oversight

Food Tampering: Legal Authority Adequate to Deal With Threats

Published by the Government Accountability Office on 1990-10-31.

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

Report to the Honorable
Leon 1%E’anetta, House of
Representatives



FOOD TAMPERING
Legal Authority
Adequate to Deal
With Threats


                            142567
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                                                                                                                     I.
                 United States
GAO              General Accounting OffIce
                 Washington, DC. 20648

                 Human Resources Division

                 B-239068
                 October 341990

                 The Honorable Leon E. Panetta
                 Houseof Representatives
                 Dear Mr. Panetta:

                 In the wake of the March 1989 discovery of cyanide in grapes from
                 Chile and the subsequentS-day suspensionof all Chilean fruit imports,
                 you expressedconcern that such food tampering incidents could seri-
                 ously disrupt the American food supply. You asked us to assesswhether
                 there is sufficient legal authority and other mechanismsin place to mini-
                 mize the effects of future incidents. As agreedwith your office, we
                 reviewed whether the Food and Drug Administration (FLN)

             l has sufficient regulatory authority to deal with food tampering threats;
             . complied with pertinent laws and regulations in its action against
               Chilean fruit, and whether its actions were consistent with actions taken
               on other food tampering incidents; and
             l consults with other federal agenciesand affected parties on food tam-
               pering threats.

                 We also agreedto summarize studies on the potential impact of food
                 tampering threats involving product recalls in the U.S. food supply.


                 The,Federal Food, Drug, and CosmeticAct provides the basic statutory
Background       authority governing the treatment of domestic and imported food prod-
                 ucts. The act requires that foods that are imported or distributed and
                 sold in the United States be pure and wholesome,safe to eat, and pro-
                 duced under sanitary conditions. It prohibits the importation or sale in
                 the United States of any food that contains an added poisonous or other
                 harmful substancethat may pose a health risk.

                 Under the act and applicable regulations, FDA has been delegatedrespon-
                 sibility from the Secretary of Health and Human Services(HHS) for
                 ensuring that domestic and imported products it regulates meet the
                 requirements of the act.’ The U.S. CustomsService shares responsibility
                 with FDA for regulating imported food products in that it controls the
                 entry of all imported products into the United States. Imported foods
                 that fail to meet the requirements of the law are to be detained at the

                 ‘Meat, poultry, and eggsare regulatedby the U.S.Departmentof Agriculture. The Departmentof
                 Commerceand FDAshareresponsibility for seafoodinspections.



                 Page 1                                                       GAO/IiRB91-20   Faod Tampering
                   entry location and must be brought into compliance, destroyed, or
                   removed from the United States.
                   The Chilean fruit episodedemonstrates FDA’S use of its authority.2 In
                   March 1989, the U.S. Embassy in Chile received warnings that Chilean
                   fruit destined for the United States had been poisoned with cyanide. As
                   a result, FDAincreasedits inspection of Chilean fruit and, on March 12,
                   1989, found grapes that contained cyanide, which were from a vessel
                   carrying Chilean fruit that had arrived in Philadelphia. Basedon this
                   finding, fruit imports from Chile were suspendedfor 5 days, beginning
                   March 13, while FDAdeveloped a more comprehensiveinspection pro-
                   gram for Chilean fruit. On March 17, the suspensionwas lifted and all
                   Chilean fruit that passedFDA’sinspection was allowed to enter U.S. mar-
                   kets. That sameday, FDAwas notified of a third telephone threat in
                   Chile. However, no additional contaminated fruit was found and import
                   inspections returned to normal by mid-April 1989.

                   It appears that FDAhas sufficient statutory authority and procedures in
Results in Brief   place to deal with food tampering threats. FDAhas a variety of options it
                   can use to deal with unsafe food, ranging from encouragementof volun-
                   tary actions on the part of product owners, manufacturers, or importers
                   to correct a problem to court-ordered seizure of food products. For
                   example, in light of threats and a finding of contamination involving
                   Chilean fruit, ~12~had sufficient authority to (1) suspendChilean fruit
                   imports, (2) warn consumersnot to eat Chilean fruit, (3) recommend
                   that retailers remove Chilean fruit from the market, (4) deny entry to an
                   entire shipment of Chilean fruit, and (6) conduct increasedinspections
                   of arriving Chilean fruit. If these actions had not been sufficient to keep
                   the contaminated fruit out of commerce,FDA could have seizedthe
                   product.
                   FDA’Sactions taken during the Chilean fruit incident were consistent
                   with the actions it took on prior tampering threats involving imported
                   food, FDAofficials believe that FDAhas sufficient regulatory authority to
                   deal with food tampering threats.
                   FDAis not required by law to consult with other federal agenciesbefore
                   taking action against an adulterated food product. Nevertheless,FDAhas
                   sought advice from others when confronted with a food tampering

                   2Fora relatedGAO report on FDA’sactionson Chileanfruit importaseeFoodTampering:FDA’s
                   Actions on ChileanFruit Basedon SoundEvidence(GAO/HRDQO-164,Sept.    6,199O).




                   Page 2                                                   GAO/IUD-91-20   Food Tampering
              threat. During the Chilean fruit incident, FDA consulted with several fed-
              eral agenciesand affected parties, including the Departments of State
              and Agriculture and representatives of the Chilean government and
              food industry, regarding proposals to confront the danger.
              We did not identify any studies that assessedthe impact of food tam-
              pering incidents or food recalls on the U.S. food supply. In this regard,
              FDAis not required by law to consider the economicor supply conse-
              quencesof its actions on the American or international food markets
              before acting. Nevertheless,in exercising its authority, FDA has been sen-
              sitive to the impact of its actions. In the Chilean fruit incident, FDA took
              into account the possible effects of its actions on the U.S. food supply in
              deciding how to respond to the tampering threat. Becausethe United
              States is the single largest market for Chilean fruit exports, FDA also rec-
              ognized that any actions taken against Chilean fruit imports could have
              serious consequencesfor US. importers as well as the Chilean economy.
              Thus, F’DAdiscussedwith Chilean representatives an inspection plan that
              was intended to protect public health and return Chilean fruit to the
              market.

              In performing our work, we focused primarily on the requirements of
Scope and     the Federal Food, Drug, and CosmeticAct becausethis is FDA's primary
Methodology   authority for regulating food, and on FDA'S responseto threats made
              against Chilean fruit, becausethis was the most recent imported food
              tampering incident to affect the United States. We also interviewed and
              obtained information from FDAofficials, including the former F+DA  Com-
              missioner who was responsible for the actions taken against the Chilean
              fruit, the CustomsService,the Department of Agriculture, the Depart-
              ment of State, the Federal Bureau of Investigation (FBI), and the Chilean
              Exporters Association.
              To determine whether FDA’sactions on Chilean fruit imports were con-
              sistent with applicable laws and regulations, we reviewed court deci-
              sions interpreting the applicable statutes. We also reviewed the manner
              in which FDArespondedto prior threats against imported food to com-
              pare whether its actions were consistent with those it took in the
              Chilean fruit incident.
              To determine whether FDA consults with other federal agenciesand
              affected parties when confronted with a food tampering threat, we
              reviewed FDArecords of meetings and discussionswith others during the
              course of the Chilean fruit tampering threat and interviewed various


              Page 3                                           GA0/I3RD91-20   Food Tampering
                          federal and private officials. We also attempted to identify any studies
                          conducted on the potential effect of food tampering incidents on the U.S.
                          food supply.

                          We performed our work between October 1989 and June 1990 in accor-
                          dance with generally acceptedgovernment auditing standards.


                          FIN’Sauthority appears adequate to deal with food tampering threats
x-   11m nucqude          and its actions in the Chilean fruit incident were within its authority.
Authority to Deal         Current law and FLMregulations governing adulterated food products
With Food Tampering       provide FDAwith several regulatory options to assurethe safety of
                          domestic and imported food products.
Threats
                          For domestic food products, FDAhas authority to conduct periodic
                          inspections of food facilities and to analyze product samples.When vio-
                          lations are discovered,FDAmay request firms or owners to voluntarily
                          correct problems or to destroy or recall a product. When FDA believes a
                          domestic food product is adulterated and no corrective action is taken
                          voluntarily, it must pursue legal action through the Department of Jus-
                          tice, which must convince a court that the questioned goodsare in fact
                          adulterated. Only after this has occurred can the goodsbe kept off the
                          market. Personsor firms responsible for violations may be prosecuted in
                          federal court, and, if found guilty, be fined, or imprisoned, or both.

                          In contrast, FDAmay refuse entry if an imported food appears to be
                          adulterated. There is no requirement that the imported food actually be
                          adulterated or that FBAmake such a determination. If FM determines
                          that an imported product appears to be adulterated, the owner, shipper,
                          or importer has three options: (1) destroy the product; (2) remove it
                          from the United States; or (3) with FDA’Spermission, bring the product
                          into compliance with the law, if possible. In a caseinvolving cyanide
                          poisoning, the product cannot be brought into compliance; thus, it must
                          be destroyed or shipped out of the United States.
                          In the caseof the Chilean fruit, once FDAdetermined that somefruit
                          unloaded from a ship in Philadelphia contained cyanide, FDA

                      l refused to admit any of the ship’s fruit,
                      . notified state health departments and other countries that also imported
                        Chilean fruit of the cyanide finding,




                          Page 4
                          B-229068




                                                                                             ~~~~-
                      l recommendedthat US. retail outlets remove Chilean fruit from distribu-
                        tion and that consumersrefrain from eating Chilean fruit they had pur-
                        chased,and
                      . increased inspections of incoming Chilean fruit and fruit in cold storage
                        warehouses.
                          These actions were consistent with FDA’S statutory authority and regula-
                          tions for dealing with imported foods that appear to be adulterated. In
                          the opinion of FDA, the Federal Food, Drug, and CosmeticAct and FDA
                          regulations provide FDA with sufficient authority to take action when
                          confronted with an adulterated food product resulting from a tampering
                          threat.


FDA Has Taken             Between 1984 and 1989, FDA investigated about 3,800 tampering threats
                          and incidents involving a wide variety of food, drugs, and other prod-
Similar Action on         ucts that FDA regulates. Cur review of two prior threats involving
Other Imported Food       imported food showed that FDA has been consistent in its actions. FDA
                          officials said that the Chilean fruit incident was the largest tampering
Tampering Incidents       incident FDA has investigated becausethe threat did not specify the
                          type(s) of fruit poisoned or the vessel(s)on which the fruit was being
                          shipped, as had been done in someother tampering incidents. It was also
                          the first occasionthat FDA found an imported food product that had
                          beentampered with actually arriving in the United States. Thus, FDA
                          had no exact precedent to guide its investigation of this incident. How-
                          ever, FDA’S actions on the Chilean fruit were consistent with its actions
                          on two previous tampering threats involving imported food.
                          One 1986 incident involved tea, An unknown person sent a letter to the
                          U.S. Embassy in Sri Lanka claiming that tea bound for the United States
                          had been poisoned with cyanide. Similar to its actions on Chilean fruit,
                          m (1) refused entry of Sri Lankan tea into the United States and (2)
                          increased its examinations of Sri Lankan tea for cyanide. After receiving
                          no additional threats nor finding cyanide in tea that was sampled, m
                          lifted its ban on Sri Lankan tea imports 4 months after denying them
                          entry.

                          The secondincident occurred in 1978 when terrorists contaminated with
                          metallic mercury a shipment of Israeli orangesbound for Germany and
                          the United States. Orangesunloaded in Germany were found to contain
                          mercury. When the remainder of the shipment arrived in the United
                          States, FDA performed visual examinations and conducted other tests on
                          77,000 oranges.FDA did not find mercury in any of the inspected


                          Page 6                                         GAO/HlZD-91-20   Food Tampering
                      5239009




                      oranges.After detaining the shipment for 4 days while tests were being
                      conducted, m releasedit for distribution to markets.

                      The Federal Food, Drug, and CosmeticAct doesnot require FDA to con-
FDA Has Consulted     sult with other federal agenciesin determining that a food product is
With Other Agencies   adulterated and, thus, posesan imminent danger to health. Nor doesthe
on Food Tampering     act require FDA to consult with other agencieson how to remedy the
                      problem or on the potential impact of its actions.
Incidents
                      However, in practice, FDAhas consulted with federal and private agen-
                      cies before deciding on a course of action involving food tampering inci-
                      dents. In the incident involving Sri Lankan tea, FDA consulted with the
                      Department of State, the Sri Lankan Ambassador, the Office of the Sec-
                      retary of HHS, and the tea trade association regarding actions necessary
                      to deal with the threat. m also notified Canada and other countries of
                      the threat.3
                      In the Chilean fruit incident, after determining that fruit aboard the
                      vesselthat arrived in Philadelphia was adulterated, FDAconsulted with
                      several federal agenciesregarding proposals to confront the danger.
                      Before taking action against Chilean fruit imports on March 13, 1989,
                      the FDACommissionercontacted the Secretary of HHS and the Office of
                      the President on the proposed actions. Both the Secretary of HHS and the
                      Office of the President supported the Commissioner’sproposals. Addi-
                      tionally, FDA consulted with the Departments of State and Agriculture
                      and the CustomsService. BecauseFDAis the primary public health
                      agency for dealing with these situations, these agenciesdeferred any
                      decisionsregarding the fruit to FDA and made no recommendationsto
                      FDAfor dealing with the tampering incident.
                      Although the various federal agenciesmade no recommendationsto FDA,
                      they did provide FDA with technical and other assistance.U.S. Depart-
                      ment of Agriculture personnel, who grade incoming fruit for quality,
                      provided FDAinspectors with guidance on normal and abnormal defects
                      they might encounter, such as nail or staple holes and blemishes.When
                      the CustomsService becameaware of the initial threat against Chilean
                      fruit, it placed a temporary hold on arriving shipments while it con-
                      sulted with m on an appropriate course of action. When m subse-
                      quently discovered contaminated fruit, Customs suspendedChilean fruit

                      3FDArecordson the extent of consultationsheld on the incident involving Israeli orangeswere not
                      available.



                      Page 6                                                         GAO/HRD9180       Food Tampering
1
                         B239069




                         imports at FDA’srequest while FW developed a more comprehensive
                         inspection plan for arriving Chilean fruit.


FDA Consulted With the   The State Department also played a key role during the course of the
State Department and     Chilean fruit tampering incident and was in closecommunication with
                         FDA.The Department notified FDA of the initial and subsequenttam-
Chilean Organizations    pering threats and supported FDA'S efforts to convince representatives
                         of the Chilean government and fruit industry of the need for increased
                         inspections of incoming Chilean fruit shipments,

                         Additionally, FDAconsulted with the Chilean Foreign and Agricultural
                         Ministers, the Chilean Ambassador to the United States, and representa-
                         tives of the Chilean Exporters Association and the American Produce
                         Association. The main focus of these consultations was to devise an
                         inspection plan for Chilean fruit and releaseany fruit that passed
                         inspection. The Chilean representatives made recommendationsto FDA
                         concerning the proposed plan. They recommendedthat FDAexamine 1 to
                         2 percent of the shipments becauseof the time and expenseof per-
                         forming more extensive examinations. However, FDA believed this
                         inspection level was too low. FDA’sstatistical calculations showed that a
                         lo-percent inspection level was necessaryto provide a sufficient level of
                         confidence that any additional tainted fruit would be found.

                         The State Department helped to convince the Chilean representatives of
                         the need to inspect more fruit than what Chile proposed. Ultimately, FDA
                         and the Chilean government agreedon an inspection level for incoming
                         Chilean fruit.

                         In sum, although FDAis not required by law to consult with others in
                         determining that a food product might be adulterated or on how to
                         remedy the problem, it has consulted with and sought advice on how to
                         deal with a food tampering threat.

                         ERA’Sprimary mission is to protect the public from unsafe food products.
FDA Has Considered       The Federal Food, Drug, and CosmeticAct doesnot require FDAto mini-
the Economic and         mize disruption to the American food supply in considering action when
Supply Impact of Its     it discovers an adulterated food product. Neither doesthe law require
                         IQAto consider the economicimpact of its actions. However, FDAhas
Actions  ”               consideredthese matters in its decisionsinvolving food tampering
                         incidents.



                         Page 7                                         GAO/IiRB91JO   Food Tampdng
Although we did not identify any studies on the impact on the American
food supply from the tampering incident, it would appear there were no
significant disruptions. Fruit was available in the United States from
other sourcesand the suspensionof Chilean fruit imports lasted for only
6 days.

Becausethe United States is the largest single market for Chilean fruit
exports, FDAwas aware of the serious financial consequenceson U.S.
importers and the Chilean economythat would likely result from a sus-
pension of Chilean fruit imports. Therefore, a major focus of FDA'S dis-
cussionswith Chilean government and food industry representatives
was to develop an inspection plan that would protect public health and
return Chilean fruit to the marketplace. FDA appears to have achieved its
objectives. No additional contaminated Chilean fruit was found and
while there was an impact on the Chilean economyit appears to have
been shortlived. Oneyear after the poisoning incident Chilean fruit
exports to the United States reached an all time high, indicating that
exports to the United States and other countries have not been seriously
affected by the incident.

We did not obtain written commentson the report, but discussedit with
FDAofficials, Where appropriate, we incorporated their comments into
the report.

We are sending copiesof this report to other interested committees; the
Secretary of Health and Human Services;the Director, Office of Manage-
ment and Budget; and other interested parties. We will also make copies
available to others on request.
Should you have any questions concerning this report, please call me at
(202) 276-6196.Other major contributors are listed in the appendix.
Sincerely yours,




Mark V. Nadel
Associate Director for National and
  Public Health Issues



Page 8                                         GAO/HRIbBl-20   Food Tampering
Page 9   GAO/HRD9l-20   Food Tampering
Appendix I                                                                                       .-
Major Contributors to This Report


                        Janet L. Shikles, Director, Health Financing and Policy Issues,
Human Resources           (202)276-6461
Division,               Albert B. Jojokian, Assistant Director
Washington, DC.         Rodney E. Ragan,Assignment Manager


                        Sara Herlihy, Investigator
Office of Special
Investigations

                        Barry R. Bedrick, Associate General Counsel
Office of the General   Julian P. Klazkin, Attorney Advisor
Counsel

                        Thomas P. Hubbs, Evaluator-in-Charge
Philadelphia Regional   Margaret A. Klucsarits, Evaluator
Office




(108786)                Page 10                                        GAO/HitD-91-20   Food ‘hnwrine
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