GAO

United States General Accounting Office

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

Page 1 GAO/RCED-00-255 Safety of Animal Feed

Contents

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
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Page 3 GAO/RCED-00-255 Safety of Animal Feed

United States General Accounting Office

Washington, D.C. 20548

Resources, Community, and

Economic Development Division

B-285212 Letr

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 
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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).
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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.
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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.
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• 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.
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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 

Illnesses Have Been 

Traced to Animal Feed 

in the United States

In the United States, few incidents of human illness have been traced to 

contaminated animal feed. With respect to bacterial contamination, even 

though Salmonella is a known contaminant of animal feed, FDA has 

identified only two incidents of human illness resulting from contaminated 

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.
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Direct Link Between Animal 

Feed Contaminated With 

Bacteria and Human Illness 

Is Difficult to Document

Public health officials have identified only two incidences of human illness 

resulting from bacteria-contaminated animal feed in the past 30 years. In 

1970, an outbreak of a relatively rare strain of Salmonella in chicken caused 

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 

Been Identified in the 

United States

As of January 2000, USDA’s Animal and Plant Health Inspection Service had 

collected brain matter from nearly 10,000 cattle from nearly every state. 

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 
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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 

Chemically Contaminated 

Animal Feed and Human 

Illness Is Difficult to 

Document 

As of July 2000, there have been no reported cases in the United States of 

human illness resulting from chemically contaminated animal feed. 

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

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

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).
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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 

to Better Ensure the 

Safety of Animal Feed, 

but Further 

Improvements Are 

Possible

The public health and economic consequences to the nation’s feed, dairy, 

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 

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

regulation and delays in issuing a new feed ingredient regulation that will 

strengthen controls over bacterial contamination could result in human 

illness. Furthermore, according to Department of Transportation officials 

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 

Been Fully Implemented by 

the Feed Industry

To determine how firms were implementing the June 1997 BSE regulation, 

FDA, with the assistance of state officials, inspected over 9,100 firms from 

January 1998 through January 2000. Table 1 shows the types and number of 

firms inspected. 

Table 1: Types of Firms Inspected

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—

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

Othera 1,027

Total 9,184
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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. 
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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 

Time Frame for Issuing a 

New Regulation to 

Strengthen Controls for 

Microbial Contamination

FDA is drafting a new regulation to strengthen controls over bacterial and 

other contaminants in animal feed but has not established a timetable for 

its issuance. FDA told us the new regulation is intended to limit 

contamination in feed ingredients and will require manufacturers to (1) 

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 

Safeguard the Transport of 

Animal Feed

As of July 2000, the Department of Transportation had not issued 

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

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).
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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 
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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 

Executive Action

To ensure that animal feed in the United States remains free of 

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 
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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.
B-285212

Page 17 GAO/RCED-00-255 Safety of Animal Feed

Scope and 

Methodology

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

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 
B-285212

Page 18 GAO/RCED-00-255 Safety of Animal Feed

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
Page 19 GAO/RCED-00-255 Safety of Animal Feed
Page 20 GAO/RCED-00-255 Safety of Animal Feed

Appendix I

Comments From the Food and Drug Apendxies

Administration ApendxiI
Appendix I

Comments From the Food and Drug 

Administration

Page 21 GAO/RCED-00-255 Safety of Animal Feed
Appendix I

Comments From the Food and Drug 

Administration

Page 22 GAO/RCED-00-255 Safety of Animal Feed
Page 23 GAO/RCED-00-255 Safety of Animal Feed

Appendix II

Comments From the Centers for Disease 

Control and Prevention ApendxiI

Note: GAO’s comments 

supplementing those in the 

report text appear at the end 

of this appendix.

See comment 1.
Appendix II

Comments From the Centers for Disease 

Control and Prevention

Page 24 GAO/RCED-00-255 Safety of Animal Feed

See comment 2.

See comment 3.
Appendix II

Comments From the Centers for Disease 

Control and Prevention

Page 25 GAO/RCED-00-255 Safety of Animal Feed

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.
Appendix II

Comments From the Centers for Disease 

Control and Prevention

Page 26 GAO/RCED-00-255 Safety of Animal Feed

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.
Page 27 GAO/RCED-00-255 Safety of Animal Feed

Appendix III

Comments From the President's Council on 

Food Safety ApendxiI

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