In order to be comprehensive and ensure an effective implementation, a national legislative system on biosafety and biosecurity has to be considered in the context of other pertinent legislation and extant measures, and should have “buy-in” from all relevant stakeholders. In Georgia, such stakeholders include the Ministry of Labor, Health and Social Affairs (MOHLSA); the Ministry of State Security; the Ministry of Interior; and the Ministry of Infrastructure.
Ensuring biosafety and biosecurity in Georgia is one of the main responsibilities of the 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. NCDC was built on the foundation of the Georgian Station for Plague Control in 1996 and its statute was approved by the President of Georgia by Presidential Decree 55 on 21 February 2003. NCDC now employs 440 personnel (60% are specialists with graduate-level education).
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. Moreover, experts from Georgia are very active in collaborating with the WHO and other organizations and partners in technical consultations related to the IHR. For instance, Georgian experts participated in the technical consultation on checklist and indicators for monitoring progress in the implementation of IHR core capacities in Member States organized by WHO in Lyon, France, 4-6 August 2009.
Georgia joined the Biological Weapons Convention in 1995 and has extensive measures in place to ensure that all activities on its territory are treaty-compliant and that prohibited activities are deterred and detected and perpetrators are punished. The basic tenets and understandings reached in the BWC intersessional process are implemented by Georgia through:
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Legislation and regulations;
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Biosafety and biosecurity;
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Oversight of life sciences research;
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Education and awareness of dual use issues and biological risk;
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Disease surveillance, containment, and response.
In addition, Georgia participates in the CBM process (submitting eight annual reports since it ratified the treaty) and is actively involved in the BWC intersessional process (conducting joint presentations with the U.S. and UK at the Meeting of Experts in 2009 and a joint presentation with the U.S. on Southern Caucasus Partner ships in Countering Biological Threats in 2010). On the sides of the 2010 BWC Meeting of Experts, Georgia also presented at the First European Union Joint Action Workshop, on “Practicalities for BWC Implementation and Confidence Building Measures Reporting,” since technical assistance and exchanges of experience gained from preparing the annual CBM reports can increase compliance with voluntary reporting and strengthen the BWC through increased transparency and openness.
The strategic vision for an effective and comprehensive framework for biological risk management in Georgia (comprising biosafety and biosecurity) involves a set of regulations on biosecurity (based on the U.S. Select Agents Rule and similarly covering facilities and person-nel registration, security risk assessments, emergency response, record keeping, inspections, duties of Responsible Official, training, notifications for theft, loss or release, etc); biosafety norms (consistent with the “Bio-safety in Microbiological and Biomedical Laboratories” guidance published by the U.S. Centers for Disease Control and Prevention [CDC] and the WHO “Laboratory Biosafety Manual”); regulations for import, export, containment, transfer, and handling of biological agents and toxins; and guidelines for safe transportation of infectious substances and diagnostic materials.
To that end, and in accordance with the NCDC statute which specifies “participation in preparing normative and methodological documentation under its competen-cies,” experts from the NCDC Department of Biosafety and Threat Reduction and other institutions of MOHLSA have prepared a draft model law with the components mentioned above, in consultation with personnel from the U.S. Department of Health and Human Services (HHS), U.S. Department of Defense (DoD), and U.S. Department of State. However, this effort could only partly be completed since other pertinent legislative efforts should be pursued in parallel (for instance those regarding the criminal code and also the administrative code of Georgia, which will contribute to deterrence by increasing the penalties for misuse, theft, and diversion of biological agents). A close collaboration among the public health, law enforcement, the judicial branch and other stakeholders is necessary to ensure that the biological risk management framework is viewed holis-tically in the context of the national legislative system.
The recently revised legislation on public health (adopted on 27 June 2007) currently specifies in its Chapter V, “Providing Biosecurity/Biosafety,” the relevant measures, authorities and responsibilities in these areas, as follows:
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C1.16 – Providing Biosecurity/Biosafety;
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C1.17 – Limitation of Posession, Use, Transfer, Transportation and Destruction of Causative Agents of Especially Dangerous Infections;
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Cl.18 – Destruction of Causative Agents of Especially Dangerous Infections;
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Cl.19 – Import and Export of Causative Agents of Especially Dangerous Infections;
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Cl.20 – Institutions Responsibilities on Biosafety/Biosecurity;
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Cl.21 – Establishing a Unique Laboratory System for Detection, Surveillance and Response to Causative Agents of Especially Dangerous Infections.
In addition to drafting and implementing pertinent legislation, Georgia is collaborating with the United States on enhancing its biosafety and biosecurity by training its workforce and improving its biological infrastructure. The Defense Threat Reduction Agency (DTRA) is leading in Georgia the Cooperative Biological Engagement Program (CBEP) aimed at reducing the biological risk by securing/consolidating pathogens, training scientists in biosafety and biosecurity techniques, and regulatory reform; establishing a sustainable detection, response, and communication network to monitor biological outbreaks; and undertaking cooperative biological research projects to understand disease baseline, increase transparency, encourage higher ethics standards, and strengthen the integration of scientists into the international community.
Georgia is also closely collaborating with the U.S. Department of Health and Human Services. The CDC is working to help strengthen the public health systems of Georgia, Armenia, and Azerbaijan by improving each country’s disease detection response and control through improvements in laboratory systems, epidemiology workforce, and public health management skills. For instance, the South Caucasus Regional Field Epidemiology and Laboratory Training Program (FELTP) is based at NCDC in Tbilisi, Georgia, but also involves the neighboring countries of Armenia and Azerbaijan. The two-year in-service training program in applied epidemiology and public health laboratory practice trains residents in field epidemiology and public health laboratory for leadership positions in various levels of their respective ministries of health or agriculture. The FELTPs have a strong focus on biosafety and biosecurity.
Georgia supports the USNCR 1540 and submitted its report on national measures taken in implementation of its goals on 28 October 2004 with additional information provided to the 1540 Committee on 28 January 2006. The report outlined the legislative framework in Georgia; measures taken with regard to nonproliferation of chemical and biological weapons and disposal of radioactive sources; the introduction of Georgian system of export control of dual use materials, equipment and technologies; and the series of bilateral agreements with the United States on preventing the proliferation of WMD materials and technologies, counterterrorism, border security and export control. Georgia is also working on updating its legislation in order to cover all aspects of its obligations under the Resolution.
In addition to enhancing biosecurity and biosafety in Georgia through the IHR (2005), BWC and 1540 mechanisms, Georgia also supports the European Security Strategy (“A secure Europe in a better world”) and the European Union Strategy against the Proliferation of WMD (“Effective multilateralism, prevention and international cooperation”), adopted by the European Council on 12 December 2003, which identify proliferation as one of the five key challenges to international security, together with terrorism, regional conflicts, State failure, and organized crime.
Similarly, Georgia supports the North Atlantic Treaty Organization (NATO)’s “Comprehensive, Strategic-Level Policy for Preventing the Proliferation of WMDs and Defending against CBRN Threats” of 2009, which focuses on prevention and strengthening international non-proliferation mechanisms (i.e. BWC, UNSCR 1540, the Proliferation Security Initiative, etc.); and increased information exchange, engagement, cooperation, and joint training with Partner nations, international and regional organizations, and civilian entities.
International workshops and training in Georgia
Under the auspices of NATO’s Science for Peace Program, Georgia organized in June 2008 a workshop on “Emerging and endemic pathogens: advances in surveillance detection, and identification,” which was attended by more than 50 experts from 10 countries (Georgia, U.S., UK, Russia, Ukraine, Kazakhstan, Macedonia, France, Germany and Azerbaijan).
Georgia also hosted and co-organized The Southern Caucasus Workshop on Public Health, Security, and Law Enforcement Partnership in Bio-Incident Pre-Planning and Response and the associated Southern Caucasus BioShield 2010 Tabletop Exercise (TTX) which were held in Tbilisi, Georgia, 11-12 May 2010. These events were a joint effort of DTRA, HHS’s Office of the Assistant Secretary for Preparedness and Response (ASPR), and Georgia’s NCDC [9].
Over 80 participants were in attendance at the May 2010 meeting, from inter-governmental organizations (WHO, International Criminal Police Organization [INTERPOL], NATO), U.S. Government (DoD, HHS, Department of Energy, Department of State, and Federal Bureau of Investigation [FBI]), and from public health, security, or law enforcement organizations from Georgia, Azerbaijan, Armenia, Kazakhstan, Moldova, and Romania. Non-governmental organizations such as VERTIC (Verification Research, Training and Information Centre), Bechtel, and Global Green USA also participated in these events.
The workshop and tabletop exercise aimed to:
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Foster improved understanding of the respective procedures and requirements of public health, security, and law enforcement communities in response to a biological incident, and enhance their joint effectiveness in pre-planning and response at the national and regional/international level;
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Enhance understanding of intergovernmental organizations’ role and their interaction in the process of sharing information and coordinating the international response;
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Emphasize the concept that information exchange in the early stages of a biological incident is critical to effectively containing the outbreak/mitigating the consequences of a biological incident and to apprehending the potential perpetrators;
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Review existing legal and regulatory infrastructure of national measures consistent with the obligations under the BWC, UNSCR 1540, and IHR(2005) to deter, prevent, or respond to biological incidents or threats.
These events successfully linked the international response to a bioterrorism incident stemming from the convergence of criminal and terrorist networks, with prevention via the nonproliferation mechanisms described in this paper:
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The BWC – by emphasizing the effective prohibition of the development, production, acquisition, transfer, retention, stockpiling and use of biological and toxin weapons and highlighting the treaty as a key element in the international community’s efforts to address the proliferation of WMD;
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UNSCR 1540 – by emphasizing the requirement that all UN Member States refrain from providing support to non-state actors that attempt to develop, acquire, manufacture, possess, transport or use nuclear, chemical or biological weapons and their means of delivery, and the obligation of Member States to establish and to enforce domestic controls to secure WMD-related materials and prevent their proliferation; and
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NATO’s Comprehensive, Strategic-Level Policy for Preventing the Proliferation of WMDs and Defending against CBRN Threats – by emphasizing its focus on prevention and strengthening international nonproli-feration mechanisms and increased information exchange, engagement, cooperation, and joint training with Partner nations, international and regional organizations, and civilian entities.