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United States Government Accountability Office:
GAO: 

Report to Congressional Committees: 

July 2012: 

Food Safety: 

FDA's Food Advisory and Recall Process Needs Strengthening: 

GAO-12-589: 

GAO Highlights: 

Highlights of GAO-12-589, a report to congressional committees. 

Why GAO Did This Study: 

Numerous outbreaks of foodborne illnesses in past years continue to 
draw public attention to the safety of the nation’s food supply. 
Prompt responses from government entities and the food industry can 
play a vital role in stopping the spread of illnesses and deaths, but 
unwarranted recalls of food products can trigger serious economic 
losses for the food industry. In response to congressional direction 
regarding the FDA Food Safety Modernization Act, GAO (1) examined 
government entities having the authority to order product recalls and 
how FDA implements its authority; (2) examined the challenges FDA 
faces, if any, in advising the public about food recalls or outbreaks 
of foodborne illness and how the agency has addressed these 
challenges; and (3) identified mechanisms that may compensate the food 
industry for erroneously ordered food recalls or erroneous food-
related advisories. GAO reviewed documents from FDA and other 
government entities and FDA data and interviewed stakeholders from the 
food industry and consumer organizations, government officials, and 
experts in food safety or food law. 

What GAO Found: 

Several government entities, including federal agencies such as the 
Food and Drug Administration (FDA) and the Consumer Product Safety 
Commission, and some states such as Texas, have the authority to order 
product recalls. Generally, FDA is to follow the same process for 
implementing its food recall authority as other federal agencies use 
to order recalls of other products, including (1) determining that 
available evidence of a threat meets a standard of proof to order a 
recall, (2) offering a company the opportunity to voluntarily recall a 
product before a recall order is issued, and (3) providing the company 
with an opportunity to challenge a recall decision. FDA has internal 
procedures describing the steps it will take to order a food recall, 
although these procedures are not yet public and the agency has not 
issued regulations or industry guidance to clarify its ordered food 
recall process. 

FDA faces a number of communication challenges when advising the 
public about food recalls or outbreaks of foodborne illness, ranging 
from balancing technical accuracy with timeliness of communications to 
coordinating messages with other agencies to meeting the needs of 
diverse public audiences. The agency has taken steps to begin meeting 
these challenges but has yet to fully address recommendations from GAO 
and others to fashion a comprehensive food recall communication policy 
and related implementation plans. Specifically, FDA has not (1) 
adopted a recommendation from its Advisory Committee on Risk 
Communication to create a policy for emerging events to more 
comprehensively address several of its communication challenges; (2) 
created plans recommended by the Institute of Medicine and National 
Research Council to help address coordination challenges surrounding 
its communications; or (3) fully implemented a recommendation from GAO’
s past work to determine jointly with the Department of Agriculture 
what, if any, additional approaches are needed for advising consumers 
about recalls. When GAO asked FDA officials how they had responded to 
these recommendations, they provided information on some actions they 
are taking. However, FDA’s stated actions do not fully implement these 
recommendations. As a result of not implementing them, FDA may be 
missing opportunities to more comprehensively address its 
communications challenges. 

Various government mechanisms-—each with advantages and disadvantages 
described by individuals GAO interviewed-—might be available to 
compensate food producers in case of an erroneously ordered food 
recall or erroneous food-related advisory, but GAO found no examples 
of such mechanisms that have been used to provide compensation. The 
mechanisms include a dedicated federal government program or federal 
government-subsidized insurance, among others. For example, 
individuals GAO interviewed said that a potential advantage of a 
dedicated program would be assurance to industry that a mechanism 
would be available, but a potential disadvantage may be that in lean 
budget times, funding for such a program may be difficult to obtain. 
Individuals GAO interviewed identified several factors that may come 
into play when deciding to establish any compensation mechanism, such 
as defining what constitutes an error or mitigating the potential for 
unintended consequences. 

What GAO Recommends: 

GAO recommends, among other things, that FDA issue regulations or 
industry guidance to clarify its ordered food recall process and 
implement recommendations from others to address FDA communication 
challenges in advising the public about food recalls and outbreaks. 
The agency neither agreed nor disagreed with GAO’s recommendations but 
cited ongoing agency actions that are to address most recommendations. 

View [hyperlink, http://www.gao.gov/products/GAO-12-589]. For more 
information, contact Lisa Shames at (202) 512-3841 or shamesl@gao.gov. 

[End of section] 

Contents: 

Letter: 

Background: 

Several Key Entities Have Recall Authority, but FDA Has Not Issued 
Regulations or Industry Guidance on Its Ordering of Food Recalls: 

FDA Has Taken Steps to Begin Meeting Communication Challenges When 
Advising the Public about Food Recalls and Outbreaks: 

Several Mechanisms Might be Available to Compensate the Food Industry 
for Erroneously Ordered Recalls or Erroneous Food-Related Advisories: 

Conclusions: 

Recommendations for Executive Action: 

Agency Comments and our Evaluation: 

Appendix I: Objectives, Scope, and Methodology: 

Appendix II: Processes for Ordering Product Recalls at Key Federal 
Agencies: 

Appendix III: FDA Data Related to Ordered Recalls: 

Appendix IV: Comments from the Department of Health and Human Services: 

Appendix V: GAO Contact and Staff Acknowledgments: 

Tables: 

Table 1: Key Federal, State, and International Government Entities 
Having the Authority to Order Product Recalls: 

Table 2: Steps Key Federal Agencies Take When Ordering Product Recalls: 

Table 3: Problems with FDA Data Related to Ordered Recalls: 

Figure: 

Figure 1: FDA's Statutorily Required Process for Ordering Food Recalls 
Other Than Infant Formula: 

Abbreviations: 

AGR: Adjusted Gross Revenue: 

APHIS: Animal and Plant Health Inspection Service: 

CDC: Centers for Disease Control and Prevention: 

CORE: Coordinated Outbreak Response and Evaluation: 

FDA: Food and Drug Administration: 

FSMAFDA: Food Safety Modernization Act: 

HHS: Department of Health and Human Services: 

OMB: Office of Management and Budget: 

USDA: U.S. Department of Agriculture: 

[End of section] 

United States Government Accountability Office: 
Washington, DC 20548: 

July 26, 2012: 

Congressional Committees: 

Numerous outbreaks of foodborne illnesses in past years continue to 
draw public attention to the safety of the nation's food supply. In 
the last several years, major outbreaks and product recalls have been 
associated with foods including peanut products, eggs, spinach, and 
cantaloupes. When such outbreaks are discovered, prompt responses from 
government and companies in the food distribution chain--the network 
of handlers, suppliers, and others involved in the production of food--
can play a vital role in stopping the spread of illnesses and keeping 
the food supply safe; delays can result in more illnesses, as well as 
deaths. If unwarranted, however, advisories about adulterated or 
misbranded food products and recalls of those products can trigger 
serious economic losses for the food industry and discourage the 
consumption of healthful food, such as fresh produce. For example, in 
2008, during an outbreak of illnesses caused by the bacterium 
Salmonella, the Department of Health and Human Services' (HHS) Food 
and Drug Administration (FDA) first warned consumers about certain 
tomatoes on the basis of information provided by other government 
agencies. Early in their work, government investigators used available 
evidence to associate the outbreak with raw tomatoes, but FDA's 
investigation subsequently implicated jalapeño and serrano peppers. 
Meanwhile, according to a tomato industry representative, tomato 
growers and shippers in several states lost an estimated $145 million 
in revenue. 

Federal oversight of food safety has remained on our list of high-risk 
areas in need of broad-based transformation to achieve greater 
economy, efficiency, effectiveness, accountability, and sustainability 
since we added it in 2007,[Footnote 1] largely because of 
fragmentation (i.e., 15 agencies collectively administering at least 
30 laws) that has caused inconsistent oversight, ineffective 
coordination, and inefficient use of resources. FDA and the U.S. 
Department of Agriculture (USDA) have primary responsibility for the 
safety of the domestic and imported food supply. USDA is responsible 
for meat, poultry, processed egg products, and as soon as recently 
proposed regulations are finalized, catfish. Under the Federal Food, 
Drug, and Cosmetic Act, FDA is responsible for ensuring the safety of 
virtually all other food. FDA monitors recalls of food by industry and 
works with other agencies--including state and local governments, 
HHS's Centers for Disease Control and Prevention (CDC), and USDA--to 
identify and investigate multistate outbreaks of foodborne illnesses 
and alert the public to outbreaks. 

In January 2011, the FDA Food Safety Modernization Act (FSMA) amended 
the Federal Food, Drug, and Cosmetic Act to give FDA authority to 
order the recall of food products other than infant formula, when a 
company fails to voluntarily recall the products.[Footnote 2] Under 
FSMA, after FDA determines that there is a reasonable probability that 
a food product is adulterated under the Federal Food, Drug, and 
Cosmetic Act or misbranded with respect to labeling for major food 
allergens, and the use or exposure to that food will cause serious 
adverse health consequences or death to humans or animals, it must 
provide the company with the opportunity to voluntarily undertake a 
recall. Food is deemed to be adulterated under the Federal Food, Drug, 
and Cosmetic Act if, among other things, it bears or contains any 
poisonous or deleterious substance that may render it injurious to 
health. Until passage of this act, FDA could ask companies to 
voluntarily recall adulterated or misbranded food products, but it 
could not order them to do so, except for infant formula. 

FSMA directed us to report on issues associated with FDA's new 
authority to order food recalls, as well as on the authority held by 
government entities to order recalls of other products. Accordingly, 
this report (1) examines key government entities having the authority 
to order product recalls and how FDA implements its authority; (2) 
examines the challenges FDA faces, if any, in advising the public 
about food recalls or outbreaks of foodborne illnesses and examines 
how FDA has addressed these challenges; and (3) identifies mechanisms 
that may compensate the food industry for erroneously ordered food 
recalls or erroneous food-related advisories, including the advantages 
and disadvantages of each. 

To address these objectives, we reviewed information from the 
Congressional Research Service, the National Academies, and our own 
past work, as well as from academic sources and industry publications. 
We gathered documentation and met with officials from FDA, CDC, the 
Consumer Product Safety Commission, the Environmental Protection 
Agency, the Department of Transportation's National Highway Traffic 
Safety Administration, the Department of State, and USDA. We also 
gathered documentation from and met with representatives of the food 
industry, consumer organizations, and others to understand issues 
surrounding recalls and food-related advisories. To address our first 
objective, we identified key government entities with the authority to 
order product recalls by reviewing our prior work in this area, 
collecting legal documentation, interviewing agency officials, and 
working with the Association of Food and Drug Officials to contact 
their member states via e-mail. We examined how FDA implements its 
authority to order food recalls (other than infant formula) by 
reviewing FSMA and interim internal procedures from FDA. We also 
reviewed statutes, regulations, and guidance on ordered recalls of 
other products from FDA and the other federal agencies we identified. 
We also collected data from FDA on the number of ordered recalls and 
assessed the reliability of those data by reviewing documentation on 
the agency's data systems and interviewing FDA officials and found 
that the data were not reliable for our reporting purposes, which we 
discuss further in the report. To address our second objective, we 
reviewed documents from FDA and the National Academy of Sciences, 
among others. We also interviewed FDA officials, representatives of 
consumer and industry organizations, government officials from other 
state and federal agencies, and experts in food safety. To address our 
third objective, we reviewed the relevant literature and interviewed 
officials from international government entities such as the European 
Union. We also conducted semistructured interviews with 
representatives of consumer groups and industry organizations, 
officials from federal or state government, and experts in food safety 
or food law. We chose these interview respondents to reflect a range 
of perspectives. For further information on our scope and methodology, 
see appendix I. 

We conducted this performance audit from May 2011 to July 2012 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. 

Background: 

In addition to harming human health, outbreaks of foodborne illness 
can have serious economic consequences and undermine consumer 
confidence in the safety of the nation's food supply. In the past 
several years, consumers in the United States and abroad have 
experienced several noteworthy outbreaks of foodborne illness, 
including the following: 

* A 2011 outbreak of Listeria monocytogenes bacteria associated with 
cantaloupes grown in Colorado. During this outbreak, CDC reported a 
total of 146 cases in 28 states, including 30 deaths and one 
miscarriage. According to a USDA document, this event was the largest 
outbreak of Listeria since a 1985 outbreak linked to a Mexican-style 
soft cheese which, according to HHS, resulted in 28 deaths and 20 
miscarriages. The long-term economic effects to industry are not yet 
known, but USDA reported in November 2011 that prices for cantaloupe 
dropped about 34 percent in the wake of the outbreak. 

* A 2011 outbreak of E. coli O104:H4 bacteria in Germany and France, 
associated first with cucumbers, lettuce, and tomatoes but later 
traced to sprouts grown from fenugreek seeds exported by an Egyptian 
company. During this outbreak, Germany's Robert Koch Institute 
reported 3,842 cases and 53 deaths. According to a European Union 
press document, farmers lost more than €227 million from May 26 
through the end of June 2011. On the basis of requests for 
compensation from European Union member states, €227 million was 
expected to cover 50 percent (or 70 percent in some cases) of the 
usual producer price of cucumbers, tomatoes, lettuce, zucchini, and 
sweet peppers withdrawn from the market from May 26 through June 30, 
2011. 

* A 2010 outbreak of Salmonella Enteritidis bacteria associated with 
shell eggs from Iowa. CDC estimates that adulterated eggs caused 1,939 
illnesses, and FDA reported that the outbreak prompted a nationwide 
recall of more than 500 million eggs packaged under several brand 
names. According to congressional testimony from an FDA official, this 
was the largest reported outbreak of Salmonella Enteritidis since the 
agency's outbreak surveillance started in the early 1970s. According 
to industry estimates, the generic shell-egg industry lost about $100 
million in the month after the recall was announced, although prices 
returned within a few months to levels before the recall. 

* A 2008-2009 outbreak of Salmonella Typhimurium associated with 
peanut products from the Peanut Corporation of America, resulting in a 
recall of products made at its production facilities in Georgia and 
Texas. Peanut products include commodities such as peanut butter and 
peanut paste, commonly used as ingredients in cookies, crackers, 
cereal, candy, ice cream, pet treats, and other foods. FDA reported 
that more than 3,900 products were recalled by more than 200 
companies. During this outbreak, CDC identified 714 cases in 46 
states, and according to CDC, the contamination may have contributed 
to the deaths of nine people. According to research from USDA's 
Economic Research Service, retail sales data indicate that, in the 
months following the initial CDC advisory on peanut products, demand 
declined for several months but returned to previous-year levels a few 
months later. 

* A 2008 outbreak of Salmonella Saintpaul associated with peppers from 
Mexico, which sickened at least 1,440 people in 43 states and the 
District of Columbia and, according to a tomato industry 
representative, caused an estimated $145 million loss to tomato 
growers and shippers. Early in their work on this outbreak, government 
investigators identified a statistically significant association 
between consumption of certain types of tomatoes and illness. FDA's 
investigation subsequently confirmed the pathogen on samples of a 
pepper and in irrigation water from a farm in Mexico. A recall of 
tomatoes was never associated with this outbreak. 

* A 2006 outbreak of E. coli O157:H7 linked to fresh spinach from 
California. FDA and the California Department of Public Health 
reported that this outbreak resulted in 205 confirmed illnesses and 
three deaths in 26 states. Industry representatives have reported that 
the outbreak caused an estimated $100 million loss to the spinach 
industry. 

FDA is responsible for overseeing recalls of all food products under 
its jurisdiction. To carry out its responsibilities, FDA may issue 
advisories about adulterated food and may seek voluntary recalls by 
producers of food products; if a firm does not voluntarily recall a 
food product, FDA may use its new authority to order the recall of an 
article of food other than infant formula. Once a recall is under way, 
FDA monitors the effectiveness of a company's recall actions by 
verifying that customers in the food distribution chain receive notice 
of the recall and that the food is located and removed from the 
marketplace or that its labeling is corrected.[Footnote 3] FDA can 
also take enforcement action, such as initiating the seizure of 
adulterated or misbranded products or levying civil monetary penalties 
against food companies under certain circumstances. 

* Many agencies, such as the following, play a role in responding to 
multistate outbreaks of foodborne illnesses: 

Local and state governments. Local agencies play two main roles: they 
(1) inspect food service and food retail establishments and (2) 
investigate cases of suspected foodborne illnesses, which may be 
reported to them by health care providers, clinical laboratories, or 
affected persons or someone close to them. State agencies also play a 
major part in identifying and investigating foodborne illnesses: state 
health departments typically receive and analyze routine disease 
surveillance reports, coordinate surveillance among local health 
departments, and report cases of foodborne illnesses to CDC. 

CDC. When CDC receives reports of outbreaks of foodborne illnesses 
from local and state governments, it determines the extent of an 
outbreak by linking cases or clusters of foodborne illnesses that have 
been reported. To make these links, it uses tools such as 
PulseNet[Footnote 4] and the Listeria Initiative.[Footnote 5] CDC then 
uses the medical science of epidemiology (which concerns the 
incidence, distribution, and control of disease and the factors 
affecting the presence or absence of a disease or pathogen) to 
identify the food associated with illnesses and provides that 
information to FDA. CDC also works with FDA to understand if the 
product's distribution can explain the observed geographic 
distribution of cases and to gather information on the root cause of 
the outbreak, to help prevent future problems. 

* FDA. FDA participates in responding to outbreaks of foodborne 
illnesses by, among other things, participating in the epidemiologic 
investigation of the suspect food and conducting "traceback" 
investigations to determine how contamination occurred and, if 
applicable, which products should be recalled. The traceback process 
follows the product back through the supply chain to identify a common 
source. 

In addition to us, other organizations have been tasked with reviewing 
FDA's oversight of food safety, including its public communications 
during foodborne illness outbreaks or recalls. Specifically, in 2007 
Congress directed the Secretary of HHS to establish the Advisory 
Committee on Risk Communication (risk communication committee) to 
advise FDA on methods to effectively communicate risks associated with 
products regulated by the agency. In addition, the Institute of 
Medicine and the National Research Council, which are two of the four 
organizations in the National Academies,[Footnote 6] published a 
report in 2010 on FDA's food safety oversight, including its public 
communications during events such as recalls or foodborne illness 
outbreaks.[Footnote 7] 

Several Key Entities Have Recall Authority, but FDA Has Not Issued 
Regulations or Industry Guidance on Its Ordering of Food Recalls: 

Several key federal, state, and international government entities, 
including FDA, have the authority to order product recalls. Under 
FSMA, FDA's process for ordering food recalls generally follows the 
same steps it and other federal agencies use to order recalls of other 
products. FDA has internal procedures describing the steps it will 
take to order a food recall, but these procedures are not yet public. 
Also, the agency has not issued regulations or industry guidance to 
clarify its ordered food recall process, and FDA officials told us 
that they have not decided whether they will do so and that FSMA 
contains no such requirement. In addition, FDA's ordered recall data 
for products other than food appear to be inconsistent or unreliable. 

Entities with Authority to Order Product Recalls Use Processes with 
Similar Steps: 

Through our review, we identified several key government entities with 
the authority to order product recalls, including four federal 
agencies, at least four states, and at least five international 
government entities (see table 1). Officials from many of these 
entities reported, however, that ordered recalls are rare and that the 
majority of recalls are voluntary. Specifically, officials from the 
Consumer Product Safety Commission, the Environmental Protection 
Agency, and the National Highway Traffic Safety Administration 
reported no ordered recalls of products they oversee from fiscal year 
2006 through fiscal year 2010. In addition, officials from several 
states and international entities we identified told us that they 
rarely use their authority to order product recalls. Officials from 
Texas told us that they use their authorities to order recalls in only 
the most extreme circumstances and officials from Canada said they use 
it as a last resort, such as when a company cannot be located to 
implement a voluntary recall. See table 1 for a list of the entities 
we identified as having the authority to order product recalls. 

Table 1: Key Federal, State, and International Government Entities 
Having the Authority to Order Product Recalls: 

Federal agencies: 

Entity: Consumer Product Safety Commission; 
Products: Many consumer goods. 

Entity: Environmental Protection Agency; 
Products: Vehicles and engines, pesticides. 

Entity: FDA; 
Products: Human biological products, foods within its jurisdiction 
(including infant formula[B]), medical devices, radiation-emitting 
electronic products, and tobacco products. 

Entity: National Highway Traffic Safety Administration; 
Products: Motor vehicles, child safety seats, tires, and other motor 
vehicle equipment. 

States[A]: 
Entity: Alaska; New Mexico; South Carolina; Texas; 
Products: Foods. 

Entity: International entities[A]; 
Entity: Australia; Canada; European Union; Japan; New Zealand; 
Products: Foods. 

Sources: GAO analysis of multiple sources (see application I). 

[A] The listed states and international entities represent those that 
we identified in our review as having authority to order a recall of 
food products or some specific type of food product (e.g., milk or 
bottled water), and our list may not be comprehensive because we did 
not review statutes and regulations for all states and entities. 

[B] FDA has had the authority to order infant formula recalls 
since1986. If the Secretary of Health and Human Services determines 
that infant formula presents a risk to human health, the manufacturer 
must recall shipments immediately. 

[End of table] 

FDA's statutory process for ordering food recalls other than infant 
formula[Footnote 8] includes three steps, which are also used by key 
federal agencies to order recalls of other product types. These steps 
are to (1) determine that available evidence of a threat meets a 
specific standard of proof, (2) offer a company the opportunity to 
voluntarily recall a product before a recall order is issued, and (3) 
provide the company with an opportunity to challenge a recall 
decision. Specifically: 

* Standard of proof: Before ordering a recall, each federal entity 
authorized to order product recalls is to determine--with a specified 
degree of certainty--that a problem exists. For example, before FDA 
may order a recall of food (other than infant formula), it is required 
by FSMA to determine that a reasonable probability exists that an 
article of food is adulterated under the Federal Food, Drug, and 
Cosmetic Act, or misbranded with respect to labeling for a major food 
allergen and that use of or exposure to that food will cause serious 
adverse health consequences or death to humans or animals. Similarly, 
the Environmental Protection Agency must first determine that certain 
vehicles or engines do not conform to emission standards before it may 
order a recall. In addition, to order a recall of motor vehicles or 
replacement equipment, the National Highway Traffic Safety 
Administration is to determine that a safety-related defect exists or 
that a product does not comply with an applicable motor vehicle safety 
standard. 

* Opportunity for voluntary recall. For most products they oversee, 
the federal agencies we reviewed offer companies the chance to 
voluntarily recall product(s) in question before the agencies may 
order a recall. For example, for foods (other than infant formula), 
FDA is to provide companies an opportunity to cease distribution of 
the implicated food and recall it. Similarly, for medical devices, FDA 
is to provide companies an opportunity to consult with the agency, and 
companies can voluntarily recall the product before FDA may order a 
recall. In addition, after notifying a company of its determination 
that a product contains a defect which creates substantial risk of 
injury to the public, the Consumer Product Safety Commission provides 
the company an opportunity to voluntarily recall the product. 

* Opportunity to challenge the agency. For most products they oversee, 
the federal agencies we reviewed are to provide an opportunity for 
companies to challenge an agency's decision to order a recall. For 
example, for foods (except infant formula), medical devices, and 
tobacco products, FDA is, by statute, to provide a company with an 
opportunity for an informal hearing on why the product in question 
should not be recalled. For licensed biological products, such as 
vaccines, the statute specifies that recall orders are subject to an 
agency hearing. However, there is no such requirement for infant 
formula recalls: FDA may determine that an infant formula presents a 
risk to human health, which would require that the company immediately 
take all actions necessary to recall the infant formula with no option 
for a hearing. At the National Highway Traffic Safety Administration, 
the agency is required to offer the company an opportunity to present 
information, views, and arguments that there is no defect or 
noncompliance before ordering a recall. 

* Figure 1 illustrates the steps required by statute for FDA's process 
of ordering food recalls (other than infant formula). For detailed 
descriptions of the ordered recall process for each federal agency we 
reviewed, see appendix II. 

Figure 1: FDA's Statutorily Required Process for Ordering Food Recalls 
Other Than Infant Formula: 

[Refer to PDF for image: illustration] 

FDA identifies a threat and determines the standard of proof has been 
met[A]; 
* FDA informs company. 

FDA offers company opportunity to recall product voluntarily[A]: 
* Company recalls product voluntarily[A]; 
* Company does not recall. 

FDA orders company to cease distribution, and notifies, supply chain. 
* FDA offers company opportunity for hearing. 
* FDA offers company opportunity for hearing. 
 
FDA may hold hearing in response to company's request. 
* FDA does not order company to recall product[A]; 
* FDA orders company to recall product.[B] 

[A] Steps used by FDA and other federal agencies FDA orders. 

[B] FDA orders.           

Source: GAO analysis of FDA Food Safety Modernization Act. 

[End of figure] 

FDA Has Not Made Public Procedures for Ordering Food Recalls: 

FDA has interim internal procedures describing the steps it will take 
to order a food recall, but these procedures have not been made 
public, and the agency has not provided information on when they will 
be. Federal internal control standards call for federal agencies to 
clearly document policies, procedures, techniques, and mechanisms for 
implementing management directives and to make that documentation 
readily available for examination.[Footnote 9] About a week-and-a-half 
before our closing meeting, FDA officials provided us interim internal 
procedures for ordering recalls of food. These interim procedures 
include detailed information on such topics as which officials are to 
be involved in an ordered food recall decision and what methods and 
timelines FDA officials will use to communicate with companies 
involved in such a recall. The interim procedures also state that FDA 
is to incorporate procedures into the agency's publicly available 
Regulatory Procedures Manual and other FDA documents. FDA officials 
have not, however, provided timelines on when they expect to make 
procedures publicly available. 

Similarly, FDA officials told us that they have not decided whether 
they will issue regulations or industry guidance to clarify for the 
public FDA's procedures for ordering food recalls and that FSMA has no 
requirement to do so. Federal internal control standards direct 
federal agencies to ensure adequate means of communicating with and 
obtaining information from external stakeholders who may have a 
significant impact on the agency achieving its goals.[Footnote 10] FDA 
and others have highlighted the value of clarifying procedures in 
regulations or industry guidance, as follows: 

* Regulations. FDA's policy that applies to voluntary recalls is 
included in the Code of Federal Regulations. The policy states that it 
is intended to clarify and explain the agency's practices and 
procedures, enhance public understanding, improve consumer protection, 
and ensure uniform and consistent application of practices and 
procedures throughout the agency. FDA has issued regulations on its 
procedures for ordering recalls of biological products, medical 
devices, and radiation-emitting electronic products. In addition, the 
Consumer Product Safety Commission and the National Highway Traffic 
Safety Administration have issued regulations outlining their 
procedures for ordering recalls of other products. 

* Industry guidance. FDA's good guidance practices[Footnote 11] state 
that when significant changes are made to statute, the agency will 
review and, if appropriate, revise its guidance documents. These 
practices note that such changes reflect FDA's expectations of those 
subject to its oversight, including new expectations that may not be 
readily apparent--arguably the case with FDA's new authority to order 
food recalls: food industry stakeholders publicly asked FDA in June 
2011 to explain how it will implement its new authority, indicating 
that they would benefit from more clarity. FDA's good guidance 
practices also indicate that guidance documents are subject to public 
comment and can be revised when appropriate. Nevertheless, FDA's 
current guidance for industry on voluntary product recalls has not 
been updated to describe the agency's procedures for ordering food 
recalls. 

Furthermore, unlike other agencies with the authority to order product 
recalls, FDA has not documented--in internal agency procedures or its 
regulations or guidance--how it weighs evidence to determine if a food 
recall is warranted and thereby if it has met the standard of proof 
necessary to order a food recall. The following examples describe how 
other agencies with the authority to order product recalls have 
documented their investigation procedures, including how they weigh 
evidence on possible safety problems: 

* The Consumer Product Safety Commission and National Highway Traffic 
Safety Administration have developed guidance to help stakeholders 
such as consumers and industry members understand how the agencies 
investigate and uncover problems that may lead to product recalls. 
These guidance documents also detail the types of evidence the 
agencies consider when determining whether a product poses safety 
risks or violates standards. For example, when reviewing whether a 
safety-related defect exists in a motor vehicle or related equipment, 
the National Highway Traffic Safety Administration's guidance notes 
that the agency will consider data on complaints, crashes, injuries, 
warranty claims, modifications, and part sales when conducting an 
investigation. 

* Canadian public health and food safety agencies in 2011 published 
guidance on collecting and weighing evidence during outbreaks of 
foodborne illnesses to assist in deciding, among other things, whether 
a recall may be warranted.[Footnote 12] Canadian officials published 
this guidance to provide criteria for, among other things, proceeding 
with a food recall. Officials told us that documenting procedures for 
weighing evidence can be helpful in answering questions from 
stakeholders about why they made a particular recall decision. 

FDA has not gone as far as other agencies in explaining how the agency 
will weigh evidence to determine that a standard of proof has been met 
before ordering food recalls. FDA regulations state that the agency 
will conduct a health hazard evaluation for any product being 
considered for recall. In addition, FDA's interim procedures on 
ordered recalls do provide some information--including, for example, 
that officials from several FDA offices are to meet to determine 
whether the standard of proof for ordering a recall has been met. 
However, these regulations and procedures do not explain how FDA will 
weigh evidence to make that determination. We acknowledge, as an FDA 
official has pointed out, that each potential recall situation is 
different and requires that officials work with incomplete data to 
make decisions using the collective experience of seasoned 
professionals. Nevertheless, as the guidance from Canadian food safety 
agencies points out, documented procedures are intended to facilitate 
timely and appropriate actions by the agency, not to impose 
constraints. We also acknowledge that FDA has had the authority to 
order food recalls for a fairly short time--since FSMA was signed into 
law in January 2011. But without publicly available procedures, 
regulations, or industry guidance on how the agency will implement its 
authority--including how the agency will weigh evidence on whether a 
recall is necessary--the agency cannot ensure that it applies 
practices uniformly or consistently or that it provides clear 
information for the food industry to follow or consumers and the 
public to understand. Such ambiguity could be particularly troublesome 
with regard to outbreaks of foodborne illnesses, which can occur any 
time--indeed, have already occurred since FDA assumed its new 
authority--and demand clear and timely agency reactions. 

FDA's Data on Ordered Recalls Appear to Be Unreliable: 

Since FSMA was signed into law in January 2011, FDA has not ordered 
any recalls of food products, according to agency officials. To learn 
more about ordered recalls for other products the agency oversees, we 
asked FDA officials for data on the number of ordered recalls of 
medical devices, radiation-emitting electronic products, and 
biological products, and we received conflicting information. 
Specifically, when we asked officials for the total number of ordered 
recalls in the agency's history, FDA officials from different offices 
within the agency provided us with inconsistent data that appeared to 
be insufficiently reliable for public reporting. Examples include the 
following: 

* Biological products. Officials from FDA's Center for Biologics 
Evaluation and Research--the center that regulates biological products 
for human use--told us there were two ordered recalls in 2006 and one 
in the 1980s. Officials from FDA's Office of Regulatory Affairs--the 
office that manages the agency's central recall database known as the 
Recall Enterprise System--told us there were two ordered recalls of 
biological products in the agency's history according to this 
database. Later, however, officials from the Office of Regulatory 
Affairs and the Center for Biologics Evaluation and Research stated 
that their counts were in error, explaining that the two events in 
fiscal year 2006 were not ordered recalls but, rather, orders for 
companies to cease manufacturing. These officials later provided us 
with information on a single ordered recall that took place in fiscal 
year 2002. 

* Medical devices and radiation-emitting electronic products. 
Officials from FDA's Office of Regulatory Affairs told us there were 
nine ordered recalls in the agency's history, with no such recalls 
occurring from fiscal years 2006 through 2010 according to data in the 
Recall Enterprise System. Officials from FDA's Center for Devices and 
Radiological Health also told us there were nine ordered recalls in 
the agency's history, but three of these occurred from fiscal years 
2006 through 2010. 

We asked FDA officials to clarify these issues and received some 
responses, but the information they provided did not clarify all 
observed inconsistencies in the data. (For more information on the 
inconsistencies and inaccuracies we identified, see appendix III.) 

According to FDA's Regulatory Procedures Manual, its Recall Enterprise 
System allows the agency to (1) provide a central, searchable database 
to efficiently track information and generate and disseminate reports 
of recall activities; (2) increase communication of recall information 
among different FDA offices; and (3) reduce duplication of efforts 
across different FDA offices, among other things. In addition, under 
federal internal control standards,[Footnote 13] federal agencies are 
to employ controls over information processing; such control includes 
application control, which is designed to help ensure completeness and 
accuracy of a system's data, among other things. Nevertheless, the 
inconsistencies we observed in the data caused us to question the 
Recall Enterprise System's data on ordered recalls. Moreover, our 
review also showed that FDA used multiple data systems, which may lead 
to inconsistencies in its data if controls over information processing 
are not in place. Both of these issues limit the agency's ability to 
use the Recall Enterprise System to meet the database's goals to 
efficiently track information, communicate recall information among 
different FDA offices, and reduce duplication of effort across 
offices. These issues also indicate that the agency may not have 
sufficient internal control for its information processing, reducing 
the agency's ability to accurately report information on ordered 
recalls to Congress and the public as follows: 

* The Recall Enterprise System's categories for ordered recalls do not 
have documented definitions, leading to incomplete and inaccurate 
data. When entering information on an ordered recall into the agency's 
data system, FDA staff can choose from several categories of ordered 
recalls. Our analysis indicated several problems with these 
categories. For example, the list of ordered recall categories is 
incomplete because the system currently does not include categories 
for ordered recalls of infant formula or tobacco products. In 
addition, a few categories are inaccurate: two of the categories--"FDA 
requested" and "FDA ordered seizure"--are not ordered recalls. When we 
reviewed the user guide and data dictionary[Footnote 14] for the 
Recall Enterprise System, we were unable to find written definitions 
for categories of ordered recalls, without which FDA officials cannot 
be sure that users consistently apply the same information when 
categorizing a recall. When we talked to FDA officials about this 
issue, they acknowledged these problems and told us that they are 
leading a team to evaluate the definitions of these categories and 
instructions for FDA staff on the use of each category. 

* The databases that contain recall data do not fully share 
information. FDA officials told us they use multiple databases to 
track recall data and, because some of the databases do not fully 
share data, staff must sometimes enter data into the Recall Enterprise 
System and then reenter the same data into another database. The fact 
that these databases do not have a two-way connection to ensure that 
all inputs are received in the Recall Enterprise System could have led 
to some of the inconsistencies we noted and runs counter to FDA's goal 
of having its central system reduce duplication of effort among FDA 
offices. We have reported on similar issues in the past. In October 
2004, we reported that FDA's Center for Food Safety and Applied 
Nutrition, which is responsible for protecting the public's health by 
ensuring that food within FDA's jurisdiction is safe, sanitary, 
wholesome, and honestly labeled, maintained its own database outside 
of the Recall Enterprise System.[Footnote 15] We also reported that 
(1) inconsistencies between the Recall Enterprise System and the 
Center for Food Safety and Applied Nutrition's system raised 
significant questions about the validity and reliability of the data 
and that (2) FDA's investment of more than $3 million to implement the 
Recall Enterprise System would not be entirely realized until the 
agency used the system as the only one for collecting and managing 
recall data. As a result, we recommended that FDA direct the food 
recall staff to use the Recall Enterprise System as the sole data 
system to capture recall information, manage food recalls, and 
generate reports to Congress. In response, FDA officials told us that 
they would implement this recommendation, but in September 2008 we 
again reported that staff in the Center for Food Safety and Applied 
Nutrition continued to maintain a separate unofficial database for 
food recalls.[Footnote 16] FDA once again agreed to use the Recall 
Enterprise System as its sole recall data system. In a February 2010 
report, we identified modernizing information systems as a major 
management challenge that could affect FDA's ability to carry out its 
mission.[Footnote 17] A survey we conducted for that report showed 
that 79 percent of FDA managers reported that improving FDA's 
information technology and information management would greatly 
improve their ability to contribute to FDA's goals and 
responsibilities, but 39 percent reported that FDA was making great 
progress in this area.[Footnote 18] Furthermore, when we asked FDA 
managers in that survey to identify the top priorities that FDA 
leadership should address, improving information technology was the 
third most commonly identified issue.[Footnote 19] In March 2012, we 
reported that the Center for Food Safety and Applied Nutrition 
maintains 21 different databases and systems and had not adequately 
assessed data-sharing opportunities.[Footnote 20] We recommended that 
the agency assess the center's information sharing needs and 
capabilities to identify potential improvements to achieve more 
efficient information sharing among databases and develop a plan for 
implementing these improvements. During our present review, we asked 
officials in the Center for Food Safety and Applied Nutrition why they 
continue to maintain a database separate from the Recall Enterprise 
System, and the officials responded that in certain cases, the 
center's database was easier to search than the Recall Enterprise 
System. 

FDA Has Taken Steps to Begin Meeting Communication Challenges When 
Advising the Public about Food Recalls and Outbreaks: 

FDA faces a number of communication challenges when it needs to advise 
the public about food recalls and outbreaks of foodborne illness, 
ranging from balancing technical accuracy with timeliness of 
communications to coordinating messages with other agencies to meeting 
the needs of diverse public audiences, such as consumers, 
representatives of the food industry, medical professionals, and other 
government organizations. The agency has taken several steps to begin 
meeting these challenges but has yet to fully adopt recommendations 
from us and others to develop a comprehensive food recall 
communication policy and related implementation plans. 

FDA Faces Challenges in Seven Related Categories and Has Taken Some 
Steps to Address Them: 

Through publications from FDA and the National Academies, meeting 
materials of FDA's risk communication committee, and our own past 
work, as well as interviews with government officials, experts, and 
stakeholders, our review identified seven communications challenges 
FDA faces in advising the public about food recalls and outbreaks. 
These challenges include (1) balancing the goals of timeliness and 
accuracy, (2) using precise language while being understandable to a 
general audience, (3) serving a wide range of audiences and audience 
needs, (4) maintaining public trust in FDA communications, (5) 
coordinating messages with other agencies, (6) testing draft 
communications with users, and (7) communicating when an outbreak or 
recall is over. To address these challenges, FDA has taken numerous 
actions, as outlined in the agency's Strategic Plan for Risk 
Communication[Footnote 21] and other sources. 

Balancing the Goals of Timeliness and Accuracy: 

During an outbreak or recall, FDA faces the challenge of quickly 
providing information to the public about the event, often as the 
event is unfolding and information about its cause is evolving, while 
also being accurate and specific. FDA officials, as well as the 
experts and stakeholders we spoke with, widely agreed that this 
challenge was the most important one confronting FDA when advising the 
public about food recalls and outbreaks. To make determinations about 
what information to provide and when to provide it, FDA officials told 
us that they use professional experience to look for a "tipping 
point," that is, a time when evidence collected from a variety of 
sources--including epidemiological studies (which form and test 
hypotheses about an outbreak's cause), field investigations, and 
laboratory results--is sufficient to allow the agency to provide 
consumers with information that will help them avoid unsafe food. FDA 
officials also stated that it is often only in hindsight, when all 
information is known, that they can confidently say when the right 
time was to provide what type of information. For example, officials 
said, they are sometimes criticized for providing information after 
other entities, such as state agencies, have already done so. The 
officials explained that FDA must use well-developed evidence when 
deciding whether to advise the public about a food safety issue. 
Conversely, during a 2006 outbreak of E. coli associated with fresh 
bagged spinach, FDA officials advised consumers to avoid eating fresh 
spinach before they knew specifically which brands were implicated. 
FDA officials said they took this action to protect consumers, but 
spinach industry representatives reported suffering economic harm from 
FDA's advisory. 

FDA has taken steps to address this challenge. For example, in 
September 2011, the agency announced the formation of the Coordinated 
Outbreak Response and Evaluation (CORE) network, staffed with several 
full-time FDA employees focused on preparing for, coordinating, and 
carrying out responses to foodborne illness outbreaks. Before 
establishing the CORE network, FDA officials said, the agency 
responded to outbreak events by bringing staff together on an ad hoc 
basis; according to FDA documentation, the CORE network aims to 
improve the agency's response to outbreaks, as well as the speed and 
accuracy of its public communications. In addition, FDA officials told 
us that they are creating an expedited clearance process for outbreak-
related advisories and that they hope this process will allow FDA to 
prepare and issue advisories within 6 hours, rather than the current 
time frame that ranges from 24 hours to 3 days. As of April 20, 2012, 
FDA had not finalized this process. 

Providing Precise, Complete Information Understandable to a General 
Audience: 

FDA faces the following two related challenges in this area: 

* Technical precision. According to FDA officials, the precision 
sought by scientists and attorneys for the agency's public 
communications can result in highly technical language that may not be 
understandable to a general audience. To address this issue, FDA has 
used input from its risk communication committee to create a template 
for its recall press releases. According to FDA, the template helps to 
provide more consumer-friendly information and includes for each 
recall specifics on the problem, symptoms of illness, and what 
consumers or others can do to protect themselves. In addition, FDA's 
Strategic Plan for Risk Communication states that the agency plans to 
regularly review documents provided to the public to ensure that they 
use plain language and are geared to target audiences' reading levels; 
the agency requires each operating unit to report annually on its 
implementation of this effort. When we requested information on these 
annual implementation reports, however, we learned that FDA had not 
produced any. 

* Large amounts of information. FDA must sometimes provide large 
amounts of information on the types and number of products involved in 
a recall or outbreak. For example, during the 2010 outbreak of 
Salmonella associated with shell eggs, the implicated eggs came from 
two producers. These producers, however, sold their eggs to other 
companies, which then marketed the eggs under at least 46 separate 
brand names or used the eggs as ingredients in other foods. Similarly, 
according to FDA's website, a 2008-2009 outbreak of Salmonella 
associated with peanut products led to a recall of more than 3,900 
products because the peanut products in question had been used as 
ingredients in many foods. To address this challenge, FDA has provided 
searchable databases on its website of products affected by such 
recalls for several prior outbreaks, including the 2010 outbreak of 
Salmonella associated with shell eggs and the 2008-2009 outbreak of 
Salmonella associated with peanut products.[Footnote 22] 

Serving a Wide Range of Audiences and Audience Needs: 

FDA officials reported that the agency serves a variety of audiences--
including consumers; industry organizations such as producers, 
distributors, and retailers; medical professionals; and other 
governmental organizations, such as states--all with different needs 
and uses for food safety information. FDA has taken actions to address 
this challenge. For example, in accordance with FSMA requirements, FDA 
redesigned its recalls website in April 2011, which, according to FDA, 
now contains a more consumer-friendly search engine, with search 
results displayed in a table of food recalls since 2009 by date, 
product brand name, product description, reason for recall, and 
recalling company. FDA also posts photos of recalled products affected 
by Class I and high-priority Class II recalls on its website.[Footnote 
23] In addition, according to an FDA website, the agency has committed 
to support industry efforts to enable consumers to distinguish 
recalled products from those not subject to a recall. For example, 
during a recall of pistachio products in 2009, FDA's website provided 
a link to an industry-sponsored website listing companies whose 
products did not contain recalled pistachios. Third, FDA officials 
reported increased use of blogs and other social media to communicate 
with the public and, according to these officials, offer information 
in multiple languages. 

Maintaining Public Trust in FDA Communications: 

FDA officials reported that if the public does not see the agency as 
trusted and credible, its communications will be less effective. FDA 
is undertaking efforts to address this challenge. For example, 
according to FDA's Strategic Plan for Risk Communication, the agency 
plans to (1) regularly monitor the Internet for non-FDA websites that 
misleadingly report FDA information and (2) develop talking points, 
where appropriate, to address such misleading communications. In 
addition, FDA officials told us that the agency intends for the leader 
of its CORE network to serve as the main agency spokesperson during 
outbreaks. According to our review of risk communication committee 
meeting transcripts, a few members of this committee agree that having 
a single spokesperson creates a recognizable face for the agency, 
which could improve public trust and understanding. 

Coordinating Messages with Other Agencies: 

According to experts and stakeholders from state and local health and 
agriculture departments, not having systematic communication, 
including communication between governmental agencies and the public, 
is a key challenge in creating an effective food safety system. They 
noted that, in some cases, when many agencies are involved in 
responding to an outbreak of foodborne illness, these agencies may 
deliver to the public as many messages as there are agencies, which 
can cause confusion. In addition, a 2010 National Academies study by 
the Institute of Medicine and National Research Council reported that 
consumers are unaware of the frequency of food recalls and have 
misconceptions about the division of responsibilities between federal 
agencies. This challenge is not unique to FDA's communications during 
food-related outbreaks or recalls. In a February 2010 report, we 
identified coordinating internally and externally as a major 
management challenge that could affect FDA's ability to carry out its 
mission.[Footnote 24] In a survey we conducted for that report, we 
showed that 49 percent of FDA managers reported that improved 
coordination and communication with other governmental entities would 
improve their ability to contribute to meeting FDA's goals and 
responsibilities, and 19 percent reported great progress in improving 
coordination and communication with other federal agencies.[Footnote 
25] 

To address cross-agency coordination, FDA has undertaken several 
efforts. For example, in 2011, FDA signed a memorandum of 
understanding with USDA to provide a framework for the two agencies to 
communicate and cooperate in the timely and full exchange of 
information, and FDA officials told us that they meet weekly with 
officials from both USDA and CDC to discuss outbreaks and recalls 
reported by FoodSafety.gov--a website that disseminates food safety 
information and alerts consumers about food outbreaks and recalls. In 
addition, FDA officials told us that they formally share press 
releases with CDC, and that FDA informally shares press releases with 
USDA and the Environmental Protection Agency. Such frequent 
communications among collaborating agencies are consistent with what 
we reported in October 2005 that can facilitate working across agency 
boundaries and prevent misunderstandings.[Footnote 26] With respect to 
better coordination with states, in 2011, FDA and a group of state-
level officials developed a draft guide on improving federal-state 
communications during outbreaks. 

Testing Draft Communications with Users: 

According to an FDA publication, effective communication requires 
understanding and addressing audience needs that can be identified 
only by talking with targeted audiences. Members of FDA's risk 
communication committee stated that testing is very important because 
it is difficult to know how a communication will be understood by 
those receiving it unless it is tested. For example, during the 2011 
outbreak of Listeria associated with cantaloupes, a watermelon 
industry representative stated that FDA officials used the generic 
term "melon," rather than "cantaloupe," in some of its early 
communications on the outbreak, and this term might have been 
interpreted to include all melons, creating losses for the watermelon 
industry. Testing before releasing communications might uncover this 
type of issue. To do such testing however, FDA must comply with the 
Paperwork Reduction Act, which requires that it submit to a formal 
clearance process through the Office of Management and Budget (OMB) 
before it can obtain information from 10 or more individuals. To 
address this challenge, FDA has taken a few actions. First, in 2010, 
the agency established an internal network of FDA employees to review 
draft messages before they are released publicly. Second, in 2010, FDA 
officials said that they requested OMB approval for a "generic" 
clearance that would allow the agency to test (using focus groups) 
food-safety-related messages, and in June 2012, the agency announced 
that it had received approval from OMB on that clearance. 

Communicating When an Outbreak or Recall Is Over: 

FDA's Strategic Plan for Risk Communication reported that once a 
recall is over, effective communication is needed to assure consumers 
that it is once again safe to consume a previously recalled or 
implicated product. The plan also stated that consumers do not always 
know that a recall or outbreak has ended and may continue to avoid 
affected foods. An FDA official stated that it can be difficult for 
the agency to know when implicated products are no longer a danger and 
a recall may be over, since some products may mistakenly remain for 
sale for a very long time or sit on consumers' shelves. To address 
this issue, an FDA report, as well as a report by the Institute of 
Medicine and National Research Council--both produced in June 2010--
recommended the agency reconsider its policy, stating that if FDA 
determines that a recall is terminated, this information should be 
disclosed to the public. FDA officials told us that they are reviewing 
options for addressing this challenge but that they have not made any 
changes to their policies. 

FDA Has Not Fully Adopted Some Recommended Communication Policies or 
Plans Related to Identified Challenges: 

Beyond the steps it has taken to date, FDA has not implemented several 
recommendations that could help the agency better respond to its 
communication challenges. Specifically, it has not (1) adopted a 2009 
recommendation from its risk communication committee on creating a 
policy for emerging events to more comprehensively address all its 
communication challenges; (2) created plans recommended in 2010 by the 
Institute of Medicine and National Research Council to help address 
coordination challenges surrounding its communications; or (3) fully 
implemented a recommendation from our past work to determine jointly 
with USDA what, if any, additional approaches are needed for alerting 
consumers about recalls. When we asked FDA officials how they had 
responded to these recommendations, they provided us information on 
some actions they are taking. However, FDA's stated actions do not 
fully implement these recommendations. As a result of FDA's not taking 
full action on these recommendations, the agency may be missing 
opportunities to more comprehensively address the challenges it faces. 

FDA has not implemented a 2009 recommendation from its risk 
communication committee to create a communication policy for use 
during emerging events, including outbreaks of foodborne illness and 
large-scale food recalls. The committee recommended that such a policy 
and resulting communications address several topics, including the 
nature of potential risks and benefits of a product, the quality of 
the agency's evidence, actions that might be taken by vulnerable 
populations, and actions that FDA is taking. The committee stated 
that, over time, such a policy would help make FDA's actions 
increasingly predictable and its communications better understood. 
Ideally, according to the committee, by developing useful and timely 
communications and monitoring the effects of those communications, FDA 
would enable individuals to follow emerging events, take protective 
action, or decide that no action was needed. During our review, we 
contacted a former member of the committee, who told us that 
implementing this recommendation could help the agency make progress 
with respect to several of the communication challenges we identified, 
including, for example, balancing the goals of timeliness and accuracy 
and maintaining public trust in FDA communications. When we asked FDA 
officials about whether they had implemented this recommendation, they 
told us that the agency is working toward creating communications that 
are as consistent as possible, subject to differences between the 
types of products the agency oversees. In addition, FDA has created a 
checklist for FDA staff to use when developing public communications. 
According to FDA, this checklist is intended to help specify roles and 
responsibilities of different FDA experts in communications 
development. Nevertheless, the checklist does not include information 
on the topics recommended by the risk communication committee. It also 
does not clarify for those outside the agency what to expect from FDA 
communications. 

In addition to not implementing the risk communication committee's 
recommendation, FDA has not developed plans to address its 
coordination challenges when providing public information, as 
previously recommended by the Institute of Medicine and National 
Research Council. In response to a congressional request, the 
institute and council in 2010 published a report on FDA's food safety 
oversight in which the institute and council recommended that FDA 
create, in conjunction with other federal agencies, a coordinated plan 
for communicating with affected parties during crises. According to 
FDA officials, the agency expressed appreciation for the efforts of 
those involved in producing the report and would consider the report's 
recommendations. However, the agency has not developed a concrete plan 
to improve such coordination; thus the agency continues to risk 
providing information on foodborne illnesses that conflicts with the 
information provided by other agencies or confuses consumers who may 
receive conflicting messages from several sources. 

Furthermore, FDA has not fully implemented a recommendation from our 
October 2004 report,[Footnote 27] in which we reviewed recall 
communications at both FDA and USDA and stated that the procedures 
both agencies use to advise consumers of a recall--press releases and 
web postings--may not be effective. We recommended that FDA work 
jointly with USDA to determine what, if any, additional approaches 
were needed for advising consumers about recalls. To show us how they 
had responded to this recommendation, FDA officials provided us a copy 
of recall response guidelines issued by the Coalition to Improve 
Foodborne Outbreak Response--a working group of federal agencies 
including FDA, USDA, and CDC, along with associations of state and 
local health professionals. These guidelines provide broad advice to 
agencies on improving communication with the public during a recall, 
but they do not address the two public notification topics we 
discussed in detail in our 2004 report--posting recall press releases 
on agency websites and providing information on the retail outlets 
that received recalled food. We followed up with USDA and FDA on these 
two topics and learned that USDA's public notifications have changed 
but that FDA's have not, as follows: 

* Posting recall information on agency websites. Both FDA and USDA 
post recall press releases on their websites. According to USDA 
guidelines, USDA authors its own releases, while our review of FDA web 
postings indicated that the agency often posts releases that are 
crafted by the companies issuing the recall rather than issuing its 
own information on the recall. A representative of a consumer 
organization testified before FDA's risk communication committee that 
FDA does not have full control of the message sent to the public when 
it does not issue its own press releases. For example, industry press 
releases often note that they are "voluntarily" recalling a product. 
Such statements may be technically correct, but a representative of a 
consumer organization testified before FDA's risk communication 
committee that such statements may cause consumers to underestimate 
the seriousness of a recall. In addition, FDA's own Transparency 
Initiative--an FDA effort to identify and implement actions to 
increase transparency--reported in May 2010 that FDA is in the best 
position to ensure that useful, actionable information is provided to 
the public about a problem with an FDA-regulated product. During a 
meeting of FDA's risk communication committee in November 2010, 
several committee members stated that FDA's practice of posting and 
relying on industry releases for recall information could decrease 
public trust in FDA communications. 

* Providing information on the retail outlets that received recalled 
food. As we reported in 2004, FDA and USDA stated that the agencies 
generally do not have the authority to provide information on the 
retail stores selling a recalled food because it is considered 
confidential business information. In 2008, however, USDA changed its 
policy: the department now collects and posts public information on 
which retail outlets received products associated with recalls posing 
the most serious health risks.[Footnote 28] Further, in its technical 
comments to our draft report, HHS stated that FDA can provide 
confidential commercial information, including the identity of a 
retail store associated with products implicated in a recall, if such 
information is necessary to effect a recall. 

By not fully addressing our recommendation, specifically concerning 
the two public notification topics we discussed in detail in our 2004 
report, FDA has missed opportunities to work with USDA to learn from 
its experiences with public communications during recalls. We continue 
to believe that FDA is missing opportunities to strengthen the 
effectiveness of its procedures to advise consumers of a recall and 
that FDA can learn from USDA's experiences with public communications 
during recalls. 

Several Mechanisms Might be Available to Compensate the Food Industry 
for Erroneously Ordered Recalls or Erroneous Food-Related Advisories: 

Individuals we interviewed identified a variety of government 
mechanisms--each with advantages and disadvantages described by the 
individuals--that might be available to compensate food producers in 
case of an erroneously ordered food recall or erroneous food-related 
advisory, but we found no examples of such mechanisms being used to 
provide compensation. Among others, these mechanisms include a 
dedicated government program and government insurance. Individuals we 
interviewed also identified several factors that may come into play 
when deciding to establish any new compensation mechanism, such as 
defining what constitutes an error or mitigating the potential for 
unintended consequences. 

Each Compensation Mechanism Has Advantages and Disadvantages: 

Through a series of interviews with stakeholders and others, including 
representatives of consumer groups and industry organizations, federal 
and state officials, and experts in food safety or food law, as well 
as our review of relevant literature, we identified a variety of 
government mechanisms that others have suggested might compensate the 
food industry in case of an erroneously ordered food recall or 
erroneous food-related advisory, each with advantages and 
disadvantages described by those we interviewed. We did not 
independently evaluate the viability of these mechanisms, their 
advantages, or their disadvantages, and none of the mechanisms has 
been used to provide compensation in such instances. The first of the 
mechanisms described below has an established government structure in 
place to administer it; the others would require congressional action 
to initiate. 

The Judicial Process: 

Individuals have suggested that remedies may be available through the 
judicial process, a mechanism that already exists. At least one 
company--a South Carolina tomato farm--filed suit against the federal 
government for FDA's 2008 warning of an apparent link between eating 
raw red tomatoes and a Salmonella outbreak. The government responded 
by asserting, among other things, that FDA is immune to the particular 
claim. A few respondents have told us that the judicial process might 
allow for cases to be handled individually, which would allow each 
plaintiff a chance to be heard and for each case to be decided on its 
merits. Assuming a filed claim is valid, however, some others told us 
that the judicial process can be slow and expensive. In the case of 
erroneously ordered recalls or advisories, for example, smaller 
companies could be heavily burdened with the costs of bringing suit 
against the federal government. 

A Dedicated Program: 

A federal program established by Congress could pay eligible 
companies, according to the relevant literature and our interviews 
with stakeholders and others. For example, at USDA, the Animal and 
Plant Health Inspection Service (APHIS) administers a series of 
programs that compensate producers whom APHIS orders to destroy their 
cattle to control or eradicate disease. The APHIS program implements 
cost sharing with the states and may pay producers from 50 to 100 
percent of the animals' market value in compensation. An APHIS 
official told us that the reason for such compensation is to encourage 
producers to participate in the programs. Some respondents also 
identified government purchase programs of food commodities, such as 
USDA's National School Lunch Program, as a possible dedicated program 
that could offer producers another avenue for selling their food. USDA 
purchases food products through commodity purchase programs in support 
of the National School Lunch Program and the School Breakfast Program. 
One respondent suggested it may be possible to amend the current 
programs to assign preference to particular growers who were affected 
by an erroneously ordered recall or advisory, as long as the products 
were determined to be safe. 

Some respondents said that a potential advantage of a dedicated 
program would be the assurance to industry that a formal mechanism 
would be available to compensate them in the event of an erroneously 
ordered recall or advisory. Further, according to a few respondents, a 
dedicated program could allow eligibility requirements to be set up 
ahead of time, providing a structured method for determining 
compensation. In addition, according to a few respondents, an 
advantage of this mechanism would be that it could be administered by 
an agency other than FDA, which could help FDA avoid spending 
resources administering a compensation program (a source of concern 
for stakeholders from consumer organizations). On the other hand, 
respondents also noted disadvantages. For example, some told us that 
in lean budget times, funding for such a program may be difficult to 
obtain. A few others stated that setting up a system to administer the 
program could take significant time and resources. Specific to the 
suggestion to modify current government purchase programs, one 
respondent observed that selling erroneously recalled produce to 
schools may not be a popular policy with school boards or parents. 

One-Time Funding for Specific Events: 

Congress could consider a one-time legislative act for specific events 
as a mechanism to provide one-time funding for affected industry 
members after a specific instance of an erroneous food recall or 
advisory, according to the relevant literature and our interviews with 
stakeholders and others. For example, Congress considered a bill in 
2008 that proposed $100 million in emergency assistance to tomato 
growers and handlers to address losses associated with FDA's 2008 
advisory related to the Salmonella outbreak first linked to tomatoes 
then later to peppers. In another example, member states of the 
European Commission (one of the main institutions of the European 
Union that manages the day-to-day business of implementing European 
Union policies and spending its funds) agreed to provide €227 million 
in emergency funding to support the vegetable producers who suffered 
losses due to an E. coli outbreak in spring 2011, according to 
commission press documents. In this instance, German health officials 
had originally identified cucumbers, raw tomatoes, and lettuce as 
significantly associated with the outbreak but later linked the 
outbreak to bean sprouts. In this case, a European Union official told 
us that the European Commission provided aid to farmers who were 
suffering financially and that this aid was not intended as 
compensation for government error. 

Several respondents told us that an advantage of one-time funding for 
specific events would be that compensation could be tailored to each 
erroneously ordered recall or erroneous food-related advisory. But 
several stakeholders also said that a disadvantage of a one-time 
legislative act for specific events is that such an act is inherently 
subject to political realities. For example, companies growing 
specialty crops in only one location in the country could have more 
trouble garnering broad-based political support than a group of larger 
growers who produce crops in many parts of the country. Further, some 
respondents said that it could take a long time for such funding to 
work its way through the legislative process, which could create 
difficulties for food producers, and that such a program could be 
expensive for government to administer. 

Government Insurance: 

If established by Congress, government insurance could help mitigate 
companies' losses, according to the relevant literature and our 
interviews with stakeholders and others. For example, USDA subsidizes 
federal crop insurance premiums, helping food producers mitigate the 
risk of losing (1) revenue because of either market fluctuations or 
extreme weather and (2) crops because of extreme weather.[Footnote 29] 
In this program, backed by the federal government, producers pay 
premiums that are, in aggregate, lower than the amount needed to cover 
expected claims. As a result, the federal government is subsidizing 
the balance. According to USDA officials, the policies do not cover 
losses related to either an erroneously ordered recall or an erroneous 
food-related advisory. Federal crop insurance covers most major crops, 
such as corn and wheat, against these natural disasters, but insurance 
coverage for more specialized crops, such as fruits and vegetables, is 
generally available in the primary growing areas for those 
crops.[Footnote 30] USDA offers coverage only if it can find there is 
sufficient actuarial data in each county to provide insurance. A few 
food safety experts have suggested that a specific type of crop 
insurance called Adjusted Gross Revenue (AGR) might cover losses 
associated with price drops or a reduction in demand due to a 
foodborne illness outbreak. However, USDA officials told us that, as 
with other forms of federal crop insurance, AGR does not cover losses 
related to an erroneously ordered recall or an erroneous food-related 
advisory. Further, crop insurance policies cover only producers, not 
suppliers, distributors, or other companies in the distribution 
chain.[Footnote 31] In addition to a government insurance program, we 
identified private-sector options and learned that the private sector 
does offer policies to insure against losses from recalls; a few 
respondents, however, told us that these policies may be cost-
prohibitive for some companies. Further, according to private-sector 
insurance representatives we contacted, private insurance policies 
typically do not cover losses to companies whose food products are not 
adulterated but that may instead suffer "collateral damage" from 
declines in prices for their products; such collateral damage could 
result if or when consumers stop purchasing any product for which the 
government ordered a recall or issued a food-related advisory. 
Similarly, as one respondent stated, no private-sector policies cover 
damages for advisories (rather than recalls), perhaps, as insurance 
literature indicates, because a large number of claims could be filed 
at the same time, resulting in potentially catastrophic losses for 
insurers. In addition to traditional insurance, one respondent 
suggested that the use of a "check-off" program--in which a group of 
producers creates a form of self-insurance (not government 
subsidized)--could help producers mitigate the risk of broader market 
effects from a recall or advisory. Under such a program, companies 
could pay a set amount (e.g., per production unit) into a fund, which 
could then be used to pay participants if the market experienced a 
decline in consumer demand resulting from a recall or advisory. 

A few respondents said that a potential advantage of government 
insurance programs is that they may be relatively easy to implement 
because the agricultural sector is familiar with them, and one 
respondent stated the infrastructure to administer such programs 
already exists. Further, according to a few respondents, government 
insurance provides clear criteria and guidance to develop a program in 
advance of when it might be needed. One disadvantage, however, is 
that, as with any insurance program, insured participants might take 
greater risks if they were no longer entirely responsible for losses 
due to those risks, a concept referred to as "moral hazard." Another 
challenge to managing insurance programs arises when people who face 
higher risks enroll in greater numbers than those who face lower 
risks, increasing the likelihood that the insurer will pay more in 
claims, a concept termed "adverse selection." 

In addition, insurance premiums could be difficult to calculate 
because the expected behavior of those purchasing insurance and the 
risks of erroneous government actions are not well known.[Footnote 32] 
For example, one respondent said it could be difficult for insurers to 
calculate actuarially sound premiums for insurance in the case of 
erroneously ordered recalls or erroneous food-related advisories. One 
reason is that if a policyholder adopts risky agricultural practices, 
he or she may increase the likelihood that the insurer will have to 
pay a claim, which creates difficulties in assessing the likelihood 
that a policy will have to pay. Further, economists from USDA's 
Economic Research Service told us that the risks associated with 
erroneously ordered recalls or erroneous food-related advisories are 
not well known. Without data, setting appropriate premiums and policy 
requirements is difficult. 

Loans: 

If established by Congress, a specific program could be set up by the 
government to provide or guarantee loans to companies suffering losses 
from an erroneously ordered food recall or erroneous food-related 
advisory, and such a program could offer some form of subsidy, 
according to the relevant literature and our discussions with 
stakeholders and others. For example, the government could pay a 
portion of the interest on a loan to a company suffering such losses, 
provide a grace period before requiring a borrower to begin making 
interest payments, or charge lower fees than are needed to keep the 
program self-sustaining. USDA currently offers emergency loans to 
eligible producers in some instances, such as in a natural disaster. 
Other federal agencies, such as the Small Business Administration, 
offer loans with a variety of subsidy levels. Some respondents said an 
advantage of loans is that producers could receive a loan payment 
quickly, but some respondents said they would not consider a loan as 
adequate compensation for a government error. Further, administering 
loan programs could require additional government resources, such as 
staff and credit management systems to service loans and monitor 
default rates. 

Nonmonetary Compensation: 

The government could offer nonmonetary compensation to the food 
industry, such as a government promotional campaign or a public 
statement acknowledging an error in recalling a product, according to 
the relevant literature and our discussions with stakeholders and 
others. The European Commission used this mechanism with a campaign to 
promote European fresh produce in response to financial losses 
stemming from the 2011 outbreak of E. coli first associated with 
cucumbers, lettuce, and tomatoes, then later linked to sprouts grown 
from fenugreek seeds. Specifically, the European Commission undertook 
a promotional campaign across all European Union member states to send 
a message to consumers that European produce was safe and healthful to 
consume. The campaign used print and audiovisual media to send the 
message to consumers that cucumbers, tomatoes, and other produce were 
not connected with the E. coli crisis and that European Union food 
safety standards were strong. Regarding promotional campaigns, some 
respondents said that their relatively low cost was an advantage, 
while some said that such campaigns may not be effective. Further, 
some respondents stated that consumers could be confused if the 
government warns them not to eat a certain food and then later begins 
a campaign promoting that food. A few respondents also said the 
government should be careful not to promote a specific food or 
industry. 

Several Factors May Influence the Development of New Compensation 
Mechanisms: 

Several factors highlighted by stakeholders and others may come into 
play when deciding to establish a new compensation mechanism for the 
food industry. 

Defining What Constitutes an Error: 

Defining what constitutes an erroneously ordered recall or erroneous 
food-related advisory and identifying the portion of harm for which 
the government is responsible may be difficult and specific to each 
case, in part because of the complexity of identifying the food 
responsible for an outbreak. For example, some respondents stated that 
it can be difficult to attribute the cause of a foodborne outbreak 
with as much certainty as the cause in recalls of products like cars 
or baby cribs. This difficulty arises in part because one of the main 
tools used for investigating an outbreak is an epidemiological 
investigation, which involves, among other things, interviewing those 
infected about the foods they ate and creating hypotheses about what 
caused the outbreak. CDC officials acknowledged that epidemiology can 
be a science that requires a high level of experience and judgment in 
public health decision making. One legal expert representing industry 
organizations also told us that, in many cases, the scientific 
evidence may be inconclusive about whether a recall is justified. 

In addition, some respondents stated that it could be difficult to 
show definitively that a recall or advisory was truly erroneous. For 
example, an epidemiologist we spoke with told us that when FDA issued 
an advisory in 2006 identifying spinach as the source of an E. coli 
outbreak, the epidemiology was done correctly to identify spinach as 
the source. The produce industry expressed concern that advisories 
such as these were too broad. Nevertheless, FDA officials said they 
issued a broad advisory because they were still unsure of the exact 
scope of the problem and chose to be cautious in safeguarding public 
health. In another example, members of the tomato industry expressed 
concern that CDC and FDA made errors in identifying and announcing 
tomatoes as the source of the 2008 Salmonella outbreak when the source 
was later determined to be peppers. An article published in the New 
England Journal of Medicine in March 2011, however, states that the 
initial public advisory warning consumers to avoid certain types of 
tomatoes was supported by a strong association between illness 
outbreaks and the consumption of raw tomatoes. The article states that 
although an epidemiologic association with raw tomatoes was identified 
early in the investigation, subsequent epidemiologic and laboratory 
evidence implicated jalapeño and serrano peppers. The article also 
states that there was a decline in cases shortly after FDA's 
nationwide tomato advisory, which could be explained if consumer 
avoidance of raw tomatoes indirectly reduced their exposure to 
contaminated jalapeño and serrano peppers. 

Identifying the Extent of Government's Responsibility: 

Identifying the extent of the government's responsibility for losses 
companies suffer from an erroneously ordered food recall or an 
erroneous food-related advisory may be difficult. Some losses may be 
directly attributable to federal actions, while others could be 
largely outside of government control, such as shifts in consumer 
demand. For example, the 2011 Listeria outbreak in cantaloupes shows 
that forces largely beyond government control--such as a general 
decrease in demand for cantaloupes despite FDA's targeted advisory on 
cantaloupes from one producer in Colorado--also affect industry losses 
during an outbreak. For example, during the 2011 outbreak, some 
respondents praised FDA for its timely and targeted public advisories. 
Even so, demand for cantaloupes plummeted, and USDA reported in 
November 2011 that prices for cantaloupe dropped about 34 percent 
during the outbreak. In another example, a USDA study of the E. coli 
outbreak in 2006 found that while spinach sales fell, total 
expenditures for leafy greens remained unchanged, suggesting that 
producers of other leafy greens benefited from FDA's advisory against 
eating fresh spinach.[Footnote 33] Issues such as these could make 
determining government's responsibility more difficult. 

Mitigating Potential for Unintended Consequences on Public Health: 

In funding a mechanism to compensate food producers, some respondents 
stated that unintended consequences to public health could surface. 
For example, a few respondents said that if a public health agency, 
such as FDA, was responsible for funding a mechanism to compensate the 
food industry and the amount of compensation were large, the agency's 
ability to carry out its other responsibilities might be hampered. In 
the case of the 2008 Salmonella tomato-pepper outbreak, for example, 
industry representatives reported an estimated loss of around $145 
million to tomato growers and shippers in several states. These 
respondents stated that, given that this amount was equivalent to a 
large portion of FDA's food safety budget in 2008, having to pay 
industry such an amount could overwhelm the budget of a public health 
agency like FDA. 

In addition, according to some respondents, if FDA were overly 
concerned about providing compensation, it might wait longer to order 
recalls or provide food-related advisories until it was sure it had 
targeted the correct adulterant, potentially exacerbating an 
outbreak's severity or keeping adulterated products on the shelves, 
both of which could increase the likelihood that more consumers could 
become ill or even die. Some respondents told us that making FDA 
responsible for compensating producers might create perverse 
incentives for the agency to act in ways that could undermine the 
public health goals of recalls or food-related advisories. In response 
to this concern, FDA officials told us they aim to make decisions 
based on the science of public health and not other factors. Some 
respondents said that one way to mitigate this problem would be to 
separate compensation mechanisms from the agencies providing public 
health services. 

Determining Eligibility and Losses Depends on Goals and Objectives: 

The goals and objectives for any new compensation mechanism provide 
criteria for decisions, including those on which to base eligibility 
and funding. For example, some respondents raised questions about 
eligibility, including which companies along the distribution chain 
might be eligible for any compensation and whether foreign companies 
would be included. Some respondents also stated that administering a 
new mechanism would require determinations about which losses might be 
covered and that a variety of methods--such as measuring the market 
value of affected foods or, in the case of farmers, tying compensation 
to lost production--would be used to determine individual payments. 

Similarly, one respondent stated that compensation for recalls versus 
compensation for advisories could be very different in terms of the 
number of companies affected, as well as the total overall costs. For 
example, ordered recalls would be targeted and specific: FDA would not 
order a generic recall for an entire commodity; rather, the agency 
would target a lot number or a particular type of product. In such a 
case, the companies involved would be well known. On the other hand, a 
food-related advisory can be broader and include a larger group of 
industry participants throughout the distribution chain. Compensation 
for an erroneous food-related advisory could require more emphasis on 
eligibility requirements and criteria for determining which parties 
would be compensated. 

Conclusions: 

FSMA gave FDA a new tool to use in ensuring the safety of the many 
foods the agency oversees: the authority to order companies to recall 
foods other than infant formula that it determines to be adulterated 
and unsafe. To implement this authority, FDA officials have drafted 
their internal interim procedures for ordering recalls. It remains 
unclear, however, how effective the agency will be in fully 
implementing this new authority. First, FDA has not made public 
procedures for ordering food recalls. Specifically, (1) FDA's internal 
procedures have not been made public, and (2) the agency has not 
issued regulations or industry guidance publicly clarifying its 
procedures for ordering food recalls--including how the agency will 
weigh evidence on whether a recall is necessary--and FDA officials 
told us the agency had not decided whether to provide such 
information. Without this information, the agency cannot ensure that 
it applies practices uniformly or consistently or that it gives clear 
information to the food industry or to consumers and the public. 
Second, FDA's data on ordered recalls of nonfood products appear to be 
unreliable. As it relates to this data, (1) the categories for ordered 
recalls in its central database have undocumented definitions and (2) 
the databases that contain recall data do not fully share information. 
Given these issues, it is not clear whether or to what extent the 
agency's data on ordered food recalls can be relied upon to report 
accurate information to Congress and the public. Third, FDA faces 
challenges in how it communicates information about food recalls and 
outbreaks of foodborne illnesses. FDA has taken several steps to begin 
meeting these challenges, but the agency has not adopted a 
recommendation from its risk communication committee to develop a 
policy for communications during emerging events or from the Institute 
of Medicine and National Research Council to develop, in conjunction 
with other federal agencies, a coordinated plan for crisis 
communications. As a result, FDA is not clarifying for those outside 
the agency what to expect from FDA communications, and the agency 
continues to risk providing information on foodborne illnesses that 
conflicts with the information provided by other agencies or confuses 
consumers. In addition, FDA has not fully adopted a recommendation 
from our prior report to work jointly with USDA to identify any 
additional approaches needed to advise consumers about 
recalls,[Footnote 34] despite input from others to consider new 
approaches and a related change in USDA policy concerning public 
notifications. We continue to believe that in not implementing this 
recommendation, FDA is missing opportunities to learn from USDA's 
experiences and strengthen its food recall and advisory procedures. 

Recommendations for Executive Action: 

We recommend that the Secretary of Health and Human Services direct 
the Commissioner of FDA to take the following seven actions: 

To strengthen FDA's process for ordering recalls, 

* document FDA's process for ordering food recalls in publicly 
available procedures; 

* document FDA's process for ordering food recalls in regulations or 
industry guidance to include information on how the agency will weigh 
evidence on whether a recall is necessary; 

* document definitions for categories of ordered recalls in the 
agency's central recall database; and: 

* identify and implement ways to improve information sharing among its 
databases that contain recall data. 

To address FDA's communication challenges in advising the public about 
food recalls and outbreaks, implement recommendations: 

* from FDA's risk communication committee to develop a policy for 
communications during emerging events; 

* from the Institute of Medicine and National Research Council to 
develop, in conjunction with other federal agencies, a coordinated 
plan for crisis communications; and: 

* following from our prior work and others' input to consult with USDA 
on lessons learned in advising consumers about recalls to determine 
whether any of USDA's practices may be feasible at FDA, as consistent 
with applicable law. 

Agency Comments and our Evaluation: 

We provided a copy of our draft report to the Department of Health and 
Human Services for their review and comment. We also provided a draft 
of this report as a courtesy to the Consumer Product Safety 
Commission, Environmental Protection Agency, the Department of 
Transportation's National Highway Traffic Safety Administration, the 
Department of State, and USDA. On July 9, 2012, we received written 
comments from HHS, which are reproduced in appendix IV. HHS neither 
agreed nor disagreed with the recommendations in the report, but 
stated that HHS and FDA will explore each recommendation as they 
consider how to implement the recall provisions of FSMA. HHS also 
provided information on actions in process that are to address most of 
the recommendations we made in our draft report. The additional 
information related to each of our seven recommendations follows: 

* Document FDA's process for ordering food recalls in publicly 
available procedures: HHS stated that FDA is in the process of 
incorporating these procedures formally into its Regulatory Procedures 
Manual (a publicly available document), and expects the procedures for 
recalls of ordered food to be available in that manual by fall 2012. 

* Document FDA's process for ordering food recalls in regulations or 
industry guidance to include information on how the agency will weigh 
evidence on whether a recall is necessary: HHS stated that FDA agrees 
on the importance of providing information to stakeholders on how the 
agency will weigh evidence on whether a recall is necessary and has 
convened workgroups that are actively considering options for 
providing information to stakeholders. 

* Document definitions for categories of ordered recalls in the 
agency's central recall database: HHS stated that FDA has begun work 
to update the agency's central recall database and is updating its 
data to more adequately reflect the different types of recalls 
documented in that system. HHS stated that FDA expects to complete 
these changes by fall 2012. 

* Identify and implement ways to improve information sharing among its 
databases that contain recall data: HHS stated that FDA maintains the 
central recall database as its primary system for documenting and 
managing recalls of all FDA-regulated products, and that FDA's Office 
of Information Management manages information technology to ensure FDA 
has a robust information technology foundation enabling 
interoperability across FDA and the development of systems necessary 
to meet FDA's mission. 

* Implement recommendations from FDA's risk communication committee to 
develop a policy for communications during emerging events: HHS stated 
that FDA is exploring the feasibility and objectives of a policy for 
communications during emerging events. 

* Implement a recommendation from the Institute of Medicine and 
National Research Council to develop, in conjunction with other 
federal agencies, a coordinated plan for crisis communications: HHS 
stated that FDA's work with the Department of Homeland Security's 
National Incident Management System will address this recommendation 
and will provide for a consistent nationwide approach for federal, 
state, local, and tribal governments to work effectively and 
efficiently together to prepare for, prevent, respond to, and recover 
from domestic incidents. 

* Implement recommendations following from our prior work and others' 
input to consult with USDA on lessons learned in advising consumers 
about recalls to determine whether any of USDA's practices may be 
feasible at FDA, as consistent with applicable law: HHS stated that 
FDA will continue to work with USDA to gain insight and determine 
whether any of USDA's current practices may be feasible at FDA. 

The actions HHS describes, if appropriately implemented, could help to 
address most of the recommendations we made. However, HHS did not 
provide information on actions related to our recommendation that it 
identify and implement ways to improve information sharing among its 
databases that contain recall data. We continue to believe that 
improved information sharing among these databases could help to 
ensure the data are consistent and accurate. HHS also provided 
technical comments, which we incorporated as appropriate. 

We are sending copies of this report to the Secretaries of Health and 
Human Services, Agriculture, and State; the Administrators of the 
Environmental Protection Agency and the Department of Transportation's 
National Highway Traffic Safety Administration; the Chairman of the 
Consumer Product Safety Commission; appropriate congressional 
committees; and other interested parties. In addition, the report is 
available at no charge on the GAO website at [hyperlink, 
http://www.gao.gov]. 

If you or your staff members have any questions about this report, 
please contact me at (202) 512-3841 or shamesl@gao.gov. Contact points 
for our Offices of Congressional Relations and Public Affairs may be 
found on the last page of this report. GAO staff who made key 
contributions to this report are listed in appendix V. 

Signed by: 

Lisa Shames: 
Director, Natural Resources and Environment: 

List of Committees: 

The Honorable Debbie Stabenow: 
Chairwoman: 
The Honorable Pat Roberts: 
Ranking Member: 
Committee on Agriculture, Nutrition, and Forestry: 
United States Senate: 

The Honorable Tom Harkin: 
Chairman: 
The Honorable Michael Enzi: 
Ranking Member: 
Committee on Health, Education, Labor, and Pensions: 
United States Senate: 

The Honorable Frank Lucas: 
Chairman: 
The Honorable Collin Peterson: 
Ranking Member: 
Committee on Agriculture: 
House of Representatives: 

The Honorable Fred Upton: 
Chairman: 
The Honorable Henry Waxman: 
Ranking Member: 
Committee on Energy and Commerce: 
House of Representatives: 

[End of section] 

Appendix I: Objectives, Scope, and Methodology: 

This report (1) examines key government entities having the authority 
to order product recalls and how the Food and Drug Administration 
(FDA) implements its authority; (2) examines the challenges FDA faces, 
if any, in advising the public about food recalls or outbreaks of 
foodborne illnesses and examines how FDA has addressed these 
challenges; and (3) identifies mechanisms that may compensate the food 
industry for erroneously ordered food recalls or erroneous food-
related advisories, including the advantages and disadvantages of 
each.[Footnote 35] 

To address all our objectives, we reviewed information from the 
Congressional Research Service, the National Academies, and our own 
past work, as well as from academic sources and industry publications. 
We also gathered documentation and met with officials from FDA, the 
Centers for Disease Control and Prevention (CDC), the Consumer Product 
Safety Commission, the Environmental Protection Agency, the Department 
of Transportation's National Highway Traffic Safety Administration, 
the Department of State, and the Department of Agriculture (USDA), as 
well as with representatives of the food industry, consumer groups, 
and others to understand the broader issues surrounding recalls and 
FDA's food-related advisories. 

To address our first objective, we first determined key state, 
federal, and international government entities with authority to order 
recalls. To identify key state agencies, we used help from the 
Association of Food and Drug Officials to send an e-mail to its 
members inquiring about their authority to order recalls. A total of 
16 states and Puerto Rico responded to the association's inquiry. We 
followed up with officials from those states and territory to clarify 
their authorities and collect supporting documentation, such as state 
statutes and regulations, and through this process, we identified 
those with the authority to order food recalls. To identify key 
federal agencies, we reviewed our prior work in this area, collected 
legal documentation, and interviewed officials from FDA, the Consumer 
Product Safety Commission, the Environmental Protection Agency, the 
National Highway Traffic Safety Administration, and USDA. To identify 
international government entities with the authority to order food 
recalls, we reviewed a 2010 report from the National Academies on 
FDA's oversight of food safety, as well as our prior work in this 
area. We also interviewed officials from Australia, Canada, the 
European Union, and New Zealand. To determine how FDA implements its 
authority to order food recalls (other than infant formula), we 
reviewed the FDA Food Safety Modernization Act (FSMA) and internal 
interim procedures on food recalls as provided by FDA officials. The 
information presented in appendix II of this report on the steps FDA 
takes to order food recalls (other than infant formula) is based on 
statute. To compare how FDA implements its authority for food with how 
FDA and other agencies implement their authority for other products, 
we reviewed relevant documents obtained from key federal agencies, as 
well as some countries such as Canada. Key documents we reviewed 
included statutes; regulations; guidance to industry such as the 
Consumer Product Safety Commission's Regulated Products Handbook; 
[Footnote 36] and internal guidance for staff. This internal guidance 
included FDA's Regulatory Procedures Manual;[Footnote 37] the National 
Highway Traffic Safety Administration's Office Procedures for 
Conducting Defect Investigations;[Footnote 38] and the Environmental 
Protection Agency's Federal Insecticide, Fungicide, and Rodenticide 
Act Inspection Manual.[Footnote 39] We also collected information on 
the number of ordered recalls from fiscal year 2006 through fiscal 
year 2010 from FDA, the Consumer Product Safety Commission, the 
Environmental Protection Agency, and the National Highway Traffic 
Safety Administration. We requested from FDA the number of ordered 
recalls in the agency's history. FDA officials reported that the data 
they provided us came from the agency's current database for recall 
information, known as the Recall Enterprise System. We determined that 
these data were not reliable for our reporting purposes. A larger 
discussion of these issues is contained our first objective. 

To address our second objective, we first identified challenges FDA 
may face in advising the public about food recalls or outbreaks of 
foodborne illnesses by reviewing the following reports: FDA's 
Strategic Plan for Risk Communication[Footnote 40] and FDA's 
Communicating Risks and Benefits: An Evidence-Based User's Guide; 
[Footnote 41] the Institute of Medicine and National Research 
Council's 2010 report, Enhancing Food Safety: The Role of the Food and 
Drug Administration;[Footnote 42] and Stronger Partnerships for Safer 
Food: An Agenda for Strengthening State and Local Roles in the 
Nation's Food Safety System.[Footnote 43] We also reviewed documents 
from relevant meetings of FDA's Advisory Committee on Risk 
Communication (risk communication committee) and our prior work. We 
verified the challenges we identified during meetings with FDA 
officials, representatives from the food industry and consumer 
organizations, state and federal government officials, and experts in 
food safety. To determine the steps FDA is taking to address these 
challenges, we used three methods. First, we compared the challenges 
we identified with our analysis of FDA's Strategic Plan for Risk 
Communication, the Institute of Medicine and National Research 
Council's 2010 report on FDA's food safety role, transcripts from 
meetings of FDA's risk communication committee, other relevant agency 
documents, and our prior work. Second, we interviewed consumer and 
industry stakeholders, government officials, and experts in food 
safety or food law for their perspectives on FDA's actions to address 
these challenges. And third, we interviewed FDA officials about their 
efforts to address each challenge. 

To address our third objective, we first gathered information on what 
mechanisms might be used by meeting with representatives of consumer 
and industry organizations, experts in food safety and food law, and 
officials from state and other federal agencies. We also reviewed the 
relevant literature, including The Tools of Government: A Guide to the 
New Governance,[Footnote 44] an authoritative work about government 
policy tools. In addition, we collected documentation and interviewed 
officials from international government entities including Australia, 
Canada, the European Union, and New Zealand about their knowledge of 
possible compensation mechanisms. 

To gather information on the advantages and disadvantages of possible 
mechanisms, we conducted semistructured interviews with 16 individuals 
having expertise or a stake in this topic and analyzed their 
responses. We chose the 16 to reflect a range of perspectives. 
Specifically, we interviewed 5 representatives each from consumer and 
industry organizations, 3 officials from federal or state government, 
and 3 experts in food safety or food law. To develop and execute these 
interviews, we first developed draft interview questions and a script 
to follow to ensure that interviewers asked the same questions in the 
same manner in every interview. We also conducted two pretests of the 
interview questions and script and made modifications based on those 
pretests. In advance of each interview, we provided each respondent 
with a list of factors to consider and possible mechanisms that we 
would cover during our interview. We conducted all our semistructured 
interviews via telephone. To characterize the results of these 
interviews, we defined the words used to quantify the results as 
follows: "one" means one respondent, "a few" means two or three 
respondents, "some" means four or five respondents, and "almost half" 
means six or seven respondents. We gathered stakeholders' perspectives 
on each mechanism but did not independently evaluate the viability of 
any mechanism, its advantages, or disadvantages. 

We conducted this performance audit from May 2011 to July 2012 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. 

[End of section] 

Appendix II: Processes for Ordering Product Recalls at Key Federal 
Agencies: 

Four key federal agencies have the authority to recall products they 
regulate, and each agency's process for ordering a recall conforms 
with provisions in statutes, regulations, and procedures, as 
summarized in table 2. While companies can voluntarily recall their 
products at any time, the table below specifies points in the ordered 
recall process when agencies generally offer companies the opportunity 
to voluntarily issue a recall. 

Table 2: Steps Key Federal Agencies Take When Ordering Product Recalls: 

Agency: Food and Drug Administration; 
Product: Foods; 
Steps: 
1. The agency determines there is a reasonable probability that a 
food, other than infant formula, is adulterated under the Federal 
Food, Drug, and Cosmetic Act, or misbranded with respect to labeling 
for a major food allergen and that use of or exposure to the food will 
cause serious health consequences or death to humans or animals; 
2. Company is provided with an opportunity to voluntarily cease 
distribution of the food and recall it; 
3. If company does not take voluntary action, FDA may order company to 
cease distribution and notify all others along the supply chain to 
cease distribution; 
4. FDA provides the company an opportunity for informal hearing before 
the agency; 
5. If FDA determines that removal of the product is necessary then the 
agency shall, as appropriate, amend the cease-distribution order to 
require recall of the product. 

Agency: Food and Drug Administration; 
Product: Infant formula; 
Steps: 
1. Agency determines that formula processed by the manufacturer 
presents a risk to human health; 
2. The manufacturer must immediately recall the product and report on 
actions taken to implement the recall.[A]; 
3. The Federal Food, Drug, and Cosmetic Act prohibits the failure to 
provide such reports to FDA or take certain actions, as directed by 
FDA in regulation, to inform the public of the recall. 

Agency: Food and Drug Administration; 
Product: Medical devices; 
Steps: 
1. Agency determines there is a reasonable probability that a medical 
device would cause serious adverse health consequences or death; 
2. Company may, under FDA policy, voluntarily recall the product.[A]; 
3. If company does not voluntarily recall the product, the agency may 
order the company to immediately cease distribution and notify health 
professionals and device user facilities of the order and instruct 
them to stop using the device; 
4. Company has an opportunity for an informal hearing before the FDA 
Commissioner; 
5. Agency may amend the cease-distribution order to require a recall 
of the product. 

Agency: Food and Drug Administration; 
Product: Radiation-emitting electronic products; 
Steps: 
1. FDA determines a product contains a defect relating to safety of 
use by reason of emission of electronic radiation or does not comply 
with applicable standards; 
2. Agency notifies the company of defect or failure to comply with 
standards; 
3. Company may, under FDA policy, voluntarily recall the product.[A]; 
4. The company is given an opportunity to respond to FDA and present 
its views and evidence before the agency; 
5. Following a hearing, if FDA maintains that the product has a defect 
relating to safety of use by reason of emission or electronic 
radiation or does not comply with applicable standards, the agency 
will direct the company to provide notification of defect or failure 
to comply with standards; 
6. The company must bring the product into conformity, replace the 
product, or refund the cost.[B]. 

Agency: Food and Drug Administration; 
Product: Licensed biological products; 
Steps: 
1. Agency determines a product presents an imminent or substantial 
hazard to the public health; 
2. FDA issues an immediate recall; 
3. Company is afforded an opportunity for a formal hearing. 

Agency: Food and Drug Administration; 
Product: Tobacco products; 
Steps: 
1. Agency determines that there is a reasonable probability that a 
tobacco product contains a manufacturing defect not ordinarily 
contained in tobacco products on the market that would cause serious, 
adverse health consequences or death; 
2. Company may, under FDA policy, voluntarily recall the product.[A]; 
3. If the company does not voluntarily recall the product, the agency 
orders company to cease distribution of the product; 
4. Company is provided with an opportunity for an informal hearing; 
5. Agency may amend the cease-distribution order to require recall of 
the product. 

Agency: Consumer Product Safety Commission; 
Product: Consumer goods: products presenting a substantial hazard[C]; 
Steps: 
1. Agency determines that a product does not comply with applicable 
consumer product safety rules or any other rule, regulation, standard, 
or ban under the Consumer Product Safety Act or any other statute 
enforced by the commission or contains a defect that could create a 
substantial product hazard or creates an unreasonable risk of serious 
injury or death; 
2. Agency notifies company of its analysis and determination and 
orders the company to cease distribution and provide notification; 
3. Agency offers company an opportunity to take voluntary action and 
correct the violation. Company may request an informal hearing and 
present information contrary to commission's determination; 
4. Agency may order the company to repair, replace, or refund the 
product. 

Agency: Consumer Product Safety Commission; 
Product: Consumer goods: products presenting an imminent hazard[D]; 
Steps: 
1. Agency determines that a product presents imminent and unreasonable 
risk of death, serious illness, or severe personal injury; 
2. Agency files an action in U.S. District Court for court approval 
for a recall order. 

Agency: Environmental Protection Agency; 
Product: Vehicles and engines; 
Steps: 
1. Agency determines that a substantial number of a class or category 
of vehicles or engines do not conform to emission standards as 
specified in regulations; 
2. Agency notifies company of noncompliance and requires company to 
submit a plan to remedy the nonconformity; 
3. Company has opportunity to submit a plan for a recall and may 
implement voluntary recall; 
4. Company is provided an opportunity for a public hearing; 
5. Agency requires company to remedy the nonconformity. 

Agency: Environmental Protection Agency; 
Product: Pesticides; 
Steps: 
1. Agency determines a pesticide does not comply with statutory 
requirements or causes unreasonable adverse effects on human health or 
the environment; 
2. Agency notifies the registrant and the public of the intent to 
cancel or to hold a hearing on whether or not to cancel a pesticide's 
registration; 
3. If agency determines the pesticide causes an imminent hazard, it 
will suspend the registration, pending the completion of the 
cancellation process; 
4. Company is offered an expedited hearing on whether an imminent 
hazard exists; 
5. Agency determines that a pesticide with a registration that has 
been suspended and canceled should be recalled to protect health or 
the environment; 
6. If agency determines a voluntary recall may be safe or effective, 
it may request a recall plan from the company; 
7. If agency approves the voluntary recall plan, the company can 
implement the voluntarily recall plan; 
8. If agency finds a mandatory plan is necessary or that the requested 
recall plan is inadequate, it shall issue a regulation that prescribes 
a plan for recalling the pesticide. 

Agency: National Highway Traffic Safety Administration; 
Product: Motor vehicles, replacement equipment; 
Steps: 
1. Agency makes an initial determination that a safety-related defect 
exists or that a product does not comply with an applicable federal 
motor vehicle safety standard; 
2. Agency gives manufacturer an opportunity to present information. 
This may be by way of a public meeting, hearing, or submission of 
written comments; 
3. Manufacturer may voluntarily recall the product; 
4. If the company does not voluntarily recall the product, the agency 
may make a final decision that a safety-related defect exists or that 
a product does not comply with an applicable federal motor vehicle 
safety standard; 
5. If agency still determines recall is warranted, it may order the 
company to provide notice and recall the product. 

Sources: GAO analysis of statutes, regulations, and procedures. 

[A] FDA's Regulatory Procedures Manual states that firms may initiate 
a recall at any time, such as following notification of a problem by 
FDA or a state agency, to fulfill their responsibility to protect 
public health from products presenting a risk of injury or gross 
deception that are otherwise defective. 

[B] For purposes of this report, the term recall includes a firm's 
removal or correction of a marketed product. Corrections may include 
repair, modification, adjustment, relabeling, destruction, or 
inspection of a product without its physical removal to some other 
location. 

[C] A substantial product hazard is defined as (1) a failure to comply 
with an applicable consumer product safety rule, regulation, standard 
or ban under any other act enforced by the Consumer Product Safety 
Commission which creates a substantial risk of injury to the public or 
(2) a product defect which creates a substantial risk of injury to the 
public. 

[D] An imminently hazardous consumer product means a consumer product 
that presents imminent and unreasonable risk of death, serious 
illness, or severe personal injury. 

[End of table] 

[End of section] 

Appendix III: FDA Data Related to Ordered Recalls: 

[End of section] 

We noted a number of inconsistencies in FDA's data on ordered recalls 
during our analysis, which are described in table 3. 

Table 3: Problems with FDA Data Related to Ordered Recalls: 

Recall Enterprise System recall event identification number: 25991; 
Fiscal year: 2002; 
Product: Biological product; 
Problem: Center for Biologics Evaluation and Research officials told 
us that there were two ordered recalls of biological products in 
fiscal year 2006. Officials from the Office of Regulatory Affairs 
provided data from the Recall Enterprise System also indicating two 
ordered recalls in the agency's history but not occurring in fiscal 
year 2006. Officials from the Center for Biologics Evaluation and 
Research later stated that, after further investigation, they realized 
the two presumed ordered recalls from fiscal year 2006 were actually 
orders to cease manufacturing, not orders to recall. When asked about 
this new information, Office of Regulatory Affairs officials 
reexamined Recall Enterprise System data and acknowledged they 
erroneously told us there were two ordered recalls for fiscal year 
2006; the officials confirmed that these two events were orders to 
cease manufacturing, not orders to recall. Officials also told us that 
one ordered recall had occurred, in 2002. 

Recall Enterprise System recall event identification number: 26205; 
Fiscal year: 2003; 
Product: Medical device; 
Problem: Center for Devices and Radiological Health officials provided 
data indicating ordered recalls of medical devices had occurred but 
the Recall Enterprise System data indicated that the recalls were 
ordered under regulations governing the recall of human tissue 
intended for transplantation, which are biological products, not 
medical devices. 

Recall Enterprise System recall event identification number: 26286; 
Fiscal year: 2003; 
Product: Medical device; 
Problem: Center for Devices and Radiological Health officials provided 
data indicating ordered recalls of medical devices had occurred but 
the Recall Enterprise System data indicated that the recalls were 
ordered under regulations governing the recall of human tissue 
intended for transplantation, which are biological products, not 
medical devices. 

Recall Enterprise System recall event identification number: 34692; 
Fiscal year: 2006; 
Product: Not provided; 
Problem: Following its original data submission to GAO, Center for 
Devices and Radiological Health officials provided data indicating 
three additional ordered recalls of a product regulated by the center 
occurred in fiscal years 2006 and 2010. Agency officials told us these 
three recalls were not FDA-ordered recalls but voluntary recalls 
initiated by FDA. In the Recall Enterprise System, FDA requested 
recalls are inaccurately categorized as ordered recalls. 

Recall Enterprise System recall event identification number: 55825; 
Fiscal year: 2010; 
Product: Not provided; 
Problem: Following its original data submission to GAO, Center for 
Devices and Radiological Health officials provided data indicating 
three additional ordered recalls of a product regulated by the center 
occurred in fiscal years 2006 and 2010. Agency officials told us these 
three recalls were not FDA-ordered recalls but voluntary recalls 
initiated by FDA. In the Recall Enterprise System, FDA requested 
recalls are inaccurately categorized as ordered recalls. 

Recall Enterprise System recall event identification number: 56162; 
Fiscal year: 2010; 
Product: Not provided; 
Problem: Following its original data submission to GAO, Center for 
Devices and Radiological Health officials provided data indicating 
three additional ordered recalls of a product regulated by the center 
occurred in fiscal years 2006 and 2010. Agency officials told us these 
three recalls were not FDA-ordered recalls but voluntary recalls 
initiated by FDA. In the Recall Enterprise System, FDA requested 
recalls are inaccurately categorized as ordered recalls. 

Recall Enterprise System recall event identification number: 27549; 
Fiscal year: 2004; 
Product: Radiation-emitting electronic product; 
Problem: Center for Devices and Radiological health officials provided 
data indicating that this recall was ordered, but an internal memo 
stated that this recall would be classified as a voluntary recall. 

Recall Enterprise System recall event identification number: 38233; 
Fiscal year: 2007; 
Product: Radiation-emitting electronic product; 
Problem: These recalls were reflected in data reported by Center for 
Devices and Radiological Health officials but not included in data 
reported by Office of Regulatory Affairs officials. Officials from 
both said their data came from the Recall Enterprise System. 

Recall Enterprise System recall event identification number: 38248; 
Fiscal year: 2007; 
Product: Radiation-emitting electronic product; 
Problem: These recalls were reflected in data reported by Center for 
Devices and Radiological Health officials but not included in data 
reported by Office of Regulatory Affairs officials. Officials from 
both said their data came from the Recall Enterprise System. 

Recall Enterprise System recall event identification number: 56425; 
Fiscal year: 2011; 
Product: Medical device; 
Problem: A notice posted on FDA's website indicates that the agency 
ordered this recall. Center for Devices and Radiological Health 
officials provided data from the Recall Enterprise System indicating 
this recall was court ordered. Center for Devices and Radiological 
Health officials provided data from the Recall Enterprise System 
indicating that this recall occurred in fiscal year 2010. Office of 
Regulatory Affairs officials said the date in the Recall Enterprise 
System was incorrect and that the recall occurred in fiscal year 2011. 

Source: GAO analysis of FDA data. 

[End of table] 

[End of section] 

Appendix IV: Comments from the Department of Health and Human Services: 

Department Of Health & Human Services:  
Office Of The Secretary: 
Assistant Secretary for Legislation: 
Washington, DC 20201: 

July 9, 2012: 

Lisa Shames: 
Director, Natural Resources and Environment: 
U.S. Government Accountability Office: 
441 G Street NW: 
Washington, DC 20548: 

Dear Ms. Shames: 

Attached are comments on the U.S. Government Accountability Office's 
(GAO) report entitled, "Food Safety: FDA's Food Advisory and Recall 
Process Needs Strengthening" (GAO-12-589). 

The Department appreciates the opportunity to review this report prior 
to publication. 

Sincerely, 

Signed by: 

Jim R. Esquea: 
Assistant Secretary for Legislation: 

Attachment: 

[End of letter] 

General Comments Of The Department Of Health And Human Services (HHS) 
On The Government Accountability Office's (GAO) Draft Report Entitled, 
"Food Safety: FDA's Food Advisory And Recall Process Needs 
Strengthening" (GAO-12-589): 

The Department appreciates the opportunity to comment on this draft 
report. HHS and FDA will explore each recommendation fully as we 
consider how to implement the recall provisions of the FDA Food Safety 
Modernization Act (FSMA). FDA has already put processes and systems in 
place that will address many of GAO's recommendations. 

Food recalls are complex and multi-faceted, and they require 
expeditious yet thorough action by industry, FDA, and its federal and 
state partners in an effort that combines science and corrective 
action. A precedent for many recalls, whether voluntary or mandatory, 
is a rigorous epidemiological investigation that requires the 
cooperation of the states, the Centers for Disease Control and 
Prevention (CDC), and FDA. 

FSMA gives FDA, CDC, and other federal agencies new responsibilities 
to enhance federal, state, and local surveillance systems for 
foodborne illness so that they can identify and control outbreaks more 
rapidly. While FSMA gives FDA the authority to order that certain 
adulterated or misbranded foods are promptly removed from commerce, 
FSMA also provides a framework for heightened multi-agency involvement 
that will strengthen FDA in its recall efforts. 

GAO Recommendations: 

1. That FDA document its process for ordering food recalls in publicly 
available procedures. 

FDA has completed an interim Standard Operating Procedure (SOP) that 
outlines the steps for ordering food recalls. FDA is currently in the 
process of incorporating these SOPs formally into the Regulatory 
Procedures Manual (RPM). FDA anticipates that the procedure for 
ordered recalls of foods will be available in the RPM by Fall 2012. 

2. That FDA establish regulations or industry guidance (or both) for 
ordering food recalls. 

FDA agrees that it is important to provide information to stakeholders 
on how the Agency will weigh evidence on whether a recall is necessary 
and has convened workgroups that are actively considering options for 
providing information to stakeholders. 

3. That FDA develop definitions for categories of ordered recalls in 
the agency's central recall database. 

FDA has begun work to update the Agency's central recall database 
known as the Recall Enterprise System (RES). FDA is also in the 
process of updating the data set of recalls in RES to more adequately 
reflect the different types of recalls that are documented in the 
system, i.e., voluntary recalls and other recalls that are undertaken 
under FDA's recall authorities. FDA expects to complete the changes to 
RES by Fall 2012. 

4. That FDA identify and implement ways to improve information sharing 
among its databases that contain food recall data. 

FDA maintains the RES as the primary enterprise-wide system for 
documenting and managing recalls of all FDA-regulated products. FDA's 
Office of Information Management manages information technology (IT) 
and other related services including technical oversight of system 
development processes, policies, and methodologies and management of 
IT infrastructure to ensure FDA has a robust IT foundation that 
enables interoperability across FDA and allows development of systems 
necessary to meet FDA's mission of promoting and protecting public 
health in an efficient, effective, productive, and timely manner. 

5. That FDA implement recommendation from FDA's Risk Advisory 
Committee to develop a policy for communications during emerging 
events. 

FDA is exploring the feasibility and objectives of a policy for 
communications during emerging events. FDA has developed a new format 
for news releases that addresses issues mentioned by the committee. 
FDA first used this new format in the Spring 2010. FDA also 
established a procedure for expediting the clearance of outbreak-
related press releases by establishing a maximum 6-hour timeline from 
the start of the review of the draft of a public health 
emergency/outbreak-related press release to its dissemination to the 
media. 

The Interagency Foodborne Outbreak Response Working Group, with 
membership from FDA, CDC, and the United States Department of 
Agriculture (USDA), is working to improve federal interagency 
collaboration and communication during multistate foodborne illness 
outbreak investigations and response. Projects include: (1) evaluating 
interagency communication after interagency outbreak response, (2) 
developing procedures for rapid coordination and clearance of public 
information products during outbreaks, and (3) developing templates 
and Standard Operating Procedures for public communications related to 
outbreaks and how to communicate uncertainty and changes in messaging 
as new information becomes available. 

6. That FDA implement a recommendation from the IOM and National 
Research Council to develop, in conjunction with other federal 
agencies, a coordinated plan for crisis communications. 

FDA's work with the National Incident Management System (NIMS), 
developed and administered by the Department of Homeland Security, 
will address this recommendation. NIMS will provide for a consistent 
nationwide approach for federal, state, local, and tribal governments 
to work effectively and efficiently together to prepare for, prevent, 
respond to, and recover from domestic incidents, regardless of cause, 
size, or complexity. 

NIMS enhances the management of domestic incidents by establishing a 
single, comprehensive system for incident management and helps to 
achieve greater cooperation among agencies at all levels of 
government. Implementing the NIMS strengthens each agency's capability 
and resolve to fulfill its responsibilities to the public during 
emergencies. 

7. That FDA implement a recommendation from GAO's prior work and 
other's input to consult with USDA on lessons learned in advising 
consumers about recalls to determine whether any of USDA's practices 
may be feasible at FDA, as consistent with applicable law. 

FDA will continue to work closely with USDA's Food Safety and 
Inspection Service to gain insight and determine whether any of USDA's 
current practices may be feasible at FDA. 

[End of section] 

Appendix V: GAO Contact and Staff Acknowledgments: 

GAO Contact: 

Lisa Shames, (202) 512-3841 or shamesl@gao.gov: 

Staff Acknowledgments: 

In addition to the individual named above, Karen Jones (Assistant 
Director), Kevin Bray, Mark Braza, Candace Carpenter, Ellen W. Chu, 
Barbara El Osta, Brendan Kretzschmar, Kirsten B. Lauber, Angela Miles, 
and Kiki Theodoropolous made key contributions to this report. 

[End of section] 

Footnotes: 

[1] See GAO, High-Risk Series: An Update, [hyperlink, 
http://www.gao.gov/products/GAO-11-278] (Washington, D.C.: February 
2011). See also GAO, High-Risk Series: An Update, [hyperlink, 
http://www.gao.gov/products/GAO-07-310] (Washington, D.C.: January 
2007). 

[2] For purposes of this report, the term recall includes a firm's 
removal or correction of a marketed product. Corrections may include 
repair, modification, adjustment, relabeling, destruction, or 
inspection of a product without its physical removal to some other 
location. Similarly, the term order includes an agency's authority to 
directly mandate, require, or to make a determination that would 
require a recall under the law, or an agency's authority to obtain 
such an order through a court. Under the Federal Food, Drug, and 
Cosmetic Act, food includes both human and animal food, and the 
provisions of FSMA authorizing FDA to order food recalls apply to both 
human and animal food. This report, however, discusses only human 
food. Before January 2011, FDA had authority to order recalls for 
medical devices, radiation-emitting electronic products, biological 
products, tobacco products, and infant formula but not foods other 
than infant formula. 

[3] We have reviewed FDA's oversight of food recalls twice since 2000. 
See GAO, Food Safety: USDA and FDA Need to Better Ensure Prompt and 
Complete Recalls of Potentially Unsafe Food, [hyperlink, 
http://www.gao.gov/products/GAO-05-51] (Washington, D.C.: Oct. 6, 
2004), and Food Safety: Actions Needed by USDA and FDA to Ensure That 
Companies Promptly Carry Out Recalls, [hyperlink, 
http://www.gao.gov/products/GAO/RCED-00-195] (Washington, D.C.: Aug. 
17, 2000). 

[4] PulseNet is a network of state and local public health 
laboratories, as well as federal food regulatory laboratories, that 
performs molecular surveillance of foodborne infections by conducting 
DNA "fingerprinting" on bacteria and exchanging findings among 
laboratories. The network permits rapid comparison of these 
"fingerprint" patterns through an electronic database at CDC. 

[5] The Listeria Initiative collects information on laboratory-
confirmed cases of human listeriosis in the United States using a 
standardized, extended questionnaire to interview patients as cases 
are reported, rather than after clusters of cases are identified by 
public health professionals. According to CDC officials, this 
information, used in conjunction with data from PulseNet, allows 
professionals to more quickly identify epidemiologically related and 
nonrelated illnesses for further analysis. 

[6] The other two organizations are the National Academy of Sciences 
and National Academy of Engineering. 

[7] Robert B. Wallace and Maria Oria, eds., Enhancing Food Safety: The 
Role of the Food and Drug Administration (Washington, D.C.: National 
Academies Press, 2010). 

[8] In the wake of reports during 1979 that more than 100 infants 
became seriously ill as a consequence of using soybean-based formulas 
marketed with an insufficient amount of chloride, Congress passed the 
Infant Formula Act of 1980. This act established specific requirements 
for infant formulas--considered food under the Federal Food, Drug, and 
Cosmetic Act. The 1980 act established notification requirements and 
recall procedures when a manufacturer of an infant formula has reason 
to believe the infant formula fails to provide required nutrients or 
is otherwise adulterated or misbranded and presents a risk to human 
health. In 1986, these infant formula provisions were amended so that 
a recall of an infant formula would become mandatory if FDA determined 
the infant formula presented a risk to human health. Key differences 
between FDA's authority to order recalls of food and infant formula 
are noted in appendix II. 

[9] See GAO, Standards for Internal Control in the Federal Government, 
[hyperlink, http://www.gao.gov/products/GAO/AIMD-00-21.3.1] 
(Washington, D.C.: November 1999). These standards, issued pursuant to 
the requirements of the Federal Managers' Financial Integrity Act of 
1982, provide the overall framework for establishing and maintaining 
internal control in the federal government. 

[10] [hyperlink, http://www.gao.gov/products/GAO/AIMD-00-21.3.1]. 

[11] Administrative Practices and Procedures: Good Guidance Practices, 
65 Fed. Reg. 56,468 (Sept. 19, 2000) (codified at 21 C.F.R. § 
10.115(k)(2)). 

[12] Health Canada, Public Health Agency of Canada, and Canadian Food 
Inspection Agency, Weight of Evidence: Factors to Consider for 
Appropriate and Timely Action in a Foodborne Illness Outbreak 
Investigation (Ottawa: January 2011). 

[13] [hyperlink, http://www.gao.gov/products/GAO/AIMD-00-21.3.1]. 

[14] A data dictionary is a centralized repository of information 
about data in a database such as its meaning, relationships to other 
data, origin, usage, and format. 

[15] [hyperlink, http://www.gao.gov/products/GAO-05-51]. 

[16] GAO, Food Labeling: FDA Needs to Better Leverage Resources, 
Improve Oversight, and Effectively Use Available Data to Help 
Consumers Select Healthy Foods, [hyperlink, 
http://www.gao.gov/products/GAO-08-597] (Washington, D.C.: Sept. 9, 
2008). 

[17] GAO, Food and Drug Administration: Opportunities Exist to Better 
Address Management Challenges, [hyperlink, 
http://www.gao.gov/products/GAO-10-279] (Washington, D.C.: Feb. 19, 
2010). 

[18] GAO, Food and Drug Administration: 2009 FDA Managers Survey on 
Performance and Management Issues, an E-supplement to [hyperlink, 
http://www.gao.gov/products/GAO-10-279], [hyperlink, 
http://www.gao.gov/products/GAO-10-280SP] (Washington, D.C.: Feb. 19, 
2010). 

[19] The first most commonly identified issue was, "recruiting, 
retaining, and developing a workforce with the knowledge, skills, and 
abilities necessary to carry out its mission." The second most 
commonly identified issue was, "improving coordination and 
communication within FDA." 

[20] GAO, Information Technology: FDA Needs to Fully Implement Key 
Management Practices to Lessen Modernization Risks, [hyperlink, 
http://www.gao.gov/products/GAO-12-346] (Washington D.C.: Mar. 15, 
2012). 

[21] Department of Health and Human Services, Food and Drug 
Administration, Strategic Plan for Risk Communication (Silver Spring, 
MD: Fall 2009). 

[22] See [hyperlink, 
http://www.accessdata.fda.gov/scripts/shelleggsrecall/] for the 2010 
shell egg recall products database and [hyperlink, 
http://www.accessdata.fda.gov/scripts/peanutbutterrecall/index.cfm] 
for the 2008-2009 peanut products recall database. 

[23] As part of their recall programs, both FDA and USDA classify 
recalls on the basis of their severity. Class I recalls present the 
greatest risk to human health: they cover situations where there is a 
reasonable probability that the use or exposure to the product will 
cause serious adverse health consequences or death and may involve 
food contaminated with disease-causing bacteria, such as Listeria or 
Salmonella, or foods containing a major food allergen such as nuts or 
eggs, not identified on the label. Class II and Class III recalls 
involve foods from which the risk of adverse health consequences is 
remote or not likely, respectively. For example, according to FDA 
documentation, a Class III recall might include a lack of English 
labeling on a food product. 

[24] [hyperlink, http://www.gao.gov/products/GAO-10-279]. 

[25] [hyperlink, http://www.gao.gov/products/GAO-10-280SP]. 

[26] GAO, Results-Oriented Government: Practices That Can Help Enhance 
and Sustain Collaboration among Federal Agencies, [hyperlink, 
http://www.gao.gov/products/GAO-06-15] (Washington, D.C.: Oct. 15, 
2005). 

[27] [hyperlink, http://www.gao.gov/products/GAO-05-51]. 

[28] USDA posts information on its website as to which retail outlets 
receive products associated with Class I recalls. 

[29] For more information on crop insurance, see GAO, Crop Insurance: 
Savings Would Result from Program Changes and Greater Use of Data 
Mining, [hyperlink, http://www.gao.gov/products/GAO-12-256] 
(Washington, D.C.: Mar. 13, 2012), and GAO, Crop Insurance: 
Opportunities Exist to Reduce the Costs of Administering the Program, 
[hyperlink, http://www.gao.gov/products/GAO-09-445] (Washington, D.C.: 
Apr. 29, 2009). 

[30] On June 19, 2012, the United States Senate voted to amend the 
Senate's proposed 2012 Farm Bill to require that USDA submit a report 
to the House Committee on Agriculture and the Senate Committee on 
Agriculture, Nutrition, and Forestry evaluating insurance policies and 
plans that provide protection for production or revenue affected by 
food safety concerns, including those that result in advisories or 
recalls. This report would determine whether offering such policies 
for specialized crops, such as fruits and vegetables, would benefit 
agricultural producers. See 158 Cong. Rec. S4276 (daily ed. June 19, 
2012) (vote on amendment 2309 amending Agriculture Reform, Food, and 
Jobs Act of 2012, S. 3240, 112th Cong, § 11017). 

[31] In the Federal Crop Insurance Act, "producer" is defined as a 
"person" (as defined by the Secretary of Agriculture) who is 18 years 
of age and has a bona fide insurable interest in a crop as an owner-
operator, landlord, tenant, or sharecropper. 7 U.S.C. § 1520. 

[32] For more on the difficulty of charging premiums that fully 
reflect risks, see our reports on the National Flood Insurance 
Program, such as GAO, Flood Insurance: Public Policy Goals Provide a 
Framework for Reform, [hyperlink, 
http://www.gao.gov/products/GAO-11-670T] (Washington, D.C.: June 23, 
2011), and [hyperlink, http://www.gao.gov/products/GAO-11-278]. 

[33] Carlos Arnade et al., "Consumers Response to the 2006 Foodborne 
Illness Outbreak Linked to Spinach," Amber Waves, vol. 8, no. 1 
(Washington, D.C.: USDA Economic Research Service, March 2010), 
accessed September 29, 2011, [hyperlink, 
http://www.ers.usda.gov/amberwaves/march10/features/outbreakspinach.htm]
. 

[34] [hyperlink, http://www.gao.gov/products/GAO-05-51]. 

[35] For purposes of this report, the term recall includes a firm's 
removal or correction of a marketed product. Corrections may include 
repair, modification, adjustment, relabeling, destruction, or 
inspection of a product without its physical removal to some other 
location. Similarly, the term order includes an agency's authority to 
directly mandate, require, or make a determination that would require 
a recall under the law, or an agency's authority to obtain such an 
order through a court. 

[36] U.S. Consumer Product Safety Commission. Regulated Products 
Handbook (Washington, D.C.: 2005). 

[37] U.S. Department of Health and Human Services, Food and Drug 
Administration, Regulatory Procedures Manual. (Silver Spring, MD: 
2011). 

[38] U.S. Department of Transportation, National Highway Traffic 
Safety Administration, Office Procedures for Conducting Defect 
Investigations (Washington, D.C.: 2009). 

[39] U. S. Environmental Protection Agency, Office of Enforcement and 
Compliance Assurance, Federal Insecticide, Fungicide, and Rodenticide 
Act (FIFRA) Inspection Manual (Washington, D.C.: 2002). 

[40] U.S. Department of Health and Human Services, Food and Drug 
Administration, Strategic Plan for Risk Communication (Silver Spring, 
MD: Fall 2009). 

[41] U.S. Department of Health and Human Services, Food and Drug 
Administration, Communicating Risks and Benefits: An Evidence-Based 
Use's Guide (Silver Spring, MD: August 2011). 

[42] Robert B. Wallace and Maria Oria, eds., Enhancing Food Safety: 
The Role of the Food and Drug Administration (Washington, D.C.: 
National Academies Press, 2010). 

[43] Michael R. Taylor and Stephanie D. David, Stronger Partnerships 
for Safer Food: An Agenda for Strengthening State and Local Roles in 
the Nation's Food Safety System (Washington, D.C.: George Washington 
University School of Public Health and Health Services, April 2009). 

[44] Lester Salamon, ed., The Tools of Government: A Guide to the New 
Governance (New York: Oxford University Press, 2002). 

[End of section] 

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