Biosafety/Biosecurity in Georgia

Lela Bakanidze, Ph.D.National Center for Disease Control and Medical Statistics of Georgia

Scientific Networking and the Global Health Supercourse for the Prevention of

Threat from Man Made and Natural Disasters

Kaunas, August 9, 2005

Decree of President of Georgia # 55 (21.02.2003) approved

National Center for Disease Control and Medical Statistics of Georgia and its Statute. The Statute, among other goals, functions and activities, lists “detection of agents causing epidemics and outbreaks”, “carrying out surveillance”, “establishing national collection of bacteria and viruses”, ”participation in preparing normative and methodological documentation under its competencies” , etc.

Nowadays with especially dangerous pathogens we work according to

• 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.

• “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

•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 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:

Regulation is Based on:

• Laboratory Biosafety Manual – World Health Organization - WHO/CDS/CSR/ LYO/2003.4

• Biosafety in Microbiological & Biomedical Laboratories" - US DHHS CDC Atlanta & NIH, Fourth Edition, May, 1999.

• US Federal Register- Vol. 240, N0.67. Rules and Regulations, Part IV, Department of Health and Human Services, 42 Part 73.

• WHO “Guidelines for the Safe Transport of Infectious Substances and Diagnostic Specimens” (WHO/EMC/97.3)

Regulation is in Compliance with:

• Law of Georgia ,, on Health Care ”- (10.12.1997)

• Law of Georgia on Export Control of Armament, Military Techniques and Products of Bilateral Purpose (28.04.1998)

• Law of Georgia,, Georgian Sanitary Code ”- (08.05.2003)

The Package of lab biosafety/biosecurity legislation consists of four Documents:

•Select Agents Rule•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•Guidelines for safe Transportation of Infectious Substances and Diagnostic Materials

Select Agents Rule (Registration, Security risk assessments, Safety, Security, Emergency Response, Training, Transfers, Records, Inspections, Notifications for Theft, Loss or Release, Administrative Review, Criminal Penalties, Submissions and Forms, Applicability and Related Requirements) The document establishes requirements regarding possession and use in Georgia, receipt from outside Georgia, and transfer within Georgia, of select agents and toxins.

• 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.

• 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.