Association of Food and Drug
Officials Annual Conference
Kansas City MO, 8 June 2005
Jerry Jaax
Associate Vice Provost for Research Compliance and University Veterinarian
Kansas State University

Emerging… or Intentional??

Bio-terrorism is the random use of these weapons against the public
With the purpose of demoralizing a country, exacting revenge, and/or affecting policy

Potential Targets for Biological Weapons
• Humans
– Pathogenic diseases
–
Vector-borne diseases
– Zoonotic diseases
–
Toxins
•
Food
• Animals
•
Plants
•
Materiel

Striking a balance between:
• alerting and informing the public with a realistic sense of the risk, without
• exaggerating and arousing harmful or paralyzing fears
Government,
Scientists, and the
Press

Analysis of “Threat Biology” is complex
Information looks different to different people
Accurate conclusions are difficult!!
• No information
•
Misinformation
•
Differing Agenda
•
Different Perspective
•
Interpretation
• Ideology
•
Dual-use technologies
•
Technology explosion
•
Intent

Biological Agents as
.
•
Sythian arrows dipped in blood of decomposing bodies (400 BC)
•
Diseased bodies in water supplies
•
Saliva from rabid dogs in artillery shells (Poland, 1650)
•
Smallpox infected clothing or blankets
•
Nomadic Mongols catapult bubonic plague-infested bodies into the Genoese trading post in the Crimea.
•
German Glanders efforts
•
Japanese Imperial Units 731 and 100
•
Anthrax mailings
•
Ricin mailings
Excludes “Biocrimes”

(1932 - Present)
‘96 - Diane Thompson--Dallas hospital….
Shigella in pastries (12 ill)
‘95 - Debora Green---Kansas City….
Ricin in meals (1 ill)
‘84 - Rajneeshees---Oregon...
Salmonella on salad bar (751 ill)
‘70 - Eric Kranz---Montreal… Ascriis suum in food (4-5 ill)
------
‘66 - Dr. Mitsuru Suzuki---Japan… S. typhi in food (ca.412 ill / 12 dead)
‘39 - Kikuko Hirose---Japan… Salmonella in pastries (12 ill)
‘36 - Tei-Sabro Takahashi---Japan…
Sal . in pastries (10 ill / 4 dead)
‘32 - Prince Mikasa---Japan…
Cholera in fruit (0 ill)
<1200 ill & 16 dead

Implications and Constraints for the Bioweaponeer
• Must be presented as a respirable aerosol
Magic
Involved
Therefore
• Preparation and weaponization may jeopardize viability
• Aerosols are dependant on meteorological conditions
However...
• Contagious agents can be delivered without weaponization
• Some agents can be spread by vectors
Little or No Magic Involved
Courtesy David Franz

Urban Myth: Biologics too sophisticated for terrorist use
Reality: Bloody rag, a blender and a highly contagious virus
•
1997 - New Zealand farmers illegally introduce rabbit hemorrhagic disease (RHDV) – calicivirus
•
Circumvented one of the best bio-security systems in the world
Virus entered 3 ways:
 mailed into the country in a vial
 Carried in a vial placed in an air travelers sock

Carried in a handkerchief drenched in blood/tissues from infected rabbit
Infected rabbits - lungs, spleen, and liver

Used kitchen blender to make slurry to mix with rabbit food

Not a human pathogen

Possible Indicators of a BW/BT Attack
• Disease entity not naturally-occurring in the area
• Multiple disease entities in same patients (mixed agent attack)
• Large # of military and civilian casualties (inhabit same area)
• Data suggestive of a massive point source outbreak
• Apparent aerosol or cutaneous route of invasion
• High morbidity and mortality relative to # at risk
• Localized or circumspect area for illness
• Low attack rates for personnel working with filtered air or closed ventilation systems
• Dead sentinel animals of multiple species
• Absence of a competent natural vector in area of outbreak
• Severe disease in previously healthy population

Biodefense is the
"single most significant modern challenge to U.S. sovereignty"
• "biological weapons can be delivered by a few
• present a small signature for which the U.S. has illdeveloped intelligence gathering capability
• conventional concepts of deterrence are not necessarily effective
• the nation has a limited response capability to contain the consequences."
Recommended quadrupling the
DoD biodefense budget
Defense Science Board
July 2002

"Biology is about to lose its innocence in a profound way. While physics dominated weapons in the 20th century, biology will dominate weapons in the 21st"
George Poste
Defense Science Board
• “Constructed” polio virus (3 years)
• Virus (Phi X174) built from scratch in 2 weeks (DOE funded project)
• Mouse Pox “super virus”

• Camelpoxvirus is the causative agent of
Camelpox
•
Causes Pox disease in dromedary camels - Africa and Asia
•
Iraqi BW lab with genetic engineering capability admittedly worked with the agent
WHY???
•
Primary human pathogen in non-endemic area?
•
Genetic modification as BW agent?
•
Lab surrogate for Variola?
•
Worried about Camels ??

Biowarfare in the Former Soviet Union
•
Dr. Ken Alibeckov - Biopreparat
• Defected from the FSU - wrote “Biohazard”
• Defined the scope of the FSU bio programs
• Tens of thousands scientists and technicians
•
Thousands involved in Offensive Agricultural BW programs
•
Strategic as well as Tactical Doctrine

"If you are not financially independent, it influences your moral decision-making."
Daan Goosen, former managing director of Roodeplaat
Research Laboratories (RRL) in South Africa
Russian scientists make an average of
$1,644 yearly ($137/mo); the U.S. Labor
Department puts the average annual salary for an American scientist at $59,200.
Chicago Tribune
2004

''We stockpiled hundreds of tons of anthrax and dozens of tons of plague and smallpox near
Moscow and other Russian cities for use against the United States and its allies''
Soviet defector Colonel Kanatjan Alibekov, MD
Biopreparat's deputy chief (1992)
Alibek predicts in “Biohazard” that the threat of biological attack has actually increased as techniques developed in the USSR have ''spread to rogue regimes and terrorist groups . . . they are cheap, easy to make , and easy to use

One gram, or one twenty-eighth of an ounce, highgrade anthrax can hold up to 100 billion spores.
Estimated conservatively, at 10,000 spores to a lethal dose, one gram in theory could cause about
10 million deaths
Ken Alibek

Pulmonary
(aerosol) 80%
• Spore form is extremely stable
• Inhalational disease highly lethal
• Starter cultures widely available
• Weaponized by all major offensive BW programs
• Susceptible population
Cutaneous (contact) 20%
Gastro-intestinal (oral)
**Not contagious from one individual to the other

ATLANTA, Mar 20, 2002 (BW HealthWire) –
“ Pneumonic plague
.. has the dubious distinction of placing high on the CDC list of agents that could be deployed as a bioterror weapon, according to a report in the March 20
Bioterror Medical Alert.”
“While experts note that an aerosolized release of plague would not cause a massive epidemic akin the 14th century "Black Death" scourge that killed tens of millions, a 50kilogram release of pneumonic plague over a large city could infect 150,000, causing 36,000 fatalities .

is a stable toxin easily made from the mash that remains after processing Castor beans for oil. Castor beans are grown agriculturally worldwide and the plants grow wildly in arid parts of the United States. Castor beans are slightly larger than pinto beans and have been described as looking like blood-engorged ticks. The beans are not normally used as food.
Poisoning can occur following inhalation, ingestion, or injection of ricin toxin from castor beans.
Deadly in less than milligram amounts
• Moderately toxic by inhalation
• Relatively not toxic orally
• Somewhat difficult to formulate as powder
• Quite stable
• Dose-dependant morbidity
• Castor beans widely available and popular
• Weaponization attempted by US, USSR and Iraq
No Known Treatment Available – Supportive Care only

Smallpox (
Variola major
)
• More historical deaths than plague and all wars combined
• In some ancient cultures, naming infants forbidden prior to smallpox survival
• 18th century, smallpox killed every 10th child born in Sweden and France, every
7th child in Russia
• 1949 - Last U.S. case
•
1977 Last natural case
•
Highly contagious
(not
‘extremely’)
• Quite stable
• ca. 30% mortality
•
Virus not widely available
•
Weaponized by the USSR
• Susceptible population
• No animal reservoir

What About Engineered Pathogens
“My most successful research was the finding that a bacteria called Legionella could be modified in such a way that it could induce severe nervous system disease . And the symptoms of nervous disorders [similar to those of multiple sclerosis ] would appear several days after the bacterial disease was completely "cured." So there would be no bacterial agent, but symptoms -- new and unusual symptoms -- would appear several days later
”.
NOVA interview with former Soviet biowarrior
Sergei Popov

The Biological Threat has Evolved
Cold
War
Gulf War
Dissolution of USSR
Today… and Tomorrow??
Tactical use on battlefield
….and strategic use against mainland U.S.
“Terrorist” use against military, population centers, and economic/agricultural infrastructure
Geopolitical “Asymmetry has changed the face of the game. The
U.S. has few or no “near-peers” for conventional forces
Courtesy David Franz

Diseases often mentioned in the context of Biological Warfare
Human Diseases
•
Smallpox
• Cholera
• Shigellosis
Toxins
• Botulism
• SEB
• Ricin
Zoonoses
•
Anthrax
•
Brucellosis
•
•
Melioidosis
Glanders
• Coccioidomycosis • Plague
•
VEE/EEE/WEE
•
Psittacosis
•
Marburg/Ebola
• Histoplasmosis
•
Rift Valley fever
•
Q fever
• Tularemia
•
Lassa fever
Animal Diseases
• African Swine
Fever
•
** Foot &
Mouth
• Fowl plague
• Newcastle
• Rinderpest
Plant Diseases
• Wheat Stem Rust
• Rice Blast
• Pathogenic Plant Fungi
• Karnal Bunt
Courtesy David Franz

“CDC List”
Category A
• Anthrax
• Plague
•
Smallpox
•
Tularemia
•
Viral Hemorrhagic
Fevers
•
Marburg
•
Ebola
•
Lassa
•
Machupo
High Priority http://www.bt.cdc.gov/agent/agentlist.asp
Category B Category C
•
•
• Brucellosis
• Epsilon Toxin (C. Perfringens)
•
Food and water safety threats
•
Salmonella, E. coli O157:H7, Shigella, Vibrio,
Cryptosporidium
Glanders
Meliodosis
• Emerging diseases
•
•
• Nipah
Hantavirus
Yellow Fever
•
Drug resist TB
• etc
• Psittacosis
• Q Fever
• Ricin
•
SEB
Categorizations based on various factors that affect potential as weapons
•
Typhus
•
Viral encephalitities ( VEE/EEE/WEE)
Lower Priority

“OIE List A” Animal Diseases
Transmissible diseases with potential for serious and rapid spread that are of serious socio-economic or public health consequence and major importance in international trade of animals and animal products.
•
Foot and Mouth Disease
• Rinderpest
•
Pest des petis ruminants
•
Hog Cholera
•
African Swine Fever
•
Swine Vesicular Disease
•
Vesicular Exanthema
•
African Horse Sickness
•
Exotic Newcastles
•
Avian Influenza (HPIA)
•
Sheep and Goat Pox
•
Lumpy Skin Disease
•
Rift Valley Fever
•
Vesicular Stomatitis

•
Pose a
because:
• easily transmitted from person to person
• high mortality
• require special efforts to ensure preparedness
80% of “Category A” agents are zoonotic

The Risk is Agent,
Target, and Delivery
Dependent

Prevention
BW Attack
Incubation Period
Clinical Signs
Mass Casualties
Impact
The longer a BW attack goes undetected or unrecognized, the more serious it becomes.
Early detection and effective intervention is critical

Emerging or Intentional Disease Event
Dick and Jane from Kansas City just returned from travel in the
UK and introduced Foot and
Mouth Disease into the massive food animal economy of the
United States.
Was this an innocent mistake?
Or were they Terrorists intent on damaging the U.S?

…Our ability to produce safe, plentiful, and inexpensive food creates the discretionary spending that drives the American standard of living….
Dr. Jon Wefald
President KSU

Homeland Security
Presidential Directive #9
30 Jan 04
…..a successful attack on the United States agriculture and food system could have catastrophic health and economic effects .
•
The U.S. will protect the agriculture and food system from terrorist attack, major disasters, and other emergencies by:
• Identifying and prioritizing sector-critical infrastructure and key resources for establishing protection requirements
•
Developing awareness and early warning capabilities to recognize threats
•
Mitigating vulnerabilities at critical production and processing nodes
•
Enhancing screening procedures for domestic and imported products
• Enhancing response and recovery procedures

NRC Report to the USDA on
Vulnerability of U.S. Agriculture,
20 Sept 2002
"Biological agents that could be used to harm crops or livestock are widely available and pose a major threat to U.S. agriculture."
Harley Moon, co-author
Both primary authors of the report said a biological attack on U.S. agriculture was a matter of
“
.”

Foot and Mouth
Disease (FMD)
Mad Cow Disease
(BSE)
Highly contagious virus (days)
Aerosol transmission & fomites
Not zoonotic
Widely available
Cause epidemic
Mass depopulations
Significant economic impact
Require no delivery system
Slow-acting prion (years)
Infected tissues in food
Zoonotic (vCJD)
Rare – hard to find
Isolated cases or clusters
Limited depopulations
Significant economic impact
Require thoughtful delivery
#1 Agroterrorism threat Improbable terrorism threat

Dairy
Regional concentration magnifies vulnerabilities and potential consequences.
Beef Swine
Poultry Corn Wheat http://www.nass.usda.gov/census/census97/atlas97/

Potential Impacts of Foreign Animal Disease on Industry
• Productivity losses
•
Decreases in market prices
•
Value of animals destroyed
•
Vaccination costs
•
Carcass disposal costs
• Cleanup and disinfection costs
• Profit losses
Direct Impacts
Council for Agricultural Science and Technology,
Number 28, Feb 2005

Potential Impacts of Foreign Animal Disease on Industry
•
Loss of exports and foreign demand
•
Loss of domestic sales / demand
•
Loss of competitive position domestic/export markets
•
Costs to rebuild production capabilities
Indirect Impacts
•
Decreased demand for services
(processing / marketing / etc.
•
Emotional / psychological trauma
Council for Agricultural Science and Technology,
Number 28, Feb 2005

“Prior to September 11, 2001, all known victims of criminal use of biological agents in the U.S. were exposed by the oral route - with food as the vehicle”
David Huxsoll, DVM, Ph.D.
KVMA, Jan 02

• 751 known cases of GI disease
• a more virulent strain (S. typhi could have caused many deaths

Ingrid Newkirk, PETA
President and Co-founder
"If that hideousness (FMD) came here, it wouldn't be any more hideous for the animals
— they are all bound for a ghastly death anyway. But it would wake up consumers.
I openly hope that it comes here.
It will bring economic harm only for those who profit from giving people heart attacks and giving animals a concentration camplike existence. It would be good for animals, good for human health and good for the environment .“
ABCnews.com 4/2/2001

“If vivisectors were routinely being killed , I think it would give other vivisectors pause in what they were doing in their lives… Call it political assassination or what have you…”
“ I don't think you'd have to kill too many [researchers].
I think for five lives,
10 lives, 15 human lives, we could save a million, 2 million, 10 million non-human lives.”
Jerry Vlasak, MD, Physicians Committee for
Responsible Medicine (PCRM) spokesman at an animal rights convention
The Observer, July 25, 2004 (UK)
“Would I advocate taking 5 guilty vivisector’s lives to save 100’s of millions of innocent animal lives? Yes
I would.”
Development and testing of biodefense and emerging disease countermeasures rely heavily on animal-based research

Texas Tech professor found not guilty of smuggling plague samples, but guilty of fraud and improper shipping
John Dudley Miller
Physician
Respected researcher
Family man
Convicted felon
Terrorist?
Scapegoat?
60 FBI agents on campus
• Lost his job and his medical license.
• 24 months in prison.
• Fined $15K & $38K restitution.

Oh waiter, there seems to be a rock (python) in my soup!
At least
11,600 tons of illegal bush meat
, including monkey, rat, bat, gorilla, camel and elephant, were smuggled into Britain during 2003, exposing cattle to a range of infectious diseases, including foot and mouth. The extent of the illegal trade in meat from Africa, Asia and the Middle East is revealed in an internal government report ( Department of the Environment, Food and Rural Affairs UK) , which says that the problem is far worse than had been thought. Almost all of the meat, which is bound for street markets and ethnic restaurants, is hidden in passengers' suitcases and goes undetected by airport security.
The food includes snake and antelope meat, frogs' legs, snails, and cows‘ nostrils, as well as meat from endangered species such as chimpanzees, antelopes and elephants.
The Telegraph
5 Sept 04

How are we going to counter these new and ominous threats to our national security, our people, or our economic infrastructure
We must Improve and Refine Traditional Countermeasures to potential emerging
Public Health Threats
•
Intelligence / Surveillance / Catch the Bad Guys!!
•
Vaccines, Prophylaxis, Treatments
•
Disease Surveillance
•
Genetic enhancement of resistance
•
Rapid diagnostic capabilities
•
Rapid - Incident Response
•
Consequence Management
•
Enhance Surge Capacity
•
Training
•
Increase Bio-security Profile
Virtually all are dependent upon
$$, facilities and personnel
•
Innate Immunity Ramp-up

Government
Federal
State
Local
Basic and
Applied R&D
Industry Academia
A coordinated and collaborative partnership is critical

before after
•
Vaccines
•
Prophylaxis
• Treatments
•
Enhanced resistance
Proactive Measures
•
Intelligence
•
Risk Assessment
• Surveilance
•
Regulatory Safeguards
•
Coordination / Training
•
Biosecurity
• Response & Preparation
Biological Threat
Countermeasures
Attack
• Incident
Management
• Consequence
Management
• Containment
•
Decontamination
• Disposal
•
Indemification
Reactive Measures
Big $$
Bigger
$$

We need to at least be thinking about the
“zebras” when it comes to surveillance, diagnostics, and response

Potential Consequences of Agroterrorism are High.
•
Agriculture generates 17% of U.S. GDP & 13% of U.S. jobs
•
Livestock and cropping systems are interdependent - e.g., an attack on either beef or corn affects the other
•
Failures would cause widespread international disruption
Foot and mouth disease in the UK cost an estimated
$5B to agriculture alone. Tourism losses wre an additional $7.2B - $8.5B. http://www.defra.gov.uk
http://www.whale.to/m/fmd70.html

•
West Nile
• Nipah Disease
• Prion Diseases
• Avian Influenza
•
Exotic Newcastles
•
SARS
• Marburg / Ebola
• Etc, etc, etc…

•
Heightened Awareness
•
Accelerated / Applied Research
•
New Facilities
•
Rapid Diagnostics
•
First Response capabilities
• Countermeasures (vaccines, treatments, containment strategies)
•
Pre-positioned materials/teams (vaccines, treatments, PPE)
•
Better Planning, Coordination, Communication and Training
•
Improved Intelligence, Security and Surveillance
•
Reinvigorating Public Health Infrastructure
•
Government Reorganization (Homeland Defense Dept)

“After successful prevention, the next line of defense is the development of new vaccines and antidotes for bioterror
”
The Defense Science Board estimates that we have only a few of the dozens of antidotes or vaccines needed to counter the top bioterror threats”
Christian Science Monitor
11 Feb 2003

Agriculture Seduced by our Successes
• The U.S. has been highly successful in preventing the natural or accidental introduction of many dangerous agricultural diseases for generations
•
Foot and Mouth Disease
• Rinderpest
• African Swine Fever
•
Containment and response strategies for those diseases that do occasionally occur have been effective - but costly
•
Avian Influenza
•
Exotic Newcastle disease
•
VEE
•
Classical Swine Fever (Hog Cholera)
Historical accomplishments can promote complacency and a sense of invulnerability in the face of new potential threats

Cautious Optimism??
The dual threat of emerging and intentionally inflicted disease is frightening, but there is “cause for some cautious optimism.” Scientists have an “ evergrowing toolbox of sophisticated technologies and strategies at their disposal that will help detect, prevent, treat, and respond to new and old infectious agents as they emerge, whether by an act of nature or by deliberate design.”
“… powerful new tools, including ones that expose the genetic signature of microbes
, are being used to detect and identify known and novel pathogens and to develop new drugs and vaccines.”
Forensics &
Countermeasures
Anthony Faucci MD, NIAID/NIH
Emerging Infectious Diseases/
A Clear and Present Danger to
Humanity,
JAMA. 2004;292:1887-1888.

"For the life of me, I cannot understand why the terrorists have not attacked our food supply, because it is so easy to do”
Resignation comments - Tommy Thompson,
Secretary of Health and Human Services
December 3, 2004

•
•
•
•
•
Human
Animal
Plant