Federal Oversight of Food Safety: FDA's Food Protection Plan Proposes Positive First Steps, but Capacity to Carry Them Out Is Critical
Published: 2008-01-29T00:00:00

Fast Facts:

Highlights:
section_title: Why GAO Did This Study
paragraphs: The Food and Drug Administration (FDA) is responsible for ensuring the safety of roughly 80 percent of the U.S. food supply, including $417 billion worth of domestic food and $49 billion in imported food annually. The recent outbreaks of E. coli in spinach, Salmonella in peanut butter, and contamination in pet food highlight the risks posed by the accidental contamination of FDA-regulated food products. Changing demographics and consumption patterns underscore the urgency for effective food safety oversight. In response to these challenges, in November 2007, FDA and others released plans that discuss the oversight of food safety. FDA's Food Protection Plan sets a framework for food safety oversight. In addition, FDA's Science Board released FDA Science and Mission at Risk, which concluded that FDA does not have the capacity to ensure the safety of the nation's food supply. This testimony focuses on (1) federal oversight of food safety as a high-risk area that needs a governmentwide reexamination, (2) FDA's opportunities to better leverage its resources, (3) FDA's Food Protection Plan, and (4) tools that can help agencies to address management challenges. To address these issues, GAO interviewed FDA officials; evaluated the Food Protection Plan using a GAO guide for assessing agencies' performance plans; and reviewed pertinent statutes and reports. GAO also analyzed data on FDA inspections and resources.
section_title: What GAO Found
paragraphs: FDA is one of 15 agencies that collectively administer at least 30 laws related to food safety. This fragmentation is the key reason GAO added the federal oversight of food safety to its High-Risk Series in January 2007 and called for a governmentwide reexamination of the food safety system. We have reported on problems with this system--including inconsistent oversight, ineffective coordination, and inefficient use of resources. FDA has opportunities to better leverage its resources. Efficient use of resources is particularly important at FDA because we found that its food safety workload has increased in the past decade, while its food safety staff and funding have not kept pace. GAO has recommended that FDA establish equivalence agreements with other countries to shift some oversight responsibility to foreign governments, explore the potential for certifying third party inspections, and consider accrediting private laboratories to inspect seafood, among other actions. We also reported that FDA and the U.S. Department of Agriculture (USDA) conduct similar inspections at 1,451 facilities that produce foods regulated by both agencies. To reduce overlaps, we recommended that, if cost-effective, FDA enter into an agreement to commission USDA inspectors at such facilities. FDA incorporated some of these recommendations in its Food Protection Plan. FDA's Food Protection Plan also proposes some positive first steps intended to enhance its oversight of food safety. Specifically, FDA requests authority to order food safety recalls and issue additional preventive controls for high-risk foods, both of which GAO has previously recommended. However, more specific information about its strategies and the resources FDA needs to implement the plan would facilitate congressional oversight. FDA officials acknowledge that implementing the Food Protection Plan will require additional resources. Without a clear description of resources and strategies, it will be difficult for Congress to assess the likelihood of the plan's success in achieving its intended results. The Science Board cites numerous management challenges that have contributed to FDA's inability to fulfill its mission, including a lack of a coherent structure and vision, insufficient capacity in risk assessment, and inadequate human capital recruitment and retention. In light of these challenges, GAO has identified through other work some tools that can help agencies improve their performance over time. For example, a Chief Operating Officer/Chief Management Officer can help an agency address longstanding management problems that are undermining its ability to accomplish its mission and achieve results. In addition, a well-designed commission can produce specific practical recommendations that Congress can enact. Critical success factors that can help ensure a commission's success include a statutory basis with adequate authority, a clear purpose and timeframe, leadership support, an open process, a balanced membership, accountability, and resources.

section_title: Letter
paragraphs: I am pleased to be here today to discuss the resources the Food and Drug  Administration (FDA) uses to meet one of its key regulatory  responsibilities, the oversight of food safety. FDA is responsible for  ensuring the safety of roughly 80 percent of the U.S. food supply, including  $417 billion worth of domestic food and $49 billion in imported food  annually. Contaminated food can harm human health, have severe  economic consequences, and undermine consumer confidence in the  government’s ability to ensure the safety of the U.S. food supply. The  recent outbreaks of E. coli in spinach, Salmonella in peanut butter, and  contamination in pet food, highlight the risks posed by the accidental  contamination of FDA-regulated food products. For example, according to  FDA, the recent California spinach E. coli outbreak resulted in 205  confirmed illnesses and 3 deaths, and industry representatives estimate  that economic losses ranged from $37 million to $74 million.
Changing demographics and consumption patterns underscore the  urgency for effective food safety oversight. According to FDA, shifting  demographics mean that more of the U.S. population is, and increasingly  will be, susceptible to foodborne illnesses. The risk of severe and life- threatening symptoms from infections caused by foodborne pathogens is  higher for older adults, young children, pregnant women, and immune  compromised individuals. According to FDA, these groups make up about  20 to 25 percent of the U.S. population. In addition, we are increasingly  eating foods that are consumed raw or with minimal processing and often  associated with foodborne illness. For example, according to the U.S.  Department of Agriculture (USDA), leafy greens such as spinach, are the  category of produce most likely to be associated with an outbreak, and the  average consumer ate 2.4 pounds of fresh spinach in 2005—a 180 percent  increase over 1992.
In response to these increasing challenges, FDA and other agencies  recently released plans that discuss the oversight of food safety. In  November 2007, FDA released its Food Protection Plan, which sets forth  FDA’s framework for overseeing the safety of food. Concurrently, a  twelve-agency working group presented to the President its Action Plan  for Import Safety, which contains, among other things, recommendations  for improving the safety of food imports entering the United States. Both  plans spell out numerous actions FDA plans to take to enhance food  safety, including writing new food protection guidelines for industry and  helping foreign countries improve their regulatory systems. The plans also  request new legislative authorities. One requested legislative authority is  for enhanced access to a food company’s records during food safety  emergencies. Subsequently, FDA’s Science Board, an advisory board to the  agency, released a report titled, FDA Science and Mission at Risk. This  report, which is the focus of today’s hearing, concluded that FDA is not  positioned to meet current or emerging regulatory needs, and stated that  FDA does not have the capacity, such as staffing and technology, to ensure  the safety of the nation’s food supply. In addition, the report found that  FDA’s ability to provide its basic food system inspection, enforcement, and  rulemaking functions is severely eroded, as is its ability to respond to  outbreaks of foodborne illnesses in a timely manner and to develop and  keep pace with the science needed to prevent food safety problems. The  report stated that the system cannot be fixed using available resources,  and its primary food safety recommendation was that FDA needs  additional resources to fulfill its regulatory mandate.
I will focus on four key points: (1) federal oversight of food safety is a  high-risk area that needs a governmentwide reexamination, (2) FDA has  opportunities to better leverage its resources, (3) FDA’s Food Protection  Plan proposes some positive first steps but additional information on the  plan’s strategies and resources can facilitate congressional oversight, and  (4) tools such as a commission or chief operating officer can help agencies  to address management challenges. This testimony is based on new and  previously issued work. Today, GAO is also testifying on another FDA  regulatory responsibility—inspections of medical device manufacturers.  These and other recent testimonies on food and drug safety offer  observations on FDA’s management capacity.
To assess FDA’s Food Protection Plan, we interviewed FDA officials;  reviewed pertinent statutes and reports; and evaluated the plan using a  GAO guide for assessing agencies’ performance plans. To analyze data on  FDA inspections, we examined data from FDA and determined that they  were sufficiently reliable for our analyses. We also reviewed funding data  from the Science Board and analyzed the data in real terms. To provide  updated information on our previously issued reports, we gathered  information on the status of our recommendations. We conducted our  work in January 2008 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: Federal Oversight of Food Safety Is a High- Risk Area that Needs a Governmentwide Reexamination
paragraphs: While part of today’s hearing focuses specifically on FDA’s responsibilities  for the oversight of food safety, it is important to note that FDA is one of  15 federal agencies that collectively administer at least 30 laws related to  food safety. This fragmentation is a key reason we designated federal  oversight of food safety as a high-risk area. Two agencies have primary  responsibility—FDA is responsible for the safety of virtually all foods  except for meat, poultry, and processed egg products, which are the  responsibility of USDA. In addition, among other agencies, the National  Marine Fisheries Service (NMFS) in the Department of Commerce  conducts voluntary, fee-for-service inspections of seafood safety and  quality; the Environmental Protection Agency (EPA) regulates the use of  pesticides and maximum allowable residue levels on food commodities  and animal feed; and the Department of Homeland Security is responsible  for coordinating agencies’ food security activities. This federal regulatory  system for food safety, like many other federal programs and policies,  evolved piecemeal, typically in response to particular health threats or  economic crises.
In January 2007, we added the federal oversight of food safety to our High- Risk Series, which is intended to raise the priority and visibility of  government programs that are in need of broad-based transformation to  achieve greater economy, efficiency, effectiveness, accountability, and  sustainability. Over the past 30 years, we have reported on issues—for  example, the need to transform the federal oversight framework to reduce  risks to public health as well as the economy—that suggest that the federal  oversight of food safety could be designated as a high-risk area. The  fragmented nature of the federal food oversight system calls into question  whether the government can plan more strategically to inspect food  production processes, identify and react more quickly to outbreaks of  foodborne illnesses, and focus on promoting the safety and integrity of the  nation’s food supply.
While we have reported on problems with the federal food safety system— including inconsistent oversight, ineffective coordination, and inefficient  use of resources—most noteworthy for today’s hearing is that federal  expenditures for the oversight of food safety have not been commensurate  with the volume of foods regulated by the agencies or consumed by the  public. We have reported that four agencies—USDA, FDA, EPA, and  NMFS—spent a total of $1.7 billion on food safety-related activities in  fiscal year 2003. USDA and FDA were responsible for nearly 90 percent of  those federal expenditures. However, the majority of federal expenditures  for food safety inspection were directed toward USDA’s programs for  ensuring the safety of meat, poultry, and egg products even though USDA  is responsible for regulating only about 20 percent of the food supply. In  contrast, FDA accounted for only 24 percent of expenditures even though  it is responsible for regulating about 80 percent of the food supply.
Others have called for fundamental changes to the federal food safety  system overall. In 1998, the National Academy of Sciences concluded that  the system is not well equipped to meet emerging challenges. In response  to the Academy’s report, the President established a Council on Food  Safety which released a Food Safety Strategic Plan in January 2001. The  plan recognized the need for a comprehensive food safety statute and  concluded, “the current organizational structure makes it more difficult to  achieve future improvements in efficiency, efficacy, and allocation of  resources based on risk.”
While many of the recommendations we made have been acted upon, a  fundamental reexamination of the federal food safety system is warranted.
Taken as a whole, our work indicates that Congress and the executive  branch can and should create the environment needed to look across the  activities of individual programs within specific agencies, including FDA,  and toward the goals that the federal government is trying to achieve. To  that end, we have recommended, among other things, that Congress enact  comprehensive, uniform, and risk-based food safety legislation and  commission the National Academy of Sciences or a blue ribbon panel to  conduct a detailed analysis of alternative organizational food safety  structures. We have also recommended that the executive branch  reconvene the President’s Council on Food Safety to facilitate interagency  coordination on food safety regulation and programs. According to  documents on the council’s Web site, the current administration has not  reconvened the council.
These actions can begin to address the fragmentation in the federal  oversight of food safety. Going forward, to build a sustained focus on the  safety and integrity of the nation’s food supply, Congress and the  executive branch can integrate various expectations for food safety with  congressional oversight and through agencies’ strategic planning  processes, including FDA’s. We have previously reported that the  development of a governmentwide performance plan that is mission- based, is results-oriented, and provides a cross-agency perspective offers a  framework to help ensure agencies’ goals are complementary and  mutually reinforcing. Further, with pressing fiscal challenges, this plan can  help decision makers balance trade-offs and compare performance when  resource allocation and restructuring decisions are made.
section_title: FDA Has Opportunities to Better Leverage its Resources
paragraphs: In response to the nation’s fiscal challenges, agencies may have to explore  new approaches to achieve their missions, and we have identified options  for FDA to better leverage its resources. Efficient use of resources is  particularly important at FDA because, while its food safety workload has  increased in the past decade, resources have not kept pace. FDA has  proposed actions toward implementing some of these options.
Our analysis of FDA data shows that while FDA received increased  funding for new bioterrorism-related responsibilities in 2003, subsequent  staffing levels and funding have not kept pace with the agency’s growing  responsibilities. Specifically, the number of FDA-regulated domestic food  establishments increased more than 10 percent from fiscal years 2003 to  2007––from about 58,260 in 2003 to about 65,520 in 2007. Additionally,  FDA notes that there have been dramatic changes in the volume, variety,  and complexity of FDA-regulated products arriving at U.S. ports, and  recently reported that the number of food import entry lines has tripled in  the past ten years. Meanwhile, staffing for FDA’s Center for Food Safety  and Applied Nutrition (CFSAN) has decreased. According to the Science  Board, the number of staff years for CFSAN operations at headquarters  dropped about 14 percent, from 950 in fiscal year 2003 to 812 in fiscal year  2006. During that same time period, field-based staff responsible for  carrying out inspection and enforcement activities for CFSAN-regulated  products dropped by 255 staff years, or about 11.5 percent—from 2,217 in  fiscal year 2003 to 1,962 in fiscal year 2006. In addition, while CFSAN- related funding at headquarters and in the field increased from $407  million in fiscal year 2003 to $439 million in fiscal year 2006, this  represents a decrease in real terms from about $457 million to about $451  million during that period. One consequence is that foreign inspections  have declined: GAO analysis of FDA data shows that inspections of foreign  food firms, which number almost 190,000, decreased from 211 in fiscal  year 2001 to fewer than 100 in fiscal year 2007. The Science Board  considered the funding issues to be more acute for CFSAN than for other  FDA programs: unlike the FDA programs responsible for drugs, biologics,  and medical devices, which charge manufacturers hundreds of millions of  dollars in user fees each year, CFSAN is not authorized to charge user fees  for its services.
Recent GAO work has identified opportunities for FDA to better leverage  its resources. Specifically, in 2004 we reviewed FDA’s imported seafood  safety program and identified several options that FDA could consider to  augment its resources and enhance its current program. We found that  FDA’s seafood safety program had shown some progress from a 2001  review. For example, FDA increased its laboratory testing of seafood  products at ports of entry from less than 1.0 percent in fiscal year 1999 to  about 1.2 percent in fiscal year 2002. We also recommended several  options for enhancing FDA’s oversight of seafood while leveraging outside  resources. Some of these options are presented in FDA’s Food Protection  Plan. We recommended that FDA:    Make it a priority to establish equivalence agreements with other  countries. Subject to its jurisdiction, FDA could certify that countries  exporting food products to the United States have equivalent food safety  systems before food products from those countries can enter the United  States. Such agreements would shift some of FDA’s oversight burden to  foreign governments. While FDA has not yet established equivalence  agreements with any foreign countries, the Food Protection Plan requests  that Congress allow the agency to enter into agreements with exporting  countries to certify that foreign producers’ shipments of designated high- risk products comply with FDA standards.
Explore the potential for certifying third-party inspectors. FDA could  consider developing a program that uses certified third-party inspectors to  conduct inspections on its behalf, both at foreign processing firms and  domestic importers of seafood. FDA’s Food Protection Plan requests  authority from Congress to accredit third parties to conduct voluntary  inspections for foods, and FDA officials told us that they envision using  third-party inspectors to inspect foreign facilities, where FDA conducts  few inspections. If FDA receives this authority, it can take lessons from its  own implementation of third-party inspection programs for medical device  manufacturing establishments. As we are reporting in a separate statement  today, few inspections of these establishments have been conducted  through FDA’s two accredited third-party inspection programs.
Consider accrediting private laboratories to test seafood. Currently, FDA  does not accredit or use any private laboratories to collect or analyze  seafood samples. However, for some seafood violations, it allows seafood  firms to use private laboratories to provide evidence that imported  seafood previously detained because of safety concerns is now safe and  can be removed from the detention list at the port of entry. We  recommended that FDA consider accrediting private laboratories because  it could leverage outside resources while providing FDA greater assurance  about the quality of the laboratories importers use to demonstrate that  their products are safe. FDA has not formally changed its policies or  practices, but the Action Plan for Import Safety notes that FDA intends to  issue guidance by mid-2008 on sampling and testing of imported products,  including the use of accredited private laboratories submitting data to  FDA on food safety.
Develop a memorandum of understanding with the National Oceanic  and Atmospheric Administration (NOAA) to use NOAA’s Seafood  Inspection Program resources to complete inspections on FDA’s behalf.  NOAA officials said that they could provide various services to augment  FDA’s regulatory program for imported seafood, including inspection,  training, and product sampling services. FDA has been working on a  program to refer certain export-related work to NOAA, and it is in  discussions with NOAA about commissioning its inspectors, but to date,  nothing is finalized or operational.
We have not reviewed these actions to determine whether they adequately  address our recommendations.
We separately reported on overlaps we identified in the federal oversight  of food safety, such as overlapping inspection and training activities that  exist among the agencies conducting food safety functions. Such  overlaps mean that federal agencies are spending resources on similar  activities, which may waste scarce resources and limit effectiveness.  Specifically, we found that FDA food safety activities may overlap with, if  not duplicate, the efforts of other agencies, including USDA and NMFS.  FDA could take practical steps to reduce overlap and duplication and  thereby free resources for more effective oversight of food safety, but FDA  has made little progress since our report. For example:    Domestic inspections. In fiscal year 2003, FDA and USDA spent most of  their food safety resources—about $900 million—on inspection and  enforcement activities. A portion of these activities included overlapping  and even duplicative inspections of 1,451 domestic food-processing  facilities that produce foods regulated by both agencies. Under authority  granted by the Bioterrorism Act of 2002, FDA could authorize USDA to  inspect these facilities on its behalf, but FDA has not yet reached an  agreement with USDA to do this. We recommended that, if cost effective,  FDA enter into an agreement to commission USDA inspectors at jointly  regulated facilities. FDA told us that they are working with USDA to  consider which products might be covered by each agency under such an  agreement.
Import inspections. FDA and USDA both inspect shipments of imported  food at ports of entry and also visit foreign countries that export food to  the United States. We found that both FDA and USDA maintain inspectors  at 18 U.S. ports of entry to inspect imported food. In fiscal year 2003, FDA  spent more than $115 million on imported food inspections, and USDA  spent almost $16 million. The two agencies do not share inspection  resources at these ports. Although USDA maintains a daily presence at  these facilities, the FDA-regulated products may remain at the facilities for  some time awaiting FDA inspection. Further, FDA conducted inspections  in 6 of the 34 countries that USDA evaluated in 2004 to determine whether  their food safety systems for ensuring the safety of meat and poultry are  equivalent to that of the United States. We recommended that FDA  consider the findings of USDA’s foreign country equivalence agreements  when determining which countries to visit. In their response to our  recommendation, the agency noted that they will consider USDA’s foreign  country evaluations when making such determinations.
Inspectors’ training. FDA and USDA spend resources to provide similar  training to food inspection personnel. FDA spent about $1.6 million and  USDA spent $7.8 million in fiscal year 2003. We found that, to a  considerable extent, food inspection training addresses the same subjects,  such as plant sanitation and good manufacturing practices. While other  agencies have consolidated training activities that have a common purpose  and similar content, FDA and USDA have not. We recommended that  USDA and FDA consider joint training programs, but to date, FDA has told  us that they have identified no training needs common to both agencies.
section_title: FDA’s Food Protection Plan Proposes Some Positive First Steps, but Additional Information on the Plan’s Strategies and Resources would Facilitate Congressional Oversight
paragraphs: FDA’s Food Protection Plan proposes several positive first steps that are  intended to enhance food safety oversight, including requesting several  authorities recommended by GAO, but more specific information about its  strategies and the resources needed to implement the plan would facilitate  congressional oversight. Positively, FDA’s Food Protection Plan aims to  shift the agency’s focus to prevention of foodborne illness instead of  intervention after contamination and resulting illnesses occur—an  important shift given that experts consider prevention to be a core  element of an effective food safety system. FDA says that its key  prevention steps are promoting corporate responsibility, identifying food  vulnerabilities, assessing risks, and expanding its understanding and use of  effective mitigation measures.
In addition to the actions we discuss earlier to address resource  constraints, FDA’s Food Protection Plan requests other authorities to  enhance oversight of food safety that begin to respond to prior GAO  recommendations. Specifically, the plan requests authority for FDA to:    Order food recalls. The Food Protection Plan requests the authority to  order a recall when FDA has reason to believe that food is adulterated and  presents a threat of serious adverse health consequences or death, to be  imposed only if a company refuses or unduly delays conducting a  voluntary recall. Currently, food recalls are largely voluntary—federal  agencies responsible for food safety, including FDA, have no authority to  compel companies to recall contaminated foods, with the exception of  FDA’s authority to require a recall for infant formula. FDA does have  authority, through the courts, to seize, condemn, and destroy adulterated  or misbranded food under its jurisdiction and to disseminate information  about foods that are believed to present a danger to public health.  However, government agencies that regulate the safety of other products,  such as toys and automobile tires, have recall authority not available to  FDA for food and have had to use their authority to ensure that recalls  were conducted when companies did not cooperate. These agencies have  the authority to require a company to notify the agency when the company  has distributed a potentially unsafe product, order a recall, establish recall  requirements, and impose monetary penalties if a company does not  cooperate. In a report and testimony before this subcommittee, we noted  that limitations in the FDA’s food recall authorities heighten the risk that  unsafe food will remain in the food supply and have proposed that  Congress consider giving FDA similar authorities. While FDA’s Food  Protection Plan requests mandatory recall authority, this request could  also include recall authorities held by other agencies, including  establishing recall requirements and imposing penalties for  noncompliance. FDA officials noted that while recall requirements and  penalties for noncompliance were not explicitly stated in the Food  Protection Plan, they are encompassed in the request. Further, the plan  does not propose a definition of “undue delay” by a company, another  critical element of recall authority given that timing is essential in reacting  to outbreaks, and delays can cost lives.
Issue additional preventive controls for high-risk foods. FDA is  requesting explicit authority from Congress to issue regulations requiring  foods that have been associated with repeated instances of serious health  problems or death to be prepared, packed, and held under a system of  preventive food safety controls. According to FDA, this would clarify the  agency’s ability to require industries to implement preventive Hazard  Analysis and Critical Control Point (HACCP) systems, which it currently  requires for companies that process seafood and juice. HACCP systems  are designed to improve food safety by having industry identify and  control hazards in products before they enter the market. FDA officials  told us that they are asking for explicit authority to put measures in place  for other high-risk foods, such as leafy greens. Officials told us that this  request, if granted, would allow the agency to focus its preventive efforts  on foods that present the highest risk for contamination, consistent with  the agency’s risk-based focus. However, others have expressed concern  that requiring a history of repeated outbreaks before issuing preventive  controls would not allow FDA to proactively establish regulations for  foods before they cause additional illnesses.
While FDA officials have acknowledged that implementing the Food  Protection Plan will require additional resources, FDA has not provided  specific information on the resources it anticipates the agency will need to  implement this plan. For example, the Food Protection Plan proposes to  develop food protection guidelines for industry; however FDA’s Science  Board reported that modernizing safety standards for fresh produce and  other raw foods and developing and implementing inspection programs  could cost $210 million. Additionally, the Food Protection Plan proposes  to enhance FDA’s information technology systems related to both  domestic and imported foods which the Science Board report suggests  could cost hundreds of millions of dollars. FDA officials have declined to  provide specific information on how much additional funding it believes  will be necessary to implement the Food Protection Plan, saying that  finalizing the amounts will take place during the budget process. Similarly,  the Food Protection Plan does not discuss the strategies it needs in the  upcoming years to implement this plan. FDA officials told us that they  have internal plans for implementing the Food Protection Plan that detail  timelines, staff actions, and specific deliverables. While FDA officials told  us they do not intend to make these plans public, they do plan to keep the  public informed of their progress. Without a clear description of resources  and strategies, it will be difficult for Congress to assess the likelihood of  the plan’s success in achieving its intended results.
section_title: Tools that Agencies Can Use to Address Management Challenges
paragraphs: The Science Board cites numerous management challenges that have  contributed to FDA’s inability to fulfill its mission, such as a lack of a  coherent structure and vision, insufficient capacity in risk assessment, and  inadequate human capital recruitment and retention. The Science Board  also noted that public confidence in FDA’s abilities has diminished. In light  of these challenges, we have identified through other work some tools that  can help agencies improve their performance, which may also be relevant  to FDA.
For example, we reported on the use of a Chief Operating Officer  (COO)/Chief Management Officer (CMO) as one way to address  longstanding management problems that are undermining agencies’  abilities to accomplish their missions and achieve results. Agencies with  such challenges, including FDA, could benefit from a senior leader serving  as a COO/CMO who can elevate, integrate, and institutionalize  responsibility for key management functions. While GAO has long  advocated the need for a COO/CMO position at the Department of Defense  and the Department of Homeland Security, a relatively stable or small  organization could use the existing deputy or related position to carry out  the role. In addition to GAO, a number of other organizations have  supported the need for the creation of COO/CMO positions in federal  agencies. McKinsey & Company recommended that a COO be established  in many federal agencies as the means to help those agencies successfully  achieve transformation. In addition, a working group within the National  Academy of Public Administration (NAPA) recommended creating COO  positions in federal agencies to oversee the full range of management  functions, including procurement, finance, information technology, and  human capital.
Another tool that can help federal agencies address their management  challenges is a well-designed commission that can produce specific  practical recommendations that Congress can enact. For example,  Congress created the National Commission on Restructuring the Internal  Revenue Service (IRS) in 1995 to review current practices at IRS and  report on requirements for improvement. Congress subsequently passed  the IRS Restructuring and Reform Act of 1998, which was influenced by  the Commission’s report, and reorganized the structure and management  of IRS, revised the mission of IRS, and mandated numerous other detailed  changes. Based on our recent analysis of several commissions, there are  several critical success factors that can be applied to ensure a  commission’s success including:  A statutory basis with adequate authority.  When provided with a clear  mandate and adequate authority, a commission can comprehensively  access and analyze information related to a given policy issue and thereby  provide more informed policy options for the President and Congress to  consider.
A clear purpose and timeframe.  A commission should have a clear  purpose for its objectives and activities to help guide the members in  carrying out their responsibilities. In addition, a fixed agenda and  timeframe can help keep a commission focused and on track. However, a  commission should have a broad enough scope to help ensure it has the  authority to address all the issues necessary in order to come up with a  comprehensive and integrated solution without encountering any  constraints in the process as to what it can or cannot consider.
Key leadership support.  Institutional leadership, commitment, and  support from the President and Congress are necessary to help a  commission succeed.
An open and transparent process.  By having an open and transparent  process, such as public hearings, a commission can help build consensus  among the public for its goals by gaining their input and support.
A balanced and capable membership. Balanced and capable membership  can help lessen political influences and build consensus among the  commission members when carrying out its purpose. Specifically, a  commission should involve current or former Members of Congress as  well as experts and professionals on the topic. Current or former elected  officials can ensure viability of a commission’s legislative proposals due to  their experience.
Accountability.  Clear accountability for a commission can help foster  specific, useful outputs that could help inform the public and provide  specific policy options and, hopefully, recommendations for Congress and  the President.
Resources.  The success of the commission is dependent on having the  adequate resources to carry out its purpose and any potential  recommendations.
Generally, one concern regarding commissions may be whether or not  there is sufficient buy-in from key stakeholders on the purpose of the  commission along with a commitment to act on any resulting  recommendations. Any recommendations by a commission in a final  report are generally advisory in nature and may not automatically result in  any public policy changes. Congressional action through subsequent  legislation with Presidential support may be necessary for the  commission’s recommendations to be implemented and for any changes to  occur.
Food safety concerns not only continue but will likely become more  urgent in view of changing demographics and consumption patterns.  Clearly, FDA plays a critical role in the federal oversight of food safety  because of the breadth of its responsibilities. Thus its ability to carry out  those responsibilities is necessary to help ensure the safety of the nation’s  food supply in the most efficient, effective, accountable, and sustainable  way. Nevertheless, in light of the federal government’s long-term fiscal  challenges, agencies, including FDA, need to seek out opportunities to  better leverage their resources. FDA’s Food Protection Plan is a step in the  right direction and proposes to implement many of the recommendations  made by GAO. However, additional information on the strategies and  resources needed to implement the plan can help Congress assess the  likelihood of its success. Further, concerns over FDA’s management  challenges, such as those identified by the Science Board could hinder the  implementation of the plan. Tools such as commissions and positions like  a COO/CMO can help agencies address management challenges and make  needed progress to achieve their missions. Continued congressional  oversight, including today’s hearing, and additional legislative action are  key to achieving that progress and to promoting the safety and integrity of  the nation’s food supply.
Mr. Chairman, this concludes my prepared statement. I would be pleased  to respond to any questions that you or other Members of the  Subcommittee may have.
section_title: Contact and Staff Acknowledgments
paragraphs: Contact points for our Offices of Congressional Relations and Public  Affairs may be found on the last page of this statement. For further  information about this testimony, please contact Lisa Shames, Director,  Natural Resources and Environment at (202) 512-3841 or  shamesl@gao.gov. Key contributors to this statement were Candace  Carpenter, Bart Fischer, José Alfredo Gómez, and Alison O’Neill.
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