Memorandum 21
Submission from the British Embassy, Seoul,
South Korea
Biosafety has been institutionalised in the
Republic of Korea since 1997. The first steps were taken in order
to ensure the reliability of recombinant DNA technology. The Ministry
of Health and Welfare (MOHW) published its "Guidelines
for Research Involving Recombinant DNA Molecules".
The MOHW established the Division of Biosafety
Evaluation and Control under the Korean Centre for Disease Control
(KCDC). The division is responsible for setting national biosafety
guidelines, certifying Biosafety Level (BSL) 3 and 4 facilities,
overseeing the national framework of biosafety management and
reviewing and coordinating all activities relating to living modified
organisms (LMOs) derived from modern biotechnology, highly dangerous
pathogens and toxins.
The Division is responsible for enacting mandatory
regulations relation to LMOs and high dangerous pathogens, establishing
criteria for the installation and operation of the four biosafety
level facilities, evaluating research plans which require national
permissions and the monitoring of notifications on acquisition
and transfer of highly dangerous pathogens and toxins. It also
pursues the strengthening of laboratory biosafety through the
development of human risk assessment techniques and related legislation,
including laboratory biosafety.
By what mechanism(s) are micro-organisms classified
with regards to their potential danger and their need to be contained?
What are the categories of biological containment in use?
Micro-organisms are classified by:
(a) pathogenicity of the micro-organisms;
(b) mode of transmission and host range;
(c) availability of effective preventive
measures (eg vaccines); and
(d) availability of effective treatment (eg
antibiotics).
Like many countries, including the UK, there
are four biosafety levels (BSL) for facilities:
BSL-1: organisms/toxins pose low risk to personnel
and the environment.
BSL-2: pose moderate risk to personnel and environment.
BSL-3: usually cause serious disease.
BSL-4: produce very serious disease that is often
untreatable.
There is currently no BSL-4 facility in Korea.
The MOHW revised "The Guidelines for Research Involving
Recombinant DNA Molecules" in 2007 and it now includes
categories of biological containment made on the basis of international
biological containment levels.
How are licenses to use dangerous pathogens in
research awarded?
According to the Prevention of Contagious Diseases
Act, every researcher who uses and keeps dangerous pathogens should
notify the KCDC. The KCDC issues licences. In case of non-dangerous
pathogenic micro-organisms, each laboratory should operate its
own lab biosafety management system.
What is the inspection regime for laboratories
licensed to use dangerous pathogens?
According to the Prevention of Contagious Disease
Act, all laboratories using any of the 32 kinds of dangerous pathogens
designated by the government should report the status of the pathogens'
storage to the KCDC twice a year. The KCDC inspects licensed laboratories
once a year.
What training is mandatory/recommended for staff
working in containment facilities?
The KCDC operates a 21-hour training course
for laboratory biosafety managers every year. The managers are
obliged to arrange mandatory biosafety training to all staff in
each lab once a year.
What are the regulations regarding the storage
and transportation of dangerous pathogens?
Under the Prevention of Contagious Disease Act
it is compulsory to notify the KCDC of the possession and transport
of any of the specific 32 pathogens. Most of the associated regulations
follow those of the WHO.
If researchers use unknown pathogenic material
they should request a pre-assessment to KCDC. The KCDC has 13
safety regulations to deal with unknown pathogenic material.
What measures are in place to be implemented when
pathogenic material cannot be accounted for?
There are guidelines for preventing pathogenic
material from going missing eg reporting, marking, designating
of special storage facilities, checking consumption every six
months and reporting consumption to the KCDC etc.
If material goes missing, the case must be reported
immediately to the KCDC who will investigate it. There has been
no case of missing material so far.
Who is responsible for overseeing security clearance
for research students working with dangerous pathogens—what
is the role of universities in this process?
Universities need to get permission from the
KCDC in order to build BSL-3 or 4 facilities. The university is
required to appoint an Institutional Biosafety Committee (IBC)
within the university to oversee the security clearance of research
students. In the case of building BSL1 or 2 facilities, universities
need on report the facility to the Ministry of Science and Technology.
In these cases forming an IBC in the university is recommended,
but not mandatory.
The KCDC encourages universities to manage their
own facilities through the biosaftey training.
28 January 2008
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