FOOD SAFETY

FDA’s Food Advisory 

and Recall Process 

Needs Strengthening

Report to Congressional Committees

July 2012

GAO-12-589

United States Government Accountability Office

GAO
United States Government Accountability Office

Highlights of GAO-12-589, a report to 

congressional committees

July 2012

FOOD SAFETY

FDA’s Food Advisory and Recall Process Needs 

Strengthening

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 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.

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 foodrelated 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. View GAO-12-589. For more information, 

contact Lisa Shames at (202) 512-3841 or 

shamesl@gao.gov.
Page i GAO-12-589 FDA's Food Advisory and Recall Process

Letter 1 

Background 4

Several Key Entities Have Recall Authority, but FDA Has Not 

Issued Regulations or Industry Guidance on Its Ordering of Food 

Recalls 8

FDA Has Taken Steps to Begin Meeting Communication Challenges 

When Advising the Public about Food Recalls and Outbreaks 19

Several Mechanisms Might be Available to Compensate the Food 

Industry for Erroneously Ordered Recalls or Erroneous FoodRelated Advisories 28

Conclusions 37

Recommendations for Executive Action 38

Agency Comments and our Evaluation 39

Appendix I Objectives, Scope, and Methodology 43

Appendix II Processes for Ordering Product Recalls at Key Federal Agencies 47

Appendix III FDA Data Related to Ordered Recalls 51

Appendix IV Comments from the Department of Health and Human Services 52

Appendix V GAO Contact and Staff Acknowledgments 56

Tables

Table 1: Key Federal, State, and International Government Entities 

Having the Authority to Order Product Recalls 9

Table 2: Steps Key Federal Agencies Take When Ordering Product 

Recalls 47

Table 3: Problems with FDA Data Related to Ordered Recalls 51

Contents
Page ii GAO-12-589 FDA's Food Advisory and Recall Process

Figure

Figure 1: FDA’s Statutorily Required Process for Ordering Food 

Recalls Other Than Infant Formula 11

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

FSMA FDA Food Safety Modernization Act

HHS Department of Health and Human Services

OMB Office of Management and Budget

USDA U.S. Department of Agriculture

This is a work of the U.S. government and is not subject to copyright protection in the 

United States. The published product may be reproduced and distributed in its entirety 

without further permission from GAO. However, because this work may contain 

copyrighted images or other material, permission from the copyright holder may be 

necessary if you wish to reproduce this material separately.
Page 1 GAO-12-589 FDA's Food Advisory and Recall Process

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 2007,1

 

1

See GAO, High-Risk Series: An Update, 

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 

GAO-11-278 (Washington, D.C.: February 

2011). See also GAO, High-Risk Series: An Update, GAO-07-310 (Washington, D.C.: 

January 2007).

 
 

Page 2 GAO-12-589 FDA's Food Advisory and Recall Process

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.

2

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 

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.

 

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.
 

Page 3 GAO-12-589 FDA's Food Advisory and Recall Process

these challenges; and (3) identifies mechanisms that may compensate 

the food industry for erroneously ordered food recalls or erroneous foodrelated 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 
 

Page 4 GAO-12-589 FDA's Food Advisory and Recall Process

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.

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 Mexicanstyle 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 

Background 
 

Page 5 GAO-12-589 FDA's Food Advisory and Recall Process

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 
 

Page 6 GAO-12-589 FDA's Food Advisory and Recall Process

located and removed from the marketplace or that its labeling is 

corrected.3

Many agencies, such as the following, play a role in responding to 

multistate outbreaks of foodborne illnesses:

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.

• 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 PulseNet4

and the Listeria Initiative.5

 

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, 

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 

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, 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.
 

Page 7 GAO-12-589 FDA's Food Advisory and Recall Process

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,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.7

 

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).
 

Page 8 GAO-12-589 FDA's Food Advisory and Recall Process

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.

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.

Several Key Entities 

Have Recall Authority, 

but FDA Has Not 

Issued Regulations or 

Industry Guidance on 

Its Ordering of Food 

Recalls 

Entities with Authority to 

Order Product Recalls Use 

Processes with Similar 

Steps 
 

Page 9 GAO-12-589 FDA's Food Advisory and Recall Process

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

Sources: GAO analysis of multiple sources (see app. 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’s statutory process for ordering food recalls other than infant 

formula

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.

8

 

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.

includes three steps, which are also used by key federal 

agencies to order recalls of other product types. These steps are to 

Entity Products

Federal agencies Consumer Product Safety Commission Many consumer goods

Environmental Protection Agency Vehicles and engines, pesticides

FDA Human biological products, foods within its jurisdiction 

(including infant formulab

), medical devices, radiationemitting electronic products, and tobacco products

National Highway Traffic Safety 

Administration

Motor vehicles, child safety seats, tires, and other motor 

vehicle equipment

States Alaska a

New Mexico

South Carolina

Texas

Foods

International entities Australia a

Canada

European Union

Japan

New Zealand

Foods
 

Page 10 GAO-12-589 FDA's Food Advisory and Recall Process

(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 
 

Page 11 GAO-12-589 FDA's Food Advisory and Recall Process

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

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 

FDA Has Not Made Public 

Procedures for Ordering 

Food Recalls
 

Page 12 GAO-12-589 FDA's Food Advisory and Recall Process

management directives and to make that documentation readily available 

for examination.9

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.

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.

10

• 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.

FDA and others have highlighted the value 

of clarifying procedures in regulations or industry guidance, as follows:

 

9

See GAO, Standards for Internal Control in the Federal Government, 

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.

10GAO/AIMD-00-21.3.1.
 

Page 13 GAO-12-589 FDA's Food Advisory and Recall Process

• Industry guidance. FDA’s good guidance practices11

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:

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.

• 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 

 

11Administrative Practices and Procedures: Good Guidance Practices, 65 Fed. Reg. 

56,468 (Sept. 19, 2000) (codified at 21 C.F.R. § 10.115(k)(2)).
 

Page 14 GAO-12-589 FDA's Food Advisory and Recall Process

foodborne illnesses to assist in deciding, among other things, whether 

a recall may be warranted.12

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.

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.

 

12Health 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).
 

Page 15 GAO-12-589 FDA's Food Advisory and Recall Process

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 app. 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 

FDA’s Data on Ordered 

Recalls Appear to Be 

Unreliable
 

Page 16 GAO-12-589 FDA's Food Advisory and Recall Process

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,13

• 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

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:

14

 

13

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 

GAO/AIMD-00-21.3.1.

14A 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. 
 

Page 17 GAO-12-589 FDA's Food Advisory and Recall Process

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.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.16

 

15

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 

GAO-05-51. 

16GAO, Food Labeling: FDA Needs to Better Leverage Resources, Improve Oversight, 

and Effectively Use Available Data to Help Consumers Select Healthy Foods, 

GAO-08-597 (Washington, D.C.: Sept. 9, 2008).
 

Page 18 GAO-12-589 FDA's Food Advisory and Recall Process

that could affect FDA’s ability to carry out its mission.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.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.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.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.

 

17GAO, Food and Drug Administration: Opportunities Exist to Better Address Management 

Challenges, GAO-10-279 (Washington, D.C.: Feb. 19, 2010).

18GAO, Food and Drug Administration: 2009 FDA Managers Survey on Performance and 

Management Issues, an E-supplement to GAO-10-279, GAO-10-280SP (Washington, 

D.C.: Feb. 19, 2010).

19The 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.” 

20GAO, Information Technology: FDA Needs to Fully Implement Key Management 

Practices to Lessen Modernization Risks, GAO-12-346 (Washington D.C.: Mar. 15, 2012).
 

Page 19 GAO-12-589 FDA's Food Advisory and Recall Process

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.

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 Communication21

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 

and other 

sources.

 

21Department of Health and Human Services, Food and Drug Administration, Strategic 

Plan for Risk Communication (Silver Spring, MD: Fall 2009).

FDA Has Taken Steps 

to Begin Meeting 

Communication 

Challenges When 

Advising the Public 

about Food Recalls 

and Outbreaks

FDA Faces Challenges in 

Seven Related Categories 

and Has Taken Some Steps 

to Address Them

Balancing the Goals of 

Timeliness and Accuracy 
 

Page 20 GAO-12-589 FDA's Food Advisory and Recall Process

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.

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 

Providing Precise, Complete 

Information Understandable to 

a General Audience 
 

Page 21 GAO-12-589 FDA's Food Advisory and Recall Process

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.22

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 

 

22See http://www.accessdata.fda.gov/scripts/shelleggsrecall/ for the 2010 shell egg recall 

products database and 

http://www.accessdata.fda.gov/scripts/peanutbutterrecall/index.cfm for the 2008-2009 

peanut products recall database.

Serving a Wide Range of 

Audiences and Audience Needs
 

Page 22 GAO-12-589 FDA's Food Advisory and Recall Process

recalls on its website.23

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.

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.

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 

 

23As 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.

Maintaining Public Trust in 

FDA Communications

Coordinating Messages with 

Other Agencies 
 

Page 23 GAO-12-589 FDA's Food Advisory and Recall Process

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.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.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.26

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 

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.

 

24GAO-10-279. 

25GAO-10-280SP. 

26GAO, Results-Oriented Government: Practices That Can Help Enhance and Sustain 

Collaboration among Federal Agencies, GAO-06-15 (Washington, D.C.: Oct. 15, 2005).

Testing Draft Communications 

with Users
 

Page 24 GAO-12-589 FDA's Food Advisory and Recall Process

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.

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.

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 

Communicating When an 

Outbreak or Recall Is Over 

FDA Has Not Fully 

Adopted Some 

Recommended 

Communication Policies or 

Plans Related to Identified 

Challenges
 

Page 25 GAO-12-589 FDA's Food Advisory and Recall Process

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 
 

Page 26 GAO-12-589 FDA's Food Advisory and Recall Process

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,27

• 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 

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:

 

27GAO-05-51. 
 

Page 27 GAO-12-589 FDA's Food Advisory and Recall Process

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.28

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.

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.

 

28USDA posts information on its website as to which retail outlets receive products 

associated with Class I recalls. 
 

Page 28 GAO-12-589 FDA's Food Advisory and Recall Process

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.

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 foodrelated 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.

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.

Several Mechanisms 

Might be Available to 

Compensate the Food 

Industry for 

Erroneously Ordered 

Recalls or Erroneous 

Food-Related 

Advisories 

Each Compensation 

Mechanism Has 

Advantages and 

Disadvantages

The Judicial Process
 

Page 29 GAO-12-589 FDA's Food Advisory and Recall Process

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.

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. 

A Dedicated Program

One-Time Funding for Specific 

Events 
 

Page 30 GAO-12-589 FDA's Food Advisory and Recall Process

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 broadbased 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.

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.29

 

29For more information on crop insurance, see GAO, Crop Insurance: Savings Would 

Result from Program Changes and Greater Use of Data Mining, 

In this program, backed by the 

GAO-12-256 

(Washington, D.C.: Mar. 13, 2012), and GAO, Crop Insurance: Opportunities Exist to 

Reduce the Costs of Administering the Program, GAO-09-445 (Washington, D.C.: Apr. 29, 

2009).

Government Insurance
 

Page 31 GAO-12-589 FDA's Food Advisory and Recall Process

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.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.31

 

30On 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). 

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 costprohibitive 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 

31In 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.
 

Page 32 GAO-12-589 FDA's Food Advisory and Recall Process

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 “checkoff” program—in which a group of producers creates a form of selfinsurance (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.32

 

32For 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, 

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 

GAO-11-670T (Washington, D.C.: June 23, 

2011), and GAO-11-278. 
 

Page 33 GAO-12-589 FDA's Food Advisory and Recall Process

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.

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.

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 

Loans

Nonmonetary Compensation
 

Page 34 GAO-12-589 FDA's Food Advisory and Recall Process

promoting that food. A few respondents also said the government should 

be careful not to promote a specific food or industry.

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 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 

Several Factors May 

Influence the Development 

of New Compensation 

Mechanisms

Defining What Constitutes an 

Error
 

Page 35 GAO-12-589 FDA's Food Advisory and Recall Process

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 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 benefitted from FDA’s advisory against eating fresh spinach.33

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. 

Issues such as these could make determining government’s responsibility 

more difficult.

 

33Carlos 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, 

http://www.ers.usda.gov/amberwaves/march10/features/outbreakspinach.htm.

Identifying the Extent of 

Government’s Responsibility

Mitigating Potential for 

Unintended Consequences on 

Public Health 
 

Page 36 GAO-12-589 FDA's Food Advisory and Recall Process

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.

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 foodrelated 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.

Determining Eligibility and 

Losses Depends on Goals and 

Objectives 
 

Page 37 GAO-12-589 FDA's Food Advisory and Recall Process

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,34

 

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 

GAO-05-51. 

Conclusions 
 

Page 38 GAO-12-589 FDA's Food Advisory and Recall Process

from USDA’s experiences and strengthen its food recall and advisory 

procedures.

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.

Recommendations for 

Executive Action
 

Page 39 GAO-12-589 FDA's Food Advisory and Recall Process 

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 

Agency Comments 

and our Evaluation 
 

Page 40 GAO-12-589 FDA's Food Advisory and Recall Process

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 http://www.gao.gov. 
 

Page 41 GAO-12-589 FDA's Food Advisory and Recall Process

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.

Lisa Shames

Director, Natural Resources and Environment
 

Page 42 GAO-12-589 FDA's Food Advisory and Recall Process

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
Appendix I: Objectives, Scope, and 

Methodology

Page 43 GAO-12-589 FDA's Food Advisory and Recall Process

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.1

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 

 

1

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.

Appendix I: Objectives, Scope, and 

Methodology 
Appendix I: Objectives, Scope, and 

Methodology

Page 44 GAO-12-589 FDA's Food Advisory and Recall Process

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;

2 and internal guidance for staff. This internal 

guidance included FDA’s Regulatory Procedures Manual;

3 the National 

Highway Traffic Safety Administration’s Office Procedures for Conducting 

Defect Investigations;

4 and the Environmental Protection Agency’s 

Federal Insecticide, Fungicide, and Rodenticide Act Inspection Manual.

5

 

2

U.S. Consumer Product Safety Commission. Regulated Products Handbook

(Washington, D.C.: 2005).

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.

3

U.S. Department of Health and Human Services, Food and Drug Administration, 

Regulatory Procedures Manual. (Silver Spring, MD: 2011).

4

U.S. Department of Transportation, National Highway Traffic Safety Administration, 

Office Procedures for Conducting Defect Investigations (Washington, D.C.: 2009).

5

U. S. Environmental Protection Agency, Office of Enforcement and Compliance 

Assurance, Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Inspection 

Manual (Washington, D.C.: 2002).
Appendix I: Objectives, Scope, and 

Methodology

Page 45 GAO-12-589 FDA's Food Advisory and Recall Process

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 

Communication6 and FDA’s Communicating Risks and Benefits: An 

Evidence-Based User’s Guide;

7 the Institute of Medicine and National 

Research Council’s 2010 report, Enhancing Food Safety: The Role of the 

Food and Drug Administration;8 and Stronger Partnerships for Safer 

Food: An Agenda for Strengthening State and Local Roles in the Nation’s 

Food Safety System.

9

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 

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.

 

6

U.S. Department of Health and Human Services, Food and Drug Administration, 

Strategic Plan for Risk Communication (Silver Spring, MD: Fall 2009).

7

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).

8

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).

9

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).
Appendix I: Objectives, Scope, and 

Methodology

Page 46 GAO-12-589 FDA's Food Advisory and Recall Process

relevant literature, including The Tools of Government: A Guide to the 

New Governance,

10

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.

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.

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.

 

10Lester Salamon, ed., The Tools of Government: A Guide to the New Governance (New 

York: Oxford University Press, 2002).
Appendix II: Processes for Ordering Product 

Recalls at Key Federal Agencies

Page 47 GAO-12-589 FDA's Food Advisory and Recall Process

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 Product Steps 

Food and Drug 

Administration

Foods 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.

Infant formula 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.

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.

a

Medical devices 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.

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.

a

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.

Appendix II: Processes for Ordering Product 

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

Recalls at Key Federal Agencies

Page 48 GAO-12-589 FDA's Food Advisory and Recall Process

Agency Product Steps 

Radiation-emitting 

electronic products

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.

4. The company is given an opportunity to respond to FDA and present its 

views and evidence before the agency.

a

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

Licensed biological 

products

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.

Tobacco products 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.

3. If the company does not voluntarily recall the product, the agency orders 

company to cease distribution of the product.

a

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.

Consumer Product Safety 

Commission

Consumer goods: 

products presenting a 

substantial hazard

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.

c

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.

Consumer goods: 

products presenting an 

imminent hazard

1. Agency determines that a product presents imminent and unreasonable 

risk of death, serious illness, or severe personal injury. d

2. Agency files an action in U.S. District Court for court approval for a 

recall order.
Appendix II: Processes for Ordering Product 

Recalls at Key Federal Agencies

Page 49 GAO-12-589 FDA's Food Advisory and Recall Process

Agency Product Steps 

Environmental Protection 

Agency

Vehicles and engines 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.

Pesticides 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.

National Highway Traffic 

Safety Administration

Motor vehicles, 

replacement equipment

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.
Appendix II: Processes for Ordering Product 

Recalls at Key Federal Agencies

Page 50 GAO-12-589 FDA's Food Advisory and Recall Process

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.
Appendix III: FDA Data Related to Ordered 

Recalls

Page 51 GAO-12-589 FDA's Food Advisory and Recall Process

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

Fiscal 

year Product Problem

25991 2002 Biological product 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.

26205 2003 Medical device 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.

26286 2003

34692 2006 Not provided 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.

55825 2010 Not provided

56162 2010 Not provided

27549 2004 Radiation-emitting 

electronic product

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.

38233 2007 Radiation-emitting 

electronic product 

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.

38248 2007

56425 2011 Medical device 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.

Appendix III: FDA Data Related to Ordered 

Recalls
Appendix IV: Comments from the Department 

of Health and Human Services

Page 52 GAO-12-589 FDA's Food Advisory and Recall Process

Appendix IV: Comments from the 

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

of Health and Human Services

Page 53 GAO-12-589 FDA's Food Advisory and Recall Process
Appendix IV: Comments from the Department 

of Health and Human Services

Page 54 GAO-12-589 FDA's Food Advisory and Recall Process
Appendix IV: Comments from the Department 

of Health and Human Services

Page 55 GAO-12-589 FDA's Food Advisory and Recall Process
Appendix V: GAO Contact and 

Staff Acknowledgments

Page 56 GAO-12-589 FDA's Food Advisory and Recall Process

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

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.

Appendix V: GAO Contact and Staff 

Acknowledgments 

GAO Contact

Staff 

Acknowledgments 

(361290)
The Government Accountability Office, the audit, evaluation, and 

investigative arm of Congress, exists to support Congress in meeting its 

constitutional responsibilities and to help improve the performance and 

accountability of the federal government for the American people. GAO 

examines the use of public funds; evaluates federal programs and 

policies; and provides analyses, recommendations, and other assistance 

to help Congress make informed oversight, policy, and funding decisions. 

GAO’s commitment to good government is reflected in its core values of 

accountability, integrity, and reliability.

The fastest and easiest way to obtain copies of GAO documents at no 

cost is through GAO’s website (www.gao.gov). Each weekday afternoon, 

GAO posts on its website newly released reports, testimony, and 

correspondence. To have GAO e-mail you a list of newly posted products, 

go to www.gao.gov and select “E-mail Updates.”

The price of each GAO publication reflects GAO’s actual cost of 

production and distribution and depends on the number of pages in the 

publication and whether the publication is printed in color or black and 

white. Pricing and ordering information is posted on GAO’s website, 

http://www.gao.gov/ordering.htm. 

Place orders by calling (202) 512-6000, toll free (866) 801-7077, or 

TDD (202) 512-2537. 

Orders may be paid for using American Express, Discover Card, 

MasterCard, Visa, check, or money order. Call for additional information.

Connect with GAO on Facebook, Flickr, Twitter, and YouTube. 

Subscribe to our RSS Feeds or E-mail Updates. Listen to our Podcasts. 

Visit GAO on the web at www.gao.gov. 

Contact:

Website: www.gao.gov/fraudnet/fraudnet.htm

E-mail: fraudnet@gao.gov

Automated answering system: (800) 424-5454 or (202) 512-7470

Katherine Siggerud, Managing Director, siggerudk@gao.gov, (202) 512-

4400, U.S. Government Accountability Office, 441 G Street NW, Room 

7125, Washington, DC 20548

Chuck Young, Managing Director, youngc1@gao.gov, (202) 512-4800

U.S. Government Accountability Office, 441 G Street NW, Room 7149 

Washington, DC 20548

GAO’s Mission

Obtaining Copies of 

GAO Reports and 

Testimony 

Order by Phone

Connect with GAO

To Report Fraud, 

Waste, and Abuse in 

Federal Programs

Congressional 

Relations 

Public Affairs

Please Print on Recycled Paper.