Over the last several months, Universal Adversary (UA) terrorists within the U.S. have obtained the necessary equipment and supplies to attack the United States food supply using botulinum toxin. After months of underground laboratory experimentation, the terrorists have identified a means to deliver botulinum toxin to the milk supply of a large U.S. city.
To infiltrate the U.S. food system without detection, one of the UA terrorists secures a job at a milk manufacturing facility. After several months of employment, he has been given access to the pasteurized milk holding tank, which he contaminates with C. botulinum neurotoxin prior to final packaging in paperboard cartons or plastic jugs. The vendor distributes the milk product regionally in interstate commerce, and is the primary supplier of milk to a single large U.S. city.
Timeline Event Dynamics
- Zero Day: UA terrorist contaminates a pasteurized milk holding tank with botulinum toxin Serotype A.
- Day 1: The contaminated milk is bottled and delivered to area supermarkets and convenience stores.
- Day 2: The contaminated milk is first consumed.
- Day 3: Several individuals including several small children present to area hospitals with cranial nerve palsies and progressive descending flaccid paralysis resulting in respiratory failure. Within hours, emergency rooms around the city are overflowing with patients with similar symptoms. The large number of patients with flaccid paralysis quickly triggers healthcare professionals to suspect food contamination.
- Local public health and law enforcement officials are alerted through proper protocol due to the unusually large number of patients.
- Federal and State public health official and law enforcement officials are alerted because local officials suspect a terrorist involvement, and deploy public health and law enforcement investigators to investigate a suspected terrorist foodborne attack.
- Law enforcement organizations begin criminal and forensic investigative efforts for evidence collection and preservation.
- Health departments, the Centers for Disease Control and Prevention (CDC), Food and Drug Administration (FDA), and other public health entities begin epidemiological investigations to trace the biological source of the contamination, which is later confirmed via laboratory assay. Presumably, State Public Health officials will have begun their health surveillance and epidemiological investigations shortly after foodborne contamination was suspected.
NOTE: The time from exposure to the toxin until the onset of symptoms for food botulism is variable and thought to be dose dependent. The latent period for food botulism is typically 18 to 36 hours with varying degrees of efficacy after exposure, with clinical symptoms presenting shortly thereafter. The time from exposure to clinical manifestation varies with each form (serotype) of botulinum.
- Day 4: The CDC is requested to deliver antitoxin, ventilators and other supplies. Many of these commodities will be drawn from the Strategic National Stockpile (SNS).
- Antitoxin, ventilators and other supplies are received from the SNS.
- The local news is quickly informed of the outbreak and concerned citizens soon flood emergency rooms. News of the event soon hits the national news.
- Investigations conducted by the CDC, State and local health departments reveal the source of the contamination. Epidemiological investigations lead to the confirmation that the contaminated milk source is the Dairy Pride manufacturer.
- Area hospitals have reached capacity.
- The milk product is recalled and a public announcement warns residents to discontinue the purchase and consumption of the contaminated product.
- Dairy Pride halts production of milk.
Geographical Considerations/Description: The toxin is delivered at one milk processing facility. Following distribution of the product, the contaminated milk is contained in one region.
- A biological attack of this magnitude using botulinum toxin in a food source will be considered a terrorist attack and will require an incident response and crime scene investigation (FBI) simultaneously.
- A preparation of Clostridium botulinum toxin will likely have some vegetative bacteria and spores. Therefore, the UA will not be introducing a preparation of 100% pure toxin to the bulk milk tank.
- Biological incidents may not be immediately recognized and would only be detected after the first patients arrived at healthcare facilities displaying classic symptoms of botulinum toxin intoxication.
- A biological attack with a botulinum toxin could be a significant incident that could overwhelm the capabilities of many State, Local, Tribal, or Territorial (SLTT) governments to respond, and could require (and seriously challenge) existing federal response capabilities, resulting in the declarations regarding the incident significance (e.g. Presidential, Public Health, etc.) immediately or otherwise.
- The Secretary of Homeland Security may issue a National Terrorism Advisory System alert.
- Participating non-federal hospitals of the National Disaster Medical System (NDMS), as well as available VA Primary Receiving Centers (PRCs) and available DOD Military Treatment Facilities (MTFs) may be authorized by respective Secretaries to provide definitive care to casualties of a catastrophic mass casualty incident.
- Medical providers responding to a botulinum attack may need to adopt crisis standards of care and deviate from medical practice standards that apply in normal circumstances depending on the situation.
- Casualties requiring medical care following a biological attack will present at hospitals near the incident site for treatment. It should be noted however, given that cases typically present 12-72 hours after consumption, some contaminated people may have traveled far from the attack site prior to developing symptoms.
- There will be increased need to support at-risk individuals.
- The psychological dimensions of a biological incident and exposure to a covert biological agent will present social management challenges and concerns.
- Upon public notification of the event, there will be a significant number of people concerned about food safety or who will present themselves to healthcare providers with concerns and anxieties that they have been exposed to a biological agent, although they may not have been affected. These patients will consume additional health care resources and time, including mental health care.
- Public anxiety related to a catastrophic (large-scale) incident will require effective public messaging and will require mental health services.
- Clinicians will be the first to recognize the effects of foodborne illness and identify botulinum toxin as the probable cause.
- Upon identification and classification of the outbreak, State and local public health officials will immediately notify public health officials at the federal level.
- A large-scale incident involving any part of the food continuum will require a federal response.
- Emergency response is primarily a local responsibility; however, many State and federal agencies will become involved in the response and recovery phase of the incident.
- During a large-scale food-related incident, schools, child care centers, restaurants, retail food stores, and food manufacturing or processing establishments will work cooperatively for a rapid and smooth coordination of HHS response and recovery operations.
Mission Areas Activated
Prevention/Deterrence: Milk production facilities may take proactive security measures, such as locking of trucks, tanks, silos, and rigorous oversight at transfer sites, in accordance with established federal guidance, State regulations, and industry best practice standard operating procedures at milk production facilities to prevent an intentional contamination.
Emergency Assessments/Diagnosis: Determining cause of illness and tracking the contaminated source is critical. FDA is the primary federal responding agency for illness attributed to consumption of milk. FDA has regulatory responsibility for 80% of the food consumed in the U.S. The U.S. Department of Agriculture (USDA) has regulatory responsibility for meat, poultry, egg products, and catfish.
Emergency Management/Response: In the event of a confirmed contamination attack, HHS will coordinate with other federal departments and agencies to ensure that available federal assets are identified and adequately prepared to respond. HHS will provide public messaging themes to allay public concerns, deploy personnel and teams for hospital staff augmentation and support of triage, emergency room, and hospital decompression. The CDC will play an integral role in the delivery of medical supplies, devices, and equipment that might be needed to respond to the terrorist-caused illness. Medical personnel caring for patients with suspected botulism should use universal precautions. Patients with botulism do not require isolation as the condition is not communicable. Finally, an effective public health risk communications plan will be the most effective way to manage this crisis.
Hazard Effects Mitigation: Once disease outbreak occurs, decisions must be made regarding continued milk production, distribution, and/or sale. Effects of this incident may resonate throughout the nation and international communities. Upon identification of botulinum, introduction of the antitoxin will be the best mitigating strategy to combat the effects of the toxin. For those patients requiring intensive clinical treatment, ICU beds with ventilators and clinical support staff will enhance survival rates of the affected population. Effective public messaging and a risk communication plan are essential to inform the public about the effects and treatment of botulinum. Effective public health communication and follow through by the general public will mitigate hazard effects.
Victim Care: Respiratory failure due to paralysis of the respiratory muscles is the most serious complication of botulinum intoxication and is generally the cause of death. Prolonged ventilator assistance is usually required for survival. Intensive and prolonged nursing care is required for most patients. Antitoxin should be given to patients with neurological signs of botulism as soon as possible after clinical diagnosis. It may be as long as three months before there are any signs of improvement, and up to one year for complete resolution of symptoms.
Recovery and Remediation
Milk Disposal: Contaminated milk will require proper disposal. In most cases, this calls for heating the contaminated product above 80o C or more for at least 10 minutes. The effect is to inactivate the botulinum toxin. FDA's Center for Food Safety and Applied Nutrition (CFSAN) will release information regarding the recall of milk contaminated with botulinum toxin A along with instructions where consumers may take the contaminated milk for proper disposal.
- FDA does not recommend that a consumer heat the product on the stove and then discard it in the trash or down the drain. There is too much of a chance the toxin could be aerosolized by opening the milk container, therefore, FDA recommends that the consumer place the milk container in a separate plastic trash bag and seal, possibly double bagging, then following the instructions of local authorities take the contaminated milk to the locally designated collection point for proper disposal.
- If the product is still on grocery store shelves or in school and child care center inventories, it should be removed and appropriately bagged, sealed and picked up by the appropriate regulatory agency for disposal. If the milk facility distributes the product in interstate commerce, the product would fall under FDA jurisdiction and FDA would work with the processing firm to have the product recalled. FDA does NOT have mandatory recall authority; therefore, everything would be done as a voluntary recall. The processing firm will work with the EPA, State, and local environmental waste management to decide how to appropriately dispose of the contaminated milk.
- Site Restoration: The dairy plant, milk tank, processing equipment, and other sites where botulism contamination may have occurred will need to be decontaminated and sanitized; therefore, milk production at these locations will be disrupted. Personnel working at these locations will need to be closely monitored for botulinum intoxication.
Secondary Hazards/Events: As a result of news of the contaminated milk, there may be great public concern regarding food safety, and concerned citizens could potentially tax local healthcare facilities in seeking medications even when there has been no exposure. Pressure could be placed directly on healthcare providers to dispense antitoxins, though there may be no available data to support the need to dispense the antitoxin.
Concerned citizens would want to know very quickly if it is safe to consume milk and related dairy products. Many persons could refrain from consuming dairy products, regardless of the public health guidance that is provided –fearing continued botulinum food contamination release and perceived continued threat from the “contaminated” products. Therefore, dairy product sales may decrease, triggering a significant elevation of unemployment in the local industry. Public health and law enforcement communities would attempt to determine whether any other contaminates were released at the same time as the botulinum food contamination attack. A factual and coordinated public message will allay public concerns.
Casualties: The number of casualties will depend on several factors: the volume of contaminated product distributed; amount of contaminated product consumed by each patient; the number of days to detection of the event; the amount of toxin in the contaminated product; the amount ingested by any one individual; and the availability of appropriate supportive care including but not limited to mechanical ventilators and antitoxin.
Property Damage: Property damage is minimal. The public may not know that antitoxin is not available at hospitals or pharmacies and may rush these facilities in error. These facilities may require Security personnel for crowd control and to avoid property damage.
Service Disruption: Service disruption is significant in the local dairy industry.
Economic Impact: The manufacturing facility may close due to the community’s loss of confidence. Local consumers may pay more for milk and other dairy products as a result. The economic implications of this event could be far reaching, especially when news reaches a national audience.
Potential for Multiple Events: Yes
Recovery Timeline: Botulism patients who survive the initial attack may spend weeks or months on mechanical ventilators straining the national healthcare system for some period of time. The dairy industry will take time to recover, even after successful mitigation of the event.
||Ventilator Treatment Only
||Antitoxin Treatment Only
||Antitoxin & Ventilator Treatment
Long-Term Health Issues: As the BoNT persists in the neuronal cells for periods of time that are distinct for each BoNT serotype and the mechanisms for muscle recovery may be dependent on each serotype, the length of time a patient is paralyzed and therefore requires intensive supportive care is dependent on the exposure dose and the specific serotype. Intensive and prolonged supportive care (weeks to months), including mechanical ventilation and parenteral nutrition, is the mainstay of therapy (Arnon et al., 2001) 5. The proportion of patients with botulism who require mechanical ventilation has varied from 20% in a food outbreak to more than 60% 6 in infant botulism (Arnon et al, 2001). In a bio-terrorism scenario, the proportion of patients who require mechanical ventilation will depend on the dose and serotype of BoNT to which they are exposed, as well as how quickly they are treated with antitoxin. Presently, across the country there are approximately 60,000 full-feature mechanical ventilators 7, 65,000 limited-function mechanical ventilators 8 for surge purposes in hospitals, and an additional 9,000 mechanical ventilators in the SNS 9 . The number of available ventilators in any given region is of course much less. For example, in San Francisco, there are approximately 210 ICU beds, with an average occupancy rate of greater than 90%. As few as thirty cases of botulism would fill all empty ICU beds and occupy them for 6 weeks or longer eliminating the availability of ICU beds for post-operative patients requiring ICU care. Skilled personnel will be needed to manage the patients on ventilators, as well as to maintain the ventilators. Considering that on average 40% of the patients with botulism will require ventilation, in an event involving 50,000 patients, approximately 20,000 ventilators will be needed. It is important to consider that some types of portable ventilators may not be indicated or effective in long term support. Similarly, many portable ventilators do not have pediatric or neonate capabilities, therefore, some ventilators currently used in the healthcare industry will not be clinically useful in the treatment of a BoNT agent. In a large outbreak of botulism, the need for mechanical ventilators, critical care beds, and skilled personnel will quickly exceed local capacity and persist for weeks or months, indicating the need for appropriate planning and training of emergency response teams. This type of event will overwhelm local and State resources. The long-term health issues depend on the survivor’s recovery from the toxin and ability to cope with exposure to traumatic events, which may require long-term mental health services.
Public Messaging: Public messaging will be the federal government’s greatest tool in helping to mitigate the effects of the attack. Many concerned citizens will respond favorably to an effective public messaging program that provides them relevant information about the signs, symptoms, and effects of botulinum toxin poisoning and can offer self care steps to deal with the perception or reality of contamination. Allaying public concerns early will have a dramatic impact on local authority’s ability to respond to a more manageable number of actual casualties, will also increase the amount of time that local and federal health departments can focus on the investigation of the source vehicle. Public messaging will go a long way in informing the public about the proper steps and procedures to acquire the services needed to treat and care for those citizens that have been exposed. To ensure that public messaging reaches all segments of the affected population, provide messaging in multiple languages and alternate formats, as appropriate.
Depending on the size and location of the attack, it may be necessary to notify and involve foreign governments and agencies. International notification in accordance with the International Health Regulations (IHRs) to the World Health Organization (WHO) may be necessary; additionally notification to the Food and Agriculture Organization of the United Nations in international food contamination cases may be prudent. The action steps, communications and outreach sections address this requirement.
4 Casualty numbers are derived from the Public Health Consequence model completed by BARDA for the DHS Material Threat Assessment of 2004. The numbers reflect a cumulative total during an effected period from first date of consumption through day 8.
5 Arnon SS, Schechter R, Inglesby TV, Henderson DA, Bartlett JG, Ascher MS, Eitzen E, Fine AD, Hauer J, Layton M, Lillibridge S, Osterholm MT, O'Toole T, Parker G, Perl TM, Russell PK, Swerdlow DL, Tonat K. Botulinum toxin as a biological weapon. In: Henderson DA, Inglesby TV, O'Toole T, editor(s). Bioterrorism : guidelines for medical and public health management. Chicago (IL): American Medical Association; 2002. p.141-65.
6 The 60% reference from Arnon et al is not relevant for a foodborne scenario since infant botulism is a result of intestinal colonization and not a point exposure to toxin in a contaminated product (CDC)
7 Rubinson, Lewis, etal. Disaster Medicine and Public Health Preparedness. 2010; Vol. 4, No. 3, pp 199-206.
8 Rubinson, Lewis. Botulism Integrated Program Team briefing, February 2010, presentation slide 18.
9 SNS Annual Review October 2011, data valid as of June 30, 2011.
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