Enhancing Biosecurity in the Life Sciences National Science Advisory Board for Biosecurity

The “Dual Use” Issue  Life sciences research underpins: –Biomedical and public health advances –Improvements in agriculture –Safety and quality of food supply –Environmental quality –Strong national security and economy  However, good science can be put to bad uses

National Academies Report on Dual Use Research Report of the National Research Council of the National Academies: “Biotechnology Research in an Age of Terrorism: Confronting the Dual Use Dilemma” (October 2003)

Definitions  Dual Use Research –Biological research with legitimate scientific purpose that may be misused to pose a biologic threat to public health and/or national security (NSABB Revised Charter)  Dual Use Research of Concern –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 materiel (Oversight Framework Document)

US Government Response  Agreement that new biosecurity measures warranted  USG launched a series of biosecurity initiatives, including establishment of National Science Advisory Board for Biosecurity (NSABB) –NSABB to recommend strategies for the efficient and effective oversight of federally funded dual use life sciences research  Consider both national security concerns and needs of the life sciences research community

NSABB Expertise  Molecular/genomics  Microbiology  Clin. ID/diagnostics  Lab biosafety/security  PH/epidemiology  Health physics  Pharm. production  Veterinary medicine  Plant health  Food production  Bioethics  National security  Intelligence  Biodefense  IBCs  Export controls  Law, law enforcement  Scientific publishing  Perspectives from academia, industry, public, RAC

NSABB: A USG-wide Initiative  Advisory to heads of all Federal entities that conduct/support life sciences research  Supported by 15 USG agencies with a role/interest in life sciences research  Appoint ex officio member(s)  Consider recommendations of NSABB when developing and implementing life sciences research programs and policies

NSABB ex officios  Exec. Office of the President  Department of Health and Human Services  Department of Energy  Department of Homeland Security  Department of Veteran’s Affairs  Department of Defense  Environmental Protection Agency  United States Department of Agriculture  Department of Interior  National Sciences Foundation  Department of Justice  Department of State  Department of Commerce  National Aeronautics and Space Administration  Intelligence community

Questions for the NSABB  How do we recognize dual use research?  How should research be reviewed? By whom? When?  How do we raise awareness of dual use research and foster strategies to minimize its misuse?  Should dual use research of concern be communicated? If so, how can this be done responsibly?  How can we promote international engagement on these issues?  “Other duties as assigned”

Concerns  Need for more effective oversight of dual use research  Laws and regulations may be necessary Scientific Public Community  Evidence of problem?  Red tape and restraints on research and communication slow progress  Restricting communication - - starting down a slippery slope to censorship?

NSABB Considered These Concerns  NSABB Deliberations –What is the problem? –How big is it?  NSABB Conclusions –Threat of misuse exists and consequences could be severe –Response to threat of misuse of research findings must be carefully measured  Continued rapid progress of life sciences is paramount

Draft Oversight Framework: Main Elements  Guiding principles  Roles and responsibilities  Criterion for identifying dual use research of concern  Risk assessment and management  Responsible communication of dual use research  Considerations for code of conduct

Identifying Dual Use Research of Concern: Key Concepts  Most life sciences research could be considered dual use research –Need to identify that subset with highest potential for misuse to threaten public health and safety (dual use research of concern)  Evaluation should be based on current understanding of ways information could be directly misused  Scope of potential threat is important –e.g., broad potential consequences for public health rather than for individuals

Criterion for Identifying Dual Use Research of Concern  Research that, based on current understanding, can be reasonably anticipated to provide knowledge, products, or technologies that could be directly misapplied by others to pose a threat to: –Public health –Agriculture –Plants –Animals –Environment –Materiel Elements of national security

Considerations for Identifying Dual Use Research of Concern  Anticipated to be a very small subset of life sciences research  Characterization of research as dual use of concern should not be viewed pejoratively  Applying the criterion is subjective and can be challenging  To assist in application of the criterion, NSABB identified categories and examples of information, products, or technologies that, if produced by research, might make that research considered dual use of concern

Principles of Communication  Communication is vital for scientific progress and occurs throughout the research process  Communicate research to the fullest extent possible Restriction of scientific communication should be a rare exception  Important to consider whether the disclosure of certain information might pose a significant threat to national security  Consider a range of communication options — The decision to communicate information is not necessarily binary

Considerations in Developing a Code of Conduct  Provides a key resource document outlining core principles  Intended to foster development of codes of conduct on dual use research by scientific associations and institutions

Core Responsibilities  At any stage of life sciences research, individuals are ethically obligated to avoid or minimize the risks and harm that could result from malevolent use of research outcomes.  Towards that end, scientists should: — Assess their own research efforts for dual use potential and report as appropriate; — Seek to stay informed of literature, guidance, and requirements related to dual use research; — Train others to identify dual use research of concern and manage it appropriately and communicate it responsibly; — Serve as role models of responsible behavior, especially when involved in research that meets the criteria for dual use research of concern; and — Be alert to potential misuse of research.

Available on the NSABB website: Status: Submitted to HHS OS

Biosecurity Concerns and Synthetic Genomics

State of the Science and Technology Increasingly feasible to synthesize > gene- length DNA constructs Reagents and machines readily available Methods, technology, sequences in public domain Gene/genome synthesis is a globalized and largely privatized industry – Currently no accepted “best practices” in record keeping, sequence tracking, etc.

Available on the NSABB website: D ECEMBER 2006

Selected Findings and Recommendations  Increase awareness among investigators and service providers about their responsibility to know what they possess, manufacture and/or transfer  Need for additional guidance and tools for screening orders and interpreting results  Foster international dialogue and collaboration Develop and implement universal standards and preferred practices for screening sequences  Need to ensure that biosafety guidelines address synthetic nucleic acids  18 USC 175c (aka “Variola Amendment”) is highly problematic

USG Response to NSABB Reports USG has thoroughly reviewed the recommendations of the NSABB regarding Synthetic Genomics and is engaged in an inter-agency process to implement most of the recommendations USG is in the process of carefully considering the NSABB’s proposed Oversight Framework

Federation of American Scientists Dual-Use Education Case Studies Computer-based modules to extend lessons beyond the classroom. Multimedia presentations that will teach graduate students and advanced undergraduates awareness of dual use research. Use real case scenarios to illustrate the ethical dilemmas and the potential misuse of research. Spark discussion of the responsibility of scientists to limit risks.

Federation of American Scientists First 8 Modules 1. Introduction 2. Polio from scratch: Eckard Wimmer 3. Inhalation drugs: David Edwards 4. Mousepox virulence: Ron Jackson 5. Antibiotic Resistance: Stuart Levy 6: RNAi: Greg Hannon 7: 1918 Influenza: Chris Basler 8. Public Concerns: ??????

Federation of American Scientists Overall PRELIMINARY results show Fear of power and unhealthy paranoia. They respect scientific credentials over authority. Misunderstanding of what LE would contact them for. Worried about being monitored. Worried about having their research interfered with. However, 62% agreed to be contacted by FAS again.

A Continuum of Strategies for International Engagement Awareness Communication Cooperation Coordination Collaboration Agreement