Select Committee on Innovation, Universities, Science and Skills Written Evidence

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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