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National Series Lecture 4 National Measures Armenia

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1 National Series Lecture 4 National Measures Armenia
Bradford Disarmament Research Centre Division of Peace Studies, University of Bradford, UK National Series Lecture 4 National Measures Armenia This lecture aims to develop your understanding of the national implementation by countries of measures derived from key elements of the Web of Prevention (discussed in Lecture 3). It specifically illustrates how internationally agreed norms can be integrated into the policy processes of individual countries. Picture Image Transparent Globe by digitalart - from:

2 Outline Public health Arms control Engagement of life scientists
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

3 National implementation
1 International agreement 2 Signature and ratification by states 3 National measures in states Legislation, regulation order or other forms Notes: National implementation is a process to domestically implement the norms agreed under an international treaty/agreement in the form of legislation, regulation, order or other measures within the specific legal and political system of a state.

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

5 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] of essential safety practices and procedures. (WHO 2004) Notes: “The WHO Laboratory Biosafety Manual is a helpful reference and guide to states that accept the challenge to develop and establish national codes of practice for securing theirmicrobiological assets, yet ensuring their availability for clinical, research and epidemiological purposes.” Establishing “national codes of practice securing microbiological assets…[that] is a listing of the most essential laboratory practices and procedures that are basic to GMT [good microbiological techniques]. Ref: WHO. (2004) Laboratory Biosafety Manual, Geneva: WHO. 3rd ed.

6 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 Notes: Access “1. The international biohazard warning symbol and sign (Figure 1) must be displayed on the doors of the rooms where microorganisms of Risk Group 2 or higher risk groups are handled. 2. Only authorized persons should be allowed to enter the laboratory working areas. 3. Laboratory doors should be kept closed. 4. Children should not be authorized or allowed to enter laboratory working areas. 5. Access to animal houses should be specially authorized. 6. No animals should be admitted other than those involved in the work of the laboratory. Personal Protection 1. Laboratory coveralls, gowns or uniforms must be worn at all times for work in the laboratory. 2. Appropriate gloves must be worn for all procedures that may involve direct or accidental contact with blood, body fluids and other potentially infectious materials or infected animals. After use, gloves should be removed aseptically and hands must then be washed. 3. Personnel must wash their hands after handling infectious materials and animals, and before they leave the laboratory working areas. 4. Safety glasses, face shields (visors) or other protective devices must be worn when it is necessary to protect the eyes and face from splashes, impacting objects and sources of artificial ultraviolet radiation. 5. It is prohibited to wear protective laboratory clothing outside the laboratory, e.g. in canteens, coffee rooms, offices, libraries, staff rooms and toilets. 6. Open-toed footwear must not be worn in laboratories. 7. Eating, drinking, smoking, applying cosmetics and handling contact lenses is prohibited in the laboratory working areas. 8. Storing human foods or drinks anywhere in the laboratory working areas is prohibited. 9. Protective laboratory clothing that has been used in the laboratory must not be stored in the same lockers or cupboards as street clothing. Procedures 1. Pipetting by mouth must be strictly forbidden. 2. Materials must not be placed in the mouth. Labels must not be licked. 3. All technical procedures should be performed in a way that minimizes the formation of aerosols and droplets. 4. The use of hypodermic needles and syringes should be limited. They must not be used as substitutes for pipetting devices or for any purpose other than parenteral injection or aspiration of fluids from laboratory animals. 5. All spills, accidents and overt or potential exposures to infectious materials must be reported to the laboratory supervisor. A written record of such accidents and incidents should be maintained. 6. A written procedure for the clean-up of all spills must be developed and followed. 7. Contaminated liquids must be decontaminated (chemically or physically) before discharge to the sanitary sewer. An effluent treatment system may be required, depending on the risk assessment for the agent(s) being handled. 8. Written documents that are expected to be removed from the laboratory need to be protected from contamination while in the laboratory. Laboratory working areas 1. The laboratory should be kept neat, clean and free of materials that are not pertinent to the work. 2. Work surfaces must be decontaminated after any spill of potentially dangerous material and at the end of the working day. 3. All contaminated materials, specimens and cultures must be decontaminated before disposal or cleaning for reuse. 4. Packing and transportation must follow applicable national and/or international regulations. 5. When windows can be opened, they should be fitted with arthropod-proof screens. Biosafety management 1. It is the responsibility of the laboratory director (the person who has immediate responsibility for the laboratory) to ensure the development and adoption of a biosafety management plan and a safety or operations manual. 2. The laboratory supervisor (reporting to the laboratory director) should ensure that regular training in laboratory safety is provided. 3. Personnel should be advised of special hazards, and required to read the safety or operations manual and follow standard practices and procedures. The laboratory supervisor should make sure that all personnel understand these. A copy of the safety or operations manual should be available in the laboratory. 4. There should be an arthropod and rodent control programme. 5. Appropriate medical evaluation, surveillance and treatment should be provided for all personnel in case of need, and adequate medical records should be maintained.” Ref: WHO. (2004) Laboratory Biosafety Manual, Geneva: WHO. 3rd ed.

7 Laboratory measures Biosafety level (BSL) 3 Biosafety level (BSL) 4
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 Notes: BSL3 The code of practice for basic laboratories – Biosafety Levels 1 and 2 applies except where modified as follows. 1. The international biohazard warning symbol and sign displayed on laboratory access doors must identify the biosafety level and the name of the laboratory supervisor who controls access, and indicate any special conditions for entry into the area, e.g. immunization. 2. Laboratory protective clothing must be of the type with solid-front or wrap-around gowns, scrub suits, coveralls, head covering and, where appropriate, shoe covers or dedicated shoes. Front-buttoned standard laboratory coats are unsuitable, as are sleeves that do not fully cover the forearms. Laboratory protective clothing must not be worn outside the laboratory, and it must be decontaminated before it is laundered. The removal of street clothing and change into dedicated laboratory clothing may be warranted when working with certain agents (e.g. agricultural or zoonotic agents). 3. Open manipulations of all potentially infectious material must be conducted within a biological safety cabinet or other primary containment device. 4. Respiratory protective equipment may be necessary for some laboratory procedures or working with animals infected with certain pathogens. BSL4 The code of practice for Biosafety Level 3 applies except where modified as follows: 1. The two-person rule should apply, whereby no individual ever works alone. This is particularly important if working in a Biosafety Level 4 suit facility. 2. A complete change of clothing and shoes is required prior to entering and upon exiting the laboratory. 3. Personnel must be trained in emergency extraction procedures in the event of personnel injury or illness. 4. A method of communication for routine and emergency contacts must be established between personnel working within the maximum containment laboratory – Biosafety Level 4 - and support personnel outside the laboratory. Ref: WHO. (2004) Laboratory Biosafety Manual, Geneva: WHO. 3rd ed.

8 Laboratory measures The Biosafety Association for Central Asia and Caucasus (BACAC) was formed in November 2008 to promote biosecurity and biosafety in the region and provide a forum for sharing of best practices. The newly formed professional association draws its members from Armenia, Kazakhstan, Kyrgyzstan, Tajikistan, Uzbekistan, Azerbaijan, Georgia, Turkmenistan, Afghanistan and Mongolia. The first annual BACAC conference “Biosafety and Bacterial-Viral Zoonotic Diseases” will be held May 18-20, 2009 in Almaty, Kazakhstan. Key topics include: Global Biosafety – Integrating Central Asia Biosafety Practices for Reducing Zoonotic Diseases Biocontainment, Biosafety and Biosecurity Guidelines, Standards and Regulations Biosafety and Biosecurity Challenges in Central Asia Pre-conference training workshops will also be offered in the areas of Risk Assessment, Biosafety Level 3 Facilities, Biological Safety Cabinets, and Laboratory Biorisks. (BACAC 2012) Note: BACAC (2012) Biosafety Association for Central Asia and Caucasus. Available from:

9 Laboratory safety/security: whose responsibility?
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). Organize the class into several groups and distribute an article on a real case of laboratory malpractice (the case of Thomas Butler: available at Give 10 minutes for discussion and ask groups to report their views back to the class. Ref: Malakoff, D., and Enserink, M. (2003) Butler Cleared on Most Biosecurity Charges, Convicted of Fraud, Science, 302(5651), p

10 Laboratory measures 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; Notes: “The requirements of this standard are generic and are intended to be applicable to all organizations handling biological agents and/or toxins, regardless of type, size and biological agents handled. This standard takes a risk-based approach but it does not employ biological agent risk classification or laboratory safety/containment levels, although such approaches can be entirely compatible with this standard.” “The following should trigger either a new risk assessment or review of an existing one: a) commencement of new work or changes to the programme of work including the introduction of new biological agents or alterations to work flow or volume; b) new construction / modifications to laboratories, plant and equipment or its operation; c) introduction of altered and unplanned staffing arrangements (including contractors, visitors and other non-core personnel); d) significant alterations to Standard Operating Procedures (SOPs) or working practices (e.g. disinfection / waste management methodologies, PPE provision / usage entry / exit protocols, etc.); e) when unexpected events that may have relevance for the management of biorisks are observed; f) when actual or potential non-conformity with internal / external rules and regulations is identified (e.g. introduction of new legislation or major accident exposure); g) when considering emergency response and contingency planning requirements; h) as part of the existing management system review process (e.g. annually or at another appropriate and predetermined frequency).” Ref: CEN. (2008) Laboratory biorisk management standard, CWA 15793, February.

11 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. Notes:“Top management shall ensure that roles, responsibilities and authorities related to biorisk management are defined, documented and communicated to those who manage, perform and verify work associated with the control of biological agents and toxins.” “Overall responsibility for management of biorisk rests with top management but tasks may be delegated through the organization provided that they are passed to competent individuals with adequate resources to perform the activities safely and securely. In smaller organizations, one individual may hold more than one role described in the standard. It is important to define roles and responsibilities and that there is clear communication within the organization in terms of the actions that need to be taken, and who has the required authority.” “Application of the management systems approach principle leads to the following actions: a) defining the system by identifying or developing the processes that affect a given objective; b) structuring the system to achieve the objective in the most effective manner; c) understanding the interdependencies among the processes of the system; d) continually improving the system through measurement and evaluation, and; e) establishing resource constraints prior to action.” Ref: CEN. (2008) Laboratory biorisk management standard, CWA 15793, February.

12 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 Notes: “The organization shall continually improve the effectiveness of the biorisk management system through the use of the policy, objectives, self-audit programme, audit results, analysis of data, risk assessment, corrective and preventive actions and the management review.” Ref: CEN. (2008) Laboratory biorisk management standard, CWA 15793, February.

13 Public health measures
The stated purpose of the International Health Regulations (IHR) 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 Notes: “In response to the exponential increase in international travel and trade, and emergence and reemergence of international disease threats and other health risks, 194 countries across the globe have agreed to implement the International Health Regulations (IHR) (2005)” “Because the IHR are not limited to specific diseases, but are applicable to health risks, irrespective of their origin or source, they will follow the evolution of diseases and the factors affecting their emergence and transmission.” (WHO 2012) 1. “The NFP [national focal point] is a national centre, established or designated by each State Party, accessible at all times (7/24/365) for IHR related communications and collaborative risk assessment with WHO IHR Contact Points. Mandatory functions of the NFPs include: (1) sending to WHO IHR Contact Points urgent communications concerning IHR (2005) implementation; and (2) disseminating information to, and consolidating input from, relevant sectors of the administration within the country, including those responsible for surveillance and reporting, points on entry, public health services, clinics and hospitals.” (WHO 2012) 2. “Under the IHR (2005), notification is based upon the identification and assessment by the State Party of "events" within its territory "which may constitute a public health emergency of international concern" ("PHEIC"). Each State Party is required to assess public health events according to the multi-factor decision instrument provided in Annex 2 of the IHR (2005). States Parties must notify WHO of any event that meets at least 2 of the 4 decision criteria within 24 hours after having carried out the assessment.” (WHO 2012) 3. “The IHR (2005) require each State Party to develop, strengthen and maintain core national public health capacities at the primary, intermediate and national levels in order to detect, assess, notify and report events and to respond promptly and effectively to public health risks and emergencies. The IHR (2005) set out a two-phase process to assist States Parties to plan for the implementation of their capacity strengthening obligations”. (WHO 2012) “Phase 1: 15 June June 2009 By 15 June 2009, States Parties must assess the ability of their existing national public health structures and resources to meet the core surveillance and response capacity requirements described in Annex 1A of the IHR (2005).” (WHO 2012) “Phase 2: 15 June June 2012 By 15 June 2012, the surveillance and response capacities set out in Annex 1A are expected to be implemented by each State Party. States Parties that experience difficulties in implementing their national plans may request an additional 2-year period until 15 June 2014 to meet their Annex 1A obligations.” (WHO 2012) Ref: WHO (2005) International Health Regulation, Geneva: WHO. Available from: WHO (2012a) Top priorities for States Parties to implement the IHR (2005), Geneva: WHO. Available from:

14 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. Notes: “The IHR (2005) provide obligations and rights for States Parties. States Parties have been required to comply with and implement the IHR starting with their entry into force in To do so, States Parties need to have an adequate legal framework to support and enable implementation of all of their obligations and rights. In some States Parties, implemention of the IHR may require that they adopt implementing or enabling legislation for some or all of these obligations and rights.” “The effective implementation of the IHR requires multisectoral/multidisciplinary approaches through national partnerships for effective alert and response systems. Coordination of nation-wide resources, including the designation of an IHR NFP, which is a national centre for IHR communications, is a key requisite for IHR implementation.” “The IHR require the rapid detection of public health risks, as well as the prompt risk assessment, notification, and response to these risks. To this end, a sensitive and flexible surveillance system is needed with an early warning function is necessary.” “Command, communications and control operations mechanisms are required to facilitate the coordination and management of outbreak operations and other public health events. Multidisciplinary/multisectoral Rapid Response Teams (RRT) should be established and be available 24 hours a day, 7 days a week.” “Preparedness includes the development of national, intermediate and community/primary response level public health emergency response plans for relevant biological, chemical, radiological and nuclear hazards.” “Risk communications should be a multi-level and multi-faceted process which aims to help stakeholders define risks, identify hazards, assess vulnerabilities and promote community resilience, thereby promoting the capacity to cope with an unfolding public health emergency.” “Strengthening the skills and competencies of public health personnel is critical to the sustainment of public health surveillance and response at all levels of the health system and the effective implementation of the IHR.” “Laboratory services are part of every phase of alert and response, including detection, investigation and response, with laboratory analysis of samples performed either domestically or through collaborating centres.” Ref: WHO. (2011) Checklist and Indicators for Monitoring Progress in the Development of IHR Core Capacities in States Parties. Geneva: WHO. Available from: See Checklist and Indicators for Monitoring Progress in the Development of IHR Core Capacities in States Parties (WHO/HSE/IHR/ Rev.1)

15 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) Notes: “Although the IHR (2005) do not include an enforcement mechanism per se for States which fail to comply with its provisions, the potential consequences of non-compliance are themselves a powerful compliance tool.” “The consequences of non-compliance may include tarnished international image, increased morbidity/mortality of affected populations, unilateral travel and trade restrictions, economic and social disruption and public outrage.” Ref: WHO. (2012b) Frequently asked questions about the International Health Regulations [online] Geneva: WHO. Available from:

16 Public health measures (IHR)
Armenia To pilot and further develop a flexible tool for the assessment of the country’s capacity for emergency preparedness and response with special reference to: the legal framework and institutional arrangements in place for the prevention and mitigation of, preparedness for and response to potential natural and man-made disasters11 ; the compatibility of the national legal framework with the provisions of the IHR; the core capacity necessary for IHR implementation; the capacity to deal with disasters resulting from the release of chemical substances, be they accidental or intentional; the capacity to deal with emerging threats related to climate change, including increased morbidity and mortality from heat, heat waves, floods, windstorms, and communicable diseases (vector-borne, waterborne and foodborne). the compatibility of preparedness plans for avian influenza and pandemic influenza (and other plans related to outbreaks of communicable diseases) with the generic preparedness and response plans. (WHO EUROPE 2007) Notes: WHO EUROPE. (2007) Assessment of Health and Security Crisis Management: Armenia, [online] Available from:

17 2. Arms control

18 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.”  Notes: Article I of the BTWC stipulates that: Each State Party to this Convention undertakes never in any circumstances to develop, produce, stockpile or otherwise acquire or retain: (1) Microbial or other biological agents, or toxins whatever their origin or method of production, of types and in quantities that have no justification for prophylactic, protective or other peaceful purposes; (2) Weapons, equipment or means of delivery designed to use such agents or toxins for hostile purposes or in armed conflict.

19 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) Notes: National legislation is a process to domestically implement the norm embodied in an international treaty within a specific legal system of a state. Since each country possesses a different legal system, it is understood that the implementation of specific regulations are left to the discretion of States Parties. Dunworth and MCCormack explain the different legislative process between common law and civil law traditions in order to nationally implement the BTWC. Ref: Dunworth, T. and McCormack, T. L, H. (2006) National Implementation of the Biological Weapons Convention. Journal of Conflict and Security Law, 11(1), at p. 98 Republic of Korea. (2003) National Measures or Legislation to Implement the BTWC: A Conceptual Analysis, BWC/MSP.2003/MX/WP16, 6 August, Geneva: United Nations. Available from at pp. 3-4.

20 National implementation of an international legal agreement
Armenia BTWC 12 national legislation are registered with the UN website of the BTWC, including penal codes, an anti-terrorism law and an extensive set of export control laws. (VERTIC 2012) Chemical Weapons Convention (CWC) No legislation is registered with the CWC website. (OPCW) Notes: BTWC: Government Enactment No. 121 on Matters of Export Control of Primary Products, Materials, Equipment, Technologies, and Services No Description Available    Government Enactment No. 537 on the Establishment of Export Controls on Primary Products, Materials, Equipment, Technologies, and Establishes the export control system basic structure including special export licensing and permission. Presidential Decree No. 227, 1 May 1993 Establishes the Commission on Export Control under the Cabinet of Ministers. Resolution of the Cabinet of Ministers No. 391, 28 July 1993 Approves the rules and regulations of the commission, its membership and the membership of the group of experts List of Materials, Substances, Equipment and Dual-use Technologies Export of Which Must be Licensed, 27 September 1993 Contains an itemized export control list of dual-used technologies including bacteriological and poisonous weapons-related, as well as rocket weapons-related. Refers to criminal law for the penalty of illegal export of any of the items contained in the list, which envisages 3 to 8 years of imprisonment. Cabinet of Ministers Resolution No. 487, 27 September 1993 Adopts in compliance with Minsk Agreement a four part list of dual-use items and technologies requiring a licence for export, capable of being used for the production of inter alias biological and toxin weapons, and missile systems. Customs Code of January 1, 2001 (amended on July 1, 2003) The Customs Committee and the National Security Service of the Republic of Armenia are the lead agencies bearing the responsibility for preventing the import and export of unlicensed goods, investigating offences, and taking appropriate action. In all cases considered for prosecution, the Customs Committee is bound to act in accordance with the Customs Code. The Export Control Commission provides a methodological support to the companies in establishing the export control internal compliance programme by exporters and shipping companies. The Law of the Republic of Armenia on the Struggle against Terrorism, September 2001 Law of September 24, 2003 On Export control of dual-use items and technologies and its transit across the territory of the Republic of Armenia. Replaced existing export control powers and all former Governmental decrees that were regulating the export control related issues. Envisages the establishment of the Export Control Commission, responsible for issuing the permission or denial for exporting the dual use items and technologies; developing of the export control mechanisms and its improvement; creating new control list; organizing the deliberations with the participation of concerned ministries and agencies on each request, connected with dual-use item and technology; registering the exporters; providing the information to the exporters and industry on recent developments with regard to export control legislation and international non- proliferation regimes as well as for the receiving of notifications about the transit of dual use items and technologies across the territory of the country. Criminal Code of 18 April 2003 (entered into force on 2 August 2003) Criminalizes the actions prohibited by WMD non-proliferation related treaties, establishing, inter alia, the extraterritorial jurisdiction for relevant crimes and determining the criminal responsibility also for different forms of complicity. Articles 14 and 15 Territorial and extra-territorial jurisdiction. Article 386 (Section 13, Chapter 33 - Crimes against peace and security), on «Manufacture or proliferation of mass destruction weapons» Prohibits the development, production, acquiring or selling of WMD, which envisages from 4 to 8 years of imprisonment. Article 215 prohibits the smuggling of nuclear, chemical, biological or other mass destruction weapons, or dual-use materials, devices, or technologies which can also be used for the creation or use of mass destruction weapons or missile delivery systems thereof. This article provides, as sanction, the imprisonment from 4 to 8 years with confiscation of property or without it. Article 217 Defines terrorism and, if it is accompanied with use of weapon of mass destruction, radioactive materials or with a threat to use other means causing mass losses, is punished with imprisonment for the term of 10 to15 years. Government Decree No. 212-N of 19 February Establishes the rules and composition of the Export Control Commission. Governmental Decree No. 765-N of 20 May On rules and procedures for inspection of controlled items and technologies by experts. Ref: OPCW. (2012) CWC national implementing legislation database [online] Available from: VERTIC. (2012) BWC Legislation Database [online] Available from:

21 BTWC: Armenia’s Submission of Confidence Building Measures (CBMs)
1987 1988 1989 1990 1991 1992 1993 1994 1995 1996 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009 2010 2011 2012 Armenia has a good record of its CBM submission to the Convention since the establishment of the CBM mechanisms. Currently the government’s submission is not opened for the public and the CBM returns are only available to the members of the BTWC. Notes: This slide shows the record of Iraq’s CBM submission to the UN between 1991 and 2012. According to Macintosh, CBMs are “a form of arms control possessing genuine promise for reducing the chances of unintended or accidental war and for improving the basic quality of a specific political environment” (Macintosh 1990). “The Second Review Conference (1986) agreed to introduce Confidence-building Measures "in order to prevent or reduce the occurence of ambiguities, doubts and suspicions and in order to improve international co-operation in the field of peaceful biological activities". The CBMs were elaborated at a meeting of scientific and technical experts in 1987, and were modified and considerably expanded by the Third Review Conference in They have not been modified since, although the Sixth Review Conference in 2006 agreed on various improvements to the mechanisms for submission and distribution” (United Nations 2012). As agreed at the Third Review Conference, the CBMs consist of seven measures, A to G: CBM A Part 1: Exchange of data on research centres and laboratories; Part 2: Exchange of information on national biological defence research and development programmes. CBM B Exchange of information on outbreaks of infectious diseases and similar occurrences caused by toxins. CBM C Encouragement of publication of results and promotion of use of knowledge. CBM D Active promotion of contacts CBM E Declaration of legislation, regulations and other measures. CBM F Declaration of past activities in offensive and/or defensive biological research and development programmes. CBM G Declaration of vaccine production facilities.” Ref: Macintosh, J. (1990) Confidence-and security-building: A sceptical look. In: United Nations Department for Disarmament Affairs (Ed.) Disarmament. New York: United Nations, pp United Nations. (2012) Confidence Building Measures [online] Available from: Table was created based on the database of the UNOG

22 Evolution of the BTWC: strengthening national measures
2003- (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) Notes: At the end of the Cold War, a wide range of elements could be considered for strengthening the verification aspect of the BTWC regime. First, the submission of Confidence Building Measures (CBMs), agreed at the Third Review Conference of the Convention in 1991, made an unsatisfactory performance in the early years of the 1990s and the limited efficiency of CBMs in enhancing confidence in States’ compliance became apparent. Second, the agreement of the draft Chemical Weapons Convention in 1992 highlighted the lack of verification provisions of the BTWC. Third, in 1992 Boris Yeltsin acknowledged the existence of a state-run BW programme by the former Soviet Union after its ratification of the BTWC. Fourth, the United Nations Special Commission’s (UNSCOM) experiences in Iraq since 1991 raised awareness of the lack of universal membership of the BTWC regime and the significance of early detection of BW programmes and their proliferation. There were significant proliferation concerns about biological weapons at the State level in the early post-Cold War period. Under those circumstances, international efforts to strengthen the verification aspects of the BTWC were achieved firstly through the Ad Hoc Group of Governmental Experts (VEREX) process between 1992 and 1993 and, secondly, through the subsequent Ad Hoc Group (AHG) process between 1995 and 2001. However, the AHG process collapsed without adopting a verification Protocol in Importantly this was the same year when the anthrax letter incidents took place in the United States following the events of September 11th 2001, which propelled the threat of bioterrorism and actions by non-state actors onto the critical international security agenda. In this context, there was a shift in the major threat perceptions of States Parties regarding biological weapons, from state level proliferation to that at the non-state level. In response to the shift in threat perception, under the BTWC, an annual meeting process, the Inter-Sessional Process (ISP) of was developed, taking into account an increasing awareness in the international security discourse surrounding the issues of Weapons of Mass Destruction (WMD) and their potential linkages with non-state actors.

23 From a traditional disarmament regime to a security architecture
Evolution of the BTWC: strengthening national measures From a traditional disarmament regime to a security architecture 2003/06 2011- Notes: Regional groups of countries in particular have been working on this issue under the Biological and Toxin Weapons Convention (BTWC). Since 2003, the BTWC has conducted in-depth discussions on national implementation measures for the prohibition of biowarfare and bioterrorism. Due to the convergence of measures of preparedness against natural outbreaks of infectious diseases and of preparedness for bioterrorism/warfare (see Lecture 2), these discussions also included capacity-building in public health preparedness, in cooperation with the World Health Organization (WHO), the Food and Agriculture Organization (FAO) and the World Organization for Animal Health (OIE). The paying of careful attention to the public health issues under the BWTC is based on the growing understanding that there are policy overlaps in responding to and mitigating the effects of natural outbreaks of disease and also of deliberately-triggered outbreaks of disease. To further enhance biosecurity norms and practices in regard to dual-use issues, the BTWC developed specific discussions on education for biological scientists in 2008. 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)

24 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 Organize a class into several groups and give 10 minutes for discussion. Then ask them to report their views back to the class.

25 3. Engagement of life scientists
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26 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 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. Notes: There are examples of the establishment of an independent national advisory board for biosecurity. The actual experiences of this approach included the following stages: setting up a national committee to hold interdisciplinary discussions on the definition of risks, biosecurity measures and strategic recommendations for policy development in biosecurity; the establishment of an independent national board on biosecurity which provides guidelines for the oversight of scientific research, laboratory management measures, and awareness raising of scientists. In the United States, the National Research Council provided a series of advocacy reports including the influential Fink Committee Report in 2004 and the Lemon-Relman Committee Report in As a policy result of the Fink Report, The National Science Advisory Board for Biosecurity (NSABB) was established “to provide recommendations on developing programs of outreach and education on dual-use research issues for all scientists and laboratory workers at federally-funded institutions.” In a similar manner, in Israel, the Steering Committee on Issues in Biotechnological Research in the Age of Terrorism published its report in 2008 which led to the legislation of a biosecurity act and the establishment of the Council for Biological Disease Agent Research. The Council guides and oversees in-service training courses for researchers in academic fields, as well as commercial institutions, related to researching disease agents and disease generating organisms. Ref: Miller, S. and Selgelid, M. J., Ethical and philosophical consideration of the dual-use dilemma in the biological science, Science and engineering ethics. 13 (4), National Research Council. (2004) Biotechnology Research in an Age of Terrorism, Washington, D.C.: National Academies Press. National Research Council. (2006), Globalization, biosecurity and the future of the life sciences, Washington, DC: National Academies Press. NSABB. (2008) ‘Strategic Plan for Outreach and Education on Dual Use Research Issues’, Report of the NSABB Available from: Steering Committee on Issues in Biotechnological Research in an Age of Terrorism (2008) Biotechnological Research in an Age of Terrorism: Report Approved by the Council of the Israel Academy of Science and Humanities and the Israel National Security Council, Jerusalem: Israel Academy of Science and Humanities and Israel National Security Council.

27 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) Notes: The Inter-Academy Panel (IAP) is a global network of national science academies. See . Its primary aims are to “Provide high-quality, independent advice on science-related issues to government and society; Develop programmes for scientific capacity building, science education, science communication and other science-related issues of global significance; Lead efforts to forge closer collaboration among science academies and other scientific institutions.” “Released in December 2005, this IAP statement was issued ahead of the Meeting of States Parties of the Biological Weapons Convention (5 - 9 December 2005) in Geneva, and was endorsed by over 60 national science academies. The statement addresses five fundamental issues facing scientists working in the biosciences: awareness; safety and security; education and information; accountability; and oversight. Following the release of the biosecurity statement,  the Chilean Academy of Sciences, Uzbekistan Academy of Sciences and the Pontificia Academia Scientiarum have requested to be added to the listed signatories, as well as the Caribbean Academy of Sciences.” (IAP 2012) The Netherlands Academies of Arts and Sciences introduced a Code of Conduct for Biosecurity in Dando (2008a) illustrates the autonomous nature of the code, which is designed to be tailored by individual institutions for use in the awareness-raising processes of multiple institutions. The implementation of the Code is then monitored by the institutions using it, but not by a supervisory body. Dando also points out that the Dutch experience shows an effective combination of a top-down approach to set out a code and bottom up approach to tailor the code for local demands of individual institutions. Ref: Dando, M. R. (2008a) “The Dutch Experience with a Biosecurity Code of Conduct,” Bulletin of Atomic Scientists Available from IAP. (2005) IAP Statement on Biosecurity, Available From: IAP. (2012) Summary of IAP statements, Available from: Sudoyo, H. (2011) Promoting code of conduct on biosecurity for life sciences, presented at the IAP Inaugural Conference: Building Biorisk Capacity in Indonesia, September, Borobudur Hotel Jakarta, Indonesia.

28 Education: a 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 Notes: “The first 6 points are relatively easily achievable at grass-roots level in the academic and industrial sectors. The first three in particular are low- or no-cost activities that rely principally on the willingness to engage with the topic by interested, aware individuals and groups. Acknowledgement by a state’s scientific community of the need for a dual-use education plan for the present and future is a crucial starting point, requiring a either a critical mass of grass-roots individuals in support of it, or at least a powerful individual in a position to move the plan forward. Unless there is open recognition and discussion of the problem of dual-use and its biosecurity implications, then educational responses will not be forthcoming or taken up if offered.” (Sture, Shinomiya and Minehata 2012) “While it has been clearly shown that there is a significant lack of awareness amongst scientists around the world of dual-use issues, of the BTWC and the potential for harm in their own work or that of their colleagues, it is still possible to see some encouraging signs. Evidence shows that once the subject of biosecurity has been raised and discussed in a particular country, especially through the use of real-life dual use case studies, then considerable interest in the topic can be aroused, leading to requests for resources and support in the learning and teaching of biosecurity issues. A key entry-method for individuals and groups to influence their wider community of colleagues is to utilise existing provision for information-sharing and policy-making, such as institutional research boards, ethics committees and professional association meetings.” (Sture, Shinomiya and Minehata 2012) Ref: Sture, J., Shinomiya, N., and Minehata, M. (2012) Looking at the formulation of national education action plans, Medicine Conflict and Survival, [forthcoming]

29 Education: a national action plan
Structural Individual Autonomous Legal 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 6 5 4 3 Notes: 1. Malcolm Dando argues that placing open-source teaching material online, via the internet, could assist in the assimilation of biosecurity education into existing curricula, ease constraints on time spent planning and preparing materials, overcome financial constraints on the development of biosecurity programmes, and provide the expertise required for the efficient and effective integration of such material. 2. As the surveys (conducted by Dando and Rappert, see Dando 2008) suggested that scientific communities, including university lecturers, are not familiar with the biosecurity topic, the next stage in promoting biosecurity teaching would be to build the capacity of relevant professionals through the implementation of train-the trainer programmes in different institutions. 3. Other autonomous approaches are to make ethical awareness for dual-use issues an evaluation criterion for grant applications by funding bodies or review processes for scientific journals. For example, in the UK, the Biotechnology and Biological Research Council (BBSRC), the Medical Research Council (MRC) and the Wellcome Trust now require consideration of and awareness among scientists about dual-use risks in scientific research as a criterion for the assessment of grant applications (Wellcome Trust 2005). 4. Another intervention to promote dual-use bioethics education can be set out by making ethical awareness on dual-use issues an evaluation/ranking criterion for higher education bodies, such as universities. There are examples of the establishment of an independent national advisory board for biosecurity. The actual experiences of this approach included the following stages: setting up a national committee to hold interdisciplinary discussions on the definition of risks, biosecurity measures and strategic recommendations for policy development in biosecurity, and the establishment of an individual national board on biosecurity which provides guidelines for the oversight of scientific research, laboratory management measures, and awareness raising of scientists. 6. A useful policy process that could enhance national implement of international agreements is to instigate appropriate national legislation. In this specific case (Azerbaijan), this could consist of the legislation of a biosecurity act or the amendment of existing laws and regulations. Ref: Dando, M. R. (2008) “Developing Educational Modules for Life Scientists Accelerating the Process though an Open Source Initiative,” presented to the IWG–LNCV Biological workshop and round table on fostering the biosecurity norm: An educational module for life sciences students, 27 October at the Municipality of Como, Italy. Minehata, M. (2010) Incorporating “Dual-Use” in the Ethics Education of Life Scientists: Challenges and Lessons Learned, presented at the Third International Global Ethics Association Conference, University of the West of England, Bristol, 30 June - 2 July, 2010 Wllcome Trust. (2005) A joint Biotechnology and Biological Sciences Research Council (BBSRC), Medical Research Council (MRC) and Wellcome Trust Policy Statement, Available from: 2 1

30 National measures: Areas of possible improvement
Armenia Laboratory safety measures Efforts have been made and need to continue alongside development of a biosecurity framework National legislation of the BTWC and the CWC Efforts have been made, the legislative information to the OPCW can be considered. On the BTWC, the government can consider opening its CBM submission to the public through the UN (ISU-BTWC) website. Education and Codes of Conduct Implementation of the survey and the development of a national code of conduct for biosecurity will strengthen efforts Notes: the evidence collected by this project suggested that while growing efforts have been made in laboratory biosafety and biosecurity measures and national implementation of the BTWC, there are many opportunities for developing activities on education which can be further enhanced based on the “education national action plan” in the previous slide of this lecture. Developing a national code of conduct on biosecurity will be a good agenda in parallel to growing efforts on the national survey plan, seminars and training programmes in Iraq.

31 References The references cited in this presentation may be found in the Notes section of this slide. References (Lecture 4) BACAC. (2010) About BACAC [online] Available from: CEN. (2008) Laboratory biorisk management standard, CWA 15793, February. Dando, M. R. (2008a) “The Dutch Experience with a Biosecurity Code of Conduct,” Bulletin of Atomic Scientists Available from Dando, M. R. (2008b) “Developing Educational Modules for Life Scientists Accelerating the Process though an Open Source Initiative,” presented to the IWG–LNCV Biological workshop and round table on fostering the biosecurity norm: An educational module for life sciences students, 27 October at the Municipality of Como, Italy. Dunworth, T. and Mccormack, T. L, H. (2006) National Implementation of the Biological Weapons Convention. Journal of Conflict and Security Law, 11(1), at p. 98 EBSA. (2012) [Online] Available from: European Commission (2009) EU-Ukraine Association Agenda to prepare and facilitate the implementation of the Association Agreement, 23 November, Brussels: EC IAP. (2005) IAP Statement on Biosecurity, Available From: IAP. (2012) Summary of IAP statements, Available from: Macintosh, J. (1990) Confidence-and security-building: A sceptical look. In: United Nations Department for Disarmament Affairs (Ed.) Disarmament. New York: United Nations, pp Malakoff, D., and Enserink, M. (2003) Butler Cleared on Most Biosecurity Charges, Convicted of Fraud, Science, 302(5651), p Miller, S. and Selgelid, M. J., Ethical and philosophical consideration of the dual-use dilemma in the biological science, Science and engineering ethics. 13 (4), Minehata, M. (2010) Incorporating “Dual-Use” in the Ethics Education of Life Scientists: Challenges and Lessons Learned, presented at the Third International Global Ethics Association Conference, University of the West of England, Bristol, 30 June - 2 July, 2010 National Research Council. (2004) Biotechnology Research in an Age of Terrorism, Washington, D.C.: National Academies Press. National Research Council. (2006), Globalization, biosecurity and the future of the life sciences, Washington, DC: National Academies Press. NSABB. (2008) ‘Strategic Plan for Outreach and Education on Dual Use Research Issues’, Report of the NSABB Available from: OPCW. (2012) CWC national implementing legislation database [online] Available from: Republic of Korea. (2003) National Measures or Legislation to Implement the BTWC: A Conceptual Analysis, BWC/MSP.2003/MX/WP16, 6 August, Geneva: United Nations. Available from at pp. 3-4. Steering Committee on Issues in Biotechnological Research in an Age of Terrorism (2008) Biotechnological Research in an Age of Terrorism: Report Approved by the Council of the Israel Academy of Science and Humanities and the Israel National Security Council, Jerusalem: Israel Academy of Science and Humanities and Israel National Security Council. Sture, J., Shinomiya, N., and Minehata, M. (2012) Looking at the formulation of national education action plans, Medicine Conflict and Survival, [forthcoming] Sudoyo, H. (2011) Promoting code of conduct on biosecurity for life sciences, presented at the IAP Inaugural Conference: Building Biorisk Capacity in Indonesia, September, Borobudur Hotel Jakarta, Indonesia. United Nations. (2012) Confidence Building Measures [online] Available from: VERTIC. (2012) BWC Legislation Database [online] Available from: Wellcome Trust. (2005) A joint Biotechnology and Biological Sciences Research Council (BBSRC), Medical Research Council (MRC) and Wellcome Trust Policy Statement, Available from: WHO. (2004) Laboratory Biosafety Manual, Geneva: WHO. 3rd ed. WHO (2005) International Health Regulation, Geneva: WHO. Available from: WHO EUROPE. (2007) Assessment of Health and Security Crisis Management: Armenia, [online] Available from: WHO. (2011) Checklist and Indicators for Monitoring Progress in the Development of IHR Core Capacities in States Parties. Geneva: WHO. Available from: WHO (2012a) Top priorities for States Parties to implement the IHR (2005), Geneva: WHO. Available from: WHO. (2012b) Frequently asked questions about the International Health Regulations [online] Geneva: WHO. Available from:


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