Report to the Honorable Leon 1%E’anetta, House of Representatives FOOD TAMPERING Legal Authority Adequate to Deal With Threats 142567 i “, ,““1-,“, “I_ .ll.l ._.I_. “.._ ...” _.... -.._-^. __ _. .-_. - . ..^ -.--- .___-___ 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 _I “_,,,ll*“l “,l~-,l.l*l ,l--““.l”l-- 1--1 -..- “._.. .-..---- ----- -.-.------- - --- 1~ I1.S. Qrrchral Accounting Office I’. 0. Box 6015 (;;lit.hc~rsl)urg, MI) 2OH77
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)