Biosafety and Biosecurity in Georgia
The legitimate functions of science, industry, medicine and public health must be preserved at the same time addressing the risks they engender. In order to achieve this there must be understanding that the traditional boundaries to health and security are to be redrawn. The threat of infectious disease – whether naturally occurring or as a result of deliberate use – is real and growing. The global community must find appropriate ways to counter this threat without crippling the very institutions that are critical to health security.
Georgia, as one of parts of Soviet Union, shared all the legislation, and among them regulations on biosafety. More than decade has passed since Georgia became independent, but not the whole biosafety legislation has been adapted to new situation. New Georgian Laws were adopted, part of sanitary norms and regulations were renewed, but greatest part remains unchanged. The need for new Georgian regulations on biosafety /Biosecurity is evident.
The draft of new Georgian legislation on biosafety will be the package consisting four documents: (1) Select Agents Rule; (2) Rules of Import, Export, Containment, Transfer and Handling of Cultures of Infectious Diseases Causative Agents (Bacteria, Viruses, Rikketsia, etc.), Protozoa, Mycoplasma and Genetic Materials, also Toxins and Poisons of Biological Origin; (3) Sanitary Norms For Labs Working with Especially Dangerous Pathogens; and (4) Guidelines for Safe Transportation of Infectious Substances and Diagnostic Materials.
New legislation package will be agreed with all involved agencies, like the Central Sanitary Inspection of the Ministry of Labor, Health and Social Affairs of Georgia, Ministry of State Security of Georgia, Ministry of Infrastructure of Georgia and Ministry of Interior of Georgia.
Legislation on biosafety/biosecurity, like all the other legislation, rules and regulations, can be perfect, applicable, but there must be readiness in the community to follow them. Mechanisms for their implementation must be created.
The threat of infectious disease – whether naturally occurring or as a result of deliberate use – is real and growing. Expanding globalisation and advancing biotechnology drive the threat. The global community must find appropriate ways to counter this threat without crippling the very institutions that are critical to health security. Recent natural outbreaks of highly infectious diseases have had devastating consequences for public health, the international economy, and international security. The consequences of an outbreak of infectious disease resulting from the biological weapon use would be at least as damaging as a naturally occurring infection, and even more.
The risk of infectious disease resulting from an accidental release of pathogen from a laboratory setting or use of biological weapon is real and growing. The rapid expansion of the biotechnology industry has resulted in the global proliferation of bilateral use biological materials, technologies and expertise. As a result, dangerous pathogens are more accessible to a wide range of those who are interested in proliferation of biological weapon (among them terrorists).
Many different methods are being used to address global risks associated with naturally occurring and accidentally or intentionally introduced infectious diseases. Most strategies – like increasing the effectiveness and availability of therapeutics, improving diagnostic capabilities, and developing decontamination and detection technologies- focus on enhancing national responses to an outbreak of infectious disease after it had occurred.
It is difficult to identify mechanisms to counter biological threats, as no international framework exists within which they can be applied (on the contrary to other threats, like the International Atomic Energy Agency oversees the Nuclear Non-proliferation Treaty, the Organization for the Prohibition of Chemical Weapons oversees Chemical Weapons Convention).
Nearly all current strategies for biological security are national in origin and focus on the response to disease outbreaks. These include increasing the effectiveness and availability of vaccines and other therapies (such as antibiotics); improving disease surveillance and diagnostics; developing improved decontamination and detection technologies; and building public health capabilities.
U.N. Security Council Resolution 1540, adopted on April 28, 2004 under Chapter VII of the U.N. Charter, is motivated by the concern that non-State actors “may acquire, develop, traffic in or use nuclear, chemical and biological weapon sand their means of delivery”. S. Res. 1540 recognises “the need to enhance coordination of efforts on national, sub regional, regional and international levels in order to strengthen a global response to this serious challenge and threat to international security”.
Georgia, as one of parts of Soviet Union, shared all the legislation, and among them regulations on biosafety and dealing with especially dangerous pathogens, with other republics of the country. Biosafety rules in Soviet Union were very strict, and they did not leave gaps for misunderstanding, bioweapon facilities were well defined, they were components of Soviet offensive biological weapons program, and no other institutions were authorized to have any especially dangerous pathogens.
More than decade has passed since Georgia became independent, but not the whole biosafety legislation has been adapted to new situation. New Georgian Laws were adopted, part of sanitary norms and regulations were renewed, but greatest part remains unchanged. For example, even classification of pathogens by risk groups is absolutely contrary to the WHO classification. Today, when the threat of bioterrorism is more realistic, the need for new regulatory basis for biosafety became evident. Besides, scientific investigations on especially dangerous pathogens, that are very well granted by different donors, and sometimes, they do not take into account are proposed recipients of their grants eligible to carry out such investigations, and have sufficient experience or not.
There were not too many bioweapon - related institutions in Georgia (to compare e.g. with Russia and Kazakhstan) – Georgian Anti - Plague Station -at present National Center for Disease Control and Medical Statistics of Georgia (NCDC Georgia) of the Ministry of Labor, Health and Social Affairs of Georgia, was the only one that carried out surveillance on especially dangerous infections (plague, anthrax, tularemia) on the whole territory of Georgia, Biokombinat in Tabakhmela (near Tbilisi – capital of Georgia), producing live vaccines for foot and mouth disease, etc., and partially Eliava Institute of Bacteriophage, manufacturing different vaccines (rabies, anthrax, etc). All these institutions worked under strict regulations. After collapse of Soviet Union there was a significant outflow of military microbiologists to other institutions, often to private companies, and it is the source of concerns.
As we have already mentioned, Georgia, as one of parts of Soviet Union, shared all the legislation, and among them regulations on biosafety/ biosecurity. But even more than decade has passed since Georgia became independent, the biosafety/ biosecurity legislation has not been worked out and approved. New Georgian Laws (like the Law of Georgia “on Health Care” , Law of Georgia “Georgian Sanitary Code”, etc.) were adopted, part of sanitary norms and regulations were renewed, but greatest part remains unchanged.
The protection of dangerous pathogens and toxins from theft and sabotage at the facilities where they are used and stored provides the first line of defence against both biological weapons proliferation and bioterrorism by making it more difficult for proliferators to acquire dangerous biological materials.
The term “laboratory biosecurity” is newly introduced, and it is often confused with the ore widely recognised term “laboratory biosafety” (in Georgian both terms are expressed by one word). Laboratory biosecurity and laboratory biosafety – both are critical to the operation of modern bioscience laboratory – often overlap and should complement each other, though they have different objectives:
Laboratory biosafety reduces biological risk, aims to reduce or eliminate exposure of laboratory workers, or other persons, and the outside environment to potentially hazardous agents involved in bioscience or biomedical research. Laboratory biosafety is achieved by implementing various degrees of laboratory “containment”, or safe methods of managing infectious materials in a laboratory setting.
Laboratory biosecurity aims to protect pathogens, toxins and security – related information from theft and sabotage. Laboratory biosecurity is achieved by instituting a culture of responsibility among those who handle, use, and transport dangerous pathogens and toxins, and by implementing various security measures that restrict access to these materials to authorized individuals.
Although it is impossible to say how likely is that there will be a bio-terrorist attack, or the biocrime in Georgia, the likelihood is growing.
The need for new Georgian regulations on biosafety /Biosecurity is evident!
Nowadays with especially dangerous pathogens are carried out according to old Soviet regulations: (1)The Decree of the Ministry Of Health of USSR “Concerning Rules of Registration, Containment, Handling and Transfer of Cultures of Pathogenic Bacteria, Viruses, Rikketsia, Fungi, Protozoa and others, also Bacterial Toxins and Poisons of Biological Origin" approved by the Ministry of Health of USSR, 18.05.79. and (2) the “Instruction on Regime of Control of Epidemics while Working with Materials Infected or Suspected to be Infected with Causative Agents of Infectious Diseases of I-II Groups” approved by the Ministry of Health of USSR 29.06.1978.
3. New Georgian legislation on biosafety/biosecurity
NCDC Georgia was established on the basis of Georgian Anti – Plague Station of the Ministry of Health of USSR NCDC Georgia owns National Collection of Especially Dangerous Pathogens. Among different other duties of the NCDC Georgia, according to the Decree of the President of Georgia No. 55 from February 21, 2003 in its statute is “Participation in drafting normative and methodological documents on surveillance, disease control and prevention, biosafety/ biosecurity”. The Department of Biosafety and Threat Reduction, together with experts from other departments of the Ministry of Labor, Health and Social Affairs of Georgia has prepared the draft of Georgian biosafety /biosecurity legislation. It must be mentioned that during the work on legislation, we had great help from US DoD Defense Threat Reduction Agency (DTRA), US Department of Health and Human Services (DHHS) and US Department of State.
While working on the new legislation draft, we had found, that improving biosecurity in the country will be more difficult – it will need more legislative changes, like changes in the “Criminal Code of Georgia” and “Georgian Administrative Code” – the penalties for biocrimes are insignificant, to compare with bonuses that criminals may have from those aiming to obtain especially dangerous pathogens. Involvement of law enforcement agencies must be more active.
New Georgian legislation on biosafety/biosecurity is based on WHO and American regulations on biosafety, particularly, “Laboratory Biosafety Manual” – World Health Organization - WHO/CDS/CSR/ LYO/2003.4 and “Biosafety in Microbiological & Biomedical Laboratories» - US DHHS, CDC Atlanta & NIH, Fourth Edition, May, 1999.
We tried new legislation to be in compliance with Georgian national legislation, particularly:
It was decided, that Georgian legislation on biosafety will be the package consisting four documents:
Select Agents Rule is the main tool of regulating work of laboratories with select agents – especially dangerous human and animal pathogens (list of overlapping select agents is now being coordinated with veterinary services). As a basis for it US Federal Register Part IV, DHHS “Possession, Use, and Transfer of Select Agents and Toxins; Interim Final Rule” was taken. It draws mechanisms of registration, security risk assessments, safety, security, emergency response, transfers, record keeping, inspections, duties of Responsible Official, training, nnotifications for theft, loss or release, administrative review, criminal penalties (here sufficient chapters from the Administrative Code of Georgia and the Criminal Code of Georgia were used), submissions and forms, applicability and related requirements.
As a basis for “Rules of Import, Export, Containment, Transfer and Handling of Cultures of Infectious Diseases Causative Agents (Bacteria, Viruses, Rikketsia, etc.), Protozoa, Mycoplasma and Genetic Materials, also Toxins and Poisons of Biological Origin”, “Sanitary Norms For Labs Working with Especially Dangerous Pathogens” and “Guidelines for Safe Transportation of Infectious Substances and Diagnostic Materials” were taken WHO and CDC regulations.
New legislation package will be agreed with all involved agencies, like the Central Sanitary Inspection of the Ministry of Labor, Health and Social Affairs of Georgia, Ministry of State Security of Georgia, Ministry of Infrastructure of Georgia and Ministry of Interior of Georgia.
4. Summary and Conclusions.
Pathogenic microorganisms – naturally occurring or artificially brought present a significant threat to global health security. There is no clear consensus how to globally limit the distribution or availability of pathogenic microorganisms. Development of national and international norms for the security of these organisms are complicated by the fact that they appear naturally and globally, can self – replicate, are difficult to detect at distance, and can be used for harm and good. Development of security standards should be broad – based and take into consideration the needs of health, science, economics, and national and international law.
New legislation on biosafety, like all the other legislation, rules and regulations, can be perfect, applicable, but there must be readiness in the community to follow them. Mechanisms for their implementation must be created.
References:
1. Law of Georgia “on Health Care” (10.12.1997).
2. Law of Georgia “Georgian Sanitary Code ”- (08.05.2003).
3. Law of Georgia “on Export Control of Armament, Military Techniques and Products of Bilateral Purpose”, (28.04.1998).
4. Ostfield M. Bioterrorism as a foreign policy issue SAIS Review vol. XXIV, No. 1 (Winter – Spring 2004); 131 – 146.
5. Heymann DL, Aylward RB, Wolff C. Dangerous Pathogens in the Laboratory: from smallpox to today’s SARS setbacks and tomorrow’s polio-free world. The Lancet 2004; 363 16566 – 68 Editorial.
6. Steinbruner D, Harris ED. Controlling Dangerous Pathogens . Issues in Science and Technology, Spring 2003, 47-54.
7. Biotechnology Research in an Age of Terrorism: Confronting the Dual Use Dilemma, National Research Council of the National Academies, 2003, National Academy Press.
8. Tucker JB, “Biosecurity: Limiting Terrorist Access to Deadly Pathogens”, Peaceworks No. 52, US Institute of Peace, November 2003.
9. Salerno RM, The US Select Agent Rule and an International Opportunity to develop Laboratory Biosecurity Guidelines Proceedings of the International seminar on Nuclear war and Planetary Emergencies, 32nd Session, Erice. World Scientific Press, 2005, 221-228.
10. Bakanidze LG, Imnadze PG, Tsanava ShA, Tsertsvadze NS. New Georgian Legislation on Biosafety. Proceedings of the International seminar on Nuclear war and Planetary Emergencies, 32nd Session, Erice. World Scientific Press, 2005, 229 – 231.