1. Looking Ahead Edward H. You Supervisory Special Agent FBI Weapons of Mass Destruction Directorate Dangerous Liaisons: Dual Use Research in the 21 st Century February 25, 2011

2. What is ?

3. 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, agriculture, plants, animals, the environment, or materiel NSABB Definition

4. Which projects were part of a weapons program? 1.Ministry of Agriculture and Fisheries: Investigation on Bovine Contagious Abortion at the Veterinary Laboratory 2.Survival of the Foot-and-Mouth Disease virus: Virus in damp hay and bran 3.Effects of insecticides and herbicides on animals 4.Virulence of non-sporulated bacteria via the respiratory tract

5. Sir Alexander Fleming "When I woke up just after dawn on September 28, 1928, I certainly didn't plan to revolutionize all medicine by discovering the world's first antibiotic, or bacteria killer."

6. Dr. Barnett Rosenberg Platinum Electrodes Cancer Treatment Chemotherapy

7. Problem: Australian Mouse Plague

8. Dual Use Challenge

9. Carlson, Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science Volume 1 Number 3, August 2003 Biosecurity and Bioterrorism: Biodefense Strategy, Practice, and Science Volume 1 Number 3 SYNTHETIC BIOLOGY

10. Growth of the publicly available gene-sequence database from its inception through 2008 http://www.ncbi.nlm.nih.gov/Genbank/genbankstats.htm SYNTHETIC BIOLOGY New pathogens New virulence factors

11. SYNTHETIC BIOLOGY Creation of a Bacterial Cell Controlled by a Chemically Synthesized Genome

12. DNA Synthesis ExxonMobil Bets $600 Million on Algae Scientific American, July 14, 2009 Microbially Derived Artemisinin: A Biotechnology Solution to the Global Problem of Access to Affordable Antimalarial Drugs American Society of Tropical Medicine and Hygiene

13. Revealed: the lax laws that could allow assembly of deadly virus DNA Urgent calls for regulation after Guardian buys part of smallpox genome through mail order James RandersonJames Randerson, science correspondent A vial containing an incomplete sequence of smallpox DNA, obtained by the Guardian over the internet Wednesday 14 June 2006

14. Mr. Gene - Unbelievable prices in June and July! Starting at $ 0.39 bp! Simplify you life with gene synthesis! Order your gene online and concentrate on research - not on cloning! Submit your sequence SYNTHETIC BIOLOGY Reconstruction of the influenza A (H1N1) orthomyxovirus responsible for the 1918 "Spanish flu" pandemic RNA genetic code comprised of approximately 13,500 nucleotides

15. The Presidential Commission for the Study of Bioethical Issues “…It is vital that we as a society consider, in a thoughtful manner, the significance of this kind of scientific development [synthetic biology]. With the Commission’s collective expertise in the areas of science, policy, and ethical and religious values, I am confident that it will carry out this responsibility with the care and attention it deserves.”

16. Looking Ahead FBI Outreach

17. FBI Synthetic Biology Tripwire Initiative Partnership with the U.S. synthetic biology industry to report suspicious requests for genetic sequences –Reporting mechanism in place between participating industry leaders and FBI field office WMD Coordinators –Shared best practices with Germany and Canada during bilateral meetings (2009) Industry very happy that problem of “who to call” was resolved

18. “Building Bridges Around Building Genomes” FBI Synthetic Biology Conference August 4 - 5, 2009 San Francisco, California

19. Federal Guidance to Synthetic DNA Providers 1.Customer Screening 2.Sequence Screening 3.Government Notification FBI WMD Coordinator

20. 2,000 Attendees 26 Countries 127 Universities FBI Biosecurity Workshop (U.S. Dept. of Health and Human Services, UN BWC) FBI Outreach Booth

21. 2010 Winner: Slovenia DNA Guided Assembly 2009 Winner: Cambridge E. chromi 2008 Winner: Slovenia Designer Vaccine Against Heliobacter pylori iGEM Winners

22. iGEM team helps prevent rogue use of synthetic biology iGEM Winners Bronze Medal, Safety Commendation

23. May 3-4, 2010 The 3 I's: Learning through Collaboration, Connection and Community … Advancing Bioscience and Security First biosecurity conference organized by FBI WMD Directorate in partnership with the Massachusetts Society for Medical Research (MSMR) attended by: Institutional Biosafety Committee Members Institutional Review Board Members Institutional Animal Care and Use Committee Members Focused on how the research and security communities can work together in addressing biosafety and biosecurity FBI-MSMR Biosecurity Conference

25. THREAT Scientific Community FBI The Role of the FBI Meeting the Dual Use Challenge: Outreach Partnership Education/Effective Policy Making

26. Biosecurity Legislation

28. Legislation & Regulation Increased restrictions Oversight Potentially ill-informed Possible negative impact on research activities

31. Innovation Engine: Creating Low-Cost Kits & Devices Open GelBox 2.0 Microbial Fuel Cell DremelfugeLavaAmp

32. THANK YOU Edward H. You Supervisory Special Agent Biological Countermeasures Unit FBI Weapons of Mass Destruction Directorate