oversight

Food Safety: FDA's Food Advisory and Recall Process Needs Strengthening

Published by the Government Accountability Office on 2012-07-26.

Below is a raw (and likely hideous) rendition of the original report. (PDF)

             United States Government Accountability Office

GAO          Report to Congressional Committees




July 2012
             FOOD SAFETY

             FDA’s Food Advisory
             and Recall Process
             Needs Strengthening




GAO-12-589
                                           July 2012

                                           FOOD SAFETY
                                           FDA’s Food Advisory and Recall Process Needs
                                           Strengthening
Highlights of GAO-12-589, a report to
congressional committees




Why GAO Did This Study                     What GAO Found
Numerous outbreaks of foodborne            Several government entities, including federal agencies such as the Food and
illnesses in past years continue to draw   Drug Administration (FDA) and the Consumer Product Safety Commission, and
public attention to the safety of the      some states such as Texas, have the authority to order product recalls.
nation’s food supply. Prompt               Generally, FDA is to follow the same process for implementing its food recall
responses from government entities         authority as other federal agencies use to order recalls of other products,
and the food industry can play a vital     including (1) determining that available evidence of a threat meets a standard of
role in stopping the spread of illnesses   proof to order a recall, (2) offering a company the opportunity to voluntarily recall
and deaths, but unwarranted recalls of     a product before a recall order is issued, and (3) providing the company with an
food products can trigger serious
                                           opportunity to challenge a recall decision. FDA has internal procedures
economic losses for the food industry.
                                           describing the steps it will take to order a food recall, although these procedures
In response to congressional direction
regarding the FDA Food Safety
                                           are not yet public and the agency has not issued regulations or industry guidance
Modernization Act, GAO (1) examined        to clarify its ordered food recall process.
government entities having the             FDA faces a number of communication challenges when advising the public
authority to order product recalls and     about food recalls or outbreaks of foodborne illness, ranging from balancing
how FDA implements its authority; (2)      technical accuracy with timeliness of communications to coordinating messages
examined the challenges FDA faces, if      with other agencies to meeting the needs of diverse public audiences. The
any, in advising the public about food     agency has taken steps to begin meeting these challenges but has yet to fully
recalls or outbreaks of foodborne
                                           address recommendations from GAO and others to fashion a comprehensive
illness and how the agency has
                                           food recall communication policy and related implementation plans. Specifically,
addressed these challenges; and (3)
identified mechanisms that may             FDA has not (1) adopted a recommendation from its Advisory Committee on Risk
compensate the food industry for           Communication to create a policy for emerging events to more comprehensively
erroneously ordered food recalls or        address several of its communication challenges; (2) created plans
erroneous food-related advisories.         recommended by the Institute of Medicine and National Research Council to help
GAO reviewed documents from FDA            address coordination challenges surrounding its communications; or (3) fully
and other government entities and          implemented a recommendation from GAO’s past work to determine jointly with
FDA data and interviewed                   the Department of Agriculture what, if any, additional approaches are needed for
stakeholders from the food industry        advising consumers about recalls. When GAO asked FDA officials how they had
and consumer organizations,                responded to these recommendations, they provided information on some
government officials, and experts in       actions they are taking. However, FDA’s stated actions do not fully implement
food safety or food law.                   these recommendations. As a result of not implementing them, FDA may be
                                           missing opportunities to more comprehensively address its communications
What GAO Recommends                        challenges.
GAO recommends, among other
                                           Various government mechanisms—each with advantages and disadvantages
things, that FDA issue regulations or
                                           described by individuals GAO interviewed—might be available to compensate
industry guidance to clarify its ordered
food recall process and implement          food producers in case of an erroneously ordered food recall or erroneous food-
recommendations from others to             related advisory, but GAO found no examples of such mechanisms that have
address FDA communication                  been used to provide compensation. The mechanisms include a dedicated
challenges in advising the public about    federal government program or federal government-subsidized insurance, among
food recalls and outbreaks. The            others. For example, individuals GAO interviewed said that a potential advantage
agency neither agreed nor disagreed        of a dedicated program would be assurance to industry that a mechanism would
with GAO’s recommendations but cited       be available, but a potential disadvantage may be that in lean budget times,
ongoing agency actions that are to         funding for such a program may be difficult to obtain. Individuals GAO
address most recommendations.              interviewed identified several factors that may come into play when deciding to
                                           establish any compensation mechanism, such as defining what constitutes an
View GAO-12-589. For more information,
contact Lisa Shames at (202) 512-3841 or   error or mitigating the potential for unintended consequences.
shamesl@gao.gov.

                                                                                    United States Government Accountability Office
Contents


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 Food-
                 Related 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




               Page i                         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


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         Page ii                               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 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


                                   1
                                    See GAO, High-Risk Series: An Update, 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 1                             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 Under FSMA,
after FDA determines that there is a reasonable probability that a food
product is adulterated under the Federal Food, Drug, and Cosmetic Act or
misbranded with respect to labeling for major food allergens, and the use
or exposure to that food will cause serious adverse health consequences
or death to humans or animals, it must provide the company with the
opportunity to voluntarily undertake a recall. Food is deemed to be
adulterated under the Federal Food, Drug, and Cosmetic Act if, among
other things, it bears or contains any poisonous or deleterious substance
that may render it injurious to health. Until passage of this act, FDA could
ask companies to voluntarily recall adulterated or misbranded food
products, but it could not order them to do so, except for infant formula.

FSMA directed us to report on issues associated with FDA’s new
authority to order food recalls, as well as on the authority held by
government entities to order recalls of other products. Accordingly, this
report (1) examines key government entities having the authority to order
product recalls and how FDA implements its authority; (2) examines the
challenges FDA faces, if any, in advising the public about food recalls or
outbreaks of foodborne illnesses and examines how FDA has addressed


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 2                                 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 food-
related advisories, including the advantages and disadvantages of each.

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

We conducted this performance audit from May 2011 to July 2012 in
accordance with generally accepted government auditing standards.
Those standards require that we plan and perform the audit to obtain
sufficient, appropriate evidence to provide a reasonable basis for our


Page 3                          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
Background   have serious economic consequences and undermine consumer
             confidence in the safety of the nation’s food supply. In the past several
             years, consumers in the United States and abroad have experienced
             several noteworthy outbreaks of foodborne illness, including the following:

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

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

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



             Page 4                          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 5                           GAO-12-589 FDA's Food Advisory and Recall Process
located and removed from the marketplace or that its labeling is
corrected. 3 FDA can also take enforcement action, such as initiating the
seizure of adulterated or misbranded products or levying civil monetary
penalties against food companies under certain circumstances.

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

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

•   CDC. When CDC receives reports of outbreaks of foodborne illnesses
    from local and state governments, it determines the extent of an
    outbreak by linking cases or clusters of foodborne illnesses that have
    been reported. To make these links, it uses tools such as PulseNet 4
    and the Listeria Initiative. 5 CDC then uses the medical science of
    epidemiology (which concerns the incidence, distribution, and control
    of disease and the factors affecting the presence or absence of a
    disease or pathogen) to identify the food associated with illnesses and


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, 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 6                                 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 7                              GAO-12-589 FDA's Food Advisory and Recall Process
                             Several key federal, state, and international government entities,
Several Key Entities         including FDA, have the authority to order product recalls. Under FSMA,
Have Recall Authority,       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
but FDA Has Not              has internal procedures describing the steps it will take to order a food
Issued Regulations or        recall, but these procedures are not yet public. Also, the agency has not
Industry Guidance on         issued regulations or industry guidance to clarify its ordered food recall
                             process, and FDA officials told us that they have not decided whether
Its Ordering of Food         they will do so and that FSMA contains no such requirement. In addition,
Recalls                      FDA’s ordered recall data for products other than food appear to be
                             inconsistent or unreliable.


Entities with Authority to   Through our review, we identified several key government entities with
Order Product Recalls Use    the authority to order product recalls, including four federal agencies, at
Processes with Similar       least four states, and at least five international government entities (see
                             table 1). Officials from many of these entities reported, however, that
Steps                        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.




                             Page 8                           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

                               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
                                                                                                             b
                                                                                    (including infant formula ), medical devices, radiation-
                                                                                    emitting electronic products, and tobacco products
                         National Highway Traffic Safety                            Motor vehicles, child safety seats, tires, and other motor
                         Administration                                             vehicle equipment
      a
States                   Alaska                                                     Foods
                         New Mexico
                         South Carolina
                         Texas
                     a
International entities   Australia                                                  Foods
                         Canada
                         European Union
                         Japan
                         New Zealand
                                          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 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.

                                          FDA’s statutory process for ordering food recalls other than infant
                                          formula 8 includes three steps, which are also used by key federal
                                          agencies to order recalls of other product types. These steps are to



                                          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.




                                          Page 9                                                    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 10                          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 Not Made Public                 FDA has interim internal procedures describing the steps it will take to
Procedures for Ordering                 order a food recall, but these procedures have not been made public, and
Food Recalls                            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


                                        Page 11                            GAO-12-589 FDA's Food Advisory and Recall Process
management directives and to make that documentation readily available
for examination. 9 About a week-and-a-half before our closing meeting,
FDA officials provided us interim internal procedures for ordering recalls
of food. These interim procedures include detailed information on such
topics as which officials are to be involved in an ordered food recall
decision and what methods and timelines FDA officials will use to
communicate with companies involved in such a recall. The interim
procedures also state that FDA is to incorporate procedures into the
agency’s publicly available Regulatory Procedures Manual and other FDA
documents. FDA officials have not, however, provided timelines on when
they expect to make procedures publicly available.

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

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




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.
10
    GAO/AIMD-00-21.3.1.




Page 12                               GAO-12-589 FDA's Food Advisory and Recall Process
•    Industry guidance. FDA’s good guidance practices 11 state that when
     significant changes are made to statute, the agency will review and, if
     appropriate, revise its guidance documents. These practices note that
     such changes reflect FDA’s expectations of those subject to its
     oversight, including new expectations that may not be readily
     apparent—arguably the case with FDA’s new authority to order food
     recalls: food industry stakeholders publicly asked FDA in June 2011 to
     explain how it will implement its new authority, indicating that they
     would benefit from more clarity. FDA’s good guidance practices also
     indicate that guidance documents are subject to public comment and
     can be revised when appropriate. Nevertheless, FDA’s current
     guidance for industry on voluntary product recalls has not been
     updated to describe the agency’s procedures for ordering food recalls.

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

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

•    Canadian public health and food safety agencies in 2011 published
     guidance on collecting and weighing evidence during outbreaks of


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




Page 13                             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 Canadian officials published this
     guidance to provide criteria for, among other things, proceeding with a
     food recall. Officials told us that documenting procedures for weighing
     evidence can be helpful in answering questions from stakeholders
     about why they made a particular recall decision.

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




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




Page 14                              GAO-12-589 FDA's Food Advisory and Recall Process
FDA’s Data on Ordered   Since FSMA was signed into law in January 2011, FDA has not ordered
Recalls Appear to Be    any recalls of food products, according to agency officials. To learn more
Unreliable              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



                        Page 15                         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 federal agencies are to employ controls over
information processing; such control includes application control, which is
designed to help ensure completeness and accuracy of a system’s data,
among other things. Nevertheless, the inconsistencies we observed in the
data caused us to question the Recall Enterprise System’s data on
ordered recalls. Moreover, our review also showed that FDA used
multiple data systems, which may lead to inconsistencies in its data if
controls over information processing are not in place. Both of these
issues limit the agency’s ability to use the Recall Enterprise System to
meet the database’s goals to efficiently track information, communicate
recall information among different FDA offices, and reduce duplication of
effort across offices. These issues also indicate that the agency may not
have sufficient internal control for its information processing, reducing the
agency’s ability to accurately report information on ordered recalls to
Congress and the public as follows:

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




13
    GAO/AIMD-00-21.3.1.
14
  A data dictionary is a centralized repository of information about data in a database such
as its meaning, relationships to other data, origin, usage, and format.




Page 16                                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 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




15
    GAO-05-51.
16
  GAO, Food Labeling: FDA Needs to Better Leverage Resources, Improve Oversight,
and Effectively Use Available Data to Help Consumers Select Healthy Foods,
GAO-08-597 (Washington, D.C.: Sept. 9, 2008).




Page 17                            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.




17
  GAO, Food and Drug Administration: Opportunities Exist to Better Address Management
Challenges, GAO-10-279 (Washington, D.C.: Feb. 19, 2010).
18
  GAO, Food and Drug Administration: 2009 FDA Managers Survey on Performance and
Management Issues, an E-supplement to GAO-10-279, GAO-10-280SP (Washington,
D.C.: Feb. 19, 2010).
19
  The first most commonly identified issue was, “recruiting, retaining, and developing a
workforce with the knowledge, skills, and abilities necessary to carry out its mission.” The
second most commonly identified issue was, “improving coordination and communication
within FDA.”
20
  GAO, Information Technology: FDA Needs to Fully Implement Key Management
Practices to Lessen Modernization Risks, GAO-12-346 (Washington D.C.: Mar. 15, 2012).




Page 18                                GAO-12-589 FDA's Food Advisory and Recall Process
                           FDA faces a number of communication challenges when it needs to
FDA Has Taken Steps        advise the public about food recalls and outbreaks of foodborne illness,
to Begin Meeting           ranging from balancing technical accuracy with timeliness of
                           communications to coordinating messages with other agencies to
Communication              meeting the needs of diverse public audiences, such as consumers,
Challenges When            representatives of the food industry, medical professionals, and other
Advising the Public        government organizations. The agency has taken several steps to begin
                           meeting these challenges but has yet to fully adopt recommendations
about Food Recalls         from us and others to develop a comprehensive food recall
and Outbreaks              communication policy and related implementation plans.

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

Balancing the Goals of     During an outbreak or recall, FDA faces the challenge of quickly providing
Timeliness and Accuracy    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



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




                           Page 19                             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.

Providing Precise, Complete     FDA faces the following two related challenges in this area:
Information Understandable to
a General Audience              •   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



                                Page 20                         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

Serving a Wide Range of        FDA officials reported that the agency serves a variety of audiences—
Audiences and Audience Needs   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




                               22
                                 See 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.




                               Page 21                               GAO-12-589 FDA's Food Advisory and Recall Process
                              recalls on its website. 23 In addition, according to an FDA website, the
                              agency has committed to support industry efforts to enable consumers to
                              distinguish recalled products from those not subject to a recall. For
                              example, during a recall of pistachio products in 2009, FDA’s website
                              provided a link to an industry-sponsored website listing companies whose
                              products did not contain recalled pistachios. Third, FDA officials reported
                              increased use of blogs and other social media to communicate with the
                              public and, according to these officials, offer information in multiple
                              languages.

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

Coordinating Messages with    According to experts and stakeholders from state and local health and
Other Agencies                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


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




                              Page 22                                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 With respect to better coordination with states, in
                               2011, FDA and a group of state-level officials developed a draft guide on
                               improving federal-state communications during outbreaks.

Testing Draft Communications   According to an FDA publication, effective communication requires
with Users                     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


                               24
                                GAO-10-279.
                               25
                                GAO-10-280SP.
                               26
                                GAO, Results-Oriented Government: Practices That Can Help Enhance and Sustain
                               Collaboration among Federal Agencies, GAO-06-15 (Washington, D.C.: Oct. 15, 2005).




                               Page 23                             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.

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


FDA Has Not Fully             Beyond the steps it has taken to date, FDA has not implemented several
Adopted Some                  recommendations that could help the agency better respond to its
Recommended                   communication challenges. Specifically, it has not (1) adopted a 2009
                              recommendation from its risk communication committee on creating a
Communication Policies or     policy for emerging events to more comprehensively address all its
Plans Related to Identified   communication challenges; (2) created plans recommended in 2010 by
Challenges                    the Institute of Medicine and National Research Council to help address
                              coordination challenges surrounding its communications; or (3) fully


                              Page 24                         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 25                         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 in which we reviewed recall communications at
both FDA and USDA and stated that the procedures both agencies use to
advise consumers of a recall—press releases and web postings—may
not be effective. We recommended that FDA work jointly with USDA to
determine what, if any, additional approaches were needed for advising
consumers about recalls. To show us how they had responded to this
recommendation, FDA officials provided us a copy of recall response
guidelines issued by the Coalition to Improve Foodborne Outbreak
Response—a working group of federal agencies including FDA, USDA,
and CDC, along with associations of state and local health professionals.
These guidelines provide broad advice to agencies on improving
communication with the public during a recall, but they do not address the
two public notification topics we discussed in detail in our 2004 report—
posting recall press releases on agency websites and providing
information on the retail outlets that received recalled food. We followed
up with USDA and FDA on these two topics and learned that USDA’s
public notifications have changed but that FDA’s have not, as follows:

•     Posting recall information on agency websites. Both FDA and USDA
      post recall press releases on their websites. According to USDA
      guidelines, USDA authors its own releases, while our review of FDA
      web postings indicated that the agency often posts releases that are
      crafted by the companies issuing the recall rather than issuing its own
      information on the recall. A representative of a consumer organization



27
    GAO-05-51.




Page 26                           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 Further, in its technical comments to our draft
     report, HHS stated that FDA can provide confidential commercial
     information, including the identity of a retail store associated with
     products implicated in a recall, if such information is necessary to
     effect a recall.

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




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




Page 27                               GAO-12-589 FDA's Food Advisory and Recall Process
                        Individuals we interviewed identified a variety of government
Several Mechanisms      mechanisms—each with advantages and disadvantages described by the
Might be Available to   individuals—that might be available to compensate food producers in
                        case of an erroneously ordered food recall or erroneous food-related
Compensate the Food     advisory, but we found no examples of such mechanisms being used to
Industry for            provide compensation. Among others, these mechanisms include a
Erroneously Ordered     dedicated government program and government insurance. Individuals
                        we interviewed also identified several factors that may come into play
Recalls or Erroneous    when deciding to establish any new compensation mechanism, such as
Food-Related            defining what constitutes an error or mitigating the potential for
                        unintended consequences.
Advisories
Each Compensation       Through a series of interviews with stakeholders and others, including
Mechanism Has           representatives of consumer groups and industry organizations, federal
Advantages and          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
Disadvantages           mechanisms that others have suggested might compensate the food
                        industry in case of an erroneously ordered food recall or erroneous food-
                        related advisory, each with advantages and disadvantages described by
                        those we interviewed. We did not independently evaluate the viability of
                        these mechanisms, their advantages, or their disadvantages, and none of
                        the mechanisms has been used to provide compensation in such
                        instances. The first of the mechanisms described below has an
                        established government structure in place to administer it; the others
                        would require congressional action to initiate.

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




                        Page 28                         GAO-12-589 FDA's Food Advisory and Recall Process
A Dedicated Program             A federal program established by Congress could pay eligible companies,
                                according to the relevant literature and our interviews with stakeholders
                                and others. For example, at USDA, the Animal and Plant Health
                                Inspection Service (APHIS) administers a series of programs that
                                compensate producers whom APHIS orders to destroy their cattle to
                                control or eradicate disease. The APHIS program implements cost
                                sharing with the states and may pay producers from 50 to 100 percent of
                                the animals’ market value in compensation. An APHIS official told us that
                                the reason for such compensation is to encourage producers to
                                participate in the programs. Some respondents also identified
                                government purchase programs of food commodities, such as USDA’s
                                National School Lunch Program, as a possible dedicated program that
                                could offer producers another avenue for selling their food. USDA
                                purchases food products through commodity purchase programs in
                                support of the National School Lunch Program and the School Breakfast
                                Program. One respondent suggested it may be possible to amend the
                                current programs to assign preference to particular growers who were
                                affected by an erroneously ordered recall or advisory, as long as the
                                products were determined to be safe.

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

One-Time Funding for Specific   Congress could consider a one-time legislative act for specific events as
Events                          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.


                                Page 29                         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 broad-
                       based political support than a group of larger growers who produce crops
                       in many parts of the country. Further, some respondents said that it could
                       take a long time for such funding to work its way through the legislative
                       process, which could create difficulties for food producers, and that such
                       a program could be expensive for government to administer.

Government Insurance   If established by Congress, government insurance could help mitigate
                       companies’ losses, according to the relevant literature and our interviews
                       with stakeholders and others. For example, USDA subsidizes federal crop
                       insurance premiums, helping food producers mitigate the risk of losing (1)
                       revenue because of either market fluctuations or extreme weather and (2)
                       crops because of extreme weather. 29 In this program, backed by the


                       29
                         For more information on crop insurance, see GAO, Crop Insurance: Savings Would
                       Result from Program Changes and Greater Use of Data Mining, 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).




                       Page 30                             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 In addition to a government
insurance program, we identified private-sector options and learned that
the private sector does offer policies to insure against losses from recalls;
a few respondents, however, told us that these policies may be cost-
prohibitive for some companies. Further, according to private-sector
insurance representatives we contacted, private insurance policies
typically do not cover losses to companies whose food products are not
adulterated but that may instead suffer “collateral damage” from declines
in prices for their products; such collateral damage could result if or when
consumers stop purchasing any product for which the government
ordered a recall or issued a food-related advisory. Similarly, as one
respondent stated, no private-sector policies cover damages for


30
  On June 19, 2012, the United States Senate voted to amend the Senate’s proposed
2012 Farm Bill to require that USDA submit a report to the House Committee on
Agriculture and the Senate Committee on Agriculture, Nutrition, and Forestry evaluating
insurance policies and plans that provide protection for production or revenue affected by
food safety concerns, including those that result in advisories or recalls. This report would
determine whether offering such policies for specialized crops, such as fruits and
vegetables, would benefit agricultural producers. See 158 Cong. Rec. S4276 (daily ed.
June 19, 2012) (vote on amendment 2309 amending Agriculture Reform, Food, and Jobs
Act of 2012, S. 3240, 112th Cong, § 11017).
31
  In the Federal Crop Insurance Act, “producer” is defined as a “‘person’’ (as defined by
the Secretary of Agriculture) who is 18 years of age and has a bona fide insurable interest
in a crop as an owner-operator, landlord, tenant, or sharecropper. 7 U.S.C. § 1520.




Page 31                                 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 “check-
off” program—in which a group of producers creates a form of self-
insurance (not government subsidized)—could help producers mitigate
the risk of broader market effects from a recall or advisory. Under such a
program, companies could pay a set amount (e.g., per production unit)
into a fund, which could then be used to pay participants if the market
experienced a decline in consumer demand resulting from a recall or
advisory.

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

In addition, insurance premiums could be difficult to calculate because the
expected behavior of those purchasing insurance and the risks of
erroneous government actions are not well known. 32 For example, one
respondent said it could be difficult for insurers to calculate actuarially
sound premiums for insurance in the case of erroneously ordered recalls
or erroneous food-related advisories. One reason is that if a policyholder
adopts risky agricultural practices, he or she may increase the likelihood
that the insurer will have to pay a claim, which creates difficulties in
assessing the likelihood that a policy will have to pay. Further, economists


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




Page 32                                 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.

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

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


                           Page 33                        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 May            Several factors highlighted by stakeholders and others may come into
Influence the Development      play when deciding to establish a new compensation mechanism for the
of New Compensation            food industry.
Mechanisms
Defining What Constitutes an   Defining what constitutes an erroneously ordered recall or erroneous
Error                          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


                               Page 34                          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     Identifying the extent of the government’s responsibility for losses
Government’s Responsibility   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
                              Issues such as these could make determining government’s responsibility
                              more difficult.

Mitigating Potential for      In funding a mechanism to compensate food producers, some
Unintended Consequences on    respondents stated that unintended consequences to public health could
Public Health                 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.


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




                              Page 35                             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.

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

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


                              Page 36                         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
Conclusions   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 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



              34
               GAO-05-51.




              Page 37                          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
Recommendations for   the Commissioner of FDA to take the following seven actions:
Executive Action
                      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.




                      Page 38                         GAO-12-589 FDA's Food Advisory and Recall Process
                     We provided a copy of our draft report to the Department of Health and
Agency Comments      Human Services for their review and comment. We also provided a draft
and our Evaluation   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




                     Page 39                         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 40                          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 41                        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




Page 42                         GAO-12-589 FDA's Food Advisory and Recall Process
Appendix I: Objectives, Scope, and
              Appendix I: Objectives, Scope, and
              Methodology



Methodology

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




              Page 43                                GAO-12-589 FDA's Food Advisory and Recall Process
Appendix I: Objectives, Scope, and
Methodology




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
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.



2
 U.S. Consumer Product Safety Commission. Regulated Products Handbook
(Washington, D.C.: 2005).
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).




Page 44                               GAO-12-589 FDA's Food Advisory and Recall Process
Appendix I: Objectives, Scope, and
Methodology




To address our second objective, we first identified challenges FDA may
face in advising the public about food recalls or outbreaks of foodborne
illnesses by reviewing the following reports: FDA’s Strategic Plan for Risk
Communication 6 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 We also reviewed documents from relevant
meetings of FDA’s Advisory Committee on Risk Communication (risk
communication committee) and our prior work. We verified the challenges
we identified during meetings with FDA officials, representatives from the
food industry and consumer organizations, state and federal government
officials, and experts in food safety. To determine the steps FDA is taking
to address these challenges, we used three methods. First, we compared
the challenges we identified with our analysis of FDA’s Strategic Plan for
Risk Communication, the Institute of Medicine and National Research
Council’s 2010 report on FDA’s food safety role, transcripts from
meetings of FDA’s risk communication committee, other relevant agency
documents, and our prior work. Second, we interviewed consumer and
industry stakeholders, government officials, and experts in food safety or
food law for their perspectives on FDA’s actions to address these
challenges. And third, we interviewed FDA officials about their efforts to
address each challenge.

To address our third objective, we first gathered information on what
mechanisms might be used by meeting with representatives of consumer
and industry organizations, experts in food safety and food law, and
officials from state and other federal agencies. We also reviewed the


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).




Page 45                              GAO-12-589 FDA's Food Advisory and Recall Process
Appendix I: Objectives, Scope, and
Methodology




relevant literature, including The Tools of Government: A Guide to the
New Governance, 10 an authoritative work about government policy tools.
In addition, we collected documentation and interviewed officials from
international government entities including Australia, Canada, the
European Union, and New Zealand about their knowledge of possible
compensation mechanisms.

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

We conducted this performance audit from May 2011 to July 2012 in
accordance with generally accepted government auditing standards.
Those standards require that we plan and perform the audit to obtain
sufficient, appropriate evidence to provide a reasonable basis for our
findings and conclusions based on our audit objectives. We believe that
the evidence obtained provides a reasonable basis for our findings and
conclusions based on our audit objectives.




10
 Lester Salamon, ed., The Tools of Government: A Guide to the New Governance (New
York: Oxford University Press, 2002).




Page 46                              GAO-12-589 FDA's Food Advisory and Recall Process
Appendix II: Processes for Ordering Product
                                            Appendix II: Processes for Ordering Product
                                            Recalls at Key Federal Agencies



Recalls at Key Federal Agencies

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

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

Agency                     Product                      Steps
Food and Drug              Foods                        1.   The agency determines there is a reasonable probability that a food,
Administration                                               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
                                                                                                      a
                                                             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.
                           Medical devices              1.   Agency determines there is a reasonable probability that a medical
                                                             device would cause serious adverse health consequences or death.
                                                                                                                               a
                                                        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.
                                                        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.




                                            Page 47                               GAO-12-589 FDA's Food Advisory and Recall Process
                                       Appendix II: Processes for Ordering Product
                                       Recalls at Key Federal Agencies




Agency                    Product                  Steps
                          Radiation-emitting       1.   FDA determines a product contains a defect relating to safety of use by
                          electronic products           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.
                                                                                                                          a
                                                   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.
                                                   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
                                                                                     b
                                                        product, or refund the cost.
                          Licensed biological      1.   Agency determines a product presents an imminent or substantial
                          products                      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.
                                                                                                                        a
                                                   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.
                                                   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   Consumer goods:          1.   Agency determines that a product does not comply with applicable
Commission                products presenting a         consumer product safety rules or any other rule, regulation, standard, or
                                            c
                          substantial hazard            ban under the Consumer Product Safety Act or any other statute
                                                        enforced by the commission or contains a defect that could create a
                                                        substantial product hazard or creates an unreasonable risk of serious
                                                        injury or death.
                                                   2.   Agency notifies company of its analysis and determination and orders
                                                        the company to cease distribution and provide notification.
                                                   3.   Agency offers company an opportunity to take voluntary action and
                                                        correct the violation. Company may request an informal hearing and
                                                        present information contrary to commission’s determination.
                                                   4.   Agency may order the company to repair, replace, or refund the
                                                        product.
                          Consumer goods:          1.   Agency determines that a product presents imminent and unreasonable
                          products presenting an        risk of death, serious illness, or severe personal injury.
                                          d
                          imminent hazard          2.   Agency files an action in U.S. District Court for court approval for a
                                                        recall order.




                                       Page 48                               GAO-12-589 FDA's Food Advisory and Recall Process
                                        Appendix II: Processes for Ordering Product
                                        Recalls at Key Federal Agencies




Agency                     Product                        Steps
Environmental Protection   Vehicles and engines           1.     Agency determines that a substantial number of a class or category of
Agency                                                           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   Motor vehicles,                1.     Agency makes an initial determination that a safety-related defect exists
Safety Administration      replacement equipment                 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.




                                        Page 49                                                 GAO-12-589 FDA's Food Advisory and Recall Process
Appendix II: Processes for Ordering Product
Recalls at Key Federal Agencies




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.




Page 50                                     GAO-12-589 FDA's Food Advisory and Recall Process
Appendix III: FDA Data Related to Ordered
                                        Appendix III: FDA Data Related to Ordered
                                        Recalls



Recalls

                                        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    Fiscal
number            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
26286             2003
                                                        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.
34692             2006        Not provided              Following its original data submission to GAO, Center for Devices and
55825             2010        Not provided              Radiological Health officials provided data indicating three additional ordered
                                                        recalls of a product regulated by the center occurred in fiscal years 2006 and
56162             2010        Not provided              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.
27549             2004        Radiation-emitting        Center for Devices and Radiological health officials provided data indicating
                              electronic product        that this recall was ordered, but an internal memo stated that this recall would
                                                        be classified as a voluntary recall.
38233             2007        Radiation-emitting        These recalls were reflected in data reported by Center for Devices and
38248             2007        electronic product        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.
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.




                                        Page 51                                    GAO-12-589 FDA's Food Advisory and Recall Process
Appendix IV: Comments from the
             Appendix IV: Comments from the Department
             of Health and Human Services



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




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
                            Appendix V: GAO Contact and
                            Staff Acknowledgments



Acknowledgments

                  Lisa Shames, (202) 512-3841 or shamesl@gao.gov
GAO Contact
                  In addition to the individual named above, Karen Jones (Assistant
Staff             Director), Kevin Bray, Mark Braza, Candace Carpenter, Ellen W. Chu,
Acknowledgments   Barbara El Osta, Brendan Kretzschmar, Kirsten B. Lauber, Angela Miles,
                  and Kiki Theodoropolous made key contributions to this report.




(361290)
                  Page 56                          GAO-12-589 FDA's Food Advisory and Recall Process
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