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CFSAN/Office of Regulations and PolicyOcotber 7, 2003

  FDA Statement on Foodborne Illness Risk Assessment

# Risk Assessment for Food Terrorism and Other Food SafetyConcerns

        - Introduction
        -  Risk Assessment            - HazardIdentification
          - Hazard  Characterization              - Illness  and deaths
            - Economic  effects
            - Social and political implications 
          - Exposure Assessment
          - Risk Characterization 
        - Conclusion

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## I. Introduction:  

The events of September 11, 2001, and the subsequent anthrax incidents(1)gave rise to concerns about unconventional terrorist attacks, including the threatof attacks on the U.S. food supply. Those events also heightened internationalawareness that nations could be targets for biological or chemical terrorism--athreat that had long concerned military and public health officials. 

In the aftermath of those incidents, the Foodand Drug Administration (FDA) took steps to improve its ability to prevent,prepare for, and respond to, incidents of food sabotage. Though motivated bythe concerns about deliberate contamination, those activities built upon andexpanded the agency's continuing efforts to protect consumers from foods thathave been unintentionally contaminated (e.g., through processing failures orhandling errors).

As part of those activities, FDA assessed therisk to, and vulnerability of, the U.S. food supply to an act of terrorism.(2)However, most of those assessments contain classified information. To promote transparency, FDA prepared thispublicly available assessment of the risks to public health of a terroristattack on the food supply and of serious illness due to inadvertent foodcontamination.(3)

The Risk Assessment follows the generallyaccepted framework for risk assessments endorsed by the Codex AlimentariusCommission, the U.S. National Academy of Sciences, and other authoritativebodies.(4)The framework divides risk assessment into four components:  (1) hazardidentification, (2) hazard characterization (or dose-response assessment), (3)exposure assessment, and (4) risk characterization. Unlike traditional riskassessments, however, which focus on one hazard, this assessment addresses thebroad range of hazards available to terrorists intending to sabotage food, aswell as hazards that accidentally are introduced into food.

This Risk Assessment uses scientific evidence onfood terrorism to the extent that it exists and is available, but balances thisdisclosure with the need to maintain the integrity of classified information. Thus, this assessment is based solely on unclassified information. Inaddition, the very nature of "bioterrorism" and the fact that it is arelatively new and evolving threat present challenges in quantitativelyevaluating the associated risks. FDA has prepared a qualitative riskassessment that presents various risk scenarios, as well as discusses thequality of information available for, and the uncertainties associated with,the assessment. The agency has determined that this qualitative riskassessment, which discusses prior incidents of food contamination and availableunclassified information on prior acts of food sabotage, is appropriate to thecircumstances.
II. Risk Assessment

### A. Hazard Identification 

Even before the September 11thattacks, the U.S. Centers for Disease Control and Prevention (CDC) haddeveloped a strategic plan on biological and chemical terrorism. The CDC planidentified and ranked several foodborne pathogens as critical agents forpossible terrorist attacks. Among the high-priority biological agents("Category A" agents) were *Bacillus anthracis* (anthrax) and *Clostridiumbotulinum* (botulism), both of which are deadly pathogens and maycontaminate food. Most of the foodborne biological agents identified by CDCwere classified as "Category B" agents because they are moderately easy todisseminate and cause moderate morbidity and low mortality. The Category Bbiological agents include *Salmonella* spp., *Shigella dysenteriae, E. coli* O157:H7, and ricin.(5)Notably, several of the pathogens identified by CDC as critical biologicalagents also are known to pose a significant threat due to unintentionalcontamination of food.(6)

In addition, the CDC identified certainchemicals as possible agents for a terrorist attack. Those included heavymetals, such as arsenic, lead, and mercury, and pesticides, dioxins, furans,and polychlorinated biphenyls (PCBs), all of which may be used to contaminatefood.(7)These toxins also have been introduced inadvertently into foods and linked tohuman health effects.(8)

The CDC further warned:
> ... [P] ublic health agencies mustprepare also for the special features a terrorist attack probably would have ...Terrorists might use combinations of these agents, attack in more than onelocation simultaneously, use new agents, or use organisms that are not on thecritical list (e.g., common, drug-resistant, or genetically engineeredpathogens).(9)

Acts of deliberate food contamination havealready occurred in the U.S. In 1984, for example, the members of a religiouscult contaminated salad bars with *Salmonella typhimurium* in order todisrupt a local election. This incident caused 751 cases of salmonellosis andresulted in the hospitalization of 45 of the victims.(10)In another incident, in 1996, a disgruntled laboratory worker deliberatelyinfected food to be consumed by co-workers with *Shigella dysenteria* type2, causing illness in 12 people. Four of the victims had to be hospitalizedand five others were treated in hospital emergency rooms.(11)Furthermore, in May 2003, a supermarket employee pleaded guilty tointentionally poisoning 200 pounds of ground beef with an insecticide containingnicotine. Although the tainted meat was sold in only one store, 111 people,including approximately 40 children, were sickened.(12)

Examples of food sabotage can be drawn fromother countries' experiences, as well. In September 2002, nearly 40 peopledied and more than 200 were hospitalized near Nanjing, China after the owner ofa fast-food outlet poisoned a competitor's breakfast foods with rat poison.(13)One year earlier, 120 people in China were sickened when the owners of a noodlefactory reportedly laced their food with rat poison.(14)A dozen children in Holland and West Germany were hospitalized in 1978 aftercitrus fruit from Israel was deliberately contaminated with mercury.(15)Finally, in Canada in 1970, a postgraduate student tainted his roommates' foodwith the parasite *Ascaris suum*. Four of the victims became seriouslyill; two of these suffered acute respiratory failure.(16)

The incidents discussed above illustrate a fewof the possible agents for food terrorism. The range of such agents is broad,and their characteristics varied; they may include:
      - Biological and chemical agents;
      - Naturally occurring, antibiotic-resistant, and genetically    engineered substances; 
      - Deadly agents and those tending to cause gastrointestinal    discomfort; 
      - Highly infectious agents and those that are not communicable;
      - Substances readily available to any individual and those that are    more difficult to acquire; and
      - Agents that must be weaponized and those that are accessible in a    useable form.

This assessment addresses the risk to publichealth not only of deliberate contamination of the food supply, but also ofhazards that are inadvertently introduced into foods that FDA regulates.

### B. Hazard Characterization

The hazard characterization analyzes themagnitude of the risk (i.e., the severity and duration of adverse effects),using reports of foodborne disease caused by unintentional contamination. Suchreports are relevant to an analysis of both inadvertently and deliberatelyintroduced hazards, because many of the pathogens that historically have beenlinked to unintentional food contamination, such as *E. coli* O157:H7 and *Salmonella*spp., were identified by the CDC as "critical" agents for food terrorism.(17)Moreover, the risk to consumers and the public health response to these knownpathogens would be comparable, regardless of whether the contamination wasdeliberate or accidental. Officials responding to a foodborne illness outbreakprobably would not know whether the contamination was accidental or intentionaluntil an investigation was performed to determine the source of the outbreak. Even then, officials might never be able to conclusively determine whether thefood was deliberately sabotaged or inadvertently contaminated. For all ofthese reasons, the risk assessment uses incidents of unintentional foodcontamination as the basis for a characterization of hazards that could beeither deliberately or unintentionally introduced into food. 

#### *1. Illnesses anddeaths*

The World Health Organization (WHO) estimatesthat microbiologically contaminated food and water cause approximately twomillion children worldwide to die from diarrhea each year. Even inindustrialized countries, WHO estimates that one person in three suffers from afoodborne disease annually.(18)Recognizing that foodborne illnesses "significantly affect people's health andwell-being," the World Health Assembly in 2000 adopted a resolution statingthat the assembly was "[d]eeply concerned that foodborne illness associatedwith microbial pathogens, biotoxins and chemical contaminants in food representa serious threat to the health of millions of people in the world."(19)

In the U.S., the CDC estimates that 76 millionillnesses, 325,000 hospitalizations, and 5,000 deaths occur annually due tofood that has been inadvertently contaminated by pathogens.(20)Based on current population data, this roughly translates to an estimate that,each year, one out of every four Americans will develop a foodborne illness.(21)

Major outbreaks of foodborne illness occur alltoo frequently, sometimes affecting hundreds of thousands of people. Among thelargest reported outbreaks caused by unintentional biological contamination wasan outbreak of *Salmonella typhimurium* infection that sickenedapproximately 170,000 people in 1985 and was linked to post-pasteurizationcontamination of milk from a U.S. dairy plant.(22)An outbreak of hepatitis A caused by tainted clams affected nearly 300,000people in China in 1991 and may be the largest foodborne disease incident in history.(23)In 1994, an outbreak of *Salmonella* Enteritidis infection linked to acontaminated ice cream pre-mix sickened an estimated 224,000 people in 41states in the U.S.(24)In 1996, about 8,000 children in Japan became ill, and some died, after eating *E. coli* 0157:H7-tainted radish sprouts served in school lunches.(25)

Illnesses from pesticides, mycotoxins, heavymetals, cyanide, and other acutely toxic chemicals also have been reported. Inone deadly incident, over 800 people died and about 20,000 were injured by achemical agent present in cooking oil sold in Spain in 1981.(26)In 1985, nearly 1,400 people in the U.S. reported becoming ill after eatingwatermelon grown in soil treated with the pesticide aldicarb.(27)In Iraq in 1971-1972, more than 6,500 people were hospitalized withneurological symptoms and 459 died after eating bread made frommercury-contaminated wheat. Additionally, in the 1960's, more than 200 peoplein Japan suffered from mercury poisoning after eating highly contaminated fishcaught in polluted waters.(28)

In today's global marketplace, the contaminationof food in one country can have a significant effect on public health in otherparts of the world. In 1989, approximately 25,000 people in 30 states in the U.S. were sickened by *Salmonella* chester** in cantaloupes imported from Mexico.(29)In 1996 and 1997, 2,500 people in 21 states in the U.S. and two Canadianprovinces developed *Cyclospora* infections after eating taintedGuatemalan raspberries.(30)

If an unintentional contamination of one food,such as clams, can affect 300,000 individuals, a concerted, deliberate attackon food could be devastating, especially if a more dangerous chemical,biological, or radionuclear agent were used. It would be reasonable to assumethat a terrorist using the food supply as a vehicle for attack would use anagent that would maximize the number of deaths associated with thecontamination. Many of these agents are the same pathogens that have beenlinked to significant outbreaks of foodborne illness due to unintentionalcontamination.

#### *2. Economic effects*

Deliberate or accidental contamination of foodalso may have enormous economic implications in the U.S., where one out ofevery eight Americans is estimated to work in an occupation directly linked tofood production.(31)Indeed, food terrorists may have economic disruption as their primary motive. For example, the sabotage of Israeli citrus fruit exports, discussed above, wasallegedly intended to damage Israel's economy.(32)

At least three types of economic effects may begenerated by an act of food terrorism:  Direct economic losses attributable tothe costs of responding to the act; indirect multiplier effects fromcompensation paid to affected producers and the losses suffered by affiliatedindustries, such as suppliers, transporters, distributors, and restaurantchains; and international costs in the form of trade embargoes imposed bytrading partners.(33)

Though the costs associated with the foodsabotage discussed above are unavailable, reports from unintentional contaminationincidents demonstrate the tremendous costs of responding to such events. In1998, a company in the U.S. recalled nearly 16,000 metric tons of frankfurtersand luncheon meats potentially contaminated with *Listeria monocytogenes*,at a total cost of $50 million to $70 million.(34)The company reported spending more than $100 million in the following two yearsto improve food safety and convince consumers that its products were safe.(35)Indirect costs can be staggering as well. The U.S. Department of Agricultureestimates that foodborne illnesses linked to five pathogens costs the economy$6.9 billion annually.(36)The outbreak from *Salmonella*-contaminated ice cream, discussed above,was estimated to have cost the U.S. economy about $18.1 million in medical careand time lost from work.(37)In addition, costs arise from the disruption of international trade, as wasdemonstrated when Belgium's dioxin incident caused the recall of food productsdistributed globally.(38)

#### *3. Social and politicalimplications*

The response to the 2001 anthrax incidentsshowed that limited dissemination of biological agents by simple means cancause considerable disruption and public anxiety, even if only a few cases ofillness result.(39)The potential magnitude of social impacts arising from a food terrorismincident may be best illustrated by examining the effects of the BovineSpongiform Encephalopathy (BSE) (also known as "mad cow disease") crisis in Great  Britain in the 1990's. When researchers first discovered BSE in Britishcattle in 1986, some speculated that BSE could be spread to humans.(40)However, for the next decade British authorities consistently reassuredcitizens that BSE was only an animal disease.(41)When, in 1996, authorities acknowledged that BSE could be linked to humandisease and announced that ten people in the U.K. had been infected or diedfrom a human form of mad cow disease, widespread panic erupted.(42)

Even though the tollof human fatalities--137 deaths to date--was lower than the death toll from manyother diseases, the effects of this public health crisis were widespread andlong-lasting.(43)Bans on imports of British beef lasted for several years.(44)Furthermore, the public's shattered confidence in government forced thecreation of a new food regulatory authority, the Foods Standards Agency.(45)The slaughter of millions of cattle and other BSE control measures, togetherwith depressed markets for British beef, crippled the country's cattleindustry.(46)Some key issues from the BSE crisis lingered until recently.

Fear and anxiety may contribute to reducedconfidence in the political system and government, and may result in politicaldestabilization, as was seen in Great Britain during the mad cow crisis. 

### C. Exposure Assessment

As discussed above, the CDC estimates that unsafefood causes 76 million illnesses, 325,000 hospitalizations, and 5,000 deathseach year in the U.S.(47)This roughly translates to an estimate that, each year, one in every fourAmericans will develop an illness due to the accidental food contamination.

Although the CDC has identified certainpathogens as critical agents for food terrorism, it is difficult for FDA topredict with any certainty the likelihood that an act of food terrorism willoccur. Indeed, Codex has recognized that uncertainty may be prevalent in therisk assessment process:
> Many sources of uncertainty exist inthe process of risk assessment . . . of food related hazards to human health. The degree of uncertainty and variability in the available scientificinformation should be explicitly considered in the risk analysis.(48)

FDA further recognizes that the potential impact of a foodterrorism event is influenced not only by the likelihood of occurrence, butalso by the specific target and agent selected by a terrorist.

Despite theseuncertainties, the WHO has warned that "the malicious contamination of food forterrorist purposes is a real and current threat."(49)The CDC's infectious disease experts similarly have concluded that sabotage offood and water is the easiest means of biological or chemical attack largelybecause such attacks (albeit on a small scale) have been successful in thepast.(50)In addition, the CDC experts explain, the relative centralization of foodproduction in the U.S. and the global distribution of food products give food a"unique susceptibility," and many points of vulnerability to sabotage intendedto affect a large number of people exist in the food production and fooddistribution processes.(51)

The threat to the U.S. foodsupply is more than theoretical. When U.S. troops entered the caves and safehouses of members of the al Qaeda terrorist network in Afghanistan in themonths following the September 11th attacks, they found hundreds of pages of U.S. agricultural documents that had been translated into Arabic.(52)A significant part of the group's training manual is reportedly devoted toagricultural terrorism--specifically, the destruction of crops, livestock, andfood processing operations.(53)

Moreover, recent threats of food sabotage fromknown terrorist groups have been reported. Specifically, the U.S. CentralIntelligence Agency stated in January 2003 that it was investigating whetherone of al Qaeda's leading experts on chemical and biological warfare wasinvolved in a plot to poison food intended for British troops. Theinvestigation stemmed from the discovery of ricin in a London apartment linkedto suspected militants, one of whom worked for a catering company. Thesuspects were believed to have been in contact with people who worked on atleast one British military base.(54)

In early September 2003, the U.S. Federal Bureauof Investigation (FBI) issued a bulletin warning that terrorists might use twonaturally occurring toxins, nicotine and solanine, to poison U.S. food or watersupplies. The FBI noted that terrorist manuals and documents recovered in Afghanistanrefer to the use of these substances as poisons. Citing the supermarketemployee that deliberately contaminated ground beef with an insecticide containingnicotine, FBI officials advised:  "Such lone offenders, whether al-Qaida [*sic*]sympathizers or domestic criminals, are a concern to FBI because they are sodifficult to detect."(55)

The U.S. is not alone in its concern about afood terrorist event. The WHO Secretariat noted last year that severalcountries have reported heightened states of alert for a biological or chemicalattack on air, water, or food.(56)The events of September 11, 2001, and evidence from al Qaeda validate concernsabout threat of terrorism against the United States.(57)

### D. RiskCharacterization

This Risk Assessment addresses a broad range ofhazards that may be deliberately or accidentally introduced into the foodsupply that FDA regulates. Despite the difficulty of developing a quantitativerisk assessment of cumulative risk in the present circumstance, FDA notes thatthe public health impact of unintentionally contaminated food has been documentedby the CDC estimate that 76 million illnesses, 325,000 hospitalizations, and5,000 deaths from foodborne illness occur annually in the U.S. Other journalarticles and risk assessments, referenced here, also provide data on risk ofillness from the accidental introduction of pathogens into food. For example,the government's quantitative risk assessment for *Salmonella* Enteritidis(SE) in shell eggs and egg products estimated, based on modeling, that anaverage of 660,000 illnesses occur each year in the U.S. due to SE-contaminatedeggs. The predicted average risk is 3.5 SE illnesses per one million eggservings per year.(58)

It  is more difficult for FDA to characterizethe risk of food terrorism, largely because of uncertainties associated withestimating the likelihood of occurrence--even though documented incidents ofsabotage have occurred and recent reports have surfaced of al Qaeda plots topoison food supplies. Traditional risk assessments for acute hazards,particularly those using modeling, often generate estimates of risk on anannual basis, as was done in the SE risk assessment.(59)In the present circumstance, the agency has determined that the magnitude ofthe risk of food terrorism, and the uncertainty associated with that riskcharacterization, depend on the temporal basis of the risk estimate. Specifically, if a small increment of time, such as one day, is used toestimate the risk of an act of deliberate contamination, then the likelihood ofoccurrence would be low. If, however, a larger increment of time, such as theperiod of one month, is used, then the risk would be greater, and if the agencyconsiders the likelihood of occurrence over the period of one year, then therisk of an act of food terrorism is significantly higher. To ensure that thisassessment is useful for planning purposes, FDA has determined that it is appropriateto characterize the risk of occurrence of an act of food sabotage or asignificant incident of unintentional food contamination on an annual basis.

The agency has considered, forthe purposes of risk characterization, the known exposure to food that has beeninadvertently contaminated and the past incidents of deliberate contamination,as well as the evidence that terrorists have targeted our food supply. Inlight of this information and the uncertainties attendant to characterizing therisk of an act of food terrorism, FDA has concluded that there is a highlikelihood, over the course of a year, that a significant number of people willbe affected by an act of food terrorism or by an incident of unintentional foodcontamination that results in serious foodborne illness. 

## III. Conclusion

The CDC's strategic planning workgroup onbiological and chemical terrorism warned, more than a year before the September11th attacks and the anthrax incidents:  
> An act of biological or chemicalterrorism might range from dissemination of aerosolized anthrax spores to foodproduct contamination, and predicting when and how such an attack might occuris not possible. However, the possibility of biological or chemical terrorismshould not be ignored. . . Preparing the nation to address this threat is aformidable challenge, but the consequences of being unprepared could bedevastating.(60)

Though thelikelihood of a biological or chemical attack on the U.S. food supply isuncertain, significant scientific evidence documents the risk to public healthof food that has been inadvertently contaminated. Notwithstanding theuncertainties described in this risk assessment, and given the broad range ofagents that may contaminate the food supply that FDA regulates, the agencyconcludes that there is a high likelihood, over the course of a year, that asignificant number of people will be affected by an act of food terrorism or byan incident of unintentional food contamination that results in seriousfoodborne illness. 

FDA has determinedthat this qualitative risk assessment, which discusses prior incidents of foodcontamination and available unclassified information on prior acts of foodsabotage, is appropriate to the circumstances.

----

(1)*See, e.g.*, U.S. Centers for Disease Control and Prevention, *Update:Investigation of Anthrax Associated with Intentional Exposure and InterimPublic Health Guidelines* 50 Morbidity & Mortality Weekly Report 889-93(2001); U.S. Centers for Disease Control and Prevention, *Recognition ofIllness Associated with the Intentional Release of a Biologic Agent* 50Morbidity & Mortality Weekly Report 893-7 (2001)*.*

(2)In addition, the agency prepared a report to Congress on food-related terrorismissues.

(3)This Risk Assessment specifically analyzes the risk of contamination of thebroad range of foods that FDA regulates. All foods, except meat, poultry, andprocessed egg products, fall under the agency's jurisdiction. Thus, FDAregulates approximately 80% of the U.S. food supply. The remainder isregulated by the U.S. Department of Agriculture.

(4)*See, e.g., Working Principles for Risk Analysis for Application in theFramework of Codex Alimentarius,* Codex Alimentarius Commission (ALINORM03/41) (2003) (applicable to Codex risk assessments); *Principles andGuidelines for the Conduct of Microbiological Risk Assessment,* CodexAlimentarius Commission CAC/GL-30 (1999) (applicable to risk assessmentsperformed by governments); U.S. National Academy of Sciences, Risk Assessmentin the Federal Government: Managing the Process (1983).

(5)U.S. Centers for Disease Control and Prevention, *Biological and ChemicalTerrorism: Strategic Plan for Preparedness and Response, Recommendations of theCDC Strategic Planning Workgroup*, 49 Morbidity and Mortality Weekly Report,Recommendations and Reports (RR-4) 5-8 (2000).

(6)For example, *Salmonella* bacteria introduced inadvertently into food areestimated to cause 1.3 million illnesses, 15,600 hospitalizations, and 550deaths each year in the U.S. Paul S. Mead et al., *Food-Related Illness andDeath in the**United States**,* 5 Emerging Infectious Diseases607-25 (1999).

(7)U.S. Centers for Disease Control and Prevention, *supra* note 5, at 5-8.

(8)*See, e.g.,* U.S. Food and Drug Administration, *Mercury in Fish: Causefor Concern?* FDA Consumer (Sept. 1994), available at http://www.fda.gov/fdac/reprints/mercury.html;R.J. Jackson et al., *Epidemiologic Notes and Reports: Aldicarb FoodPoisoning from Contaminated Melons--**California**,* 35 Morbidity& Mortality Weekly Report 254-8 (1986) (contamination due to unauthorizeduse of the pesticide). 

(9)U.S. Centers for Disease Control and Prevention, *supra* note 5, at 4.

(10)LTC George W. Christopher et al., *Biological Warfare: A HistoricalPerspective*, 278 Journal of the American Medical Association 412, 416(1997).

(11)World Health Organization, Terrorist Threats to Food: Guidance for Establishingand Strengthening Prevention and Response Systems 5 (2002).

(12)  U.S. Centers for Disease Control and Prevention, *Nicotine Poisoning AfterIngestion of Contaminated Ground Beef --**Michigan**, 2003*, 52Morbidity & Mortality Weekly Report 413-6 (2003); James Prichard, *Ex-groceryworker sentenced to nine years for poisoning supermarket beef*, South BendTribune, Sept. 20, 2003.

(13)BBC News, Death sentence for China poisoning, Sept. 30, 2002; CNN.com, Death sentence over Chinese poisonings, Sept. 30, 2002; CBSNews.com, Jealousy eyed inChina poison case, Sept. 17, 2002.

(14)*Id.*

(15)Ali Khan et al., *Precautions against Biological and Chemical TerrorismDirected at Food and Water Supplies*, 116 Public Health Reports 4 (2001).

(16)*Id.,* at 5, *citing,* James A. Phills et al., *PulmonaryInfiltrates, Asthma and Eosinophilia due to* Ascaris Suum*Infestation inMan*, 286 New England Journal of Medicine 965-70 (1972).

(17)*See, e.g.,* U.S. Food Safety and Inspection Service, Draft RiskAssessment of the Public Health Impact of *Escherichia coli* O157:H7 inGround Beef (Sept. 2001); U.S. Food Safety and Inspection Service, *Salmonella*Enteritidis Risk Assessment: Shell Eggs and Egg Products (Aug. 1998). 

(18)World Health Organization & World Trade Organization, WTO Agreements &Public Health: A joint study by the WHO and the WTO Secretariat 62-63 (2002).

(19)World Health Organization, WHO global strategy for food safety: safer food forbetter health 20 (2002), *citing* World Health Assembly, Resolution WHA53.15 on food safety (May 2000).

(20)Mead, *supra* note 6.

(21)  U.S. Census Bureau, Census 2000 Brief: Population Change and Distribution(April 2001).

(22)C.A. Ryan et al., *Massive outbreak of antimicrobial-resistant salmonellosistraced to pasteurized milk*, 258 Journal of the American Medical Association3269-74 (1987).

(23)M.L. Halliday et al., *An epidemic of hepatitis A attributable to theingestion of raw clams in Shanghai, China*, 164 Journal of InfectiousDiseases 852-9 (1991).

(24)T.W. Hennessy et al., *A national outbreak of* Salmonella enteritidis *infectionsfrom ice cream*, 334 New England Journal of Medicine 1281-6 (1996).

(25)J.H. Mermin & P.M. Griffin,*Invited commentary: public health crisis incrisis-outbreaks of* Escherichia coli *0157:H7 in**Japan*, 150American Journal of Epidemiology 797-803 (1999).

(26)World Health Organization, *supra* note 11, at 4, *citing,* WorldHealth Organization, Regional Office for Europe, Toxic oil syndrome: Mass foodpoisoning in Spain, Report of a WHO meeting, Madrid, 21-25 May 1987;77:1431-4.

(27)  Jackson, *supra* note 8. *See also,* T. Prendergast et al., *EndrinPoisoning Associated with Taquito Ingestion--**California**,* 38Morbidity & Mortality Weekly Report 345-7 (1989).

(28)U.S. Food and Drug Administration, *supra* note 8.

(29)U.S. General Accounting Office, Food Safety: Federal Efforts to Ensure theSafety of Imported Foods Are Inconsistent and Unreliable (GAO/RCED-98-103) 47(1998).

(30)Barbara Herwaldt et al., *An outbreak in 1996 of cyclosporiasis associatedwith imported raspberries*, 336 New England Journal of Medicine 1548-56(1997); Barbara Herwaldt et al., *The Return of* Cyclospora*in 1997:Another Outbreak of Cyclosporiasis in North America Associated with ImportedRaspberries*, 130 Annals of Internal Medicine 210-20 (1999).

(31)Peter Chalk, RAND, Terrorism, Infrastructure Protection, and the U.S. Food andAgricultural Sector (CT-184) 2 (2001).

(32)Jason Pate & Gavin Cameron, Covert Biological Weapons Attacks againstAgricultural Targets: Assessing the Impact against U.S. Agriculture, BCSIADiscussion Paper No. 2001-9 8 (Aug. 2001).

(33)Chalk, *supra* note 31, at 3, 5-6.

(34)Khan, *supra* note 15, at 4.

(35)  U.S. Department of Agriculture, Economic Research Service, *WeighingIncentives for Food Safety in Meat and Poultry,* Amber Waves 36-7 (April2003).

(36)U.S. Department of Agriculture, Economic Research Service, Economics offoodborne disease: feature, available at www.ers.usda.gov/briefing/FoodborneDisease/features.htm. The five pathogens are nontyphoidal *Salmonella* spp., *E. coli* O157:H7,*E. coli* non-O157:H7 STEC, *Campylobacter* spp., and *Listeriamonocytogenes.**Id.*

(37)U.S. General Accounting Office, Food-Processing Security: Voluntary Efforts AreUnder Way, but Federal Agencies Cannot Fully Assess Their Implementation(GAO-03-342) 2 (2003).

(38)Pate & Cameron, *supra* note 32, at 16.

(39)Jeremy Sobol et al., *Threat of a biological terrorist attack on the**US**food supply: the CDC perspective*, 359 The Lancet 874, 875 (2002).

(40)  Swedish National Defence College, Crisis Management Research and Training,The EU Commission's Management of the Mad Cow Crisis in 1996 1 (2001).

(41)*Id.*

(42)*Id.*

(43)U.K. Department for Environment Food and Rural Affairs, BSE: Monthly Report onMeasures Taken by the UK 27 (June 2003).

(44)  Swedish National Defence College, *supra* note 40, at 2.

(45)U.S. General Accounting Office, Food Safety: Experiences of Four Countries inConsolidating Their Food Safety Systems (GAO/RCED-99-80) 5-6 (1999).

(46)Approximately 4.5 million head of cattle were destroyed in the U.K., at a costof $ 4 billion. U.S. Department of State, Mad Cow Disease: Agriculture Issues(Mar. 12, 2001). Attaché reports from London in 1996 indicated that nearly10,000 people in the transport and meat processing industries were laid off asa result of the mad cow crisis. U.S. Department of Agriculture, ForeignAgriculture Service, BSE Update 04/02/96. *See also id.* at 5-6.

(47)Mead, *supra* note 6. This estimate accounts for underreporting offoodborne illness, as well as the proportion of foodborne illness that iscaused by pathogens or agents that have not yet been identified and thus cannotbe diagnosed. *Id.* at 607.

(48)Codex (ALINORM 03/41), *supra* note 4.

(49)World Health Organization, *supra* note 11, at 1. 

(50)Khan*, supra* note 15, at 3-4 (comparing aerosolized attacks to food andwater sabotage).

(51)*Id.* at 4-5.

(52)Katherine Peters, *Officials fear terrorist attack on**U.S.**foodsupply*, Government Executive (June 10, 2003).

(53)*Id.*

(54)James Risen & Don Van Natta, Jr., *Plot to poison food of British troopsis suspected*, New York Times, Jan. 24, 2003, at A1; *CIA looks intopossible al-Qaeda link to ricin plot*, Sydney Morning Herald, Jan. 29, 2003; ABCNewsonline, *CIA probes possible Al Qaeda link to British ricin plot*, Jan. 28, 2003.

(55)Curt Anderson, *FBI: al-Qaida May Try to Poison Water,* Assoc. Press** (Sept. 4, 2003).

(56)World Health Organization, *supra* note 11, at 2.

(57)*See, e.g.,* the U.S. Department of Homeland Security, Homeland SecurityAdvisory System, available at *http://www.dhs.gov/dhspublic/display?theme=29* (Aug. 29, 2003) ("We remain a nation at risk to terroristattacks and will remain at risk for the foreseeable future.").

(58)U.S. Food Safety and Inspection Service, *Salmonella* Enteritidis RiskAssessment*, supra* note 17, at 14.

(59)*Id.**See also,* U.S. Food Safety and Inspection Service, DraftRisk Assessment of *E. coli* O157:H7 in Ground Beef, *supra* note 17.

(60)U.S. Centers for Disease Control and Prevention, *supra* note 5, at 1.

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