United States General Accounting Office

GAO Report to the Chairman, Permanent

Subcommittee on Investigations,

Committee on Governmental Affairs,

U.S. Senate

October 1999 FOOD SAFETY

Agencies Should

Further Test Plans for

Responding to

Deliberate

Contamination

GAO/RCED-00-3

GAO United States

General Accounting Office

Washington, D.C. 20548

Resources, Community, and

Economic Development Division

B-283528 

October 27, 1999

The Honorable Susan M. Collins

Chairman, Permanent Subcommittee on Investigations

Committee on Governmental Affairs

United States Senate

Dear Madam Chairman:

Concerned about the vulnerability of the nation’s food supply to acts of

deliberate contamination with a biological agent, you asked that we review

the preparedness of the federal food safety regulatory agencies to respond

to acts or threats of deliberate food contamination, including those by

terrorists. The federal food safety agencies primarily concerned with such

contamination are the U.S. Department of Agriculture’s (USDA) Food Safety

and Inspection Service (FSIS), which regulates the safety of meat, poultry,

and some egg products, and the Department of Health and Human

Services’ Food and Drug Administration (FDA), which regulates the safety

of all other food products.1

 In some cases, such as eggs, the

responsibilities of these two agencies overlap. Other federal, state, and

local agencies also share responsibility for the safety of the nation’s food

supply.

Specifically, you asked us to (1) determine the extent to which food has

been deliberately contaminated with a biological agent (bacteria, virus, or

toxin) or threatened to be contaminated with such an agent and

(2) describe the plans and procedures that federal food safety regulatory

agencies have for responding to threats and acts of deliberate food

contamination with a biological agent.

Results in Brief To date, deliberate contamination of food with a biological agent has

rarely occurred in the United States, according to federal agencies. We

identified two such acts since 1984, both of which produced short-term

illnesses among a combined total of about 765 people, but no deaths.

Similarly, threats of contamination with a biological agent occur

infrequently: From October 1995 through March 1999, federal agencies

reported receiving three such threats—two of these were hoaxes, and the

other is still an open investigation.

1

Food Safety: U.S. Needs a Single Agency to Administer a Unified, Risk-Based Inspection System

(GAO/T-RCED-99-256, Aug. 4, 1999).

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FDA has written procedures for contacting key FDA and other federal

officials and experts to quickly develop an approach to respond to threats

or acts of contamination. The approach may involve assessing the

credibility of a threat or requesting a recall of the contaminated food. FSIS

also has written procedures for responding to acts of contamination,

which include conducting a preliminary investigation to assess the health

hazards and, if necessary, requesting a recall. For threats of

contamination, FSIS is developing a plan that will include coordination

steps with other affected federal agencies.

We are recommending that the effectiveness of federal food safety

procedures be tested using a variety of scenarios involving food

deliberately contaminated with biological agents and including various

players, such as state and local agencies.

Background A number of federal, state, and local agencies have responsibilities for

responding to incidents of food contamination. FSIS and FDA lead the

federal food safety efforts and play a key role in removing contaminated

food from the marketplace. In addition, these two agencies and the

Department of Health and Human Services’ Centers for Disease Control

and Prevention (CDC) may work with state and local health departments to

investigate foodborne illnesses.2

 Finally, the Department of Justice’s

Federal Bureau of Investigation (FBI) may lead criminal investigations

associated with incidents of deliberate food contamination.

Biological agents can be introduced into food either

inadvertently—through poor food-handling or food-processing

techniques—or deliberately. Deliberate food contamination with a

biological agent can be identified (1) during an investigation of an

outbreak of a foodborne illness or (2) by a warning or threat of

contamination. Many investigations of foodborne outbreaks are conducted

each year, but distinguishing between deliberate and inadvertent

contamination of a foodborne outbreak can be difficult. Moreover, it is

often difficult to associate an outbreak of foodborne illness with a specific

incident of contamination. Food contamination can result in illnesses that

range from temporary maladies, which may not require medical treatment;

to acute and chronic illnesses, such as kidney failure in infants; to death.

2

According to CDC, it also has the overall responsibility to lead an effort to upgrade the national public

health capability to counter bioterrorism and, in fulfilling this responsibility, is preparing a strategic

plan for bioterrorism preparedness and response.

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B-283528 

Under federal law, acts or threats of deliberate food contamination using a

biological agent can be investigated and prosecuted as acts of tampering

or terrorism.3

 The Federal Anti-Tampering Act of 1983 was enacted after

an unknown individual(s) contaminated Tylenol packages with cyanide,

killing seven people in the Midwest. This law makes it a federal crime to

tamper with certain consumer products, including food, that travel in

interstate commerce. USDA’s Office of Inspector General, FDA’s Office of

Criminal Investigations, and the FBI have concurrent jurisdiction to

investigate tampering of food products. With few exceptions, the agency

responsible for regulating the affected product—FDA or USDA—is the lead

agency for the criminal investigation. If the food contamination appears to

be caused by a terrorist, then the FBI is the lead criminal investigative

agency. Terrorism is a deliberate act or threat committed by an individual

or group for political or social objectives, according to the FBI.

4

 Individuals

can also be prosecuted for deliberate actions that result in the adulteration

of meat, poultry products, and other food under the Federal Meat

Inspection Act, the Poultry Products Inspection Act, and the Federal Food,

Drug, and Cosmetics Act, respectively.

Deliberate Food

Contamination Using

a Biological Agent Is

Infrequent

Acts or threats of deliberate food contamination using a biological agent

have been rare in the United States, according to federal agencies. We

identified two such acts in the last 15 years. The bacterial pathogens used

in these incidents—Salmonella and Shigella—cause severe diarrhea and

death in certain vulnerable groups. The Salmonella case is considered the

only act of terrorism using a biological agent in the United States,

according to the FBI. Similarly, threats of such contamination have been

rare—three were reported by federal officials from October 1995 through

March 1999.

The first act of deliberate contamination occurred in September 1984,

when 751 persons became ill with gastroenteritis, an inflammation of the

stomach and intestines. The local health department, with assistance from

CDC, found through its investigation that food at salad bars was

contaminated with Salmonella Typhimurium.5

 More than a year later, the

3

18 U.S.C. section 1365; 18 U.S.C. section 175-178 and 2331-2339; and 50 U.S.C. chapter 40.

4

There is no uniform definition of terrorism among federal government agencies.

5

The Salmonella germ is a group of bacteria that can cause diarrheal illness in humans. In the United

States, the most common types are Salmonella Typhimurium and Salmonella Enteritidis. Many raw

foods of animal origin (eggs, poultry, and meat) have naturally occurring pathogens, such as

Salmonella, but thorough cooking kills them. Ready-to-eat foods that are contaminated with

Salmonella and are eaten without cooking may cause illness.

Page 3 GAO/RCED-00-3 Agencies’ Response to Deliberate Contamination
B-283528 

FBI learned through a former member of a religious cult that the cult had

used the Salmonella to contaminate the food. The cult’s intent was to

incapacitate people so they would be unable to vote in a local election.

Because of the political intent, the FBI subsequently considered the

incident as an act of terrorism. Two former members pled guilty to

tampering with consumer products under the Federal Anti-Tampering Act

of 1983. They were each sentenced to 4-1/2 years in prison.

The second act, in October 1996, affected 13 persons who developed

severe diarrhea. Twelve of these individuals worked in a laboratory at a

large medical facility, and the other had eaten food brought home from

work. No deaths resulted, but five individuals were treated and released

from emergency centers, and four were hospitalized with acute diarrhea.

Within 4 days, state and local public health officials determined that the

affected individuals had been infected with the same strain of Shigella

dysenteriae, which was also found in leftover food at the laboratory.

Because this strain of bacteria is generally found only in the developing

world, public health officials suspected that the food was deliberately

contaminated. The local government successfully prosecuted the

responsible individual, who was sentenced to 20 years in prison.

Three threats of deliberate food contamination with a biological

agent—two cases were determined to be hoaxes and the other is still an

open investigation—occurred from October 1995 through March 1999,

according to the federal officials we contacted. Two involved

FDA-regulated food, while the other was an FSIS-regulated product.

Specifically:

• In the first threat, in March 1997, a disgruntled employee made financial

demands on a bottling plant company, stating that a carbonated beverage

had been contaminated with a biological agent. FDA’s Office of Criminal

Investigations and the FBI jointly investigated the case and within 1 week

determined that the claim was a hoax. The defendant was sentenced in

September 1997 to 1 year in prison and 1 year on probation.

• In the second case, in December 1998, a police department received a call

directing them to locate a note. The note indicated that a person

associated with a terrorist group threatened to contaminate meat with a

biological agent at an FSIS-regulated slaughter and processing facility. A

large response effort was undertaken. The FBI and USDA’s Office of

Inspector General conducted a detailed search of the plant and its

warehouses to determine whether products had been tampered with. FSIS,

with advice from CDC and the Occupational Safety and Health

Page 4 GAO/RCED-00-3 Agencies’ Response to Deliberate Contamination
B-283528 

Administration, evaluated the health risk. The FBI and USDA’s Office of

Inspector General interviewed over 800 individuals to identify and

eliminate suspects. Within 3 days, the company was allowed to distribute

its products. The case is still open. The responsible individual has not been

identified.

• In the third case, in March 1999, a state agriculture department was

notified that a note had been found alleging that milk had been

contaminated with a biological agent. Within hours, state and local public

health and law enforcement agencies, as well as the state agriculture

department, quarantined the suspected milk, and the FBI launched a

criminal investigation. In the same period, the plant, at the request of FDA

and the state agriculture department, halted production. The case was

confirmed as a hoax within 12 hours; no criminal charges were brought.

FDA and FSIS Have or

Are Developing

Procedures to

Respond to Deliberate

Food Contamination

Both FDA and FSIS have written policies and procedures for responding to

acts of deliberate food contamination with a biological agent. FDA has

written procedures for responding to threats of contamination as well. FSIS

is developing procedures for responding to such threats.

FDA Has Procedures to

Respond to Threats or Acts

of Deliberate

Contamination

FDA has procedures to respond 24 hours a day to threats or acts of

deliberate contamination with a biological agent. These procedures guide

the investigation of a possible food contamination incident and, if

necessary, the removal of contaminated food from the marketplace. More

specifically, FDA headquarters is primarily responsible for coordinating the

initial response to an incident. Typically, this effort involves first notifying

CDC, FBI, USDA, FDA’s Office of Criminal Investigations, industry

representatives, and/or other countries to alert them to the possibility of

contaminated food. Next, the procedures call for FDA headquarters to

contact key officials and field staff to share information and determine

FDA’s best course of action to protect public health. At the same time, FDA

initiates an investigation—generally led by its field staff—to determine,

among other things, the source and extent of contamination. This

investigation can include (1) interviewing affected persons, medical

personnel, local and state health officials, and law enforcement officials;

(2) sampling any suspected product; and (3) determining the specific

pathogen and food involved. Finally, on the basis of the investigation

results, FDA can request the manufacturer or distributor to recall the

product. If the manufacturer or distributor does not voluntarily comply

Page 5 GAO/RCED-00-3 Agencies’ Response to Deliberate Contamination
B-283528 

with FDA’s recall request, the agency can request (1) states to immediately

embargo the product, (2) the Department of Justice to file a complaint to

prevent the company from further distributing the product, and/or (3) the

Department of Justice to seek a court order to allow FDA to seize the

contaminated food. In addition to the investigation that may result in the

possible recall of deliberately contaminated food, the FBI and/or FDA’s

Office of Criminal Investigations may conduct a criminal investigation of

the incident. This investigation begins as soon as it is suspected that the

contamination was caused deliberately.

FDA officials believed their procedures worked well in the case of the

March 1999 milk contamination threat. However, on the basis of this

incident, they slightly modified their procedures. The key modification

instructed field staff to let the FBI—rather than FDA—collect food samples

in situations where it is suspected that a terrorist contaminated the food

with a biological agent. Another modification directed field staff to take a

new step—alerting the local FDA Office of Criminal Investigations and the

local FBI office to possible criminal activity. While FDA headquarters would

also notify the FBI, this additional step is designed to ensure redundancy in

order to provide a fail-safe notification system.

FSIS Has Procedures for

Responding to Acts of

Deliberate Food

Contamination and Is

Developing Procedures for

Threats

Like FDA, FSIS has written procedures to evaluate the public health risk

posed by contaminated food and to determine whether a recall needs to be

requested. However, the agency does not have procedures for responding

to threats of food contaminated with a biological agent.

In August 1999, FSIS developed a manual that consolidates its procedures

for responding to reports of deliberately and inadvertently contaminated

meat and poultry. Under these procedures, the agency conducts a

preliminary investigation to help determine whether a recall of the product

is warranted. Like FDA’s investigation procedures, FSIS’ procedures may

have staff interview affected persons, contact state and local health

departments, and collect samples. If this investigation indicates a recall is

necessary, FSIS convenes a recall committee, which makes a final decision.

In unusual cases, FSIS may call upon a team of its scientists to assess

public health hazards, such as those posed by pathogens that FSIS does not

normally investigate. If FSIS requests a recall, it asks the manufacturer or

distributor to develop an action plan and then monitors the company’s

effort. If the company refuses to recall the contaminated product, the

agency may detain the product for 20 days while seeking a court order to

seize it. Although FSIS does not have the authority to enforce a recall, the

Page 6 GAO/RCED-00-3 Agencies’ Response to Deliberate Contamination
B-283528 

agency has not used its detention authorities because no company has

refused a recall request.

The December 1998 threat of meat contamination prompted FSIS to begin

developing a plan to respond to threats of contamination. The plan will

cover tampering and terrorism, and will include, among other things,

coordination activities for emergency response planning. FSIS expects to

complete the plan by December 1999.

For the December 1998 threat, USDA used its congressionally mandated

Food Emergency Rapid Response and Evaluation Team for the first time.

The team is designed to quickly bring together all the different USDA

agencies that may need to respond to a food emergency. FSIS is the lead

agency for the team, which consists of high-ranking departmental officials

and is chaired by the Under Secretary for Food Safety, who also oversees

FSIS. During the December 1998 threat, the team was used to inform top

departmental officials about the nature and status of the Department’s

response. Since its creation in April 1998, the team has met quarterly to,

among other things, develop its charter and a departmentwide plan for

food emergencies.

In addition to establishing the emergency response team, the Department

recently took another action to improve its ability to deal with incidents of

deliberate food contamination. In August 1999, USDA and the Department

of Defense jointly planned and conducted a multiagency exercise in which

a terrorist, without warning, deliberately contaminated FSIS-regulated food

with a biological agent.6

 Participants included numerous USDA agencies,

FDA, CDC, the FBI, a state agriculture department, state and local health

departments, local physicians, and industry. The exercise gave the

agencies a chance to familiarize themselves with each other’s roles and

responsibilities in responding to such a terrorist incident. USDA is awaiting

the evaluation of the exercise, which is being done by a Department of

Defense contractor.

Conclusions Although few actual incidents or threats of deliberate food contamination

with a biological agent have occurred to date, there is little assurance that

this track record will continue. Consequently, it is important that federal

food safety regulatory agencies be prepared to respond quickly to protect

6

During this exercise, the participants progressed through a scenario and reacted as if the situation

were real. Combating Terrorism: Analysis of Federal Counterterrorist Exercises

(GAO/NSIAD-99-157BR, June 25, 1999) discusses the 201 counterterrorism exercises conducted by the

federal government in recent years.

Page 7 GAO/RCED-00-3 Agencies’ Response to Deliberate Contamination
B-283528 

the public health. FDA and FSIS have or are in the process of developing

response plans or procedures for contamination incidents. However, the

effectiveness of these procedures is largely untested. The recent USDA

exercise to test federal, state, and industry responsiveness to a

hypothetical contamination incident was certainly a reasonable start in

assessing the effectiveness of current plans and procedures. However, this

exercise was limited to examining how effectively the food safety system

responded to one of many possible sets of circumstances in which food

could be deliberately contaminated with a biological agent. For example,

the exercise did not examine how the system would respond to deliberate

contamination involving food regulated by FDA or food jointly regulated by

FSIS and FDA. More extensive testing of federal, state, local, and industry

responses to a variety of different types of contamination incidents would

help ensure that appropriate plans and procedures are in place to deal

with actual cases of deliberate food contamination.

Recommendation To better ensure the effectiveness of the federal food safety regulatory

agencies’ response to deliberate food contamination using a biological

agent, we recommend that the Secretaries of Agriculture and Health and

Human Services direct the Under Secretary for Food Safety and the

Commissioner, Food and Drug Administration, respectively, to test the

effectiveness of their response plans and procedures, using simulated

exercises and, where appropriate, to modify their plans and procedures on

the basis of these tests. The exercises should be designed to evaluate the

effectiveness of responses by federal, state, and local agencies, as well as

industry, to a variety of incidents of deliberate food contamination with a

biological agent.

Agency Comments We provided a draft of this report to FDA, USDA, CDC, and the FBI for review

and comment. We met with FDA officials, including the Senior Advisor for

Regulatory Policy, who agreed with our recommendation and said FDA

would implement it as resources become available. We also met with USDA

officials, including the Deputy Assistant to the Assistant Deputy

Administrator for District Enforcement Operations, who also agreed with

our recommendation. These officials suggested that the Congress ensure

adequate funding for food safety regulatory agencies to test the

effectiveness of their plans. In response to the recommendation in our

draft report, USDA stated that, to the extent possible, it will develop and

execute realistic exercises using available intelligence information

concerning methods of introduction, specific biological or chemical agents

Page 8 GAO/RCED-00-3 Agencies’ Response to Deliberate Contamination
B-283528 

used, and other pertinent information. USDA also said it will use lessons

learned from both the exercises and the intelligence community to help

design additional scenarios. Although CDC did not comment specifically on

our recommendation, the agency agreed that it is important that federal

food safety regulatory agencies be prepared to respond quickly to protect

the public health against acts of deliberate food contamination with a

biological agent. Furthermore, while CDC recognized that FDA and FSIS are

the primary food safety regulatory agencies, it pointed out that it has the

overall responsibility to lead an effort to upgrade the national public

health capability to counter bioterrorism. To fulfill that responsibility, CDC

is preparing a strategic plan for bioterrorism preparedness and response.

We have incorporated this information into our report. In addition, CDC,

FDA, and USDA made technical clarifications, which were incorporated as

appropriate. The FBI had no comments on the draft report.

Scope and

Methodology

To determine the extent to which food in the United States has been

threatened or deliberately contaminated with a biological agent, we

interviewed and obtained information from FDA, USDA, and the FBI on

threats and acts of deliberate food contamination and terrorism. The

information does not include possible cases that may have occurred and

been investigated by state and local agencies but not reported to the three

federal agencies. We also conducted a literature search and interviewed

officials from CDC and selected state health agencies to ensure the

completeness of our information.

To determine what plans and procedures federal food safety regulatory

agencies have to respond to deliberate food contamination using a

biological agent, we reviewed the following agency documents: emergency

plans, procedures, guidelines, manuals, memoranda of understanding,

presidential decision directives on terrorism, the Terrorism Incident

Annex to the Federal Response Plan, the FBI’s draft Concept of Operations

Plan, the FBI’s Weapons of Mass Destruction Incident Contingency Plan,

Health and Human Services’ (HHS) Health and Medical Services Support

Plan for the Federal Response to Acts of Chemical/Biological Terrorism,

and budget documents. In addition, we interviewed agency officials from

USDA, including FSIS, the Office of Inspector General, and the Agricultural

Research Service; HHS, including the Office of Emergency Preparedness,

CDC, and FDA and its Office of Criminal Investigations; and the FBI.

We conducted our review from February 1999 through September 1999 in

accordance with generally accepted government auditing standards.

Page 9 GAO/RCED-00-3 Agencies’ Response to Deliberate Contamination
B-283528 

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

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

this report. At that time, copies of this report will be sent to the Honorable

Carl Levin, Ranking Minority Member, Permanent Subcommittee on

Investigations, Senate Committee on Governmental Affairs; the Honorable

Dan Glickman, Secretary of Agriculture; the Honorable Donna E. Shalala,

Secretary of Health and Human Services; the Honorable Catherine E.

Woteki, Ph.D., Under Secretary for Food Safety, USDA; the Honorable

Thomas J. Billy, Administrator, Food Safety and Inspection Service, USDA;

the Honorable Roger C. Viadero, Inspector General, USDA; the Honorable

Jane Henney, M.D., Commissioner, Food and Drug Administration, HHS; the

Honorable Jeffrey P. Koplan, M.D., Director, Centers for Disease Control

and Prevention, HHS; and the Honorable William Freeh, Director, Federal

Bureau of Investigation, Department of Justice. We will also make copies

available on request.

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

or Cathy Helm, Assistant Director, at (202) 512-5138. Key contributors to

this report were Erin Barlow, Rebecca Johnson, and Rosellen McCarthy.

Sincerely yours,

Robert E. Robertson

Associate Director, Food

 and Agriculture Issues

(150097) Page 10 GAO/RCED-00-3 Agencies’ Response to Deliberate Contamination
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