Biosafety/ Biosecurity in Georgia

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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

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(No Transcript)
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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.

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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

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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.

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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)

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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)

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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

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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.

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• 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.

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• 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.