National Series Lecture 4 National Measures Georgia

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National SeriesLecture 4National
MeasuresGeorgia

• Bradford Disarmament Research CentreDivision of
  Peace Studies, University of Bradford, UK

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Outline

• Public health
• WHO Biosafety/Biosecurity Guidelines (2004)
• International Health Regulations (2005)
• Laboratory Biorisk Management Standard (2008)
• Arms control
• BTWC (1972)
• Chemical Weapons Convention (1993)
• Engagement of life scientists
• Oversight
• Codes of conduct
• Education

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National implementation
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1. Public health
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Laboratory measures

• Objective
• The WHO Laboratory Biosafety Manual is a helpful
  reference for states that accept the challenge to
  develop and establish national codes of practice
  for securing their microbiological assets, yet
  ensuring their availability for clinical,
  research and epidemiological purposes.
• Codes of practice a codified list or
  guideline or standard of required essential
  safety practices and procedures.
• (WHO 2004)

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Laboratory measures

• Biosafety level (BSL) 1-2
• Access
• Authorizing access, hazard signs, and
  gates/doors closed
• Personal protection
• Uniforms (coveralls, glasses, and footwear),
  washing hands
• Procedures
• No pipetting by mouth, limited and written
  procedures for clean-up, and procedures
  minimizing the formation of aerosols and droplets
• Laboratory working areas
• keeping neat, clean and free of potentially
  dangerous material at the end of the working day
• Biosafety management
• This is the responsibility of the laboratory
  director
• Training, evaluation, surveillance and treatment
  should be provided when necessary

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Laboratory measures

• Biosafety level (BSL) 3
• BSL 1-2 applies except where modified as follows
• Biohazard symbol must include the name of the
  laboratory supervisor
• Laboratory protective clothing upgrade
• Open manipulations of all potentially infectious
  material contained
• Respiratory protective equipment may be necessary
• Biosafety level (BSL) 4
• BSL 3 applies except where modified as follows
• The two-person rule should apply, whereby no
  individual ever works alone
• A complete change of clothing and shoes is
  required prior to entering the laboratory
• Personnel must be trained in emergency extraction
  procedures
• A method of communication for routine and
  emergency contacts

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Laboratory measures Georgia

• Association
• Is a member of the Biosafety Association for
  Central Asia and the Caucasus (BACAC)
• Provides guidelines and definitions of 1.
  Biosafety level, 2. Risk assessment, 3. BSL3
  laboratories, and 4. Biosecurity.
• Has access to a training tool (video)
• Working at Animal Biosafety Level 1, 2 and 3
• http//www.bacac.org/sections/resources_tools
• (BACAC 2010)
• Has a national network on biosafety and
  biosecurity
• Comprising a network of 11 regions and 66
  districts
• Is one of the main responsibilities of the
  National Center for Disease Control and Public
  Health (NCDC)
• (Bakanidze et al 2010)

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Laboratory measures

• The Georgian Biosafety Association (GeBSA) was
  formed in September 2009 to promote biosecurity
  and biosafety in Georgia and provide a forum for
  sharing of best practices. GeBSA has more than
  100 members from different institutions all over
  Georgia. Georgian Biosafety Association (GeBSA)
  is the union of specialists dealing with
  pathogenic biological agents.

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Laboratory measures

• Goals are to
• Promote biosafety as a priority for the country
• Assist members in the development of projects,
  programs, guidelines, standards and regulations
• Integrate international best practices of
  biosafety /biosecurity into biomedical studies
• Promote the development of research and science
  using modern biosafety and biosecurity methods
• Develop and deliver integral training programs
• Promote biosafety cooperation with international
  associations and societies
• (EBSA 2012)

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Exercise 1

• Laboratory safety/security whose responsibility?
• Who should be responsible for laboratory safety
  and security measures (scientists, PI, managers
  of the institutions or government)?. How should
  such processes be implemented?
• Read the document (the case of Thomas Bulter -
  Texas Tech University ) and report to the class
  (10 min).

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Laboratory measures

• Is physical protection enough for laboratory
  safety and security?
• Laboratory Biorisk Management Standard
  (CWA-157932008)
• Flexible risk assessment approach not based on
  an assumed static level of risk agents but
  situational
• Timing and scope when to review practices?
  (e.g.)
• Commencement of new work or changes to the
  programme of work including the introduction of
  new biological agents
• New construction / modifications to laboratories,
  plant and equipment or its operation
• When considering emergency response and
  contingency planning requirements

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Laboratory measures

• Laboratory Biorisk Management Standard
  (CWA-157932008)

• Highlighting the role of the top manager
• Top management shall take ultimate
  responsibility for the organizations biorisk
  management system.
• Top management includes Officers (Director
  General, Chief Executive Officer, Chief Operating
  Officer, Chief Financial Officer, etc.) and
  Directors of the organization.

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Laboratory measures

• Laboratory Biorisk Management Standard
  (CWA-157932008)
• Planning for hazard identification, risk
  assessment and risk control
• Identifying roles, responsibilities and
  authorities of actors
• Personnel training, awareness and competence
• Operational control (physical and technical
  procedures)
• Emergency response and contingency plans
• Wider than the physical protection of agents
  and toxins
• Each element is detailed and instructions
  provided in the document

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Public health measures

• The stated purpose of the International Health
  Regulations (IHR) 2005 are
• "to prevent, protect against, control and
  provide a public health response to the
  international spread of disease in ways that are
  commensurate with and restricted to public health
  risks, and which avoid unnecessary interference
  with international traffic and trade.
• (WHO 2012a)
• 3 top priorities of the IHR (WHO 2012) - States
  should
• Establish a functioning National IHR Focal Point
• Ensure adherence to reporting requirements and
  verification of public health events.
• Assess and strengthen national capacities

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Public health measures (IHR)

• 8 Core capacities required of States
• National legislation, policy and financing,
• Coordination and NFP communications,
• Surveillance,
• Response,
• Preparedness,
• Risk communication,
• Human resource, and
• Laboratory.

See Checklist and Indicators for Monitoring
Progress in the Development of IHR Core
Capacities in States Parties (WHO/HSE/IHR/2010.1.R
ev.1)
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Public health measures (IHR)

• Concern
• The IHRs do not have an enforcement mechanism (no
  teeth!) against non-compliance
• Rationale
• Non-compliance risks run by States
• tarnished international image
• increased morbidity/mortality of affected
  populations,
• unilateral travel and trade restrictions
• economic and social disruption and
• public outrage
• (WHO 2012b)

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Public health measures (IHR)

• National Center for Disease Control and Public
  Health (NCDC), which comprises a network of 11
  regional and 66 district (rayon) Centers for
  Public Health and also houses the Georgian
  national collection of especially dangerous
  pathogens.
• The designation of NCDC as the National Focal
  Point for the IHR provided a strong renewal of
  commitment to advance the legislative framework
  for biosafety and biosecurity in Georgia in the
  context of the national efforts to meet the core
  capacity requirements of the IHR.
• (Bakanidze, et al 2010)

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2. Arms control
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National implementation of an international
legal agreement

• Biological and Toxin Weapons ConventionArticle
  IVEach State Party to this Convention shall, in
  accordance with its constitutional processes,
  take any necessary measures to prohibit and
  prevent the development, production, stockpiling,
  acquisition, or retention of the agents, toxins,
  weapons, equipment and means of delivery
  specified in article I of the Convention.
• Chemical Weapons Convention
• Article VII
• Each State Party shall, in accordance with its
  constitutional processes, adopt the necessary
  measures to implement its obligations under this
  Convention. 

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National implementation of an international
legal agreement
in accordance with its constitutional process
No one size fits all

• Case of the BTWC options for States
• Existing national regulations are enough to
  achieve the scope of the BTWC and no further
  legislation is necessary
• Certain amendments of existing laws and
  regulations are necessary
• An act is newly enacted specifically for the
  BTWC, and
• Broader legislation is enacted not only for the
  BTWC but generally for anti-terrorism acts
• (ROK 2003)

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National implementation of an international
legal agreement

• Georgia
• BTWC
• Approximately 20 processes of legislation to
  implement the scope of the Convention, including
  via the criminal code, anti-terrorism and public
  health measures
• (VERTIC 2012)
• Chemical Weapons Convention (CWC)
• No legislation is registered with the CWC website
• (OPCW)

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BTWC Submission of Confidence Building Measures
(CBMs)
1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998
AB v v v v v
GE v v v v v
PK
TJ v v v v v
UKR v v v v v v
1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011
AB v v v v
GE v v v v v v v v v v v
PK
TJ v
UKR v v v v v v v v v v v v
AB (Azerbaijan), GE (Georgia), PK (Pakistan), TJ
(Tajikistan), UKR (Ukraine) Table was created
based on the database of the UNOG
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Evolution of the BTWC strengthening national
measures
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From a traditional disarmament regime to a
security architecture
Evolution of the BTWC strengthening national
measures
Extending threat spectrum gt Manmade, safety and
natural threats/risks All hazard
approach Institutional evolution gt terrorism,
crime and public health sectors (e.g. UNSCR1540,
Interpol, WHO, OIE, FAO, IFBA)
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Exercise2

• Are legal obligations sufficient to ensure an
  effective security culture?
• Discuss what kind of other national measures (in
  parallel to laboratory security/safety at
  institutions and legal obligations) should or
  could be developed in order to prevent the misuse
  of the life sciences in society
• What kind of other social actors can play a
  biosecurity role?
• (10 min)
• Report to the class

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3. Engagement of life scientists
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Oversight of Research

• A possible policy process for oversight
• E.g.
• USA - The National Science Advisory Board for
  Biosecurity (NSABB)
• Israel - Steering Committee on Issues in
  Biotechnological Research in the Age of Terrorism

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Codes of Conduct

• InterAcademy Panel (IAP) Statement on Biosecurity
  (2005)
• Endorsed by over 60 national science academies
• Defines five fundamental policies
• Awareness
• Safety and security
• Education and information
• Accountability
• Oversight.
• National example
• Royal Netherlands Academy of Arts and Sciences
  (2005)
• A Code of Conduct for Biosecurity
• Indonesian Academy of Sciences (forthcoming)
  (Sudoyo 2011)

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Education national action plan

• A national biosecurity dual-use action plan model
• Identify what is currently taught (a survey)
• Develop a network of interested lecturers
• Develop appropriate content for courses
• Implement pilot courses
• Monitor and evaluate pilot courses
• Identify and elucidate best practice
• Institute clear, active links between industrial
  partners/associates, defence agencies and
  academic institutions teaching biosecurity
• Develop or participate in an international
  network to share best practice
• Make dual-use/biosecurity education mandatory
• Monitor consequential growth of sensible codes
  and oversight systems
• Report on progress to BTWC and relevant
  scientific meetings

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Education national action plan

• 1. Developing an educational resource for codes
  of conduct
• 2. Developing capacity building programmes
• 3. Changing evaluation criteria of funding
  bodies or review criteria of scientific journals
• 4. Changing evaluation criteria on higher
  education institutions
• 5. Establishing a national advisory board
• 6. Legislating a biosecurity act

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5
4
3
2
1
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Engagement of scientists in Georgia

• International workshop 2008
• Emerging and endemic pathogens advances in
  surveillance detection, and identification (2008)
  
• Table top exercise 2010
• Focused on issues on public health, security and
  law enforcement (2010), addressing issues around
  the BTWC, UNSCR 1540 and IHR
• Held at a major international workshop in
  Tblisis, in cooperation with WHO, International
  Criminal Police Organization INTERPOL, NATO,
  the U.S. Government (DoD, HHS, Department of
  Energy, Department of State, and Federal Bureau
  of Investigation FBI
• (Bakanidze et al 2010)

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National measures Areas of possible improvement

• Georgia
• Laboratory safety measures
• Efforts have been made
• National legislation of the BTWC
• Efforts have been made, the legislative
  information to the OPCW can be considered
• Education and Codes of Conduct
• Further improvement can be made (e.g.)
• Biosecurty code of conduct
• Survey of the current state of biosecurity
  education

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References

• The references cited in this presentation may be
  found in the Notes section of this slide.