discourse  on food safety issues; and their diversity of experience working in food  safety, such as through prior experience working at senior levels for FDA,  CDC, or USDA or current experience working for the food industry. We  took steps to confirm the accuracy of information the experts provided  before including it in our final product. Related to USDA’s concern about  the development of legislation to create a single food safety agency, we  discuss this option in an appendix in which we list a number of options we  have identified in our past work to improve the federal food safety  oversight.
Sixth, USDA stated that in prior reports, we have written that programs  are put on the High-Risk List because of their vulnerabilities to fraud,  waste, abuse, or mismanagement, or are most in need of transformation  to address economy, efficiency, or effectiveness challenges. Given this  standard, USDA said that it continues to assert that food safety should no  longer be listed as high risk. We have identified five criteria, all of which  must be fully met for an area to be removed from our High-Risk List. In  our February 2015 High-Risk Update, we found that for federal oversight  of food safety, three of the criteria had been partially met, and two had not  been met. Our assessment of whether the criteria were met focused  largely on efforts Congress and the executive branch had made toward  developing a government-wide performance plan for food safety and  establishing a centralized mechanism for broad-based collaboration, such  as the FSWG. However, we found that USDA’s and OMB’s actions since  2014 have not fully addressed the need for government-wide planning. In  addition, we acknowledge that congressional action would be required to  formalize in statute a centralized, collaborative mechanism on food  safety, like the FSWG; however, federal food safety agencies do have the  capacity to participate in such a mechanism. We believe that a national  strategy for food safety could provide a framework for addressing the five  criteria for removing federal food safety oversight from our High-Risk List.
As agreed with your offices, unless you publicly announce the contents of  this report earlier, we plan no further distribution until 30 days from the  report date. At that time, we will send copies to the appropriate  congressional committees; the Secretary of Health and Human Services;  the Secretary of Agriculture; the Director, Office of Management and  Budget; and other interested parties. In addition, the report will be  available at no charge on the GAO website at http://www.gao.gov.
If you or your staff members have any questions regarding this report,  please contact me at (202) 512-3841 or morriss@gao.gov. Contact points  for our Offices of Congressional Relations and Public Affairs may be  found on the last page of this report. Key contributors to this report are  listed in appendix VI.
section_title: Appendix I: Participants in the June 9-10, 2016, Meeting of Experts
paragraphs: On June 9 and 10, 2016, with the assistance of the National Academies  of Sciences, Engineering, and Medicine, we convened a 2-day meeting of  food safety and government performance experts to discuss  fragmentation in the U.S. federal food safety oversight system and  suggest actions to improve that system. Table 6 lists the experts who  participated in the meeting, along with their affiliations. We selected food  safety and government performance experts on the basis of the relevance  of their knowledge; their prominence in the public discourse on food  safety issues; and their diversity of experience working in food safety,  such as through prior experience working on food safety at senior levels  in the federal government as well as through current work in food-related  industries, nongovernmental research organizations, state agencies,  foreign food safety agencies, academia, and advocacy groups.
section_title: Appendix II: Options GAO Has Identified to Improve the Federal Food Safety Oversight System
paragraphs: In our previous work, we have identified several options to improve the  federal food safety oversight system. These options include establishing a  coordination mechanism led by a central chair, a food safety inspection  agency, a data collection and risk analysis center, and a single food  safety agency and are described in table 7.
section_title: Appendix III: Actions Identified by Experts to Consider Including in a National Strategy to Improve Food Safety Oversight
paragraphs: During the 2-day meeting we convened with the assistance of the  National Academies of Sciences, Engineering, and Medicine, experts  identified a number of actions to consider including in a national strategy  to improve food safety oversight. At least 10 of the 19 experts agreed that  each of these actions described in table 8 could be appropriate to  consider for inclusion in a national strategy, but not all of the experts  agreed that every identified action should be considered. We are not  endorsing any of these actions. These actions were identified by experts  for consideration.
section_title: Appendix IV: Comments from the Department of Health and Human Services
section_title: Appendix V: Comments from the U.S. Department of Agriculture
section_title: Appendix VI: GAO Contact and Staff Acknowledgments
subsections: section_title: GAO Contact
section_title: Staff Acknowledgments
paragraphs: In addition to the contact named above, Anne K. Johnson (Assistant  Director), Kevin Bray, Candace Carpenter, Stephen Cleary, Michelle  Duren, Ellen Fried, Kirsten Lauber, Benjamin T. Licht, Marya Link, Rekha  Vaitla, Walter Vance, and Sarah Veale made key contributions to this  report.