National Series Lecture 4 National Measures Georgia Bradford Disarmament Research Centre Division of Peace Studies, University of Bradford, UK Picture Image Transparent Globe by digitalart - from:

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

National implementation 1 International agreement 2 Signature and ratification by states 3 National measures in states Legislation, regulation order or other forms

1. Public health Picture Image :Protect Heart by digitalart - from:

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)

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 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 Laboratory measures

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” (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) Laboratory measures: Georgia

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.

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) Laboratory measures

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).

Is physical protection enough for laboratory safety and security? Laboratory Biorisk Management Standard (CWA-15793:2008) 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; Laboratory measures

Laboratory Biorisk Management Standard (CWA-15793:2008) Highlighting the role of the top manager “Top management shall take ultimate responsibility for the organization’s biorisk management system.” Top management includes Officers (Director General, Chief Executive Officer, Chief Operating Officer, Chief Financial Officer, etc.) and Directors of the organization.

Laboratory measures Laboratory Biorisk Management Standard (CWA-15793:2008) 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

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

8 Core capacities required of States: 1.National legislation, policy and financing, 2.Coordination and NFP communications, 3.Surveillance, 4.Response, 5.Preparedness, 6.Risk communication, 7.Human resource, and 8.Laboratory. See Checklist and Indicators for Monitoring Progress in the Development of IHR Core Capacities in States Parties (WHO/HSE/IHR/ Rev.1) 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) 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) Public health measures (IHR)

2. Arms control

National implementation of an international legal agreement Biological and Toxin Weapons Convention Article IV “Each 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.”

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

AB√√√√√ GE√√√√√ PK TJ√√√√√ UKR√√√√√√ BTWC Submission of Confidence Building Measures (CBMs) AB √√√√ GE √√√√√√√√√√√ PK TJ √ UKR √ √√√√√√√√√√√ AB (Azerbaijan), GE (Georgia), PK (Pakistan), TJ (Tajikistan), UKR (Ukraine) Table was created based on the database of the UNOG

Evolution of the BTWC: strengthening national measures (AHG) Major threat State offensive programmes Security approach Compliance (Organization, verification) / (ISP) Major threat Primarily non-state level Terrorism, crimes Security measures – a national approach Legislation, laboratory measures, codes, oversight, public health (e.g. surveillance)

From a traditional disarmament regime to a security architecture / Extending threat spectrum > Manmade, safety and natural threats/risks = All hazard approach Institutional evolution > terrorism, crime and public health sectors (e.g. UNSCR1540, Interpol, WHO, OIE, FAO, IFBA) Evolution of the BTWC: strengthening national measures

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

3. Engagement of life scientists Picture Image Business Team With Puzzle by digitalart - from:

Committee Holding interdisciplinary discussions on the definition of risks, biosecurity measures and strategic recommendations for policy development in biosecurity Advisory board Providing guidelines for the oversight of scientific research, laboratory management measures, and awareness raising of scientists. 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 Oversight of Research

Codes of Conduct InterAcademy Panel (IAP) Statement on Biosecurity (2005) –Endorsed by over 60 national science academies –Defines five fundamental policies: 1.Awareness; 2.Safety and security; 3.Education and information; 4.Accountability; 5.Oversight. National example –Royal Netherlands Academy of Arts and Sciences (2005) A Code of Conduct for Biosecurity –Indonesian Academy of Sciences (forthcoming) (Sudoyo 2011)

A national biosecurity dual-use action plan model 1.Identify what is currently taught (a survey) 2.Develop a network of interested lecturers 3.Develop appropriate content for courses 4.Implement pilot courses 5.Monitor and evaluate pilot courses 6.Identify and elucidate best practice 7.Institute clear, active links between industrial partners/associates, defence agencies and academic institutions teaching biosecurity 8.Develop or participate in an international network to share best practice 9.Make dual-use/biosecurity education mandatory 10.Monitor consequential growth of sensible codes and oversight systems 11.Report on progress to BTWC and relevant scientific meetings Education national action plan

Structural Individual AutonomousLegal 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 Education national action plan

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) Engagement of scientists in Georgia

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

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