Transcript paketi Sedgeba oTxi ZiriTadi dokumentisagan:

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 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.
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.