Looking Ahead

Edward H. YouSupervisory Special AgentFBI Weapons of Mass Destruction Directorate

Dangerous Liaisons:Dual Use Research in the 21st Century

February 25, 2011

DUAL USE RESEARCH OF CONCERN

What 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, agriculture, plants, animals, the environment, or materiel

NSABB Definition

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

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."

Dr. Barnett Rosenberg

Platinum Electrodes

• Cancer Treatment

• Chemotherapy

Problem: Australian Mouse Plague

Dual Use Challenge

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

SYNTHETIC BIOLOGY

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?

SYNTHETIC BIOLOGY

Creation of a Bacterial Cell Controlled by a Chemically Synthesized Genome

DNA Synthesis

ExxonMobil Bets $600 Million on AlgaeScientific American, July 14, 2009

Microbially Derived Artemisinin: A Biotechnology Solution to the Global Problem of Access to Affordable Antimalarial DrugsAmerican Society of Tropical Medicine and Hygiene

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 Randerson, science correspondent

A vial containing an incomplete sequence of smallpox DNA, obtained by the Guardian over the internet

Wednesday 14 June 2006

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

$5,265.00

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.”

Looking Ahead

FBI Outreach

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

“Building Bridges Around Building Genomes”

FBI Synthetic Biology Conference

August 4 - 5, 2009 San Francisco, California

Federal Guidance to Synthetic DNA Providers

1. Customer Screening

2. Sequence Screening

3. Government Notification• FBI WMD

Coordinator

2,000 Attendees

26 Countries

127 Universities

FBI Biosecurity Workshop (U.S. Dept. of Health and Human Services, UN BWC)

FBI Outreach Booth

2010 Winner: Slovenia

DNA Guided Assembly

2009 Winner: Cambridge

E. chromi

2008 Winner: Slovenia

Designer Vaccine Against

Heliobacter pylori

iGEM Winners

iGEM team helps prevent rogue use of synthetic biology

iGEM Winners

Bronze Medal, Safety Commendation

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

THREAT Scientific CommunityFBI

The Role of the FBI

Meeting the Dual Use Challenge: • Outreach• Partnership• Education/Effective Policy Making

Biosecurity Legislation

Legislation & Regulation• Increased restrictions• Oversight

• Potentially ill-informed• Possible negative impact on

research activitiesNatio

nal Securit

y Risk?

Innovation Engine: Creating Low-Cost Kits & Devices

Open GelBox 2.0 Microbial Fuel Cell

Dremelfuge LavaAmp

THANK YOU

Edward H. YouSupervisory Special AgentBiological Countermeasures UnitFBI Weapons of Mass Destruction Directorate