Food Safety: Controls Can Be Strengthened to Reduce the Risk of Disease
Linked to Unsafe Animal Feed (Letter Report, 09/22/2000,
GAO/RCED-00-255).

Pursuant to a congressional request, GAO provided information on the
risks to human health posed by unsafe feed consumed by food-producing
animals, focusing on the: (1) extent to which unsafe feed has been
linked to human health problems in the United States; and (2) actions
Food and Drug Administration (FDA) and the Department of Transportation
(DOT) are taking to ensure the safety of animal feed.

GAO noted that: (1) in the United States, only a relatively few
incidents of human illness have been traced to contaminated animal feed;
(2) even when public health officials are able to trace the source of a
disease to a food product, such as eggs, they cannot usually determine
if the original source of the contamination is the animal feed, the
improper handling of the product, or another factor; (3) while livestock
or poultry may in some cases be immune to the contaminants themselves,
the food product from these animals can cause human illness; (4) with
respect to bovine spongiform/encephalopathy (BSE) in the United States,
health officials haven not identified any illness in livestock or in
humans caused by this disease; (5) however, the Department of
Agriculture has several studies underway to test sheep from three
Vermont farms suspected of having bovine spongiform encephalopathy BSE;
(6) no reported incidents of human illness from chemically contaminated
animal feed have been identified in the United States; (7) however,
illnesses from this source can take years to develop and would be
difficult to link to animal feed; (8) FDA has taken some actions to
better ensure the safety of animal feed, but problems such as lack of
awareness of FDA's regulation, delays in issuing a new FDA regulation to
strengthen controls over the bacterial contamination of feed, and DOT's
failure to issue regulations for the safe transport of animal feed could
lead to human illnesses; (9) in 1997, FDA issued a regulation to prevent
BSE in the United States; (10) to assess compliance with this
regulation, FDA and state inspectors have visited over 9,100 firms, such
as farms that produce their own feed and rendering plants that process
meat scraps for animal feed; (11) inspectors found that, 1,700 firms
were not aware of the regulation and thus could produce or use animal
feed that was not in compliance; (12) FDA officials also told GAO that
the agency is developing a regulation to further strengthen controls
over bacterial and other contaminants by, among other things, directing
feed manufacturers to determine which hazards pose the greatest risks to
the safety of their products and to establish controls to minimize these
risks; (13) DOT has not issued regulations to ensure the safe
transportation of animal feed, as directed by the Sanitary Food
Transportation Act of 1990; and (14) according to DOT officials GAO
spoke with, the Department has pursued a number of regulatory,
administrative, and legislative initiatives to address the statutory
mandate.

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

 REPORTNUM:  RCED-00-255
     TITLE:  Food Safety: Controls Can Be Strengthened to Reduce the
	     Risk of Disease Linked to Unsafe Animal Feed
      DATE:  09/22/2000
   SUBJECT:  Feed industry
	     Safety regulation
	     Health hazards
	     Safety standards
	     Quality control
	     Product safety
	     Contaminated foods
	     Livestock products
IDENTIFIER:  FSIS Hazard Analysis and Critical Control Point System
	     FDA: Feed Contaminant's Program
	     FDA: Medicated Feeds Program

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GAO/RCED-00-255

A

Report to the Honorable Richard J. Durbin, United States Senate

September 2000 FOOD SAFETY Controls Can Be Strengthened to Reduce the Risk
of Disease Linked to Unsafe Animal Feed

GAO/RCED-00-255

Letter 3 Appendixes Appendix I: Comments From the Food and Drug
Administration 20

Appendix II: Comments From the Centers for Disease Control and Prevention 23

Appendix III: Comments From the President's Council on Food Safety 27

Tables Table 1: Types of Firms Inspected 11

Abbreviations

BSE bovine spongiform encephalopathy CDC Centers for Disease Control and
Prevention FDA Food and Drug Administration HACCP hazard analysis and
critical control point

Resources, Community, and Economic Development Division

Lett er

B- 285212 September 22, 2000 The Honorable Richard J. Durbin United States
Senate

Dear Senator Durbin: The Centers for Disease Control and Prevention (CDC)
estimates that each year in the United States over 5,000 people die and 76
million people become ill from unsafe food. One source of transmission of
unsafe food is animal feed, which can contain harmful bacteria, such as
Salmonella. While livestock or poultry may be immune to certain bacteria,
human beings may

not be. As a result, the food product containing these bacteria can cause
illness, and even death, in the individual consuming it. Unsafe animal feed
has also contributed to diseases such as bovine spongiform encephalopathy
(BSE) in cattle, also known as “mad cow disease.” In 1989, the
United States banned the importation of cattle and animal feed from BSE-
affected countries. BSE is thought to be linked to a fatal new human

illness, known as new variant Creutzfeldt- Jakob Disease; in March 1996, the
United Kingdom announced the first cases of this disease and linked it to
BSE. By May 2000, 61 people in the United Kingdom, Ireland, and France had
died from it, and the number and rate of new cases is increasing.

Animal feed can also be contaminated with unsafe chemicals. For example, in
1999, animal feed contaminated with dioxin, a carcinogen, caused an
estimated $850 million in losses to the Belgium livestock and poultry
industries and resulted in elevated levels of the contaminant in persons who
consumed the affected food products. Although these incidents have been
limited to European countries to date, they demonstrate the

devastating public health and economic consequences that can result from
introducing contaminants into the feed supply. Under the Federal Food, Drug,
and Cosmetic Act, as amended, the Food and Drug Administration (FDA) is
responsible for ensuring that animal feeds are safe and produce no human
health hazards when used in foodproducing animals. Under the Sanitary Food
Transportation Act of 1990, the Department of Transportation was directed to
issue new regulations to ensure that motor and rail vehicles used to
transport food and food

additives (including animal feed) do not also transport nonfood products
that would make the food products unsafe to humans or animals. For example,
in 1998, a feed ingredient became contaminated by metal

shavings while in transport, and animals in two states became ill when they
ate the feed.

Concerned about the risks to human health posed by unsafe feed consumed by
food- producing animals, you asked us to examine (1) the extent to which
unsafe feed has been linked to human health problems in the United States
and (2) the actions FDA and the Department of

Transportation are taking to ensure the safety of animal feed. To conduct
this work, we reviewed scientific studies, reports, and other literature and
spoke with experts in government, academia and private industry. 1 Results
in Brief In the United States, only a relatively few incidents of human
illness have been traced to contaminated animal feed. In terms of bacteria
causing

foodborne illnesses, although Salmonella is a known contaminant of animal
feed, a direct link between the presence of bacteria in animal feed and
human foodborne illness is difficult to document. Even when public health
officials are able to trace the source of a disease to a food product, such
as eggs, they cannot usually determine if the original source of the
contamination is the animal feed, the improper handling of the product, or
another factor. They are generally only able to determine how the food
product became contaminated in certain situations, for example, when the
bacteria identified is of an unusual strain or is from an unusual source.
FDA has identified only two such incidents in the past 30 years. For
example, in 1970, an outbreak of Salmonella that caused illness in several
people was

traced to a shipment of imported fish meal that chicken had consumed. FDA
traced the source of this contamination because it involved a relatively
rare strain of Salmonella. While livestock or poultry may in some cases be
immune to the contaminants themselves, the food product from these animals
can cause human illness. With respect to BSE in the United States, health
officials have not identified any illness in livestock or in humans caused
by this disease. However, the U. S. Department of Agriculture (USDA) has
several studies underway to test sheep from three Vermont farms suspected of
having BSE. These sheep had been imported from Belgium and the Netherlands
in 1996. Finally, no reported incidents of

1 Our review did not examine the use of antibiotics in animal feed and its
potential effect on human health. We reported on this issue in April 1999:
Food Safety: The Agricultural Use of Antibiotics and Its Implications for
Human Health (GAO/ RCED-99- 74, Apr. 28, 1999).

human illness from chemically contaminated animal feed have been identified
in the United States. However, illnesses from this source can take years to
develop and would be difficult to link to animal feed. FDA has taken some
actions to better ensure the safety of animal feed, but problems such as
lack of awareness of FDA's regulation, delays in issuing a new FDA
regulation to strengthen controls over the bacterial contamination of feed,
and the Department of Transportation's failure to issue regulations for the
safe transport of animal feed, could lead to human

illnesses. In 1997, FDA issued a regulation to prevent BSE in the United
States. To assess compliance with this regulation, FDA and state inspectors
have visited over 9,100 firms, such as farms that produce their own feed

and rendering plants that process meat scraps for animal feed. Inspectors
found that, among other things, nearly 1, 700 firms were not aware of the
regulation and thus could produce or use animal feed that was not in
compliance. FDA officials also told us that the agency is developing a
regulation to further strengthen controls over bacterial and other

contaminants by, among other things, directing feed manufacturers to
determine which hazards pose the greatest risks to the safety of their
products and to establish controls to minimize these risks. However, FDA has
not set time frames for completing this regulation. In addition, the
Department of Transportation has not issued regulations to ensure the safe
transportation of animal feed, as directed by the Sanitary Food
Transportation Act of 1990. According to Transportation officials we spoke
with, the Department has pursued a number of regulatory, administrative,

and legislative initiatives to address the statutory mandate. The regulatory
initiative, however, was not completed, primarily because the Department
lacks resources for, and expertise in, food safety. Although animal feed
contaminated during transport has caused animal deaths and illnesses, it has
not resulted in any human deaths or acute illnesses. The public health and
economic consequences that could result from the introduction of
contaminants into the feed supply could be devastating. This report is
recommending that FDA develop and implement a BSE enforcement strategy to
address the deficiencies identified in its inspections of animal feed firms
and establish a schedule for completing a risk- based approach to ensuring
the safety of animal feed. This report is also recommending that the
President's Council on Food Safety work with the Department of
Transportation and FDA, among others, to develop a

regulatory strategy for ensuring the safe transportation of animal feed.

Background Several federal agencies are responsible for ensuring the safety
of animal feed and the U. S. food supply. Under the Federal Food, Drug, and
Cosmetic Act, as amended, FDA has the authority to ensure that drugs and
feeds given to animals are safe and properly labeled, and produce no human
health hazards when used in food- producing animals. The act also gives FDA
the authority to enforce the legal limits (tolerances) set by the
Environmental Protection Agency on the amounts of pesticide residues that
can be found in or on animal feed. In addition, the Department of
Transportation (DOT) has the authority under the Sanitary Food

Transportation Act of 1990 to prescribe regulations to safely transport food
and animal feed. Finally, USDA's Animal and Plant Health Inspection Service
is responsible for ensuring the health and care of animals and for improving
agricultural productivity while contributing to the nation's economy and
public health.

In addition to the agencies that have regulatory responsibilities, CDC is
charged with using the best scientific information to monitor, investigate,
control, and prevent public health problems. CDC provides scientific
assessments of health threats and works closely with state and local health
departments to monitor the frequency of specific diseases and conduct
national surveillance. State and local agencies report known or suspected
foodborne outbreaks to CDC. CDC then uses this information to identify
patterns of related illnesses and works with state, local, and FDA officials

to identify the source. Once the source is identified, state and local
public health officials generally issue warnings to the public. To carry out
its feed safety responsibilities, FDA relies primarily on inspections of
firms that manufacture animal feed products. These firms include the
following:

Feed mills, which are plants that combine various ingredients to produce an
appropriate mix for a particular age or species of animal. Some feed mills
are licensed by FDA to manufacture feed that contains certain medications,
such as antibiotics. Ruminant feeders, 2 which are operations that feed and
care for

ruminant animals. 2 A ruminant is an animal with a four- chambered stomach,
like cattle, sheep, goats, buffalo, elk, and deer.

Rendering plants, which are firms that process animals unfit for human
consumption, meat scraps, or other slaughter by- products into animal feed
ingredients and other products. Protein blenders, which are firms that
obtain processed animal and

vegetable protein from more than one source or from more than one species
and subsequently mix, blend, or redistribute as animal feed or other
products. These firms are inspected by either FDA inspectors or state
agencies that have entered into a contract to conduct these inspections in
accordance with FDA's procedures and to be reimbursed by FDA. Under state

partnership agreements, states agree to conduct inspections under their own
authorities without federal funding and to share the results with FDA.
Inspections of these firms play a major role in ensuring the safety of the
nation's feed supply. State governments play a central role in conducting
these inspections.

During fiscal years 1998 and 1999, FDA's animal feed inspections were
conducted under two programs: Feed Contaminants and Medicated Feeds. Under
the Feed Contaminants program, inspectors investigate reports of violative
feed samples and conduct random inspections and surveillance to ensure that
the health of animals is not impaired and that human health is not
compromised by food products derived from food- producing animals fed
contaminated animal feed. The firms inspected are selected according to a
number of criteria, such as how long it has been since their last

inspection and how many problems have been noted with the firm in recent
years. Inspectors also sample and analyze animal feed for contamination by
pesticides, industrial chemicals, metal, and bacterial agents. 3 Most of
these inspections are performed by state inspectors, and FDA does not
maintain a database on the number of inspections completed or their results.
During

fiscal years 1998 and 1999, FDA devoted a total of about 27 staff years to
this program.

FDA and state inspectors conduct Medicated Feeds inspections of firms
licensed to include certain medications in the animal feed they 3 To enforce
the legal limits set by the Environmental Protection Agency on the amount of
pesticide residues that can be found in or on animal feed, FDA samples both
domestically produced and imported feeds and analyzes them for pesticide
residues. If illegal residue levels are found, FDA can invoke various
sanctions, such as seizure or injunction. FDA's monitoring focuses on feeds
for livestock and poultry because these animals ultimately become, or
produce, food for human consumption.

manufacture. Inspectors determine whether the firms are in compliance with
good manufacturing practice regulations under the Federal Food, Drug, and
Cosmetic Act, encourage voluntary corrective action by the establishment
when appropriate, and initiate administrative and/ or regulatory action
against violative firms and their products. In accordance

with statutory requirements, FDA is required to inspect registered firms
every 2 years. During fiscal years 1998 and 1999, FDA devoted a total of
about 34 staff years to this program and, together with state officials,
completed a total of 1,299 inspections: 496 by FDA, 729 by state contracts,
and 74 by partnership agreements.

To prevent the emergence of BSE through unsafe feed in the United States,
FDA issued a new regulation in June 1997 that prohibits the feeding of
certain proteins derived from mammals to ruminant animals, such as cattle.

Shortly thereafter, as a part of its Feed Contaminants and Medicated Feeds
inspection programs, FDA initiated additional inspections of feed
manufacturers. From January 1998 through January 2000, FDA and state
inspectors inspected over 9,100 firms to increase industry awareness of this
regulation. FDA told us the primary purpose of these inspections was to
educate the industry about the new required procedures. According to

FDA, it took only limited enforcement actions against firms that were not in
full compliance with the new regulation.

Almost No Human In the United States, few incidents of human illness have
been traced to Illnesses Have Been contaminated animal feed. With respect to
bacterial contamination, even

though Salmonella is a known contaminant of animal feed, FDA has Traced to
Animal Feed

identified only two incidents of human illness resulting from contaminated
in the United States

feed in the past 30 years. Such incidences may be higher, but investigators
are not generally able to trace the source of contamination beyond the
immediate food product that caused the illness. With respect to BSE, U. S.
health officials have not identified any illnesses in livestock or humans
from this disease, although USDA studies are currently underway to test
sheep on three Vermont farms to determine if they have BSE. These sheep

were imported from Belgium and the Netherlands in 1996. FDA has not
identified any incidents of human illness resulting from chemically
contaminated animal feed in the United States. However, any such illness
could take years to develop and would be difficult to link to animal feed.

Direct Link Between Animal Public health officials have identified only two
incidences of human illness Feed Contaminated With resulting from bacteria-
contaminated animal feed in the past 30 years. In

Bacteria and Human Illness 1970, an outbreak of a relatively rare strain of
Salmonella in chicken caused

Is Difficult to Document illness in several people. Because of the rarity of
the strain, FDA decided to track the source of the contamination, eventually
tracing it to imported fish

meal fed to chickens. FDA is still investigating a second incident from 1999
involving 11 Canadian children who became ill from handling pet treats
contaminated with Salmonella. FDA has established that these treats were
also sold in the United States. Animals that consume contaminated animal
feed may not become ill, but food products from these animals can cause
human illness.

More incidences of foodborne illness resulting from bacteria- contaminated
animal feed may have occurred; however, public health officials typically
only attempt to trace the source to the food product consumed by those who
became ill. When the contaminated food product is identified, public health
officials generally only try to determine the original source of the
contamination in certain situations, for example, when the bacteria
identified is of an unusual strain or is from an unusual source, such as the

pet treats. Such an investigation is rare primarily because of the
difficulty in identifying the original cause of the contamination. A food
product that contains Salmonella, for example, could have acquired the
pathogen simply because someone handling the product did not properly wash
his or her hands. Nonetheless, studies by USDA and others have found
Salmonella in animal feed, and CDC has stated that sensitive testing methods
may show that the magnitude of contamination in some animal feeds may be
extremely high.

No Incidences of BSE Have As of January 2000, USDA's Animal and Plant Health
Inspection Service had

Been Identified in the collected brain matter from nearly 10,000 cattle from
nearly every state.

United States The samples were from cows with central nervous system
disorders

displaying BSE- like symptoms. However, none of these samples tested
positive for BSE. USDA officials told us, however, that sheep on three farms
in Vermont have recently tested positive for a BSE- like disease. These
sheep had been imported from Belgium and the Netherlands in 1996. The USDA
studies are currently underway to determine if the disease is BSE or a
related disease. Health officials have not reported any incidents of new
variant Creutzfeldt- Jakob Disease in the United States.

BSE is one of the most significant threats to human health that can result
from unsafe animal feed. Researchers have been unable to fully agree on

either the agent that causes BSE or its source. Most believe that the
disease is caused by abnormal proteins found in the brains of cattle and
that the cattle contract the disease from feed containing animal by-
products.

Any case of BSE reported in the United States would increase concerns about
a related risk to public health and have a potentially major economic impact
on the domestic feed, dairy, and beef industries. The U. S. Department of
Agriculture's Animal and Plant Health Inspection Service estimates that as
of 1999, the cost of BSE in the United Kingdom had

reached $6.74 billion. As of December 31, 1999, BSE had caused over 176,000
cattle to be destroyed in the United Kingdom, and the disease has spread to
France, Portugal, and other European nations. Moreover, as of May 2000,
health officials have verified a total of 61 human deaths caused by new
variant Creutzfeldt- Jakob Disease in the United Kingdom, Ireland,

and France. 4 Direct Link Between

As of July 2000, there have been no reported cases in the United States of
Chemically Contaminated human illness resulting from chemically contaminated
animal feed. Animal Feed and Human

However, any such illness could take years to develop and would be Illness
Is Difficult to

difficult to link to animal feed. During fiscal years 1998 and 1999, less
than 3 Document

percent of animal feed samples tested for pesticides contained residue
levels above established tolerances, according to the results of FDA's
testing for its residue monitoring program. Animal feed can also be
contaminated with dioxin, which occurs naturally in the environment or can
be a by- product of a manufacturing process. In 1997, dioxin was discovered
in animal feed used for poultry, fish, hogs, and cattle. This discovery
prompted FDA to stop the use of the feed, to require producers

to test dioxin levels in the animals that had consumed the feed, and
finally, to restrict the sale of some food products. 5 Chemically
contaminated feed could result in serious economic harm. For example, in
1999, animal feed contaminated with dioxin caused an estimated $850 million
in losses to the Belgium livestock industry, loss of export markets for
Belgian products, a significant loss of confidence by 4 In 1989, the Animal
and Plant Health Inspection Service began prohibiting imports of cattle

and beef products, as well as animal feed, from BSE- affected countries. 5
Food Safety: Agencies' Handling of a Dioxin Incident Caused Hardships for
Some Producers and Processors (GAO/ RCED- 98- 104, Apr. 10, 1998).

European consumers in the safety of their food supply, and contributed to
the resignation of Belgium's Ministers of Health and Agriculture. Efforts
Are Being Made

The public health and economic consequences to the nation's feed, dairy, to
Better Ensure the meat and poultry industries that can result from
contaminants in the feed supply can be devastating. Because of this, FDA is
taking action to better

Safety of Animal Feed, ensure the safety of animal feed. However, compliance
issues with its BSE

but Further regulation and delays in issuing a new feed ingredient
regulation that will Improvements Are

strengthen controls over bacterial contamination could result in human
illness. Furthermore, according to Department of Transportation officials

Possible we spoke with, the Department has not issued any regulation or
guidance on the safe transportation of animal feed, in part because it lacks
resources and food safety expertise. BSE Regulation Has Not

To determine how firms were implementing the June 1997 BSE regulation, Been
Fully Implemented by FDA, with the assistance of state officials, inspected
over 9, 100 firms from the Feed Industry

January 1998 through January 2000. Table 1 shows the types and number of
firms inspected. Table 1: Types of Firms Inspected Type of firm Number of
firms inspected

Licensed feed mill 1, 029 Nonlicensed feed mill 4,901 Ruminant feeder 1, 400
Dairy farm 495 Renderer 211 Protein blender 121 Other a 1,027

Total 9,184

a Includes haulers and distributors of feed, and firms or persons who
receive prohibited materials directly from manufacturers. Source: FDA. The
BSE inspection results revealed that 1,688 of the 9,184 firms were not aware
of the new BSE feed regulation. Furthermore, inspection results of the 2,481
firms that were identified as handling “prohibited” material-

material that is not allowed to be fed to ruminants- revealed some serious
deficiencies. For example:

Required cautionary statement not on product label. Of the firms inspected,
699, or 28 percent, did not label their products with the required
cautionary statement that the feed should not be fed to cattle or other
ruminants. Required records not properly maintained. One- hundred and
thirtyseven firms, or about 6 percent, did not properly maintain the name
and

address of the consignee of their products, which would make it difficult to
trace sales of contaminated feed. In addition, of the 1,771 firms that
manufacture both prohibited and nonprohibited material, 361, or 20 percent,
did not have a system in place to prevent commingling and cross-
contamination, as required by the regulation.

Because renderers and FDA- licensed feed mills are at the greatest risk of
introducing BSE to a wide segment of the animal feed market, the inspection
results for these firms were particularly disturbing. For example,

Twenty- three of the 211 renderers inspected, about 11 percent, were not
aware of the BSE regulation. Twenty- seven of the 163 renderers that handle
prohibited material,

about 17 percent, did not label their products with the required cautionary
statement. Ten of the 63 renderers that manufacture both prohibited and

nonprohibited material, about 16 percent, did not have a system in place to
prevent commingling.

The results for the FDA- licensed feed mills were similar. For example,
Sixty- three of the 1, 023 mills, about 6 percent, were not aware of the

regulation. Eighty- five of the 409 mills that handle prohibited material,
about 21

percent, did not label their products with the required cautionary
statement. Thirty- seven of the 300 mills that manufacture both prohibited
and

nonprohibited material, about 12 percent, did not have a system in place to
prevent commingling.

FDA told us that as a result of the BSE inspections, two warning letters
have been issued and five firms have voluntarily recalled products. As of
July 2000, however, FDA had not completed its analysis of the inspection
results and had not updated its enforcement strategy for achieving industry
compliance with the BSE regulation. FDA also told us that the next rounds of
BSE inspections will include only those firms that handle prohibited
material. In addition, FDA told us it will direct its efforts towards those
firms or segments of the industry that are not in compliance with the

regulation. FDA Has Not Established a

FDA is drafting a new regulation to strengthen controls over bacterial and
Time Frame for Issuing a

other contaminants in animal feed but has not established a timetable for
New Regulation to its issuance. FDA told us the new regulation is intended
to limit

Strengthen Controls for contamination in feed ingredients and will require
manufacturers to (1) Microbial Contamination evaluate all hazards associated
with their feed ingredients, including but not limited to microbial hazards;
(2) determine which hazards pose a risk

to the safety of the product; and (3) establish controls to minimize these
risks. FDA also told us the new regulation would be modeled after the hazard
analysis and critical control point (HACCP) management practices

currently followed by nearly all firms that handle meat, poultry, and
seafood. 6

Recent studies of animal feed demonstrate the need for this new regulation.
For example, several recent studies by USDA and others show evidence of
Salmonella in animal feed and in rendered animal proteins that often become
ingredients in animal feed.

No Regulations Issued to As of July 2000, the Department of Transportation
had not issued

Safeguard the Transport of regulations to ensure the safety of food,
including animal feed, during

Animal Feed transport by rail vehicles or trucks, as directed by the
Sanitary Food

Transportation Act of 1990. Transportation officials pursued a number of 6
The HACCP program is designed to identify the steps in food production where
contamination is most likely to occur and then establish controls that
prevent or reduce contamination. HACCP management involves seven principles
based on scientific and technical knowledge: (1) conduct a hazard analysis,
(2) identify critical control points, (3) establish critical limits for each
critical control point, (4) establish monitoring requirements,

(5) establish corrective actions, (6) establish record- keeping procedures,
and (7) establish verification procedures. See, for example, Meat and
Poultry: Improved Oversight and Training Will Strengthen New Food Safety
System (GAO/ RCED- 00- 16, Dec. 8, 1999).

regulatory, administrative, and legislative initiatives to address the
statutory mandate but cited lack of resources and expertise in food safety
as the primary reasons for not issuing the regulations. They informed us
that for fiscal year 2000, the Department requested $150,000 to fund three
new staff positions- two of which were for sanitary food liaisons. The

sanitary food liaisons would have been responsible for developing
regulations to ensure the safety of food and feed during transport. They
further advised us that funding for these positions was denied. They did not
request funding for the positions for fiscal year 2001. Although FDA told us
its staff has the required expertise, it believes these responsibilities
should

remain with the Department of Transportation. FDA said the responsibilities
set forth in the Sanitary Food Transportation Act are an extension of
Transportation's responsibility to protect the public.

FDA told us it has documented several instances in which animal feed was
contaminated while in transport. For example, in 1998, a feed ingredient
became contaminated by metal shavings while in transport, and animals in two
states became ill when they ate the feed containing the contaminated feed
ingredient. In two earlier incidents documented by FDA, livestock became ill
or died as a result of being fed grain contaminated by a chemical that had
previously been transported in the same rail vehicle. FDA officials told us
that these incidents resulted in the illness or death of many animals.

Fortunately, the contamination did not cause any human deaths or acute
illnesses. The President's Council on Food Safety may be a vehicle for
helping to

resolve implementation issues associated with regulating animal feed during
transport. The Council, formed on August 25, 1998, by executive order of the
President, was established to improve the safety of the nation's food supply
through science- based regulation and well- coordinated inspection,
enforcement, research and education. The Council is expected to, among other
things, recommend to the President how to advance

federal efforts to implement a comprehensive science- based strategy to
improve the safety of the food supply and enhance coordination among federal
agencies, state, local and tribal governments, and the private sector.

Conclusions Few incidents of human illness in the United States have been
linked directly to contaminated animal feed because public health
investigations of foodborne illness cannot usually determine if the original
source of the

contamination is the feed, handling of the product, or another factor.
However, the serious deficiencies disclosed by recent feed manufacturer

inspections and the potentially major public health and economic
consequences that could result from the introduction of contaminants into
the feed supply, suggest a need for strong regulatory controls. These
consequences became quite clear in the United Kingdom, France, and Ireland,
where 61 persons have died since 1996 from illnesses linked to BSE; the
economic losses resulting from BSE have been estimated to

exceed $6 billion in the United Kingdom. While FDA is taking action to
strengthen control systems, unfamiliarity with FDA's new BSE regulation and
delays in issuing a new regulation to strengthen controls over bacterial
contamination of animal feed need to be addressed. Furthermore, there is a
need to ensure that animal feed is not contaminated during transport. The
President's Council on Food Safety may be a vehicle that could be of
assistance in helping the Department of Transportation and the FDA to

resolve implementation issues associated with regulating animal feed during
transport.

Recommendations for To ensure that animal feed in the United States remains
free of Executive Action

contaminants that would cause BSE, we recommend that the Commissioner of FDA
develop and implement an enforcement strategy that contains specific goals
and time frames for establishing a system to correct the deficiencies
identified during the agency's 2 years of inspecting animal feed firms and
to ensure that firms in the future continue to remain in compliance with the
regulation.

We further recommend that the Commissioner establish a schedule for
completing the agency's HACCP- based approach for ensuring the safety of
animal feeds.

To ensure the safe transportation of animal feed, we recommend that the
President's Council on Food Safety work with the Department of
Transportation and FDA, among others, to develop a strategy to regulate

animal feed while in transport. Agency Comments We provided a draft copy of
this report to FDA, CDC, the Department of Transportation, and the
President's Council on Food Safety for their review and comment. FDA agreed
with all three of our recommendations and stated that it (1) has initiated
an enforcement strategy that will correct the deficiencies identified during
the initial round of BSE inspections to help ensure a high rate of
compliance in the future; (2) has placed issuing the

new feed regulation on its priority list; and (3) agreed to cooperate with
and assist the President's Council on Food Safety and the Department of
Transportation to develop a strategy for regulating animal feed while it is
in

transit. With regard to FDA's response to the first recommendation, while we
agree that FDA has initiated an enforcement strategy, we believe that the
strategy, which was developed in December 1998, needs to be updated to
include specific goals and time frames to correct existing deficiencies and
to ensure that firms continue to remain in compliance with the

regulation. CDC said it believed the draft report inappropriately implied
that contaminated animal feed is an infrequent cause of human illness. CDC
said that contaminated animal feed could actually be an important source of
Salmonella and other causes of human illness, but important gaps in national
surveillance data make it nearly impossible to follow the chain of events
from farm to table to implicate contaminated animal feed as the

source of human illness. We have revised to our report to further highlight
that microbial agents in animal feed pose a risk to human health.

We met with officials from the Department of Transportation, including the
Associate Administrator for Hazardous Materials Safety, and they provided
oral comments on our draft report. Department officials stated that the

report provided an accurate overview of the issues, and they agreed with our
recommendation that the Department work with the President's Council on Food
Safety and FDA to develop a strategy to regulate animal feed while in
transport. In addition, the Department provided several

technical and clarifying comments that we incorporated into the report as
appropriate.

The President's Council on Food Safety concurred with the recommendation
that it should work with FDA and the Department of Transportation, among
others, to develop a strategy to regulate animal feed while in transport.

FDA and CDC provided a number of editorial and technical comments, which we
incorporated into the report as appropriate. Comments from FDA, CDC, and the
President's Council on Food Safety and our responses are included as
appendixes I through III.

Scope and To determine the extent to which unsafe feed has been linked to
human Methodology

health problems in the United States, we interviewed officials and reviewed
records from the FDA, the National Institutes of Health, CDC, and USDA's
Animal and Plant Health Inspection Service. We also discussed this issue
with USDA's Food Safety and Inspection Service and the Environmental

Protection Agency. In addition, we interviewed industry trade officials from
the American Feed Industry Association, the National Grain and Feed
Association, the National Cattlemen's Beef Association, the National Milk
Producers Federation, and the National Renderers Association. In addition,

we spoke with researchers from the Harvard Center for Risk Analysis. To
determine the actions FDA and the Department of Transportation are taking to
ensure the safety of animal feed, we reviewed inspection reports from FDA's
Feed Contaminants and Medicated Feeds inspection programs

and interviewed officials with the Department of Transportation and with FDA
about provisions for the safe transport of feed contained in the Sanitary
Food Transportation Act of 1990. We also discussed this issue with the
President's Council on Food Safety. In addition, we analyzed FDA's BSE
inspection results and reviewed its enforcement strategy for achieving
industry compliance with the BSE regulation. Finally, we interviewed FDA
officials about their efforts to address the potential for bacterial
contamination in animal feed. We also visited a feed mill to observe
procedures for manufacturing feed and analyzing feed ingredients.

We performed our review from November 1999 through August 2000 in accordance
with generally accepted government auditing standards.

As agreed with your office, unless you publicly announce its contents
earlier, we plan no further distribution of this report until 30 days from
the date of this letter. At that time, we will send copies of this report to
the congressional committees with jurisdiction over food safety issues; the
Honorable Dan Glickman, Secretary of Agriculture, and the Honorable Donna E.
Shalala, Secretary of Health and Human Services, in their capacities as co-
chairs of the President's Council on Food Safety; the

Honorable Rodney E. Slater, Secretary of Transportation; the Honorable Jane
Henney, M. D., Commissioner of the Food and Drug Administration; the
Honorable Neal Lane, Co- Chair, President's Council on Food Safety; the
Honorable Jeffrey P. Koplan, Director, Centers for Disease Control and
Prevention; and the Honorable Jacob J. Lew, Director, Office of

Management and Budget; and other interested parties. We will also make
copies available upon request.

If you or your staff have any questions about this report, please contact me
at (202)- 512- 5138. Key contributors to this report were Robert C. Summers,
John M. Nicholson Jr., Stuart Ryba, and Janice M. Turner.

Sincerely yours, Lawrence J. Dyckman, Director, Food and

Agriculture Issues

Appendi xes Comments From the Food and Drug

Appendi x I Administration

Comments From the Centers for Disease

Appendi x II

Control and Prevention Note: GAO's comments supplementing those in the
report text appear at the end of this appendix.

See comment 1.

See comment 2. See comment 3.

Now on p. 10. See comment 4.

See comment 5. Now on pp. 9 and 10. See comment 4.

Now on p. 10. See comment 4.

See comment 5.

GAO's Comments 1. We agree. Contaminated feed could be an important source
of Salmonella and other causes of human illness. However, as we state in

the report, a direct link between the presence of bacteria in feed and human
illness is difficult to document. 2. We agree and have revised our report to
recognize the findings of the U. S. Animal Health Association. 3. We agree
and have revised our report to include data from the U. S.

Animal Health Association. 4. We agree and have revised our report. 5. We
agree. However, because FDA has not completed its analyses of the

BSE inspection data, we were unable to compare the results of (1) major
producers' awareness of the regulations versus small producers' awareness
and (2) inspection deficiency rates in 1998 compared with 1999.

Comments From the President's Council on

Appendi x II I Food Safety (150161) Lett er

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Appendix I

Appendix I Comments From the Food and Drug Administration

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Appendix I Comments From the Food and Drug Administration

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Appendix II

Appendix II Comments From the Centers for Disease Control and Prevention

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Appendix II Comments From the Centers for Disease Control and Prevention

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Appendix II Comments From the Centers for Disease Control and Prevention

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Appendix III

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