Oversight Mechanisms of Research and Development in the Biological Defence Sector

1. Skugga Oversight Mechanisms of Research and Development in the Biological Defence Sector Addressing Future Challenges to the Biological and Toxin Weapons Convention in Connection with Scientific and Technological Developments, SIPRI, Stockholm,5-6 March, 2011 Roger Roffey FOI Swedish Defence Research Agency, Stockholm, roger.roffey@foi.se

2. BTWC, S&T and Biodefence 7th RC The rapid S&T developments effects biodefence. Threats more complex and difficult to gather reliable intelligence and assessing if state/non-state actors pursuing covert BW program and most technology and agents are needed for legitimate peaceful purposes. Biodefence, concerns national security: best handled in the BTWC framework where biodefence is and has been a core issue and there is no other international forum to handle it. BTWC Article I still covers all scientific developments like synthetic biology

3. Promote transparency of biodefence R&D Need for enhanced transparency of biodefence but the trend is decreasing transparency. It has not been helpful to try and circumvent the BTWC by focusing on other issues that might well be of some importance while not discussing the core issues. Need to provide confidence in BTWC compliance, transparency (CBMs) essential to prevent orreduce the occurrence of ambiguities, doubts and suspicions. Deter actors from engaging in prohibited activities and dispel concerns of non-compliance. Can increase cooperation among states.

4. Biodefence programs reported for 2009 in openly available CBMs Annual funding 2009 as declared under the CBM form: United States 613 223 $ million United Kingdom 84 $ million Germany 13 $ million Sweden 5 $ million The number of biological defence R&D programs increased from 13 in 1992 to 25 in 2007.Since 1991, 8 new programs in the EU

5. Past offensive BW programmes Past offensive biological weapons (BW) programs using the CBM Form F: Canada, France, Iraq, Russia, United Kingdom and USA. The U.S. State Dept new arms-control compliance report 2010 “there still remains uncertainty about BW programs in Iran, North Korea, and Syria and neither China nor Russia have come completely clean about their past”.

6. Offensive or defensive R&D Difficult to distinguish between defensive and offensive R&D and even harder to monitor from outside. Research not mentioned in BTWC, but when does research go over into development. Slippery slope: One step can lead to the next, from theoretical assessment of threat agents, computer modelling effects, produce new/modified agents to test protection and stability of agent in environment. The progress in biotechnology will make it more difficult to distinguish between defensive and offensive activities.

7. U.S. Biodefence program 2001 - 2011, $56.58 bln on US biodefence >300 institutes and 12000 scientists. For 2011 $6.48 bln. Biodefence R&D programs at the centre to strengthen the BTWC during the Ad Hoc Group negotiations. The sensitivity of the topic and the related perceived risks to national security if too much information were shared with other BTWC States was an important factor together with the risk of visits, why U.S. could not agree the protocol negotiated. Biodefense programs are motivated by national security and information about them cannot be totally disclosed. Information on prohibited programs has so far depended on defectors and human intelligence.

8. Threat assessment as threat generator The major risk is that state run programs take advantage of S&T developments. No indication that non-state actors aim for such S&T. US bio-threat assessment based on technologically feasibility and not actual threat.BTCC Biological Threat Characterization Center will investigate, novel threats, delivery of threats, packaging, and perform Red teaming.Can involve creation of new genetically modified pathogens.Earlier US projects Bacus, Clear Vision and Jefferson raised questions. Novel agents or information on these will leak out due to active intelligence gathering. It is enough that information of such work is available - this has probably initiated similar threat studies in other states. A consequence of that intelligence has not been able to acquire reliable information on state BW-programs or bioterrorist capabilities.

9. US view on biodefence transparency in BTWC AHG Ambassador Donald Mahley, Special Negotiator for Chemical and Biological Arms Control for the Department of State, made clear to Congress that, “the United States has an extensive biodefense program designed to protect both our armed forces and our population from rogue states and terrorists. Providing extensive information…in an unclassified format under the guise of ‘transparency’ runs the risk of providing a proliferator or terrorist with a roadmap to exploit our vulnerabilities.”

10. National oversightmechanisms of biodefence Germany and the UK do not have formal BWC compliance review processes but rely on a variety of internal, legal and other control mechanisms Germany chosen not to carry out sensitive experiments for example for threat assessment. Australia has an oversight committee for biodefence work and a code of conduct for scientists in the program. Canada’s national oversight committee annually reviews CB defence research, development, and training activities. In U.S. each government department like DoD has their own internal mechanism but no common national oversight. NSABB) issues guidelines for reviews of experiments of concern and framework for oversight of dual use life sciences. This does not apply for industrial or DoD R&D.

11. Mandatory code of conduct What support can scientists be provided? For biodefence R&D there should be a mandatory code of conduct for involved scientists. This should be signed by all scientists or technicians when they are recruited. The text should be made public. The code could be developed by team of scientists involved int biodefence programs and presented for SP to the BTWC as a guide. One by NGOs from 2002.

12. Transparency of which biodefence R&D ? Crucial - transparency of national biological defence R&D programs to build trust. CBM submissions has increased from 30 in 1987 and 70 in 2010. CBM returns from 14 States are openly available on the Internet National biological research and development programs as in BTWC CBM, but what does this cover? An understanding that should be added concerning the CBMs, is that it covers all national R&D for protection of humans, animals or plants against hostile use biological agents including toxins. Often understood as funded by MoD but should include any organisation funding program. All facilities should be declared. Today many MoD funded biodefence “programs” work on defence and civilian funding. Some “programs” split into defence and civilian parts dealing with bioterrorism. Some do not have a “program” structure. Note: biodefence R&D program does not cover test and evaluation.

13. Increasing biodefence transparency EU actions Meeting of concerned parties with biodefence programs similar to CBM, meeting 1990 at FOI where West/East first time presented biodefence programs. Agreed on what could and what could not be included in CBMs. Result 3rd RC CBMs Nat. Biological R&D programs and past programs. 1. EU analysis of CBMs on biodefence and a specific forum/ meeting among EU MS Biodefence programs, exchange information, present R&D, develop how to improve CBM formats, develop clarification mechanism, elaborate other transparency measures. EU should submit accurate info. 2. Invite views from US, Canada, Australia, NZ, Norway, Switzerland for discussion. 3. Common EU proposal for 7th BTWC RC.

14. Conclusions Biodefence CBM made mandatory. Modify title to Declaration of National R&D Program for Protection of Humans, Animals or Plants against the Hostile Use of Biological Agents and Toxins. (Includes bioterrorism) If no biodefence program, a written statement. All facilities involved in the national biodefence programs to be listed Describe the internal and external oversight mechanisms in program and develop model for an oversight mechanism of biodefence R&D. Specify if mandatory/voluntary code of conduct for scientists and develop example of mandatory code of conduct for personnel in biodefence. Develop and include a clarification mechanism for CBM returns. EU should initiate Group & Forum to present ideas on increasing transparency in biodefence, for the 7thRC.

15. Conclusions Submit CBMs in UN language + English, place CBM reports on the Web and States set up a national entity for implementation of the CBMs. Further develop the BTWC Article V consultation process. Propose and develop the mandate for a Scientific Advisory Board or Panel for the BTWC to monitor and annually report on S&T with BTWC relevance Work to create a whistleblowermechanism for concerned scientists in the BTWC. Could be an International Ombudsman affiliated with UN. How develop mechanism, mandate and ensure cooperation with governments? Letting intelligence organizations carry out secret biodefense R&D is not confidence building and its intent?