GAO

United States General Accounting Office

Report to Congressional Requesters

August 2000 FOOD SAFETY

Actions Needed by

USDA and FDA to

Ensure That

Companies Promptly

Carry Out Recalls

GAO/RCED-00-195

Page 1 GAO/RCED-00-195 USDA and FDA Food Recalls

Contents

Letter 3

Appendixes Appendix I: Scope and Methodology 24

Appendix II: Selected Information on USDA’s and FDA’s Recall

Programs 26

Appendix III: Bacterial and Viral Contaminants Identified in Recalls

Associated With Outbreaks of Foodborne Illnesses 36

Appendix IV: Cases in Which FDA Believed Companies Delayed

Initiating a Recall 37

Appendix V: Two Class I Recalls in Which USDA Appeared to be

Slow and/or Indecisive 39

Appendix VI: Comments From the U.S. Department of Agriculture 40

Appendix VII: Comments From the Department of Health and Human

Services 43

Related GAO Products 48

Tables Table 1: USDA- and FDA-Documented Food Recalls Since 1984 and

Recalls Associated With Outbreaks of Foodborne Illness

Identified by the Agencies 8

Table 2: Contaminants Identified in the Recalls Associated With

Foodborne Illness Outbreaks 12

Table 3: Foods in Recalls Associated With Foodborne Illness

Outbreaks 12

Table 4: Category of FDA Recalls, Fiscal Years 1997 Through 1999 31

Figures Figure 1: USDA’s and FDA’s Classification by Potential Risk

Since 1984 10
Page 2 GAO/RCED-00-195 USDA and FDA Food Recalls

Abbreviations

CDC Centers for Disease Control and Prevention

CFSAN Center for Food Safety and Applied Nutrition

FDA Food and Drug Administration

HACCP hazard analysis and critical control point

ORA Office of Regulatory Affairs

USDA U.S. Department of Agriculture
Page 3 GAO/RCED-00-195 USDA and FDA Food Recalls

United States General Accounting Office

Washington, D.C. 20548

Resources, Community, and

Economic Development Division

B-285727 Letr

August 17, 2000

The Honorable Tom Harkin

Ranking Minority Member

Committee on Agriculture, Nutrition, and Forestry

United States Senate

The Honorable Lynn Rivers

House of Representatives

The Centers for Disease Control and Prevention (CDC) estimates that

approximately 76 million people suffer from foodborne illnesses and 5,000

die from these illnesses in the United States each year. While many

foodborne illnesses may be caused by poor food handling and preparation,

they may also be caused by eating contaminated or adulterated foods, or

foods whose labels do not identify potential allergens. To reduce the

number of foodborne illnesses from contaminated, adulterated, and

mislabeled foods that may be on the market, manufacturers can recall food

that poses a risk of illness or injury. Problems warranting a recall may be

identified by the manufacturer, a state or local health department, the U.S.

Department of Agriculture (USDA), the Food and Drug Administration

(FDA), CDC, or consumers. The types of problems and risks associated

with food recalls vary. For example, a food contaminated with bacteria,

such as E. Coli 0157:H7, may cause serious illness, even death, while a food

that contains more water than specified on its label would present no

imminent health risk.

USDA has a program in place to assist, coordinate, and track recalls that

involve USDA-regulated meat and poultry products, such as ground beef

and chicken. FDA operates a program to assist, coordinate, and track

recalls involving all other foods, such as fruit juices and alfalfa sprouts.

USDA and FDA can request companies to voluntarily recall food that is

contaminated, adulterated, or mislabeled. If the manufacturer does not

voluntarily do so, USDA and FDA can seek a court order to seize the food.

Although FDA has direct legislative authority to require recalls that involve

infant formula, neither agency has authority under its food safety laws to

require a company to conduct a recall of any other food.

To assist your consideration of legislative proposals that would give

mandatory recall authority to USDA and FDA, you asked us for information
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on several aspects of the current, voluntary recall programs. Specifically,

this report provides information on (1) the number of food recalls

documented by USDA and FDA since 1984, and of those, the number

associated with outbreaks of foodborne illnesses; (2) for recalls associated

with such outbreaks, the extent to which USDA and FDA identified the

cause of the outbreak and how the product became contaminated; (3) the

extent to which companies delayed or did not comply with USDA- or FDArequested recalls; and, (4) the economic impact of recalls on affected

companies, to the extent identifiable. As defined by CDC, an outbreak of

foodborne illness occurs when two or more people come down with the

same illness after consuming the same contaminated food.

To conduct this review, we analyzed data from USDA’s electronic recall

database, which contains information dating back to 1984, and summary

data from multiple FDA electronic files dating back to 1986. We analyzed

detailed case files on each of the recalls associated with outbreaks of

foodborne illnesses. We also discussed the economic impact of recalls with

major food industry associations and analyzed the coverage and limitations

of insurance available for recalls. See appendix I for detailed information

on our scope and methodology.

Results in Brief USDA and FDA documented more than 3,700 food recalls from the mid1980s through 1999. USDA, which generally maintains its data by calendar

year, identified 515 recalls of fresh and processed meat and poultry from

calendar year 1984 through 1999. FDA, which began compiling such data

electronically in 1986, identified 3,248 recalls of other foods from fiscal

year 1986 through fiscal year 1999. Neither agency has tracked whether

recalls were associated with outbreaks of foodborne illnesses over those

time periods. However, USDA, according to its electronic recall files since

1992 and its staff’s recollections, identified 12 recalls from 1988 through

1999 that were associated with outbreaks of foodborne illnesses. Likewise,

FDA, according to its staff’s recollections and data on illness outbreaks that

it has collected since fiscal year 1997, identified 49 recalls for 1997 through

1999 that were associated with outbreaks of foodborne illnesses.

USDA and FDA were able to identify a specific contaminant for each of the

61 recalls they considered to be associated with an outbreak; in total, the

agencies believe strains of five bacteria and two viruses were responsible.

However, the agencies generally were unable to determine how the food

became contaminated. According to USDA and FDA officials, efforts to

determine the cause of contamination are generally not successful because
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so much time passes—up to several weeks or months—before an illness is

linked to a specific food. Recently implemented systems by CDC to track

foodborne illnesses could reduce that lag time and may improve the

agencies’ ability to determine points of contamination.

Both agencies believe that companies have generally initiated recalls

without delays—either on their own initiative or in response to requests to

voluntarily do so. USDA said there were no instances in which companies

delayed or failed to initiate a recall. FDA identified nine cases out of several

thousand where companies delayed or failed to initiate a recall. For both

agencies, information on companies’ recall efforts is based on the

recollections of agency officials because neither agency systematically

measures the full extent of companies’ recall activities. Although both

agencies selectively check with customers to determine whether recalls are

implemented, neither can assure the public that companies are carrying out

recalls in a timely manner. In addition, neither agency’s written guidance to

companies specifies time frames for initiating or carrying out recalls, even

for recalls that involve potentially serious health risks.

Neither USDA nor FDA compiles information on the economic impact of

recalls on affected companies. Similarly, the food industry associations we

contacted do not collect this information. However, according to food

industry officials, recalls can have a significant economic impact on

affected companies through lost sales and food retrieval costs. The extent

of this impact depends on such factors as the amount and value of the food

recalled, its location in the distribution process, and the severity of the

health risk. In addition, following a recall, consumers may stop buying a

company’s products or switch to another company’s brand for future

purchases.

We are making recommendations to USDA and FDA to strengthen their

guidance to companies on recalls that involve serious health risks and to

improve their agencies’ ability to assess the timeliness of companies’ recall

actions.

Background USDA and FDA share federal responsibility for ensuring the safety of the

nation’s food supply. USDA, under the Federal Meat Inspection Act, the

Poultry Products Inspection Act, and the Egg Products Inspection Act, is

generally responsible for meat, poultry, and certain egg products. FDA,

under the Federal Food, Drug, and Cosmetic Act, is responsible for all

other foods, including certain canned, frozen, and otherwise packaged
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foods containing meat, poultry, and eggs that are not regulated by USDA.1, 2

FDA has regulatory jurisdiction only if the food or its ingredients have been

offered into interstate commerce, whereas USDA has regulatory

jurisdiction over meat and poultry products that may or may not be in

interstate commerce. USDA’s and FDA’s respective recall programs track

recalls involving the foods they regulate. Both agencies include multiple

food items in a recall when multiple foods from the same manufacturer are

linked to the same contamination. (For additional information on USDA’s

and FDA’s regulatory responsibilities regarding food safety, see Related

GAO Products listed at the end of this report.)

Companies initiate recalls on their own initiative or at the request of USDA,

FDA, or states. Both USDA and FDA consider a recall to be a voluntary

action by a company to remove or correct a food after it has left the

possession and control of the company responsible for the food’s becoming

contaminated, adulterated, or mislabeled. Under their recall procedures,

when the agencies determine that food may be contaminated and a recall

warranted, they work informally with the company to encourage it to

initiate a recall. If this informal approach does not work, USDA can detain

the product for up to 20 days while it seeks a court order to seize the food,3

whereas FDA can issue a written request that the company voluntarily

conduct the recall. If the company does not initiate the recall following this

formal request, FDA, which does not have detention authority for food

under the Federal Food, Drug, and Cosmetic Act, can seek a court order to

seize the food.

The recalling company is generally the manufacturer or an importer. A

recall may involve a relatively small amount of food—such as a portion of a

single day’s production run of a single item—or a very large quantity—such

as all the production of a plant over several days. Some or all of a recalled

1

FDA is responsible for meats that are not explicitly named in the Federal Meat Inspection

Act (such as venison and buffalo) and poultry not explicitly named in the Poultry Products

Inspection Act (such as quail and pheasant). USDA is responsible for food containing 2

percent or more cooked, or 3 percent or more raw, USDA-regulated meat or poultry.

2 FDA, under the Public Health Service Act, may have authority to issue mandatory recall

regulations for foods that are “vectors of communicable diseases.” FDA has never used this

authority with regard to food recalls. It has used the Public Health Service Act authority to

issue recall regulations for human tissue.

3

USDA can also remove its inspectors from a plant, which would force the plant to close.
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Page 7 GAO/RCED-00-195 USDA and FDA Food Recalls

food may be retrieved—or its label corrected—before any of it reaches the

consumer.

Both USDA and FDA classify recalls on the basis of their potential health

threat and provide written guidance to their staff and the recalling firms for

conducting recalls. Both agencies provide direct assistance and monitoring

through their field office staff and maintain individual case files on recalls

in field and headquarters offices. The agencies also maintain selected

information on all recalls electronically at headquarters. In addition, USDA

has delegated certain recall responsibilities to states that have

implemented inspection programs equal to USDA’s and have sought the

responsibility. Appendix II provides additional information on USDA’s and

FDA’s recall programs and procedures.

State and local public health and agriculture officers and inspectors, who

generally carry out food safety inspections in retail stores, restaurants,

warehouses, institutional settings (such as hospitals, nursing homes, and

prisons), and at food processors, often discover problems that warrant

recalls. The state and local public health departments are also often the

first to identify outbreaks of foodborne illnesses and collect data to link the

outbreak to a common food source. The state and local public health

departments report outbreaks to CDC, which monitors and investigates

outbreaks of foodborne and other illnesses nationwide. Neither companies

nor the states are required by law or regulation to notify USDA or FDA of

recalls.4

Agencies Have

Documented Over

3,700 Food Recalls

Together, USDA and FDA have documented more than 3,700 food recalls

from 1984 through 1999. However, neither agency has maintained

information on the number of recalls associated with outbreaks of

foodborne illnesses.

USDA, which generally maintains recall data by calendar year, identified

515 recalls of fresh and processed meat and poultry during calendar years

1984 through 1999.5 FDA, which maintains recall data by fiscal year and

began compiling such data electronically in 1986, identified 3,248 recalls of

4 FDA’s laws and regulations require companies to notify FDA when they conduct a recall

regarding infant formula due to risk to human health.

5

USDA can sort its recall data by fiscal year but numerically codes recalls by calendar year.
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Page 8 GAO/RCED-00-195 USDA and FDA Food Recalls

other foods during fiscal years 1986 through 1999. Neither agency has

tracked whether these recalls were associated with outbreaks of foodborne

illnesses over those time periods. However, USDA, relying on its electronic

recall files since 1992 and its staff’s recollections, identified 12 recalls

associated with such outbreaks since 1988. FDA, which began tracking

outbreaks for FDA-regulated foods in 1997, did not record whether these

outbreaks resulted in a recall. From FDA’s review of its outbreak data and

the recollections of FDA staff, FDA identified 49 recalls associated with

outbreaks of foodborne illness during fiscal years 1997 through 1999. Table

1 shows the number of recalls documented by USDA and FDA annually

since 1984 and the number of recalls associated with outbreaks of

foodborne illness that the agencies identified. As table 1 indicates, the

number of recalls has varied considerably from year to year.

Table 1: USDA- and FDA-Documented Food Recalls Since 1984 and Recalls

Associated With Outbreaks of Foodborne Illness Identified by the Agencies

a

Calendar year for USDA; fiscal year for FDA.

USDA-documented food recalls FDA-documented food recalls

Yeara Total

Associated with

outbreaks of

foodborne illness Total

Associated with

outbreaks of

foodborne illness

1999 62 1 275 15

1998 45 4 219 6

1997 27 1 254 28

1996 25 0 235 b

1995 36 2 229 b

1994 48 1 227 b

1993 38 0 233 b

1992 36 0 222 b

1991 37 1 179 b

1990 28 1 197 b

1989 26 b 192 b

1988 21 1 169 b

1987 43 b 253 b

1986 15 b 364 b

1985 18 bc b

1984 10 bc b

Total 515 12 3,248 49
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b

The agencies did not have this information.

c

FDA does not maintain electronic data for this year.

Source: USDA and FDA.

USDA and FDA classify recalled products by the potential health risk they

may present. Both agencies define recalled products as Class I if eating the

product poses a reasonable probability of causing serious adverse health

consequences or death. USDA defines recalled products as Class II if they

present a remote probability of adverse health consequences. FDA defines

recalled products as Class II if they present a remote probability of serious

adverse health consequences or if they may cause temporary or medically

reversible adverse health consequences. USDA defines Class III products

as those involving foods that will not cause adverse health consequences,

while FDA defines Class III products as those that are not likely to cause

adverse health consequences.

As figure 1 shows, USDA classified about 56 percent of the 515 recalls it

documented since 1984 as Class I. Of this total, 187 involved foods with

bacterial contamination. FDA classified 796 of its 3,248 recalls as Class I.

These recalls included foods with bacterial contamination and ingredients

not identified on the label, such as peanuts, that can be life-threatening to

individuals sensitive to those products.
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Figure 1: USDA’s and FDA’s Classification by Potential Risk Since 1984

Source: USDA and FDA.

Regarding the number of documented recalls since 1984, the 3,248 FDAdocumented recalls do not include recalls when the food and all its

ingredients were produced and distributed within a single state—that is,

when the food and its ingredients were never part of interstate commerce;

responsibility for recalls of such foods rests with the state. FDA has

regulatory jurisdiction, under the Federal Food, Drug, and Cosmestic Act,

only if the food has been offered into interstate commerce or contains an

ingredient that has traveled in interstate commerce. The 515 USDAdocumented recalls do not include recalls where the food and all its

ingredients were produced and distributed within a single state if the state

has a USDA-approved state inspection system and was responsible for

inspecting the plant. It includes, however, intrastate recalls in states that do

not have approved systems because USDA inspectors must monitor the

recalls in these states. Twenty-three states have USDA-approved inspection

systems for meat and poultry, and 2 others have approved state inspection

56% • Class I

37%

USDA FDA

•

Class II

•

7%

Class III

24% • Class I

45% • Class II

•31%

Class III
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Page 11 GAO/RCED-00-195 USDA and FDA Food Recalls

systems for meat only.6 Unlike FDA, USDA has regulatory jurisdiction even

when the food and its ingredients were never part of interstate commerce.

In addition, because food safety laws do not require states or companies to

report recalls (except those involving infant formula) to USDA or FDA, the

agencies may not have been made aware of all recalls initiated by

companies or states.

Agencies Identified the

Contaminant but

Generally Not the

Cause of

Contamination for

Outbreak-Related

Recalls

USDA and FDA identified a specific bacterial or viral contaminant for each

of the 61 recalls they considered to be associated with outbreaks of

foodborne illnesses. However, the agencies generally were unable to

determine how the food became contaminated. Such information could

assist companies’ and food safety inspectors’ efforts to prevent future

problems. Making such determinations are difficult, however, given the

considerable time lag—often several weeks or months—between

individuals’ becoming ill and the identification of the specific food that

caused the illness.

The agencies believe strains of five bacterial and two viral contaminants

were responsible in the recalls associated with outbreaks of foodborne

illnesses. The particularly virulent bacteria—E. Coli O157:H7—was

responsible in 7 of the 12 recalls of USDA-regulated foods associated with

outbreaks of foodborne illness, while a virus common to shellfish—

Norwalk or Norwalk-like virus—was responsible in 22 of the 49 recalls of

FDA-regulated foods. Table 2 shows the contaminants responsible for the

recalls associated with outbreaks of foodborne illnesses. In addition,

appendix III provides information about bacterial and viral contaminants

that can cause foodborne illnesses, including the length of time for the

onset of illness after eating contaminated food, the symptoms of the illness,

and examples of foods that have carried the contaminant.

6

The following states have USDA-approved inspection systems for meat and poultry:

Alabama, Arizona, Delaware, Illinois, Indiana, Iowa, Kansas, Louisiana, Minnesota,

Mississippi, Montana, New Mexico, North Carolina, Ohio, Oklahoma, South Carolina, Texas,

Utah, Vermont, Virginia, West Virginia, Wisconsin, and Wyoming. In addition, Georgia and

South Dakota have USDA-approved inspection systems for meat.
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Table 2: Contaminants Identified in the Recalls Associated With Foodborne Illness

Outbreaks

a

One salmonella recall also involved E. Coli contamination.

Source: USDA and FDA data.

The outbreak-related recalls involved 10 foods. As table 3 shows, the

highest number of recalls for USDA was associated with ground beef, and

for FDA, the highest number was associated with raw oysters.

Table 3: Foods in Recalls Associated With Foodborne Illness Outbreaks

Source: USDA and FDA data.

Number of recalls

Bacterial contaminant FDA USDA

E.coli O157:H7 3 7

Staphyloccocus toxin 0 1

Vibrio parahaemolyticus 4 0

Listeria monocytogenes 0 1

Salmonella 14a 3

Viral contaminant

Hepatitis A 6 0

Norwalk or Norwalk-like 22 0

Total 49 12

Number of recalls

Food FDA USDA

Raw oysters 26

Ground beef 5

Sprouts/seeds 9

Frozen strawberries and products with the strawberries 6

Unpasteurized fruit juice/cider 4

Cold cuts and hot dogs 6

Mamey (a tropical fruit) 2

Chicken/pork dressing 1

Toasted oats cereal 1

Chili rellenos 1

Total 49 12
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For all but one of the outbreak-related recalls, USDA and FDA were not

able to determine with certainty how the foods became contaminated. In

the case in which USDA made a determination, it concluded that

salmonella got into a chicken/pork dressing mix through a cracked seal in a

pump that transferred the mix from the cooking vat to the packaging line.

According to USDA officials, their inspectors do not attempt to determine

the cause of contamination for every recall. They believe this is the

responsibility of the recalling company. Since January 2000, all plants that

USDA inspects are required by regulation to have a hazard analysis critical

control point (commonly called HACCP) plan for each process in the plant.

According to USDA officials, when a company conducts a recall of a

contaminated food, it must determine the cause of the contamination and

take immediate corrective action to prevent a recurrence as part of its

responsibilities under a HACCP plan. According to FDA officials, their

inspectors attempt to determine the cause of contamination for every

recall. In fact, FDA guidance to its inspectors says that the facility will be

examined to determine how the food became contaminated.

This information is important to ensure that points of contamination are

corrected. As CDC reports, an investigation that clarifies the nature and

mechanism of contamination can provide critical information even if the

outbreak is over; understanding the contamination event can lead to

prevention measures that reduce the risk of similar outbreaks elsewhere.

According to USDA and FDA officials, tracing a foodborne illness to a

specific food source is difficult and time-consuming. It can often take

several weeks or longer from the time contaminated food is eaten until

individuals become ill and food safety agencies can link the illnesses to a

specific food. And even when a specific food source is initially isolated, the

food itself may not be the problem. For example, a local health department

may conclude that 12 people became ill with food poisoning after eating a

certain brand of chili at a neighborhood party, but the chili may not have

been contaminated. Rather, the bowl in which the chili was served may

have been contaminated or the chili could have been left out too long.

According to CDC, many foodborne illnesses are due to improper food

handling or preparation.

We have recently begun to examine, at your request, the extent to which

two 5-year old surveillance systems for foodborne illnesses facilitate food

safety agencies’ efforts to identify the cause of an outbreak of foodborne

illness. The Foodborne Diseases Active Surveillance Network—known as
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FoodNet—is a collaborative project of CDC, USDA, FDA, and nine states. It

provides a network for responding to new and emerging foodborne

diseases and for identifying the sources of specific foodborne diseases.

CDC also operates PulseNet, a national network of public health

laboratories to “fingerprint” bacteria cultures submitted by state health

laboratories. These two tracking systems could reduce the lag time in

linking foodborne illnesses to specific foods, which, in turn, may improve

inspectors’ ability to determine points of contamination for recalled foods.

USDA and FDA Believe

Companies Conduct

Timely Recalls, but the

Agencies Do Not

Maintain Data to

Confirm This View

USDA and FDA believe companies typically cooperate and act without

delay in initiating recalls, but the agencies do not systematically measure

and maintain data on companies’ performance. Moreover, USDA’s and

FDA’s guidance to companies does not specify time frames for initiating

and carrying out recalls without delays.

When asked for cases in which companies delayed initiating a recall

following an informal request by the agency, USDA officials told us that

USDA had not had any such instances, whereas FDA officials identified

nine cases out of over 3,000 recalls. This information is based on the

recollections of agency officials, because neither agency systematically

measures or compiles data on companies’ recall activities, such as the

dates that problems warranting recalls were first discovered, the dates that

companies initiated recalls,7 the dates and methods companies used to

notify their distributors and the public, and the dates companies completed

their recalls. In addition, FDA does not track the dates it asked the

companies to conduct a recall. However, both agencies selectively check

with customers of the recalling companies to determine whether recalls

have been implemented. The extent of this verification is determined on a

case-by-case basis. Our review of case files in agency headquarters and

district offices showed that these files contained some information on

company recall activities, but such information is not being captured and

analyzed systematically.

Of the nine recalls FDA officials identified as involving a delayed response

by the companies to an informal request, six involved a subsequent formal

written FDA request to conduct a voluntary recall. According to FDA, a

formal written request is the last step before it takes regulatory action,

7

Beginning in fiscal year 1999, FDA included in its recall database the recall initiation date.
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such as seeking an injunction to prevent further manufacturing and

distribution, or a court order to seize the food. For five of these six cases,

the company recalled the products after receiving FDA’s formal request. In

the sixth case, the firm, claiming that there was no more product on the

market, refused to make the recall. FDA issued a public warning that the

product posed a serious risk to consumers’ health because FDA believed

that a number of consumers who had purchased the product might still

have it in their homes. FDA said seizure was not a viable option because it

was unlikely that FDA would find sufficient quantities of the product to

seize. For two of the other recalls, although the companies did not recall

the foods immediately in response to an informal FDA request, they did so

before FDA had an opportunity to issue a written request. In the other case,

the firm complied with FDA’s informal request, but the firm’s distributor

refused to recall the product or provide distribution data to FDA. FDA

issued a press release warning consumers not to eat the product but did not

pursue court authority to seize the product because it did not know where

the product had been distributed. Beginning in fiscal year 1999, FDA

included information in its recall database indicating whether it had

formally requested the recall. See appendix IV for more information on

each of the nine cases.

USDA officials said there were no recalls involving a delayed response by

the company to a recall request. However, two USDA Class I recalls have

received considerable publicity regarding the timeliness of recall activities.

In the first, USDA increased dramatically the amount of ground beef patties

it requested the company to recall because of potential contamination with

E. Coli 0157:H7—from 20,000 pounds initially, to 1.2 million pounds 3 days

later, and finally, to 25 million pounds by the ninth day. In the second, USDA

did not advise the company to initiate a recall of hot dogs and other

packaged deli meats suspected of being contaminated with listeria

monocytogenes, although it had epidemiological data8 linking 40 illnesses

and 4 deaths to the products. According to USDA officials, the agency did

not believe that the epidemiological data conclusively implicated the

products and it was unable to find contamination in unopened samples.

The company on its own initiative decided to recall the products. More

information on each of these cases is in appendix V.

8

Epidemiological data are data showing the distributions and determinants of health-related

conditions or events in specified populations.
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In addition, while both agencies’ guidance instructs companies to promptly

implement recalls, neither agency provides specific time frames for

initiating or carrying them out. For example, although both agencies’

guidance instructs companies to notify their distributors promptly that the

food is being recalled, neither instructs them to use the most expeditious

means for Class I recalls. Thus, even for recalls involving life-threatening

contaminants, companies may use mail to contact their distributors—

instead of the telephone, E-mail, or facsimile—which could unnecessarily

delay by several days the removal of contaminated food. Many of the

recalls associated with outbreaks of foodborne illnesses, for example,

involved perishable foods, such as fresh sprouts and raw oysters, that

would have been sold and consumed within those few days.

Agencies differ in how they notify the public of the most serious recalls of

contaminated food. Under its procedures for recalls prior to February 2000,

USDA was required to issue press releases for all Class I recall products

that could be identified by consumers. In February 2000, USDA began

issuing press releases for all three classes of recalls, even if the product is

not identifiable to consumers. We found that press releases for the

outbreak-related recalls involving USDA-regulated foods (all were Class I)

were generally issued on the same day the company decided to recall the

product; in only one instance was the press release issued more than 24

hours later.

FDA believes that press releases are necessary for Class I and selected

Class II recalls and prefers that the company, not FDA, issue the press

release. According to FDA officials, if the company does not issue a press

release promptly, FDA will issue a release. FDA stated that it would issue

the press release if the company did not do so within 24 hours. It further

noted that in some instances CDC and state and local agencies may issue

their own press releases to alert the public about outbreaks associated with

specific foods and/or recalls. If FDA considers these press releases

adequate, it will not pursue additional press coverage. However, FDA has

not issued written guidance to companies telling them that they are

expected to issue press releases within 24 hours of initiating a recall. We

were unable to obtain sufficient information from FDA case files to analyze

the timeliness of press releases on the 49 recalls associated with outbreaks

of foodborne illness.

According to USDA and FDA officials, press releases are intended to alert

consumers about food they may have in their homes. Consumers are not

routinely informed of the particular restaurants, caterers, or institutions,
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such as hospitals or retirement homes, that may have served recalled

foods, even when this information could mean the difference between life

and death for high-risk individuals.9 According to USDA and FDA officials,

however, the agencies cannot divulge such information to the public

because it is considered confidential business information.10 According to

CDC, listeria monocytogenes can cause illness anywhere from 2 to 8 weeks

after consumption; while generally mild, the illness can be severe for a

person with a weakened immune system, and an infection during

pregnancy can lead to the loss of a fetus. If individuals at risk of serious

illness were aware that they might have eaten listeria-contaminated food,

they could seek medical attention.

USDA can more readily confirm than FDA that contaminated meat and

poultry products are removed from distribution. Unlike FDA, USDA has

access to companies’ distribution records at all points in the distribution

chain. In addition, USDA inspectors, store employees, and consumers can

more readily identify recalled canned meat and poultry products because,

under the federal meat and poultry products acts and implementing

regulations, the canned products must be marked with a code, which

allows production lots to be identified. FDA-regulated foods, with the

exception of infant formula and low acid and acidified foods, are not

required to have label encoding.

USDA officials told us that if a coding system were required for all USDAregulated processed foods, everyone (for example, inspectors, grocery

stores, and consumers) could more readily identify the recalled food.

According to FDA officials, access to distribution data and product coding

would facilitate FDA’s recall efforts and help ensure that contaminated

foods are removed from grocery shelves.

9

Beginning in February 2000, USDA included in some of its press releases a statement to the

public to check with any restaurants where they may have eaten the recalled food.

10According to USDA, it has a rulemaking in process to allow the disclosure of customer lists

to other federal and state agencies. As part of the rulemaking, agencies would not be able to

divulge the information to the public.
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Information on the

Economic Impact of

Recalls Is Lacking, but

a Number of Factors

Are Cited as

Contributing to Any

Impact

Neither USDA nor FDA compiles information on the economic impact of

recalls on affected companies. Similarly, the food industry associations we

contacted do not collect this information. However, according to food

industry officials, recalls can have a significant economic impact on

affected companies through lost sales and food retrieval costs. The extent

of this impact depends on such factors as the amount and value of the food

recalled, its location in the distribution process, and the severity of the

health risk. In addition, following a recall, consumers may stop buying a

company’s products or switch to another company’s brand for future

purchases.

Although comprehensive data on the economic impact of recalls are

lacking, food industry officials noted that this impact may be substantial in

terms of lost sales and retrieval costs. In some cases, this impact may lead

to a company’s going out of business, particularly if the company is

marginally profitable or already experiencing other problems. For example,

several food industry associations told us that Hudson Foods went out of

business after recalling approximately 25 million pounds of ground beef

patties. However, USDA officials noted that management problems,

including poor record-keeping, had contributed to this company’s failure.

Specifically, poor record-keeping led to a larger recall than otherwise might

have been necessary because the company was unable to determine the

extent to which meat from various production batches may have been

combined.

In general, the economic impact of a recall depends on the amount and

value of the food recalled, its location in the distribution process at the

time of recall, and the severity of the anticipated health risk. For example,

the affected company loses expected revenues associated with the sale of

the recalled product. It may also lose future sales revenues if consumers

stop buying the company’s products or switch to another brand. Regarding

the distribution process, a company conducting a recall bears the cost of

retrieving and replacing the food throughout its distribution chain. These

costs increase if the product has already reached the market because the

company must then notify consumers of the risk. The severity of the

anticipated health risk is also an important factor. A recall involving

contamination by harmful bacteria may result in the destruction of the

affected food and the loss of sales revenue. However, if the recall is

conducted because the food has been mislabeled, the affected company

may redistribute the food into commerce after making the necessary label

corrections.
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Recalls may also have an economic impact on companies other than the

one conducting the recall. For example, according to the Food Marketing

Institute, retail supermarkets may experience a drop in sales if consumers

avoid the recalled food and other products by the same manufacturer or

even other brands of the recalled item. In addition, companies that use a

recalled product as an ingredient can incur significant costs from a recall.

For example, if a particular brand of pepperoni is recalled, a company

using that brand in its frozen pizzas may have to recall the pizzas. Although

the pizza manufacturer should be reimbursed for the lost revenues and

replacement costs, it may also experience a drop in future sales if

consumers have a negative impression of the pizza because of the recall.

Because the economic impact of a recall may be significant, some food

companies carry recall insurance to cover lost revenues and retrieval costs.

However, according to several food industry associations, many of their

member companies consider recall insurance to be too expensive and thus

have not purchased it. According to an insurance broker who works with

the meat industry, a typical policy for a company with $1 billion in annual

sales might have a $25 million limit, $250,000 deductible, and a $60,000

annual premium, while a smaller company with $20 million in annual sales

might have a policy with a $3 million limit, $10,000 deductible, and a

$13,300 annual premium.

Conclusions While USDA and FDA believe companies conduct timely recalls, they do

not have data to support this view. Although both agencies track

information on their own recall activities, they do not systematically track

companies’ activities to ensure that recalls, particularly of foods that may

cause serious adverse health consequences, are initiated and carried out

without delay. Specifically, USDA does not track when companies initiate

recalls, and neither agency tracks when or how companies notify their

distribution chains of the recalls, when or how they notify the public, and

when recalls are completed. Neither USDA nor FDA has provided guidance

to companies on specific time frames for initiating and carrying out recalls.

Recommendations To ensure that companies initiate and carry out recalls without delays,

particularly of foods that may cause serious adverse health consequences,

we recommend that the Secretaries of Agriculture and of Health and

Human Services direct the Food Safety and Inspection Service and the

Food and Drug Administration, respectively, to
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• Provide specific guidance to companies on 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.

• Modify existing recall databases, as necessary, to include information on

the timeliness of companies’ recall activities to determine whether

companies delay in initiating and carrying out recalls. The information

should, at a minimum, include the dates a company (1) finds out about

the problem warranting a recall, (2) initiates the recall, (3) notifies the

distribution chain, (4) notifies the public, and (5) completes the recall.

In addition, the database should track the methods the company used to

notify its distributors and the public, and the date(s) on which the

agencies requested the company to initiate the recall.

Agency Comments We provided USDA and FDA with a draft of this report for review and

comment. USDA said that the recommendations are doable but does not

believe that they will fundamentally help speed up or make the recall

process more effective. While we agree that our recommendations, when

implemented, will not by themselves speed up the recall process, we

believe that their implementation will provide USDA with information on

whether, and where in the process, delays are occurring. USDA also said

that our draft report is somewhat unbalanced and mischaracterizes the

Department’s oversight of firms’ recall activities. USDA contends that since

January 2000, the responsibility for the food recall process has rested with

food companies, which were required to implement HACCP systems that

are designed to identify problems in meat and poultry production

processes and prevent their recurrence. We have revised the report to more

fully describe HACCP’s role. The merits of HACCP notwithstanding, we

believe that USDA, as part of its responsibility for ensuring the safety of

meat and poultry, must have sufficient information on companies’ recall

actions to assure itself that consumers are adequately protected. USDA

also contends that it needs mandatory recall authority and additional

enforcement tools to improve food safety and has supported proposed

legislation that would provide this assistance. USDA’s comments and our

detailed responses are presented in appendix VI.

FDA concurred, for the most part, with our recommendations and found

the report to be an accurate reflection of the many administrative,

regulatory, and legal challenges it faces in monitoring companies’ recall

activity. FDA stated that it already tracks the date companies initiate a

recall and whether FDA had formally requested the recall. While our report
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Page 21 GAO/RCED-00-195 USDA and FDA Food Recalls

recognized this, we clarified our recommendation to reflect these actions.

However, FDA also stated that it would have difficulty tracking some of the

information we are recommending, such as the date the company finds out

about the problem necessiating the recall and the date the company

notifies the distribution chain. We disagree. Our recommendation would

not preclude entering multiple dates for activities, such as the date

companies notify distributors. FDA told us that it is in the process of

revising its recall procedures and guidance to companies. This provides a

good opportunity to clearly define terms and time frames for expediting

recalls, especially recalls of foods that pose serious health risks. FDA’s

letter and our responses appear in appendix VII.

USDA and FDA both expressed the view that the title of our draft report

was misleading because they both believe they know whether companies

are initiating and carrying out recalls promptly. We disagree. While both

agencies maintain certain information in detailed recall files about when

recalls were initiated and how they were carried out, neither agency

collects consistent information on all recalls or systematically compiles

such information. As a result, we continue to believe that actions are

needed by the agencies to ensure that companies promptly carry out

recalls. However, we have changed our title to more clearly reflect the

recommendations of the report regarding the need to maintain data on the

timeliness of companies’ recall actions and the need for specific guidance

on time frames for initiating and carrying out recalls.

USDA and FDA also made technical clarifications, which we incorporated

as appropriate.

As arranged with your offices, unless you announce its contents earlier, we

plan no further distribution of this report until 30 days after the date of this

letter. At that time, we will send copies of this report to congressional

committees with jurisdiction over these matters. We will also send copies

of this report to the Honorable Dan Glickman, Secretary of Agriculture; the

Honorable Donna E. Shalala, Secretary of Health and Human Services; the

Honorable Thomas J. Billy, Administrator, Food Safety and Inspection

Service, USDA; the Honorable Jane Henney, M.D., Commissioner, Food and

Drug Administration, Department of Health and Human Services; and the

Honorable Jacob J. Lew, Director, Office of Management and Budget. We

will also make copies available to others on request.
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Page 22 GAO/RCED-00-195 USDA and FDA Food Recalls

If you or your staff have any questions about this report, please contact me

or Erin Lansburgh at (202) 512-5138. Key contributors to this report were

Rosellen McCarthy and Jay L. Scott.

Lawrence J. Dyckman

Director, Food and Agriculture Issues
Page 23 GAO/RCED-00-195 USDA and FDA Food Recalls
Page 24 GAO/RCED-00-195 USDA and FDA Food Recalls

Appendix I

Scope and Methodology ApApenednxidexiIs

To determine the number of food recalls documented by the U.S.

Department of Agriculture (USDA) and the Food and Drug Administration

(FDA) since 1984, we analyzed data from USDA’s electronic recall database

and relied on FDA to provide similar data, which it extracted from its recall

databases. USDA officials told us that all recalls since 1984 were contained

in USDA’s electronic database. FDA began electronically tracking food

recalls in 1986 and thus provided data back to 1986, not 1984. We obtained

the computerized file for these recalls and summarized the recalls and

classification of recalls by year. For recalls associated with outbreaks of

foodborne illnesses, we traced file information to the database and found

no discrepancies. Additionally, we interviewed the USDA official

responsible for maintaining the database to determine how recall

information is added to it. On the basis of our review of the recalls for the

outbreak cases and the simplicity of the database, we believe the

information we used from the database is sufficiently accurate to identify

the number of recalls.

To determine the number of recalls associated with outbreaks of foodborne

illnesses, we relied on the agencies to provide such data. Although neither

agency records whether a recall was associated with an outbreak of

foodborne illness, USDA reviewed its recall files and relied on the

recollections of its staff to identify specific cases. Although FDA began

tracking outbreaks of foodborne illnesses for FDA-regulated foods in 1997,

it did not record whether those outbreaks resulted in a recall. From FDA’s

review of its outbreak data and the recollections of FDA staff, FDA

identified recalls associated with outbreaks of foodborne illness during

fiscal years 1997 through 1999.

To determine the extent to which USDA and FDA identified the causes of

the outbreaks of foodborne illnesses and how the recalled product became

contaminated, we analyzed case files on each of the outbreak-related

recalls and discussed the cases with USDA and FDA officials.

To determine the extent to which companies delayed or did not comply

with USDA or FDA requests to recall products, we relied on USDA and

FDA officials’ recollections of such requests because the agencies’

electronic databases do not identify if companies delayed action. We

reviewed case file documents for seven of the nine FDA-identified recalls.

(FDA could not find documentation on two of the cases.) Also, to gain an

understanding of consumers’ perspective on whether companies delayed

or did not comply with USDA and FDA recall requests, we interviewed the
Appendix I

Scope and Methodology

Page 25 GAO/RCED-00-195 USDA and FDA Food Recalls

director for food safety of the Center for Science in the Public Interest and

reviewed some of the Center’s reports and testimony.

To determine the economic impact of recalls on companies, we discussed

economic factors and costs with USDA’s Economic Research Service and

food industry associations, including the American Meat Institute,

American Frozen Food Institute, Food Marketing Institute, National Food

Processors Association, United Fresh Fruit and Vegetable Association,

National Fisheries Institute, and the National Chicken Council. We also

analyzed the coverage and limitations of a recall insurance policy and

discussed coverage, cost, and limitations with associations and two recall

insurance brokers. Furthermore, to gain perspective on recalls, we

reviewed proposed legislation dealing with mandatory food recall authority

for USDA.

We conducted our review from December 1999 through July 2000 in

accordance with generally accepted government auditing standards.
Page 26 GAO/RCED-00-195 USDA and FDA Food Recalls

Appendix II

Selected Information on USDA’s and FDA’s

Recall Programs ApendxiI

This appendix discusses the phases of USDA’s and FDA’s food recall

programs.

USDA’s Recall Program USDA defines a recall as a firm’s voluntary removal of distributed meat or

poultry products from commerce when there is reason to believe that such

products are adulterated or misbranded under the provisions of the Federal

Meat Inspection Act or the Poultry Products Inspection Act.

Determining the Need for a

Recall

USDA can learn about the possibility of unsafe meat or poultry in several

ways: (1) often, through test results of meat and poultry samples taken by

USDA as part of its sampling program; (2) from information gathered or

observations made by USDA field inspectors and compliance officers, in

the course of their routine duties, that may lead to the discovery of unsafe

or improperly labeled products in commerce; and (3) from consumer

complaints, epidemiological data submitted by state and local public health

departments, other USDA agencies, FDA, and the company that

manufactured or distributed the product in question.

According to USDA, when it learns that unsafe meat or poultry may be in

commerce, it conducts a preliminary investigation to help determine

whether a recall of the product is warranted. The preliminary investigation

may include collecting and verifying information about suspected

products, documenting a chronology of events, contacting the

manufacturer of the products for more information, holding discussions

with USDA field inspection and compliance personnel, interviewing a

consumer who allegedly became ill or injured from eating the product,

collecting and analyzing product samples, and contacting state and local

health departments.

If the preliminary investigation indicates that calling back an adulterated or

misbranded product may be necessary to protect the public health or

welfare, USDA convenes a meeting of its Recall Committee, usually by

teleconference. Members of the committee include USDA scientists,

technical experts, field inspection managers, and enforcement personnel.

They evaluate the available information to determine whether a recall is

necessary to protect consumers. As part of this evaluation, the committee

may review laboratory reports, health department reports, and other

documents, and consult with USDA field personnel who may be able to

clarify conflicting or incomplete information.
Appendix II

Selected Information on USDA’s and FDA’s

Recall Programs

Page 27 GAO/RCED-00-195 USDA and FDA Food Recalls

On the basis of this evaluation, the committee assigns a classification to the

recall, according to the relative health risk the product presents. In a Class

I recall, USDA has determined that a strong likelihood exists that a product

will cause serious adverse health consequences or death. For example, a

meat product that is contaminated with pathogenic bacteria would be

subject to a Class I recall. Examples of adulterants that would lead to Class

I recalls are listeria monocytogenes in a ready-to-eat product; E. coli

0157:H7 in ground beef; and the inclusion of an allergen, such as eggs, as an

ingredient in a processed meat product that is not listed on the product’s

label.

A Class II recall would be declared when a remote possibility exists of an

adverse health consequence resulting from consuming the meat or poultry

product. For example, a Class II recall would be warranted if pistachios, a

Class II allergen, were an ingredient in a sausage product without listing

pistachios on the label.

In a Class III recall, the consumption of the product will not cause adverse

health consequences—for example, an improperly labeled processed meat

product in which added water is not listed on the label, as required by

federal regulations.

In addition to determining the class of the recall, the committee identifies

and recommends the depth and scope of the recall. The depth of a recall is

the lowest level of distribution that the recall is targeting, such as a recall to

the “consumer level.” This recall level targets household consumers and

includes alerting consumers through the media as well as directly

communicating with the recalling firm and its distributors. A recall to the

“user level” is targeted to restaurants and other food service institutions

when product is not in the hands of consumers. A recall to the “retail level”

includes all types of retail sales; and the “wholesale level” extends only to

wholesale distributors.

The scope of a recall concerns the amount and kind of product recalled.

For example, if sampling by USDA indicates Listeria monocytogenes in a

frankfurter, the Recall Committee evaluates relevant data to determine

whether frankfurters made by the plant during other shifts or days need to

be included in the recall and whether other ready-to-eat products made by

the plant during those times also need to be recalled.

During the latter part of the committee meeting, a representative of the

company that processed the product participates in a telephone
Appendix II

Selected Information on USDA’s and FDA’s

Recall Programs

Page 28 GAO/RCED-00-195 USDA and FDA Food Recalls

conference. The committee advises the company representative of its

recommendation that the company conduct a Class I, II, or III recall and

asks the company representative questions to add to or clarify the

information it has obtained. If the company believes that the product

should not be recalled or that the depth and scope of the recall should be

modified, it is given the opportunity to supply data to support its position.

The Recall Committee considers any new information before advising the

company representative of its recommendation.

Notifying the Public On February 1, 2000, USDA began issuing a press release for all recalls. The

press release

• describes the product being recalled along with any identifying marks or

codes, the reason for the recall, and an explanation of the risk involved

in consuming the product;

• provides instructions to the public on what to do with the product if

they can identify it and have it in their possession, and the name and

telephone number of a company contact for consumers with any

questions;

• explains, for products that are not in the public domain or for products

that consumers cannot identify by labeling or packaging, that the

product is being recalled before consumers can obtain it; and

• provides general information about a product’s destination but does not

identify the specific recipients of product (e.g., grocery store,

restaurant, airline) unless the supplier chooses to release the

information to the public.

Prior to February 2000, the Recall Committee evaluated how products were

distributed and recommended whether USDA should issue a press release

about a recall. A decision to issue a press release was based on the relative

risk associated with the use of the product and whether the product being

recalled was in the hands of consumers. The purpose of a press release was

to advise consumers who had the product not to eat it but instead to return

it to the place where they bought it.

A recall of a product sold only to food service establishments or to firms for

further processing usually would not have warranted a press release. In

such cases, USDA relied on recall effectiveness checks to verify that a firm

conducting the recall provided appropriate notification to all holders of the

recalled products. The notification would have included instructions to
Appendix II

Selected Information on USDA’s and FDA’s

Recall Programs

Page 29 GAO/RCED-00-195 USDA and FDA Food Recalls

stop serving or processing the products and to return or properly dispose

of them.

In addition to press releases, USDA provides the public with details about

all meat and poultry product recalls through recall notification reports that

are posted on its recall Web site. Recall notification reports are also sent by

facsimile and electronic mail to food safety and public health officials

throughout the country at the federal, state, and local levels. This

notification provides the public health community with important data to

use in following up on illnesses, if any, and determining whether those

illnesses may have been caused by the recalled product.

Effectiveness of Recalls Both USDA and the recalling firms conduct effectiveness checks to

determine that (1) the company provided adequate notice about the recall

to all distributors and (2) distributors located and controlled the recalled

products and followed the recalling firm’s instructions for removing the

product. In the event that USDA effectiveness checks disclose that

distributors were not notified of the product recall or did not act as

requested by the recalling firm, USDA can detain any products posing a

health risk, notify the firm, take additional regulatory action, and/or issue

another press release.

Extent of USDA

Involvement in Recalls

USDA gets involved in all recalls made by all meat and poultry plants it

inspects. This includes all plants that ship their products in interstate

commerce and all plants in states that do not have USDA-approved state

inspection systems for meat and poultry.

USDA is not involved in, and may not know about, recalls made by meat

and poultry plants it does not inspect. These plants include those in the

states that have USDA-approved state inspection systems for meat and

poultry and only ship their products within the state. For meat and poultry,

these are Alabama, Arizona, Delaware, Illinois, Indiana, Iowa, Kansas,

Louisiana, Minnesota, Mississippi, Montana, New Mexico, North Carolina,

Ohio, Oklahoma, South Carolina, Texas, Utah, Vermont, Virginia, West

Virginia, Wisconsin, and Wyoming. In addition, Georgia and South Dakota

have USDA-approved inspection systems for meat only.

USDA is not involved in, and may not know about, recalls made by stateinspected retail establishments.
Appendix II

Selected Information on USDA’s and FDA’s

Recall Programs

Page 30 GAO/RCED-00-195 USDA and FDA Food Recalls

FDA’s Recall Program FDA defines a recall as a firm’s removal or correction of a marketed

product that FDA considers to be in violation of the laws it administers and

against which it would initiate legal action, such as a seizure1

. According to

FDA, a recall is a voluntary action that takes place because manufacturers

and distributors carry out their responsibility to protect public health and

well-being from products that present a risk of injury or gross deception or

are otherwise defective.

In situations where a product presents a significant risk of illness or injury

and the firm does not voluntarily initiate a recall on the basis of discussions

with FDA, FDA may request in writing that the firm conduct a recall. This

FDA-requested recall is considered a voluntary action by the firm. Under

the Federal Food, Drug, and Cosmetic Act, FDA has statutory authority to

require recalls only for infant formula.2

FDA’s jurisdiction over foods under the Federal Food, Drug, and Cosmetic

Act is limited to those in domestic interstate commerce and those offered

for import into the United States.

FDA’s recall regulations request that a firm notify FDA when the firm

removes or corrects a distributed product. The regulations describe how a

firm should communicate the recall to its customers and request that the

firm provide FDA with periodic recall status reports. FDA’s procedures for

its staff to use in handling recalls of FDA-regulated food products are

described in the agency’s Regulatory Procedures Manual.

Problems warranting a recall can be identified in several ways: (1) FDA’s

investigation of consumer complaint or FDA’s sampling during an

inspection of a firm; (2) companies’ discovery of a violative product; (3) an

outbreak of foodborne illness traced to an FDA-regulated product; and (4)

1

FDA does not have independent seizure authority. FDA must initiate a seizure through the

U.S. Attorney’s Office, which employs U.S. marshals to effect the seizure. According to

FDA, the process takes at least a couple of weeks, even on an emergency basis. While the

paperwork is being prepared, the items in question may be moved, even sold, with no

penalty because FDA does not have detention authority for foods under the Federal Food,

Drug, and Cosmetic Act.

2

FDA, under the Public Health Service Act, may have authority to issue mandatory recall

regulations for foods that are “vectors of communicable diseases.” FDA has never used this

authority with regard to food recalls. It has used the authority to issue recall regulations for

human tissue.
Appendix II

Selected Information on USDA’s and FDA’s

Recall Programs

Page 31 GAO/RCED-00-195 USDA and FDA Food Recalls

state agencies discovery of violations through inspections, surveillance

sampling, follow-ups on complaints, or other activities.

FDA-, State-, and FirmInitiated Food Recalls

Since fiscal year 1997, FDA has categorized food recalls as FDA-, state-, and

firm-initiated. FDA-initiated recalls are those in which FDA contacts the

firm, and a recall decision and action begin after the FDA contact. Stateinitiated recalls are those initiated by the regulated firm after having out-ofcompliance situations brought to its attention. Firm-initiated recalls are

those initiated by industry, regardless of the reason, without any FDA

contact or input into the decision to take the recall action. Table 4 below

identifies the number of FDA-, firm-, and state-initiated recalls in fiscal

years 1997 through 1999.

Table 4: Category of FDA Recalls, Fiscal Years 1997 Through 1999

Source: FDA.

The Recall Process FDA’s district offices, Center for Food Safety and Applied Nutrition

(CFSAN), and Office of Regulatory Affairs (ORA) are involved in the food

recall process. Once the firm informs the district office that a recall has

been or will be initiated, the district obtains preliminary information from

the firm, including the name(s) and lot number(s) of the product(s) under

recall and the reason for recalling the product. The district should provide

CFSAN and ORA with this information within 24 hours in a document

referred to as the “24-hour alert.”

CFSAN reviews the alert and determines if the problem with the product is

one that has been evaluated previously. If the problem is new or unique,

CFSAN conducts a preliminary health hazard evaluation with its Health

FDA recalls

Fiscal year Total FDA-initiated Firm-initiated State-initiated

1999 275 69 92 114

1998 219 66 93 60

1997 254 67 113 74

Total

(percentage)

748

(100%)

202

(27%)

298

(40%)

248

(33%)
Appendix II

Selected Information on USDA’s and FDA’s

Recall Programs

Page 32 GAO/RCED-00-195 USDA and FDA Food Recalls

Hazard Evaluation Board. The Board consists of a group of CFSAN

scientists and health professionals.

The district office obtains additional information from the firm and

prepares a document called a “recall recommendation.” In addition to the

information the district already provided in the 24-hour alert, the recall

recommendation describes the volume of the recalled product in

commerce, its distribution pattern, the firm’s and FDA’s strategy for

handling the recall, the name of the firm’s contact, and a recommendation

about the classification (Class I, II, or III) of the recall. The district submits

the recall recommendation to CFSAN, along with any additional supporting

documents (e.g., copies of labels, copies of the firm’s recall communication

to its customers, test results, and copies of consumer complaints).

The district office may assist the firm in developing its recall strategy. The

recall strategy includes things such as the manner in which a firm contacts

and gives instructions to its customers on how to handle the recalled

product and the method the firm will use to determine if the recall is

effective. The amount of FDA assistance required usually depends on the

firm involved in the recall. A small firm that has not conducted a recall in

the past may require more assistance than a large corporation that has

recall procedures in place. Firms are not required to consult with FDA or

modify its recall strategy on the basis of FDA’s recommendations.

CFSAN prepares a written health hazard evaluation when it receives all the

necessary information from the district office. The evaluation discusses the

problem(s) with the product(s) under recall, describes the hazard posed by

the product(s), and assesses the severity of the hazard. The completed

evaluation has the signed concurrence of at least two health hazard

evaluation board members. CFSAN uses the conclusion in the evaluation to

classify the recall. A recall may involve multiple products that pose

different levels of hazard. For Class II and III recalls, CFSAN conveys the

classification of each product directly to the district in a memorandum. The

memorandum also assigns a recall number to each product under recall.

If one or more of the products involved in a recall pose a serious or lifethreatening hazard, then either the CFSAN Deputy Director or the

Associate Commissioner for Regulatory Affairs must approve the Class I

designation before the classification memorandum can be sent to the

district. The Deputy Director approves certain Class I recalls (i.e., recalls

for ready-to-eat foods contaminated with listeria monocytogenes and foods

with undeclared peanuts, sulfites, tree nuts, and eggs), and the Associate
Appendix II

Selected Information on USDA’s and FDA’s

Recall Programs

Page 33 GAO/RCED-00-195 USDA and FDA Food Recalls

Commissioner approves the other Class I recalls. CFSAN issues the

classification memorandum for Class I recalls to the district with a copy to

the ORA recall coordinator and the Office of Public Affairs. The district

then prepares a letter to the firm (1) advising it of the classification of the

recalled product(s) and recall number(s) assigned and (2) providing

concurrence with or recommending changes to the firm’s recall strategy.

FDA monitors the progress of a firm’s recall by conducting audit checks

and by reviewing the firm’s status reports. FDA conducts audit checks by

contacting a portion of the firm’s customers to determine if the recalling

firm informed them of the recall and if they followed the recalling firm’s

instructions. The district issues audit check assignments after consulting

with CFSAN. If the recalled product was widely distributed, the audit check

assignment may be issued to more than one FDA district office. The district

issues audit check assignments for Class I recalls before the recall has been

formally classified and after the formal classification for Class II recalls.

FDA districts do not normally conduct audit checks for Class III recalls,

since the product(s) are not likely to cause adverse health consequences.

The results of the audit checks are reported back to the monitoring district.

The district may request that firms submit periodic status reports detailing

the progress of their recall, for example, detailing how many of the

customers have been successfully contacted and how much of the product

has been retrieved, disposed of, or corrected.

If it appears that the recall is not progressing in a timely manner or that

customers are not aware of the recall, the district contacts the recalling

firm and attempts to resolve the issue.

FDA considers a recall to be completed when a firm has made all

reasonable efforts to remove or correct the product on the market. If the

recalling firm retrieves the recalled product (as opposed to correcting or

destroying the products at the business site of their customers), the district

office continues monitoring to ensure that the recalled product is

reconditioned or destroyed and not inadvertently redistributed. The district

may request that the firm allow it to witness the reconditioning or

destruction of the product. Once the reconditioning or destruction is

completed, the FDA district moves to terminate the recall.

To terminate the recall, the district prepares a recall termination

recommendation that summarizes the activities associated with a recall,

including the amount of product recovered/corrected, disposition of the

recalled product, results of audit and effectiveness checks, and action that
Appendix II

Selected Information on USDA’s and FDA’s

Recall Programs

Page 34 GAO/RCED-00-195 USDA and FDA Food Recalls

the firm is taking to prevent similar problems. After the recall termination

recommendation is approved, the district advises the firm in a letter that its

recall has been terminated.

Notifying the Public About a

Recall

At the onset of a recall, FDA considers the need for a press release, taking

into account the level of hazard posed by the product, the manner in which

it was distributed, the type of customer who received the product, and the

customer’s ability to identify the product.

According to FDA, it encourages the recalling firm to issue a press release

for Class I recalls and selected Class II recalls. FDA developed and issued

model press releases providing standardized language for the types of Class

I recalls that the agency most frequently encounters—situations involving

Clostridium botulinum, listeria monocytogenes, all types of salmonella, E.

coli 157:H7, and undeclared allergens.3 To facilitate the use of the model

press releases, FDA issued a guidance document to its district offices on

how to assist recalling firms in preparing press releases for the problems

covered in the models. FDA has given responsibilities to its district offices

to work with recalling companies to issue a notice, discuss the press

release with the firm, and provide it with the relevant model recall press

release (also available on FDA’s Web site). When a recall involves a problem

that is not covered by a model press release, FDA works with the recalling

firm to develop appropriate language for its press release. FDA advises the

firm that FDA monitors the adequacy of the media coverage for a press

release involving a Class I recall. If the press release does not receive

adequate coverage, FDA will either ask the firm to reissue its press release

or issue its own press release. FDA asks the firm to provide its draft press

release for review prior to publication. FDA tells the firm that if it does not

issue a press release within 24 hours of initiating a recall, FDA will issue its

own press release informing the public about the firm’s recall, including

any appropriate warning about avoiding consumption of the firm’s product.

According to FDA, in some instances CDC and state and local agencies may

issue their own press releases to alert the public about outbreaks

associated with specific foods and/or recalls. If these press releases are

adequate, FDA will not pursue additional press coverage.

3

Undeclared allergens include peanuts and other tree nuts (chestnuts, brazil nuts, walnuts,

hazelnuts, pecans, pine nuts, and cashews); eggs; and sulfites.
Appendix II

Selected Information on USDA’s and FDA’s

Recall Programs

Page 35 GAO/RCED-00-195 USDA and FDA Food Recalls

The district recall coordinators are expected to speak for FDA in telling a

firm that a Class I food recall warrants the issuance of a press release by

the firm on its own letterhead. According to FDA, firms should be told that

publicizing their recall to consumers promptly is an important part of their

overall recall strategy and demonstrates their concern for their customers.

FDA does not require public notification of a recall when the product is (1)

not expected to be in the hands of consumers; (2) in bulk and the consumer

is unable to distinguish the recalled product from the nonrecalled product;

(3) an ingredient used by food manufacturers, and firms’ distributors can

be contacted in an expeditious manner; and (4) sold through mail order,

and the firm can contact recipients in an expeditious manner. If the FDA

district office believes that no press is needed on the basis of these criteria,

the district should confirm the adequacy of its decision with CFSAN.

Within a week of the recall’s classification, the Office of Public Affairs

publishes information about the recall in the weekly FDA Enforcement

Report. The report is posted on FDA’s Web site and is available in hard copy

via paid subscription. The enforcement report lists the recalled product

and its sizes; product coding; the name of the manufacturer; the name of

the recalling firm and how and when the recall was initiated (e.g., by letter

and the date); the distribution of the product (e.g., names of the states); the

quantity of product being recalled; the product’s classification; and the

reason for the recall.

FDA does not generally require companies to issue press releases for Class

II and III recalls.

FDA’s Recall Database CFSAN and ORA maintain databases on recalls. CFSAN’s database tracks

food recalls only, whereas the ORA database tracks all FDA recalls,

including those for food, devices, and drugs.

FDA’s recall databases do not include recalls when the food and all its

ingredients were produced and distributed within a single state. In such

instances, the responsibility rests exclusively with the state.
Page 36 GAO/RCED-00-195 USDA and FDA Food Recalls

Appendix III

Bacterial and Viral Contaminants Identified in

Recalls Associated With Outbreaks of

Foodborne Illnesses ApendxiI

Bacterial contaminant Incubation period Symptoms

Some foods that have contained the

contaminant

E.coli 157:H7 1 to10 days; usually 3

to 4 days

Bloody diarrhea, abdominal cramps,

little or no fever.

Ground beef, salami, lettuce, unpasteurized

milk, and juice.

Listeria monocytogenes 2 to 8 weeks Fever, muscle aches, and sometimes

nausea and/or diarrhea.

Hot dogs and packaged meats; uncooked

vegetables.

Salmonella 12 to 72 hours Abdominal cramps, fever, and

diarrhea, and sometimes nausea and

vomiting.

Foods of animal origin such as beef, poultry,

milk, or eggs.

Staphyloccocus toxin 30 minutes to 8 hours Diarrhea, vomiting, nausea,

abdominal cramps, and exhaustion

lasting 24 to 48 hours.

Fermented sausage and salads.

Vibrio parahaemolyticus 24 hours Diarrhea, often with abdominal

cramps, nausea, vomiting, fever, and

chills.

Raw oysters.

Viral contaminant

Hepatitis A 15 to 50 days, with an

average of 28 days

Some people may have no

symptoms. If symptoms occur, they

can include fever, fatigue, loss of

appetite, nausea, abdominal cramps,

dark urine, and jaundice.

Cold cuts and sandwiches, fruits and fruit

juices, milk, vegetables, salads, shellfish, and

iced drinks.

Norwalk or Norwalk-like 24 to 48 hours Vomiting, abdominal cramps,

diarrhea, nausea, and headache.

Shellfish and salad ingredients.
Page 37 GAO/RCED-00-195 USDA and FDA Food Recalls

Appendix IV

Cases in Which FDA Believed Companies

Delayed Initiating a Recall ApendxiIV

The following describes FDA’s experiences with companies the agency

believes delayed initiating a recall.

• Nutritional supplements contaminated with salmonella. This

recall, which occurred in 1988, involved a company that had voluntarily

recalled products contaminated with salmonella. After the recall, the

firm moved its manufacturing operations to a new location. State

inspectors found salmonella contamination in ingredients at the new

facility. When FDA asked the company to extend the recall to include

supplements manufactured at the new facility, it refused. The firm

agreed to extend the recall after FDA sent a letter formally requesting

one and issued a press release.

• Dairy products contaminated with salmonella. This recall occurred

in 1993 and involved a company that dried and packaged products, such

as powdered milk and ice cream mixes. The company did not respond to

FDA’s informal request to conduct a recall. The firm agreed to recall the

products after FDA formally requested the recall and issued a press

release.

• Dietary supplements that contained ma huang (an amphetaminelike chemical that acts as a stimulant) and kola nut (a source of

caffeine). The combination of these ingredients, according to FDA,

posed a life-threatening hazard to the health of certain segments of the

population. According to its label, the product was useful for weight loss

and energy enhancement. FDA formally requested a recall in 1995. The

firm replied to FDA that there was no justification for a recall and

refused. Because the company failed to recall the product, FDA issued a

public warning that the product posed a risk to consumers’ health. FDA

said seizure was not a viable option since it was unlikely that FDA

would find sufficient quantities of product to seize.

• Chop suey vegetables, bean sprouts, and Chinese mixed

vegetables that were processed under conditions that FDA found

could result in deadly botulism poisoning. According to FDA, the

firm said it would recall the products but did not. In 1995, FDA formally

requested that the company conduct a recall. According to FDA, the

company complied with the formal request.

• Hummus dips and salad products contaminated with listeria

monocytogenes. In this 1997 case, FDA wanted the company to expand

an ongoing recall. Although initially the company refused to do so, it

expanded the recall after FDA made a formal request.
Appendix IV

Cases in Which FDA Believed Companies

Delayed Initiating a Recall

Page 38 GAO/RCED-00-195 USDA and FDA Food Recalls

• Cold smoked fish products contaminated with listeria

monocytogenes. This recall, which occurred in March 2000,1 was a

formal request to extend an earlier recall to include all lots/batches of

cold smoked fish products—not just a limited amount as in the earlier

recall. The request letter noted that the firm, during the prior 6 months,

had demonstrated a clear pattern of producing cold smoked fish

contaminated with listeria monocytogenes. The company extended its

recall after receiving the formal request.

• Sprouts associated with a 1998-99 outbreak of salmonellosis.

Although epidemiological data linked the salmonella illnesses to the

consumption of sprouts, the company that grew and packaged the

sprouts resisted initiating a recall. About a day or 2 after these data were

available, while FDA was drafting a formal written request to the

company to recall the product, the company agreed to conduct the

recall.

• Unpasteurized orange juice associated with a 1999 salmonella

outbreak. Epidemiological data indicated contaminated juice, but the

company initially was reluctant to initiate a recall when FDA informally

requested one. According to an FDA official, the company’s sampling of

the product indicated no contamination. However, the company

reconsidered and decided to recall. Following the recall, a more refined

sampling methodology found salmonella contamination, according to an

FDA official.

• Imported smoked salmon contaminated with listeria

monocytogenes. In this 1997 case, the importer initiated a recall of the

product and ceased importing it; however, the sole distributor would not

cooperate. When FDA informally requested a recall, the distributor

refused to recall the salmon or to provide FDA with further distribution

information. FDA issued a press release warning consumers not to eat

the salmon but did not pursue court authority to seize the salmon

because it did not know where it had been distributed.

1

Because this recall occurred in 2000, it was not among the recalls enumerated earlier for

the period 1984 through 1999.
Page 39 GAO/RCED-00-195 USDA and FDA Food Recalls

Appendix V

Two Class I Recalls in Which USDA Appeared

to be Slow and/or Indecisive ApendxiV

We identified two instances in which USDA did not appear to take prompt

action or appeared to be indecisive about initiating a recall.

On August 12, 1997, at USDA’s request, Hudson Foods voluntarily recalled 1

day’s production linked to an outbreak of E. Coli 0157:H7—20,000 pounds

of frozen ground beef patties. The following day, USDA dispatched one of

its compliance officers to the plant to review production records. The

records indicated 1.2 million pounds of patties should be subject to recall.

On August 15, 1997, following USDA’s advice, Hudson expanded the recall

to include 1.2 million pounds of patties. On August 17, 1997, a USDA team

arrived at the plant to investigate the discrepancy in the amount of product

recalled. The team found that it was Hudson Foods’ practice to use ground

beef left over from one day’s production for subsequent production, thus

possibly contaminating all subsequent production. USDA found that

Hudson Foods did not have adequate records to determine when the risk of

potential contamination would have ended. On August 21, 1997, again

following USDA’s advice, Hudson Foods expanded the recall to include all

Hudson Foods brand beef burgers and beef patties—an estimated 25

million pounds—distributed nationwide and closed the plant where the

beef patties had been made.

On December 22, 1998, Bil Mar Foods voluntarily recalled an estimated 35

million pounds of hot dogs and other packaged deli meats that were

epidemiologically linked to 40 illnesses and 4 deaths from a rare strain of

listeria monocytogenes. In addition to the epidemiological data, listeria

monocytogenes was found in an opened package of Bil Mar hot dogs.

Throughout the month of December, as the evidence linking the outbreak

to Bil Mar’s products grew, Bil Mar sought advice from USDA about

whether the company should conduct a recall, but USDA never

recommended it. Although USDA can recommend a recall on the basis of

epidemiological data, USDA officials did not believe the epidemiological

evidence was sufficient to warrant a recall, and USDA inspectors had not

found the bacteria in unopened packages from the suspect production lots.
Page 40 GAO/RCED-00-195 USDA and FDA Food Recalls

Appendix VI

Comments From the U.S. Department of

Agriculture ApendxiVI

See comment 1.

Note: GAO's comments

supplementing those in the

report text appear at the end

of this appendix.

See comment 2.

See comment 3.
Appendix VI

Comments From the U.S. Department of

Agriculture

Page 41 GAO/RCED-00-195 USDA and FDA Food Recalls

See comment 4.
Appendix VI

Comments From the U.S. Department of

Agriculture

Page 42 GAO/RCED-00-195 USDA and FDA Food Recalls

GAO's Comments 1. We disagree. The report presents a balanced and accurate picture of

federal efforts regarding food recalls. It describes the information USDA

maintains as well as the information it does not maintain. While USDA

believes it has good information on companies' efforts to initiate and carry

out recalls, it could not tell us, for example, the average length of a recall

from start to finish or the specific length of time of each individual recall.

We believe this information should be an integral part of USDA's food

safety monitoring and oversight.

2. We added information about hazard analysis and critical control point

(HACCP) systems to the report, including the fact that plants must take

immediate corrective action to determine the cause and prevent recurrence

of the problem that caused a recall. HACCP systems notwithstanding, we

believe that USDA must have sufficient information on companies' recall

actions to assure itself that consumers are adequately protected as part of

its responsibilities for ensuring the safety of meat and poultry.

3. USDA has requested recalls solely on the basis of epidemiological data;

in fact, the initial recall request to Hudson Foods was based on

epidemiological data. This suggests that reliance on epidemiological data is

already an administrative option for USDA. Nonetheless, if USDA believes

that the current statute needs to be adjusted to allow the Food Safety and

Inspection Service to request a recall solely on the basis of epidemiological

data, and that this would be more protective of human health and food

safety, it should seek such authority.

4. While we agree that our recommendations, when implemented, will not,

by themselves, speed up the recall process, they will provide USDA with

information on whether, and where in the process, delays are occurring.

This should provide the impetus for taking action to further strengthen the

federal food safety system.
Page 43 GAO/RCED-00-195 USDA and FDA Food Recalls

Appendix VII

Comments From the Department of Health

and Human Services ApendxiVI

Note: GAO’s comments

supplementing those in

the report text appear at

the end of this appendix.
Appendix VII

Comments From the Department of Health

and Human Services

Page 44 GAO/RCED-00-195 USDA and FDA Food Recalls

See comment 1.
Appendix VII

Comments From the Department of Health

and Human Services

Page 45 GAO/RCED-00-195 USDA and FDA Food Recalls

See comment 2.

See comment 3.

See comment 4.
Appendix VII

Comments From the Department of Health

and Human Services

Page 46 GAO/RCED-00-195 USDA and FDA Food Recalls

See comment 5.
Appendix VII

Comments From the Department of Health

and Human Services

Page 47 GAO/RCED-00-195 USDA and FDA Food Recalls

GAO's Comments 1. Appendix II recognizes that FDA has issued guidance to companies and

provided model press releases to companies, and that FDA works with

companies in developing their recall strategies. However, FDA has not

issued specific guidance to companies on 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.

2. While we acknowledge that there may be several points in time that

could be considered to be “the date the company finds out about the

problem that warrants the recall,” we believe that FDA could define a

meaningful point in time to record in its database for monitoring the

company's recall performance.

3. As we stated in the draft and the final report, FDA, beginning in fiscal

year 1999, included in its recall database the recall initiation date.

4. We recognize that a company may have to issue more than one notice to

address a recall problem in its product. We believe that FDA could develop

a system that captures multiple dates of notification.

5. We believe that this information can be readily identified in a data system

by, for example, having a data field for each type of method of notification

(e.g., telephone, facismile, E-mail, letter).
Page 48 GAO/RCED-00-195 USDA and FDA Food Recalls

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