Potential Threats from Biotechnology and Life Sciences: What is Dual-Use Research?

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Potential Threats from Biotechnology and Life Sciences: What is Dual-Use Research? Adapted from presentation by Nonproliferation Education Program James Martin Center for Nonproliferation Studies Monterey Institute of International Studies Created for the Nuclear Threat Initiative Teacher s Toolkit

Biological Dual-Use Research Biotechnology represents a dual use dilemma in which the same technologies can be used legitimately for human betterment and misused for bioterrorism. Biotechnology Research in an Age of Terrorism, National Academy of Sciences, 2004 Learnodes.com/Judy Breck research that, based on current understanding, can be reasonably anticipated to provide knowledge, products, or technologies that could be directly misapplied by others to pose a threat to public health, agriculture, plants, animals, the environment, or materiel. US National Science Advisory Board for Biosecurity

Research on the same biotechnologies Dual-Use Public Health Biodefense Bioterrorism Diagnostics Drugs Vaccines Antivirals Defends against military use of bioweapons Develops capabilities for military use of bioweapons Bioweapons States Terrorists Fermenter used for production of weaponized anthrax.

Research on the same biotechnologies Dual-Use Public Health Biodefense Bioterrorism Diagnostics Drugs Vaccines Antivirals Defends against military use of bioweapons Develops capabilities for military use of bioweapons Bioweapons States Terrorists Fermenter used for production of weaponized anthrax.

Who Does Infectious Disease Research With Dual-Use Potential? Military Government Private companies (commercial) Academia NGOs etc.

It s not all about the microbes Ball Mill

Examples of diseases often mentioned in the context of biological warfare/bioterrorism Human diseases Zoonoses Animal diseases Smallpox Cholera Shigellosis Anthrax Brucellosis Coccidioidomycosis EEE / VEE / WEE Japanese B Ebola/Marburg Histoplasmosis Melioidosis Glanders Plague Psittacosis Q Fever Rabies Tularemia African Swine Fever Foot and Mouth Fowl Plague Newcastle Rinderpest Botulism SEB intoxication

US CDC Classification of Select Agents Anthrax DNA, in a gel electrophoresis plate, fluoresces under ultraviolet light. Brucella Culture Minnesota Department of Health, Infectious Disease Epidemiology, Prevention, and Control Division US Centers for Disease Control and Prevention, Department of Health and Human Services

Discussion Does a Select Agent list make us more safe or less safe? A. More safe B. Less safe

Sources of Microorganisms Most are naturally occurring endemic diseases that can be obtained from a hospital or clinic laboratory. Purchased from commercial repository. May be traded, stolen, or obtained gratis from other research, clinical, veterinary laboratories or scientists.

Discussion Which of the following statements is accurate regarding organisms on the Select Agent List? A. All are rare and exotic B. Many are uniformly fatal C. Many are endemic in developing countries D. All are treatable E. No available vaccines

Discussion Does a Select Agent list make us more safe or less safe? A. More safe B. Less safe

Types of Risks from Dual-Use Research Technologies that deliver beneficial drugs to the body could be used for weaponizing biological agents. Research could have unintended consequences. Dangerous agents could be released accidentally from the lab through infected personnel. Research results can be published in easily accessible journals and on the Internet. Knowledge or techniques could help to create novel pathogens with unique properties or create entirely new classes of threat agents. Dangerous agents could be stolen or diverted for non-peaceful purposes. IRRI Images

Examples of Risk Potential Weaponization of New Technologies 1997: Dr. David Edwards developed a way to deliver aerosolized medicine using large porous carrier particles. The method dramatically increased the amount of drug that made it deep into the lungs. His research appeared in Science, bringing into question whether someone could use the information for weaponizing anthrax and other aerosolized agents. Federation of American Scientists See: Dual Use Research in Aerosol Drug Delivery www.fas.org Dr. David A. Edwards, Harvard University

Examples of Risk Unintended Consequences of Genetic Engineering Australian researchers genetically altered mousepox, an infectious virus that affects mice, to induce sterility in the mice. The researchers inadvertently produced a recombinant virus with greatly increased lethality. Their paper was published in the Journal of Virology in 2001, leading to concern that the same technologies could be used to weaponize smallpox and other pox viruses that affect humans. See: Jackson et al., J Virol 2001 75(3):1205-10.

Examples of Risk De Novo Synthesis of Poliovirus In the fall of 2001, Dr. Eckard Wimmer announced that his lab had been able to assemble synthetic poliovirus by piecing together the viral genome based on its sequence, publicly available on the internet. These experiments established the proof of principle that more dangerous biological agents could in theory be made from scratch. See: Cello et al, Science 2002 297:1016-18

Examples of Risk Accidental Exposure of Laboratory Personnel 2005: Three Boston University researchers became ill after being exposed to tularemia, a highly lethal pathogen The scientists believed they were working with a research strain that would not cause illness, but a highly infectious strain was accidentally mixed with the harmless variety. The researchers violated biosafety procedures that required them to work with tularemia inside an enclosed box, called a hood, that sends air through sophisticated filters. See: http://www.bphc.org/programs/cib/environmentalhealth/biologicalsafety/fo rms%20%20documents/tularemia_report_2005.pdf

Examples of Risk Anthrax: Stolen or Diverted 2008: A U.S. Army Medical Research Institute scientist, Dr. Bruce Ivins, committed suicide after the FBI suspected him of diverting anthrax spores from his research lab and using them in the 2001 anthrax letter attacks. Dr. Ivins had worked on an experimental vaccine to treat anthrax. The FBI claimed that a preponderance of circumstantial evidence led to him, and the strain of the anthrax used in the letter attacks matched the anthrax in his laboratory. Dr. Bruce Ivins B. anthracis

Summary: Potential Dual Use Threats from Biotechnology and Life Sciences Creating a bioweapon requires the skills and materials to handle and grow agents, isolate, and disseminate them. Any medical advance that improves the ease of engineering, handling, or delivering treatment has the potential to be applied by those wishing to do harm and can be considered dual-use. Each year hundreds of dual-use research articles are published, making them accessible to any member of the research community. Thousands of pieces of scientific equipment are purchased on the Internet. Dual Use Research in Aerosol Drug Delivery www.fas.org

Discussion Does openness create the risk that available information, reagents, or equipment will be used to create dangerous biological weapons? What steps can we take to ensure that our resources/equipment/knowledge are not used inappropriately? Is it a question of Who could or Who would?