oversight

Food Safety: Agencies Should Further Test Plans for Responding to Deliberate Contamination

Published by the Government Accountability Office on 1999-10-27.

Below is a raw (and likely hideous) rendition of the original report. (PDF)

                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
                   United States
GAO                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.


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



                   Page 1                       GAO/RCED-00-3 Agencies’ Response to Deliberate Contamination
             B-283528




             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.


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



             Page 2                         GAO/RCED-00-3 Agencies’ Response to Deliberate Contamination
                        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.


                        Acts or threats of deliberate food contamination using a biological agent
Deliberate Food         have been rare in the United States, according to federal agencies. We
Contamination Using     identified two such acts in the last 15 years. The bacterial pathogens used
a Biological Agent Is   in these incidents—Salmonella and Shigella—cause severe diarrhea and
                        death in certain vulnerable groups. The Salmonella case is considered the
Infrequent              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.


                                 Both FDA and FSIS have written policies and procedures for responding to
FDA and FSIS Have or             acts of deliberate food contamination with a biological agent. FDA has
Are Developing                   written procedures for responding to threats of contamination as well. FSIS
Procedures to                    is developing procedures for responding to such threats.

Respond to Deliberate
Food Contamination
FDA Has Procedures to            FDA  has procedures to respond 24 hours a day to threats or acts of
Respond to Threats or Acts       deliberate contamination with a biological agent. These procedures guide
of Deliberate                    the investigation of a possible food contamination incident and, if
                                 necessary, the removal of contaminated food from the marketplace. More
Contamination                    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     Like FDA, FSIS has written procedures to evaluate the public health risk
Responding to Acts of       posed by contaminated food and to determine whether a recall needs to be
Deliberate Food             requested. However, the agency does not have procedures for responding
                            to threats of food contaminated with a biological agent.
Contamination and Is
Developing Procedures for   In August 1999, FSIS developed a manual that consolidates its procedures
Threats                     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.


              Although few actual incidents or threats of deliberate food contamination
Conclusions   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.


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


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


              To determine the extent to which food in the United States has been
Scope and     threatened or deliberately contaminated with a biological agent, we
Methodology   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
Ordering Information

The first copy of each GAO report and testimony is free.
Additional copies are $2 each. Orders should be sent to the
following address, accompanied by a check or money order
made out to the Superintendent of Documents, when
necessary. VISA and MasterCard credit cards are accepted, also.
Orders for 100 or more copies to be mailed to a single address
are discounted 25 percent.

Orders by mail:

U.S. General Accounting Office
P.O. Box 37050
Washington, DC 20013

or visit:

Room 1100
700 4th St. NW (corner of 4th and G Sts. NW)
U.S. General Accounting Office
Washington, DC

Orders may also be placed by calling (202) 512-6000
or by using fax number (202) 512-6061, or TDD (202) 512-2537.

Each day, GAO issues a list of newly available reports and
testimony. To receive facsimile copies of the daily list or any
list from the past 30 days, please call (202) 512-6000 using a
touchtone phone. A recorded menu will provide information on
how to obtain these lists.

For information on how to access GAO reports on the INTERNET,
send an e-mail message with "info" in the body to:

info@www.gao.gov

or visit GAO’s World Wide Web Home Page at:

http://www.gao.gov




PRINTED ON    RECYCLED PAPER
United States                       Bulk Rate
General Accounting Office      Postage & Fees Paid
Washington, D.C. 20548-0001           GAO
                                 Permit No. G100
Official Business
Penalty for Private Use $300

Address Correction Requested