Food Safety: Agencies Should Further Test Plans for Responding to
Deliberate Contamination (Letter Report, 10/27/1999, GAO/RCED-00-3).

Pursuant to a congressional request, GAO reviewed the preparedness of
the federal food safety regulatory agencies to respond to acts or
threats of deliberate food contamination, including those by terrorists,
focusing on the: (1) 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) plans and
procedures that federal food safety regulatory agencies have for
responding to threats and acts of deliberate food contamination with a
biological agent.

GAO noted that: (1) deliberate contamination of food with a biological
agent has rarely occurred in the United States, according to federal
agencies; (2) GAO identified two such acts since 1984, both of which
produced short-term illnesses among a combined total of about 765
people, but no deaths; (3) 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; (4) the
Food and Drug Administration (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; (5) the
approach may involve assessing the credibility of a threat or requesting
a recall of the contaminated food; (6) the Food Safety and Inspection
Service (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; and
(7) for threats of contamination, FSIS is developing a plan that will
include coordination steps with other affected federal agencies.

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

 REPORTNUM:  RCED-00-3
     TITLE:  Food Safety: Agencies Should Further Test Plans for
	     Responding to Deliberate Contamination
      DATE:  10/27/1999
   SUBJECT:  Food inspection
	     Safety regulation
	     Contaminated foods
	     Health hazards
	     Safety standards
	     Terrorism
	     Biological warfare
	     Consumer protection

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Cover
================================================================ COVER

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

Agencies' Response to Deliberate Contamination

(150097)

Abbreviations
=============================================================== ABBREV

  USDA -
  FSIS -
  FDA -
  CDC -
  FBI -
  HHS -

Letter
=============================================================== LETTER

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 threatstwo of these
were hoaxes, and the other is still an open investigation. 

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. 

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. 

--------------------
\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). 

\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. 

\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. 

   DELIBERATE FOOD CONTAMINATION
   USING A BIOLOGICAL AGENT IS
   INFREQUENT
------------------------------------------------------------ Letter :1

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 incidentsSalmonella 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 rarethree 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 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
agenttwo cases were determined to be hoaxes and the other is still
an open investigationoccurred 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 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. 

--------------------
\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. 

   FDA AND FSIS HAVE OR ARE
   DEVELOPING PROCEDURES TO
   RESPOND TO DELIBERATE FOOD
   CONTAMINATION
------------------------------------------------------------ Letter :2

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
---------------------------------------------------------- Letter :2.1

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 investigationgenerally led by its field staffto
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 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 FBIrather 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
---------------------------------------------------------- Letter :2.2

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
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. 

--------------------
\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. 

   CONCLUSIONS
------------------------------------------------------------ Letter :3

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 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
------------------------------------------------------------ Letter :4

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
------------------------------------------------------------ Letter :5

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 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
------------------------------------------------------------ Letter :6

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. 

---------------------------------------------------------- Letter :6.1

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

*** End of document. ***