Food Safety: USDA and FDA Need to Better Ensure Prompt and Complete Recalls of Potentially Unsafe Food

Food Safety: USDA and FDA Need to Better Ensure Prompt and
Complete Recalls of Potentially Unsafe Food (07-OCT-04,
GAO-05-51).

Two large food recalls completed in 2003 were associated with 8
deaths and nearly 100 serious illnesses in at least 16 states.
Manufacturers voluntarily recall potentially unsafe food by
notifying their customers to return or destroy it. The U.S.
Department of Agriculture (USDA), for meat, poultry, and egg
products, and the Food and Drug Administration (FDA), for other
food, have programs to monitor voluntary food recalls, verify
that companies contact their customers, and maintain recall data.
GAO (1) examined the recall programs and procedures USDA and FDA
use to protect consumers from unsafe foods and (2) compared their
food recall authority with the authority of agencies to recall
other consumer products.
-------------------------Indexing Terms-------------------------
REPORTNUM: GAO-05-51
ACCNO: A12884
TITLE: Food Safety: USDA and FDA Need to Better Ensure Prompt
and Complete Recalls of Potentially Unsafe Food
DATE: 10/07/2004
SUBJECT: Consumer protection
Contaminated foods
Customer service
Food industry
Food inspection
Food supply
Health hazards
Information disclosure
Product recalls
Product safety
Voluntary compliance

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GAO-05-51

United States Government Accountability Office

GAO Report to Congressional Requesters

October 2004

FOOD SAFETY

USDA and FDA Need to Better Ensure Prompt and Complete Recalls of Potentially
Unsafe Food

GAO-05-51

Highlights of GAO-05-51, a report to congressional requesters

GAO proposes that Congress consider legislation requiring a company to
notify USDA or FDA if it discovers it has distributed unsafe food and
giving agencies authority to order food recalls, and recommends that the
agencies take actions to ensure prompt, complete recalls and better recall
monitoring. USDA said the report was generally accurate and its May 2004
directive will address weaknesses GAO found. FDA did not believe its
system lengthened recalls or its processes reduced recovery. FDA disagreed
with some recommendations. GAO continues to believe its recommended
actions are needed to protect consumers.

October 2004

FOOD SAFETY

USDA and FDA Need to Better Ensure Prompt and Complete Recalls of Potentially
Unsafe Food

Weaknesses in USDA's and FDA's food recall programs heighten the risk that
unsafe food will remain in the food supply and ultimately be consumed.
Specifically, USDA and FDA do not know how promptly and completely the
recalling companies and their distributors and other customers are
carrying out recalls, and neither agency is using its data systems to
effectively track and manage its recall programs. For these and other
reasons, most recalled food is not recovered and therefore may be
consumed. GAO's analysis of recalls in 2003 showed that about 38 percent
and 36 percent of recalled food was ultimately recovered in recalls
overseen by USDA and FDA, respectively. These agencies also told GAO of
instances in which companies were slow to reveal where they had
distributed the food or provided inaccurate customer lists. That
distribution information is critical because USDA's and FDA's primary role
in recalls is to monitor the effectiveness of a company's recall actions.
To do so, the agencies contact a sample of the distribution chain from
these lists to verify that customers in the food distribution chain
received notice of the recall, and that they located the food and removed
it from the marketplace. However, the methodology that the agencies use
for selecting the customers to check can result in entire segments of
complex distribution chains being overlooked. Moreover, GAO found that the
agencies did not complete verification checks for some recalls before the
shelf life of the food expired. In addition, consumer groups and others
question the usefulness of USDA's and FDA's efforts to communicate with
the public, suggesting alternatives such as posting notices in grocery
stores and direct notification of consumers.

Agencies responsible for the safety of products, such as toys, heart
pacemakers, and automobiles, have specific recall authority not available
to USDA and FDA for food. This includes the authority to (1) require a
company to notify the agency when it has distributed a potentially unsafe
product, (2) order a recall, (3) establish recall requirements, and (4)
impose monetary penalties if a company violates recall requirements. For
example, by law, companies must promptly notify the Consumer Product
Safety Commission after learning that a product may pose an unreasonable
risk of serious injury or death, or face penalties of up to $1.65 million.
Likewise, FDA has recall authority for unsafe biological products, medical
devices, radiation emitting electronic products, and infant formula.
Moreover, in contrast to its inability to penalize a company that is slow
to conduct a food recall, FDA can impose penalties of up to $100,000 per
day for a company that fails to recall a defective biological product,
such as a vaccine.

www.gao.gov/cgi-bin/getrpt?GAO-05-51.

To view the full product, including the scope and methodology, click on
the link above. For more information, contact Lawrence J. Dyckman at (202)
512-3841 or [email protected].

Contents

Letter

Results in Brief
Background
Weaknesses in USDA's andFDA's Recall Programs Heighten theRisk

That Unsafe Food Will Reach Consumers Other Government Agencies Have
Recall Authority Not Available to

USDA and FDA for Food That May Better Protect Consumers Conclusions
Matters for Congressional Consideration Recommendations for Executive
Action Agency Comments and Our Evaluation

1 4 7

25 30 31 31 32

Appendixes

Appendix I:

Appendix II:

Appendix III:

Appendix IV:

Appendix V: Appendix VI: Objectives, Scope, and Methodology 36

Federal Actions Associated with the Discovery of an Animal in the United
States Infected with BSE 39 Beef Recall Was Triggered by a BSE-Positive
Sample from

One Cow 39 Recall Begun in December 2003 Was Completed in March 2004 39
Recall Was Complicated by Inaccurate Distribution Lists and Mixing

of Potentially Contaminated and Noncontaminated Beef 40 FDA's Role in
USDA's Recall 44 USDA and FDA Worked Together on the Recall 45

Information on a 2002 Recall of Ground Beef by a ConAgra
Plant in Greeley, Colorado 48

USDA and FDA Actions on the Recommendations We Made in
2000 50

Information on the 20 Food Recalls We Examined for 2003 52

Recall Authority of Selected Government Agencies 54
USDA's Food Safety and Inspection Service 54
FDA's Center for Food Safety and Applied Nutrition 55
FDA's Center for Biologics Evaluation and Research 56
FDA's Center for Devices and Radiological Health 57
FDA's Center for Drug Evaluation and Research 59
FDA's Center for Veterinary Medicine 60
Consumer Product Safety Commission 60
Department of Transportation's National Highway Traffic Safety

Administration 61

Contents

Canadian Food Inspection Agency 62

Appendix VII:Comments from the U.S. Department of Agriculture 64 GAO
Comments 67

Appendix VIII:Comments from the Food and Drug Administration 70 GAO
Comments 74

Appendix IX:GAO Contacts and Staff Acknowledgments 76 GAO Contacts 76
Staff Acknowledgments 76

Tables Table 1:

Table 2: Table 3:

Table 4:

Table 5:

USDA and FDA Verification Rates for 20 Selected Class I
Recalls in 2003 21
Recall Authority of Selected Government Agencies 27
Detailed Timeline of USDA, FDA, and Company Actions
Related to the Discovery of an Animal Infected with
BSE 45
USDA and FDA Actions on GAO's Recommendations to
Modify Recall Data Systems 50
Selected Information on the 20 Class I Food Recalls We
Examined 52

Figures Figure 1: Figure 2:

Figure 3:

Figure 4:

USDA and FDA Recalls by Risk Classification, 2003 8
Downstream Distribution Chain May Include Multiple
Levels of Distributors, Processors, and Retailers before
the Food Reaches Consumers 10
Number of Days after Production When Recall Occurred
and Expected Shelf Lives for Four Recalls 17
USDA's Recall Verification Checks by Location and
Customer Type for Meat Associated with the Animal
Infected with BSE 43

Contents

Abbreviations

BSE bovine spongiform encephalopathy
CFIA Canadian Food Inspection Agency
CPSC Consumer Product Safety Commission
FDA Food and Drug Administration
FSIS Food Safety and Inspection Service
NHTSA National Highway Traffic Safety Administration
USDA U.S. Department of Agriculture

This is a work of the U.S. government and is not subject to copyright
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its entirety without further permission from GAO. However, because this
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separately.

United States Government Accountability Office Washington, D.C. 20548

October 6, 2004

The Honorable Tom Harkin Ranking Democratic Member Committee on
Agriculture, Nutrition, and Forestry United States Senate

The Honorable Marcy Kaptur

Ranking Minority Member

Subcommittee on Agriculture, Rural Development, Food and Drug
Administration, and Related Agencies Committee on Appropriations House of
Representatives

When food companies discover that they may have distributed food that is
contaminated with disease-causing bacteria or that contains allergens that
can cause serious illness or death, they will usually conduct a voluntary
recall. That is, they will contact their customers and instruct them to
contact the wholesalers, retailers, and others in the food's distribution
chain and ask them to return or destroy the potentially unsafe food.
Recalls may not always prevent serious health problems. In fact, two large
recalls completed in 2003 were associated with foodborne illness outbreaks
involving nearly 100 hospitalizations or serious illnesses, 8 deaths, and
3 miscarriages in at least 16 states, according to the U.S. Department of
Agriculture (USDA).

In recent years, the volume of food that companies recalled in the United
States increased substantially; for meat and poultry alone, the amount
recalled increased from nearly 6 million pounds in 1988 to about 36
million pounds in 2003. Concerns that contaminated food could reach
consumers have also intensified because of the potential susceptibility of
food to deliberate contamination. In January 2004, the President
identified the U.S. food system as vulnerable to intentional acts of
terrorism.1

Food recalls are voluntary and federal agencies responsible for food
safety have no authority to compel companies to carry out recalls-with the
exception of the Food and Drug Administration's (FDA) authority to require
a recall for infant formula. USDA provides guidance to companies

1Homeland Security Presidential Directive/HSPD-9, Defense of United States
Agriculture and Food (Jan. 30, 2004).

for carrying out voluntary recalls of meat, poultry, and egg products and
monitors those recalls. FDA provides guidance to companies for carrying
out voluntary recalls of other foods and monitors those recalls.

In August 2000, we reported that while USDA and FDA believed companies
carried out timely recalls, the two agencies did not have data to support
their views.2 We recommended that, among other things, USDA and FDA
provide specific guidance to companies, including time frames for quickly
initiating and carrying out recalls, and that the agencies maintain key
dates-such as when the recall started, when customers in the distribution
chain were notified, and when the recalls were completed-in their recall
data systems to allow the agencies to assess whether companies do indeed
carry out timely recalls.

As part of their recall programs, both USDA and FDA classify recalls on
the basis of their severity, with Class I recalls presenting the greatest
risk to human health. Class I recalls may involve food contaminated with
diseasecausing bacteria, such as Listeria monocytogenes (listeria) and
Escherichia coli (E. coli), or food containing ingredients not identified
on the label (e.g., nuts or eggs) that could cause severe illness or death
to someone allergic to that ingredient. Class II and Class III recalls
involve foods that present little or no risk of adverse health
consequences. For example, in FDA's case, these foods may cause medically
reversible adverse consequences, such as seasoned popcorn containing a
color additive not listed on the label that can cause mild allergic
reactions.

In their guidance to companies for voluntary recalls, both USDA and FDA
have procedures for companies to notify their downstream customers- such
as processors, wholesalers, distributors, institutions, and retailers in
the distribution chain-as well as procedures for returning or disposing of
the food (referred to as "recovery").

Both USDA and FDA also have guidance for their respective field staff with
procedures for monitoring the progress of the recall, ensuring that the
public is notified through press releases and Web postings, carrying out
verification checks to confirm that the company has notified its
downstream customers, and documenting certain agency and company

2GAO, 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).

recall activities in their respective recall databases-Recall Web for
USDA, and Recall Enterprise System for FDA.

In contrast to the voluntary food recall programs at USDA and FDA, other
agencies have authority to issue mandatory recall orders: the National
Highway Traffic Safety Administration's recall authority for motor
vehicles; the Consumer Product Safety Commission's recall authority for
many consumer goods; and FDA's recall authority for infant formula,
biological products, medical devices, and radiation-emitting electronic
products. At the time of our previous study, legislation had been
introduced that would have given mandatory authority to USDA and FDA for
food recalls. Similar legislation was introduced in the current Congress.3

As you requested, this report (1) examines the recall programs and
procedures USDA and FDA use to protect consumers from unsafe foods and (2)
compares USDA's and FDA's authority for food recalls with the recall
authority of agencies responsible for the safety of other consumer
products, such as toys, medical devices, and automobiles. In addition,
information you requested on USDA's and FDA's efforts to identify and
recall food from a cow slaughtered in Washington State that had bovine
spongiform encephalopathy (BSE), otherwise known as mad cow disease, is
presented in appendix II. You also requested information on a 2002 recall
of ground beef by a ConAgra plant in Greeley, Colorado, which is presented
in appendix III.

For the purpose of this report, the term "food" refers to food intended
for human consumption, the term "customer" refers to any company in the
downstream distribution chain of the company conducting the recall, and,
with respect to recall authority, the term "order" includes the authority
to order or to require a recall. To examine the recall programs and
procedures USDA and FDA use to protect consumers from unsafe foods, we
analyzed in depth 20 Class I recalls that were ongoing in fiscal year
2003-10 from USDA and 10 from FDA. We discussed these recalls with
officials from the recalling companies and with the agencies' district
offices that monitored the recalls. These recalls represented a range of
foods, contaminants, and geographical locations. In addition, we examined
the reliability of

3See, for example, the SAFER Meat, Poultry, and Food Act (H.R. 3547) and
the Consumer Food Safety Act of 2003 (H.R. 1496). In addition, legislation
was introduced to provide USDA with authority to order recalls for food
served in the school meals programs (S. 506/ H.R. 1551).

information from USDA and FDA recall data systems for that year. We also
obtained views on USDA's and FDA's recall programs from representatives of
trade and consumer organizations, such as the American Meat Institute, the
Center for Science in the Public Interest, and the Consumer Federation of
America. To compare USDA's and FDA's authority for food recalls with
recall authority available to federal agencies responsible for the safety
of other consumer products, we compared statutes and regulations and
discussed these recall programs with agency officials. This report also
provides information on, but does not evaluate, the Canadian Food
Inspection Agency's recall program. The Canadian agency has the authority
to order food recalls. Appendix I discusses our objectives, scope, and
methodology in detail. We conducted our review between May 2003 and August
2004 in accordance with generally accepted government auditing standards.

Results in Brief Even in the context of their limited recall authority,
USDA and FDA can do a better job in carrying out their food recall
programs. Weaknesses in these agencies' systems for monitoring food
recalls heighten the risk that unsafe food will remain in the food supply
and ultimately be consumed. Specifically:

o USDA and FDA do not know how promptly and completely companies are
carrying out recalls. Neither agency's guidance provides time frames for
companies on how quickly to initiate and carry out recalls. Consequently,
companies may have less impetus to notify downstream customers and remove
potentially unsafe food from the marketplace. Moreover, USDA and FDA are
not using their data systems to effectively monitor and manage their
recall programs. They do not track important dates to calculate how long
companies take to carry out recalls and the percentage of food that is
recovered. Furthermore, managers do not receive routine reports on the
progress of ongoing recalls to target program resources. Finally, we found
that FDA's food recall program staff maintain a recall data system that is
separate from FDA's official recall data system. FDA uses information from
this other data system to report to Congress because, according to program
staff, the system maintained by the program staff contains the most
accurate data. Moreover, the two systems do not contain consistent
information, which brings into question the validity and reliability of
FDA's official system.

o USDA and FDA do not promptly verify that recalls have reached all
segments of the distribution chain, yet monitoring the effectiveness of a

company's recall actions is the agencies' primary role in a food recall.
For the 10 USDA recalls we examined in depth that occurred in 2003, USDA
staff averaged 38 days to complete verification checks, and for the 10 FDA
recalls we examined in depth, FDA staff averaged 31 days. These time
frames exceeded the expected shelf life for some perishable foods that
were recalled, such as fresh ground beef and fresh-cut bagged lettuce.
Moreover, the agencies' procedures for selecting the sample of companies
to check do not ensure that all segments of a food distribution chain are
included. In May 2004, USDA issued new procedures to its staff with time
frames for completing verification checks-within 13 days for Class I
recalls-and with a methodology designed to reach all segments of the
distribution chain. If implemented, these procedures should provide
reasonable assurance that recalls are effective.

o The procedures USDA and FDA use to alert consumers to a recall- press
releases and Web postings-may not be effective. According to consumer
groups and others, relatively few consumers may see that information. They
identified additional methods to notify the public, such as posting recall
notices in grocery stores and directly notifying consumers using
"shoppers' club" information.

In contrast to the limited, or lack of, authority that federal food safety
agencies have to order food recalls, agencies responsible for the safety
of certain other consumer products have more specific recall authority
that may help them better protect consumers. This includes the authority
to (1) require a company to notify the agency when it has distributed a
potentially unsafe product, (2) order a recall, (3) establish recall
requirements, and (4) impose monetary penalties if a company does not
cooperate. For example, manufacturers of many consumer goods are generally
required to notify the Consumer Product Safety Commission within 24 hours
of obtaining information that suggests a product could create a
substantial risk of injury. The commission has the authority to impose
monetary penalties of up to $1.65 million if a company does not inform the
commission promptly about an unsafe product. Likewise, FDA has authority
to order recalls of unsafe biological products and medical devices-and it
has used this authority in the past. Furthermore, the National Highway
Traffic Safety Administration has used its authority to establish recall
requirements to require companies to directly notify the purchasers of
vehicles with defects and to remedy the defects. Finally, FDA can impose
penalties of up to $100,000 per day on companies that do not recall unsafe
biological products, such as vaccines.

We are proposing that Congress consider legislation that would require
companies to alert USDA or FDA when they discover they have distributed
potentially unsafe food and that would give both agencies mandatory food
recall authority. We are also recommending that USDA and FDA better track
and manage food recalls, achieve more prompt and complete recalls, and
determine if additional ways are needed to alert consumers about recalled
food that they may have in their homes.

In commenting on a draft of this report, USDA said the report was
generally factually accurate, and the department believes that the
procedures it adopted in late May 2004 will address most of the weaknesses
we observed in its recall program. However, USDA disagreed with our
recommendations regarding additional data collection and report
generation. USDA believes that those recommendations may be a burden to
the agency and industry. We do not believe it would be burdensome to USDA
because the department already generally collects these data in its
inspection paperwork but does not systematically capture them in its
Recall Web database, which should be able to generate the management
reports we recommend. With regard to industry, companies are already
required by law to maintain food distribution information. Appendix VII
contains USDA's written comments and our detailed response. In its
comments, FDA said we did not demonstrate that FDA recalls were lengthy
because of system inefficiencies or that weaknesses in FDA's recall
process resulted in little recovery of food. FDA agreed with our
recommendations regarding using the Recall Enterprise System to generate
routine management reports and eliminating the duplicative recall
database, but it disagreed with our recommendations regarding the need for
specific time frames for companies' actions and for recording the dates of
company and agency actions in the Recall Enterprise System. We continue to
believe that time frames are critical to reinforce the urgency for
companies to act promptly to protect consumers and that tracking these
dates is essential for FDA to effectively monitor ongoing recalls and
assess actions to improve the timeliness of recalls. Appendix VIII
contains FDA's written comments and our detailed response.

Background Food companies, USDA, and FDA may discover that unsafe food has
been distributed from customer complaints, routine facility
investigations, product testing by the company or a federal or state
government agency, or an outbreak of a foodborne illness. Depending on the
food, USDA (for meat, poultry, and egg products) or FDA (for all other
food), would generally monitor the recall.4

USDA and FDA classify recalls by the potential health risk that the food
poses, as follows:

o Class I: Recalls of food that poses a reasonable probability of causing
serious, adverse health consequences or death, such as foods that contain
listeria, salmonella, or E. coli O157:H7, or undeclared allergens such as
peanuts and eggs.5

o Class II: For USDA, recalls of food that poses a remote probability of
adverse health consequences, and, for FDA, recalls of food that presents a
remote probability of serious adverse health consequences or may cause
temporary or medically reversible adverse health consequences.

o Class III: For USDA, recalls of food that will not cause adverse health
consequences. (For example, meat or poultry that contains added water not
disclosed on the label, which USDA regulation prohibits.) For FDA, recalls
of food not likely to cause adverse health consequences. (For example,
food that contains mold or insects, which FDA regards as unfit, although
the food is unlikely to pose adverse health consequences.)

The number of food recalls has generally increased over the past decade,
with a record high of more than 500 in 2002.6 In addition, for fiscal year
2003, most recalls were Class I-for food that poses the greatest risk of
illness or death. As figure 1 shows, Class I recalls accounted for 51 (66

4The Department of Defense may also coordinate recall responsibilities
with respect to foods purchased to feed military personnel and their
families.

5USDA classifications are in the Food Safety and Inspection Service
Directive 8080.1, Revision 4. FDA recall classifications are provided in
21 C.F.R. S: 7.3(m)(2004).

6The number of food recalls each year has ranged from 260 to 519 over the
past decade, with an average of 335 recalls a year for that period.

percent) of the 77 food recalls for USDA in 2003 and 160 (54 percent) of
the 296 recalls for FDA in that year.

Figure 1: USDA and FDA Recalls by Risk Classification, 2003 FDA (296
recalls)

USDA (77 recalls)

Class III Class III (14) (35)

Class II (12) Class II

(101)

Class I Class I

(51)

Food that will not cause serious adverse health consequences or that may
cause temporary or medically reversible adverse health consequences

Food that poses a reasonable probability of causing serious illness or
death

Source: GAO analysis based on USDA and FDA recall data.

(160)

USDA and FDA generally monitor a food recall when the recalling company
alerts the agency or when the agency learns about a problem from, for
example, routine facility inspections or product tests. Typically, recalls
are monitored by the agencies' district office responsible for the
geographic area where the recalling company is located. District office
inspectors obtain preliminary information from the company, such as the
reason for the recall, the amount of food to be recalled, and the food's
labeling and packaging. For USDA, a recall committee comprised of
headquarters and district recall staff assign the risk classification,
and, for FDA, the districts assign a preliminary risk classification.

Both USDA and FDA rely on press releases and Web site postings to alert
consumers about recalls, although there is no law requiring them to
provide such notification. USDA's Food Safety and Inspection Service will
generally issue press releases for Class I and Class II recalls and post
information on its recall Web site:
http://www.fsis.usda.gov/fsis_recalls/index.asp. USDA's press releases
describe the product, including any identifying marks or codes; the reason
for the recall; and the risk involved with consuming the product. The
press releases also instruct consumers on what to do with any product in
their possession and provide a name and telephone number of a company
contact for questions.

For FDA recalls, the recalling company generally issues a press release
for Class I recalls. FDA guidance recommends that the press release be
issued promptly, and if the company fails to issue the press release, FDA
may do so. FDA posts these press releases on its recalls Web site:
http://www.fda.gov/opacom/7alerts.html, along with recalls for the other
products that it regulates. FDA provides companies with model language for
press releases for several different causes of Class I recalls (e.g.,
allergens, E. coli O157:H7, or salmonella), which covers, in general, the
same information found in USDA's press releases. In addition, USDA and FDA
food recalls are also posted on a governmentwide recall Web site:
http://www.recalls.gov, which is managed by the Consumer Product Safety
Commission.

In addition, under both USDA and FDA guidelines, a recalling company is to
alert its customers to the recall and provide them with instructions for
recovery-return or disposal-of the food. This first level of customers-
referred to as primary-can be any number and combination of processors,
distributors, retailers, or other customers and may also include
direct-toconsumer sales. For example, some frozen food companies
distribute their products by direct delivery to individual homes. The
recalling company is to ask its primary customers to pass the alert to
subsequent customers in the distribution chain (referred to as secondary
and tertiary), when they have further distributed or sold the food. As
figure 2 shows, the entire distribution chain can include multiple levels
of downstream processors, distributors, and retailers before the food
reaches consumers.

Figure 2: Downstream Distribution Chain May Include Multiple Levels of
Distributors, Processors, and Retailers before the Food Reaches Consumers

Source: GAO.

USDA's and FDA's primary role is to monitor the effectiveness of a
company's recall actions by verifying that customers in the food
distribution chain receive notice of the recall, and that the food is
located and removed from the marketplace. To carry out their verification
checks, USDA and FDA contact a percentage of the company's customers to
determine whether the recall was carried out-specifically, that the
customers were provided with recall information, and that they followed
instructions for returning or destroying the food.7 In addition, several
states have agreements with USDA and FDA to coordinate verification
responsibilities for companies in their states. States are to report the
results of the verification checks to the monitoring agency. USDA and FDA
may also request that recalling companies periodically submit status
reports on their progress, including the number of customers contacted and
the amount of the food recovered or otherwise accounted for. USDA and FDA
inspectors should be consulted prior to the destruction of the food, and
they may request that the company allow them to witness the final
disposition of the food.8

Both USDA and FDA consider a recall completed when their district
officials finish verification checks and determine that the company has
made all reasonable efforts to recall the food. The agencies are to notify
recalling companies in writing that no further action is necessary. At
this point, the agencies put summary information into their respective
data systems.

The report we issued in August 2000 provided information on several
aspects of USDA's and FDA's voluntary recall programs. It was intended to
assist congressional consideration of then-pending legislative proposals
to give mandatory recall authority to USDA and FDA. Although such
legislation has not been enacted, USDA and FDA do have authority to
detain, seize through the courts, and condemn foods as part of their
overall responsibility for food safety. Specifically:

o The Federal Meat Inspection Act, the Poultry Products Inspection Act,
and the Egg Products Inspection Act give USDA authority to detain

7USDA refers to its verification checks as "effectiveness checks," whereas
FDA refers to them as "audit checks."

8Disposition of a recalled product may include actions such as relabeling,
reworking (e.g., further cooking to sell as food or rendering to sell as
fertilizer or animal feed), or destroying the food (e.g., disposing of
food in a landfill).

meat, poultry, and egg products for up to 20 days when it has reason to
believe the food is adulterated or misbranded. These acts give USDA
authority, through the courts, to seize, condemn, and destroy unsafe food.
USDA also may withdraw meat and poultry inspectors from slaughtering and
processing facilities or withhold or remove the USDA "inspected and
passed" label-both measures that require the production line to be shut
down-if the sanitary conditions at the company's facility cause food to
become unsafe.

o The Federal Food, Drug, and Cosmetic Act gives FDA authority, through
the courts, to seize, condemn, and destroy adulterated or misbranded food
not exclusively regulated by USDA. The act also gives FDA authority to
disseminate information about foods that are believed to present a danger
to public health. In addition, the Public Health Security and Bioterrorism
Preparedness and Response Act of 20029 (commonly referred to as the
Bioterrorism Act), authorizes FDA to detain food for up to 30 days without
a court order, if the agency has evidence indicating that the food
presents a threat of serious adverse health consequences or death to
humans or animals. FDA issued its final rule for administrative detention
on June 4, 2004.10

9Pub. L. No. 107-188, 116 Stat. 594(2002).

10Administrative Detention of Food, 69 Fed. Reg. 31660 (June 4, 2004)(to
be codified at 21 C.F.R. S:S: 1.377 et seq.).

The Bioterrorism Act also authorizes FDA to establish record-keeping
requirements for companies involved in the food industry (except farms and
restaurants) so that FDA will be better able to identify companies
involved in the food distribution chain-that is, the immediate previous
sources and subsequent recipients of food. In this way, the act attempts
to address, if necessary, "credible threats of serious adverse health
consequences or death to humans or animals."11 As of August 2004, FDA had
not issued final regulations to implement these record-keeping
requirements, and the agency told us it has not determined the
applicability of the act to food recalls.12

Weaknesses in USDA's and FDA's Recall Programs Heighten the Risk That
Unsafe Food Will Reach Consumers

Even recognizing the limitations in their recall authority, federal
agencies could still better protect consumers from unsafe foods if they
addressed weaknesses we identified in their monitoring of companies'
recalls. Specifically, USDA and FDA have not set time frames to encourage
companies to act promptly, and, because the agencies do not track
important dates and recovery rates in their recall data systems, they do
not know how promptly and completely companies are carrying out recalls.
Furthermore, the agencies' procedures for conducting verification checks
do not ensure that agency staff promptly verify that recalls have reached
all segments of the distribution chain. Finally, consumer groups have
raised questions about the effectiveness of the agencies' public
notification efforts.

USDA and FDA Do Not In November 2003, FDA issued new recall guidance to
companies, and, in Know How Promptly and May 2004, USDA also issued new
guidance. However, neither agency Completely Companies included time
frames for companies to initiate and carry out recalls of food Carry Out
Recalls that involve potentially serious adverse health risks, nor
procedures for the

1121 U.S.C. S: 350c(b).

12In the preamble of the proposed regulations, FDA stated that it intends
to make this process as simple as possible for both domestic and foreign
facilities. FDA has proposed that covered entities would be required to
maintain specific information in their files, but the form or type of
records maintenance system would not be specified. The proposed
regulations would, if finalized, require companies to provide FDA with
information within specified time frames about the immediate previous
source and subsequent recipient of all food. See Establishment and
Maintenance of Records Under the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002, 68 Fed. Reg. 25188 (proposed May 9,
2003)(to be codified at 21 C.F.R. S:S: 1.326 et seq.).

companies to notify their distribution chains and alert the public.
Without specific guidance on time frames, companies may have less impetus
to promptly notify downstream customers and retrieve potentially unsafe
food from the marketplace. Of particular concern are perishable foods that
are sold and consumed within a few days. In our 2000 report, we
recommended that the agencies include time frames to ensure that companies
would initiate and carry out recalls without delay. Appendix IV provides
information on the actions USDA and FDA have taken on the other
recommendations we made to them in 2000.

Moreover, we found that, although USDA and FDA have developed new data
systems since our 2000 report, the agencies are not using the systems to
effectively monitor and manage their recall programs. The agencies do not
track some critical data for assessing the timeliness and effectiveness of
recalls. For example, USDA does not track when a company learns that it
needs to initiate a recall or when it provides complete distribution
lists. In addition, neither USDA nor FDA tracks when the company begins
and finishes notifying its customers or when the agency begins and
finishes its verification checks. Without tracking these data, the
agencies do not have the information they need to assess how quickly the
company and the agency have acted. Even when the agencies collect data,
they do not use the information to generate routine reports that would
help their managers track the progress of recalls that are ongoing or
assess the effectiveness of their recall programs' activities. Such
reports are a key prerequisite to effective management of resources, as
emphasized in the Government Performance and Results Act of 1993.13

13Pub. L. No. 103-62, 107 Stat. 285(1993).

We found, for example, that while both agencies record the information for
calculating the recovery rate, they do not calculate the recovery rate for
recalls. As a result, they did not know how much food was actually
recovered, although both agencies told us recovery was an important
indicator of a successful recall. Using the information in USDA's Recall
Web database, we calculated that the total recovery rate has generally
declined since 1988 for recalls monitored by USDA.14 We could not
similarly analyze recovery rates for FDA-monitored recalls for multiple
years because the agency has not recorded recovery information in its
database in a way that allowed us to do the calculation. That is, FDA uses
inconsistent units, such as cases, cans, boxes, or bags of food, which
prevented us from calculating annual recall volume. However, we calculated
the average recovery rate for about one-half of FDA recalls in 2003 for
which the agency used the same unit for both "quantity distributed" and
"quantity recovered."15 We found that companies' recovery rates for
FDA-regulated food was about 36 percent. In a similar analysis of USDA
recalls, about 38 percent of food was recovered.

USDA has a low expectation of recovering much food with a short shelf
life, such as fresh meat, which moves quickly through the distribution
chain. USDA said that the drop in its recovery rates may also be due, in
part, to the significant number of recalls related to its E. coli O157:H7
testing programs, which started around 1994.16 Test results take several
days. That is, because of the delay in getting the test results, meat that
tested positive for E. coli O157:H7 may have already been distributed,
sold, and consumed-thus reducing the amount that may be recovered. Some
companies told us that, to avoid recalls related to positive E. coli
O157:H7 tests taken by USDA, they have begun holding meat from
distribution until test results are back. Another reason for low recovery
rates is that USDA is

14We calculated the total recovery rate by dividing the total pounds
recovered by the total pounds recalled in each year. The first complete
year that USDA recorded pounds recovered was 1988.

15To calculate the average fiscal year 2003 recovery rate, we averaged
rates for individual recalls. For FDA, we included in our analysis 86 of
the 153 recalls started in 2003 that had been completed by the end of
February 2004 and for which FDA recorded the same unit in the fields for
"quantity distributed" and the "quantity recovered/number of units
corrected." For the remaining recalls, FDA was missing data in one or both
fields, or the fields had different units. For USDA, we were able to
include in our analysis 75 of the 77 fiscal year 2003 recalls, because
USDA recorded both the quantity distributed and the quantity recovered in
pounds.

16E. coli O157:H7 is a virulent strain of E. coli bacteria.

using epidemiological evidence, such as outbreaks of foodborne illnesses
that are traced back to the food, as a basis for requesting that companies
conduct a recall. Because traceback can be slow, recalls linked to illness
outbreaks may have low recovery rates.

Recovering perishable foods is particularly challenging because they may
be subject to recall after the product's shelf life has passed. As USDA
pointed out, it is unlikely that much food will be recovered in these
recalls. Figure 3 illustrates the timeline for 4 of the 20 recalls that we
examined in depth. Of these 4 recalls, the recall for canned soup began
well before the end of the food's shelf life, the recall for packaged
turkey sandwiches near the end, and the recalls for fresh-cut bagged
lettuce and ground beef well after the recommended shelf life of the
product. USDA recall officials pointed out that consumers could have
frozen the meat or poultry, so that some of those products could still
have been in consumers' homes. FDA also pointed out that the fresh-cut
bagged lettuce may have deteriorated in quality, but may still have been
edible after its shelf life expired.

Figure 3: Number of Days after Production When Recall Occurred and
Expected Shelf Lives for Four Recalls

Source: GAO analysis based on USDA and FDA data.

Note: The recall of canned soup began during the soup's shelf life. The
recall of ground beef began after the shelf life because of the time it
took to identify the source of the contamination following an illness
outbreak. The recall of packaged turkey sandwiches began near the end of
the sandwiches' shelf life because the turkey used in the sandwiches was
part of an expanded recall conducted by another company. The recall of
fresh-cut bagged lettuce began after the shelf life of the lettuce because
the food tested positive for listeria after it already had reached store
shelves, and the test results were slow to reach the agency and the
company.

We relied primarily on the agencies' documents for our analysis. We cannot
say with confidence that FDA's Recall Enterprise System accurately depicts
actions taken. At the end of our review, we learned that FDA's Center for
Food Safety and Applied Nutrition continues to maintain a separate food
recall data system and uses that system-not the official Recall Enterprise
System-to report recall information to Congress. According to center
program staff, FDA uses information from this unofficial data system to
report to Congress because the center's system contains the most accurate
data. FDA invested more than $3 million to implement the Recall Enterprise
System, which was designed to be a valid and reliable

automated system for capturing information about recalls across FDA's five
centers. The system is accessible to FDA staff in both headquarters and
district offices. In addition to this substantial investment and the
duplication of effort for maintaining two separate data systems, the
existence of a second recall data system raises several other concerns:

o The unofficial database reflects a substantial difference in the number
of recalls over the period we examined. For example, the unofficial
database included 296 food recalls for 2003, while the Recall Enterprise
System shows only 207. Some of the difference can be explained because
recall counts from the unofficial system are based on the year that FDA
assigns a risk classification-typically at the end of the recall-whereas
our analysis of Recall Enterprise System data used the year the recall
began. FDA was not able to provide us with enough information on the
recalls to resolve the differences.

o Data in the two systems were not consistent for individual recalls. For
example, the start date and classification date for some recalls did not
agree.

o Some fields, such as the date the company completed its recall actions,
are in both the Recall Enterprise System and the unofficial system. This
is one of the critical dates we recommended in our 2000 report that the
agency should track. However, we found that this date was not entered into
the Recall Enterprise System for a significant number of recalls- about 20
percent of recalls in 2003.

These problems raise significant questions about the validity and
reliability of the official Recall Enterprise System.

USDA and FDA Do Not Promptly Verify That Recalls Reach All Segments of the
Distribution Chain

Neither USDA nor FDA acted promptly to carry out verification checks or
used a sound methodology for selecting the sample of a company's
downstream distribution chain for verification. As a result, the agencies
could overlook entire segments of a food's distribution chain, as they did
in many of the recalls we examined in detail.

For the 10 USDA recalls from 2003 that we examined in detail, USDA did not
have guidance in place with time frames for when agency staff should
finish verifying that a company had completed its recall. In addition,
USDA does not collect in its data system information on when agency staff
begin and finish verification checks. Therefore, we could not calculate
how long

USDA took to verify all recalls for the period we reviewed. However, for
the USDA recalls, we calculated that district staff took an average of 38
days to verify whether the recalling company's customers were aware of the
recall. That length of time exceeds the shelf life of fresh meat and
poultry. Furthermore, it delays the agencies' ability to identify problems
with the recall and request corrective actions before consumers eat the
recalled food.

USDA revised its guidance to its staff in May 2004 and included a
risk-based goal for verification activities that considers the class of
the recall.17 Specifically:

o For Class I recalls, district offices should begin verification to
determine whether a company carried out the recall within 3 days of the
start of the recall and should substantially complete the verification
within 10 days thereafter.18

o For Class II recalls, verification should begin within 5 days and be
completed within 12 days.

o For Class III recalls, verification should begin within 10 days and be
completed within 17 days.

In contrast, FDA had guidance for beginning and finishing its verification
checks during the recalls we reviewed. The total process is to take 20
days: that is, checks are to begin within 10 days of the company's
starting a recall and be completed no more than 10 days after checks
begin.19 Because FDA, like USDA, does not collect information on when
agency staff begin and finish verification checks in its Recall Enterprise
System, we could not assess the extent to which FDA met its time frame for
all recalls in 2003. However, we were able to make that determination for
the 10 recalls we examined in depth. We found that FDA did not conduct
verification checks

17USDA Food Safety and Inspection Service Directive 8080.1, Revision 4,
Attachment 3, May 24, 2004.

18Had the goal for the Class I recalls been in place during 2003, USDA
would have met it for 1 of the 10 recalls that we examined for which USDA
conducted checks.

19FDA's guidance to its staff is provided in chapter 7 of its Regulatory
Procedures Manual, March 2004 edition, effective May 6, 2004
(http://www.fda.gov/ora/compliance_ref/rpm/default.htm). Additional
industry guidance is also provided in regulation (21 C.F.R. S:S:
7.40-7.59).

for 4 of those recalls. For the remaining 6 recalls, we calculated that
district staff took an average of 31 days to complete the checks-with 3
recalls taking more than the targeted number of days.

In conducting their verification checks, USDA and FDA told us that they
can be hindered in their efforts to initiate verification checks when
companies delay in providing their distribution lists or provide imprecise
lists. According to FDA, if every customer in a distribution chain takes 2
days to provide its list, even with a short distribution chain, this could
add 2 weeks to the verification process. In a May 2003 proposed rulemaking
under the Bioterrorism Act, FDA stated that the amount of time it would
take FDA to determine where a food is located "may be increased if the
[distribution] records are incomplete and FDA has to wait for missing
records to be retrieved. This possible delay would be a substantial
concern if FDA were attempting to remove [unsafe] food that presents a
threat of serious adverse health consequences or death...."20

We also found that the agencies have not been using sound methodologies
for selecting the sample of companies in the distribution chain for
verification. As part of their recall activities, USDA and FDA decided on
what percentage of the recalling company's primary and secondary customers
they would contact to determine whether the customers were aware of the
recall and had removed the food from the marketplace according to the
recalling company's instructions. If the downstream customers they checked
were aware and had removed the food, USDA and FDA generally considered the
food recall effective.

Both USDA's and FDA's recall procedures include methodologies for
conducting verification checks. Although USDA revised its procedures in
May 2004, the practice that was in effect during the recalls we reviewed
was for district staff to contact at least 20 percent of primary customers
and 10 percent of secondary customers. We found that the districts'
understanding, and therefore implementation, of that practice varied, with
some districts saying that, for example, they were to check 10 percent of
primary customers and others saying they were to check 20 percent. As
table 1 shows, for the 10 Class I recalls we examined, USDA checked
between 14 and 100 percent of primary customers.

2068 Fed. Reg. 25188, see footnote 12.

The procedures that FDA used are based on regulations that specify five
different verification levels-0, 2, 10, between 10 and 100, or 100
percent.21 However, the regulations and FDA's procedures do not specify
when to use different levels of verification. FDA officials told us that
district staff would generally not do any checks when they believe the
food is no longer on store shelves or when the company can demonstrate
that it is doing the verification checks. Agency recall officials said
that they select a level depending on the size of the distribution chain
and the risk associated with the recalled product. As table 1 shows, for
the 10 FDA Class I recalls we examined in detail, FDA checked from 0 to
100 percent of primary customers. In 4 recalls, FDA determined that no
verification checks were needed. Appendix V provides USDA's and FDA's
recall identification numbers for the 20 recalls we examined.

Table 1: USDA and FDA Verification Rates for 20 Selected Class I Recalls in 2003

Primary customers Number

Total number

Percentage of total

Agency Food Reason for recall checked

USDA Fresh ground beef E. coli 7 15
Chicken frankfurters Listeria 9 24
Ground beef E. coli 4 12
Fully cooked frozen chicken Hard piece of plastica 8 14
Fresh and frozen ground beef E. coli 51 84
Fresh and frozen ground beef E. coli 18 30
Frozen ground beef E. coli 41 129
Fresh and frozen ready-to-eat Listeria 103 757
turkey and chicken
Fresh and frozen ready-to-eat Listeria 47 144
turkey and chicken
Canned soup Cheeseb 1 1

2121 C.F.R. S: 7.42(b)(3)(i)-(v)(2004).

(Continued From Previous Page)

Primary customers Number

Total number

Percentage of totalAgency Food Reason for recall

checked

FDA Crab cakes Milkb 22 34
Ice cream Peanutsb 1 1
Salted herring Botulinum spores 2 8
Oregano Salmonella 0 11 0c
Fresh-cut bagged lettuce Listeria 0 79 0d
Packaged turkey sandwiches Listeria 0 2,700 0e
Alfalfa sprouts Salmonella 14 25
Smoked salmon Listeria 12 107
Packaged breakfast pastry Eggb 0 341 0f
Chocolate milk Excessive amounts of 4 53
vitamins A and D

Source: GAO summary of USDA and FDA data and documents.

aThe hard piece of plastic was considered to be foreign material.

bThe presence of a potential allergen (cheese, milk, peanuts, or eggs) was
not declared on the food's ingredient label.

cFDA did not conduct checks because the recalling company recovered 100
percent of the distributed oregano.

dFDA did not conduct checks because the bagged salad was 2 weeks past its
expiration date, and it concluded that the salad was not likely to be
available on store shelves.

eFDA did not conduct checks because the recalling company documented that
it visited each of its customers and recovered sandwiches.

fFDA did not conduct checks because the recalling company used a
third-party vendor to contact 100 percent of the primary customers, and
the company faxed timely status reports to update the agency.

USDA and FDA were limited in their ability to reasonably ensure that
recalls were effective because their methodologies did not take into
account the complexities of downstream distribution chains. In the recalls
we examined, USDA and FDA generally obtained the recalling company's
primary distribution lists and then checked a percentage of the customers
on those lists. The agencies then obtained customer lists only from the
primary customers that they checked, which enabled them to identify
secondary customers associated with the primary customers that they
checked. Because the agencies did not usually check all primary customers,
they were not aware of all secondary customers. As a result, the agencies
may have overlooked whole segments of a distribution chain with their
verification checks. That is, even when the agencies conducted the
recommended percentage of verification checks, they may not have conducted
enough checks across the distribution chain to be able to determine
whether the recall was effective.

Moreover, USDA's Office of Inspector General issued a report in June 2004
that was critical of USDA's verification process.22 That report
recommended that USDA's Food Safety and Inspection Service document its
recall effectiveness determinations, implement controls to ensure the data
are valid, and conduct future effectiveness checks in a timely and
methodologically sound manner.

In the future, however, USDA's verification checks may help the agency
better ascertain whether a recall was effective because USDA adopted new
verification guidance in May 2004. If properly implemented, this guidance
will provide greater assurance that downstream customers are aware of a
recall and have followed the recalling company's instructions for removing
the food from the marketplace. USDA's new guidance provides a statistical,
risk-based method that considers the class of recall, any illnesses
associated with the food, and the number of customers in the distribution
chain. Specifically, the guidance sets standards for the (1) number of
checks to conduct, (2) method for sampling which customers to check, (3)
method for conducting the checks (e.g., on-site visits or telephone
calls), and (4) critical number of verification checks, finding that
customers were not aware of the recall, beyond which USDA determines that
the recall process was inadequate and warrants further action by the
recalling company. In addition, the guidance provides time frames for
completing these checks.

For example, for a Class I recall with associated illnesses and a
distribution chain that included 1,000 customers, USDA would select 200
customers by checking every fifth customer and consider the recall
ineffective if it found any customers that were not notified of the recall
or that still had food that could reach consumers. USDA also would begin
checks within 3 days of the recall's start and finish checks within 10
days thereafter. USDA's new approach is similar to the one that the
Canadian Food Inspection Agency has used since 2001.

FDA's verification approach also does not ensure that a reasonable number
of downstream customers are aware of a recall and have taken the
appropriate action. While FDA's policy is to determine the percentage of
downstream customers to contact on the basis of the size and the risk

22U.S. Department of Agriculture, Office of Inspector General, Food Safety
and Inspection Service: Effectiveness Checks for the 2002 Pilgrim's Pride
Recall, Report No. 24601-03-Hy (June 2004).

associated with the recall, we found that the agency lacks methods for
consistently determining which level of checks-the percentage of the
downstream customers-to use in verifying a given recall. FDA's
verification approach also lacks other features of a risk-based
methodology, such as considering whether illnesses have resulted from the
unsafe food or criteria for whether to consider the recall ineffective.

Agencies and Consumer Groups Differ in Their Views on the Effectiveness of
Public Notification

More than 200 Class I food recalls occurred in 2003, but the procedures
USDA and FDA use to alert consumers to a recall-press releases and Web
postings-may not be effective. Both USDA and FDA rely on press releases as
their main tool to alert consumers to the dangers of recalled foods. Both
agencies also make recall press releases available on their Web sites as a
service to consumers; the media; and other interested parties, such as
state and local health officials.

Views on the usefulness of the agencies' efforts to communicate with the
public differ, according to the officials and organizations we
interviewed. For example, a California State health official expressed
concerns that the frequency of recall press releases can overwhelm the
public. Nevertheless, the official thought that press releases from a
government entity are given more weight by consumers and the media than
press releases issued by individual food companies; hence, that
USDA-issued press releases may have greater impact than company-issued
press releases (for FDAregulated foods).

Public interest groups presented a different view. According to the Center
for Science in the Public Interest and the Consumer Federation of America,
most press releases are not useful to consumers because the releases lack
the specificity, such as store locations, that consumers need to help them
determine whether they purchased the food that is being recalled.
According to these officials, if industry and government want consumers to
avoid eating a recalled food, information about the recall should be
prominently displayed in the grocery stores that sold the food. We
identified some stores that voluntarily provide additional information to
help consumers, including a membership warehouse that uses member
information from its "shoppers' club" to directly contact its customers
who purchased a recalled food.

According to USDA and FDA officials, the agencies generally do not have
the authority to publicly name the retail stores that are selling a
recalled food because the information is considered confidential business
information. For example, USDA provided a distribution list of the
recalled beef products to the California Department of Health Services
during the December 2003 recall of beef potentially contaminated with
BSE.23 Although California could use the list to help its inspectors
ensure that the meat was removed from store shelves, the state had to
agree not to publicly identify the stores and restaurants where the
recalled beef was sold. USDA and FDA officials told us that they plan to
look into additional options to help consumers identify recalled foods in
their homes.

Even if the agencies could disclose store locations, consumers may still
not be able to identify the recalled food. As USDA pointed out, consumers
may have difficulty identifying a recalled food because packaging may
change at different points in the distribution chain, especially for such
foods as ground beef, which may be mixed with other meat or further
processed into prepared foods such as frozen lasagna, canned ravioli, or
ready-to-eat sandwiches. In such instances, recalling companies may not
know how their downstream customers have processed or distributed these
foods.

Other Government Agencies Have Recall Authority Not Available to USDA and
FDA for Food That May Better Protect Consumers

Government agencies that regulate the safety of other products, such as
toys and automobile tires, have recall authority not available to USDA and
FDA for food and have had to use their authority to ensure that recalls
were conducted when companies did not cooperate. These recall authorities
may facilitate faster recalls and better protect consumers.

Agencies that have recall authority for other products include the
following:

23According to USDA, distribution lists obtained from a firm recalling a
meat or poultry product are considered proprietary information protected
from public disclosure. However, a USDA regulation authorizes limited
disclosure, under certain conditions, to states and other federal
government agencies to verify removal of a recalled food. 9 C.F.R. S:
390.9(2004).

o FDA, for infant formula, human biological products, medical devices and
radiation-emitting electronic products, human drugs, animal drugs, and
medicated animal feeds;24

o the Consumer Product Safety Commission, for many consumer goods; and

o the Department of Transportation's National Highway Traffic Safety
Administration, for motor vehicles, motor vehicle equipment, child safety
seats, and tires.

In addition, the Canadian Food Inspection Agency has recall authority for
foods sold in Canada.25

Table 2 compares USDA's and FDA's food recall authority with the authority
of agencies responsible for recall programs of other products we examined,
and appendix VI provides additional information for the programs we
examined.

24Some human biological products are approved for use through "new drug"
applications and are treated as human drugs for recall purposes. Likewise,
some human drugs are licensed under the same procedures as human
biological products and are treated as human biological products for
recall purposes.

25In April 1997, regulatory responsibility for food safety in Canada was
consolidated into a single agency, the Canadian Food Inspection Agency.

Table 2: Recall Authority of Selected Government Agencies

Authority to Authority to
Requirement to Authority establish impose
notify the to recall monetary
agency when a issue a requirements penalties or
company or seek
identifies a mandatory approve recall fines or
potentially recall
Products ordera
Agency covered unsafe product plans imprisonment

USDA Meat, poultry, egg No No No b products FDA Foods not exclusively No
No No b regulated by USDA

Animal feed No No No b

Source: GAO analysis of applicable laws and regulations.

aFor the purposes of this report, we define a "mandatory recall order" to
include the requirement to remove, repair, replace, or refund the cost of
a defective or unsafe product.

bNot applicable because no recall requirements exist.

cFDA's recall authority for licensed biological products is found in
section 351(d) of the Public Health Service Act (42 U.S.C. S: 262(d)) and
has not been elaborated on in implementing regulations.

dFDA's authority to assess civil monetary penalties depends on the nature
of the device violation. For example, penalties are authorized only for
significant or intentional failures to file required reports. 21 U.S.C. S:
333(g)(1).

eThe Consumer Product Safety Commission's jurisdiction does not cover
tobacco, motor vehicles and related equipment, pesticides, firearms,
aircraft, boats, food, drugs, medical devices, or cosmetics. 15 U.S.C. S:
2052(a)(1) (definition of "consumer product").

fWhile the manufacturer, retailer, or distributor may choose to repair,
replace, or refund the cost of the defective product, the Consumer Product
Safety Commission may require submission of a plan "satisfactory to the
Commission, for taking action...." 15 U.S.C. S: 2064(d).

gWhile the manufacturer may repair, replace, or refund the cost of
defective products, the National Highway Traffic Safety Administration may
order a manufacturer to take a specific action if the manufacturer's
remedy is determined to be inadequate. 49 U.S.C. S: 30120(e).

hThe applicable Canadian statute is general and there are no implementing
regulations. This information is largely based on our discussions with
Canadian officials.

As table 2 shows, in contrast to USDA and FDA, the other agencies we
examined, and FDA with regard to some products, have authority to order
recalls and to be notified about unsafe products. Specifically, they have
authority to (1) require a company to notify the agency when it has
distributed a potentially unsafe product; (2) order a recall; (3)
establish recall requirements; and (4) impose monetary penalties, or seek
fines or imprisonment, if a company violates the recall requirements.
These authorities are discussed below:

o Requirement that a company notify the agency when the company
identifies a potentially unsafe product. Companies manufacturing or
selling products regulated by some of the agencies we reviewed are subject
to stringent notification requirements. For example, companies that
manufacture consumer products, such as toys or appliances, must notify the
Consumer Product Safety Commission immediately, generally within 24 hours
of obtaining information that reasonably supports the conclusion that a
product could create an unreasonable risk of serious injury or death, such
as a toy that poses a choking danger to children. Also, if a manufacturer
of infant formula has information indicating that the formula it processed
does not contain the required nutrients or is otherwise adulterated, the
manufacturer must promptly notify FDA.

o Authority to order a company to conduct a recall if the company refuses
to do so voluntarily. Several agencies can order a company to conduct a
recall if the company refuses to do so voluntarily. For example, the
Canadian Food Inspection Agency, after determining that there are
reasonable grounds to believe that a product poses a risk to public
health, can order anyone selling, marketing, or distributing the food to
conduct a recall. The Canadian agency rarely has had to use its recall
authority. Agency officials told us that, as of April 2004, the agency had
used its mandatory authority for eight recalls since 1997. For the period
of 1997 through 2003, the agency reported that Canadian companies had
conducted 1,890 recalls.26 Likewise, FDA has authority to order recalls of
unsafe biological products and medical devices and has used this authority
in the past.

o Authority to establish recall requirements or approve recall plans,
including direct notification to consumers. Some agencies we reviewed have
authority to establish recall requirements, such as requiring direct
notification to consumers or prescribing a recall plan if voluntary
efforts are insufficient. For example, the National Highway Traffic Safety
Administration may require companies to speed up a recall or renotify
owners, purchasers, and dealers in a manner prescribed in regulation if it
determines that the initial notice was not effective. FDA has authority to
review the terms of a company's recall plan for recalls of medical devices
to ensure that the way the company proposes to fix the problem
sufficiently addresses the risk. If FDA determines that the company's
recall plan is insufficient, FDA can prescribe a recall plan that may
include repairing the device, replacing it, or refunding its cost. Also,
if FDA determines that a device recall is warranted, it must specify a
timetable for the recall and require periodic reports. In addition, for
infant formula, a recalling firm must submit to FDA in writing an
evaluation of the hazard, a recall strategy, and all recall
communications.

o Authority to impose monetary penalties or seek fines or imprisonment if
a company violates recall requirements. Most agencies we examined have the
authority to impose civil monetary penalties or seek fines or imprisonment
when companies either refuse to conduct recalls or fail to follow recall
requirements. For example,

26These recall counts are for the Canadian fiscal years 1997-98 through
2002-03. The Canadian fiscal year runs from April 1 through March 31.

failure to obey an FDA order to recall a biological product that poses an
imminent hazard to public health could result in monetary penalties of
$100,000 or more. Similarly, the Consumer Product Safety Commission can
impose monetary penalties of $7,000 for each product violation, up to
$1.65 million for related violations, if a company fails to notify the
commission promptly, in accordance with the applicable law and
regulations.

Officials in FDA, the Consumer Product Safety Commission, and the National
Highway Traffic Safety Administration, as well as Canadian officials, told
us that companies generally cooperate in recalls. Nonetheless, the
agencies have had to use the additional authority in some instances to
ensure that recalls are conducted promptly and completely.

USDA and FDA officials told us that while they believe companies generally
cooperate with food recalls, they recognize that in some instances,
recalls can be particularly challenging. For example, when the food
company has gone out of business or when the company is located overseas.

Conclusions USDA and FDA are responsible for ensuring the safety of the
food supply. While we recognize that they have limited recall authority,
we believe the agencies can do better in carrying out their food recall
programs. Consumers may be vulnerable to serious illness, hospitalization,
and even death, in part, because of weaknesses in USDA's and FDA's
programs for monitoring companies' recalls of unsafe food. Although no
single weakness may be directly linked to serious health consequences in
the recalls we examined, these weaknesses may have contributed to the
lengthy recall of unsafe food and, consequently, to relatively little
recovery of the food.

USDA and FDA could address these weaknesses-lack of time frames for
company actions, ineffective use of their data systems to monitor and
manage recalls, a verification system that does not ensure the timeliness
and completeness of a recall, and potentially ineffective consumer
notification-by modifying their existing programs. Indeed, with its new
risk-based, scientific verification procedures, USDA has taken positive
steps to improve its verification processes-the agencies' primary method
for ensuring an effective recall. FDA continues to rely on a flawed
process.

We are also concerned about the quality of data in FDA's Recall Enterprise
System-its official recall data system. FDA continues to maintain

information about food recalls in its unofficial data system. The two
systems do not contain the same information, which raises questions about
the validity and reliability of the official system and reports FDA issued
to Congress. Moreover, FDA's investment in developing the Recall
Enterprise System will not be entirely realized until the agency fully
implements it as the sole system for collecting and managing recall data.

We believe that addressing the problems we have identified could raise the
likelihood that recalled food will be removed from the marketplace more
promptly and completely. However, these corrective steps, while necessary,
will still leave fundamental vulnerabilities because the agencies lack
specific recall authority available to other agencies with consumer safety
responsibilities. Although we did not identify any instances in which
companies refused to carry out a food recall, such refusal is possible, as
Canada's experience has indicated. As in Canada, USDA and FDA may not need
this authority for most recalls, but if enacted, it would be available
when needed.

Matters for Congressional Consideration

To ensure that USDA and FDA have information and authority so they can act
quickly to remove potentially unsafe food from the marketplace and can
better protect consumers, we propose that Congress consider legislation
that would

o require a company to notify the responsible agency when it becomes
aware that a food it has distributed is unsafe and

o give USDA and FDA authority to (1) issue a mandatory recall order, (2)
establish recall requirements, and (3) impose monetary penalties or seek
fines or imprisonment for failing to follow food recall requirements.

Recommendations for To ensure that companies promptly and effectively
recall foods that may cause serious illness or death, we are making the
following five

Executive Action recommendations to the Secretary of Agriculture and the
Commissioner of FDA:

o revise agency guidance to recalling companies to include specific time
frames for notifying their customers, removing recalled food from the

marketplace, and providing the agencies with the names and locations of
customers that received the food;

o use agency data systems to routinely generate reports for recall
program managers so that they may monitor ongoing recalls and oversee
recall timeliness and effectiveness;

o track in their recall data systems the dates that companies (1) start
and finish notifying their customers, (2) provide the agency with the
lists of customers that received the food, and (3) start and finish
recovering the recalled food;

o track in their data systems the dates that the agencies start and
finish verification checks; and

o work jointly to determine what, if any, additional approaches are
needed for alerting consumers about recalls.

We also make the following four recommendations to the Commissioner of
FDA:

o revise guidance to agency staff to include risk-based time frames for
completing verification checks promptly;

o develop a sound methodology for district staff to verify that companies
have quickly and effectively carried out recalls;

o when tracking the amount of food recalled and recovered for individual
recalls, use the same units of measure to facilitate calculations of the
recovery rate; and

o direct the recall staff to use FDA's Recall Enterprise System as the
sole data system to capture recall information, manage food recalls, and
generate reports to Congress.

Agency Comments and We provided USDA and FDA with a draft of this report
for review and comment. We also provided segments of the draft describing
their

Our Evaluation respective recall authority and rules to the Consumer
Product Safety Commission, the National Highway Traffic Safety
Administration, and the Canadian Food Inspection Agency.

USDA stated that the report was generally factually correct. However, it
characterized as "alarmist" the report's statement that "Consumers may be
vulnerable to serious illness, hospitalization, and even death because of
weaknesses in USDA's and FDA's programs for monitoring companies' recalls
of unsafe food." We recognize that the cause of the illnesses,
hospitalizations, and deaths was contaminated food not the agencies'
programs. However, because the public is relying on USDA and FDA to
protect consumers from potentially unsafe food, it is important that the
agencies' recall programs be as effective as possible. As our report
points out, two large recalls in 2003 were associated with nearly 100
hospitalizations or serious illnesses and 8 deaths. Both of those recalls,
monitored by USDA, were expanded to more and more customers and,
therefore, it took some time to locate and recover the food. USDA's
Inspector General reported that during one of the two recalls, USDA's
field staff took longer than 4 months to complete their verification
checks. The Inspector General's report concluded that the department did
not identify and correct problems with the recall to maximize recovery and
take enforcement actions-potentially exposing consumers to unsafe meat.
USDA further said that it believes the new procedures adopted on May 24,
2004, will address most of the observed weaknesses we found in its food
recall program. As our report discusses, the new procedures do provide a
statistical, risk-based method that will provide greater assurance that
downstream customers are aware of recalls and that they have followed
instructions for removing food from the marketplace, and the procedures
include time frames for USDA to complete its verification checks. While
the new procedures should improve USDA's verification of recalls, it is
premature to tell whether they will address any other weaknesses we found
in USDA's recall program. Thus we continue to believe that our
recommendations-for (1) time frames for recalling companies' actions- to
encourage prompt recalls-and companies' disclosure of the locations where
they sent the food, (2) using routinely generated management reports from
the official recall data system, (3) tracking critical dates, or (4)
working with FDA on how best to alert consumers about recalls of food that
can cause serious illnesses-are needed to further strengthen the safety of
the food supply by providing for a more effective food recall system.
Finally, USDA said the report implies that the Consumer Product Safety
Commission's and the National Highway Traffic Safety Administration's
recall authorities and procedures offer better protection to consumers but
does not discuss how long those agencies work with companies before they
announce recalls. We did not independently evaluate the effectiveness of
the other agencies' recall programs nor did we imply that they were faster
or better. Our point in discussing those

programs is to show that they (1) have additional recall authority not
available to USDA and FDA for food and (2) have had to use their recall
authority. We also note that USDA has supported, as recently as late 2000,
proposed legislation that would have given the department the additional
recall authority that those other agencies have at their disposal, if and
when they need it.

FDA stated that our report did not demonstrate that FDA recalls were
lengthy because of system inefficiencies or that weaknesses in FDA's
recall process resulted in little recovery of food. We believe our report
accurately presents the current recall system's performance. The report
describes significant inefficiencies and weaknesses in FDA's verification
process that resulted in delays in identifying and correcting problems in
the recalls we examined. For example, in 3 of the 10 recalls we examined,
FDA took longer than its 20-day target for completion of verification
checks. In addition, FDA noted that, "companies are encouraged to initiate
action as soon as possible and strongly encouraged to issue press releases
within 24 hours of deciding to recall a product." FDA further stated that
its expectation of a recalling firm is immediate notification, timely
removal, and timely disposal. While such statements are appropriate, we
did not find that they were effective. Furthermore, FDA asserts that we
did not present evidence to support our point that information in its
unofficial recall database is inaccurate. Our concern is twofold. First,
maintaining two separate recall databases is an inefficient use of
resources, especially when FDA cited resource limitations as a factor for
not yet incorporating routine management reports in its Recall Enterprise
System. Second, since we identified inconsistencies in the information in
the two systems, the validity and reliability of the official system is in
question. FDA agreed with our recommendations regarding using the Recall
Enterprise System to generate routine management reports and eliminating
the duplicative recall database. However, it disagreed with our
recommendation regarding the need for specific time frames for companies'
actions and noted that it would be difficult to specify such time frames.
We believe time frames are critical to reinforce the urgency with which
companies need to act, particularly for Class I recalls where even 1 day's
delay can result in additional serious health consequences. Also, FDA sees
limited utility in our recommendations for recording the dates of company
and agency actions in its Recall Enterprise System. We continue to
maintain that these dates are essential for FDA to effectively monitor
ongoing recalls and assess actions to improve the timeliness of recalls.

USDA's written comments and our more detailed responses to them are in
appendix VII. FDA's written comments and our responses are in appendix

VIII. In addition, USDA, FDA, the Consumer Product Safety Commission, the
National Highway Traffic Safety Administration, and the Canadian Food
Inspection Agency provided technical comments, which we incorporated into
the report as appropriate.

As agreed with your offices, unless you publicly announce the contents of
this report earlier, we plan no further distribution until 30 days from
its issuance. At that time, we will send copies of this report to
interested congressional committees, the Secretary of Agriculture, the
Commissioner of Food and Drugs, and other interested parties. We will make
copies available to others upon request. In addition, the report will be
available at no charge on GAO's Web site at http://www.gao.gov.

If you or your staff have any questions about this report, please call me
at (202) 512-3841. Key contributors to this report are listed in appendix
IX.

Lawrence J. Dyckman Director, Natural Resources and Environment

Appendix I

Objectives, Scope, and Methodology

This report (1) examines the extent to which the U.S. Department of
Agriculture's (USDA) and the Food and Drug Administration's (FDA) recall
programs protect consumers from unsafe foods and (2) compares USDA's and
FDA's authority to conduct food recalls with the recall authority of
agencies responsible for the safety of other consumer products, such as
toys, medical devices, and automobiles. This report also provides
information on USDA's and FDA's efforts to identify and recall foods
associated with the December 2003 cow infected with bovine spongiform
encephalopathy (BSE), otherwise known as mad cow disease, found in
Washington State (see app. II) and information on a 2002 recall of ground
beef by a ConAgra plant in Greeley, Colorado (see app. III).

To determine the extent to which USDA and FDA recall programs have
adequately protected consumers from unsafe foods, we studied the agencies'
recall procedures and analyzed in depth agency actions during 20 recent
recalls-10 from USDA and 10 from FDA. The 20 we selected were ongoing in
fiscal year 2003 and were Class I recalls-that is, those with the
potential to cause serious illness or death. We systematically selected
recalls in order to cover (1) a wide range of food products, (2) different
types of contaminants, and (3) geographical locations. Priority was given
to large recalls of foods that were widely distributed. However, recalls
were not randomly selected and therefore are not statistically
representative of all food recalls conducted in fiscal year 2003. In
reviewing these 20 recalls, we examined USDA and FDA documents, including
verification records, and interviewed company and agency officials
responsible for monitoring them. In addition, we obtained USDA and FDA
aggregate recall data for 2003 and examined the reliability of information
in those systems. We also analyzed data from USDA's recall database and
relied on FDA to extract similar data from its recall data systems. We
obtained the computerized files for these recalls and summarized the Class
I recalls by year. Additionally, we interviewed USDA and FDA district and
headquarters officials responsible for maintaining their recall data
systems to determine how they collect recall information and add it to
their data systems.

To understand whether consumers are adequately informed of food recalls
and to get perspectives on measures that could affect the timeliness and
effectiveness of recalls, we interviewed representatives from the food
industry; trade associations; and consumer advocacy groups, including
Costco, the American Meat Institute, the Center for Science in the Public
Interest, and the Consumer Federation of America. To determine the amount
of product recovered per year for USDA, we relied on agency data to
compare the pounds of product distributed with the pounds of product

Appendix I
Objectives, Scope, and Methodology

recovered. To calculate the amount of product recovered for FDA in 2003,
we compared the database fields for "product distributed" and "product
recovered" for those recalls with identical units in the database fields.

To compare USDA's and FDA's authority to conduct food recalls with the
recall authority of agencies responsible for the safety of other consumer
products, such as toys, medical devices, and automobiles, we reviewed and
compared FDA's and other agencies' statutes and regulations. We identified
the agencies that have mandatory recall authority by conducting literature
and Internet searches and by asking officials at USDA and FDA. We also
reviewed the transcript of proceedings from the December 12, 2002, USDA
public meeting "Food Safety and Inspection Service Public Meeting-
Improving the Recall Process." We selected the following agencies and
products, which account for a substantial share of major consumer goods:

o FDA, for infant formula, human biological products, medical devices and
radiation-emitting electronic devices, human drugs, animal feed, animal
drugs, and medicated feeds;

o Consumer Product Safety Commission, for many consumer goods; and

o Department of Transportation's National Highway Traffic Safety
Administration, for motor vehicles, motor vehicle equipment, child safety
seats, and tires.

In addition, we included the Canadian Food Inspection Agency, which has
regulatory responsibility, including mandatory recall authority, for food
sold in Canada. We did not include the following agencies because they
have a narrower scope: the U.S. Coast Guard, for boats, boating equipment,
and floatation devices; the Environmental Protection Agency, for
pesticides and emission control devices; and the Department of Housing and
Urban Development, for manufactured housing.

To conduct our comparison, we first focused on USDA's and FDA's authority
to detain and seize unsafe food and then reviewed laws authorizing other
agencies to require companies to take specific recall actions. We also
examined the laws requiring manufacturers and other companies to notify
the appropriate agency when they become aware of unsafe products. To gain
insight on how different authorities are applied in practice, we
interviewed agency officials, using a standard set of questions, from
USDA's Food Safety Inspection Service; FDA's Centers for Food Safety and
Applied Nutrition, Biologics Evaluation and Research, Devices

Appendix I
Objectives, Scope, and Methodology

and Radiological Health, Drug Evaluation and Research, and Veterinary
Medicine; the Consumer Product Safety Commission; the National Highway
Traffic Safety Administration; and the Canadian Food Inspection Agency. We
compared the results of the legal review and interviews to identify
authority and related legal requirements of other agencies helpful in the
administration of recalls that are not available to USDA and FDA for food
recalls.

To examine the voluntary recall of beef products associated with the
December 2003 discovery of an animal infected with BSE, we analyzed the
distribution lists USDA collected from companies and the verification
checks it conducted to develop a diagram illustrating the location and
volume of recalled beef that reached different levels of the distribution
chain. We compared the distribution lists and verification checks to
identify how many customers listed on the distribution lists did not
receive the recalled beef and the number of customers not listed on
distribution lists that received the recalled beef. We interviewed USDA
and FDA staff involved with the recall to understand the timing of recall
actions and the challenges encountered during the recall.

To develop information on the 2002 recall of ground beef by a ConAgra
plant in Greeley, Colorado, we reviewed USDA's recall file and other
documents on the recall. We also met with the department's Office of
Inspector General and reviewed the Inspector General's September 2003
report.1

We conducted our review from May 2003 through August 2004 in accordance
with generally accepted government auditing standards.

1U.S. Department of Agriculture, Office of Inspector General, Great Plains
Region Audit Report: Food Safety and Inspection Service: Oversight of
Production Process and Recall at ConAgra Plant (Establishment 969), Report
No. 24601-2-KC (September 2003).

Appendix II

Federal Actions Associated with the Discovery of an Animal in the United
States Infected with BSE

On December 23, 2003, USDA announced that a cow in the state of Washington
had tested positive for BSE-commonly referred to as mad cow disease. This
appendix describes the actions USDA took to recall the meat and the
actions FDA took with respect to FDA-regulated products, such as animal
feed and cosmetics, made from rendered parts of the animal.

Beef Recall Was On December 9, 2003, the recalling company slaughtered 23
cows. USDA,

in accordance with its BSE surveillance policy at the time, took a sample
ofTriggered by a BSE-1 cow that was unable to walk, although the condition
of the tested cow is Positive Sample from now disputed. USDA did not
process the sample in its Ames, Iowa National One Cow Veterinary Services
Laboratory in an expedited manner because the cow

did not show symptoms of neurological disorder. USDA test results

indicated a presumptive positive for BSE on December 23, 2003.

Recall Begun in December 2003 Was Completed in March 2004

On December 23, 2003, after learning about the positive BSE test, USDA
headquarters notified the Boulder District Office, which is the field
office with jurisdiction over the recalling firm. The Boulder District
began gathering information about the recalling company's product
distribution. Field staff telephoned the recalling company and were
on-site at 7:00 p.m. The Boulder District initially thought 3 days of the
recalling company's production would have to be recalled, but further
examination of facility cleanup and shipping records revealed that it was
only necessary to recall 1 day of production. USDA recall staff convened
at 9:15 p.m. and discussed the science related to BSE and whether the
recalling company's cleanup practices were sufficient to limit the recall
to 1 day of production. Following USDA's determination to conduct a Class
II recall-that is, the beef posed a remote possibility of adverse health
consequences-USDA contacted the recalling company to discuss recall
details and the press release. The press release and Recall Notification
Report were released that evening.

On December 24, 2003, USDA's Food Safety and Inspection Service (FSIS)
sent inspectors to the recalling company's primary customers to obtain
secondary customer distribution lists and product shipping records. USDA
conducted 100 percent verification checks for this recall-it contacted
every customer that received the recalled meat. This level of verification
checks is well above the percentage of checks conducted by USDA district
offices for the Class I recalls we reviewed.

Appendix II
Federal Actions Associated with the
Discovery of an Animal in the United States
Infected with BSE

On December 26, 2003, USDA began checking the primary and secondary
customers of the recalling company that it was aware of, although the
entire product distribution chain was unknown. During the checks, USDA
tried to determine if the product was further distributed, and it used
verification checks to acquire distribution lists for secondary and
tertiary customers of the recalling company.

Verification checks continued until February 25, 2004. Three USDA
districts conducted these verification checks. The Boulder District
coordinated the checks and assigned checks to the Minneapolis District
Office for customers in Montana and to the Alameda District Office for
customers in California. USDA required that 100 percent of the primary
checks, 50 percent of the secondary checks, and 20 percent of the tertiary
checks be conducted on-site. According to USDA, more than 50 percent of
the secondary checks were actually conducted on-site. FDA officials helped
conduct verification checks. According to USDA, the recall took a long
time to complete because USDA contacted each customer at least twice. USDA
first contacted each customer to conduct the check and again to verify
product disposition.

On February 25, 2004, the Boulder District concluded that the recall was
conducted in an effective manner. On March 1, 2004, USDA's Recall
Management Division recommended that the agency terminate the recall, and
USDA sent a letter to the recalling company to document that USDA
considered the recall to be complete.

Recall Was Complicated by Inaccurate Distribution Lists and Mixing of
Potentially Contaminated and Noncontaminated Beef

USDA used distribution lists and shipping records to piece together where
the recalled product was distributed. According to USDA, one of the
recalling company's three primary customers was slow in providing its
customer list. USDA could not begin verification activities for that
primary customer without this list. Furthermore, some customers of the
recalling company provided USDA with imprecise lists that did not specify
which customers received the recalled product. As a consequence, USDA
could not quickly determine the scope of product distribution and had to
take time conducting extra research using shipping invoices to determine
which specific customers received the product.

Even when USDA determined the amount and location of beef, the agency
still had trouble tracking the beef in certain types of establishments,
such as grocery store distributors. USDA could not easily track the
individual stores where those distributors sent the beef because of
product mixing

Appendix II
Federal Actions Associated with the
Discovery of an Animal in the United States
Infected with BSE

and the distributors' record-keeping practices. Generally, distributors
purchase beef from multiple sources, mix it in their inventory, and lose
track of the source of the beef they send to the stores that they supply.
To deal with this problem, USDA first identified the dates when recalled
beef was shipped to the distributors and then asked for a list of the
stores that were shipped any beef after those dates. Consequently, some
stores were included in the recall that may never have received recalled
beef.

The recall was also complicated by repeated mixing of recalled beef with
nonrecalled beef, thereby increasing the amount of meat involved in the
recall. The recalling company slaughtered 23 cows on December 9, 2003, and
shipped those and 20 other carcasses to a primary customer on December 10,
2003. The recalling company's carcasses were tagged to identify the
slaughter date and the individual cow. The primary customer removed the
identification tags and mixed the 23 recalled carcasses with the 20
nonrecalled carcasses. Because the carcasses could not be distinguished,
the recall included all 43 carcasses at the primary customer. After one
round of processing at the primary customer, the meat from the carcasses
was shipped to two other processing facilities. Both establishments
further mixed the recalled meat from the 43 carcasses with meat from other
sources. In all, the mixing of beef from 1 BSE-positive cow resulted in
over 500 customers receiving potentially contaminated beef.

Imprecise distribution lists and the mixing of recalled beef combined to
complicate USDA's identification of where the product went. Specifically,
on December 23, 2003, USDA's initial press release stated that the
recalling company was located in Washington State. Three days later, on
December 26, 2003, USDA announced that the recalled beef was distributed
within Washington and Oregon. On December 27, 2003, USDA determined that
one of the primary customers of the recalling firm distributed beef to
facilities in California and Nevada, in addition to Washington and Oregon,
for a total of four states. On December 28, 2003, USDA announced that some
of the secondary customers of the recalling company may also have
distributed the product to Alaska, Montana, Hawaii, Idaho, and Guam, for a
total of eight states and one territory.

On January 6, 2004, over 2 weeks from recall initiation, USDA determined
that the beef went to only six states-Washington, Oregon, California,
Nevada, Idaho, and Montana-and that no beef went to Alaska, Hawaii, or
Guam. To reach that conclusion, USDA used the distribution lists, shipping
records, and sales invoices that it received from companies to piece
together exactly where the recalled beef may have been sent. The lists

Appendix II
Federal Actions Associated with the
Discovery of an Animal in the United States
Infected with BSE

showed that 713 customers may have received the recalled beef; 6 of those
may have received beef from more than one source. USDA determined that 176
customers on the lists did not actually receive recalled beef, including
the customers in Guam and Hawaii. USDA's review also indicated that
recalled beef was probably not shipped to Alaska or Utah, and USDA checked
2 retailers in Alaska and 3 retailers in Utah to confirm that was the
case. In total, USDA conducted verification checks on 537 of the 713
customers on the lists. USDA's initial checks identified an additional 45
customers that may have received the recalled beef that were not included
on the distribution lists, for a total of 582 verification checks. Figure
4 summarizes USDA's verification efforts during the recall.

Appendix II
Federal Actions Associated with the
Discovery of an Animal in the United States
Infected with BSE

Figure 4: USDA's Recall Verification Checks by Location and Customer Type
for Meat Associated with the Animal Infected with BSE

Source: GAO analysis of USDA verification check documents.

Note: USDA checked 15 primary, 40 secondary, and 526 tertiary customers
plus the recalling company, for a total of 582 verification checks.

USDA's press release stated that the recall involved 10,410 pounds of beef
products, and the USDA recall coordinator for this recall told us that
downstream processors mixed the recalled beef with nonrecalled beef, for a
total of more than 38,000 pounds of beef that was distributed at the
secondary customer level. According to USDA officials involved with the

Appendix II
Federal Actions Associated with the
Discovery of an Animal in the United States
Infected with BSE

recall, the precise amount of meat that was sold at the retail level is
unknown because retailers at the tertiary level further mixed nonrecalled
meat with potentially contaminated meat. USDA told us that more than
64,000 pounds of beef was ultimately returned or destroyed by customers,
and that, because of the mixing, it was not able to determine how much of
the original 10,410 pounds of recalled beef was contained in the 64,000
pounds that were recovered.

FDA's Role in USDA's Recall

Parts of the BSE-infected animal slaughtered on December 9, 2003, were not
used for food, but they were sent to renderers to be separated into raw
materials, such as proteins and blood. Rendered materials are used for
many purposes, including cosmetics and vaccines. FDA has jurisdiction over
renderers.

When USDA learned of the BSE-infected cow on December 23, 2003, the agency
immediately notified FDA. On December 24, 2003, FDA sent an inspection
team to a renderer that handled materials from the BSE cow. Inspectors
confirmed that the parts of the slaughtered BSE positive cow were on the
premises. FDA later identified a second company that potentially rendered
material from the slaughtered BSE cow. Both renderers agreed to
voluntarily hold all product processed from the diseased cow and dispose
of the product as directed by FDA and local authorities.

On January 7, 2004, 15 containers of potentially contaminated, rendered
material (meat and bone meal) were inadvertently loaded on a ship, and on
January 8, 2004, the ship left Seattle, Washington, for Asia. The renderer
initiated steps to recover the shipped material, so it could be disposed
of as directed by FDA and local authorities. The ship carrying the
material returned to the United States on February 24, 2004, and the
material was disposed of in a landfill on March 2, 2004.

On January 12, 2004, FDA asked both renderers to expand their voluntary
holds to rendered materials processed from December 23, 2003, through
January 9, 2004, because they may have rendered some recalled meat or trim
that was recovered from retail establishments. Both renderers agreed to
the expanded product hold. In total, FDA requested that renderers
voluntarily hold approximately 2,000 tons of rendered material. FDA
confirmed that none of the potentially contaminated, rendered material
entered commerce, because FDA accounted for all rendered material. FDA

Appendix II
Federal Actions Associated with the
Discovery of an Animal in the United States
Infected with BSE

reported that no recall was necessary because no product was distributed
commercially by the rendering companies.

USDA and FDA Worked Together on the Recall

USDA and FDA worked together in two ways. First, both agencies notified
each other if their investigations yielded any information about products
within the jurisdiction of the other agency. For instance, when conducting
the second round of verification checks, USDA tracked the disposition of
the product to renderers and landfills and notified FDA when the product
went to renderers. Second, FDA officials helped conduct verification
checks. FDA conducted 32 of the 582 verification checks (approximately 5
percent) for the USDA recall. Officials from both agencies indicated they
regularly interacted and shared information. Table 3 outlines the
agencies' actions.

Table 3: Detailed Timeline of USDA, FDA, and Company Actions Related to
the Discovery of an Animal Infected with BSE

Date USDA recall actions FDA actions Company actions
12/9/03 o USDA samples cow for o BSE cow is slaughtered.
BSE.
o Sample is sent to Ames,
12/11/03 Iowa, for BSE o Recalling company sends
testing. carcasses to primary
customer for
processing.
o Primary customer sends
12/12/03 meat
products to two other
primary
customers for further
processing.

12/12 - o Other primary customers distribute

12/23/03 recalled product to secondary customers.

o Secondary customers distribute recalled product to tertiary customers.

12/23/03 o BSE test results are o FDA notified of BSE test results.
presumptively
positive. o FDA dispatches investigation
teams.
o Recall meeting.
o Initiation of voluntary
recall.
o Press release.

12/24/03 o FDA inspects Renderer 1. o Recalling company contacts

o FDA determines some rendered primary customers. material from Renderer
1 is intended o Primary customers contact their for Indonesia.
customers.

o FDA discovers some material may have been sent to Renderer 2.

o Renderer 1 agrees to hold remaining rendered material.

Appendix II
Federal Actions Associated with the
Discovery of an Animal in the United States
Infected with BSE

(Continued From Previous Page)

Date USDA recall actions FDA actions Company actions
12/25/03 o USDA receives confirmation from
reference lab in England that cow in
question is BSE positive.

12/26/03 o Verification checks begin o FDA begins process of comparing

o USDA announces recalled product in records to ensure all products from
Washington State and Oregon. Renderers 1 and 2 are accounted for.

o Renderer 2 agrees to hold all material that may have been derived from
BSE cow. None of the rendered material has been distributed.

12/27/03 o USDA announces recalled product was o FDA issues statement
confirming that distributed in Washington State, the rendering plants that
processed Oregon, California, and Nevada. all of the nonedible material
from the BSE cow have placed a voluntary hold on all of the potentially
infectious product, none of which had left the control of the companies
and entered commercial distribution.

12/28/03 o USDA announces recalled product was distributed in Washington
State, Oregon, California, Nevada, Montana, Idaho, Alaska, Hawaii, and
Guam.

12/29/03 o Food Safety and Inspection Service determines that the
recalled meat products were distributed to 42 locations, with 80 percent
of the products distributed to stores in Oregon and Washington State.

12/31/03 o FDA offers assistance to USDA to complete recall verification
checks.

1/6/04 o USDA determines recalled product was only distributed in
Washington State, Oregon, California, Nevada, Montana, and Idaho.

1/8/04 o FDA is notified by the renderer o Rendering company notifies
that FDA of
some of the rendered material on shipment of product on hold.
hold from Renderer 1 was
inadvertently shipped to Asia.
Renderer 1 commits to isolate and
return the rendered material.

Appendix II
Federal Actions Associated with the
Discovery of an Animal in the United States
Infected with BSE

(Continued From Previous Page)

Date USDA recall actions FDA actions Company actions

1/12/04 o FDA advises Renderers 1 and 2 that they may have rendered meat
or trim subject to recall from retail stores.

o FDA requests Renderers 1 and 2 to place all rendered material from
December 23 to January 9 on hold.

o FDA determines neither renderer had shipped rendered material
manufactured after December 23, 2003.

2/9/04 o All rendered material was disposed of in landfill, except
material shipped to Asia.

2/24/04 o Ship carrying rendered material returns to U.S. port.

2/25/04 o Verification checks complete.

o USDA Boulder District Office concludes recall is effective.

3/1/04 o Recall is closed.

3/2/04 o FDA observes disposal in landfill of remaining rendered
material.

Source: GAO analysis of USDA and FDA information.

Appendix III

Information on a 2002 Recall of Ground Beef by a ConAgra Plant in Greeley,
Colorado

This appendix provides general information about the recall of 18 million
pounds of ground beef and beef products because of possible contamination
with E. coli O157:H7 by the ConAgra Beef Company (ConAgra) plant in
Greeley, Colorado, beginning in June 2002. USDA's Office of Inspector
General evaluated the effectiveness of the department's management and
oversight of the recall, issuing a report in September 2003.1 As a result,
we did not independently analyze the department's actions during this
recall.

Beginning in June 2002, at least 46 people in 16 states became ill from
contaminated meat. An epidemiological investigation by the Colorado
Department of Public Health and Environment and the Centers for Disease
Control and Prevention, confirmed that about 23 of those illnesses around
Colorado were from the same genetic strain of E. coli, which linked the
illnesses to the same source of contamination. Later testing confirmed
that beef from the ConAgra plant was the source of that contamination.

On June 30, 2002, ConAgra officials agreed to a voluntary recall of
354,200 pounds of ground beef that the company identified as having been
produced on May 31, 2002. FSIS's subsequent review of ConAgra records
showed that beef from the plant had been testing positive for E. coli
O157:H7 from April 12 through July 11, 2002. On July 18, the company
decided to expand the recall to include about 18 million pounds of ground
beef and beef trim. The expanded recall-one of the largest in U.S.
history-included fresh and frozen ground beef products produced from April
12 through June 29, 2002, and beef trimmings produced from April 12
through July 11, 2002. The Centers for Disease Control and Prevention
reported that the extent to which the recalled meat was repackaged and
distributed under other labels was unclear, potentially making it
difficult to identify the affected lots of beef by looking at the package.
According to USDA, about 3 million pounds (17 percent) of the recalled
beef was recovered.

USDA's Inspector General noted the following in 2003:

o USDA had imposed no specific requirements that plants keep production
or distribution records, which increased the difficulty USDA had in
tracking the distribution of the ground meat.

1U.S. Department of Agriculture, Office of Inspector General, Food Safety
and Inspection Service.

Appendix III Information on a 2002 Recall of Ground Beef by a ConAgra
Plant in Greeley, Colorado

o USDA did not review verification checks in time to maximize the amount
of recalled food that could be recovered, and the problems found during
those checks received limited management attention.

o Of the 490 verification checks that USDA conducted, 67 indicated that
companies in the downstream distribution chain had not been notified of
the recall. Although USDA confirmed that ConAgra notified its primary
customers of the recall, the agency took no action in the 67 cases where
it found that those customers had not notified others in the distribution
chain. These checks notwithstanding, USDA district office managers
determined that the recall was a success because to their knowledge, no
one consuming unrecovered product became ill.

o USDA conducted verification checks between July and November, 2002,
months after the recall began, with about 31 percent of checks in July, 42
percent in August, 20 percent in September, and 7 percent in October. Two
checks were performed in November.

Appendix IV

USDA and FDA Actions on the Recommendations We Made in 2000

As previously discussed in this report, our 2000 report1 on USDA's and
FDA's food recall programs recommended that USDA and FDA provide guidance
to companies with time frames for quickly initiating and carrying out food
recalls that involve potentially serious adverse health risks, including
procedures to expeditiously notify their distribution chains and alert the
public.

Our 2000 report also recommended that both USDA and FDA modify existing
recall data systems to include information on the timeliness of companies'
recall activities so that the agencies could determine whether companies
delay initiating and carrying out recalls. Both agencies acted on our
recommendations by implementing new recall data systems to help track
information about the recalls they monitor. USDA began using its new
system-Recall Web-in January 2001, and FDA began using its new
system-Recall Enterprise System-in November 2002. FDA's Recall Enterprise
System captures information on recalls of all FDA-regulated products,
including food and other products such as medical devices and drugs. As
table 4 shows, FDA implemented more of our recommendations than did USDA.

Table 4: USDA and FDA Actions on GAO's Recommendations to Modify Recall Data
Systems

Modify data systems to track the following dates and methods

Dates Methods

Company Agency Company
found requested Company Company Company Company used to Company
out
about company initiated notified notified completed notify used to
to
Agency problem initiate recall customers public recall customers notify
recall public
USDA No No Yes No No No Yes a
FDA Yes Yes Yes Yes Yes Yes Yes Nob

Source: GAO analysis of the USDA Recall Web and the FDA Recall Enterprise
System.

aRegardless of the public notification action taken by the recalling
company, FSIS will generally issue a press release for Class I and Class
II recalls. The agency also will post them on the FSIS Web site.

bAlthough FDA does not track this information in its data system,
companies generally use a press release to notify the public, and FDA
posts recall information on its Web site.

1GAO, 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).

Appendix IV USDA and FDA Actions on the Recommendations We Made in 2000

As table 4 shows, USDA did not add fields in its new data system for most
of the fields that we recommended, but its system does record the date the
company initiated a recall and the methods it used to notify its
customers. According to USDA recall staff, its system was designed to
create the letters they use to officially begin and end recalls. The
system does not track the agency's or company's actions. In contrast, FDA
added all but one of the fields we recommended.

Appendix V

Information on the 20 Food Recalls We Examined for 2003

We analyzed 20 recent recalls-10 from USDA and 10 from FDA. The 20 we
selected occurred in fiscal year 2003 and were among those with the
greatest potential to cause serious illness or death-Class I recalls.
Table 5 presents selected information on those recalls.

Table 5: Selected Information on the 20 Class I Food Recalls We Examined

Agency Agencyassigned recall number

Location of facility

Lead
district office Recalled food Reason for recall

Approximate amount recalled

Page 52 GAO-05-51 Food Recall Programs
Ashville, Fresh E. 320,000 Bronx, Chicken 26,400 Augusta, Ground E. 54,000 Elberton, Fully Hard Fresh E. ground Milwaukee, Fresh E. ground Minneapolis, Frozen E. 717,000 Fresh ready-to-eat Fresh ready-to-eat Napoleon, Canned 56,000 Crab Conestoga, Ice 14,916 New New San Smoked
USDA 107-2002 NY Albany ground coli pounds 001-2003 NY Albany frankfurters Listeria pounds 102-2002 GA Atlanta beef coli pounds 112-2002 GA Atlanta cooked piece 36,000 chicken plastica 086-2002 Milwaukee, Madison and coli 2,800,000 beef 091-2002 WI Madison and coli 568,000 beef 073-2002 MN Minneapolis ground coli pounds 090-2002 Franconia, and Listeria turkey and poundsb chicken 098-2002 Camden, and Listeria 4,200,000 turkey and chicken 008-2003 OH Chicago soup Cheesec pounds FDA Trainer, cakes Milkc 40,000 479-3 F-433-3 PA Philadelphia cream Peanutsc units F-502-3 Brooklyn, York Salted Botulinum 2,025 Downstate F-398-3 Farmingdale, York Salmonella 2,180 Downstate F-463-3 Salinas, Francisco Fresh-cut Listeria 5,622 lettuce Mukilteo, Seattle Packaged Listeria 218-3 sandwiches sandwiches Auburn, Seattle Alfalfa Salmonella 32,000 383-3 F-425-3 Clackamas, Seattle salmon Listeria 434
beef frozen of pounds WI frozen poundsb frozen pounds beef PA Philadelphia frozen 27,400,000 NJ Philadelphia frozen poundsb F-474/ PA Philadelphia pounds NY herring spores pounds NY Oregano pounds CA bagged cases F-207/ WA turkey 285,700 F-381/ WA sprouts pounds OR pounds

Appendix V Information on the 20 Food Recalls We Examined for 2003

(Continued From Previous Page)

Agency-
assigned Location Lead Approximate
recall
Agency number of facility district Recalled Reason for amount
office food recall recalled
F-185-3 Battle Detroit Packaged 730,000
Creek, MI breakfast Eggc packages
pastry
F-482-3 Barberton, Cincinnati Chocolate Excessive 490
OH milk amounts
of vitamins 1/2-gallon
A and D
containers

Source: GAO analysis of USDA and FDA data and documents.

aThe hard piece of plastic was considered to be foreign material.

bThis recall was expanded beyond the initial amount. The amount listed is
the final amount of recalled food.

CThis item is a potential allergen that was not declared on the food's
ingredient label.

Appendix VI

Recall Authority of Selected Government Agencies

This appendix provides additional explanation of the information
previously provided in table 2. It describes the requirements that
manufacturers and other companies must follow to notify agencies of unsafe
products and the authority of government agencies to recall products. The
regulatory functions and products under the jurisdiction of each agency
are discussed, followed by a description of the authority each agency has
to recall products, including required notification of unsafe products.

USDA's Food Safety and Inspection Service

USDA's FSIS is responsible for protecting the public from foodborne
illness by administering and enforcing the Federal Meat Inspection Act,
Poultry Products Inspection Act, and Egg Products Inspection Act. FSIS's
jurisdiction covers beef; pork; lamb; poultry; processed eggs; and other
products that contain meat or poultry, such as sausage, soups, stews, and
frozen pizzas or dinners. FSIS inspects individual products as well as
processing plants, tests for various types of food contamination,
establishes facility sanitation requirements, maintains a system of import
inspections and controls, prescribes labeling requirements, and develops
consumer education programs to keep the public informed on how to properly
prepare and store food. FSIS also monitors the effectiveness of voluntary
recalls to remove unsafe meat, poultry, and egg products from interstate
commerce.

FSIS does not have authority to issue a mandatory recall order or require
a company to follow certain recall procedures during a voluntary recall.
Nor are companies required to notify the agency when they identify a
potentially unsafe product. However, if a company refuses to recall a
product believed to be hazardous to the public health, FSIS may rely on
its authority to detain and seize it. If necessary, FSIS may detain meat,
poultry, or egg products for up to 20 days when there is reason to believe
they are adulterated or misbranded and may be used as human food. After
this period, a U.S. district court may be petitioned to authorize USDA to
seize and condemn the product. To encourage cooperation with a voluntary
recall, FSIS can withdraw inspectors or withhold the USDA "inspected and
passed" label, effectively shutting down a manufacturer, according to the
Secretary of Agriculture.1

1Testimony before the House Agriculture Committee, January 21, 2004.

Appendix VI Recall Authority of Selected Government Agencies

FDA's Center for Food Safety and Applied Nutrition

FDA's Center for Food Safety and Applied Nutrition, is responsible for the
safety of food not exclusively regulated by USDA.2 This includes food such
as fruits and vegetables, and infant formula. FDA shares jurisdiction with
USDA on foods such as eggs, (FDA is responsible for shell eggs while USDA
is responsible for egg products), sandwiches (depending on whether they
are open-faced or close-faced) and soups (depending on the quantity of
meat they contain). To ensure the safety of food under its jurisdiction,
center activities include regulation of certain food production facilities
and food labeling and the approval of food additives. The center also
conducts facility inspections, collects and tests food samples to detect
unsafe food, conducts research on emerging food safety issues, and
educates the public on proper food handling. If an unsafe food under its
jurisdiction enters the market, FDA may request a voluntary food recall
and issue a press release about the unsafe food.

With the exception of infant formula, FDA does not have explicit authority
to order food recalls. Instead, FDA relies on its authority to detain and
seize adulterated or misbranded foods. While adulterated or misbranded
products are subject to seizure through the courts with the assistance of
the U.S. Department of Justice, FDA may detain food for up to 30 days if
it has credible evidence or information that indicates the food presents a
threat of serious adverse health consequences or death to humans or
animals. FDA may also issue publicity about foods that present a danger to
public health. According to agency officials, companies usually conduct
voluntary recalls to avoid such adverse publicity.

For infant formula, however, FDA can require a manufacturer to conduct a
recall if FDA determines that the formula processed by the manufacturer
presents a risk to human health. An infant formula may present a risk to
human health if it does not provide the required nutrients or is otherwise
adulterated or misbranded. Manufacturers that have knowledge that
reasonably supports the conclusion that their formula may not contain the
required nutrients, or otherwise may be adulterated or misbranded, must
promptly report this information to FDA, which then will determine whether
the infant formula presents a risk to human health. Reports are also
required if there is a reasonable possibility of a causal relationship
between the consumption of the company's infant formula and infant

2FDA's Center for Food Safety and Applied Nutrition also has regulatory
responsibility for cosmetics, medical foods, and dietary supplements.

Appendix VI Recall Authority of Selected Government Agencies

death. When a company conducts a recall, it must provide information to
FDA by telephone about the infant formula within 24 hours. Within 14 days
after the recall has begun, the manufacturer must provide a written report
to FDA and at least every 14 days thereafter until the recall is
terminated. The manufacturer also must request each retail establishment
at which such formula is sold or is available for sale to post a notice of
the recall. Failure to comply with the notification, reporting, or
posting-request requirements are prohibited acts punishable by
imprisonment, a fine, or both.

The Public Health Security and Bioterrorism Preparedness and Response Act
of 2002 includes a number of provisions that establish new requirements
for those engaged in the food business and gives new authority to FDA to
take action to protect the nation's food supply. These new requirements
and powers include registration of food facilities, administrative
detention of food believed to be unsafe, maintenance of and access to
certain records, and notification of food imports prior to arrival.3

FDA's Center for FDA's Center for Biologics Evaluation and Research is
responsible for

ensuring the safety and effectiveness of biological products, such as
bloodBiologics Evaluation and vaccines. The center also regulates human
tissue intended for and Research transplant to prevent the transmission of
communicable disease.4 To

achieve its goals, the center reviews and approves biologics for
licensing, inspects the conditions of facilities manufacturing biological
products, regulates biological product quality, and conducts research to
support these programs.

3Pub. L. No. 107-188, 116 Stat. 594, S:S: 303, 305-07(2002).

4FDA has issued regulations that apply to human tissue establishments or
persons engaged in the recovery, screening, testing, processing, storage,
or distribution of human tissue. Human tissue determined to be in
violation of these regulations may be recalled. 21 C.F.R. S:
1270.43(2004).

Appendix VI Recall Authority of Selected Government Agencies

Reports of adverse events associated with biological products can help
identify whether a recall may be necessary. Manufacturers must report to
FDA if they become aware of adverse experiences associated with their
products. Such information may come from a number of sources, including
commercial marketing experience, postmarketing clinical investigations,
and scientific literature. Vaccine manufacturers and health care providers
are also required to report certain reactions associated with the
administration of routinely recommended childhood vaccines.5

The Public Health Service Act authorizes FDA to issue an order to recall a
licensed biological product after determining that it presents "an
imminent or substantial hazard to the public health...."6 Recalls must be
carried out in a manner consistent with the FDA order and pertinent
regulations. Violation of the recall requirements could result in monetary
penalties of $100,000 or more per day of violation, fines, and
imprisonment.

FDA's Center for Devices and Radiological Health

FDA's Center for Devices and Radiological Health is responsible for
ensuring the safety and effectiveness of medical devices and preventing
unnecessary human exposure to radiation from electronic products. The
center has regulatory jurisdiction over medical devices, such as heart
pacemakers and electronic thermometers, as well as radiation-emitting
electronic products, such as microwave ovens, infrared alarm systems,
ultraviolet tanning lamps, and lasers. The center evaluates and approves
certain devices for clinical trials and marketing, regulates manufacturing
practices, sets performance standards, conducts postmarket surveillance of
product performance, provides technical assistance to small manufacturers,
and educates the public.

Medical device manufacturers and importers must report device-related
deaths or serious injuries, as well as certain product corrections and
market removals to FDA, and importers must report these events to the
manufacturer(s). User facilities must report deaths that may have been
caused by the use of a medical device to FDA and the manufacturer, if

5FDA has proposed to require adverse event reporting for human tissue
products. See Current Good Tissue Practice for Manufacturers of Human
Cellular and Tissue-Based Products; Inspection and Enforcement, 66 Fed.
Reg. 1508 (proposed Jan. 8, 2001)(to be codified at 21 C.F.R. pt. 1271).
The agency is working on the final rule.

642 U.S.C. S: 262(d)(1).

Appendix VI Recall Authority of Selected Government Agencies

known. Device-related serious injuries must be reported to the
manufacturer or to FDA if the manufacturer is unknown.

FDA is authorized to order two types of recalls for medical devices: a
"repair, replacement, or refund" order and a recall order.7 The first type
may be initiated if (1) a device presents an unreasonable risk of
substantial harm to the public health, (2) there are reasonable grounds to
believe that the device was not properly designed or manufactured, (3)
there are reasonable grounds to believe that the risk is not due to
improper use or care, and (4) notification of the risk would not be
sufficient to eliminate it.

If a device meets these criteria, FDA may order the manufacturer,
importer, or distributor, or any combination of the three, to submit a
plan to repair or replace the device or to refund the purchase price. The
plan may not include a charge to anyone seeking a remedy, except
manufacturers, importers, distributors, or retailers, where there are
reasonable grounds to believe that the person or entity in question is
eligible for a remedy. It must also provide for reimbursement of the
reasonable and foreseeable expenses associated with obtaining repair,
replacement, or refund. If a plan is unsatisfactory, FDA may prescribe a
plan.

If there is a reasonable probability that a device would cause serious
adverse health consequences or death, FDA must issue an order requiring
the appropriate parties to immediately (1) cease distribution and (2)
notify health professionals and device user facilities of the order and
instruct them to stop using the device. After providing an opportunity for
an informal hearing, FDA may amend the order to require a recall of the
device specifying a time table for completion and periodic reporting. Such
recall orders do not include recall of devices from individuals, although
individuals subject to the risks associated with the recalled devices are
required to be notified.

FDA is authorized to require manufacturers to adopt a method of device
tracking for certain medical devices. According to FDA, this authority may
be used to facilitate recalls. Tracking orders may be issued for devices
(1) that if they failed, would be reasonably likely to cause serious
adverse

7Electronic products are treated separately and subject to repair,
replacement, or refund if they have a safety defect relating to the
emission of electronic product radiation or fail to comply with certain
performance standards. Failure to comply with the applicable requirements
may result in penalties as large as $300,000.

Appendix VI Recall Authority of Selected Government Agencies

health consequences, (2) that are intended to be implanted in the body for
more than a year, or (3) that are life-sustaining or life-supporting and
used outside a device user facility.

Failure to comply with requirements or orders could result in penalties up
to $15,000 per violation, not to exceed $1 million for all violations in a
single proceeding; fines; and imprisonment.

FDA's Center for Drug Evaluation and Research

FDA's Center for Drug Evaluation and Research is responsible for ensuring
the availability of safe and effective prescription and over-the-counter
drugs for the American people. To ensure that drugs are safe and effective
before they reach the market, the center reviews new drug applications and
establishes manufacturing, product quality, and labeling standards. The
center also conducts postmarket drug safety surveillance, collects samples
of and analyzes drugs to help make sure they are safe and effective,
administers a postmarket adverse drug experience program in an effort to
identify potentially unsafe drugs, and provides consumers with the
information they need to use drugs appropriately and safely.

Unlike foods, drugs must go through premarket approval and must be
determined to be safe and effective before they can be marketed. Even
after they are marketed, questions may arise regarding their safety or
effectiveness. FDA may become aware of such concerns through adverse event
reporting. Generally, manufacturers and others are required to report
serious and unexpected adverse drug events to FDA within a certain time
frame. FDA may use this information to determine whether particular drugs
should continue to be marketed. Those who fail to make the required
adverse event reports are subject to fines and imprisonment.

While FDA does not have the authority to issue a recall order for drugs
determined to be unsafe or ineffective,8 it may immediately suspend and
propose to withdraw the New Drug Application approval for such drugs if
they are found to constitute an "imminent hazard."

8For human drugs regulated using a biologics license application, FDA has
express statutory recall authority. However, FDA has not developed
implementing regulations.

Appendix VI Recall Authority of Selected Government Agencies

FDA's Center for Veterinary Medicine

FDA's Center for Veterinary Medicine regulates the approval, manufacture,
and sale of animal drugs and feeds containing animal drugs. FDA may become
aware of information concerning the safety and effectiveness of animal
drugs and medicated feeds through the reporting of adverse reactions
associated with them. Manufacturers of animal drugs are required to report
serious and unexpected adverse drug events to FDA within a certain time
frame whether administered directly or through feed. Those who fail to
make the required reports may be subject to fines and imprisonment.

FDA's Center for Veterinary Medicine does not have authority to issue a
recall order if any of these products are found to be unsafe or
ineffective. However, the center may propose to withdraw marketing
approval for such drugs or propose to revoke the license of the medicated
feed manufacturer if certain conditions are not met. If the drug or
medicated feed poses an imminent hazard to human health or the animals for
which it is intended, the Secretary of Health and Human Services may
immediately suspend the drug's marketing approval or the feed
manufacturing license.

Consumer Product
Safety Commission

The Consumer Product Safety Commission (CPSC) is charged with protecting
the public from unreasonable risks of serious injury or death from over
15,000 types of consumer goods. Consumer goods generally fall under the
regulatory jurisdiction of CPSC, with the exceptions of motor vehicles and
motor vehicle equipment, food, human and animal drugs, aircraft, boats,
tobacco, firearms, cosmetics, pesticides, and medical devices. To help
protect consumers from unsafe products, CPSC develops and enforces product
safety standards; administers recalls-which may include repair,
replacement, or refund-of certain hazardous products; evaluates the safety
of products; bans unsafe products; conducts research on the safety of
products; and educates consumers.

Companies are required to notify CPSC immediately (generally within 24
hours) after obtaining information that reasonably supports the conclusion
that a product violates a product safety ban or standard, the product
contains a defect that could create a substantial product hazard or
creates an unreasonable risk of serious injury or death. The staff
verifies the defect or hazard and assists the company in developing a
remedy. According to CPSC officials, virtually all recalls are conducted
voluntarily without the need for litigation. If the commission determines
that notification of the public about a product defect or failure is
necessary, and the company does

Appendix VI Recall Authority of Selected Government Agencies

not cooperate, the law provides for a hearing. After a hearing, CPSC may
order the affected companies to give such notice publicly and through the
mail to manufacturers, distributors, retailers, or individual consumers.
Manufacturers also must notify CPSC if a product is the subject of three
or more settled civil actions or adjudicated civil actions, in favor of
the plaintiff, alleging death or grievous bodily injury-over a 2-year
period. The company must report to CPSC within 30 days of final settlement
or judgment in the third case.

Companies selling goods that a CPSC technical review finds to present
"substantial product hazards" may be ordered to conduct a recall or
develop a plan that provides for repair, replacement, or refund for the
product in question. CPSC is authorized to review and approve any plan.
Products that a U.S. district court determines to be imminently hazardous
are subject to injunction and seizure. In such cases, relief may include
notification of the risk to purchasers, public notice, recall, repair,
replacement, refund, or condemnation. If someone knowingly fails to comply
with the reporting, or a notification or recall order, CPSC may assess
civil monetary penalties of $7,000 per violation up to $1.65 million for a
related series of violations.9

Department of Transportation's National Highway Traffic Safety
Administration

The National Highway Traffic Safety Administration (NHTSA), an agency
within the Department of Transportation, is charged with a number of
responsibilities, including reducing deaths and injuries resulting from
motor vehicle traffic accidents, establishing motor vehicle safety
standards, administering motor vehicle and highway safety grant programs,
securing and analyzing data to learn about safety trends, and monitoring
the recall of defective products. Its jurisdiction covers motor vehicles
and equipment, including tires and child safety seats.

9Maximum civil monetary penalties were last revised for inflation in 1999
and are required to be revised again later in 2004. See Notice of Adjusted
Maximum Civil Penalty Amounts, 64 Fed. Reg. 51963(1999); 15 U.S.C. S:
2069(a)(3).

Appendix VI Recall Authority of Selected Government Agencies

NHTSA may become aware of problem products either through its own research
or testing, or by notification from manufacturers or consumers.
Manufacturers of motor vehicles or replacement equipment must notify NHTSA
within 5 working days if the manufacturer decides that its products
contain a defect related to motor vehicle safety or violate a motor
vehicle safety standard.10 Owners, purchasers, and dealers must also be
notified within a reasonable time and are entitled to remedies-which may
include repairs, replacement, or refunds of the defective or noncompliant
product-without charge. If there is insufficient customer response after
the initial notification, NHTSA may order the manufacturer to send out a
second notification in a manner prescribed by regulation. The
manufacturer's program to remedy the defect or noncompliance must be filed
with NHTSA, which then makes it available to the public. If NHTSA decides
that a manufacturer has not reasonably met the remedy requirements, it may
order specific action. Failure to provide notification or a proper remedy
may result in a civil monetary penalty of up to $5,000 for each violation,
up to $15 million in total for a related series of violations.

Canadian Food Inspection Agency

The Canadian Food Inspection Agency (CFIA), created in April 1997, is
Canada's science-based regulator for food safety, animal health, and plant
protection. Its responsibilities include activities that had been divided
among four Canadian government departments. It is responsible for the
administration and enforcement of 13 Canadian laws and their respective
regulations. Through the delivery of inspection and other related
services, which include inspection of food-processing facilities, analysis
of food samples for impurities, inspection of international food products
and animals, and evaluation of the safety of animal feeds and vaccines,
the agency verifies compliance with these laws. Critical to the effective
delivery of the CFIA's responsibilities is the ongoing design and
development of inspection-related tools and processes, which include the
continual review of regulations and policies and the implementation of new
science-based inspection methodologies.

The CFIA also coordinates food recalls across Canada and posts
publications of food recalls on its government Web site. According to

10Manufacturers of motor vehicles or motor vehicle equipment must notify
NHTSA within 5 working days after determining to conduct a safety recall
or other safety campaign in a foreign country on vehicles or equipment
that are identical or substantially similar to ones sold in the United
States. 49 U.S.C. S: 30166(l).

Appendix VI Recall Authority of Selected Government Agencies

agency officials, although companies are not required by statute to notify
the CFIA when they identify potentially unsafe products, the CFIA
encourages and assists companies in the coordination of food emergency
responses on a 24-hour basis. The CFIA Web site also has manuals and
checklists for companies to structure food safety emergency response
policies.

CFIA officials told us that although companies generally cooperate in
recalls, the CFIA has mandatory recall authority that it may use in cases
where cooperation is not forthcoming and a recall must be done promptly
and completely. Section 19 of the Canadian Food Inspection Agency Act
provides that the Minister of Agriculture and Agri-Food may order a recall
of a particular product where there are reasonable grounds to believe that
the product poses a risk to public, animal, or plant health. A recall
order under this section applies to anyone who sells, markets, or
distributes the product, and violation of a recall order may result in a
fine of up to $50,000 and imprisonment.11

11The applicable Canadian statute is general and there are no implementing
regulations. This information is largely based on our discussions with
Canadian officials.

Appendix VII

Comments from the U.S. Department of Agriculture

Note: GAO comments supplementing those in the report text appear at the
end of this appendix.

See comment 1.

See comment 2.

Appendix VII
Comments from the U.S. Department of
Agriculture

See comment 3.

See comment 4.

See comment 5.

See comment 6.

Appendix VII
Comments from the U.S. Department of
Agriculture

See comment 7.

Appendix VII
Comments from the U.S. Department of
Agriculture

The following are GAO's comments on the U.S. Department of Agriculture
letter received August 31, 2004.

GAO Comments 1.

USDA believes the new recall directive adopted May 24, 2004, will address
most of the observed weaknesses we found in its food recall program. As
the report already noted, the new directive does provide a statistical,
risk-based method that will give greater assurance that downstream
customers are aware of recalls and that they have followed instructions
for removing food from the marketplace, and the directive includes time
frames for USDA to complete its verification checks. However, although the
directive includes general procedures to, among other things, determine
the need for a recall and the actions the agency expects the company to
take to ensure maximum recovery in the shortest amount of time, the
procedures do not provide specific time frames as guidance to the
companies. In particular, the new directive does not address our
recommendations that USDA (1) set time frames for recalling companies'
actions-to encourage prompt recalls-including time frames for companies to
disclose the locations where they sent the food, (2) use routinely
generated management reports from the official recall data system, (3)
track critical dates, and (4) work with FDA on how best to alert consumers
about recalls of food that can cause serious illnesses. While the new
directive should improve USDA's verification of recalls, we believe it is
premature to say whether it will address any other weaknesses we found in
USDA's recall program.

USDA believes that our recommendations regarding additional data
collection and report generation may be a burden to the agency, overly
prescriptive, and costly to industry and USDA. We continue to believe that
our recommendation is sound. Our review of specific recalls disclosed that
inspectors generally are already capturing the additional data, such as
the dates that the company started and completed the recall, in their
paperwork. Our recommendations would have USDA systematically capture this
information and other critical information in its Recall Web database to
help the department better manage its recall program. With respect to
routine management reports, both headquarters and district offices need
routine reports to carry out their oversight responsibilities. Now that
recalls are run and coordinated directly from the district offices, under
the May 2004 procedures, it is particularly important for headquarters to
be able to monitor the recall activities of USDA's 17 different district
offices to ensure the new

Appendix VII
Comments from the U.S. Department of
Agriculture

procedures are uniformly implemented. Finally, with respect to the cost to
industry, companies are already legally required to maintain distribution
information. Our recommendation speaks to instances where USDA district
staff told us they received broad customer lists instead of the specific
locations where the recalled food was sent.

3.
We recognize that USDA uses press releases and Web postings to notify the
public after it learns about a recall. Our recommendation that USDA and
FDA work jointly to determine what, if any, additional approaches are
needed for alerting consumers addresses the situation in which consumers
may not see the press release or Web posting and therefore may consume
recalled food that is in their home.

4.
We agree that the purpose of a recall is to remove potentially harmful
food from commerce and alert consumers to potential risks of consumption.
Consequently, the report defines "recovery" to include food that is
returned or disposed of by firms in the distribution chain. That is, food
that is removed from commerce. We revised the report to reflect that the
recovery rate is an important indicator of a successful recall, rather
than the purpose of a recall. As we note in the report, we remain
concerned about how effectively the agencies are alerting consumers to
potentially harmful foods that may be in their homes.

5.
We recognize that the cause of the illnesses, hospitalizations, and deaths
was contaminated food, not the agencies' programs. However, because the
public is relying on USDA and FDA to protect consumers from unsafe food,
it is important that the agencies' recall programs be as effective as they
can. As appendix III discusses, USDA's Inspector General reported that
during one of the two recalls we mentioned that involved illnesses and
deaths, USDA's field staff took longer than 4 months to complete their
verification checks. The Inspector General's report concluded that the
department did not identify and correct problems with the recall to
maximize recovery and take enforcement actions-thereby potentially
exposing consumers to the unsafe meat. Therefore, we believe our report's
presentation is fair and consistent with the facts.

6.
With respect to the recall authority of other agencies, we sought to show
that other agencies have recall authority and have had to use that
authority. We did not evaluate those recall programs nor did we imply that
they were faster or better. For example, FDA currently has explicit recall
authority for infant formula and certain other products that the

Appendix VII
Comments from the U.S. Department of
Agriculture

agency regulates and has had to use that authority. In comments on our
August 2000 report on USDA's and FDA's recall programs, USDA told us that
it has supported proposed recall legislation that specifically included
"civil penalties, mandatory recall authority, mandatory
notification...when contaminated meat or poultry may enter the market."
USDA noted that, for the most part, the voluntary system works but that
mandatory authority would provide "an insurance policy guaranteeing that
consumers will be protected from potentially dangerous meat or poultry
without delay." Moreover, because the President has identified the food
supply as at risk for intentional contamination, such authority is
important. Finally, USDA's suggestion that mandatory recall authority
could conceivably slow the recall process was not raised as an issue by
any of the agencies we cite. Rather, they saw their recall authority as a
useful tool-not a replacement for voluntary recalls-when companies are
slow or uncooperative and consumers are at risk.

7.
We revised the report to include a statement that USDA is considering
additional options to help consumers identify recalled foods in their
homes.

Appendix VIII

Comments from the Food and Drug Administration

Note: GAO comments supplementing those in the report text appear at the
end of this appendix.

Appendix VIII
Comments from the Food and Drug
Administration

See comment 1.

See comment 2.

See comment 3.

Appendix VIII
Comments from the Food and Drug
Administration

See comment 4.

Appendix VIII
Comments from the Food and Drug
Administration

See comment 5.

See comment 6.

Appendix VIII
Comments from the Food and Drug
Administration

The following are GAO's comments on the Food and Drug Administration
letter dated August 27, 2004.

GAO Comments 1.

FDA believes that Class I recall actions were not lengthy because of
system inefficiency, and that the relatively small percentage of recalled
food that is recovered is not a result of weaknesses in FDA food recall
processes. While we do not believe that these are the sole reasons why
FDA's recalls may be slow or result in low recovery, we do believe that
its system and processes are contributing factors. As FDA pointed out, the
most significant stage of a recall is the initial action the recalling
company takes to notify the public and its customers to have the food
removed from the marketplace, with the assistance of FDA investigators
and/or district recall coordinators. However, FDA staff from several
district offices told us that companies sometimes conduct recalls without
contacting FDA and therefore without the benefit of FDA assistance. Our
report does note that FDA encourages companies to initiate promptly when
deciding to recall a product and that companies usually agree to carry out
recalls. That notwithstanding, FDA staff told us that, in some instances,
they had to place considerable pressure on companies before they
"voluntarily" conducted the recall. In addition, as our report points out,
FDA's verification process serves a critical function in recalls-to
identify and correct problems with recall notification and product
removal-a process that does not consistently meet FDA's timeliness
guidelines.

As FDA states, the recall completion date reflects the amount of time that
the recalling company took to complete all actions related to the recall
effort. We agree that this time can vary significantly depending on the
particular circumstances of the recall. However, we continue to believe,
as we stated in our 2000 report, that it is important to document the
completion date as an important indicator for FDA's recall managers to
assess the overall promptness of company actions to protect consumers from
unsafe food in the marketplace.

We did not assess the reliability or validity of the unofficial database
maintained by FDA's Center for Food Safety and Applied Nutrition. However,
we are concerned that the information in FDA's official database-the
Recall Enterprise System-was not the same as information in the center's
database. FDA comments state that the differences we found are the result
of information in the pilot database that preceded the Recall Enterprise
System. We did not compare

Appendix VIII
Comments from the Food and Drug
Administration

information in the pilot database. Rather, we compared information in the
Recall Enterprise System and the center's database for such dates as when
the recalls started and when they were classified by risk. We continue to
believe that these differences reflect potential weaknesses in the
reliability and validity of FDA's official recall database.

4.
FDA believes that it would be difficult to specify workable time frames to
companies, and that such time frames may serve no better purpose than
current procedure to have recall notifications and press releases issued
as soon as possible. We continue to believe that more specific time frames
are needed as guidance to industry. This is particularly important for
Class I recalls, which pose serious health risks, where even a day's delay
may have adverse health consequences. FDA also states that firms are
advised about time frames via a letter. However, for the 10 recalls we
examined in detail, FDA sent this letter between 26 and 213 days after the
company initiated the recall. According to FDA officials, it is commonly
FDA's practice to send the letter at the end of the recall. Therefore, we
do not believe the letter serves as a timely means of instructing the
recalling company to act quickly.

5.
We agree that data should only be captured if they provide useful
information to recall program managers. As FDA states, "the most
significant stage of a recall is the initial action taken by the recalling
[company] to notify its [customers]...of the product recall and have the
product removed from the marketplace." We therefore believe that the
Recall Enterprise System should capture those critical dates so field
staff can monitor ongoing recalls and headquarters recall managers can
determine how much time elapses between critical steps of the recall
process and take steps to reduce time frames, to the extent possible.

6.
FDA believes that data available on recalled food may not include
individual product or case breakdown. While capturing details about the
amount recalled and amount recovered may not always be possible, we
believe that FDA field staff should be instructed to take care that, when
such information is available, it be captured in the Recall Enterprise
System using comparable units.

Appendix IX

GAO Contacts and Staff Acknowledgments

GAO Contacts
Lawrence J. Dyckman, (202) 512-3841 J. Erin Lansburgh, (202) 512-3017

Staff
In addition to those named above, Terrance N. Horner, Jr.; Julian Klazkin;
Lynn Musser; Jennifer Popovic; Julia A. Roberts; Carol Herrnstadt

Acknowledgments
Shulman; Joseph Thompson; and Jonathan Weiss made key contributions to
this report.

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