Enhancing Biosecurity in the Life Sciences

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Enhancing Biosecurityin the Life Sciences
National Science Advisory Board for Biosecurity
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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

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National AcademiesReport 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)
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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)

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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

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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
  

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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

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NSABB ex officios

• Exec. Office of the President
• Department of Health and Human Services
• Department of Energy
• Department of Homeland Security
• Department of Veterans 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

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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

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Concerns
Scientific Public
Community

• Need for more effective oversight of dual use
  research
• Laws and regulations may be necessary

• Evidence of problem?
• Red tape and restraints on research and
  communication slow progress
• Restricting communication -- starting down a
  slippery slope to censorship?

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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

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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

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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

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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
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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

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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

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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

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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.

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Available on the NSABB website
www.biosecurityboard.govStatus Submitted to
HHS OS
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Biosecurity Concerns andSynthetic Genomics
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State of the Science and Technology

• Increasingly feasible to synthesize gt 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.

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DECEMBER 2006
Available on the NSABB website
www.biosecurityboard.gov
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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

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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 NSABBs proposed Oversight Framework

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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.

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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 ??????

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(No Transcript)
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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.

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A Continuum of Strategies for International
Engagement
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• http//www.biosecurityboard.gov