• The Institutional Biosafety Committee (IBC) ensures the safety and efficiency of recombinant DNA experiments conducted at KAIST and simultaneously reviews, discusses, and provides advice on the appropriate management and supervision of infectious materials and other substances that may pose biological hazards.
• Responsibilities of IBC
  • Review, discussion, and approval of the safety and scientific validity of all research, experiments, investigations, and educational plans involving recombinant DNA experiments and other biological hazards
  • Matters related to the formulation and revision of KAIST's biosafety management regulations and biosafety management guidelines.
  • Management and supervision of the installation and operation of research facilities
  • Management and supervision of all experiments involving recombinant DNA and other biological hazards
  • Matters related to biosafety education, training, and health management
  • Other matters delegated by the president or chair based on legal requirements or for the purpose of ensuring biosafety
  • Assessment and approval of the potential hazards of experiments involving high-risk pathogens
  • Discussion of matters related to the use of inactivated high-risk pathogens

• The biosafety management grade of biological agents is classified into four risk groups based on the degree of harm to humans. The list of biological agents by risk group adheres to the guidelines for recombinant DNA experiments.
  • Risk Group 1: Biological agents known not to cause disease in healthy adults
  • Risk Group 2: Biological agents that, if they infect humans, can cause diseases with symptoms that are not severe and are relatively easy to prevent or treat
  • Risk Group 3: Biological agents that, if they infect humans, can cause diseases with severe or potentially fatal symptoms, but for which prevention or treatment is possible
  • Risk Group 4: Biological agents that, if they infect humans, can cause diseases with extremely severe or fatal symptoms, and for which prevention or treatment is difficult
• Biosafety level of facilities and agents by risk group

• High-risk pathogens refer to infectious agents that, if used for the purpose of bioterrorism or accidentally released externally, may pose a serious threat to public health.
• Handling of high-risk pathogens should only be conducted in designated facilities, and depending on the safety management grade, approval from the Commissioner of the Korea Disease Control and Prevention Agency or notification to the Commissioner is required. Additionally, separation, distribution, or transportation of high-risk pathogens must be reported to the Commissioner.
• Types of high-risk pathogens

See Attached Table No. 1 related to Article 5 of Enforcement Rules of Infectious Disease Control and Prevention Act

• Living modified organisms (LMOs) refer to living organisms whose genes have been artificially altered (inserted, deleted, or modified) using modern biotechnology.
• LMOs can only be handled in LMO research facilities with a corresponding or higher biosafety level, and when importing or exporting LMOs, approval or notification must be obtained from the central administrative agency. Additionally, experiments involving specific LMOs require approval from the institution and the central administrative agency.

• Scope of LMO import approval

  • LMOs obtained using microorganisms that are not specifically identified and whose human pathogenicity has not been determined
  • LMOs capable of producing protein toxins with less than 100 ng of lethal dose (the amount of protein toxin that can kill 50% of the experimental animal group within a specific time) per 1 kg of body weight in vertebrates: Botulinum toxins (A, B, C, D, E, F types), tetanus toxin, botulinum neurotoxin, diphtheria toxin, etc.
  • LMOs with intentionally introduced drug resistance genes However, the following cases are exempt from approval (excluding LMOs with drug resistance genes specified by the Minister of Health and Welfare)
    • LMOs developed using the host-vector system with recognized ampicillin, chloramphenicol, hygromycin, kanamycin, streptomycin, tetracycline, puromycin, or zeocin resistance genes
  • LMOs obtained from direct use of high-risk pathogens requiring national management for public health, or from the use of the synthesized genes of such pathogens

  For import approval application, please submit the required documents specified by the Commissioner of the Korea Disease Control and Prevention Agency to the LMO manager

• LMO report and notification

  • LMO import report: Please complete the following documents and submit them to the person-in-charge via e-mail (lmort@kaist.ac.kr).
    • Application for LMO import for experimental research
    • Copy of the transaction record (invoice) or e-mail (original) in the case of donations, including Korean translation
    • Transportation plan
    • LMO utilization plan
  • LMO research facility report: Please complete the following documents and submit them to the person-in-charge via e-mail (lmort@kaist.ac.kr).
    • LMO research facility report application
    • LMO research facility inspection report

    For change or closure of LMO research facilities, contact the person-in-charge via e-mail (lmort@kaist.ac.kr) for information on related documents.

  • LMO export notification: Please complete the following documents and submit them to the person-in-charge via e-mail (lmort@kaist.ac.kr).
    • One copy of application for LMO export notification
    • Cartagena Protocol document on biosafety
      • For environmental release: Documents that comply with the contents of Annex I
      • For non-environmental release: Documents that comply with the contents of Annex II

• Contagious animal disease pathogens refer to veterinary life resources that cause infectious diseases in animals. These are classified according to the following categories, taking into consideration national quarantine, public health, etc.
  • Pathogens requiring special management: Type 1 contagious animal disease pathogens specified in the Act on the Prevention of Contagious Animal Diseases and pathogens designated by the head of Animal and Plant Quarantine Agency (Regulations on the Management of Veterinary Life Resources, Attached Table No. 1)
  • Pathogens subject to general management: Pathogens, excluding specially managed pathogens, specified as Type 2 or 3 contagious animal disease pathogen in the Act on the Prevention of Contagious Animal Diseases, pathogens designated by head of Animal and Plant Quarantine Agency (Regulations on the Management of Veterinary Life Resources, Attached Table No. 2), and other pathogens causing infectious diseases in animals
  • Other pathogens: Pathogens excluded from specially managed pathogens and generally managed pathogens
• Importing specially managed pathogens or generally managed pathogens (including LMOs) from abroad requires approval from the head of Animal and Plant Quarantine Agency.

• Experiments subject to national approval

  • When conducting experiments related to environmental release, including packaging tests
  • Using microorganisms whose species are not specified, and human pathogenicity has not been determined
  • When utilizing genes that have the ability to produce protein toxins with a lethal dose of less than 100ng per 1kg of body weight in vertebrates
  • When intentionally transferring drug-resistant genes to organisms in a manner not naturally occurring (excluding drug-resistant genes falling under Attached Table No. 1-3)
  • When directly using genes of high-risk pathogens or utilizing synthesized genes of the corresponding pathogens

• Experiments subject to institutional approval

  • Experiments using organisms of Risk Group 2 or higher as host-vector systems or DNA donors
  • Experiments involving mass cultures
  • Experiments using genes capable of producing protein toxins with a lethal dose (LD50) ranging from 0.1 μg to 100 μg per 1 kg of body weight in vertebrates
  • Experiments using organisms of Risk Group 2 or higher that are deemed to pose a high risk to human health and the environment

    Researchers intending to conduct institution-approved experiments must submit the Biosafety Experiment Review Application Form (Attached Table No. 2-1 of the Biosafety Management Guidelines), along with the following documents (including electronic documents), to the IBC.

    • Hazard assessment report using the form in Attached Table No. 2-2
    • Research plan using the form in Attached Table No. 2-3

• Experiments subject to institutional report

  • Experiments using organisms of Risk Group 1 as host-vector systems or DNA donors (excluding exempted experiments)
  • Experiments involving LMOs
  • Other experiments designated by the IBC for reporting

    Researchers intending to conduct institution-reported experiments must submit a Biosafety Experiment Report (Attached Table No. 2-6 of the Biosafety Management Guidelines) to the IBC, with the research plan (Attached Table No. 2-3) as an attachment.

  If researchers using LMOs have obtained approval from the IACUC for experiments, they are deemed as having reported to the institution. However, experiments involving the injection of biologically hazardous substances into genetically modified animals, where there is a high potential for harm to humans and the environment, require approval from both the IACUC and the IBC.

• Exempt experiments (from reporting)

  • Experiments that utilize one of the following host-vector systems, and employ Risk Group 1 organisms as the sole donor.
    • Escherichia coli K12 host-vector systems
    • Saccharomyces cerevisiae host-vector systems
    • Bacillus subtilis (or licheniformis) host-vector systems
  • Experiments that use recombinant DNA molecules composed of DNA segments derived from one or more microorganisms within a microbial group where natural DNA exchange is known to occur to propagate specific species within each group. The list of species for each group is as follows.
    • Group 1
      • Genus Citrobacter - including Levinea
      • Genus Enterobacter
      • Genus Erwinia
      • Genus Escherichia
      • Genus Klebsiella - including oxytoca
      • Genus Salmonella - including Arizona
      • Genus Shigella
      • Pseudomonas aeruginosa, Pseudomonas fluorescens, Pseudomonas mendocina 및 Pseudomonas putida
      • Serratia marcescens
      • Yersinia enterocolitica
    • Group 2
      • Bacillus amyloliquefaciens
      • Bacillus aterrimus
      • Bacillus globigii
      • Bacillus licheniformis
      • Bacillus nato
      • Bacillus niger
      • Bacillus pumilus
      • Bacillus subtilis
    • Group 3
      • Streptomyces aureofaciens
      • Streptomyces coelicolor
      • Streptomyces rimosus
    • Group 4
      • Streptomyces cyaneus
      • Streptomyces griseus
      • Streptomyces venezuelae
    • Group 5
      • One way transfer of Streptococcus mutans (or Streptococcus lactis) DNA into Streptococcus sanguis
    • Group 6
      • Streptococcus faecalis
      • Streptococcus mutans
      • Streptococcus pneumoniae
      • Streptococcus pyogenes
      • Streptococcus sanguis

    Excludes experiments involving organisms classified in Risk Group 3 or higher, mass cultures, and experiments that produce protein toxins exceeding a specified quantity

• In accordance with Article 13-2 (1) of the Act on the Control of the Manufacture, Export and Import of Specific Chemical Substances and Biological Agents for the Prohibition of Chemical and Biological Weapons, those who possess biological agents or toxins must report the quantity, possession details, and possession period to the Minister of Trade, Industry and Energy within 30 days from the date of possession. However, exemption from reporting applies to toxins below a certain quantity as specified in the Enforcement Decree of the Chemical and Biological Weapons Act.
• List of biological agents

  Classification	Pathogenic organism
  Virus (pathogenic organism)	Crimean-Congo haemorrhagic fever virus Eastern equine encephalitis virus Ebola virus Lassa fever virus Marburg virus Monkey pox virus Rift Valley fever virus Tick-borne encephalitis virus(Russian Spring-Summer encephalitis, Kyasanur Forest, Omsk Hemorrhagic Fever) Variola virus Venezuelan equine encephalitis virus Hendra virus(Equine morbillivirus) South American haemorrhagic fever(Sabia, Flexal, Guanarito, Junin, Machupo) Nipah virus Severe acute respiratory syndrome coronavirus Human infection with avian influenza virus Bovine Spongiform encephalophathy agent
  Microorganism (pathogenic organism)	Bacillus anthracis Brucella melitensis Clostridium botulinum Francisella tularensis Burkholderia mallei Vibrio cholerae Yersinia pestis Burkholderia pseudomallei Coxiella burnetii Rickettsia prowazekii Rickettsia rickettsii
  Virus (animal)	African swine fever virus Avian influenza virus(Highly pathogenic) Bluetongue virus Foot and mouth disease virus Goat pox virus Lyssa virus Peste des petits ruminants virus Swine vesicular disease virus Rinderpest virus Sheep pox virus Vesicular stomatitis virus Lumpy skin disease virus African horse sickness virus
  Microorganism (animal)	Mycoplasma mycoides
  Virus (plant)	Potato Andean latent tymovirus Potato spindle tuber viroid (PSTVd)
  Microorganism (plant)	Xanthomonas albilineans Xanthomonas campestris pv. citri Xanthomonas campestris pv. oryzae Clavibacter michiganese subsp. sepedonicum Ralstonia solanacearum Colletotrichum coffeanum var. virulans Cochliobolus miyabeanus(Helminthosporium oryzae) Mycrocyclus ulei(syn. Dothidelia ulei) Puccinia graminis(syn. Puccinia graminis f. sp. tritici) Puccinia striiformis(syn. Puccinin glumarum) Pyricularia grisea / Pyricularia oryzae

• Amount of toxins exempt from reporting

  • Less than 0.5 mg of botulinum toxins
  • Less than 100 mg of clostridium perfringens epsilon toxins
  • Less than 100 mg of conotoxin
  • Less than 100 mg of shiga toxin
  • Less than 100 mg of staphylococcus aureus toxins
  • Less than 100 mg of tetrodotoxin
  • Less than 100 mg of verotoxin
  • Less than 100 mg of microcystin (cyanginosin)
  • Less than 100 mg of aflatoxins
  • Less than 100 mg of abrin
  • Less than 1000 mg of diacetoxyscirpenol toxin
  • Less than 1000 mg of T-2 toxin
  • Less than 100 mg of volkensin toxin

• Users of LMO research facilities must complete LMO safety education for a minimum of 2 hours annually.
• Importing LMO without filing an LMO import report or exporting LMO without submitting an LMO export notification can result in imprisonment for up to 2 years or a fine of up to 30 million won.
• In LMO research facilities, the "LMO Management and Operation Register for Testing and Research Purposes" and the "LMO Handling and Management Register for Testing and Research Purposes" must be prepared and managed. These records must be retained for 5 years

• Transboundary Movement of Living Modified Organisms Act, Ministry of Trade, Industry and Energy
• Genetic Recombination Experiment Guidelines, Ministry of Health and Welfare
• LMO Information System for Experimental Research https://www.lmosafety.or.kr/mps
• Korea Veterinary Culture Collection, Animal and Plant Quarantine Agency
• Biosafety Management Rules and Guidelines