Biological Weapons During the Cold War

Biological Weapons During the Cold War
Lecture No. 4

1. Outline At the end of World War II The US Programme
Slides 2 - 3 The US Programme Slides The Anti-Crop Aspect of US Activities Slides The Soviet Programme Slides Notes: The aim of this lecture is to provide a brief overview of important aspects of the offensive BW programmes of the Cold War period. As in previous lectures references are given to current views on key agents. However, the three issues that are picked out are the huge US and Soviet programmes and anti-plant biological warfare. It should be noted that there probably remains much information that is not in the public domain, particularly about the Soviet programme. Also no attention is given here to the early postwar programmes of countries like the UK and France, or to the later programmes of Iraq and South Africa. All such issues can be followed up in Mark Wheelis, M., Rózsa, L., and Dando, M. R. (Eds.), (2006) Deadly Cultures: Biological Weapons since 1945, Massachusetts: Harvard University Press.

2. At the End of the War Canadian concerns
“…in the spring of 1944…intelligence reports indicated that the German military had added botulinus toxin to its arsenal…” “…Canada’s military leaders were also impressed by …experiments which had demonstrated why botulinus toxin was an effective weapon…” Notes: At the end of World War II all of the major victorious powers regarded BW as a significant threat. This example is taken from Donald Avery’s analysis of Canada’s programme in SIPRI No 18. Canada was concerned that botulinum toxin might be used against the allies when they landed in Europe. These fears were eventually dismissed and immunization with toxoids was not carried out, but botulinum toxin remains as a possible biological weapon and would clearly cause enormous difficulties if used on a large scale against a civilian population today. Ref: Avery, D (1999) ‘Canadian biological and toxin warfare research, development and planning, 1925–45’, In Geissler, E., and van Courtland Moon, J. (Eds.) Biological and Toxin Weapons Research, Development and Use from the Middle Ages to 1945 (SIPRI Chemical & Biological Warfare Studies No. 18). Oxford: Oxford University Press. pp

3. Botulinum Toxin as a Biological Weapon
“Botulinum toxin is the most poisonous substance known….the toxin is a zinc proteinase that cleaves 1 or more of the fusion proteins by which neuronal vesicles release acetylcholine into the neuromuscular junction.” “…In a large outbreak of botulism, the need for mechanical ventilators, critical care beds, and skilled personnel might quickly exceed local capacity and persist for weeks or months…” Notes: These notes are taken from ‘Botulinum Toxin as a Biological Weapon’ in JAMA vol 285 no 8 , 1059 – When used as a weapon the toxin might directly contaminate food or be used as an aerosol to attack the victims through inhalation into the lungs.

4. Stages of the US Programme
Research and Planning (1946 – 49) Expansion during the Korean War (1950 – 53) Reorganisation (1954 – 58) The Limited War Period (1959 – 62) Adaptation to Counter insurgency (1963 – 68) Disarmament and Phased Down (1973 – 77) Notes: This and the following slides on the US programme are taken from the unclassified US Department of the Army report of February 1977 titled ‘US Army Activities in the US Biological Warfare Programs’ by L.L.Laughlin, Jr. What is clear in this summary of the stages of the programme is that an effort to produce biological weapons for military purposes persisted for two and a half decades.

“When World War II ended, the CWS (Chemical Warfare Service) had as its major mission preparedness for CW and BW in the context of a policy of retaliation only…” …Activities were concentrated on BW agent research and defensive aspects; some applied research on dissemination devices; the collation and digestion of the large scale R&D effort carried out during World War II; and the formation of sound research and development program frameworks...” Notes: Two points are worth stressing here. First, the clear policy of retaliation only (ie deterrence), and secondly, building on the large scale work done during the war, the formulation of a new research and development program. This was not some small scale ad hoc effort.

“The first limited BW retaliatory capability was achieved in 1951 when an anticrop bomb was developed, tested and placed in production for the Air Force…” “…The first large area vulnerability test was conducted in San Francisco Bay in September 1950 using the simulants BG, and flurescent particles…” Notes: Needless to say in this Cold War period the inhabitants of areas where such large area tests were carried out were not informed beforehand.

– 58 (i) “…in July 1953, construction of the BW production plant at Pine Bluff Arsenal (PBA), was nearing completion….It became operational in the spring of 1954 with the first production of Brucella suis (the causative agent of undulant fever). Large scale production of the lethal agent Pastuerella tularensis (tularemia) began a year later.” Notes: It is important for students to understand that whilst only a small number of pathogens and toxins are suitable for biological warfare, careful study in a number of offensive programmes in the last century lead to the firm and repeated conclusion that some had properties that could make them useful agents of warfare. Here we see the US programme going into production of the very incapacitating agent that causes brucellosis and the much more lethal agent that causes tularemia.

– 58 (ii) “…The Working Group on Civilian Biodefense considers F tularensis to be a dangerous potential biological weapon because of its extreme infectivity, ease of dissemination, and substantial capability to cause illness and death.” “…In the 1950s and 1960s, the US military developed weapons that would disseminate F tularensis aerosols…” Notes: These quotations are taken from ‘Tularemia as a Biological Weapon’ in JAMA, vol 285, no 21, 2763 – Clearly an aerosolised agent would cause infection through inhalation and without rapid treatment would result in many deaths. Moreover, later Soviet work is said to have produced drug resistant agents.

– 58 (iii) “…The Soviet pronouncements clearly stated the tenet that CW and BW weapons would be used for mass destruction in future wars. In 1956, a revised BW/CW policy was formulated to the effect that the US would be prepared to use BW or CW in a general war to enhance military effectiveness…” (original emphasis) Notes: Many people who have not studied BW do not believe that this form of warfare could be contemplated. Here, however, is a clear official statement to the contrary. The intention was not just to hold biological weapons as a retaliatory deterrent.

“By the end of 1959, the Chemical Corps mission reached a height of emphasis unprecedented since WWII. The military Services were submitting requirements for BW munitions, which included dissemination means for artillery, missiles, drones, and other lesser weapon systems…” “In the summer of 1960, the CW/BW national policy…which had been revised from ‘retaliation only’ in March 1958 was revalidated…” Notes: At this time there was increasing concern about limited warfare and thus an increasing interest also in CW and BW agents that might be used as incapacitants to limit casualties in small scale conflicts. Such interests have resurfaced several times since, most recently in the guise of so-called ‘non-lethal’ agents.

“The overall emphasis in Defence programs during this period was on supporting the Vietnam War….The primary…BW efforts were directed towards meeting production requirements of antipersonnel and anticrop agents. Production facilities at Pine Bluff Arsenal were completed and between 1964 and 1967, the plant produced several different BW agents. Various types of BW munitions hardware were delivered to PBA, filled, and stored there…” Notes: Towards the end of the 1960s the US began the process of rejecting BW and eventually the BTWC was negotiated in the early 1970s. However, at that time the Soviet Union, having destroyed its genetics community in the Lysenko fiasco, decided to rebuild its modern biology around a massive offensive BW programme. Before we get to that programme it is essential that students understand that the anticrop activities of the US in Vietnam involved a synthetic plant bioregulator that should be viewed as much as a BW agent as a CW agent given the future threat that bioregulators may pose.

12. The Anti-Crop Aspects of US Activities
Origins Research Testing Agents Targets Notes: A range of anti-crop biological warfare agents including fungi, bacteria, and subsequently, viruses, were tested to assess the effectiveness of agents upon crops. An appreciation of this programme – which lasted 25 years and resulted in the assimilation of deployable capabilities (agents and munitions) into the day-to-day routines and organisation of the US armed forces – can be developed from an examination of the following aspects of the programme: origins, research, testing, agents and targets.

13. Aspects of US Activities - Origins
Intelligence and press speculation regarding possible German BW attacks against agriculture in Europe lead to increased (Anglo) American urgency in developing a retaliatory anti-crop capability. Further impetus to develop such a capability came from uncertainty expressed in US intelligence reports of Soviet anti-crop biological warfare capabilities immediately after the war. Notes: Intelligence reports overestimated both German intentions and capabilities and the immediate post-war capabilities of the former Soviet Union. Nevertheless, German anti-animal and anti-crop biological warfare attacks during WWI existed as an ominous reminder of possible future intentions.

14. Aspects of US Activities - Research
The following summarises the microbial anti-crop programme in the US which began in the early 1940s and endured for a period of 25 years: “strain selection…,development of optimal growth conditions and harvesting techniques and preparation in the form suitable for dissemination.” Notes: British and US research and development into developing a capability to wage biological warfare against crops shared – in terms of the choice of agents - some similarities. Whilst the British programme was much smaller and focussed on fundamental laboratory research, both programmes, for example, explored the possible use of chemical and biological agents with research, regarding the latter, being conducted into the potential destructiveness of fungal plant pathogens. Ref: Whitby, S., and Rogers, P. (1997) ‘Anti-crop Biological Warfare – Implications of the Iraqi and US Programs’, Defense & Security Analysis, 13(3), pp. 303 – 317.

15. Aspects of US Activities - Agents and Munitions
By 1949 it was reported that production by the US of plant pathogens was feasible: “one ton of spores may be harvested from 80 acres of infected cereal growth…[and] sufficient quantities of plant pathogens to carry out retaliatory strikes [could be] acquired in …six months”. 5 fungal anti-crop pathogens were produced in large quantities and stockpiled. A range of weapons, including particulate bombs, balloon bombs, cluster munitions and missiles were available for deployment. Notes: Due the secrecy that still surrounds the US programme, the identity of 2 of the above five pathogens is not publicly-available. It is understood that it is most likely that all were fungal plant pathogens – those that spread rapidly, and if conditions prevail, to epidemic proportions within the space of a single growing season. The agents of choice affected some of the world’s most important food and cash crops. Research was conducted into the feasibility of the use of bacteria; and subsequently into the use of certain plant viruses.

16. Aspects of US Activities - Targets
“By the 1950s the US capability was considered to offer both strategic advantage and deterrence in the face of communist aggression from the former Soviet Union and China. In respect of the USSR, one report noted that, a large fraction of the diet is threatened if wheat can be successfully attacked…” Another noted that, “mainland China appears to be particularly vulnerable to anti-rice warfare…” Notes: US capabilities were at the time thought to provide a significant strategic and deterrent retaliatory capability. However, if used in an offensive capacity, in the 21st Century, this form of warfare can be considered to be of particular concern to a range of countries including advanced countries with a reliance on large-production of monocultures; and, developing countries with poor plant pathology extension services, domestic over-reliance on the consumption of staple food crops, and those vulnerable to non-indigenous pathogen strains.

17. The Soviet Programme (i)
“It is generally believed that the Soviet Union had the largest, most extensive biological weapons program of any country. The highly secret program, which was expanded on the basis of a decision taken in 1973 by the Central Committee of the Soviet Communist Party continued until at least 6 March 1992…. The program reportedly involved the development and fielding of both tactical and strategic BW systems. Estimates of the number of people employed…are generally put at between 25,000 and 60,000…” Notes: We still do not have an official study of the whole of the Soviet programme in the open literature. This quote is taken from John Hart’s chapter on the programme in Deadly Cultures. Ref: Cited at p. 132 in Hart, J. (2006) ‘The Soviet Biological Weapons Program’, In: Mark Wheelis, M., Rózsa, L., and Dando, M. R. (Eds.), (2006) Deadly Cultures: Biological Weapons since 1945, Massachusetts: Harvard University Press. pp

18. The Soviet Programme (ii)
“Over a twenty-year period….through our covert programme, 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 Western allies.” “What went on in Biopreparat’s labs was one of the most closely guarded secrets of the Cold War.” Notes: We do have in the open literature some autobiographical accounts from people who worked in the programme. These quotes are from Ken Alibeck’s book ‘Biohazard’. Another less well known account is by Ivor Domaradskij in his book ‘Biowarrior’. It is of course necessary to treat such accounts with some caution, but the fact that there was a massive programme is undoubtedly correct. Ref: Domaradskij, I. V., and Orent, W. (2003) Biowarrior: Inside the Soviet/Russian Biological War Machine, New York: Prometheus Books. Alibek, K., and Handelman, S. (1999) Biohazard: The chilling True Story of the largest Covert Biological Weapons Program in the World—Told from Inside by the Man Who Ran it. New York: Delta

19. The Soviet Programme (iii)
Plague “…Soviet scientists were able to manufacture large quantities of the agent suitable for placing into weapons. More than 10 institutes and thousands of scientists were reported to have worked with plague in the former Soviet Union…” “…There have been assertions that Russian scientists have engineered multi-drug resistant strains of Y pestis, although there is as yet no scientific publication confirming this. Notes: The US programme was carried out in the first half of the Cold War. The hugely expanded Soviet programme took place in the second half of the Cold War. It had some clear differences to the US programme. Here we see the weaponisation of a contagious agent and assertions that it was subject to genetic manipulation. The quotes are taken from ‘Plague as a Biological Weapon’ in JAMA, vol 283, no 17, 2281 – On the later point see also Pomerantsev, A.P. et al (1997) Expression of cereolysine AB genes in Bacillus anthracis….Vaccine, vol 15, no 17/ and Borzenkov, V.M. et al (1993) Additive synthesis of regulatory peptide in vivo: the introduction of the vaccine strain of Francisella tularensis producing Beta-Endorphin. Bulletin of Experimental Biology and Medicine, vol 116, no 8, 942 – 944.Both of these papers seem to have caused concern in the West.

20. The Soviet Programme (iv)
“…The former Soviet Union…produced large quantities of Marburg, Ebola, Lassa, and New World arenaviruses….Soviet Union researchers quantified the aerosol infectivity of Marburg viruses for monkeys, determining that no more than a few virions are requires to cause infection….Arguments asserting that the absence of effective antiviral therapy and vaccines would make these viruses too dangerous to develop are not supported by the historical record.” Notes: These quotes are taken from ‘Hemorrhagic Fever Viruses as Biological Weapons’in JAMA, vol 287, no 18, It is not unreasonable to suggest that the historical record demonstrates that successive offensive biological weapons programmes used the cutting edge of life science research in the development of weapons.

Sample Questions 1. Outline the evolution of the U.S. biological warfare programme in the three decades before the agreement of the Biological and Toxin Weapons Convention of Why did the policy for the use of biological weapons change at different times? 2. In what ways can the U.S. use of the synthetic plant bioregulator – Agent Orange – in Vietnam be seen as an indicator of what future biological warfare could be like? 3. What were the critical scientific and legal differences between the U.S. biological warfare programme and that of the former Soviet Union during the Cold War period? 4. Discuss what still need to be done to improve defensive measures in regard to any two of the anti-personnel agents known to have been weaponised in the biological warfare programmes of the 20th century.

References (Slide 1) Mark Wheelis, M., Rózsa, L., and Dando, M. R. (Eds.), (2006) Deadly Cultures: Biological Weapons since 1945, Massachusetts: Harvard University Press (Slide 2) Avery, D (1999) ‘Canadian biological and toxin warfare research, development and planning, 1925–45’, In Geissler, E., and van Courtland Moon, J. (Eds.) Biological and Toxin Weapons Research, Development and Use from the Middle Ages to 1945 (SIPRI Chemical & Biological Warfare Studies No. 18). Oxford: Oxford University Press. pp

(Slide 3) Arnon, S. S., Schecter, R., Inglesby, T. V., Henderson. D. A., Bartlett, J. G., Ascher. M. S., Eitzen, E. M. Jr., Fine, A. D., Hauer, J., Layton, M., Lillibridge, S., Osterholm, M. T., Toole, T. O’., Parker, G., Perl, T. M., Russel, P. K., Swerdlow, D. L., and Tonat, K. (2001) ‘Botulinum Toxin as a Biological Weapon: Medical and Public Health Management’, JAMA 285(8), pp (Slide4) Laughlin L.L., (1977) U.S. Army Activity in the U.S. Biological Warfare Programs, Volume 1, p Cited in Simon Whitby (2001) ‘The Potential Use of Plant Pathogens against Crops’, Microbes and Infection, 3. pp

(Slide 8-10) Dennis, D. T., Inglesby, T. V., Henderson. D. A., Bartlett, J. G., Ascher. M. S., Eitzen, E. M. Jr., Fine, A. D., Friedlander, A. M., Hauer, J., Layton, M., Lillibridge, S., McDade, J., Osterholm, M. T., Toole, T. O’., Parker, G., Perl, T. M., Russel, P. K., and Tonat, K. ‘Tularemia as a Biological Weapon: Medical and Public Health Management’, JAMA 285(21), pp (Slide 11) National Research Council (2006) Globalization Biosecurity, and the Future of the Life Sciences, Washington, D.C.: National Academy Press. Chapter 1 is available from

(Slide 14) Whitby, S., and Rogers, P. (1997) ‘Anti-crop Biological Warfare – Implications of the Iraqi and US Programs’, Defense & Security Analysis, 13(3), pp. 303 – 317. Available from (Slide 17) Hart, J. (2006) ‘The Soviet Biological Weapons Program’, In: Mark Wheelis, M., Rózsa, L., and Dando, M. R. (Eds.), (2006) Deadly Cultures: Biological Weapons since 1945, Massachusetts: Harvard University Press. pp (Slide 18) Domaradskij, I. V., and Orent, W. (2003) Biowarrior: Inside the Soviet/Russian Biological War Machine, New York: Prometheus Books. Alibek, K., and Handelman, S. (1999) Biohazard: The chilling True Story of the largest Covert Biological Weapons Program in the World—Told from Inside by the Man Who Ran it. New York: Delta

(Slide 19) Inglesby, T. V., Dennis, D. T., Henderson. D. A., Bartlett, J. G., Ascher. M. S., Eitzen, E. M. Jr., Fine, A. D., Friedlander, A. M., Hauer, J., Koerner, J. F., Layton, M., McDade, J., Osterholm, M. T., Toole, T. O’., Parker, G., Perl, T. M., Russel, P. K., Schoch-Spana, M., and Tonat, K. (2000) ‘Plague as a Biological Weapon: Medical and Public Health Management’, JAMA 283(17), pp (Slide 20) Borio, L., Inglesby, T. V., Peters, C. J., Hughes, J. M., Jahrling, P. B., Ksiazek, T., Johnson, K. M., Meyerhoff, A., Toole, T. O’., Ascher. M. S., Bartlett, J., Breman, J. G., Eitzen, E. M. Jr., Hamburg, M., Hauer, J., Henderson. D. A., Johnson, R. T., Kwik, G., Layton, M., Lillibridge, S., Nabel, G. J., Osterholm, M. T., Perl, T. M., Russel, P. K., and Tonat, K. (2002) ‘Hemorrhagic Fever Viruses as Biological Weapons: Medical and Public Health Management’, JAMA 283(18), pp

Calculations of the Potential Impact of BW and BT
Lecture No. 5 Notes: The aim of this lecture is to give students a firm basis for understanding the dangers involved if there is a resurgence of offensive biological weapon programmes by discussing some of the numerical data available in the open literature.

1. Overview Military Characteristics of BW Agents
Slides 2 - 5 WMD/Strategic BW Attacks Slides Production of BW Agents Slides Other Types of BW Attack Slides Notes: Much of this lecture draws on chapters of Dando, M.R. (1994) Biological Warfare in the 21st Century: Biotechnology and the Proliferation of Biological Weapons. Brassey’s, London. However, references are given to the original literature used. Ref: Dando, M.R. (1994) Biological Warfare in the 21st Century: Biotechnology and the Proliferation of Biological Weapons. Brassey’s, London

2. Military Characteristics (i)
The diversity of potential BW attacks Different targets (humans, animal and plants) Different agents (bacteria, viruses, fungi, toxins, bioregulators) Different scales (assassination, tactical military, strategic military, WMD) Different purposes (overt or covert war or terror) Notes: It is important to stress at the outset that although the lecture concentrates on military strategic aspects of BW because of the link to state-level offensive programmes there is a very wide diversity of possible BW attacks.

3. Military Characteristics (ii)
A military classification of BW agents Potentially infectious from first victim Incapacitating (e.g influenza virus) Lethal (e.g. Yersinia pestis - plague) Not infectious from first victim Incapacitating (e.g. Coxiella burnetii - Q-fever) Lethal (e.g. Bacillus anthracis - anthrax) Notes: Clearly it would be possible to greatly degrade the efficiency of a military force if an effective incapacitating agent was used in an attack and in fact such agents were weaponised in the last century’s offensive programmes. Most attention is naturally given to lethal agents, but this is to misunderstand the range of possibilities. Again it is often believed that only non-infectious agents were weaponised, but plague, for example, was weaponised by the former Soviet Union.

4. Military Characteristics (iii)
Militarily-desirable characteristics of BW agents An agent should produce a certain effect consistently The dose needed to produce the effect should be low There should be a short and predictable incubation period The target population should have little or no immunity Notes: This and the following slide set the context for the later discussion of the doses needed for BW attacks on people.

5. Military Characteristic (iv)
Militarily-desirable characteristic of BW agents (cont.) Treatment for the disease should not be available to the target population The user should have means to protect troops and civilians It should be possible to mass produce the agent It should be possible to disseminate the agent efficiently The agent should be stable in storage and transport in munitions.

6. WMD/Strategic Attacks (i)
United Nations Study in 1969 Single bomber using 10tons of BW agent Area affected 100,000 km2 Morbidity 50%, 25% deaths if no treatment Area affected if a 1 megaton nuclear bomb was used 300 km2 Area affected if 15 tons of nerve agent was used 60 km2 Notes: In the lead up to the negotiation of the BTWC the United Nations Secretary General published a report on Chemical and Bacteriological (Biological) Weapons and the Effects of their Possible Use. This example is taken from the report. It makes clear that in the right conditions biological weapons could be even more dangerous than nuclear weapons in causing illness and death. It should be stressed that the international experts, who were the consultants for the report, were people who knew what they were dealing with. An example is Sir Solly Zuckerman, Chief Scientific Adviser to the UK Government.

7. WMD/Strategic Attacks (ii)
SIPRI 1973 Study Single bomber with 5-6 ton bombload Area in km2 over which 50% casualties would be possible High explosive 0.22 VX nerve gas 0.75 10kt nuclear bomb 30 Biological agent (depending on weather conditions) Notes: In the early 1970s the Stockholm International Peace Research Institute (SIPRI) published its classic series of books on The Problem of Chemical and Biological Warfare. This example is taken from volume II CB Weapons Today. The huge potential impact of the use of a BW agent is again very clear in comparison to other possible weapons Ref: SIPRI (1973) The Problem of Chemical and Biological Warfare: CB Weapons Today. Vol. II. Stockholm: Almqvist & Wiksell.

8. WMD/Strategic Attacks (iii)
Fetter’s 1991 study in the journal International Security Missile with throw weight of one tonne attacking a large city with 30 people per hectare density 20kt nuclear weapon would kill 40,000 300kg Sarin would kill ,000 30kg anthrax would kill 20, ,000 Notes: Fetter’s study Ballistic missiles and weapons of mass destruction: What is the threat? What should be done? International Security 16, (1) 5-42 was published as the Cold War was coming to an end. Thus 20 years had passed since the UN and SIPRI studies, but the view of the comparative danger of BW as against other weapons had not changed. Ref: Fetter, S. (1991). ‘Ballistic Missiles and Weapons of Mass Destruction: What is the Threat? What should be Done?’, International Security 16(1): Available from

9. WMD/Strategic Attacks (iv)
US Office of Technology Assessment 1993 report: Scenario I Attack with a missile delivered on an overcast day or night, with a moderate wind on a city with 3,000 to 10,000 unprotected people per km2 12.5 kt nuclear weapon would destroy 7.8km2 and kill 23,000-80,000 people 300kg of Sarin would kill people in an area of 0.22km2 30kg of anthrax would kill between 30,000 to 100,000 in cigar shaped plume from the warhead covering 10km2 Notes: The Office of Technology Assessment was a highly regarded institution and its reports were considered authoritative around the world. This report on Proliferation of Weapons of Mass Destruction :Assessing the Risks, OTA-ISC-559 of August 1993 has been quoted by many subsequent authors. The comparative effects of the different types of weapon remain as in other studies reviewed here. Ref: U.S. Congress, Office of Technology Assessment. (1993). Proliferation of Weapons of Mass Destruction: Assessing the Risks (Document No. OTA-ISC-559). Washington, DC: U.S. Government Printing Office. At p. 53

10. WMD/Strategic Attacks (v)
US Office of Technology Assessment 1993 report: Scenario II Attack by a plane releasing 10kg of anthrax along a line on the windward side of a city like Washington DC On a clear sunny day with a light breeze, 46km2 would be affected and 130,000 to 460,000 people could die Ref: U.S. Congress, Office of Technology Assessment. (1993). Proliferation of Weapons of Mass Destruction: Assessing the Risks (Document No. OTA-ISC-559). Washington, DC: U.S. Government Printing Office. At p. 54.

11. WMD/Strategic Attacks (vi)
OTA Scenario II (cont) On an overcast day or night with a moderate wind, 140km2 would be affected and 420,000 to 1,400,000 people could die On a clear, calm night an area of 300km2 would be affected and between 1 and 3 million people could die Clearly the use of such a line source of such an agent in ‘ideal’ conditions (e.g. in the absence of UV light that would kill the spores more rapidly) could be devastating as it would be difficult to assist so many people Notes: Such scenarios developed by well-informed analysts have to be taken seriously. While anthrax is treatable if antibiotics are started early enough it is hard to see how any public health system could cope with disease on this scale. Ref: U.S. Congress, Office of Technology Assessment. (1993). Proliferation of Weapons of Mass Destruction: Assessing the Risks (Document No. OTA-ISC-559). Washington, DC: U.S. Government Printing Office. At p. 54.

12. WMD/Strategic Attacks (vii)
Some munitions known from the US BW programme Warhead for guided missile M210 with bomblets (M143) in the warhead under development in 1967 Spray tank for liquid agent A/B45Y-1 used by high speed tactical aircraft under development in 1965 Notes: The authors of the SIPRI volume II gave a list of a wide variety of munitions under development in the US programme and there were clearly increases in the efficiency of the munitions as the research and development effort continued over two and a half decades. Indeed, BW attacks were increasingly subject to careful calculation as the last century progressed. As we shall see in the following slides, calculations can be made of the dose required to be delivered to infect 50% of the people in a particular area if certain parameters are known.

13. Production of BW Agents (i)
Growth of a bacterial agent by fermentation requires A seed culture of the virulent pathogen Initial propagation in small fermenters Growth in production-scale fermenter Collection of the agent from the fermenter Final processing such as freeze drying Notes: In 1993 the Office of Technology Assessment also produced a background report on Technologies Underlying Weapons of Mass Destruction (Document No. OTA-BP-ISC-115), December. This outlines the means by which bacterial and other agents could then be produced. This listing is taken from the report. It should not, however, be assumed that the production of an effective agent would be straightforward. Leaving aside the difficulties of obtaining a virulent strain and difficulties in final processing, bacterial fermentation can be damaged by contamination and genetic mutation that lead to loss of agent potency. Ref: Office of Technology Assessment. (1993). Technologies underlying Weapons of Mass Destruction (Document No. OTA-BP-ISC-115). Washington, DC: U.S. Government Printing Office. At p. 87

14 Production of BW Agents (ii)
Estimation of the quantity of agent needed for a line attack Consider first a point source from which the dose (D) received by a victim is Q the source strength (units/m) times b the breathing rate (volume/minute) divided by h the depth of the air layer times ū the mean surface wind speed Thus This simple model was used by a UK official in a NATO Advanced Research Workshop in 1996 to estimate the amount of agent required and thus the size of production needed in a discussion of the possibility of detecting such production. Ref: Annex A produced in Bartlett, T. B. (1996) The Arms Control Challenge: Science and Technology Dimension, Paper presented at the NATO Advanced Research Workshop, The Technology of Biological Arms Control and Disarmament Budapest, March. D= Q.b h.ū

15. Production of BW Agents (iii)
Consideration of a point source (cont) The source strength required is clearly Q= D.h.ū b Using typical values for these quantities b=20 litres/min ( m3min-1); h=1km (103m); ū= 5m/s ( 3.102mmin-1) Thus if D is 10 times the Infective Dose (ID50) Q=10.ID So the attacker needs about 108ID50/m = ID50

16. Production of BW Agents (iv)
For a line source 10km long attacker needs 108 ID50 times 104 =1012ID50 Assume a concentration of 108 bacterial cells per ml is possible in the fermenter so the attacker will need to produce 1012 times (No. of cells equivalent to 1 ID50)/108times1000) liters of suspension Given the ID50 for anthrax is about 104 the attacker would need about 100,000 liters which would be possible in ten runs of ten fermenters of 100 liters capacity Notes: This illustrative calculation for a box model shows that making reasonable assumptions the attacker needs 1012 ID50 to be released into the atmosphere. This is called the ‘trillion dose criterion’ and similar values are said to come from the consideration of other scenario models. Ref: Annex A produced in Bartlett, T. B. (1996) The Arms Control Challenge: Science and Technology Dimension, Paper presented at the NATO Advanced Research Workshop, The Technology of Biological Arms Control and Disarmament Budapest, March.

17. Other Types of BW Attack (i)
Anti-Agriculture BW Low-tech, high consequence bioterrorism Little specialist knowledge required, highly contagious pathogens (but not to humans) and huge costs to agriculture For example one study stated “Pathogens that cause diseases such as FMD, rinderpest, African swine fever (ASF), soybean rust, Philippine downy mildew of maize, potato wart, and citrus greening could, if introduced into the continental United States, have serious consequences for the US economy.” Notes: This form of attack should be given special attention because it is often not realized that it is perhaps the most likely devastating form of terrorism we are likely to see in the near future.. The quote is taken from Wheelis, M.L., Madden, L.V. and Cassagrande, R. (2002) Biological attacks on agriculture:low tech, high impact bioterrorism. Bio-Science, 52, at p. 570

18. Other Types of Attack (ii)
Terrorist attacks on people US Congressional Research Service 2004 report cautions against drawing direct analogies from consideration of State programmes “C/B agents that were considered high threats in other frameworks appear to present a lesser threat when viewed in the small scale attack context. Conversely, C/B agents that were considered of lesser threat when considering mass casualty attacks may be ranked more highly in the small scale context, as barriers to mass use may be missing when the agent is used on a small scale.” Notes: The Congressional Research Service report by Shea, D.A. and Grotton, F. was titled Small-Scale Terrorist Attacks Using Chemical and Biological Agents: An Assessment Framework and Preliminary Comparisons. It is discussed in Chapter 7 of Dando, M.R.(2006) Bioterror and Biowarfare, Oneworld Publications, Oxford. The point that needs to be made is that when considering possible smaller scale attacks it is very important to rethink what would be easy for the terrorist to do. As the next two slides show, even in attacking people there may be great differences from the barriers that need to be overcome in relation to state programmes.

19. Other Types of Attack (iii)
World Health Organisation 1970 report considered a range of possible WMD and other scenarios A lethal and incapacitating antibiotic-resistant biological weapon without secondary cases (tularaemia) A lethal and incapacitating antibiotic-sensitive biological weapon with secondary cases (pneumonic plague) Contamination of the water supply with typhoid bacillus or botulinal toxin A Notes; In the run up to the agreement of the BTWC the World Health Organization published the first (1970) edition of its account of ‘Health Aspect of Chemical and Biological Weapons’. In annex 4 this considers ‘Medical and Public Health Effects of Attack with Chemical or Biological Weapons’. This annex reviews a range of possible WMD attack scenarios and their consequences. Annex 5, however, considers sabotage of water supplies - a different type and scale of attack.

20. Other Types of Attack (iv)
1kg of freeze dried culture of typhoid used to attack the water supply of a city of 1 million in a hot arid developing country. The attack was without warning so no special precautions were taken by the authorities Raw water consumption assumed to be two litres per person per day and so 125,000 people calculated to receive 100,000 microorganisms and many would therefore become ill If no facilities were available for mass treatment some 4,500 people might die because of the attack Notes: The WHO assumed that the amount of culture would be reduced by 95% because of die off in the mains. The infection rate was calculated from known human data and the death rate without treatment was calculated to be 10%. So it has been clear from such analyses for decades that many other types of effective attack could be carried out with biological agents. Note that typhoid would not figure high on the pathogens of concern in state-level programmes - just as shown in slide 18.

Sample Questions 1. Critically evaluate the military-significant features of: Plague, Influenza, Tularaemia, Botulinum Toxin and Q Fever. 2. What are the structural difficulties that make a large scale antipersonnel biological attack rather unlikely at this time? 3. Discuss some of the calculations in the open literature that suggest that under certain conditions biological weapons could be used as Weapons of Mass Destruction (WMD). 4. Anti-agriculture is the most likely form of very successful bioterrorism today. Discuss.

References (Slide 1) Dando, M.R. (1994) Biological Warfare in the 21st Century: Biotechnology and the Proliferation of Biological Weapons. Brassey’s, London (Slide 6) United Nations (1969) Chemical and bacteriological (biological) weapons and the effects of their possible use: report of the Secretary-General. A/7575/Rev.1, S/ 9292/Rev.1, New York, United Nations. Available from

(Slide 7) Robinson, J. P., Hedén, Carl-Göran., and von Schreeb, H. (1973) The Problem of Chemical and Biological Warfare: CB Weapons Today. Vol. II. Stockholm: Almqvist & Wiksell. Available from (Slide 8) Fetter, S. (1991). ‘Ballistic Missiles and Weapons of Mass Destruction: What is the Threat? What should be Done?’, International Security 16(1): Available from (Slide 9-11) U.S. Congress, Office of Technology Assessment. (1993). Proliferation of Weapons of Mass Destruction: Assessing the Risks (Document No. OTA-ISC-559). Washington, DC: U.S. Government Printing Office.

(Slide 13) Office of Technology Assessment. (1993). Technologies underlying Weapons of Mass Destruction (Document No. OTA-BP-ISC-115). Washington, DC: U.S. Government Printing Office (Slide 14 and 16) Bartlett, T. B. (1996) The Arms Control Challenge: Science and Technology Dimension, Paper presented at the NATO Advanced Research Workshop, The Technology of Biological Arms Control and Disarmament Budapest, March. (Slide 17) Wheelis, M. Madden, L.V. and Cassagrande, R. (2002) Biological Attacks on Agriculture: Low Tech, High Impact Bioterrorism. Bio-Science, 52, Available from

(Slide 18) Shea, D. A., and Gottron, F. (2004) Small-scale Terrorist Attacks Using Chemical and Biological Agents: An Assessment Framework and Preliminary Comparisons, CRS Report for Congress [Online] FAS [accessed 27 January 2009] available from (Slide 19) World Health Organization (1970) Health Aspects of Chemical and Biological Weapons, Geneva: WHO. Available from

Assimilation of BW through State Offensive Programmes
Lecture No. 6

1.Outline The CBW Prohibition Threats to the Prohibition Regime
Slide 1 Threats to the Prohibition Regime Slides Assimilation in State Programmes Slides Bioterrorism Slides Notes: The aim of this lecture is to inform students that previous scientific and technological revolutions have been applied in major ways for both benign and hostile purposes. If modern biotechnology is widely used to produce new forms of weaponry for armed forces in coming decades it could be very dangerous for international security. BT could also become widespread.

2.The CBW Prohibition Given the growth in molecular biology chemistry and biology are increasingly one subject Yet historically the prohibition of CBW has evolved through the 1925 Geneva Protocol on non-use being supported by two Conventions – the 1975 Biological and Toxin Weapons Convention (BTWC) and the 1997 Chemical Weapons Convention (CWC) These three international agreements are supported by a range of other policies such as export controls in what is called a ‘Web of Prevention’, but the international prohibition is not secure as there are weaknesses in the international agreements, particularly in the BTWC Notes: The international community eventually moved in the latter part of the last century to add restrictions such as non-development to the ban on use of CBW embodied in the 1925 Geneva Protocol. We deal in more detail with the BTWC in lecture 7. Here it is important for students to note that despite the addition of other policies such as export controls on dangerous materials in a ‘web of prevention’ the prohibition is far from secure.

3.Threats to the Prohibition Regime (i)
Before World War I “Armaments for what we would nowadays recognise as chemical warfare (CW) was under study in several countries prior to 1914, among them Britain, Germany and Japan. This early research appears to have been a low-key affair, driven more by general growth of industrial chemistry than by perceptions of military need: and such weapons as were designed aroused little military interest.” Notes: The quotations from this and the next slide are from Perry Robinson, J.P. (1989) Supply, Demand and Assimilation in Chemical-Warfare Armament. In H.G.Brauch (Ed.) Military Technology, Armaments Dynamics and Disarmament. St. Martin’s Press, New York. Available from They introduce the key concept of assimilation as shown in the next slide. Ref: Quoted at p in Perry Robinson, J.P. (1989) Supply, Demand and Assimilation in Chemical-Warfare Armament. In H.G.Brauch (Ed.) Military Technology, Armaments Dynamics and Disarmament. St. Martin’s Press, New York. Available from

4.Threats to the Prohibition Regime (ii)
After World War I “By mid-1918 a million people had become casualties of CW armament, and there were artillery units on both sides of the Western Front that were firing as much poison-gas shell as high explosive. CW weapons were starting to become what are today called ‘conventional’. They were being integrated into the prevailing doctrine, organisation and day-to-day routines of armed forces. They were now, in other words, firmly caught up in that process of ‘assimilation’ which is discernible in the history of most technologies, civil as well as military.” Notes: Following World War I the 1925 Geneva Protocol essentially banned the first use of chemical and biological weapons. Huge stocks of chemical weapons were held by both sides in World War II but these were not used on a large scale – in Perry Robinson’s opinion largely because the battlefields were too fast moving for CW to be of much military utility

5. Threats to the Prohibition Regime (iii)
After World War II “Thus the straightforward answers to our three questions* are not in dispute. The major states that ended on the winning side after World War II had developed BW programs because such weapons were seen to be potentially important militarily for retaliation in kind, and they continued or restarted them for the same reason. The two states [South Africa and Iraq] definitely known to have begun offensive programs later in the century also had military reasons for their programs...” Notes: *The concluding chapter to Deadly Cultures: Biological Weapons Since 1945 attempted to answer three basic questions. (1) Why have states continued or begun programs for acquiring BW? (2) Why have states terminated BW programs? and (3) How have states demonstrated to other states that they have indeed terminated their BW programs? The first question was why were offensive BW programmes under taken by States. This quotation gives a quite clear answer that military reasons were key. Ref: This quotation of the slide and questions in the note section are from chapter 17 of Mark Wheelis, M., Rózsa, L., and Dando, M. R. (2006) Deadly Cultures: Biological Weapons since 1945, Massachusetts: Harvard University Press.

6. Threats to the Prohibition Regime (iv)
Considerations in the CWC negotiations “The draft treaty…was a delicate structure in which compromises - on six central matters: the scope of obligations, verification of compliance…were balanced against one another...” “…Potential parties were, in effect, being invited to decide… whether they would be better off inside that package of compromises than outside it…” Notes: This quote is from a paper published just before the second review conference of the CWC by Perry Robinson, J.P. (2008) Difficulties facing the chemical weapons convention. International Affairs, 84, (2), In the paper Perry Robinson analyses the dangers that may lead to a breakdown in the CWC prohibition regime. Similar considerations also can be seen in regard to the stability of the BTWC regime. Ref: The quotations are from p. 224 in Robinson, J. P. (2008) ‘Difficulties Facing the Chemical Weapons Convention’, International Affairs, 84 (2), 223–239. Available from

7. Threats to the Prohibition Regime (v)
“…Any development or change that causes a state to question its continuing adherence to the CWC would be a challenge to the treaty. If major or many states were to start such questioning, the challenge would be serious….For each state party the constant question would be whether benefits flowing from the CWC regime continued to outweigh the attendant costs and to compensate for any penalties there might be to national interest: are we still better off inside the regime or outside it?” Notes: Perry Robinson does not suggest that states make such judgements in such an abstract or holistic manner. Rather , he suggests, decisions would be driven by the usual bureaucratic and domestic political interests. However, such a cost-benefit framework does provide a means by which we can assess such developments. His paper goes on to list a number of serious reasons why the regime might come under significant challenge. Ref: At p. 225 in Robinson, J. P. (2008) ‘Difficulties Facing the Chemical Weapons Convention’, International Affairs, 84 (2), 223–239. Available from

8. Threats to the Prohibition Regime (vi)
Significant threat list New utilities for chemical weapons Change in the nature of warfare New knowledge in the life sciences New weapons for counterterrorism Proliferation of chemical weapons Accommodation of national interests Pernicious ignorance Creeping legitimization Notes: Perry Robinson’s paper lists four main threats and a number of types under each heading. We have just given examples under the first heading as it is of most interest to us here.

9.Threats to the Prohibition Regime (vii)
General Rupert Smith’s view of modern war “The ends for which we fight are changing from the hard absolute objectives of interstate industrial war We fight amongst the people Our conflicts tend to be timeless We fight so as not to lose the force One each occasion new uses are found for old weapons…since the tools of industrial war are often irrelevant to war amongst the people The sides are mostly non-state…” Notes: General Rupert Smith who recently retired from the British Armed Forces was described by the historian John Keegan as ‘Britain’s outstanding soldier of modern times’. Smith’s (2005) book The Utility of Force: The Art of War in the Modern World, Penguin, London sets out a view of modern war from a western interventionist standpoint, but the point is that it describes the nature of the new wars in the same way as Perry Robinson does when considering the possible use of chemical weapons. Ref: The quote is at p. 17 in Smith, R. (2005) book The Utility of Force: The Art of War in the Modern World. New York: Penguin

10. Threats to the Prohibition Regime (viii)
“…Conflicts these past two decades in the Balkans, the Caucasus, the Horn of Africa, Rwanda, Liberia, Sierra Leone, Angola, Sri Lanka, Afghanistan and post-invasion Iraq have eroded formerly clear distinctions between war, organised crime and large-scale erosion of human rights. These wars are fought by seeking political control through the displacement, or worse, of civilian populations and sowing the seeds of fear and hatred. Because chemical weapons can lend themselves particularly effectively to such objectives, they may conceivably have a greater affinity to the new wars than they did to the old. So notwithstanding the CWC, the weapons could have an expanding future…” Notes: Perry Robinson’s paper goes directly on to enumerate instances of the use and accusations of the use of chemical weapons in such circumstances. All students should be familiar with the use of chemical weapons against the Iraqi Kurds for example.

11. Threats to the Prohibition Regime (ix)
“A second major source of new utility for chemical weapons is the propensity of knowledge newly gained in the life sciences to suggest novel modes of attack that could be the basis for militarily or politically attractive new forms of weapon. For example, if a new molecule is discovered that can exert novel disabling effects on the human body at low dosage, attempts to weaponize it may well ensue….The prospect is not necessarily remote...” Notes: At this point Perry Robinson footnotes the ‘Lemon-Relman’ report of the US National Academies. This is the subject of lectures in Section C of this lecture series.

12. Assimilation in State Programmes (i)
“Traditional BW agents are all naturally occurring organisms or their toxic products. From the perspective of a biological warfare scientist, traditional BW agents have serendipitously evolved a select group of traits: toxicity, stability, and ease of production.…that aided researchers in choosing select organisms [but] also limited BW applications to the characteristics of available agents.” Notes: In 2003 a group of US military analysts tried to envisage what the future might look like if biochemical weapons did become assimilated into military forces. The paper by Petro et al begins by dealing with the traditional agents like anthrax. As they point out there are a limited number of naturally occurring agents that have properties that lend themselves to biological warfare. Moreover, as there are a limited number of such agents it can be expected that the defence would eventually be able to deal with attacks using such agents. Ref: Petro, J. B., Plasse, T. R., and McNulty, J. A. (2003) ‘Biotechnology: Impact on Biological Warfare and Biodefense’, BioSecurity and Bioterrorism: Biodefense Strategy, Practice, and Science 1(3), pp at p Available from

13. Assimilation into State Programmes (ii)
“With the advent of recombinant DNA technology, researchers have developed standard methodologies for altering an organism’s genetic makeup. Application of this technology to enhance traditional biological warfare agents has led to the classification of genetically modified BW agents…Examples…include antibiotic resistance, increased aerosol stability, or heightened pathogenesis..” Notes: As the defence can eventually deal with traditional BW agents these authors suggest that the attackers will move to genetically modify the agents in order to overcome the defence. But as the number of modifications that can be made is also limited clearly in an offense/defence arms race the defence should eventually also be able to cope with these modified traditional agents. Ref: Petro, J. B., Plasse, T. R., and McNulty, J. A. (2003) ‘Biotechnology: Impact on Biological Warfare and Biodefense’, BioSecurity and Bioterrorism: Biodefense Strategy, Practice, and Science 1(3), pp at p Available from

14. Assimilation into State Programmes (iii)
“Emerging biotechnologies likely will lead to a paradigm shift in BW agent development; future biological agents could be rationally engineered to target specific human biological systems at the molecular level. This is a departure from the traditional model of BW agent development, which is focused on the naturally occurring agent, not the target organism.” Notes: Given that genetically engineered agents could eventually be countered there would be a move to take advantage of cutting edge research which would allow a paradigm shift in BW. The focus would be on the specific biological system required to be affected and the choice of the way to achieve that end. As there are many systems that could be targeted and many ways to attack each target the attacker would be dominant for a protracted period should such an arms race be allowed to break out. Of course the situation would be more complex as the three types of agent could all be in use at the end of the process.

15. Assimilation in State Programmes (iv)
Threat Advanced Biological Agents Genetically Modified Traditional Agents/ Biochemical Agents Notes: Petro and his colleagues presented a graphic image of what might happen over the next decades. Their figure is reproduced in this slide. Ref: The graph was cited at p. 163 in Petro, J. B., Plasse, T. R., and McNulty, J. A. (2003) ‘Biotechnology: Impact on Biological Warfare and Biodefense’, BioSecurity and Bioterrorism: Biodefense Strategy, Practice, and Science 1(3), pp at p Available from Traditional Agents Pre-Genomic Era Genomic Era (Age of Biotechnology) 1940’s 1999 Human Genome Sequenced 2003 2020

16. Assimilation in State Programmes (v)
Stages in the development of an offensive programme part (i) “1. Establishment of one or more facilities and associated personnel with organisational and physical provisions for the conduct of work in secret; 2. Research on microbial pathogens and toxins, including the isolation or procurement of virulent or drug-resistant strains; 3. Pilot production of small quantities of agent in flasks or small fermenter systems; 4. Characterization and military assessment of the agent, including its stability, infectivity, course of infection, dosage, and the feasibility of aerosol dissemination; 5. Research, design, development, and testing of munitions and/or other dissemination equipment; 6. Scale-up production of agent (possibly in several stages) and freeze-drying;” Notes: In 1993 the then US Office of Technology Assessment published a background paper on Technologies Underlying Weapons of Mass Destruction, OTA-BP-ISC-115, December. As shown in the next slide, establishing an offensive BW programme and thus assimilation of BW into a states military system is not a simple or quickly achieved goal. Ref: Office of Technology Assessment. (1993). Technologies underlying Weapons of Mass Destruction (Document No. OTA-BP-ISC-115). Washington, DC: U.S. Government Printing Office. At pp

17. Assimilation in State Programmes (vi)
Stages in the development of an offensive programme part (ii) “7. Stabilization of agent (e.g. through microencapsulation) and loading into spray tanks, munitions, or other delivery systems; and 8. Stockpiling of filled or unfilled munitions and delivery vehicles, possibly accompanied by troop training, exercises, and doctrinal development” Notes: The difficulties of establishing such a programme are well illustrated by the flow chart used in the OTA report Ref: Office of Technology Assessment. (1993). Technologies underlying Weapons of Mass Destruction (Document No. OTA-BP-ISC-115). Washington, DC: U.S. Government Printing Office. at p. 87

18. Bioterrorism (i) Aum Shinrikyo and CBW
In 1995 a Japanese religious sect – Aum Shinrikyo – attacked the Tokyo subway system with Sarin gas killing 12 people and injuring approximately 1,000. Aum had attempted to use biological weapons including Anthrax and Botulinum Toxin from 1990 to 1995, although the attempts failed due to technical inadequacies A domestic law implementing the BTWC was enhanced to deal with bio crimes in Japan in However, difficulties to deal with bioterrorism still remain. Notes: Bioterrorism is certainly possible. However, there is very little evidence of it in the historical record and if it does occur in the near future it is likely to be relatively unsophisticated. In the case of Aum, Japan enhanced the domestic law to make the use of biological weapons liable to indefinite period of imprisonment or for minimum 2 years, or maximum fine of ten million yen [approximately £47,200/$93,000], and shall fine an unlawful discharge of biological agents or toxins with maximum 10 years or minimum 5 years imprisonment, or maximum fine of ten million yen [approximately £47,200/$93,000]. However, difficulties to deal with bioterrorism still remained. Sugishima points out that “a primitive form of biological attack (e.g., contamination of foods with pathogens) like the ones that occurred before the Aum incident, would not be covered by this law.”

19.Bioterrorism (ii) Salmonellosis in Oregon
“This outbreak of salmonellosis, affecting at least 751 persons, was caused by intentional contamination of restaurant salad bars by members of a religious commune. It was the largest outbreak of foodborne disease...in the United States in 1984. The source of the outbreak strain of S.Typhimurium was finally identified in October During a search by law enforcement agents, an Oregon Public Health Laboratory official found an open vial of commercial stock culture disks containing S.Typhimurium in a clinical laboratory operated by the religious commune...” Notes: One incident of bioterrorism that is well documented is the attempt by the Rajneesh religious commune to influence a local election by making large numbers of voters ill. Nobody was killed and it took more than a year for the attack to be understood (and that as a result of an unrelated police investigation).

20. Bioterrorism (iii) A terrorist campaign
“…Attackers who use biological weapons probably can avoid prompt detection and stockpile or replenish resources that permit repeated attack. Making a gram of readily aerosolized anthrax spores in a weaponized 1-to-5 micron range is a technical challenge, but, once production is accomplished, it is a much lesser challenge to make I kilogram…” “…Biological terrorism affords the possibility of repeated attack, undermining confidence and forcing ever-escalating investments of resources to achieve a modicum of defense…” Notes: Just because bioterrorism has not been a major threat in the past does not mean that we can ignore it in the future if an offense/defence arms race breaks out. One possibility described by Richard Danzig – of a terrorist campaign – is too frequently omitted from consideration even today.

Sample Questions 1. What is meant by the concept of the “assimilation” of a technology? How has that concept been applied to chemical and biological warfare? 2. What is your assessment of the view that the nature of modern warfare is changing in ways that would increase the perceived utility of chemical and biological weapons? 3. Outline the view put forward by Pero et al., of the possible impact of biotechnology in future biowarfare and biodefence. What is your assessment of their view? 4. What would be the difficulties to effectively deal with BW-terrorism by the domestic application of the BTWC of 1972? Discuss the case of Aum Shinrikyo.

References (Slide 2) International Committee of the Red Cross (2003) Biotechnology, Weapons and Humanity. [cited 6 November 2008]. Available from (Slide 3-4) Perry Robinson, J.P. (1989) Supply, Demand and Assimilation in Chemical-Warfare Armament. In H.G.Brauch (Ed.) Military Technology, Armaments Dynamics and Disarmament. St. Martin’s Press, New York. Available from

(Slide 5) Mark Wheelis, M., Rózsa, L., and Dando, M. R. (2006) Deadly Cultures: Biological Weapons since 1945, Massachusetts: Harvard University Press (Slide 6-11) Robinson, J. P. (2008) ‘Difficulties Facing the Chemical Weapons Convention’, International Affairs, 84 (2), 223–239. Available from (Slide 9) Smith, R. (2005) book The Utility of Force: The Art of War in the Modern World. New York: Penguin.

(Slide 12-15) Petro, J. B., Plasse, T. R., and McNulty, J. A. (2003) ‘Biotechnology: Impact on Biological Warfare and Biodefense’, BioSecurity and Bioterrorism: Biodefense Strategy, Practice, and Science 1(3), pp Available from (Slide 16-17) Office of Technology Assessment. (1993). Technologies underlying Weapons of Mass Destruction (Document No. OTA-BP-ISC-115). Washington, DC: U.S. Government Printing Office (Slide 18) Sugishima, M. (2003) Aum Shinrikyo and the Japanese Law on Bioterrorism Prehospital and Disaster Medicine, 18(3), 179–183. Available from

(Slide 19) Török, T. J., Tauxe, R. V., Wise, R. P., Livengood, J. R., Sokolow, R., Mauvais, S., Birkness, K. A., Skeels, M. R., Horan. J. M., and Foster, L. R. (1997) ‘A Large Community Outbreak of Salmonellosis caused by Intentional Contamination of Restaurant Salad Bars’, JAMA, 278(5). pp Available from (Slide 20) Danzig, R. (2003) Catastrophic Bioterrorism – What is to be done?, Washington, D.C.: Center for Technology and National Security Policy. Available from at p. 2.

THE BIOLOGICAL AND TOXIN WEAPONS CONVENTION
Lecture No. 7

1. Outline The BW Proliferation Regime The 1925 Geneva Protocol
Slide 2 The 1925 Geneva Protocol Slide 3 The Biological and Toxin Weapons Convention (BTWC) Slides 4-18 The current situation Slides 19-20 Notes: Life scientists do not need to know all of the fine details about the BTWC and its negotiation history. What this lecture is intended to do is review the main features of the Convention in order that the process of further strengthening of the Convention can be better understood.

2. The BW Prohibition Regime
The 1925 Geneva Protocol Bans the use of BW (Biological Weapons) The BTWC Adds further bans e.g. on development of BW The Chemical Weapons Convention Also covers toxins The ‘Web of Prevention’ Adds other related laws and regulations Notes: The BW prohibition regime has developed incrementally over the last century as perception of the threat of the use of biological weapons has increased. The three central elements – the 1925 Geneva Protocol, the 1975 BTWC, and the 1997 Chemical Weapons Convention – are supported by a ‘web’ of other related laws and regulations such as the Australia Group restrictions on exports of agents and equipment.

3. The 1925 Geneva Protocol Negotiated following use of CW in WWI
Polish delegation argued BW just as dangerous and easy to obtain so ban should be extended to BW Almost universal adherence and removal of reservations now reinforces ban on use Protocol builds on earlier agreements, but by present standards is a very simple international agreement Notes: It is important to make clear here that because of the Protocol the use of BW is now effectively prohibited without exception by customary international law.

4. The BTWC The Convention Structure of the Convention
Negotiated in the late 1960s/early 1970s Now moving towards universal adherence Structure of the Convention Preamble sets out aims of negotiators 15 Articles set out legal agreement Five-Year Review Conferences Allow for evolution of the Convention Notes: Making sure that students have a good grasp of the Convention and the obligations it imposes is the main point of this lecture. Students might best be provided with a copy of the Convention when this slide is shown.

5. BTWC Obligations (i) Article I
“Each State Party to this Convention undertakes never in any circumstances to develop, produce, stockpile, or otherwise acquire or retain: 1. Microbial or other biological agents, or toxins whatever their origin or method of production, of types and in quantities that have no justification for prophylactic, protective or other peaceful purposes;” Notes: Article 1.1 states what has been called ‘The General Purpose Criterion’. This allows any civil use of biological and toxin agents but nothing that cannot be justified for prophylactic, protective or other peaceful purposes. The prohibition is thus all embracing. The lecturer should if possible obtain a copy of Sims’s book as it underpins this lecture. Ref: Sims, Nicholas (2001) The Evolution of Biological Disarmament (SIPRI Chemical & Biological Warfare Studies No. 19). Oxford: Oxford University Press.

6. BTWC Obligations (ii) Article II Article III Article IV
To destroy any biological or toxin weapons or divert them to peaceful purposes within 9 months Article III Not to transfer biological or toxin weapons to any recipient, and not to assist, encourage or induce anyone to acquire them Article IV To take any necessary measures to give domestic legal effect, within each state party, to its international obligations under the Convention Notes: Article IV is crucial for students to understand as it has become clear in recent years that state parties see the potential dual-use aspects of civil life science as coming within the purview of the Convention (see linked document).

7. BTWC Obligations (iii)
Article V To consult and cooperate in solving any problems that may arise including the use of international procedures within the framework of the United Nations Article VI To cooperate with the UN Security Council in any investigation it may initiate if it receives a complaint from one state party that another state party is in breach of its obligations Notes: A major deficiency of the BTWC is the lack of any effective compliance mechanism to ensure that state parties are living up to their obligations. These articles have been little used.

8. BTWC Obligations (iv) Article IX Article X
To continue negotiations in good faith in order to reach agreement on a chemical weapons disarmament treaty Article X To pursue international cooperation in the peaceful uses of microbiology for the prevention of disease and other peaceful purposes; and to implement the BTWC in such a way as to avoid hampering the economic and technological development of states parties or international cooperation Notes: It took 20 years of hard bargaining before the Chemical Weapons Convention was agreed. Clearly the BTWC, like other non-proliferation treaties, involves obligations for cooperation with the developing world as well as reducing the risks of hostile misuse of weapons of mass destruction. There has been much contention over the potential contradiction between Article III and Article X.

9. Understanding the BTWC
The BTWC can be considered to consist of several ‘regimes’ Regime of Compliance Regime of Development Regime of Permanence/Institutionalisation Regime of Research These regimes have developed unevenly, and, in particular, the regime of research requires much further elaboration Notes: Sims’ thinking on these regimes is to be found in chapters 2 to 7 in his book The Evolution of Biological Disarmament. Students who look into the international relations literature are likely to be confused by the many meanings of the word ‘regime’ in that field of research. You might want to use the word ‘aspect’ or ‘dimension’ when presenting this lecture to clarify the meaning intended here. We have added institutionalisation to Sims regime of permanence by way of extra clarification. Ref: Revill, J., and Dando, M. R (2008) Life scientists and the need for a culture of responsibility: after education … what?. Science and Public Policy, February 35(1), Available from

10. Compliance (i) Compliance and verification are separate concepts
The central disarmament obligations are set out in Articles I,II and III Articles IV,V, VI and VII provide substitutes for effective verification As the original verification system is inadequate other means have been added Confidence-Building Measures (CBMs) agreed in 1986 and improved in 1991 VEREX and the Ad Hoc Group negotiations throughout most of the 1990s that failed to produce a Verification Protocol in 2001 Notes: This issue is complex and contentious. All students need to know at this stage is that the greater the transparency about relevant work, particularly in biodefence, the less likelihood there is for misunderstandings and action/reaction arms racing. However, too great transparency might threaten national security and commercial confidentiality so progress is always going to be hard won. Ref: Sims, A. N (2007) The Future of Biological Disarmament: New Hope after the Sixth Review Conference of the Biological Weapons Convention. Non Proliferation Review, 1 July 14(2), Available from

11. Compliance (ii) Confidence-Building Measures
Agreed first in 1986 Second Review Conference and defined in 1987 Required Annual Declarations of Exchange of data on research centres and laboratories that meet very high biosafety standards Exchange of information on all outbreaks of infectious diseases or similar occurrences by toxins that seem to deviate from normal patterns Encouragement of publication of results of biological research directly related to the Convention in generally available scientific journals Active promotion of contacts between scientists engaged in biological research directly related to the Convention, including exchanges for joint research on a mutually agreed basis Notes: Although the Convention text does not specifically mention research we see here that research was seen early on as being amongst the activities that could be of concern.

12. Compliance (iii) Improvements to the CBMs in 1991
CBMs were developed and reorganised into a new set of seven labelled A to G For example CBM ‘A’ changed the declaration of high containment facilities to a declaration of national defence activities A new CBM ‘E’ required declaration of legislation, regulations and other measures implementing the BTWC under Article IV Unfortunately CBM returns have been unsatisfactory in number and often in quality However, some States are now putting their returns openly on the web so that civil society can examine them Notes: CBM are an obvious area in which further strengthening of the Convention could take place. It is also an area where scientific expertise might greatly help in deciding what best might be done.

13. Development Article X has a promotional obligation
“The States Parties to this Convention undertake to facilitate, and have the right to participate in, the fullest possible exchange of equipment, materials and scientific and technological information for the use of bacteriological (biological) agents and toxins for peaceful purposes…” Article X also has a regulatory obligation “The Convention shall be implemented in a manner designed to avoid hampering the economic or technological development of States Parties…or international cooperation in the field of peaceful bacteriological (biological) activities…” This article has been subject to little development or activity Notes: The disputes over the apparent contradiction between this article and Article III have declined in recent years as many developing countries have seen the need for export controls to prevent misuse of materials and technologies, but there is clearly a need for more to be done to implement the positive aspects of Article X and scientists could play a constructive role in this activity.

14. Permanence/Institutionalisation (i)
Article XII states “Five years after the entry into force of this Convention…a conference of States Parties…shall be held at Geneva, Switzerland, to review the operation of the Convention, with a view to assuring that the purposes of the preamble and the provisions of the Convention, including the provisions concerning negotiations on chemical weapons, are being realised…” The Article continues “…Such review shall take into account any new scientific and technological developments relevant to the Convention.” Notes: The Review Conferences are the main mechanism through which the BTWC has been developed. All of the agreed Final Declarations of the agreements reached at these important reviews are available on the web. Note the importance given to scientific and technological developments. Whilst the Depository States for the Convention are the United States, the UK and Russia the conferences and other BTWC meetings are held in Geneva and staffed by the UN.

15. Permanence/Institutionalisation (ii)
BTWC entered into force in 1975 First Review Conference held in 1980 Second Review Conference held in 1986 Mandated first CBMs These were defined in 1987 Third Review Conference held in 1991 Mandated development of CBMs Mandated VEREX analysis of scientific and technological aspects of verification Notes: The seconds review conference was held as the cold war was beginning to end. CBMs (annual data exchanges) were seen as a means of increasing confidence in compliance. By the time of the third review there were increasing concerns about BW so the CBMs were improved and the VEREX meetings were mandated to examine verification from a scientific and technological viewpoint.

16. Permanence/ Institutionalisation (iii)
Special Conference of 1994 Received results of VEREX and mandated Ad Hoc Group negotiation of a Verification Protocol Fourth Review Conference of 1996 Encouraged completion of the Ad Hoc Group’s work Fifth Review Conference of Instituted new Inter-Sessional Process (ISP) Sixth Review Conference of 2006 Agreed new phase of ISP meetings Agreed small Implementation Support Unit (ISU) Notes: The BTWC is weak because it has no effective verification mechanism to ensure states are living up to their obligations and no international organisation to take care of its activities and development. Great efforts were expended during the 1990s in an effort to agree a verification protocol, but that was not possible (see linked ‘marked text’ on disagreements). Since then efforts have been concentrated on areas of strengthening where agreement seems more likely.

17. Research (i) Research is not mentioned in the text of Article I of the BTWC Yet the 1991 Review Conference demonstrated that research can be of concern “The Conference notes that experimentation involving open-air release of pathogens or toxins harmful to man, animals or plants that has no justification for prophylactic, protective or other peaceful purposes is inconsistent with the undertakings contained in Article I.” But it may not be easy to determine when research crosses the line into prohibited activity Notes: Research is not mentioned in Article I if the BTWC, and, as we shall see in later lectures, the issue of dual-use civil research and how it should be overseen is complex. Again, however, application of the expertise of scientists could help to solve these problems.

18. Research (ii) The 2006 Sixth Review Conference reaffirmed the comprehensive nature of the prohibition “The Conference reaffirms the importance of Article I, as it defines the scope of the Convention. The Conference declares that the Convention is comprehensive in its scope and that all naturally or artificially created microbial and other biological agents and toxins, regardless of their origin and method of production and whether they affect humans, animals or plants, of types and in quantities that have no justification for prophylactic, protective or other peaceful purposes, are unequivocally covered by Article I.” Notes: Increasing concerns about the possible misuse of the advances in life sciences can be seen in the Final Declarations of successive review conferences. Rather than adding more examples of areas that could be of concern the Sixth Review Conference simply stated that Article I was comprehensive in its scope – everything was covered. There is thus no room for any doubt about whether a particular new advance such as synthetic biology is covered by the prohibition.

19. The First ISP (i) Topics for meetings in 2003-2005
“i. the adoption of necessary national measures to implement the prohibitions set for the in the Convention, including the enactment of penal legislation; ii. National measures to establish and maintain the security and oversight of pathogenic microorganisms and toxins; iii. Enhancing international capabilities for responding to, investigating and mitigating the effects of cases of alleged use of biological or toxin weapons or suspicious outbreaks of disease; Notes: The ISP meetings were not negotiation sessions but attempts to discuss and promote common understandings on the topics agreed. Decisions were to be taken if necessary at the following review conference. Thus the meetings had lesser objectives, but were more relaxed and constructive because of that. Whist the BTWC is primarily still aimed at preventing state level offensive BW programmes it cannot be denied that the increasing focus on national measures and the prevention of inadvertent assistance to misuse must make bioterrorism more difficult as well. Results of these annual meetings at both expert and state party level can be found on the web.

20. The First ISP (ii) Topics for 2003 – 2005 continued
“iv. Strengthening and broadening national and international institutional efforts and existing mechanisms for the surveillance, detection, diagnosis and combating of infectious diseases affecting humans, animals and plants; v. the content, promulgation, and adoption of codes of conduct for scientists.” Notes: During the 1990s efforts to strengthen the BTWC were made with very little interest from outside of the diplomatic community. The ISP process has brought many more “stakeholders” to Geneva. For scientists and scientific organisations the meetings in 2005 on the fifth topic were particularly important and has led on to much further work for example by the Inter Academy Panel of national scientific academies. This involvement has continued in the second series of ISP meetings since the Sixth Review Conference.

Sample Questions Briefly outline the major elements of the BW Prohibition Regime. What are the major deficiencies that need to be corrected? 2. Sims has suggested that the Biological and Toxin Weapons Convention has four ‘regimes’ or dimensions. What are these four dimensions and which Articles of the Convention related to each dimension in particular? 3. To what extent do the Biological and Toxin Weapons Convention deal with the problem of bioterrorism? 4. How is the new Inter-Sessional Process different from the Ad Hoc Group negotiations in the 1990s? Do you think the new process has been success?

References (Slide2) International Committee of the Red Cross. Responsibilities of actors in the life sciences to prevent hostile use [Online]. 20 January 2004 [Cited 15 September 2008]. Available from: (Slide3) Protocol for the Prohibition of the Use in War of Asphyxiating, Poisonous or Other Gases, and of Bacteriological Methods of Warfare (Geneva Protocol) Geneva, 17 June 1925 Reproduced in International Humanitarian Law Treaties and Documents ICRC. [Online]. [Last updated 2005]. Available:

(Slide4) The Biological and Toxin Weapons Convention Website. Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on Their Destruction [online]. Undated [cited 15 September 2008]. Available from: Bradford Project on Strengthening the Biological and Toxin Weapons Convention (BTWC), Video Background Briefings [Online] BDRC [Cited 15 June 2009]. Available from (Slide5) Sims, Nicholas (2001) The Evolution of Biological Disarmament (SIPRI Chemical & Biological Warfare Studies No. 19). Oxford: Oxford University Press. Bradford Project on Strengthening the Biological and Toxin Weapons Convention (BTWC), Video Background Briefings [Online] BDRC [Cited 15 June 2009]. Available from

(Slide6) Japan (2006) Sixth Review Conference of the Parties to the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction. Review of National Implementation of the Biological and Toxin Weapons Convention, BWC/CONF.VI/WP.17 [Online]. 15 November [Cited 15 September 2008]. Available from: (Slide7) Pearson, G. S (2005) Article IV: Lodging of Complaints with and Their Investigation by the Security Council. Key Points of the Fifth Review Conference. Bradford: University of Bradford [online] November [cited 15 September 2008]. Available from:

(Slide8) Convention on the Prohibition of the Development, Production, Stockpiling and Use of Chemical Weapons and on their Destruction (Chemical Weapons Convention). Reproduced in the Organization for the Prohibition of the Chemical Weapons Convention, Available at (Slide9) Revill, J., and Dando, M. R (2008) Life scientists and the need for a culture of responsibility: after education … what?. Science and Public Policy, February 35(1), Available from (Slide10) Sims, A. N (2007) The Future of Biological Disarmament: New Hope after the Sixth Review Conference of the Biological Weapons Convention. Non Proliferation Review, 1 July 14(2), Available from

(Slide12) Littlewood, J (2008) Confidence-building measures and the Biological Weapons Convention: where to from here? (Compliance Chronicles. No. 6). Ottawa: The Canadian Centre for Treaty Compliance. Available from (Slide 13) Pearson, G. S (2006) Article X: Exchange of Equipment, Materials and Scientific and Technological Information: International Cooperation and Development, Key Points of the Sixth Review Conference. Bradford: University of Bradford [Online] BDRC [Cited 15 September 2008]. Available from: (Slide14) United Nations (2006) Sixth Review Conference of the Parties to the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction. Final Declaration, BWC/CONF.VI/6 [Online]. 8 December [Cited 15 September 2008]. Available from:

(Slide15) United Nations (1991) Third Review Conference of the Parties to the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction. Final Declaration, BWC/CONF.III/23 [Online]. 27 September [Cited 15 September 2008]. Available from: (Slide16) United Nations (2000) Ad Hoc Group of the Parties to the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction. FOC Marked Text, BWC/AD HOC GROUP/50 (Part I) [Online] BDRC [Cited 15 September 2008]. Available from: (Slide17) Tucker, J. B (2004) Biological Threat Assessment: Is the Cure Worse Than the Disease?. Arms Control Today, [online] October [cited 15 September 2008]. Available from:

(Slide 18) United Nations (2006) Sixth Review Conference of the Parties to the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction. Final Declaration, BWC/CONF.VI/6 [Online]. 8 December [Cited 15 September 2008]. Available from: (Slide19) United Nations (2003) States Parties of the Parties to the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction. Report of the Meeting of States Parties, BWC/MSP/2003/4 (Vol. I) [Online] 26 November [Cited 15 September 2008]. Available from: (Slide 20) United Nations (2005) States Parties of the Parties to the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction. Report of the Meeting of States Parties, BWC/MSP/2005/3 [Online] 14 December [Cited 15 September 2008]. Available from:

Development of the BTWC: 1980-2008
Lecture No. 8

1. Outline How the BTWC deals with scientific and technological developments Slides 2-6 The First Review Conference Slides 7-8 The Second and Third Review Conferences Slides 9-12 The Fourth and Fifth Review Conferences Slides 13-18 The Sixth Review Conference Slides 19-20 Notes: The aim of this lecture is to give a thorough introduction to how the State Parties to the BTWC have considered and dealt with the scientific and technological changes that have taken place as the revolution in the life sciences has developed since In order to do that the main mechanism of consideration and deliberation at the Review Conferences is introduced and then each of the conferences in 1980, 1986, 1991, 1996, and 2006 are considered. There is a wealth of official documentation for this lecture that is easily available on the internet for the students.

2. Factors Affecting the BTWC
Perceptions of the threat State programmes in the early 1990s –Iraq, South Africa, the USSR CB terrorism – Sarin in Tokyo, anthrax letters Techniques of arms control Confidence-Building Measures as the Cold War ended Universalisation and National Implementation to help prevent terrorism Scientific and technological change Notes: Many political and diplomatic factors have affected the development of the BTWC since it was agreed in the early 1970s. Few outside of the various experts involved knew about this ‘orphaned’ Convention and what was happening to it. But scientific and technological change relevant to the Convention was ever wider in scope and faster in pace. So we concentrate just on scientific and technological change here. Ref: Pearson, G. S (1993) Prospects for Chemical and Biological Arms Control: The Web of Deterrence. Washington Quarterly, Spring 16(2), Alternatively Pearson, G. S. (1998) The Vital Importance of the Web of Deterrence [Online] Department of Peace Studies, University of Bradford [Cited 15 June 2009]. Available from

3. The Impact of Scientific and Technological Change
Article X Development possibilities Article IV Biosafety standards Biosecurity requirements Article III Export control arrangements Article I The central prohibitions Notes: Scientific and technological change will necessarily impact on a number of the Articles of the BTWC, for example in the understanding of biosafety standards and biosecurity requirements.

4. The Impact on Article I Meselson’s question in 2000
“Every major technology – metallurgy, explosives, internal combustion, aviation, electronics, nuclear energy – has been exploited, not only for peaceful purposes but also for hostile ones. Must this also happen with biotechnology, certain to be a dominant technology of the twenty-first century?” “At present we appear to be approaching a crossroads – a time that will test whether biotechnology, like all predecessor technologies, will come to be intensively exploited for hostile purposes or whether instead our species will find the collective wisdom to take a different course…” Notes: As Professor Meselson of Harvard explained, all previous scientific and technological revolutions have been applied in major ways for both peaceful and hostile purposes. The major question for life scientists is what can they do to help prevent this happening to the life sciences because if it does terrible new threats to humans, animals and plant life can be anticipated.

5. The BTWC and Scientific and Technological Change
Article XII The Five-Yearly Review Conferences are required to take relevant scientific and technological changes into account Background Document on scientific and technological changes of relevance Contributions are requested from States Parties and the document is made available at the conference The document is considered at the Review Conference Agreements reached by consensus and incorporated in the Final Declaration under each article Impact on the central prohibitions is considered under Article I Notes: The BTWC only gained a small Implementation Support Unit (with a very restricted mandate) in 2006 and has no Scientific Advisory Board. So only the Review Conferences and what they mandate can develop the Convention and keep it up to date with regard to scientific and technological changes. This contrasts sharply with the modern Chemical Weapons Convention.

6. A Regime of Research Sims argued in The Evolution of Biological Disarmament that the Fifth Review Conference “…might, for example, return to the language of the British draft conventions of 1969 and 1970 and state that the parties recognise an obligation ‘not to conduct assist or permit research aimed at production of the kind prohibited’ under Article I…” “It might also declare that research and development are so intrinsically related to each other that, in order for the ban on BTW development to be upheld, it is necessary for research to be constrained by the same condition…” Sims added that it is not clear at what point a line of research would cross the threshold of prohibition but while “…That practical problem would remain…the burden of proof would be shifted to the practitioner of research…” Notes: Neither of Sims’ suggestions came to fruition in the fractured Fifth Review Conference of and we remain a long way from a regime of research equivalent to the other regimes under the convention (see lecture 7). However, research has come to be more incorporated within the purview of the BTWC – including, as we shall see in later lectures, benignly intended civil research that might be misused by those with hostile intent. Ref: United Kingdom, ‘Draft Convention for the Prohibition of Biological Methods of Warfare and Accompanying Security Council Resolution’, ENDC/255, 10 July 1969 [reproduced in The Disarmament Negotiations 1969, Cmnd 4399, July 1970, pp ] [Illustration is available at Part I, Chapter 9 pp in SIPRI (1971) The CB Disarmament Negotiations, (The Problem of Chemical and Biological Warfare: CB Weapons Today. Vol. IV.) Stockholm: Almqvist & Wiksell.] The UK Draft Biological Warfare Convention, August 8, 1970 (CCD/255/Rev.2). [Text is available at pp in SIPRI (1971) The CB Disarmament Negotiations, (The Problem of Chemical and Biological Warfare: CB Weapons Today. Vol. IV.) Stockholm: Almqvist & Wiksell.]

7. The First Review Conference of 1980
The three Depositary States – the USSR, the USA and the UK produced a joint contribution “10 (b) Although recombinant DNA techniques could facilitate genetic manipulation of micro-organisms for biological or toxin warfare purposes, the resulting agents are unlikely to have advantages over known natural agents sufficient to provide compelling new motives for illegal production or military use in the foreseeable future…” Sweden appeared less sanguine “These genetic techniques imply a potential to change existing potential BW-agents, e.g. in order to increase their ability to survive in different environments….It cannot be excluded that new BW-agents (e.g. combinations between existing viruses or combinations between viruses and other genes) could be constructed…” Notes: Despite the difference in tone, both the contribution by the Depositary States and that by Sweden suggested that scientific and technological developments relevant to the BTWC needed to be reviewed again in the future.

8. Final Declaration of the First Review Conference
Agreement on Article I Just two short paragraphs Stating “The Conference notes the importance of Article I as the Article which defines the scope of the Convention and reaffirms its support for the provisions of this Article.” “The Conference believes that Article I has proved sufficiently comprehensive to have covered recent scientific and technological developments relevant to the Convention.” Notes: This sanguine agreement was to be progressively altered in the following five Review Conferences and since the turn of the century emphasis has increasingly been given to the possibility of inadvertent assistance being given to those with hostile intent from the progress made in civil life science. This “dual-use” problem is the subject of later lectures (11-18) in the series.

9. The Second Review Conference of 1986
Four countries made contributions to the background document on relevant scientific and technological changes The UK concluded (para 7.2) that “The 1980 paper…doubted that such improvements provided compelling advantages for production or use in the foreseeable future. In the event, the rapid pace of development across a range of peaceful activities indicates that there is greater potential than was perhaps evident at the time.” And (para 4.1) “In 1980, the depositaries paper considered solely the chemical synthesis of toxins….The possibilities for microbial synthesis of toxins provided by GE [Genetic Engineering] offer much greater opportunities… to achieve useful quantities of toxins for… significant military use...” These points were strongly reinforced in Sweden’s contribution to the background document Notes: It would be useful for students to study this short background document as in many ways it foresees the scientific and technical developments over the next 20 years.

10. Final Declaration of the Second Review Conference
Agreement on Article I Five paragraphs mostly dealing with the impact of scientific and technological developments Including “The Conference, conscious of the apprehensions arising from the relevant scientific and technological developments, inter alia, in the fields of microbiology, genetic engineering and biotechnology, and the possibilities of their use for purposes inconsistent with the objectives and provisions of the Convention, reaffirms that the undertakings given by the States Parties in Article I applies to all such developments.” “The Conference reaffirms that the Convention unequivocally applies to all natural or artificially created microbial or other biological agents or toxins whatever their origin or method of production. Consequently, toxins (both proteinaceous and non-proteinaceous) of a microbial, animal or vegetable nature and their synthetically produced analogues are covered.” Notes: Here we see a clear statement of growing apprehensions and a focus on ensuring that toxins which appeared to be the most pressing threat were properly covered by the prohibitions in Article I.

11. The Third Review Conference of 1991
Seven countries contributed to the background document on relevant scientific and technological changes Canada in addition to its contribution distributed another document on Novel Toxins and Bioregulators The contribution from the USA also noted the problem of increasing knowledge of bioregulators “Their range of activity covers the entire living spectrum, from mental processes (e.g. endorphins) to many aspects of health such as control of mood, consciousness, temperature control, sleep, or emotions, exerting regulatory effects on the body. Even a small imbalance in these natural substances could have serious consequences, including fear, fatigue, depression or incapacitation. These substances would be extremely difficult to detect but could cause serious consequences or even death if used improperly.” Notes: The third Review Conference was very successful in improving the 1986/7 CBMs and mandating the VEREX meetings. The background document on science and technology was equally detailed and serious in its assessment.

12. Final Declaration of the Third Review Conference
Agreement on Article I Seven paragraphs most again dealing with the impact of scientific and technological change Including Some repeats of material in the 1986 Final Declaration New material including “The Conference notes that experimentation involving open-air release of pathogens or toxins harmful to man, animals or plants that has no justification for prophylactic, protective or other peaceful purposes is inconsistent with the undertakings contained in Article I.” And a direct appeal to the scientific communities of States Parties to support the BTWC. Notes: See also the paragraphs agreed under Article IV in regard to the scientific community. In the context of the BTWC toxins are taken to include bioregulators. The concerns about experiments involving open-air release would therefore also have covered bioregulators. Clearly, as Sims has argued, there is no differentiation between research and development in the open-air release agreed paragraph.

13. The Fourth Review Conference of 1996
Four countries contributed to the background document on relevant scientific and technological developments Switzerland amongst others emphasised the scope and pace of change “During the last decades biotechnology and genetechnology have revolutionized (and is still doing so) many areas of biological and medical sciences. The possibilities of studying and manipulating genetic information have provided a huge amount of knowledge on basic principle of life…” The UK raised the question of ethnic targeting “…It cannot be ruled out that information from genetic research could be considered for the design of weapons targeted against specific ethnic or racial groups…” Notes: By 1996 there was clearly a recognition that a wide-ranging revolution was taking place in the life sciences and that vast amounts of new information that might be subject to misuse was becoming widely available.

14. Final Declaration of the Fourth Review Conference
Agreement on Article I Nine paragraphs on Article I included repeats of those from 1991 on open-air experiments and the appeal to scientific communities Most noticeable, however, was para 6 which expanded the range of fields of work causing apprehensions “6. The Conference, conscious of apprehensions arising from relevant scientific and technological developments, inter alia, in the fields of microbiology, biotechnology, molecular biology, genetic engineering, and any applications resulting from genome studies, and the possibilities of their use for purposes inconsistent with the objectives and provisions of the Convention, reaffirms that the undertakings given by States Parties in Article I applies to all such developments.” Notes: The inclusion of “any applications resulting from genome studies” was significant in recognising the burgeoning power of the life sciences at the end of the 20th Century.

15. The Fifth Review Conference of 2001-2002 (i)
Five countries contribute to the background document, four in BWC/CONF.V/4 and the UK in BWC/CONF.V/4/Add.1 South Africa’s contribution to BWC/CONF.V/4 concentrated on a subject which had not previously been given much attention – the developments of plant biocontrol agents and plant inoculants. It concluded, for example, that Plant inoculants are relevant because “a. A growing industry and more sophisticated production facilities that have the potential to be diverted to BW producing facilities, as in the case of vaccine production facilities.” Biocontrol of plant pests and weeds is relevant because “b. Undesirable plants, exotic plants and even noxious plants in one country may be natural, essential and in many cases utilised for commercial purposes (crops) in other countries Notes: This is an excellent example to stress that the BTWC is relevant to prevention of attacks on animal husbandry and plant staple crops as well as to attacks on human populations.

16. The Fifth Review Conference of 2001-2002 (ii)
The background document in 2001 was unusual in the additional 29 page addition by the UK. This consisted of A. Introduction/Overview (pages 1-6) B. Detailed Science and Technology Review (pages 7-29) Part A concluded that “18…Given the accelerating pace a in science and technology, the UK wonders whether it is prudent to maintain a five year gap between such assessments under the BTWC. The UK suggests that the upcoming Review Conference consider establishing a mechanism for State Parties to work together on a more frequent basis to conduct such scientific and technical reviews and to consider any implications at the necessary level of expertise.” Notes: The fractured review was unable to reach a proper consensus Final Declaration covering the article by article review. Thus nothing came of this wise suggestion – made 7 years ago.

17. The Fifth Review Conference of 2001-2002 (iii)
The UK’s detailed science and technology review covered 23 separate topics Genomics and proteomics Bioinformatics Human Genome Project and human diversity Gene therapy Virulence and pathogenicity Vaccines and novel therapies Recombinant protein expression Toxins and other bioactive molecules Detection and identification technologies Human infectious disease patterns Smallpox destruction Drug resistance Notes: Some of these developments were seen as useful in protecting against disease and BW, but many were seen as causes of concern.

18. The Fifth Review Conference of 2001-2002 (iv)
The UK list of topics continued as follows Disease in agriculture Pest control in agriculture Global initiatives to tackle disease Molecular biology applications and crops Trends in protein production technologies International co-operation and biosafety: activities under the Biodiversity Convention Means of delivery of agents and toxins Use of pathogens to control weeds and ‘criminal’ crops Bioremediation: the destruction of material Countering the threat of BW terrorism Impact of the entry into force of the CWC Notes: This is probably the most useful summary paper for students to read in order to understand the range of concerns about misuse of the life sciences.

19.The Sixth Review Conference of 2006
For the first time the Conference Secretariat provided a summary of the States Parties contributions rather than just collating them Nevertheless the original contributions can be found on the web What stands out in these contributions is the new concerns that are still arising as the revolution in the life sciences progresses. Thus the Netherlands argued “14…one could imagine that in the future microscopic machines built of DNA and protein particles could be made to intervene in biological processes by imitating the effect of an enzyme or toxin. This degree of artificiality might exclude the technology from the Convention….we recommend…that misuse of… developments in the field of nanotechnology and derived applications is in fact a violation of Article I.” Notes: So here we see nanotechnology being considered as a potential cause of concern. Synthetic Biology was equally of concern as was interference RNAi. Clearly the potential problems were not getting any simpler in the eyes of these State Parties. Ref: OPBW (2006) Review Conferences: Sixth Review Conference 20 November – 8 December, 2006’, Contributions to the Science and Technology Background Document [Online]. Available from

20. Final Declaration of the Sixth Review Conference
Agreement on Article I Just four paragraphs but a sweeping statement in para 2 that “The Conference reaffirms that Article I applies to all scientific and technological developments in the life sciences and in other fields of science relevant to the Convention.” Agreement on annual inter-sessional meetings, including in 2008 “(iii) National, regional and international measures to improve biosafety and biosecurity, including laboratory safety and security of pathogens and toxins. (iv) Oversight, education, awareness raising, and adoption and/or development of codes of conduct with the aim of preventing misuse in the context of advances in bio-science and bio-technology research with the potential of use for purposes prohibited by the Convention.” Notes: So here we see that all aspects of relevant life and associated sciences are covered by Article I of the Convention and that civil science and technology research is within the purview of the Convention. All life and associated scientists and technologists have responsibilities.

Sample Questions 1. How is the problem of keeping the Biological and Toxin Weapons Convention up-to-date in regard to scientific and technological change carried out? Do you think the present mechanism is adequate? 2. How does the assessment of the impact of scientific and technological change made in the First Review Conference of 1980 compare with that made in the Sixth Review Conference of 2006? 3. What do you consider to be some of the key scientific and technological changes relevant to the Convention since 1980? Discuss one of these in detail. 4. How all do you think the Final Declarations of Review Conferences reflect the Background Papers on science and technology changes? Give some examples of either adequate or inadequate reflections of the scientific view point.

References (Slide2) Pearson, G. S (1993) Prospects for Chemical and Biological Arms Control: The Web of Deterrence. Washington Quarterly, Spring 16(2), Alternatively Pearson, G. S. (1998) The Vital Importance of the Web of Deterrence [Online] Department of Peace Studies, University of Bradford [Cited 15 June 2009]. Available from Dept. of NBC Defence (1998) Proceedings of the Sixth International Symposium on Protection Against Chemical and Biological Warfare Agents, (Stockholm, Sweden, May 1998) Stockholm: National Defence Research Establishment. [Reprinted in BP. No14 (2nd Series)]

(Slide3) Mathews, R. J (2004) The Development of the Australia Group Export Control Lists of Biological Pathogens, Toxins and Dual-Use Equipment, The CBW Conventions Bulletin, December 66, 1-4. Available from (Slide4) Meselson, M (2000) Averting the Hostile Exploitation of Biotechnology, The CBW Conventions Bulletin, June 48, Available from Bradford Project on Strengthening the Biological and Toxin Weapons Convention (BTWC), Video Background Briefings [Online] BDRC [Cited 15 June 2009]. Available from (Slide5) Balali-Mood, M., Steyn, P. S., Synes L. K., and Trapp. R (2008) Impact of Scientific Developments on the Chemical Weapons Convention, Pure and Applied Chemistry, 80(1), pp. 175–200.

(Slide6) United Kingdom, ‘Draft Convention for the Prohibition of Biological Methods of Warfare and Accompanying Security Council Resolution’, ENDC/255, 10 July 1969 [reproduced in The Disarmament Negotiations 1969, Cmnd 4399, July 1970, pp ] [Illustration is available at Part I, Chapter 9 pp in SIPRI (1971) The CB Disarmament Negotiations, (The Problem of Chemical and Biological Warfare: CB Weapons Today. Vol. IV.) Stockholm: Almqvist & Wiksell.] The UK Draft Biological Warfare Convention, August 8, 1970 (CCD/255/Rev.2). [Text is available at pp in SIPRI (1971) The CB Disarmament Negotiations, (The Problem of Chemical and Biological Warfare: CB Weapons Today. Vol. IV.) Stockholm: Almqvist & Wiksell.] (Slide7) United Nations (1980) Views of States Parties on new scientific and technological developments relevant to the Convention, BWC/CONF.I/6 [Online] 29 February [Cited 15 September 2008]. Available from:

(Slide8) United Nations (1980) First Review Conference of the Parties to the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction. Final Declaration, BWC/CONF.I/10 [Online]. 21 March [Cited 15 September 2008]. Available from: (Slide9) United Nations (1986) Background Paper on New Scientific and Technological Developments relevant to the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction, BWC/CONF.II/4 [Online] 18 August [Cited 15 September 2008]. Available from: (Slide10) United Nations (1986) Second Review Conference of the Parties to the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction. Final Declaration, BWC/CONF.II/13/II [Online]. 26 September [Cited 15 September 2008]. Available from:

(Slide11) United Nations (1991) Background Paper on New Scientific and Technological Developments relevant to the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction, BWC/CONF.III/4 [Online] 26 August [Cited 15 September 2008]. Available from: (Slide12) United Nations (1991) Third Review Conference of the Parties to the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction. Final Declaration, BWC/CONF.III/23 [Online]. 27 September [Cited 15 September 2008]. Available from: (Slide 13) United Nations (1996) Background Paper on New Scientific and Technological Developments relevant to the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction, BWC/CONF.IV/3 [Online] 28 October [Cited 15 September 2008]. Available from:

(Slide14) United Nations (1996) Fourth Review Conference of the Parties to the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction. Final Declaration, BWC/CONF. IV/9 [Online]. 6 December [Cited 15 September 2008]. Available from: (Slide15) United Nations (2001) Background Paper on New Scientific and Technological Developments relevant to the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction, BWC/CONF.V/4 [Online] 14 September [Cited 15 September 2008]. Available from: Bradford Project on Strengthening the Biological and Toxin Weapons Convention (BTWC), Video Background Briefings [Online] BDRC [Cited 15 June 2009]. Available from

(Slide16) United Nations (2001) Background Paper on New Scientific and Technological Developments relevant to the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction, BWC/CONF.V/4/Add.1 [Online] 26 October [Cited 15 September 2008]. Available from:

(Slide 19) United Nations (2006) Background Information Document on New Scientific and Technological Developments Relevant to the Convention, BWC/CONF.VI/INF.4, 28 September, Geneva: United Nations. Available from OPBW (2006) Review Conferences: Sixth Review Conference 20 November – 8 December, 2006’, Contributions to the Science and Technology Background Document [Online]. Available from (Slide 20) United Nations (2006) Sixth Review Conference of the Parties to the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction. Final Declaration, BWC/CONF.VI/6 [Online]. 8 December [Cited 15 September 2008]. Available from:

The New Inter-Sessional Process of the BTWC 2007 – 2010
Lecture No. 10

1. Outline The First Intersessional Process -Slides 2-3
The Sixth Review Conference -Slides 4-8 The BTWC 2007 Meetings -Slides 9-10 The BTWC 2008 Meetings -Slides Expectations for the BTWC 2009 & 2010 Meetings -Slides The Future of the Biological and Toxin Weapons Convention. -Slide 19 The Role of Scientists in the BTWC -Slide 20 Notes: The aim of this lecture is to provide an overview of what has variously been termed second Intersessional process or the second inter-Review Conference Process of the Biological and Toxin Weapons Convention (BTWC), specifically looking at the role of scientists in the discussions over the course of the meetings up to 2009.

2. The First Intersessional Process (i)
After the collapse, in 2001, of the negotiations for a verification protocol over the 1990s, the 5th Review Conference was resumed in 2002 and based on bilateral negotiations states parties were able to agree a: “Fresh approach to combat the deliberate use of disease as a weapon.” Rather than international negotiations for a verification regime, the focus turned into discussions aimed at improving national implementation. Notes: Quotation is from the US rejection of the Protocol. See lecture 9.

3. The First Intersessional Process (ii)
Initially the delegations in Geneva were sceptical with regard to the potential of the (first) intersessional process. However, by 2005, states were much more positive about the value of such discussions. “The intersessional programme of work not only helped to focus States Parties on specific issues but also facilitated new thinking.” Notes: Many commentators were initially cynical with regard to the potential of the (first) Intersessional Process. However by 2005 it became clear that states parties had found the process surprisingly successful and useful in facilitating new thinking and sharing ideas on national implementation measures.

4. The Sixth Review Conference (i)
The value of the intersessional process was recognised by the States Parties to the BTWC, in the Final Document, which stated: “The Conference notes that the Meetings of States Parties and Meetings of Experts functioned as an important forum for exchange of national experiences and in-depth deliberations among States Parties. The Meetings of the States Parties engendered greater common understanding on steps to be taken to further strengthen the implementation of the Convention.” Notes: It is further notable that the Intersessional Process also helped improve the environment for the 6th Review Conference in 2006.

5. The Sixth Review Conference (ii)
Agreed “…to discuss, and promote common understanding and effective action on: (i) Ways and means to enhance national implementation, including enforcement of national legislation, strengthening of national institutions and coordination among national law enforcement institutions. (ii) Regional and sub-regional cooperation on implementation of the Convention.” Notes: The success of the First Intersessional Process is further evidenced in the agreement to hold a second intersessional process between 2007 and 2010.

6. The Sixth Review Conference (iii)
“…(iii) National, regional and international measures to improve biosafety and biosecurity, including laboratory safety and security of pathogens and toxins. (iv) Oversight, education, awareness raising, and adoption and/or development of codes of conduct with the aim of preventing misuse in the context of advances in bio-science and bio-technology research with the potential of use for purposes prohibited by the Convention.”

7. The Sixth Review Conference (iv)
“…(v) With a view to enhancing international cooperation, assistance and exchange in biological sciences and technology for peaceful purposes, promoting capacity building in the fields of disease surveillance, detection, diagnosis, and containment of infectious diseases: (1) for States Parties in need of assistance, identifying requirements and requests for capacity enhancement; and (2) from States Parties in a position to do so, and international organizations, opportunities for providing assistance related to these fields.”

8. The Sixth Review Conference (v)
“…(vi) Provision of assistance and coordination with relevant organizations upon request by any State Party in the case of alleged use of biological or toxin weapons, including improving national capabilities for disease surveillance, detection and diagnosis and public health systems.”

9. The BTWC 2007 Meetings (i) 2007 Discussed: “Ways and means to enhance national implementation… [and]… Regional and sub-regional cooperation on implementation of the Convention.” Several Common themes emerged including the “Recognition that there is no ‘one-size-fits-all’ solution for national implementation…” “The need to help States Parties build capacity: in addition to guidance on enacting legislation and regulations, States Parties need practical assistance to build their capacity to enforce and manage such measures.”

10. The BTWC 2007 Meetings (ii) “The States Parties recognised the value of ensuring that national implementation measures: (i) penalize and prevent activities that breach any of the prohibitions of the Convention, and are sufficient for prosecuting prohibited activities; (ii) prohibit assisting, encouraging or inducing others to breach any of the prohibitions of the Convention…”

11. The BTWC 2008 Meetings (i) The 2008 BTWC meetings focused on:
“1. National, regional and international measures to improve biosafety and biosecurity, including laboratory safety and security of pathogens and toxins. 2. Oversight, education, awareness raising, and adoption and/or development of codes of conduct with the aim of preventing misuse in the context of advances in bio-science and bio-technology research with the potential of use for purposes prohibited by the Convention…”

12. The BTWC 2008 Meetings (ii) Biosecurity, in the context of BTWC was defined by the secretariat in a background paper produced for the meeting of Experts. “In the setting of the BWC, it is most commonly used to refer to mechanisms to establish and maintain the security and oversight of pathogenic microorganisms, toxins and relevant resources, as discussed during the 2003 meetings of the Convention.”

13. The BTWC 2008 Meetings (iii)
“States Parties noted their common understanding that in the context of the Convention... biosecurity refers to the protection, control and accountability measures implemented to prevent the loss, theft, misuse, diversion or intentional release of biological agents and toxins and related resources as well as unauthorized access to, retention or transfer of such material.” Notes: Further information about biosecurity can be founded in the Report produced by the Sandia National Laboratories.

14. The BTWC 2008 Meetings (iv) States Parties agreed on the value of
“National authorities defining and implementing biosafety and biosecurity concepts … such as those produced by the FAO, OIE and WHO…” “National governments taking the leading role ... ensuring effective enforcement and regular review of relevant measures.” “National governments... using tools such as: accreditation, certification, audit or licensing for facilities, organizations or individuals; requirements for staff members to have appropriate training in biosafety and biosecurity; mechanisms to check qualifications, expertise and training of individuals.”

15. The BTWC 2008 Meetings (v) On the issue of Education it was agreed that: “States Parties noted that formal requirements for seminars, modules or courses, including possible mandatory components, in relevant scientific and engineering training programmes and continuing professional education could assist in raising awareness and in implementing the Convention.”

16. The BTWC 2008 Meetings (vi) On the issue of Oversight it was agreed that: “Having considered the oversight of science, States Parties recognised the value of developing national frameworks to prohibit and prevent the possibility of biological agents or toxins being used as weapons, including measures to oversee relevant people, materials, knowledge and information, in the private and public sectors and throughout the scientific life cycle.”

17. Expectations for the BTWC 2009 & 2010 Meetings (i)
“…enhancing international cooperation, assistance and exchange in biological sciences and technology for peaceful purposes, promoting capacity building in the fields of disease surveillance, detection, diagnosis, and containment of infectious diseases…” There is a clear role for scientists in engaging on this topic. Notes: For the 2009s meetings follow the information button in the slide and go to the section of “Advance Versions of Papers”.

18. Expectations for the BTWC 2009 & 2010 Meetings (ii)
“Provision of assistance and coordination with relevant organizations upon request by any State Party in the case of alleged use of biological or toxin weapons, including improving national capabilities for disease surveillance, detection and diagnosis and public health systems.” Notes: This serves a secondary role in building trust between life science professionals and, as such, facilitating peaceful exchanges, supporting cooperation in the life sciences and capacity building. In order to achieve this, however, in the future scientists need to make a further contribution to the research dimension to more clearly identify where technology can be transferred safely and legally.

19. The Future of the Biological and Toxin Weapons Convention.
Scientists have always played a role in the BTWC either through ad hoc requests by states parties or through contributing to the review conference background papers. The Additional Understandings that have emerged from successive Review Conference have made various requests to the scientific and professional community. However, the role of scientist in the BTWC is likely to grow.

20. Role of Scientist in the BTWC
Dimension of the BTWC Action suggested for life scientists Development dimension Clearly identify where technology can be transferred safely and legally Facilitating transfers of peaceful: agents; technologies and expertise Compliance dimension Supporting the implementation of the BTWC’s Article IV Reinforcing the normative element of the BTWC; Ensure states are aware of their responsibilities Supporting a continuous process of awareness-raising; Research dimension Helping to draw the line between permitted and prohibited research in the future and flagging research of concern; Contributing to research oversight committees, which would conduct pre-project reviews. Institutional dimension Building relations and drawing attentions to areas of concern. Contributing to the Inter-Sessional process topics. Ref: this table is based on the content from Revill. J & Dando. M. R (2007) "Life Scientists and a Culture of Responsibility: After Education. What?" Science & Public Policy Special Issue. 35(1), February 2008. Ref: Revill. J & Dando. M. R (2007) "Life Scientists and a Culture of Responsibility: After Education. What?" Science & Public Policy Special Issue. 35(1), February Available from 159

Sample Questions Assess the different definitions of Biosecurity?
2. Should the states be regulating science and “taking the leading role in ensuring effective enforcement” of Biosecurity? 3. Discuss whether Biosecurity Education should be mandatory? Do you think scientists have a responsibility for the misapplication of their research results? 4. Do you think the oversight of science is possible or indeed useful? Would national frameworks and “measures to oversee relevant people, materials, knowledge and information” be useful?

References (Slide 2) United Nations (2002) “Final Document” BWC/CONF.V/17, Geneva: United Nations. Available from Mahley [US] (2001) “Statement by the United States to the ad hoc group of biological weapons convention states parties” Geneva, Switzerland July 25, (Slide 3) United Nations (2005) “Report of the Meeting of States Parties”, BWC/MSP/2005/3, 14 December 2005, Geneva: United Nations. Available from (Slide 4-8) United Nations (2006) “Final Report” BWC/CONF.VI/6, December 8, 2006, Geneva: United Nations. Available from

(Slide 9 and 10) United Nations Office at Geneva (2007) Biological Weapons Convention Experts Meeting Concludes. News and Media. Available from (Slide 11) United Nations (2008) “Report of the Meeting of States Parties”, BWC/MSP/2008/MX/3 8 September 2008, Geneva: United Nations. Available at (Slide 12) Implementation Support Unit (2008) “Biosafety and Biosecurity” (BWC/MSP/2008/MX/INF.1). Geneva: UNOG. Available at: (Slide 13)

(Slide 14-16) United Nations (2008) “Report of the Meeting of States Parties”, BWC/MSP/2008/MX/3 8 September 2008, Geneva: United Nations. Available at (Slide 17) United Nations Office at Geneva (2009) Disarmament: Meeting of Experts ( August 2009) - Information for Action. Available from (Slide 18) (Slide 20) Revill. J & Dando. M. R (2007) "Life Scientists and a Culture of Responsibility: After Education. What?" Science & Public Policy Special Issue. 35(1), February Available from

Ethics in Life Sciences: From theory to the real world
Lecture No. 11 164

1. Ethics - theory to practice
Outline: Normative and descriptive ethics Slides 2-6 Applied ethics Slides 7 – 12 New bioethics and cultural impacts Slides 13 – 14 Reviewing and changing our practice Slides Notes: This slide serves to introduce the idea of normative ethics – what we “ought” to think is right and wrong. Explanation about different types of ethics – applied ethics, descriptive ethics, meta-ethics and so on will simply introduce the scope of the various types of ethics that are discussed in philosophy. There is no need to go into detail about all the different types of ethics – the aim here is to situate the role of normative ethics as a philosophical approach to understanding how people come to decisions about what is “right” and wrong”. 165

2. Ethics – various approaches
Descriptive ethics: What do you or I think is right? Normative (prescriptive) ethics: How should you and I think/act? Applied ethics: How do you and I take “moral” knowledge and put it into practice? 166

3. Normative ethics Normative ethics are concerned with the rightness or wrongness of actions – how should people think? There are two ways of looking at this: Teleological ethics - argues that the morality of an action depends on the action's outcome Deontological ethics – argues that decisions should be made considering duties and rights - some things are always wrong or right 167

4. Norms versus description
We cannot take a norm (what people SHOULD do) from a description (what people ACTUALLY do)…. Cultural relativism says that we should accept cultural differences as all equally valid But this does not allow for questioning and a way forward in conditions of disagreement 168

5. Normative ethics – the teleological approach
Consequentialism - an action is judged as “good” or “bad” by reference to its outcome; Utilitarianism is a teleological approach to ethics – promoting the greatest good for the greatest number – maximising pleasure and minimising pain Consequences tend to outweigh other considerations Teleological ethics – Jeremy Bentham James Mill John Stuart Mill David Hume Henry Sidgwick RM Hare Pete Singer GEM Anscombe We are concerned here with normative ethics in the dual use scenario, because we are considering what people ought to think is right and wrong in terms of the use of our life sciences research. We, as life scientists and bioethicists, are involved in the definition of new norms and this involves consideration of normative ethics and the existing approaches within that perspective. There are two views of normative ethics – teleological ethics and deontological ethics. Teleological ethics are commonly referred to as “consequentialism” or “utilitarianism”, although there are other approaches as well. These approaches tend (but not always) to be taken by politically liberal groups. These titles derive from the writings of a number of authors and generally take the view that an action can be considered good or bad depending on the outcome the occurs as a result of that action. Thus, a bomb killing a number of people in the short term may be considered good if it killed people who were involved in bomb-making who would have killed even more people in the long term. Obviously there are problems with this. The utilitarian view also considers that “the good” results from actions taken to maximise pleasure and minimise pain for the greatest number of people. This may mean that it is acceptable for a few people to suffer to allow others not to suffer and even to get positive benefit. Again, there are problems with this. However, despite the apparent negative ramifications to the teleological approach, these perspectives are commonly taken by many in social, political, economic and other arenas of life. 169

6. Normative ethics – the deontological approach
Some acts themselves are “good” or “bad” no matter what the consequences are It is our duty to take right action when we can identify it Not always the same as moral absolutism Some deontologists hold that a “bad” act may bring about a good outcome so is acceptable – others disagree Deontological ethics: Immanuel Kant Thomas Aquinas John Locke WD Ross CD Broad This perspective, the deontological view, considers that consequences are insufficient characteristics to use as means of assessing the rightness or wrongness of an action. This approach tends (but not always) to be taken by politically conservative groups. In this view, certain acts are always wrong or always right (generally speaking). For example, this view may hold that murder is always wrong, even if the murder of a future serial killer was to be arranged, thereby saving the lives of the killer’s future victims. This view may also hold that saving life is always right, even if it involves prolonging a life of poor quality in which a person suffers unbearable pain or distress. Many religious decisions are taken using this approach, but decisions in other areas of life, such as in the political arena, in social situations and in the criminal justice system, may also use this approach. This view is often associated with moral absolutism but this does not have to be the case. 170

7. Applied ethics There are various fields of applied ethics:
Medical ethics Environmental ethics Research ethics Bioethics And more….. Some of these fields can help us in the life sciences as we move towards an agreed ethical position on dual-use 171

8. From applied medical ethics…
We can consider ideals about: the sanctity of human life Our power to end life Our power to enhance life Our power to interfere with life processes Power relationships between ourselves and the public and between ourselves and our fellow-researchers 172

9. From applied environmental ethics….
We can consider ideals about: conservation of the world as we know it preserving life quality for humans And non-humans the value of biological life And the intrinsic value of the environment Ref: Singer, Peter. " Environmental Values. The Oxford Book of Travel Stories. Ed. Ian Marsh. Melbourne, Australia: Longman Chesire, fro IF-2 173

10. From applied research ethics….
We can take ideals of responsibility towards people as subjects of research through regard for their: Privacy, anonymity and confidentiality Autonomy, consent, right to information Self-determination Expectancy of coming to no harm Reasonable requirements of benefit Expectations of the reasonable publication of our work 174

11. From applied bioethics….
We can take ideals of how to consider the impact of new technology and knowledge on people Of how we can recognise the uses and limitations of technology in life Of how we can recognise potential mis-use of biotechnologies…… 175

12. Common factors All of the fields of applied ethics that we have looked at have some points in common: Relationships of power Rights of individuals (rather than populations) Notions of responsibility on one or more sides Attempts to define rules or guidelines to prevent harm A lack of accurate, definite predictions of outcomes 176

13. NEW applied ethics: dual-use bioethics
Relationships of power - BETWEEN scientists and misusers & BETWEEN scientists and thepublic Rights of individuals AND populations Notions of responsibility to the wider world Attempts to define rules or guidelines to prevent harm – TO AVOID or MINIMISE dual-use risks A lack of accurate, definite predictions of outcomes – WE CAN PREDICT CLEAR OUTCOMES IN THIS FIELD 177

14. Cultural impacts of dual-use risks
All of the preceding characteristics are inherent in our technological developments and have impacts on: social and political life economic life and religious aspects of life and on how we express ourselves (language) – honesty, or lack of it Notes: Groups of any sort – among the public or among scientists and activists, may be social, political, religious, technological, economic or linguistic. Groups with one common characteristic may cross boundaries in other characteristics – which has the strongest effect? Why? Usually the “winning” driver is either financial, national (political) or religious, but other imperatives play a role, for example, scientific progress. 178

15. Acting on a bioethics of dual-use
We need to introduce and apply these ideals in suitable places and at times in which these issues can be introduced to all life scientists: In education contexts In work contexts In peer-review and sharing contexts In global contexts 179

16. In universities By tackling these thorny issues in the educational context, life scientists can consider them from an early stage of their careers Can discuss them in a relatively safe, unpressured environment (usually) Can locate themselves in an ethical philosophy on which to base their future work 180

17. At work To recognise and takes steps to minimise the risks of dual-use of technological advances, such as: Changes in research practice – access to data, analysis and interpretation Which may raise issues for individual scientists or research groups Which may require support from external groups 181

18. In peer-sharing contexts
Reducing the risk of dual-use of life science developments may involve: Changes in peer communications Changes in conference practices – access to sessions, curtailed paper and online publications after meetings Changes in journal publication practices, selectively publishing low-risk and not publishing high-risk research 182

19. Changes in scientific practice
Many of the risk-reducing activities involve changes in practice that appear to compromise the scientific method We need to work together to provide agreed guidance, support and fairness of practice in the life sciences And to develop new, fair practice in which dual-use risk is a normal consideration within the scientific method 183

20. From the individual to the wider world
This has to start with individual scientists, and progress “upward” through: Research groups Subject areas Commercial/industrial contexts National contexts International/global contexts 184

Sample Questions 1. Discuss what kind of specific changes can be expected in your research under ethical consideration about dual-use issues? 2. Explain how can we share our work with colleagues or wider audience through publication locally and globally who may have different ethical values? 3. Consider how can we raise awareness of dual-use risks among our colleagues and future scientists? 4. Critically discuss who should have a final-say about ethical consideration about scientific research, i.e. scientists or security policy makers?

References (Slide 9) Marshall, A. (2002) The Unity Of Nature: Wholeness And Disintegration In Ecology And Science. London: Imperial College Press. Singer, P. (1991) ‘Environmental Values’, in Ian Marsh (Ed.) Environmental Challenge. The Oxford Book of Travel Stories. Melbourne, Australia: Longman Chesire, (Slide 13) Selgelid, M. (2009) ‘Dual-Use Bioethics’, Department of Peace Studies Research Briefing No. 4, 26 June. Available from

The Obligations Built into the Biological and Toxin Weapons Convention (BTWC)
Lecture No. 12

1. Outline BTWC Regime Role of the Preamble and the BTWC
Slides 2-3 Role of the Preamble and the BTWC Slides 4-6 Ethical Responsibilities under the BTWC Slides 7-8 Practicing BTWC Norms Slides 9-14 Ethical Norms in Specific BTWC Articles Slides 15-18 Scientific Background Papers Slides 19-20 Notes: The objective of this lecture is to consider how the internationally envisaged norms against the biological and toxin weapons can be directed towards practical implementation. Ethical responsibilities of scientists and non-scientists can be discharged by: 1, strengthening the BTWC to enhance the global framework against the misuse of science at the international level; 2, implementing national measures under the BTWC and other relevant international regulations at the national level; and 3, promoting ethical awareness of scientists at the individual level in creating and maturing a culture of responsibility.

2. Regime International law is central to a regime and this is seen as the starting point of an international norm from which dual-use ethics in life sciences can be considered. Regime refers to: “principles, norms, rules and decision making procedures around which actor expectations converge in a given issue area.” (Krasner, 1982) Notes: Compared to the concept “governance”, regime is understood to be an internationally arranged cooperative process to deal with a specific “issue area” such as ban on biological and toxin weapons.

3. The BTWC Regime “given issue area”: “principles, norms, rules”:
international prohibition against biological and toxin weapons; “principles, norms, rules”: The Biological and Toxin Weapons Convention “decision making procedures”: Review Conferences, Intersessional Processes, and other Meetings to sustain and develop the regime Ref: Krasner, S. D. (1982) Structural Causes and Regime Consequences: Regimes as Intervening Variables. International Organization, 36(2), p Available from

4. Preamble: Norms of the BTWC
Role of Preamble of a Treaty: Preamble of a treaty addresses grand principles and norms of the treaty enshrined in its specific mission Not a substantive article but an interpretive guide Article 31(2) Vienna Convention on the Law of Treaties of 1969 states: “The context for the purpose of the interpretation of a treaty shall comprise, in addition to the text, including its preamble and annexes” and subsequent agreements of the Parties to the treaty [Article 31(3)] Notes: Regarding the interpretation of treaties, the Vienna Convention also states in its Article 31(3) that “there shall be taken into account, together with the context: (a) any subsequent agreement between the parties regarding the interpretation of the treaty or the application of its provisions”. This indicates that the updated interpretations of the BTWC at the each Review Conference are valid reference to interpret the BTWC as a legal principle.

5. Original Preamble of the BTWC
States Parties: “Determined to act with a view to achieving effective progress towards general and complete disarmament, … and convinced that the prohibition of the development, production and stockpiling of chemical and bacteriological (biological) weapons and their elimination, … …Determined for the sake of all mankind, to exclude completely the possibility of bacteriological (biological) agents and toxins being used as weapons,” Texts in Bold are essential elements of the normative scope of the Convention. Notes: Principles and Norms of the BTWC is to prohibit the development, production and stockpiling of chemical and bacteriological (biological) weapons and their elimination and the use of pathogens and toxins for non peaceful purposes.

6. BTWC Solemn Declaration in 2006
States Parties solemnly declared that “terrorists must be prevented from developing, producing, stockpiling, or otherwise acquiring or retaining, and using under any circumstances, biological agents and toxins, equipment, or means of delivery of agents or toxins, for nonpeaceful purposes…” Normatively, the prohibition of biological and toxin weapons are envisaged both over state and non-state levels. Notes: Although it is often argued that otherwise by uninformed commentators, the Norms and Principles cover the obligation of States Parties to deal with the threats posed by terrorism.

7. Ethical Responsibilities of Scientists under the BTWC
Ethical considerations of scientists can be started by considering which aspects in scientific and technological research and practice can be potentially non-peaceful in relation to: developing, producing, stockpiling, or otherwise acquiring or retaining and using* biological agents and toxins, equipment, or means of delivery of agents or toxins, under any circumstances. Notes: Robin Coupland from the International Committee of the Red Cross argues that the risk posed by the illicit use of science arises not only from specific type of agents or area-research. Instead, potential dual-use concerns in scientific research needs to be considered in relation to “design and development” affecting potential effect of the weapons, “production and transfer” affecting potential number of weapons in use, “use” affecting physical and psychological effects on victims, and finally “vulnerability” of potential victims from the perspective of public health. * Regarding the prohibition on “use”, see the section of Article I in the United Nations (1996) Final Declaration, BWC/CONF.IV/9 Part II, December 6, 1996, Geneva: United Nations. Available from (Further Inf.1 of the Slide) 194

8. Social Responsibilities of Non-Scientists under the BTWC
Ethical considerations of non-scientists can be started by considering how risk-minimization about the dual-use issues can be pursued in a way not to harm the scientific freedom of scientists. This consideration should be made in relation to every aspects of measures to prevent and respond to developing, producing, stockpiling, or otherwise acquiring or retaining, and using of knowledge and practice in life sciences. Notes: The Report of the MSP07 stated that “Recognising the importance of developing a coordinated and harmonised domestic mechanism to implement the obligations of the Convention, the States Parties agreed on the value of … raising awareness of the Convention among all relevant stakeholders, including policy makers, the scientific community, industry, academia, media and the public in general, and improving dialogue and communication among them.” United Nations, (2007) Report of the Meeting of States Parties, at p. 5. 195

9. Changing Norms into Practice (i) International/Regime Level
Substantial areas of the BTWC but difficult elements to be strengthened Compliance; 1, Article I, II, III, IV, V, VI and VII (See lecture 7 for the role of each Article); 2, Confidence Building Measures; and 3, Verification Protocol negotiation failed in （See lecture 8) Development; “economic and social development, particularly in the developing countries” (BTWC Final Declaration 1980). It has been less developed element under the BTWC. Research; Difficulty in development under the BTWC regime due to: 1, difficulty to identify “real” intention of researcher; 2, Article I does not prohibit “research”; 3, no other legal constrains to prohibit research concerning BTW. Permanence; Prohibition enshrined in Article I is comprehensive and unlimited duration of Article XIII is secured. Notes: Those elements are essentials to develop the scope and global reach of the treaty regime to deal with the threat of biological and toxin weapons.

10. Changing Norms into Practice (ii) State Level
Nationalising the BTWC Article IV: National Implementation “Each State Party to this Convention shall, in accordance with its constitutional processes, take any necessary measures to prohibit and prevent the development, production, stockpiling, acquisition, or retention of the agents, toxins, weapons, equipment and means of delivery specified in article I of the Convention...“ Difficulty of implementation Article IV itself neither instructs the specific implementation of the Article, nor clarifies whether those measures require legislations or not. Notes: for further illustration of national implementation of the BTWC, see lecture No. 20. Ref: Dunworth, T., Mathews, R. J., and McCormack, T. L. H. (2006) National Implementation of the Biological Weapons Convention. Journal of Conflict and Security Law, 11 (1), p. 98. Available from

11. Changing Norms into Practice (iii) State Level
Guides/References for national legislation From the BTWC: Section of Article IV of the Final Declarations at the Review Conferences are the useful references for realising the scope of the Convention From States Parties: National legislations, which have been already implemented by other States Parties, could be referred as relevant models and States Parties agreed on the value of international cooperation for this specific purpose at the BTWC MSP2007 From other sources: VERTIC: Collection of National Implementation Legislation, BTWC Model Laws Notes: The Final Report of the Meeting of the States Parties of the BTWC in 2007 noted that “The States Parties agreed on the value of promoting international cooperation at all levels, in order to exchange experiences and best practices on the implementation of the Convention.” at para, 26. Ref: For Final Declarations of the BTWC from 1980 to 2006, see the Section of the Review Conferences at the Biological and Toxin Weapons Convention Website. Available from

12. Changing Norms into Practice (iv) Individual Level
Discussed topics during the Inter-Sessional Process (ISP) and included: Oversight of research; Codes of conduct; Awareness raising and Education about the dual-use issues Active engagement of scientists to develop effective culture in awareness raising is essential States Parties should facilitate scientists to have initiatives to develop such culture, since they are the forefront of cutting edge science Notes: At the national and individual level, the Report of the MSP2005 recognised that “that the involvement of scientists is crucial in the development and adoption of codes of conduct to ensure that codes are effective in preventing the misuse of science while not impeding scientific freedom,” p. 10. This may also apply to the effort to develop risk assessment models to suggest potential research areas of dual-use concern, develop educational resource, develop acceptable framework of oversight of scientific research… and so on.

13. Changing Norms into Practice (v) Individual Level
Guides/references for codes of conduct Inter Academy Panel Statement on Biosecurity “This statement presents principles to guide individual scientists and local scientific communities that may wish to define a code of conduct for their own use”. Code of Conduct for Biosecurity by Royal Netherlands Academy of Arts and Sciences “The rules laid down in the Biosecurity Code of Conduct call for implementation and compliance at different levels. … Calls for awareness, accountability and oversight are targeted mainly at individuals: researchers, laboratory workers, managers and others.”

14. Changing Norms into Practice (vi) Individual Level
Guides/references for awareness raising and education Biosecurity Education Portal by Federation of American Scientists mainly provides a set of online educational modules developed by different institutions Dual-Use Bioethics by Bradford Disarmament Research Centre provides ‘modifiable’ online educational module resources

15. Article I Firstly; Ethical responsibilities of life scientists can be discharged by firstly, considering how their own scientific research can be prevented from dual-use concern in regard to each aspect of ‘develop, produce, stockpile or otherwise acquire biological agents, toxins, weapons, equipment or means of delivery for non-peaceful purposes’. Secondly; considerations should be actively practiced by promoting culture of prevention against the misuse of science.

16. Article III The ethical responsibilities are also discharged by considering how dual-use scientific knowledge and technology can be utilized to strengthen the effort “not to transfer [prohibited material for prohibited activities in Article I] to any recipient whatsoever, directly or indirectly, and not in any way to assist, encourage, or induce any State, group of States or international organizations”.

17. Article X Ethical responsibilities can be discharged by considering how best dual-use science and technology can be peacefully exchanged with a view to promoting global health and social developments and securing dual-use risks. Ethics for security and ethics for development. For some states or individuals ‘security’ is the first ethical priority and ‘development’ is for others. Although both are indispensable and interconnected, Notes: Nicholas Sims argues that development based on Article X “has little basis in the BTWC and is derived more from subsequent interpretation of the convention at the first four review conferences than from the treaty text”. The author further argues that “[t]he obligation which the BTWC proclaims as incumbent upon states parties are primarily disarmament obligations that barely extent into the realm of development.

18. Article XII No single ethics regarding dual-use issue
However, only clear point is updated knowledge about cutting edge research in life sciences at each time is the most fundamental point to consider how responsibilities of scientists can be ethically and effectively discharged. In this context, Article XII is significant, since it opens a channel for States Parties to update their scientific understandings. Article XII reads that Review Conference “…shall take into account any new scientific and technological developments relevant to the Convention.” Notes: It is clear that ethical responsibilities of life scientists are highly context dependent. Ethical responsibilities in different scientific research in different individual scientists can consist of potential dual-use risks at different dimensions. It is impossible for the government to iron out universal ethics to discharge responsibility of life scientists at the practical level. The complexity of these issues have been indicated by the range of topics in the meetings of the NSABB.

19. Scientific Background papers (i)
Secretariat of the Review Conference compile the updated scientific input by States Parties. Background papers review diverse scientific advances and assess relevance of those in relation to the scope of the BTWC. At the 6th Review Conference, alongside the background paper by secretariat, some 10 individual papers contributed by States Parties.

20. Scientific Background papers (ii)
Reviewing process of increasingly advancing science only at five-yearly intervals can be slow compared to rapidly advancing life sciences, and successive input of the updating effort by States Parties to the BTWC regime is preferred. For this purpose, the engagement of individual scientists to provide their scientific knowledge to the BTWC regime is significant.

Sample Questions 1. Discuss to what extent ethical responsibilities on dual-use issues is required by to practice life sciences research. 2. Explain why non-scientists have ethical responsibilities to consider dual-use risks in scientific research. 3. Evaluate the potential roles of scientists to strengthen the BTWC to develop national legislation and to promote awareness raising. 4. Consider at which educational level, awareness raising of life scientists should be started to develop their dual-use ethics.

References (Slide 2) Krasner, S. D. (1982) Structural Causes and Regime Consequences: Regimes as Intervening Variables. International Organization, 36 (2), Rosenau, J. N., and Czempiel, E.-O. (1992) Governance without Government: Order and Change in World Politics. Cambridge: Cambridge University Press. (Slide 4) Vienna Convention on the Law of Treaties. Reproduced in United Nations Treaty Law Series, Vol. 1155, p Available at (Slide 5) Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on Their Destruction. Reproduced in the Biological and Toxin Weapons Convention Website. Available from

(Slide 6) United Nations (2006) “Final Report” BWC/CONF.VI/6, December 8, 2006, Geneva: United Nations. Available from (Slide 7) United Nations (1996) Final Declaration, BWC/CONF.IV/9 Part II, December 6, 1996, Geneva: United Nations. Available from Robin M. Coupland, “Modelling Armed Violence: A Tool for Humanitarian Dialogue in Disarmament and Arms Control,” in John Borrie and Vanessa M. Randin, eds.,), Alternative Approaches in Multilateral Decision Making (Geneva: UNIDIR, 2005). Available from (Slide 8) United Nations, (2007) Report of the Meeting of States Parties, BWC/MSP/2007/5, 14 December, Geneva: United Nations. Available from

(Slide 9) Sims, Nicholas (2001) The Evolution of Biological Disarmament (SIPRI Chemical & Biological Warfare Studies No. 19). Oxford: Oxford University Press. (Slide 10) Dunworth, T., Mathews, R. J., and McCormack, T. L. H. (2006) National Implementation of the Biological Weapons Convention. Journal of Conflict and Security Law, 11 (1), Available from (Slide 11) Biological and Toxin Weapons Convention Website. Available from VERTIC, (2003) VERTIC: Collection of National Implementation Legislation [Online]. Available from VERTIC (2009) A Sample Act for National Implementation of the1972 Biological and Toxin Weapons Convention and Related Requirements of UN Security Council Resolution 1540, London: VERTIC. Available from

(Slide 12) United Nations (2005) “Report of the Meeting of States Parties”, BWC/MSP/2005/3, 14 December 2005, Geneva: United Nations. Available from (Slide 13) InterAcademy Panel (2005) “Statement on Biosecurity”, Available from Royal Netherlands Academy of Arts and Sciences (2008) A Code of Conduct for Biosecurity: Report by the Biosecurity Working Group, Amsterdam: KNAW. Available from (Slide 14) Federation of American Scientists (2008) Biosecurity Education Portal [Online] Available from

(Slide 15) Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on Their Destruction. Reproduced in the Biological and Toxin Weapons Convention Website. Available from (Slide 16) Mathews, R. J (2004) The Development of the Australia Group Export Control Lists of Biological Pathogens, Toxins and Dual-Use Equipment, The CBW Conventions Bulletin, December 66, 1-4. Available from (Slide 17) Sims, N. (2001) The Evolution of Biological Disarmament (SIPRI Chemical & Biological Warfare Studies No. 19). Oxford: Oxford University Press.

Pearson, G. S. (2006) ‘ARTICLE X: Exchange of Equipment, Materials and Scientific and Technological Information’, in Nicholas A. Sims and Malcolm R. Dando (Eds.) Key Points for the Sixth Review Conference. Bradford: University of Bradford. Available from (Slide 18) Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on Their Destruction. Reproduced in the Biological and Toxin Weapons Convention Website. Available from (Slide 19) United Nations (2006) Background Information Document on New Scientific and Technological Developments Relevant to the Convention, BWC/CONF.VI/INF.4, 28 September, Geneva: United Nations. Available from United Nations (2001) Background Paper on New Scientific and Technological Developments Relevant to the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on Their Destruction, BWC/CONF.V/4 Add October, Geneva: United Nations. Available from

The Growth of Dual-Use Bioethics
Lecture No.13 215

1. Outline Dual-use as an ethical issue
Slides 2 – 3 Duties associated with dual-use science Slides 4 – 9 Tensions in benefit and risk analysis Slides 10 – 12 Precautionary principle Slides 13 – 16 Statement on Scientific Publication and Security Slides Decision making for dual-use dilemmas Slides Notes: The aim of this lecture is to introduce students to the ways in which bioethical reasoning may be used to help resolve ethical problems raised by the dual-use dilemma. 216

2. Dual-use as an ethical issue (i)
The dual-use dilemma arises in the context of research in the biological and other sciences as a consequence of the fact that one and the same piece of scientific research sometimes has the potential to be used for harm as well as for good. Notes: See Lectures 14 and 15 for more on dual use. 217

3. Dual-use as an ethical issue (ii)
Dual-use raises the ethical question: should we hold an agent morally responsible for the consequences of an action when those consequences were not intended and were, in some cases, beyond the agent’s control? It asks whether a person is morally bound to take pre-emptive precautions to avoid unwanted future outcomes. Notes: Dual use is an ethical dilemma then for researchers because of the potential actions of others, e.g. malevolent non-researchers who might steal dangerous biological materials or make use of the original researchers’ work to cause harm. 218

4. Duties associated with dual-use science (i)
One influential definition of the bioethical principle of non-maleficence (the obligation to do no harm) states that not to do harm covers not only intentional actions but also imposing risks of harm. Individuals can therefore harm or place another person at risk without harmful intent – and crucially, be morally responsible for doing so. Notes: So there is a basic conflict between the freedom of the researcher and the duty to prevent harm which is difficult to solve because it is unclear what the contribution to the relevant action is and to what degree this is controllable. 219

5. Duties associated with dual-use science (ii)
Five criteria for the obligation to prevent harm. Researchers should strive to prevent harm that is: - Within their professional responsibility - with their professional capacity and ability - Reasonably foreseeable risk - Proportionally greater than the benefits - Not more easily achieved by other means. Notes: This article aims to analyse the moral obligations of scientists engaged in dual use research. Five criteria for what constitutes preventable harm are suggested and a number of proposed obligations for life scientists are considered against these criteria. 220

6. Duties associated with dual-use science (iii)
The authors propose the following ethical obligations to: - Prevent bioterrorism - Engage in response activities to bioterror attacks - Consider the negative implications of their research - Not publish or share sensitive information - Oversee and limit access to dangerous material - Report activities of concern Notes: See Kuhlau et al pp 221

7. Duties associated with dual-use science (iv)
The authors conclude that the: “more reasonable obligations are duties to consider potential negative implications of one's research, protect access to sensitive material, technology and knowledge, and report activities of concern. Responsibility, therefore, includes obligations concerned with preventing foreseeable and highly probable harm.” 222

8. Duties associated with dual-use science (v)
“The question here is not how far a scientist is responsible for the intended effects of his action, but how far he is responsible for the foreseen effects of his research, for their prevention and also for the effort to predict certain results.” Notes: For a summary of this article and Kuhlau et al, see Dando, M. R. (2009) ‘Bioethicists Enter the Dual-Use Debate’, Bulletin of Atomic Scientists 20 April. Available from Ref: Ehni, H-J. (2008). Dual Use and the Ethical Responsibility of Scientists Archivum Immunologiae et Therapiae Experimentalis 56(3) Available from 223

9. Duties associated with dual-use science (vi)
This author proposes a general duty to not contribute to dual-use that is malign and, as far as controllable, to help to prevent it. This leads to more specific duties which include: - Do not carry out a certain type of research - Systematically anticipate dual-use applications in order to warn of dangers generated by them - Inform public authorities about such dangers - Do not disseminate results publicly, but keep dangerous scientific knowledge secret Notes: So we can see that two key issues are: whether or not to conduct an experiment with possible security implications and whether or not to disseminate results which may have security consequences. 224

10. Tensions in benefit and risk analysis (i)
What is at stake are rights to academic freedom and scientific progress against the public’s right to not be put at risk by the very research which is meant to help them. Notes: This tension of course characterises much of the literature in the dual-use debate. Secrecy ‘strikes at the heart’ of science Oppenheimer is to have said. And yet both Einstein and Bohr struggled publicly and privately to sort out this question of personal responsibility. As Einstein said in an address at a Nobel Anniversary dinner, ‘Today, the physicists who participated in forging the most formidable and dangerous weapon of all time are harassed by an equal feeling of responsibility, not to say guilt’. 225

11. Tensions in benefit and risk analysis (ii)
Ethics requires us to recognise a balance of rights and responsibilities. Ethical analyses of dual-use research in the biological sciences would seek to quantify actual and potential benefits and risks, and actual and potential recipients/bearers of these benefits and risks. Notes: As Miller and Selgelid note, difficult questions remain regarding how the risks and benefits of publication should in practice be determined in any given case, and who should have ultimate authority to make decisions about the censorship of science. This will be addressed in later slides. 226

12. Tensions in benefit and risk analysis (iii)
“A commonsense position is that trade-offs need to be made between rights to disseminate and scientific progress on the one hand, and security/public health needs on the other. On this view, we should sometimes be willing to make at least small sacrifices in the way of public health and/or security when this is necessary to achieve enormous benefits with regard to the progress of science; and we should sometimes be willing to make at least very small sacrifices with regard to the progress of science when this is necessary to achieve enormous benefits regarding public health and/or security.” Notes: See Miller and Selgelid, p. 553. 227

13. Precautionary Principle (i)
The Precautionary Principle (PP) constitutes a principle for decision-making that applies to cases where serious adverse effects can occur with an unknown probability. A fundamental message of the PP is that 'on some occasions, measures against a possible hazard should be taken even if the available evidence does not suffice to treat the existence of that hazard as a scientific fact'. Notes: As Kuhlau et al note, one frequently quoted formulation of the PP was introduced at the Wingspread Conference in 1998 stating that: 'Where an activity raises threats of harm to the environment or human health, precautionary measures should be taken even if some cause and effect relationships are not fully established scientifically'. Another PP is expressed in the 1992 Rio Declaration: 'Where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation.’ Ref: Kuhlau, F., Hoglund, A., Evers, K., and Eriksson, S. (2009) A Precautionary Principle for Dual Use Research in the Life Sciences, Bioethics, [Early View] Available from 228

14. Precautionary Principle (ii)
The precautionary principle is implied in many Biosecurity Codes of Conduct. For example, “All persons and institutions engaged in any aspect of the life sciences must seek to restrict dissemination of dual-use information and knowledge to those who need to know in cases where there are reasonable grounds to believe that the information or knowledge could be readily misused through bioterrorism or biowarfare.” Ref: Somerville, M. A., and Atlas, R. A. (2005) Ethics: A Weapon to Counter Bioterrorism, Science 307(5717) Available from 229

15. Precautionary Principle (iii)
There are four main conceptual dimensions, which commonly occur in different versions of the precautionary principle : threat, uncertainty, prescription and action. So that: “if there is (1) a threat, which is (2) uncertain, then some kind of (3) action is (4) mandatory”. The authors highlight arguments from others against the utility of PP – for example that it stifles scientific development, lacks practical applicability and is poorly defined and vague – but conclude that a PP is applicable to dual-use in that it inspires to reflect upon science's role in society and how scientific developments should be directed and justified by informed choices and decisions. For more see on conceptual aspects of PP see the references to Sandin’s work within the Kuhlau et al 2009 article. 230

16. Precautionary Principle (iv)
The authors propose a precautionary principle for dual-use: “When and where serious and credible concern exists that legitimately intended biological material, technology or knowledge in the life sciences pose threats of harm to human health and security, the scientific community is obliged to develop, implement and adhere to precautious measures to meet the concern.” Notes: Factors such as credibility of the threat, availability of information, clear prescriptive demands on responsibility and directives on how to act, determine the suitability and success of a precautionary principle. Of course, as the authors state, there may be a credible biological weapon's threat but why should that concern an individual microbiologist at a university? So not only does the threat therefore have to be generally credible, it specifically has to be credible to the actors who are asked to be cautious. This link between the scientist and the threat may be considered insufficient by some. However, it can be argued that the strength of the PP is that it offers a possible reply to demands on a clear link because it allows for this uncertainty. 231

17. Statement on Scientific Publication and Security (i)
“We recognize that on occasion an editor may conclude that the potential harm of publication outweighs the potential societal benefits. Under such circumstances, the paper should be modified or not be published. Journals and scientific societies can play an important role in encouraging investigators to communicate results of research in ways that maximize public benefits and minimize risks of misuse.” Notes: The idea that a balance must be struck between the promotion of security on the one hand and scientific freedom/openness on the other is expressed in the important joint ‘‘Statement on Scientific Publication and Security’’ of the ‘‘Journal Editors and Authors Group’’ which was simultaneously published by Science, Nature, the Proceedings of the National Academy of Sciences, and the American Society for Microbiology Journals in February This statement resulted from discussions between scientists, the scientific publishing community, and the security community at a workshop (motivated by public outcry over the mousepox and polio studies in particular, which are covered in Lecture 15). See Miller and Selgelid, pp. 554. Ref: Journal Editors and Authors Group. (2003) Uncensored Exchange of Scientific Results, PNAS 100(4) Available from 232

18. Statement on Scientific Publication and Security (ii)
“The Statement claims that editors may sometimes make censorship decisions, but it gives no reasons for thinking that editors, or the scientific community in general, for that matter, are especially qualified to judge security risks. An important question thus concerns the extent to which the government, bioethicists and/or the security community should be involved in scientific censorship.” Notes: See Miller and Selgelid, p.556. As this slide indicates, one key question in the bioethics of dual-use is where responsibility lies. This is addressed in the ending slides. Also, see Lectures 14 and 18 for more on dual-use and research dissemination. 233

19. Decision making for dual-use dilemmas (i)
- Complete autonomy of individual scientist - Institutional control - Mix of institutional and governmental control - An independent authority - Full governmental control Notes: For details on the advantages and disadvantages of each, see Miller and Selgelid, pp 234

20. Decision making for dual-use dilemmas (ii)
Most bioethicists believe that only a mixed authority which is constituted by the scientific community together with government bodies can address the dual-use dilemma. Determining who is responsible in a given case will be “context dependent”. Notes: So Kuhlau et al, Ehni, and Miller and Selgelid then are all in agreement that responsibility is to be shared between the individual researcher, the scientific community, and external authorities (such as the government and/or independent bodies). However, the actual structure and organisation of a decision-making authority remains a subject of debate as the situation evolves. 235

Sample Questions Why is dual-use an ethical problem?
2. What are the ethical obligations that ethicists propose for scientists working in dual-use? Do you agree with them and why/why not? 3. What is the precautionary principle and what is its relevance to dual-use? 4. What are the options for ethical decision-making in the dual-use context and which options do you think are best?

References (Slide 2) Miller, M., and Selgelid, M. (2007) Ethical and Philosophical Consideration of the Dual-Use Dilemma in the Biological Sciences, Science and Engineering Ethics 13(4) Available from (Slide 3) Kelley, M. (2006) Infectious Diseases Research and Dual-Use Risk, Virtual Mentor 8(4) Available from (Slide 5) Kuhlau, F., Eriksson, S., Evers, K., and Hoglund, A. (2008) Taking Due Care: Moral Obligations in Dual Use Research, Bioethics 22(9) Available from (Slide 8) Dando, M. R. (2009) ‘Bioethicists Enter the Dual-Use Debate’, Bulletin of Atomic Scientists 20 April. Available from

Ehni, H-J. (2008). Dual Use and the Ethical Responsibility of Scientists Archivum Immunologiae et Therapiae Experimentalis 56(3) Available from (Slide 13) Kuhlau, F., Hoglund, A., Evers, K., and Eriksson, S. (2009) A Precautionary Principle for Dual Use Research in the Life Sciences, Bioethics, [Early View] Available from (Slide 14) Somerville, M. A., and Atlas, R. A. (2005) Ethics: A Weapon to Counter Bioterrorism, Science 307(5717) Available from (Slide 17) Journal Editors and Authors Group. (2003) Uncensored Exchange of Scientific Results, PNAS 100(4) Available from

Dual-Use: The Fink Report
Lecture No. 14

I. Outline The concept of dual-use The Fink Committee Report
Slides 2 - 6 The Fink Committee Report Objective and structure of the report Slides Recommendations of the report Slides Experiments of concern Slides Notes: This lecture introduces the concept of ‘dual-use’ in a systematic manner making particular use of the influential Fink Committee report of the US National Academies.

2. Dual-Use (i) Traditionally the concept of ‘dual-use’ described technologies developed by the military that came to have civil uses. The internet is an example of a military technology which was used in this way. Now, in regard to the life sciences, the concept refers to materials, technologies and knowledge developed for benign civil purposes that might be misused by others for hostile purposes. Notes: For life scientists it really is very important that the possibility of this new form of dual-use is grasped. Only when they understand that their benignly-intended work could be misused for hostile purposes can they see the importance of considering their own obligations to help prevent such misuse. The concept is , however, used in complex ways as explained in the paper by Atlas and Dando, but we will stick here to the straightforward idea given in this slide. Ref: Atlas, R. M. and Dando, M. R. (2006) The Dual-Use Dilemma for the Life Sciences: Perspectives, Conundrums, and Global Solutions. Biosecurity and Bioterrorism, 4(3), Available from

3 Dual-Use (ii) Newsweek 2007
“…Just as physics shocked the world in the 20th century, it is now clear that the life sciences will shake up the world in the 21st. In a handful of years, your doctor may be able to run a computer analysis of your personal genome to get a detailed profile of your health prospects….A new technology called RNA interference may also allow your doctor to control how your DNA is ‘expressed’, helping you circumvent potential health risks…” Notes: Many commentators have pointed out that the life sciences are undergoing a fundamental revolution which will have profound impacts. This quotation is from an article published in the journal Newsweek which interestingly made a direct analogy between what happened in physics at the start of the 20th century with what is happening in the life sciences at the start of the 21st.

4. Dual-Use (iii) Bioregulators as instruments of terror
“…Bioregulators are structurally diverse compounds that are capable of regulating a wide range of physiologic activities, such as bronchial and vascular tone, muscle contraction, blood pressure, heart rate, temperature, and immune responses. These substances can be harmful, however, in large concentrations or if modifications to them bring about changes in the nature or duration of their action…” Notes: Whilst welcoming the advances in the life sciences for the undoubted benefits they bring, other analysts have pointed out the potential for hostile misuse. This interesting example published in 2001 focused on the potential for misuse of our growing understanding of the bioregulatory chemicals of living organisms rather than having the usual focus on pathogens. It thus was an early example of a growing awareness of the much wider range of concerns that will be illustrated in later lectures. Ref: Kagan, E. (2001) Bioregulators as Instruments of Terror, Clinics in Laboratory Medicine, 22(3), pp Available from

5. Dual-Use (iv) Some examples of bioregulators that could be misused
Cytokines E.g. IL-1, IL-6 Eicosanoids E.g. PGD2, LTC4 Neurotransmitters and hormones E.g. Catecholamines, Neuropeptides, Insulin Plasma proteases Kallikrein, bradykinin Notes: Kagan’s paper details why these and other bioregulators have physiological actions that could be severely disrupted. Ref: Kagan, E. (2001) Bioregulators as Instruments of Terror, Clinics in Laboratory Medicine, 22(3), pp Available from

6. Dual-Use (v) Advantages of Bioregulators to attackers
Readily available Clinical effects are nonspecific Rapid onset of action Not on standard list of threat agents No vaccines available Potential for widespread dissemination While there are limitations to the hostile misuse of such bioregulators, Kagan’s paper also makes clear that there are some important advantages for the attacker.

7. The Fink Committee Report: Objective/Structure (i)
Biotechnology Research in an Age of Terrorism “Although the National Academies have had many reports on national security, this is the first to deal specifically with national security and the life sciences….much has happened to justify an examination of the life sciences in this contest - the discovery of nations with clandestine research programs dedicated to the creation of biological weapons, the anthrax attacks of 2001, the rapid pace of progress in biotechnology, and the accessibility of these new technologies…” Notes: The kind of concerns raised in the previous slides eventually lead to the US Nationa Academies setting up the ‘Committee on Research Standards and Practices to Prevent the Destructive Application of Biotechnology’. The committee was chaired by Gerald Fink and its its influential report was published in It was the first national academies report to examine national security and the life sciences.

8. The Fink Committee Report: Objective/Structure (ii)
The committee’s view of the dual-use problem “…Our committee addressed one important part of this spectrum…of possible misuse: the capacity for advanced biological research activities to cause disruption or harm.... Broadly stated, that capacity consists of two elements: (1) the risk that dangerous agents that are the subject of research are stolen or diverted for malevolent purposes; and (2) the risk that the research results,knowledge, or techniques could facilitate the creation of ‘novel’ pathogens with unique properties or create entirely new classes of threat agents…” Notes: The committee made it clear that there was a wide spectrum of potential misuse, but that it would concentrate on just two points: the risk that dangerous material might be stolen from laboratories and the risk that the results of research could be misused. It is the second of these risks that is the primary concern here, but the first should not be neglected either in considerations of biosecurity.

9. The Fink Committee Report: Objective/Structure (iii)
The international dimension “Although the focus of the report is on the United States, this country is only one of many pursuing biotechnology research at the highest level….It is entirely appropriate for the United States to develop a system to provide oversight of research activities domestically, but the effort will ultimately afford little protection if not adopted internationally…” Notes: It is clear from the outset of the report that it was intended to be read internationally - as this quotation from the Executive Summary makes very clear.

10.The Fink Committee Report: Objective/Structure (iv)
The Structure of the report: 1. Introduction 2. The evolving regulatory environment for life sciences research in the 21st century 3. Information restrictions and control regimes 4. Conclusions and recommendations Notes: The committee’s report covered both the scientific issues that are of primary concern in this and the following lectures but also the development of the regulation of the life sciences to help prevent misuse. Life scientists simply have to take the time to examine both of these aspects of the report. The problem of regulation becomes more prominent in the later lectures in this series.

11. The Fink Committee Report: Recommendations (i)
Recommendations of the report “1. Educating the Scientific Community We recommend that national and international professional societies and related organizations and institutions create programs to educate scientists about the nature of the dual-use dilemma in biotechnology and their responsibilities to mitigate its risks.” Notes: Recognizing that scientists cannot apply their specific knowledge to assist in the prevention of misuse until they have a grasp of the problem the report’s first recommendation is that education courses need to be developed.

12. The Fink Committee Report: Recommendations (ii)
“2. Review of Plans for Experiments We recommend that the Department of Health and Human Services (DHHS) augment the already established system of review of experiments involving recombinant DNA conducted by the National Institutes of Health to create a review system for seven classes of experiments (the Experiments of Concern) involving microbial agents that raise concerns about their potential for misuse.” Notes: The committee took an incremental approach to regulation here by suggesting that a new oversight system should build on the well-known established system used to control recombinant DNA experimentation. We will look in more detail at the experiments of concern at the end of this set of lecture slides.

13. The Fink Committee Report: Recommendations (iii)
3. Review at the Publication Stage “We recommend relying on self-governance by scientists and scientific journals to review publications for their potential national security risks. ….publication of research results provides the vehicle for the widest dissemination, including to those who would misuse them. It is thus appropriate to consider what sort of review procedures can be put in place at the stage of publication to provide another layer of protection…” Notes: Once again here the committee opted for an incremental approach.Many journals were moving in this direction and the committee argued that this form of self-governance was much preferable to government regulation.

14. The Fink Committee Report: Recommendations (iv)
“4. Creation of a National Science Advisory Board for Biodefense We recommend that the Department of Health and Human Services create a National Science Advisory Board for Biodefense (NSABB) to provide advice, guidance and leadership for the system of review and oversight we are proposing.” Notes: This was the most radical proposal that the committee put forward. It was accepted by the US government and a National Science Advisory Board for Biosecurity (not biodefense) was set up following the report. Almost all of the NSABB’s meetings are open to the public and proceedings are available on the web so that the Board’s work in meeting its mandate can be followed in some detail. Ref: Charter, Voting Member and Ex Officio Members of the NSABB is available from the following website. National Institute of Health Office of Science Policy (2008) About NSABB. Available from

15. The Fink Committee Report: Experiments of concern (i)
“The committee identified seven classes of experiments that it believes illustrate the types of endeavors or discoveries that will require review and discussion by informed members of the scientific and medical community before they are undertaken or, if carried out, before they are published in full detail…” Notes: The committee recommended a system of review at the institution where the work was to be carried out and to begin with it again opted for an incremental approach by specifying just seven classes of experimentation that should be subject to review. However, as we shall see in the next slide it was fully aware of the need to go beyond this set of experiment.

16. The Fink Committee Report: Experiments of concern (ii)
“The seven areas of concern listed here only address potential microbial threats….Over time, however, the Committee believes that it will be necessary…to expand the areas of concern to cover a significantly wider range of potential threats to humans, animals or crops…” Notes: The proposed oversight system was to apply to NIH funded work, but in this section of the conclusions it was also made clear that the committee expected more of life science in the US - for example in private companies - to eventually be incorporated.

17. The Fink Committee Report: Experiments of concern (iii)
Experiments of concern would be those that 1. Would demonstrate how to render a vaccine ineffective. This would apply to both human and animal vaccines. 2. Would confer resistance to therapeutically useful antibiotics or antiviral agents. This would apply to therapeutic agents that are used to control disease agents in humans, animals or crops. Introduction of ciprofloxacin resistance in Bacillus anthracis would fall into this class.”

18. The Fink Committee Report: Experiments of concern (iv)
“3. Would enhance the virulence of a pathogen or render a nonpathogen virulent. This would apply to plant, animal and human pathogens. Introduction of cereolysin toxin gene into Bacillus anthracis would fall into this class. 4. Would increase the transmissibility of a pathogen. This would include enhancing transmission within or between species. Altering vector competence to enhance disease transmission would fall into this class.”

19. The Fink Committee Report: Experiments of concern (v)
“5. Would alter the host range of a pathogen. This would include making nonzoonotics into zoonotic agents. Altering the tropism of viruses would fit into this class. 6. Would enable the evasion of diagnostic/detection modalities. This could include microencapsulation to avoid antibody based detection and/or the alteration of gene sequences to aviod detection by established molecular methods.”

20. The Fink Committee Report: Experiments of concern (vi)
“7. Would enable the weaponization of a biological agent or toxin. This would include environmental stabilization of pathogens.” The report notes that “All of the experiments that fall within the seven areas of concern should currently require review by an Institutional Biosafety Committee (IBC)…We thus recommend relying on the system of IBCs as the first review tier for experiments of concern..” Notes: The list of experiments of concern and the fact that they would already require a review by the institutional IBC again emphasies the careful incremental nature of the the recommendations made by the Fink Committee.

Sample Questions 1. What is the modern concept of “dual-use”? Give three examples of experiments that could be of dual-use concern. 2. Do you think that advances in the life sciences are likely to increase the number and types of experiments of dual-use concern? 3. Outline the structure of the Fink Committee’s Report. What do you think were the most important recommendations? 4. Discuss the seven classes of experiments that the Fink Committee singled out for particular attention. Do these cover all the types of experiment of potential concern?

References (Slide 2) Atlas, R. M. and Dando, M. R. (2006) The Dual-Use Dilemma for the Life Sciences: Perspectives, Conundrums, and Global Solutions. Biosecurity and Bioterrorism, 4 (3), Available from (Slide 3) Silver, L. (2007) ‘Science: The Year of Miracles’, Newsweek, 15th October, pp Available from (Slide 4) Kagan, E. (2001) Bioregulators as Instruments of Terror, Clinics in Laboratory Medicine, 22(3), pp Available from (Slide 7) National Research Council (2004) Biotechnology Research in an Age of Terrorism. Washington: National Academies Press. Available from

(Slide 8) National Research Council (2004) Biotechnology Research in an Age of Terrorism. Washington: National Academies Press. Available from (Slide 9) National Research Council (2004) Biotechnology Research in an Age of Terrorism. Washington: National Academies Press. Available from (Slide 10) National Research Council (2004) Biotechnology Research in an Age of Terrorism. Washington: National Academies Press. Available from (Slide 11) National Research Council (2004) Biotechnology Research in an Age of Terrorism. Washington: National Academies Press. Available from

(Slide 12) National Research Council (2004) Biotechnology Research in an Age of Terrorism. Washington: National Academies Press. Available from (Slide 13) National Research Council (2004) Biotechnology Research in an Age of Terrorism. Washington: National Academies Press. Available from (Slide 14) National Institute of Health Office of Science Policy (2008) About NSABB. Available from The Secretary of Health and Human Services (2008) Charter: National Science Advisory Board for Biosecurity, Washington, D. C. Available from (Slide 15) National Research Council (2004) Biotechnology Research in an Age of Terrorism. Washington: National Academies Press. Available from

(Slide 16) National Research Council (2004) Biotechnology Research in an Age of Terrorism. Washington: National Academies Press. Available from (Slide 17) (Slide 18) (Slide 19) National Research Council (2004) Biotechnology Research in an Age of Terrorism. Washington: National Academies Press. Available from (Slide 20)

Dual-Use Examples Lecture No. 15
265

1. Outline Contentious Research Mousepox Synthesis of Polio Virus
Slides 2 - 8 Mousepox Slides Synthesis of Polio Virus Slides 15 – 18 Influenza Virus Slide 19 Virulence in Smallpox Slides 20-21 Notes: The aim of this lecture is to look in more detail at the Fink committee’s treatment of dual-use in the life sciences and, in particular to review the three examples they give of ‘contentious research’ in the life sciences. Links are provided to the original papers and to some other papers of interest in considering this issue. 266

2. Contentious Research (i)
Fink Chapter 1 The Life Sciences Today The “Dual use” Dilemma A Brief History of Biological Warfare* U.S. Policy and the Creation of the Biological and Toxin Weapons Convention *Annex: Biological Warfare in History Notes: The first half of the introductory chapter of the Fink Committee’s report sets the problem of the potential misuse of the modern life sciences in the kind of wider context that is developed in the earlier lectures in this series. The modern history of biological warfare, for example, is expanded in a short annex describing the pre-scientific history of biological warfare. 267

3. Contentious Research (ii)
Fink Chapter 1 (continued) The New Threat Recent Examples of “Contentious Research” in the Life Sciences The Response of the Life Science Community to Previous Challenges Committee Charge and Process Note: Another point made in the introductory chapter to the Fink Committee’s report is that the scientific community responded quickly when concerns arose about the new techniques of gene splicing and the 1975 Asilomar Conference discussion on the safety of such experiments led to guidelines for such research being developed in the US and in many other countries. So the dual-use problem is not an entirely new challenge for life scientists. 268

4. Contentious Research (iii)
The Life Sciences Today “The biological sciences have experienced enormous growth over the last century…” “The ever-expanding research activity has resulted in numerous new…products that are transforming medicine…” “Biotechnology research is now a truly global enterprise…” “In addition to the dispersed research enterprise, publications and personnel are also widely spread…” Notes: The report enumerates the well-known characteristics of the modern life sciences and the draws a fundamental conclusion which is set out in the next slide. 269

5. Contentious Research (iv)
The Life Sciences Today (continued) “The rapid spread of scientific knowledge and applications owes much to a research culture in which knowledge and biological materials are shared among scientists and people move freely between universities, government agencies, and private industry. Large numbers of foreign graduate students and postdoctoral associates have been an essential ingredient of the success of the biological research enterprise. The scientific workforce is increasingly international…” Notes: So the great success of the modern life sciences in providing for human welfare is based on a system in which people and ideas move with considerable freedom. To close down that freedom of movement would not be sensible unless there are overwhelmingly powerful reasons to do so. That then is the context in which the committee set its discussion of the dual use dilemma. 270

6. Contentious Research (v)
The Dual Use Dilemma “The regulation of dual use biotechnology research is a highly contentious technical, political, and societal issue. In the language of arms control and disarmament, dual use refers to technologies intended for civilian application that can also be used for military purposes…” “…The key issue is whether the risks associated with misuse can be reduced while still enabling critical research to go forward.” Notes: Given their view of the need for openness in the scientific enterprise and their recognition of the possibility of misuse the committee formulated their key concern as “whether the risks associated with misuse can be reduced while still enabling critical research to go forward”. This introductory chapter then makes the risks clear in its sections on the history of biological warfare and briefly introduces the Biological and Toxin Weapons Convention before turning its attention to the new threat. 271

7. Contentious Research (vi)
The New Threat “Every major technology - metallurgy, explosives, internal combustion, aviation, electronics, nuclear energy - has been intensively exploited, not only for peaceful purposes but also for hostile ones. Must this also happen with biotechnology, certain to be a dominant technology of the coming century…?” Notes: The report uses this famous question from Professor Matthew Meselson to illustrate what is really the question that life scientists face today. What are the responsibilities of scientists in the prevention of the misuse of their work? Failure to prevent the intensive exploitation of the life sciences for hostile purposes could lead to dreadful consequences as Meselson made clear in the next sentences of this quotation (set out on the next slide). 272

8. Contentious Research (vii)
The New Threat (continued) “…During the century just begun, as our ability to modify fundamental life processes continues its rapid advance, we will be able not only to devise additional ways to destroy life but…also…to manipulate it - including the processes of cognition, development, reproduction, and inheritance. A world in which these capabilities are widely employed for hostile purposes would be a world in which the very nature of conflict has radically changed. Therein could lie unprecedented opportunities for violence, coercion, repression, or subjugation.” Notes: So here is the big problem set out clearly. If the life sciences are applied in a major way to conflict the nature of conflict will change in ways that none of us would wish to see (recall the discussion of warfare in the modern world in lecture 6). This section of the introduction then leads into the committee’s review of three examples of what it calls ‘contentious research’. That is research which had been carried out for benign civil reasons but which had clearly caused concern about the possible misuse for hostile purposes. p. 23 273

9. Mousepox (i) “…Probably the most celebrated recent case involving the dissemination of research with the potential for bioterrorist uses was the report of an unexpected effect of the bioengineering of a strain of ectromelia virus (mousepox) that was intended to help eradicate mice in Australia…. Some have felt that the publication of this paper provides a blueprint or roadmap for terrorist to engineer a more virulent strain of smallpox that could overwhelm the human immune system in even well-vaccinated individuals…” Notes: This paper is undoubtedly very well known amongst people concerned with security issues even though it is not very well known amongst practicing life scientists. The original academic paper was published in the Journal of Virology in It should be carefully studied by students. 274

10. Mousepox (ii) “The authors of the paper had originally set out to make an infectious immunocontraceptive for wild mice by incorporating a gene encoding an antigen from fertilized mouse eggs into the genome of ectromelia virus. Since the expression of this egg antigen of the virus did not result in infertility, the authors attempted to increase the virulence of ectromelia with the hope that this would increase the immune response…” Notes: The civil objective of the work was clear. In order to deal with rodent plagues a naturally infective pox virus was modified so that it produced an egg protein. This it was hoped would generate a sufficient immune response to lead to the rejection of the eggs by mice and thus prevent the build up of the plague of mice (which if you have seen film of such a plague is quite startling). 275

11. Mousepox (iii) “They drew on previously published work…in which it had been shown that incorporating the gene for…IL-4 into the viral genome and thus overexpressing it in vivo enhanced the virulence of vaccinia virus in mice. The increased virulence is probably due to suppression of the antiviral immune response mediated through competing cytokines like IL-2…which work by stimulating immune effector cells to kill virus-infected cells and thus control the virus infection.” Notes: Thus the plan was to create a double modification of the mousepox virus. First the gene for an egg protein was inserted and the when that did not produce a sufficient immune response they sought to enhance the response by also adding the gene for IL-4. 276

12. Mousepox (iv) “…They then demonstrated that this engineered mousepox virus was much more virulent than the parent virus and killed 60% of infected mice, even if the mice were from a genetically resistant strain. Even more unexpected was their observation that mice that had been vaccinated and were completely resistant to the parent virus…were now killed by the IL-4 gene-expressing virus.” Notes: What the scientists did not expect was that the doubly modified mousepox virus now killed mice which has been vaccinated against the original virus. Moreover they had used quite simple techniques that were described in the methods section of the paper. The Fink Committee’s report then goes on to discuss the pros and cons of publication in the academic literature (though it should be noted that prior to publication in the Journal of Virology there was an major article and editorial about the work in the popular science New Scientist which made the potential connection to a modified smallpox very clear). 277

13. Mousepox (v) “Some have felt that the publication of this paper provides a blueprint or roadmap for terrorists to engineer a more virulent strain of smallpox that could overwhelm the human immune system in even well-vaccinated individuals…. It has been suggested that either the paper should not have been published, or at the very least the ‘materials and methods’ section…should have been altered or omitted entirely from the published article…” Notes: The authors consulted about whether the paper should be submitted for publication and the editors of the journal also sought guidance. Eventually, however, the paper was published exactly as submitted. 278

14. Mousepox (vi) Reasons for publication?
“…First, knowledge of these experiments allows the scientific community to explore how to overcome such engineered viruses…” “…Second, it suggests that we should be prepared to treat infections caused by such an engineered virus with antibodies that inactivate the relevant cytokine, with gamma interferon that would counter the effect of IL-4, or with both…” Notes: Notwithstanding the fact that even vaccinated mice were killed by the doubly modified mousepox the report gives reasons to support the publication as shown in the quotations given in this slide. Of course, given the prominence of this experiment there is a large literature on the topic that students could easily explore on the internet. An example of earlier work of relevance is given in the first link below to another paper in the Journal of Virology in Later work can be followed in the link to the 2008 paper in Antiviral Research provided in the second link below. Ref: Parker, S., Touchette, E., Oberle, C., Almond, M., Robertson, A., Trost, L. C., Lampert, B., Painter, G.., and Buller, R. M.(2008) Efficacy of Therapeutic Intervention with an Oral Ether-lipid Analogue of Cidofovir (CMX001) in a Lethal Mousepox Model. Antiviral Research 77(1): Available from 279

15. Synthesis of Polio Virus (i)
“Wimmer and colleagues reported that they had reconstructed poliovirus from chemically synthesized oligonucleotides that were linked together and then transfected into cells. The report attracted considerable attention in the news media and concern in some segments of the public….This…raised public concern about bioterrorism because it suggested that the Wimmer experiment provided a recipe for terrorists to manufacture the virus…” Notes: Wimmer published his work in 2002 and following the anthrax letters in the US it again attracted considerable attention and concern enough to provoke a resolution in congress. Ref: Cello, J., Paul, A. V., and Wimmer, E. (2002) Chemical Synthesis of Poliovirus cDNA: Generation of Infectious Virus in the Absence of Natural Template, Science 297(5583), 1016 – Available from 280

16. Synthesis of Polio Virus (ii)
“Many scientists concluded that the Wimmer experiment was neither a novel discovery nor a potential threat. The general principle that one could make live poliovirus from a DNA template was already known in 1981, when Baltimore and colleagues reported that a DNA copy of the positive strand RNA genome of poliovirus could be taken up into living cells under appropriate conditions and result in the generation of encapsulated, infectious virus…” Notes: The Fink committee’s report was rather unconvinced about the threat of bioterrorism arising from misuse of this work, particularly as the method used had been laborious and taken a long time. However, for many people not familiar with life scientist’s interest in matching their capabilities in genome sequencing with capabilities in genome synthesis this work came as something of a surprise. More surprises were to quickly follow as the next slide demonstrates. 281

17. Synthesis of Polio Virus (iii)
“We have improved upon the methodology and dramatically shortened the time required for the accurate assembly of a 5- to 6-kb segments of DNA from synthetic oligonucleotides. As a test of this methodology, we have established conditions for the rapid (14-day) assembly of the complete infectious genome of the bacteriophage  X174 (5,386 bp) from a single pool of chemically synthesized oligonucleotides…” Notes: In December 2003 Science carried another paper by Craig Venter and his colleagues that demonstrated a much faster method of synthesis and in 2004 Nature carried a paper by George Church and his colleagues that described gene synthesis using programmable chips. There could be no doubt that DNA synthesis capabilities were moving forward rapidly. 282

18. Influenza Virus (iv) “Influenza A virus has been responsible for widespread human epidemics because it readily transmits form humans to humans by aerosol. Recent events have highlighted the potential of influenza A virus as a bioterrorist weapon: the high virulence of influenza A virus that infected people in Hong Kong in 1997: and the development of laboratory methods to generate influenza A viruses by transfection of DNAs without a helper virus…” Notes: This quotation is taken from a careful examination of the potential for influenza to be used as a bioweapon by Robert Krug. Of course all of these concerns became very clear when the 1918 Spanish Influenza was recreated in 2005 (see the next lecture). Ref: Krug, M. R. (2003) The Potential Use of Influenza Virus as an Agent for Bioterrorism, Antiviral Research 57, Available from 283

19. Virulence in Smallpox (i)
“Variola major virus causes smallpox, which has a % mortality rate,whereas vaccinia virus, which is used to vaccinate humans against smallpox, causes no disease in immunocompetent humans….Both viruses have an inhibitor of immune response enzymes - vaccinia virus complement control protein (VCP) and smallpox inhibitor of complement enzymes (SPICE). The authors focused on a comparison of the genes encoding this inhibitor…” Notes: This third example used in the Fink report deals with a paper by Rosengard and colleagues which deals directly with an aspect of the virulence of smallpox - certainly a very dangerous potential bioweapons agent. 284

20. Virulence in Smallpox (ii)
“…As live variola is not available for study, they used standard techniques to synthesize the SPICE gene. They found that variola spice has a greater degree of specificity for human complement and is nearly a hundredfold more active than VCP in inactivating this component of the human immune system (human complement component C3b)…” Notes: Again the report finds reasons for agreeing that this work should have been carried out, but as we saw in the last lecture they also recommended that an oversight of research projects of this kind was needed. We shall examine oversight systems in more detail in lecture No. 18. 285

Sample Questions Do you agree with Meselson’s view that there is a grave danger that the modern life sciences will be used in a major way for hostile purposes? If you agree how do you think this might be prevented? If you disagree set out your reasons and discuss one of them in detail. 2. Outline the mousepox experiment. Should this work have been reported in the scientific literature? Give the reasons for your consideration. 3. “Wimmer’s synthesis of polio virus was not on example of dual-use research of concern”. Discuss. 4. Could influenza virus be used as a serious bioterrorism/biowarfare agent?

References (Slide 2) National Research Council (2004) Biotechnology Research in an Age of Terrorism. Washington: National Academies Press. Available from (Slide 4) National Research Council (2004) Biotechnology Research in an Age of Terrorism. Washington: National Academies Press. Available from (Slide 5 and 6) National Research Council (2004) Biotechnology Research in an Age of Terrorism. Washington: National Academies Press. Available from (Slide 7) Meselson, M (2000) Averting the Hostile Exploitation of Biotechnology, The CBW Conventions Bulletin, June 48, Available from

(Slide 8) National Research Council (2004) Biotechnology Research in an Age of Terrorism. Washington: National Academies Press. Available from (Slide 9) National Research Council (2004) Biotechnology Research in an Age of Terrorism. Washington: National Academies Press. Available from Jackson, R. J., Ramsay, A. J., Christensen, C. D., Beaton, S., Hall, D. F., and Ramshoaw, I. A. (2001) Expression of Mouse Interleukin-4 by a Recombinant Ectromelia Virus Suppresses Cytolytic Lymphocyte Responses and Overcomes Genetic Resistance to Mousepox. Journal of Virology, 75(3), 1205–1210. Available from National Research Council (2004) Biotechnology Research in an Age of Terrorism. Washington: National Academies Press. Available from

(Slide 12 and 13) National Research Council (2004) Biotechnology Research in an Age of Terrorism. Washington: National Academies Press. Available from (Slide 14) National Research Council (2004) Biotechnology Research in an Age of Terrorism. Washington: National Academies Press. Available from Bembridge, G. P., Lopez, J. A., Cook, R., Melero, J. A., and Taylor, G.. (1998) Recombinant Vaccinia Virus Coexpressing the F Protein of Respiratory Syncytial Virus (RSV) and Interleukin-4 (IL-4) Does Not Inhibit the Development of RSVSpecific Memory Cytotoxic T Lymphocytes, whereas Priming Is Diminished in the Presence of High Levels of IL-2 or Gamma Interferon, Journal of Virology 72(5): Available from Parker, S., Touchette, E., Oberle, C., Almond, M., Robertson, A., Trost, L. C., Lampert, B., Painter, G., and Buller, R. M.(2008) Efficacy of Therapeutic Intervention with an Oral Etherlipid Analogue of Cidofovir (CMX001) in a Lethal Mousepox Model. Antiviral Research 77(1): Available from

(Slide 15) National Research Council (2004) Biotechnology Research in an Age of Terrorism. Washington: National Academies Press. Available from Wimmer, E. (2007) The Test-Tube Synthesis of a Chemical Called Poliovirus, EMBO Reports Special Issue 7, 3-9. Available from Cello, J., Paul, A. V., and Wimmer, E. (2002) Chemical Synthesis of Poliovirus cDNA: Generation of Infectious Virus in the Absence of Natural Template, Science 297(5583), 1016 – Available from (Slide 16) National Research Council (2004) Biotechnology Research in an Age of Terrorism. Washington: National Academies Press. Available from

(Slide 17) Smith, H. O., Hutchison, C. A., Pfannkoch, C., and Venter, J. C. (2003) Generating a Synthetic Genome by Whole Genome Assembly: _X174 Bacteriophage from Synthetic Oligonucleotides, PNAS, 100(26), 15440– Available from Tian, J., Gong, H., Sheng, N., Zhou, X., Gulari, E., Gao, X., and Church, G.. (2004) Accurate multiplex gene synthesis from programmable DNA microchips, Nature, 432(23/30). Available from (Slide 18) Krug, M. R. (2003) The Potential Use of Influenza Virus as an Agent for Bioterrorism, Antiviral Research 57, Available from (Slide 19) Rosengard, A. M., Liu, Y., Nie, Z., and Jimenez, R. (2002) Variola virus immune evasion design: Expression of a highly efficient inhibitor of human complement, PNAS, 99(13), 8808–8813 Available from

The Lemon-Relman Report
Lecture No. 16

1. Outline The Lemon-Relman Report The Recommendations
Slides 2 - 7 The Recommendations Slides Assessing Relevant Scientific Developments Slides Notes: The lecture starts with a detailed discussion of the concerns raised by the 2006 Lemon-Relman Committee: that biotechnology of concern is global and that the potential threat is much wider than just from pathogens and toxins. Examples of concern in regard to traditional agent modifications and new types of agent are introduced to illustrate the dangers.

2. The Lemon-Relman Report (i)
“…the committee has worked in the shadows of the…Fink report. However, there is a clear difference….Our focus has been on the advances in the life sciences and related and convergent technologies that are likely to alter the biological threat spectrum over the next 5 to 10 years. To a greater extent [also] we have attempted to take a global perspective…” Notes: In 2006 the US National Academies published a report which followed on from the report of the Fink Committee. This report was produced by a committee chaired by Stanley Lemon and David Relman. Hence, for short, it is called the Lemon-Relman report. It adds significantly to the understanding of the threats and possible preventive responses developed in the Fink report.

3. The Lemon-Relman Report (ii)
“…the biological agent used in the postal attacks was anthrax, a ‘classic’ choice of those intent on waging biological warfare…and the the biodefense research priorities… evolved subsequently with a nearly exclusive focus on well-recognised, ‘traditional’ biowarfare agents. Such a focus is dangerously narrow…” Notes: The anthrax contaminated letters sent in the US just after the September 11th attacks in the US alerted many to the dangers that could arise from the use of well-prepared biological agents. However, the Lemon-Relman report announced on its first page that it had great concerns that just thinking about the threat in terms of the traditional biowarfare agents was a grave mistake.

4. The Lemon-Relman Report (iii)
“…The committee’s charge has been to examine current trends and future objectives of research in the life sciences that may enable the development of a new generation of future biological threats….While this has been far from easy…several conclusions stand out with startling clarity…” Notes: The committee tried to frame its task to look over a five to ten year period in order to make it manageable. Even then the committee emphasized the difficulties, but, crucially, it thought that there were some very clear conclusions that could be drawn from its analysis. These are set out in the next two slides.

5. The Lemon-Relman Report (iv)
“First, the future is now. Even in the short time since the creation of the committee, we have seen the phenomenon of RNA interference capture the collective consciousness of the life science community….Similarly ‘synthetic biology’, an approach embraced… by few at the time the committee was formed, has…been promoted to the cover of one of the most widely read scientific journals…” Notes: As the committee points out, neither of these developments, that illustrate the pace of change in the life sciences, could have predicted just a few years back. This then leads them to their second conclusion which is set out on the next slide.

6. The Lemon-Relman Report (v)
“…This leads to the second conclusion, that the task of surveying current technology trends in order to anticipate what new threats may face us down the road will be never ending. This report, published in early 2006, will in some respects be out of date by 2007.” Notes: Following on from this second conclusion the committee went on to stress how different the problem of threat reduction was in the biological sciences from that in regard to nuclear weapons and this point led them to stress the responsibilities of those working (and therefore having expert knowledge) in the life sciences. Their view is quoted in the next slide.

7. The Lemon-Relman Report (vi)
“…it is increasingly important that life scientists… take every possible step to ensure that…their work [is] not exploited in a malevolent fashion.…This will require that those working in the life sciences achieve a much greater appreciation of the dangers than that now held by most and a greater willingness to shoulder this responsibility. A new ethos is required, and it must be achieved on a global scale…” Notes: It is interesting to see that the committee all agreed with this aim, but that none of them could see a ‘clear path to its achievement’. Instead they regarded their report as a first step in that direction.

8. The Recommendations (i)
“1. The committee endorses and affirms policies that, to the maximum extent possible, promote the free and open exchange of information in the life sciences. 2. The committee recommends adopting a broader perspective on the ‘threat spectrum’.” Notes: The committee decided on five recommendations. The first again emphasized the need for openness in the life sciences in order for progress to be made for the benefit for society. The second on the necessary of the expansion of the threat spectrum will be developed in a later slide.

9. The Recommendations (ii)
“3. The committee recommends strengthening and enhancing the scientific and technical expertise within and across the security communities. 4. The committee recommends the adoption and promotion of a common culture of awareness and a shared sense of responsibility within the global community of life scientists. 5. The committee recommends strengthening…public health… and existing response and recovery capabilities.” Notes: These later recommendations clearly are directed at preventing the hostile misuse of the life sciences. In addition to the culture of responsibility amongst life scientists they argue for better scientific expertise amongst those dealing with security and improvement of public health and response capabilities.

10. The Recommendations (iii)
“2a. Recognize the limitations inherent in any agent-specific threat list and consider the intrinsic properties of pathogens and toxins that render them a threat and how such properties have been or could be manipulated by evolving technologies.” Notes: What is of particular interest is the details that the committee added in regard to their Recommendation number 2 on adopting a broader view of the threat spectrum. Here in 2a they are concerned with the potential manipulation of pathogens and toxins - both as has been done in the past and as may be done in the future. It is important to note that ‘toxin’ in the context of the BTWC includes bioregulators like neurotransmitters.

11. The Recommendations (iv)
“2b. Adopt a broadened awareness of threats beyond the classical ‘select agents’ and other pathogenic organisms and toxins, so as to include, for example, approaches for disrupting host homeostatic and defense systems and for creating synthetic organisms.” Notes: The ‘select agents’ list refers to a list of potential threats used in the US at the time of the report. It clearly did not encompass the much wider view of potential threat agents considered by the committee to need attention. This is a very significant change and reflects the kind of thinking we saw from Petro and his colleagues in regard to new agents developed from a consideration of how the target organism might be attacked rather than how the agent might be modified.

12. Assessing Relevant Scientific Developments (i)
Structure of the Report Chapter 1. Framing the Issue Chapter 2. Global Drivers and Trajectories of Advanced Life Sciences Technologies 3. Advances in Technologies with Relevance to Biology: The Future Landscape 4. Conclusions and Recommendations Notes: The report gives a wide ranging introduction to the general problem in its first chapter and covers the global nature of developments in the life sciences in chapter 2. Of most interest here is chapter 3 on the advances in relevant technologies. We concentrate on the treatment of these advances in the later slides.

13. Assessing Relevant Scientific Developments (ii)
“…this chapter (1) highlights technologies likely to have obvious or high-impact near-term consequences; (2) illustrates the general principles by which technological growth alters the nature of future biological threats; and, (3) highlights how and why some technologies are complementary or synergistic in bolstering defense against future threats while also enhancing or altering the nature of future threats.” Notes: The objectives of this chapter are threefold as set out in this slide. The committee also concluded that whilst the future direction of the advances could not easily be predicted, certain technologies had shared characteristics which allowed them to be grouped together in a way that helped thinking about future possibilities. We will proceed to detail these groups.

14. Assessing Relevant Scientific Developments (iii)
“1. Acquisition of novel biological or molecular diversity “…Technologies in this category include those dedicated toward DNA synthesis; the generation of new chemical diversity (i.e. through combinatorial chemistry); those that create novel DNA molecules (from genes to genomes) using directed in vitro molecular evolution (e.g. ‘DNA shuffling’); and those that amplify or simply collect previously uncharacterized sequences (genomes) directly from nature (i.e. bioprospecting)…” Notes: The first grouping of technologies is concerned with the generation or finding of diversity in molecules or genomes that might be used for good or ill.

15. Assessing Relevant Scientific Developments (iv)
2. Directed design “These are technologies that involve deliberate efforts to generate novel but predetermined and specific biological or molecular diversity….Example include but are not limited to rational, structure-aided design of small-molecule ligands; the genetic engineering of viruses or microbes, and, the emerging field of ‘synthetic biology’.” Notes: All of these advances could be of concern, but the genetic engineering of viruses in particular provoked debate as we see in the next slide.

16. Assessing Relevant Scientific Developments (v)
“With the complete genetic sequencing of the H1N1influenza virus…some have questioned whether these studies should have been published in the open literature given concerns that terrorists could, in theory, use the information to reconstruct the 1918 flu virus…” Notes: Given the very large number of people who died of the 1918 ‘Spanish Influenza” it is not surprising that the sequencing and synthesis of the genome caused debate. Still the committee argues that the editors of Science checked carefully with a number of experts before agreeing to publication. Ref: Tumpey, T.M., Basler, C. F., Aguilar, P. V., Zeng, H., Solórzano, A., Swayne, D. E., Cox, N. J., Katz, J. M., Taubenberger, J. K., Palese, P., García-Sastre, A., (2005) Characterization of the Reconstructed 1918 Spanish Influenza Pandemic Virus, Science, 310(5745). pp Available from

17. Assessing Relevant Scientific Developments (vi)
3. Understanding and manipulation of biological systems. “Examples include, ‘systems biology’; gene silencing (e.g., RNA interference); the generation of novel binding (affinity) reagents; technologies focused on developmental programs (e.g.,embryonic stem cells); genomics and genomic medicine; the study of modulators of homeostatic systems; bioinformatics; and advanced network theory.” Notes: This listing gives a very good idea of the range of the modern life sciences that could be misused by those with hostile intent.

18. Assessing Relevant Scientific Developments (vii)
“…The quest to identify the molecular circuits and control systems in each specialized cell type in the body, and to understand the perturbations that give rise to disease, is a dominant research theme in contemporary biology….Burgeoning knowledge about the composition and regulation of homeostatic molecular circuits…epitomizes the dual-use dilemma created by rapid advances in systems biology…” Notes: The focus on the regulatory systems of living organisms and the dangers that they could be manipulated for hostile purposes is an important new focus in the report. We will concentrate on this problem by reference to advances in our understanding of the nervous system in lecture No. 17.

19. Assessing Relevant Scientific Developments (viii)
“A greater understanding of how small molecules and naturally occurring bioregulatory peptides function in higher organisms will open up novel opportunities to design agents - for good or bad - that target particular physiological systems and processes, such as the brain and the immune system, in very precise ways…” Notes: This comment on the development of new understanding of modulators of homeostatic systems is particularly relevant to an understanding of the future dangers human society could encounter.

20. Assessing Relevant Scientific Developments (ix)
4. Production, delivery, and ‘packaging’ “These are technologies driven by efforts in the pharmaceutical, agriculture, and healthcare sectors to improve capabilities for producing, reengineering, or delivering biological or biology-derived products and miniaturizing these processes. Examples include…aerosol technology, microencapsulation, microfluids/microfabrication; nanotechnology; and gene theraphy technology…” Notes: Clearly, it is hard to think of anything nearer to weaponization than work on such technologies.

Sample Questions Give a brief overview of the structure of the Lemon-Relman report and of its main argument. How do you evaluate the validity of this argument? 2. Do you agree with the authors of the Lemon-Relman report’s authors that life scientists should achieve a much greater appreciation of the dangers and how a greater willingness to shoulder their responsibilities? 3. Should the 1918 Spanish Influenza Pandemic Virus has reconstructed? 4. What are the four groups of technologies listed in the Lemon-Relman Report? Discuss one of these in detail and analyse the potential misuse that could arise from developments in this particular group of technologies.

References (Slide 2) National Research Council (2006) Globalization, Biosecurity, and the Future of the Life Sciences, Washington, D.C.: National Academy Press. Available from (Slide 3) National Research Council (2006) Globalization, Biosecurity, and the Future of the Life Sciences, Washington, D.C.: National Academy Press. Available from (Slide 4) National Research Council (2006) Globalization, Biosecurity, and the Future of the Life Sciences, Washington, D.C.: National Academy Press. Available from

(Slide 4) National Research Council (2006) Globalization, Biosecurity, and the Future of the Life Sciences, Washington, D.C.: National Academy Press. Available from (Slide 5) (Slide 6) (Slide 7) National Research Council (2006) Globalization, Biosecurity, and the Future of the Life Sciences, Washington, D.C.: National Academy Press. Available from (Slide 8) National Research Council (2006) Globalization, Biosecurity, and the Future of the Life Sciences, Washington, D.C.: National Academy Press. Available from

(Slide 9) National Research Council (2006) Globalization, Biosecurity, and the Future of the Life Sciences, Washington, D.C.: National Academy Press. Available from (Slide 10) (Slide 11) National Research Council (2006) Globalization, Biosecurity, and the Future of the Life Sciences, Washington, D.C.: National Academy Press. Available from (Slide 12) National Research Council (2006) Globalization, Biosecurity, and the Future of the Life Sciences, Washington, D.C.: National Academy Press. Available from

(Slide 13) National Research Council (2006) Globalization, Biosecurity, and the Future of the Life Sciences, Washington, D.C.: National Academy Press. Available from (Slide 14) National Research Council (2006) Globalization, Biosecurity, and the Future of the Life Sciences, Washington, D.C.: National Academy Press. Available from (Slide 15)

(Slide 16) National Research Council (2006) Globalization, Biosecurity, and the Future of the Life Sciences, Washington, D.C.: National Academy Press. Available from Tumpey, T.M., Basler, C. F., Aguilar, P. V., Zeng, H., Solórzano, A., Swayne, D. E., Cox, N. J., Katz, J. M., Taubenberger, J. K., Palese, P., García-Sastre, A., (2005) Characterization of the Reconstructed 1918 Spanish Influenza Pandemic Virus, Science, 310(5745). pp Available from (Slide 17) National Research Council (2006) Globalization, Biosecurity, and the Future of the Life Sciences, Washington, D.C.: National Academy Press. Available from

(Slide 18) National Research Council (2006) Globalization, Biosecurity, and the Future of the Life Sciences, Washington, D.C.: National Academy Press. Available from (Slide 19) National Research Council (2006) Globalization, Biosecurity, and the Future of the Life Sciences, Washington, D.C.: National Academy Press. Available from (Slide 20) National Research Council (2006) Globalization, Biosecurity, and the Future of the Life Sciences, Washington, D.C.: National Academy Press. Available from

Regulation of the Life Sciences
Lecture No. 18

1. Outline Literature Reviews Regulating Synthetic Genomics
Slides Regulating Synthetic Genomics Slides NSABB Proposals Slides Controlling Dangerous Pathogens Slides Notes: The aim of this lecture is to introduce students to the discussions going on about what the life science community might do to reduce the risks of the hostile misuse of their work. The focus is on the control of the research and publication process.

2. Literature Reviews (i)
Minimization of the risks posed by dual-use research: A structured literature review “The MEDLINE data base was searched for studies concerning the ethics of biodefense, or the dual-use dilemma. Ten articles met all inclusion criteria and were thoroughly reviewed and analyzed.” Notes: This first literature review made a broad search using MEDLINE. Carried out by Mararita Dolgitser and published in 2007, it came to some clear conclusions that are of considerable interest. It should be noted that ‘biodefense’ here is being used in a broader sense than is usual in security circles.

3. Literature Reviews (ii)
A structured literature review (continued) “Within the peer-reviewed life science literature, the most commonly suggested strategy for minimizing the potential harm that could be caused by scientific research was self-regulation within the scientific community, followed by increased security within the scientific community, international cooperation, and finally, increased biodefense education for professionals….One article suggested that decreases in security would minimize the risk of dual-use bioterrorism through increased open scientific scrutiny and self-regulation within the community…” Notes: What we see here is a very clear preference amongst life scientists for the community to be allowed to regulate its own activities rather than for example the introduction of new legislation and regulations by the government to control dual-use risks.

4. Literature Reviews (iii)
“Among the articles that suggested self-regulation, a bottom-up approach, ideas for how this regulation needs to occur vary substantially…. Many articles also recommended increased security, or a top-down approach….Suggested increases in security ranged from physical security measures…to rigorous background checks for staff, graduate students and faculty and limitations on access to information and knowledge…” Notes: What we see here is a reflection perhaps of the lack of real debate that has so far taken place. Rather than an evolving consensus there is wide divergence of opinion not only about whether there should be a bottom-up or top-down approach but additionally there is no widespread agreement about what should be done within either type of approach.

5. Literature Reviews (iv)
“…Following increased self-regulation and security, the next most common suggestion for increased biodefense was international cooperation….Proposals…focus first and foremost on establishing a clear international consensus on bioethical approaches….Other articles suggested the necessity of international treaties and frameworks limiting the development of dual-use research…” Notes: Again here it does not seem unreasonable to suggest that the ongoing debate is not well advanced. For example, as we have seen in earlier lectures, the Biological and Toxin Weapons Convention would appear to need to be thoroughly understood in order to have an informed discussion of international cooperation to prevent the misuse of modern biology.

6. Literature Reviews (v)
“…Many articles mentioned more than one of the preceding measures, often grouping them together. It is easy to see that one commonly follows from the next, such as increased education, leading to both increased international cooperation and increased security measures. Many of the measures were suggested to be used in tandem to offer increased protections…” Notes: This is an important idea and has been much developed, for example by the ICRC, into the concept of a multifaceted ‘web of prevention’. The development of that web of policies is the subject of the last lecture (21) in this series. It is now seen to extend far beyond just the points listed in this slide.

7. Literature Reviews (vi)
“Synthetic life science is a typical ‘dual-use’ technology, it can be used for the greater good, but also for nefarious goals to cause considerable harm….When the polio study was published in 2002, most doubted that the same technique could be used to synthesize smallpox….But, technology has progressed so rapidly that the synthesis of smallpox is now possible…terrorists no longer need to gain access to the wild-type virus…” Notes: This second, more extensive review by Gabrielle Samuel and her colleagues just deals with the difficulty of controlling what they call the synthetic life sciences (taken to include synthetic genomics and synthetic biology). They are in no doubt in this 2009 review that there are grave dangers of hostile misuse as is illustrated by their reference to smallpox - one of the ‘most feared bioweapons’ as they put it.

8. Literature Reviews (vii)
“There is little disagreement that synthetic life science needs some form of regulatory control. However, the question of exactly what should be regulated, which regulatory structures should be implemented and the type of governance structures needed all remain a matter of debate. For the most part, scientists tend to support self-governance, or at least bottom-up governance and non-binding legislative frameworks…” Notes: Again here we see a lack of consensus on the details of what might best be done, but a clear preference for bottom-up self-governance by the life science community.

9. Literature Reviews (viii)
“Critics of self-governance dismiss such proposals as inadequate. They argue that the risks of synthetic life science are profound… and that research and researchers should be tightly regulated. They believe that it would be inappropriate for…[those] who might benefit…to regulate themselves. Instead they support government control - top-down governance of research and publication practices.” Notes; Here then is an alternative possibility that would at present not be acceptable to most practicing life scientists, but which could easily come about if the matter has not been thought through and some new biological attack happens. There are,however, means by which the openness of science can be preserved by merging some of the advantages of both approaches. This idea is explored in a paper by Miller and Selgelid (2007). Ref: Miller,S., and Selgelid, M. J. (2007) Ethical and Philosophical Consideration of the Dual-use Dilemma in the Biological Sciences. Science and Engineering Ethics, 13, Available from

10. Literature Reviews (ix)
“The synthetic life sciences seem to have emerged from nowhere, and their potential uses and misuses have taken the scientific and regulatory community by surprise. This illustrates not only how quickly science can develop…but also how the direction of science can be remarkably difficult to predict. More importantly, however, it is a reminder of how scientific development might leave moral, social and legal discourse in its wake, and lead to uncertainties as to how it should be regulated and controlled.” Notes: This passage from the concluding section of Samuel et al’s paper suggests that we should not be very surprised that discussion of these matters is at an early stage amongst the life science community and that we should expect to have further such surprises as the revolution in the life sciences proceeds. The rest of this lecture looks at some of the ideas for control in more detail, starting with synthetic genomics.

11. Regulating Synthetic Genomics (i)
“We define three major points for policy intervention: Commercial firms that sell synthetic DNA (oligonucleotides, genes, or genomes) to users; Owners of laboratory ‘bench-top’ DNA synthesizers with which users can produce their own DNA; The users (consumers) of synthetic DNA themselves and the institutions that support and oversee their work.” Notes: In 2007 some of the people in the US involved in synthetic genomics and some of the policy people concerned about the potential misuse of their work produced a report on what might be done to mitigate the risks. The report defined three major points of policy intervention and then suggested a range of policies that might be applied at these different points. Whilst the report did receive criticism for being inadequate to deal with the extent of the problem it did show that life scientists can contribute their expertise to the development of new policies to protect their work from misuse.

12.Regulating Synthetic Genomics (ii)
Options related to commercial firms “Require commercial firms to use approved software for screening orders. People who order synthetic DNA from commercial firms must be verified as legitimate users by an Institutional Biosafety Officer….” Require both use of approved software by the commercial firm and that verification of the user is carried out. “Require commercial firms to store information about customers and their orders.” Notes: At the first point of intervention - the commercial firm - a range of increasingly tough options are set out in the report and subject to analysis for their utility in reducing the risks and their costs of implementation. Clearly, use of approved software, for example, could help minimize the chance that someone could order parts of a dangerous genome. The same process is applied to the other two points of intervention as we shall see in the next two slides. Overall an insight is given into the possible policy landscape which is useful even though the report does not make any recommendations as to what might best be done.

13. Regulating Synthetic Genomics (iii)
Options related to DNA synthesizers “Owners of DNA synthesizers must register their machines. Owners of DNA synthesizers must be licensed. A license is required both to own DNA synthesizers and to buy reagents and services.”

14. Regulating Synthetic Genomics (iv)
Options related to users (consumers) “Incorporate education about risks and best practices as part of university curricula. Compile a manual for ‘biosafety in synthetic biology laboratories’. Establish a clearinghouse for best practices. Broaden Institutional Biosafety Committee(IBC) review responsibilities to cover risky experiments.”

15. Regulating Synthetic Genomics (v)
Options related to users (customers) continued “Broaden Institutional Biosafety Committee (IBC) review responsibilities, plus add oversight from a national advisory group to evaluate risky experiments. Broaden IBC review responsibilities, plus enhance enforcement of compliance with biosafety guidelines.” Notes: This last set of options is interesting not just because it focuses on the users but also because it introduces the idea of a tiered system of review involving the local institution and a national advisory body (such as the US NSABB that we will return to in the next slide).

16. NSABB Proposals (i) “In this report, the NSABB identifies principles that should underpin the oversight of dual use life science research, lists key features of such oversight (e.g., federal guidelines, awareness and education, evaluation and review of research for dual use potential, assessment and management of risk, compliance, and periodic evaluation at the local (e.g., research institution) and federal levels of the impact of the oversight procedures) and proposes roles and responsibilities…” Note: In 2007 the NSABB, set up by the government in the US following the report of the Fink committee, produced a report proposing a framework for the oversight of dual use life science research. This remains, probably, the most detailed official investigation of how the risks of dual use research might be mitigated.

17. NSABB Proposals (ii) “One of the fundamental tasks of the NSABB was to develop criteria for identifying dual use research of concern. The proposed criterion is ‘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 and safety, agricultural crops and other plants, animals, the environment, or material.” Notes: There are some vague points in this definition such as ‘reasonably anticipated’ and ‘directly misapplied’ but clearly the potential range of the life sciences captured by this definition is very large.

18. NSABB Proposals (iii) “NSABB members agreed that the principle investigator, using the criterion set forth…should conduct the initial evaluation of his or her research for its potential as dual use research of concern. Those projects initially identified as dual use research of concern - and NSABB members anticipate that there will be very few projects that are truly dual use of concern - would undergo additional institutional review…” Notes: Two points are of interest here: first that it is the investigator not the institutional review that makes the determination of what might be of dual use concern and second that very little is expected to be of concern.

19. Controlling Dangerous Pathogens (i)
“For maximum effectiveness, an oversight system would have to be: Globally implemented; Applied without exception to all scientists engaged in relevant research; Adequately financed; Efficiently organized; Backed by appropriate legal authority; and Accompanied by credible provisions to prevent misuse of its authority.” Notes: Probably the most detailed analysis of the dual use problem and its regulation at the level of life science research has been undertaken by a group lead by John Steinbrunner at the University of Maryland in the US. They agree with the NSABB that most life science research will not need to be subject to oversight because of dual use concerns, but they propose a much tougher system of control over what is of possible concern. So while the NSABB proposals would not , for example, cover government biodefense, the Maryland system would cover all relevant work. It would also be legally enforced and be expected eventually to extend beyond work just with pathogens and to be global rather than national.

20. Controlling Dangerous Pathogens (ii)
“The oversight process would include two key elements. The first, national licensing, would be used to identify relevant individuals and research facilities and formalize their adherence to the basic norm…. The second element is independent peer review of relevant projects prior to their initiation. Any individual interested in conducting research covered by the oversight system would be required to provide information about their proposed project to the appropriate oversight body for review and approval…” Notes: In the Maryland system then both institutions and individuals would have to be licensed nationally and the initial review of projects would be peer review at the institution. This shows a very different approach to that of the NSABB and indicated how much work needs to be done to find an efficient, effective and acceptable oversight system in many different countries.

Sample Questions What appears to be the most favoured method of oversight amongst life scientists? What are the ‘pros and cons’ of this method? 2. What do you think of the proposals put forward by Garfinkel et, al., (2007) for the regulation of synthetic genomics? 3. What is the US NSABB’s definition of dual-use research of concern? Do you think this is an adequate definition on which to base an oversight system? 4. Compare and contrast the oversight systems proposed by the NSABB and the Maryland research group.

References (Slide 2) Margarita Dolgitser (2007) Minimization of the Risks Posed by Dual-Use Research: A Structured Literature Review. Applied Biosafety, 12(3), pp Available from (Slide 7) Samuel,G.N., Selgelid, M. J., and Kerridge, Ian. (2009) Managing the Unimaginable: Regulatory Responses to the Challenges Posed by Synthetic Biology and Synthetic Genomics. EMBO Reports, 10(1), pp Available from (Slide 9) Miller,S., and Selgelid, M. J. (2007) Ethical and Philosophical Consideration of the Dual-use Dilemma in the Biological Sciences . Science and Engineering Ethics, 13, pp Available from

(Slide 11) Garfinkel, M. S., Endy, D., Epstein, G. L., and Friedman, R. M. (2007) Synthetic Genomics: Options for Governance, J.Craig Venter Institute, CSIS, MIT. Available from (Slide 16) National Science Advisory Board for Biosecurity (2007) Proposed Framework for oversight of dual use life sciences research: Strategies for Minimizing the Potential Misuse of Research Information, Washington, D.C., Available from (Slide 19) Steinbruner, J., Harris, E. D., Gallagher, N., and Okutani, S. M. (2007) Controlling Dangerous Pathogens: A Prototype Protective Oversight System, CISS, University of Maryland. Available from

The International Regulation of Biotechnology Lecture No. 19

1. Outline Introduction to the international regulation of biotechnology Slides 2-4 Arms Control Slides 5-8 Health and Disease Control Slides 9-13 Environmental Protection Slides 14-15 Trade Slides 16-17 Drugs Control Slide 18 Social and Ethical Impacts Slide 19 Summary Slide 20 Notes: The international regulation of biotechnology extends across several issue areas, with significant interactions and overlaps between the areas. Information, including the original texts of these regulations can be found online, but in a dispersed and fragmented manner. For this reason the Genomics Gateway Website was constructed. It provides information on the 37 international regulations of relevance to the control of biotechnology as well as associated international organisations, and analysis of regulatory issues.

2. Complexity of decision whether to export a genetically engineered bacterium
Export a G.E. bacterium ? Is it or might it be pathogenic? Is it a Category A or B infectious substance? Does it affect humans; humans and animals: animals only; or plants? What is the end use? Could it threaten biodiversity? Is there potential for misuse? Is it a risk to health? Trade restrictions may be applied Is it a risk to national security? What mode of transport will be used? Is it for use as food or feed? Is it for deliberate release into the environment? International Health Regulations Terrestrial Animal Health Code International Plant Protection Convention Biological and Toxin Weapons Convention Cartagena Protocol on Biosafety Guidance on Regulations for the Transport of Infectious Substances Laboratory Biosafety Manual Air Sea Rail Land Sanitary and Phytosanitary Agreement Technical Barriers to Trade Agreement Check importing country’s regulations Mixed Y N Humans Animals only Plants Humans and animals UN2814 UN2900 UN3700 B A Modal regulations should be read alongside Guidance Is it for contained use? Notes: The international regulations developed largely in separation from each other, at different times and for different purposes. This had produced a complex regulatory situation that can be very difficult for users to navigate, as demonstrated in the diagram.

3. Issue Areas (i) In which there is a need for coordinated state action and significant applications/impacts of biotechnology Arms control: The 1925 Geneva Protocol; The 1975 Biological and Toxin Weapons Convention; The 1997 Chemical Weapons Convention Health and disease control Environmental protection Notes: There are seven international issue areas in which there is an established need to coordinate state action in order to address issues of common concern and significant applications and impacts of biotechnology.

4. Issue Areas (ii) Trade Drugs control Development, and
Social and ethical impacts of human genetics

5. Arms Control Geneva Protocol for the Prohibition of the Use in War of Asphyxiating, Poisonous, or Other Gases, and of Bacteriological Methods of Warfare Biological and Toxin Weapons Convention Chemical Weapons Convention Convention on the Prohibition of Military or Any Other Hostile Use of Environmental Modification Techniques Notes: International action is necessary because for one state to feel secure in restricting its military capabilities it needs assurance that other states are doing the same. Much of the knowledge, research, materials and equipment associated with modern biotechnology is dual-use in nature, so rules that prohibit none-peaceful use of scientific advances are relevant.

6. BTWC Article X “The States Parties to this Convention undertake to facilitate, and have the right to participate in, the fullest possible exchange of equipment, materials and scientific and technological information for the use of bacteriological (biological) agents and toxins for peaceful purposes.” Notes: As well as containing prohibitions, both the BTWC and CWC contain provisions encouraging the use of science and technology for peaceful purposes.

7. CWC Article XI “The provisions of this Convention shall be implemented in a manner which avoids hampering the economic or technological development of States Parties, and international cooperation in the field of chemical activities for purposes not prohibited under this Convention…” Notes: There is an international organisation – the Organisation for the Prohibition of Chemical Weapons – associated with the CWC. There is not a corresponding organisation for the BTWC.

8. BTWC – Scope of Article I
“The Conference declares that the Convention is comprehensive in its scope and that all naturally or artificially created or altered microbial and other biological agents and toxins, as well as their components, regardless of their origin and method of production and whether they affect humans, animals or plants… are unequivocally covered by Article 1.” (6th Review Conference of the Biological and Toxin Weapons Convention, Final Declaration, 2006) Notes: States parties to the BTWC have repeatedly reconfirmed its application to all advances in the life sciences.

9. Health and Disease Control
The types of rules apply in this area: Disease control; Biosafety and biosecurity; Food safety Notes: There are three types of applicable rules in this area, those relating to: (a) disease control; (b) biosafety and biosecurity; and (c) food safety.

10. Disease Control For human health – the International Health Regulations For animal health – the Terrestrial and Aquatic Animal Health Codes For plant health – the International Plant Protection Convention Notes: Disease control requires international action because disease can spread rapidly across national boundaries, particularly through international travel and trade routes. Biotechnology may be (mis)used in the deliberate creation of disease, and these rules will apply whether or not an outbreak is of natural origin. The relevant rules are: International Health Regulations (of the World Health Organisation); the Terrestrial and Aquatic Animal Health Codes (of the Office International des Epizooties); and the International Plant Protection Convention (of the Food and Agriculture Organisation). The International Health Regulations cover any disease outbreak that: “is determined…(i) to constitute a public health risk to other States through the international spread of disease and (ii) to potentially require a coordinated international response.” (Article 1). Their purpose is: “to prevent, protect against, control and provide a public health response to the international spread of disease in ways that are commensurate with and restricted to public health risks, and which avoid unnecessary interference with international traffic and trade.” (Article 2). And they include provisions on surveillance, notifications, information sharing, public health measures and response. “The aim of the OIE Terrestrial Animal Health Code (hereafter referred to as the Terrestrial Code) is to assure the sanitary safety of international trade in terrestrial animals (mammals, birds and bees) and their products. This is achieved through the detailing of health measures to be used by the veterinary authorities of importing and exporting countries to avoid the transfer of agents pathogenic to animals or humans, while avoiding unjustified sanitary barriers.” (Foreword, Terrestrial Animal Health Code). Similarly “The aim of the Aquatic Animal Health Code is to assure the sanitary safety of international trade in aquatic animals.” (Foreword, Aquatic Animal Health Code). The aim of the International Plant Protection Convention is to ensure “common and effective action to prevent the spread and introduction of pests of plants and plant products, and to promote appropriate measures for their control” (Article 1).

11. Biosafety and Biosecurity
Laboratory Biosafety Manual Guidance on Regulations for theTransport of Infectious Substances Laboratory Biosecurity Guidance Provisions within the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals and Terrestrial Animal Health Code Notes: Given that diseases can spread rapidly internationally, rules to prevent inadvertent or deliberate release, loss or theft of dangerous pathogens are also relevant. The international rules are: Produced by the World Health Organisation Laboratory Biosafety Manual Guidance on Regulations for Transport of Infectious Substances Laboratory Biosecurity Guidance Produced by the Office International des Epizooties Provisions with the Terrestrial Animal Health Code (e.g. Chapter 5.8 International transfer and laboratory containment of animal pathogens); the Manual of Diagnostic Tests and Vaccines for Terrestrial Animals (e.g. Chapter Biosafety and biosecurity in the veterinary microbiology laboratory and animal facilities); and the Aquatic Animal Health Code (e.g. Chapter Measures concerning international transport of aquatic animal disease agents and pathogenic material).

“‘Laboratory biosafety’ is the term used to describe the containment principles, technologies and practices that are implemented to prevent unintentional exposure to pathogens and toxins, or their accidental release. ‘Laboratory biosecurity’ refers to institutional and personal security measures designed to prevent the loss, theft, misuse, diversion or intentional release of pathogens and toxins.” (Laboratory Biosafety Manual, p.47) Notes: It is important that students understand the difference between biosafety and biosecurity.

13. Food Safety The Codex Principles for the Risk Analysis of Foods Derived from Modern Biotechnology The Codex Guideline for the Conduct of Food Safety Assessment of Foods Produced Using Recombinant-DNA Microorganisms The Codex Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Plants Codex Guideline for the Conduct of Food Safety Assessment of Foods Derived from Recombinant-DNA Animals Notes: Food safety is also an international issue as food is trade globally. International food safety standards are provided by the Codex Alimentarius Commission. It has a set of principles and three guidelines specific to biotechnology based foods.

14. Environmental Protection
Convention on Biodiversity Cartagena Protocol on Biosafety (to the Convention on Biodiversity) “the conservation of biological diversity, the sustainable use of its components and the fair and equitable sharing of the benefits arising out of the utilization of genetic resources” (Convention on Biodiversity, Article 1 – Objectives) Notes: The essential interconnectedness of the global environment has been recognised for several decades, alongside the need to act internationally to resolve environmental problems. Applications of biotechnology have the potential to of both benefit and harm to the environment, and particular concerns have been raised in the area of biodiversity protection. Here there are two applicable regulations. Both are overseen by the Convention on Biodiversity Secretariat. The general scope of the Convention on Biodiversity is: “the conservation of biological diversity, the sustainable use of its components and the fair and equitable sharing of the benefits arising out of the utilization of genetic resources” (Article 1). It has a specific article (19) on handling of biotechnology and distribution of its benefits. The Convention views biotechnology as both beneficial and potentially harmful to biodiversity. The Cartagena Protocol to the Convention on Biodiversity applies to transboundary movements of living (i.e. genetically) modified organisms. It works through an ‘advance informed agreement’ procedure between the importing state and the exporter.

15. National Implementation of the Cartagena protocol
The Protocol needs National Implementations For example, Japan legislated a new Law Concerning the Conservation and Sustainable Use of Biological Diversity through Regulations on the Use of Living Modified Organisms*, which entered into force in 2004. *Notes: To do research with Living Modified Organism (LMO) universities are required to register and set up special facilities, to transfer LMOs in appropriate manners and to secure LMOs against an accidental release into the environment.

16. Trade Free trade Agreement on Technical Barriers to Trade
Agreement on the Application of Sanitary and Phytosanitary Measures (b) Access to genetic resources Bonn Guidelines on Access to Genetic Resources International Treaty on Plant Genetic Resources Notes: There are three relevant sets of trade rules applicable to products and processes of biotechnology, those on: (a) free trade, (b) access to genetic resources, and (c) intellectual property protection. (a) The World Trade Organisation has various rules relating to free trade (that is international trade with minimal tariff and non-tariff restrictions). The two of particular relevance are: The TBT Agreement aims to limit technical standards to those which are scientifically justified (for quality and safety purposes) allowing some exceptions for the protection of life, health and national security reasons. The SPS Agreement allows trade restrictions, where scientifically justified, for the protection of human, animal and plant life and health. Those national measures based on international standards of the Codex Alimentarius Commission, Office International des Epizooties, or International Plant Protection Convention are automatically considered to be acceptable standards under the SPS Agreement. (b) Access to genetic resources is a long-standing international issue as all countries need access to genetic resources outside their national boundaries to maintain/enhance healthy and diverse agricultural systems. The issue has received more attention recently because genetic resources are frequently used as the basis of novel biotechnology products and processes. There are two relevant international regulations: the Bonn Guidelines on Access to Genetic Resources and the Fair and Equitable Sharing of Benefits Arising out of Their Utilisation; and the International Treaty on Plant Genetic Resources for Food and Agriculture. The Bonn Guidelines were adopted by the Conference of the Parties to the Convention on Biodiversity in 2002 and aim to assist governments in the structuring of national and regional legislation and mechanisms to ensure fair access to genetic resources, and sharing of benefits from these resources. The ITPGR was adopted by the FAO in 2001 based on an earlier International Undertaking on Plant Genetic Resources. It aims to facilitate access to key agricultural plant genetic resources through a multilateral system. (c) Companies, institutions and individuals working in the biotechnology field frequently want intellectual property protection for the innovations, usually in the form of patent rights. International rules seek to provide minimum standards of protection internationally and also to simplify applications made to multiple countries.

17. Intellectual Property Protection
Agreement on Trade Related Aspects of Intellectual Property Rights Patent Cooperation Treaty Patent Law Treaty Budapest Treaty on the Deposit of Microorganisms for the Purpose of Patent Procedure Convention for the Protection of New Varieties of Plants Notes: The World Trade Organisation is responsible for one key agreement in this area – the Agreement on Trade Related Aspects of Intellectual Property Rights, which sets the minimum international standards for patent protection (and other IPRs). It allows exemptions for national security and public health and has flexibilities designed to assist developing countries. Its coverage of living organisms remains controversial and discussion of the relevant article (27.3.b) is ongoing 13 years after the agreement’s adoption. In addition, three rules of the World Intellectual Property Organisations are relevant: the Patent Cooperation Treaty, the Patent Law Treaty, and the Budapest Treaty on the Deposit of Microorganisms for the Purpose of Patent Procedure. The PCT and PLT provide a simplified procedure for international patent applications that enables, for example, international searches to be made on prior art, but applications must still be filed in each country in which protection is sought. The Budapest Treaty provides a system for international deposit of microorganisms where required as part of disclosure requirements in patent applications. The UPOV Convention provides an alternative system of intellectual property protection in the form of plant variety rights.

18. Drugs Control Illicit drugs trade Convention on Narcotic Drugs
Convention on Psychotropic Substances Convention Against Illicit Traffic in Narcotic Drugs and Psychotropic Substances (b) Anti-Doping World Anti-Doping Code International Convention Against Doping in Sport Notes: The rules in this area cover two main topics – the illicit drugs trade and doping in sport. The trade in illicit drugs and in drugs used for doping are both international. Biotechnology can be used in production of drugs, enhancement of properties of drugs, and creation of novel drugs. The rules on the illicit drugs trade are: the Convention on Narcotic Drugs, the Convention on Psychotropic Substances, and the Convention Against the Illicit Trade in Narcotic Drugs and Psychotropic Substances. These come under the UN Office on Drugs and Crime, but are overseen by the Commission on Narcotic Drugs and the International Narcotics Control Board. They aim to reduce the illicit drugs trade through measures targeting supply, while ensuring sufficient supplies for legitimate medical and scientific purposes. The World Anti-Doping Code is overseen by the World Anti-Doping Association and is aimed at international sporting organisations and sets standards for testing and outlines punishments and appeals procedures. It is based on the principle of good sportsmanship and aims to identify, punish and prevent doping offences. It receives governmental backing through the International Convention Against Doping in Sport which was adopted through the UN Educational, Scientific and Cultural Organisation. Development is an international issue because many factors which affect it have an international dimension e.g. trade, investment, aid, health, food security, etc. Biotechnology has significant potential to assist human development but wrongly applied (i.e. without regard for its development impacts) it could instead obstruct lead to increased gaps between rich and poor. There are no separate regulations applying to biotechnology and development, but it is dealt with in capacity-building, technology transfer and technical and financial assistance clauses in some of the other regulations.

19. Social and Ethical Impacts
Universal Declaration on the Human Genome and Human Rights International Declaration on Human Genetic Data Universal Declaration on Bioethics and Human Rights United Nations Convention on Human Cloning Notes: Since biotechnology is an international technology its social and ethical implications require some consideration at the international level. There are four relevant declarations that have been adopted in relation to human genetics: the Universal Declaration on the Human Genome and Human Rights, the International Declaration on Human Genetic Data, the Universal Declaration on Bioethics and Human Rights, and the United Nations Declaration on Human Cloning. The first three were developed by the UN Educational, Scientific and Cultural Organisation, the fourth by the UN General Assembly. It has proved particularly controversial with several major states refusing to support it (including China and the UK). The declarations provide ethical principles to guide human genetics research.

20. Summary 37 regulations; 14 international organisations:
Notes: There is a complex international regulatory situation in regard to governance of biotechnology with rules in a number of issue areas overlapping and interacting. There are currently 37 international regulations and 14 international organisations operating in this area. The Genomics Gateway Website provides a central base for information on these regulations.

Questions “The international regulations regarding biotechnology developed largely isolation from each other, at different times for different purposes”. Discuss. 2. Briefly outline the range of international regulations governing biotechnology. Discuss one group of regulations, for example trade or health and disease control, in detail showing how effective, or not, they are at the present time. 3. Drug control is an essential component of the growth of international sport in the view of many people. What is your view and why do you hold that view? 4. Discuss the Cartagena Protocol on Biosafety and its relationship to the Convention of Biodiversity. How effective do you think the Protocol will be in coming decades?

References (Slide 3-5) University of Bradford (2009) Genomics Gateway [Last updated 26 March 2009]. Available from (Slide 6) The Biological and Toxin Weapons Convention Website. Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on Their Destruction [online]. Undated [cited 15 September 2008]. Available from: (Slide 7) Convention on the Prohibition of the Development, Production, Stockpiling and Use of Chemical Weapons and on their Destruction (Chemical Weapons Convention). Reproduced in the Organization for the Prohibition of the Chemical Weapons Convention, Available at

(Slide 8) United Nations (2006) Sixth Review Conference of the Parties to the Convention on the Prohibition of the Development, Production and Stockpiling of Bacteriological (Biological) and Toxin Weapons and on their Destruction. Final Declaration, BWC/CONF.VI/6 [Online]. 8 December [Cited 15 September 2008]. Available from: (Slide 9) University of Bradford (2009) Genomics Gateway [Last updated 26 March 2009]. Available from (Slide 12) WHO (2004) Laboratory Biosafety Manual. Geneva: World Health Organization. [3rd Edition]. Available from (Slide 14) University of Bradford (2009) Genomics Gateway [Last updated 26 March 2009]. Available from

(Slide 15) Minehata, M. , and Shinomiya, N
(Slide 15) Minehata, M., and Shinomiya, N. (2009) Biosecurity Education: Enhancing Ethics, Securing Life and Promoting Science: Dual-Use Education in Life-Science Degree Courses at Universities in Japan. Saitama and Bradford: National Defense Medical College and University of Bradford. Available from (Slide 16) University of Bradford (2009) Genomics Gateway [Last updated 26 March 2009]. Available from (Slide 18) University of Bradford (2009) Genomics Gateway [Last updated 26 March 2009]. Available from

(Slide 19) University of Bradford (2009) Genomics Gateway [Last updated 26 March 2009]. Available from