Food Safety: Actions Needed by USDA and FDA to Ensure That Companies
Promptly Carry Out Recalls (Letter Report, 08/17/2000, GAO/RCED-00-195).

Pursuant to a congressional request, GAO provided information on
voluntary food recall programs, focusing on: (1) the number of food
recalls documented by the Department of Agriculture (USDA) and the Food
and Drug Administration (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 FDA-requested recalls; and (4) the economic impact
of recalls on affected companies, to the extent identifiable.

GAO noted that: (1) USDA and FDA documented more than 3,700 food recalls
from the mid-1980s through 1999; (2) 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; (3) FDA, which
began compiling such data electronically in 1986, identified 3,248
recalls of other foods from fiscal year (FY) 1986 through FY 1999; (4)
neither agency has tracked whether recalls were associated with
outbreaks of foodborne illnesses over those time periods; (5) 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; (6) likewise,
FDA, according to its staff's recollections and data on illness
outbreaks that it has collected since FY 1997, identified 49 recalls for
1997 through 1999 that were associated with outbreaks of foodborne
illnesses; (7) 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; (8) however, the agencies generally were
unable to determine how the food became contaminated; (9) according to
USDA and FDA officials, efforts to determine the cause of contamination
are generally not successful because so much time passes--up to several
weeks or months--before an illness is linked to a specific food; (10)
recently implemented systems by the Centers for Disease Control and
Prevention (CDC) to track foodborne illnesses could reduce that lag time
and may improve the agencies' ability to determine points of
contamination; (11) 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; (12) neither USDA nor FDA
compiles information on the economic impact of recalls on affected
companies; (13) similarly, the food industry associations GAO contacted
do not collect this information; (14) however, according to food
industry officials, recalls can have a significant economic impact on
affected companies through lost sales and food retrieval costs; (15) 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; and (16) in addition, following a recall,
consumers may stop buying a company's products or switch to another
company's brand for future purchases.

--------------------------- Indexing Terms -----------------------------

 REPORTNUM:  RCED-00-195
     TITLE:  Food Safety: Actions Needed by USDA and FDA to Ensure That
	     Companies Promptly Carry Out Recalls
      DATE:  08/17/2000
   SUBJECT:  Contaminated foods
	     Health hazards
	     Economic analysis
	     Consumer protection
	     Food industry
	     Food inspection
IDENTIFIER:  E. coli Bacteria
	     CDC/FDA/USDA Foodborne Diseases Active
	     Surveillance Network

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GAO/RCED-00-195

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

48

Resources, Community, and
Economic Development Division

B-285727

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 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 FDA-requested 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.

USDA and FDA documented more than 3,700 food recalls from the mid-1980s
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 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.

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 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 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

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
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.

       USDA-documented food recalls        FDA-documented food recalls

 Yeara Total  Associated with outbreaks    Total  Associated with outbreaks
              of foodborne illness                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     b                            c      b
 1984  10     b                            c      b
 Total 515    12                           3,248  49

aCalendar year for USDA; fiscal year for FDA.

bThe agencies did not have this information.

cFDA 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.

Source: USDA and FDA.

Regarding the number of documented recalls since 1984, the 3,248
FDA-documented 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 USDA-documented
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 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.

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.

                            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

aOne 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.

                                                         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

Source: USDA and FDA data.

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
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.

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,
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.

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,
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
USDA-regulated 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.

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.

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.

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.

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

ï¿½ 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.

ï¿½ 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.

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 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.

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

Scope and Methodology

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 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.

Selected Information on USDA's and FDA's Recall Programs

This appendix discusses the phases of USDA's and FDA's food recall programs.

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.

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.

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 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.

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

ï¿½ 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;

ï¿½ 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;

ï¿½ 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

ï¿½ 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
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.

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.

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
state-inspected retail establishments.

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 seizure11. 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.12

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) state
agencies discovery of violations through inspections, surveillance sampling,
follow-ups on complaints, or other activities.

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.
State-initiated recalls are those initiated by the regulated firm after
having out-of-compliance 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.

                     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               748     202            298            248
 (percentage)
                     (100%)  (27%)          (40%)          (33%)

Source: FDA.

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 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
life-threatening 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 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
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.

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.13 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.

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.

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.

Bacterial and Viral Contaminants Identified in Recalls Associated With
Outbreaks of Foodborne Illnesses

 Bacterial           Incubation                       Some foods that have
 contaminant         period        Symptoms           contained the
                                                      contaminant

                     1 to10 days;  Bloody diarrhea,   Ground beef, salami,
 E.coli 157:H7       usually 3 to 4abdominal cramps,  lettuce,
                     days          little or no       unpasteurized milk,
                                   fever.             and juice.
 Listeria                          Fever, muscle
 monocytogenes                     aches, and         Hot dogs and packaged
                     2 to 8 weeks                     meats; uncooked
                                   sometimes nausea
                                   and/or diarrhea.   vegetables.
                                   Abdominal cramps,
                                   fever, and         Foods of animal
 Salmonella          12 to 72 hoursdiarrhea, and      origin such as beef,
                                   sometimes nausea   poultry, milk, or
                                   and vomiting.      eggs.
                                   Diarrhea,
                                   vomiting, nausea,
 Staphyloccocus      30 minutes to abdominal cramps,  Fermented sausage and
 toxin               8 hours       and exhaustion     salads.
                                   lasting 24 to 48
                                   hours.
                                   Diarrhea, often
 Vibrio                            with abdominal
 parahaemolyticus    24 hours      cramps, nausea,    Raw oysters.
                                   vomiting, fever,
                                   and chills.
 Viral contaminant

 Hepatitis A                       Some people may
                                   have no symptoms.
                                   If symptoms occur, Cold cuts and
                     15 to 50 days,they can include   sandwiches, fruits
                     with an       fever, fatigue,    and fruit juices,
                     average of 28 loss of appetite,  milk, vegetables,
                     days          nausea, abdominal  salads, shellfish,
                                   cramps, dark       and iced drinks.
                                   urine, and
                                   jaundice.
                                   Vomiting,
 Norwalk or                        abdominal cramps,  Shellfish and salad
 Norwalk-like        24 to 48 hoursdiarrhea, nausea,  ingredients.
                                   and headache.

Cases in Which FDA Believed Companies Delayed Initiating a Recall

The following describes FDA's experiences with companies the agency believes
delayed initiating a recall.

ï¿½ 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.

ï¿½ 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.

ï¿½ Dietary supplements that contained ma huang (an amphetamine-like 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.

ï¿½ 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.

ï¿½ 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.

ï¿½ Cold smoked fish products contaminated with listeria monocytogenes. This
recall, which occurred in March 2000,14 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.

ï¿½ 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.

ï¿½ 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.

ï¿½ 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.

Two Class I Recalls in Which USDA Appeared to be Slow and/or Indecisive

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.

Comments From the U.S. Department of Agriculture

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.

Comments From the Department of Health and Human Services

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).

Related GAO Products

Food Safety: Improvements Needed in Overseeing the Safety of Dietary
Supplements and "Functional Foods" (GAO/RCED-00-156, July 11, 2000).

Food Safety: U.S. Needs a Single Agency to Administer a Unified, Risk-Based
Inspection System (GAO/T-RCED-99-256, Aug. 4, 1999).

Food Safety: U.S. Lacks a Consistent Farm-to-Table Approach to Egg Safety
(GAO/RCED-99-184, July 1, 1999).

Food Safety: Experiences of Four Countries in Consolidating Their Food
Safety Systems (GAO/RCED-99-80, Apr. 20, 1999).

Food Safety: Opportunities to Redirect Federal Resources and Funds Can
Enhance Effectiveness (GAO/RCED-98-224, Aug. 6, 1998).

Food Safety: Federal Efforts to Ensure the Safety of Imported Foods Are
Inconsistent and Unreliable (GAO/RCED-98-103, Apr. 30, 1998).

Food Safety: Agencies' Handling of a Dioxin Incident Caused Hardships for
Some Producers and Processors (GAO/RCED-98-104, Apr. 10, 1998).

Food Safety: Information on Foodborne Illnesses (GAO/RCED-96-96, May 8,
1996).

Food Safety: Changes Needed to Minimize Unsafe Chemicals in Food
(GAO/RCED-94-192, Sept. 26, 1994).

Food Safety: A Unified, Risk-Based Food Safety System Needed
(GAO/T-RCED-94-223, May 25, 1994).

Food Safety: Risk-Based Inspections and Microbial Monitoring Needed for Meat
and Poultry (GAO/RCED-94-110, May 19, 1994).

Food Safety and Quality: Uniform, Risk-Based Inspection System Needed to
Ensure Safe Food Supply (GAO/RCED-92-152, June 26, 1992).

(150163)
  

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.

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.

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.

7. Beginning in fiscal year 1999, FDA included in its recall database the
recall initiation date.

8. Epidemiological data are data showing the distributions and determinants
of health-related conditions or events in specified populations.

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.

10. According 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.

11. 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.

12. 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.

13. Undeclared allergens include peanuts and other tree nuts (chestnuts,
brazil nuts, walnuts, hazelnuts, pecans, pine nuts, and cashews); eggs; and
sulfites.

14. Because this recall occurred in 2000, it was not among the recalls
enumerated earlier for the period 1984 through 1999.
*** End of document. ***