Federal Oversight of Food Safety: FDA's Food Protection Plan	 
Proposes Positive First Steps, but Capacity to Carry Them Out Is 
Critical (29-JAN-08, GAO-08-435T).				 
                                                                 
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.
-------------------------Indexing Terms------------------------- 
REPORTNUM:   GAO-08-435T					        
    ACCNO:   A80249						        
  TITLE:     Federal Oversight of Food Safety: FDA's Food Protection  
Plan Proposes Positive First Steps, but Capacity to Carry Them	 
Out Is Critical 						 
     DATE:   01/29/2008 
  SUBJECT:   Contaminated foods 				 
	     Contamination					 
	     Disease control					 
	     Food contamination 				 
	     Food industry					 
	     Food inspection					 
	     Food safety					 
	     Food supply					 
	     Foodborne diseases 				 
	     Risk assessment					 
	     Risk management					 
	     Safety						 
	     Safety standards					 
	     Strategic planning 				 
	     GAO High Risk Series				 

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GAO-08-435T

   

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Testimony: 

Before the Subcommittee on Oversight and Investigations, Committee on 
Energy and Commerce, House of Representatives: 

United States Government Accountability Office: 

GAO: 

For Release on Delivery Expected at 10:00 a.m. EST: 

Tuesday, January 29, 2008: 

Federal Oversight Of Food Safety: 

FDA's Food Protection Plan Proposes Positive First Steps, but Capacity 
to Carry Them Out Is Critical: 

Statement of Lisa Shames, Director: 

Natural Resources and Environment: 

FDA's Food Safety Program: 

GAO-08-435T: 

GAO Highlights: 

Highlights of GAO-08-435T, a testimony before the Subcommittee on 
Oversight and Investigations, Committee on Energy and Commerce, House 
of Representatives. 

Why GAO Did This Study: 

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. FDAï¿½s Food Protection Plan sets a framework 
for food safety oversight. In addition, FDAï¿½s Science Board released 
FDA Science and Mission at Risk, which concluded that FDA does not have 
the capacity to ensure the safety of the nationï¿½s food supply. 

This testimony focuses on (1) federal oversight of food safety as a 
high-risk area that needs a governmentwide reexamination, (2) FDAï¿½s 
opportunities to better leverage its resources, (3) FDAï¿½s 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 agenciesï¿½ performance plans; and reviewed pertinent statutes 
and reports. GAO also analyzed data on FDA inspections and resources. 

What GAO Found: 

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 systemï¿½including 
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. 

FDAï¿½s 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 planï¿½s 
success in achieving its intended results. 

The Science Board cites numerous management challenges that have 
contributed to FDAï¿½s 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 commissionï¿½s success include a statutory basis with 
adequate authority, a clear purpose and timeframe, leadership support, 
an open process, a balanced membership, accountability, and resources. 

To view the full product, including the scope and methodology, click on 
[hyperlink, http://www.GAO-08-435T]. For more information, contact Lisa 
Shames at (202) 512-3841 or [email protected]. 

[End of section] 

Mr. Chairman and Members of the Subcommittee: 

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.[Footnote 1] 
Concurrently, a twelve-agency working group presented to the President 
its Action Plan for Import Safety,[Footnote 2] 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.[Footnote 3] 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.[Footnote 4] 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. 

Federal Oversight of Food Safety Is a High-Risk Area that Needs a 
Governmentwide Reexamination: 

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,[Footnote 5] 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.[Footnote 6] 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.[Footnote 7] 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.[Footnote 8] 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. 

FDA Has Opportunities to Better Leverage its Resources: 

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.[Footnote 
9] 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.[Footnote 10] 
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.[Footnote 11] 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,[Footnote 12] 
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. 

FDA's Food Protection Plan Proposes Some Positive First Steps, but 
Additional Information on the Plan's Strategies and Resources would 
Facilitate Congressional Oversight: 

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,[Footnote 13] 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. 

Tools that Agencies Can Use to Address Management Challenges: 

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.[Footnote 14] 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.[Footnote 15] 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.[Footnote 16] 

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.[Footnote 17] 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:[Footnote 18] 

* 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. 

Contact and Staff Acknowledgments: 

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 [email protected]. 
Key contributors to this statement were Candace Carpenter, Bart 
Fischer, Josï¿½ Alfredo Gï¿½mez, and Alison O'Neill. 

Footnotes:  

[1] Department of Health and Human Services, U.S. Food and Drug 
Administration, Food Protection Plan (Washington, D.C., 2007). 

[2] Interagency Working Group on Import Safety, Action Plan for Import 
Safety (Washington, D.C., 2007). 

[3] FDA Science Board, Subcommittee on Science and Technology, FDA 
Science and Mission at Risk (Washington, D.C., November 2007). 

[4] GAO, Medical Devices: Challenges for FDA in Conducting Manufacturer 
Inspections, GAO-08-428T (Washington, D.C.: Jan. 29, 2008). 

[5] GAO, High-Risk Series: An Update, GAO-07-310 (Washington, D.C.: 
Jan. 31, 2007). 

[6] GAO, Overseeing the U.S. Food Supply: Steps Should be Taken to 
Reduce Overlapping Inspections and Related Activities, GAO-05-549T 
(Washington, D.C.: May 17, 2005). 

[7] Institute of Medicine, Ensuring Safe Food from Production to 
Consumption (Washington, D.C., 1998). 

[8] GAO, Food Safety and Security: Fundamental Changes Needed to Ensure 
Safe Food, GAO-02-47T (Washington, D.C.: Oct. 10, 2001). 

[9] According to FDA, an entry line is each portion of an import 
shipment that is listed as a separate item on an entry document. Items 
in an import entry having different tariff descriptions must be listed 
separately. 

[10] GAO, Food Safety: FDA's Imported Seafood Safety Program Shows Some 
Progress, but Further Improvements Are Needed, GAO-04-246 (Washington, 
D.C.: Jan. 30, 2004). 

[11] GAO, Oversight of Food Safety Activities: Federal Agencies Should 
Pursue Opportunities to Reduce Overlap and Better Leverage Resources, 
GAO-05-213 (Washington, D.C.: Mar. 30, 2005). 

[12] Public Health Security and Bioterrorism Preparedness and Response 
Act of 2002, Pub. L. No. 107-188, 116 Stat. 594. 

[13] GAO, Food Safety: USDA and FDA Need to Better Ensure Prompt and 
Complete Recalls of Potentially Unsafe Food, GAO-05-51 (Washington, 
D.C.: Oct. 6, 2004) and Federal Oversight of Food Safety: High Risk 
Designation Can Bring Attention to Limitations in the Federal 
Government's Food Recall Programs, GAO-07-785T (Washington, D.C.: Apr. 
24, 2007). 

[14] See for example, GAO, A Call for Stewardship: Enhancing the 
Federal Government's Ability to Address Key Fiscal and Other 21st 
Century Challenges, GAO-08-93SP (Washington D.C.: November 2007) and 
Organizational Transformation: Implementing Chief Operating Officer/ 
Chief Management Officer Positions in Federal Agencies, GAO-08-34 
(Washington, D.C.: Nov. 1, 2007). 

[15] McKinsey & Company, How Can American Government Meet its 
Productivity Challenge? (July 2006). 

[16] NAPA, Moving from Scorecard to Strategic Partner: Improving 
Financial Management in the Federal Government (October 2006). 

[17] Pub. L. No. 105-206 (July 22, 1998). 

[18] GAO, Long-Term Fiscal Challenge: Comments on the Bipartisan Task 
Force for Responsible Fiscal Action Act, GAO-08-238T (Washington, D.C.: 
Oct. 31, 2007). 

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