The Thai Draft Guidelines on Contained Uses of GMOs
Table of Contents:
CHAPTER 1. SCOPE OF GUIDELINES
CHAPTER 2. CATEGORIES OF SMALL-SCALE WORK INVOLVING GENETIC MANIPULATION
CHAPTER 3. ROLES AND RESPONSIBILITIES
CHAPTER 4. IMPORTATION AND TRANSPORTATION
APPENDIX 1. RELEVANT DOCUMENTS
APPENDIX 2. ORGANISMS KNOWN TO EXCHANGE DNA BY KNOWN PHYSIOLOGICAL PROCESSES
APPENDIX 3. LIST OF APPROVED HOST-VECTOR SYSTEMS
APPENDIX 4. INSTRUCTIONS FOR COMPLETING PROPOSAL FORMS
APPENDIX 5. TOXINS
APPENDIX 6. REQUIREMENTS FOR WORK WITH LIVE VIRAL VECTORS
APPENDIX 7. PROCEDURES FOR WORK WITH HAZARDOUS FRAGMENTS OF DNA
APPENDIX 8. SUPPLEMENTARY INFORMATION REQUIRED FOR WORK WITH WHOLE PLANTS
APPENDIX 9. REQUIREMENTS FOR PHYSICAL CONTAINMENT LEVEL C1
APPENDIX 10. REQUIREMENTS FOR PHYSICAL CONTAINMENT LEVEL C2
APPENDIX 11. REQUIREMENTS FOR PHYSICAL CONTAINMENT LEVEL C3
APPENDIX 12. REQUIREMENTS FOR PLANT-HOUSE LEVEL PH1
APPENDIX 13. NOTE ON PLANT HOUSES WITH HIGHER CONTAINMENT THAN PH1
APPENDIX 14. EQUIREMENTS FOR PLANT-HOUSE LEVEL PH3
APPENDIX 15. REQUIREMENTS FOR EXPERIMENTS INVOLVING TRANSGENIC ANIMALS
APPENDIX 16. REQUIREMENTS FOR HOUSING OF INFECTIOUS TRANSGENIC ANIMALS
APPENDIX 17. DESIGN OF TRANSGENIC-ANIMAL FACILITIES
APPENDIX 18. REQUIREMENTS FOR ANIMAL-CONTAINMENT LEVEL C1A
APPENDIX 19. REQUIREMENTS FOR ANIMAL-CONTAINMENT LEVEL C2A
APPENDIX 20. NOTE ON TRANSPORT
CHAPTER 1
SCOPE OF GUIDELINES
1. These Guidelines apply to any experiment carried out in laboratories of government, state enterprises, private organizations, or companies and involving the construction and/or propagation of viroids, viruses, cells or organisms of novel genotypes produced by genetic manipulation which are either unlikely to occur in nature or likely to pose a hazard to public health or to the environment.
2. If an investigator is uncertain if the work he/she is proposing to do falls within the scope of these Guidelines, a description of the proposed work should be submitted to the Institutional Biosafety Committee (IBC) for written clarification before work commences. If there is no IBC in the firm or institution, a description of the work proposed should be sent to the National Biosafety Committee (NBC).
CHAPTER 2
CATEGORIES OF SMALL-SCALE WORK INVOLVING GENETIC MANIPULATION
Small-scale work in the field of genetic manipulation and biotechnology is classified according to risk assessment.
Category 1 - Work which is exempted.
Category 2 - Work which may involve a low level of hazard to researchers, the community and the environment.
Category 3 - Work which may involve a high level of hazard to researchers, the community, the environment or, in the case of human gene therapy, to the patient. Included in this category is work for which the nature or the degree of hazard may be uncertain.
2.1. Category 1
Work which needs no approval from the National Biosafety Committee.
2.1.1. The following types of experiments are classified as Category 1 work:
A Any experiment involving the fusion of mammalian cells which does not generate a viable organism, for example, the creation of hybridomas to produce monoclonal antibodies (Appendix 1).
B Protoplast fusion between non-pathogenic microorganisms.
C Protoplast fusion or embryo rescue involving plant cells.
D Work with self-exchanging organisms in which the donor species is also the host species or a species known to exchange genetic information with the host species under natural conditions (Appendix 2).
E Any experiments involving approved host-vector systems (Appendix 2) if the donor DNA:
·  is not derived from microorganisms able to cause disease in humans, animals or plants;
·  does not code for any protein which regulates the growth of mammalian cells (for example, the product of an oncogene), a cytotoxic protein or a toxin for vertebrates with an LD50 of less than 100 µg/kg;
·  does not comprise or represent more than two-thirds of the genome of a virus and is not being used in an experiment in which the genetic material missing from the viral genome, and essential for producing infection, is available in the cell into which the incomplete genome is introduced or is made available by subsequent breeding processes.
Exempted work should be carried out under conditions of standard microbiological laboratory practice. If pathogenic organisms are used, the containment level appropriate to the pathogen should be employed, and personnel should have appropriate training.
2.1.2. IBC Notification
A Scientists who believe that their work falls into any of the above Category 1 exemptions are nevertheless required to notify their Institutional Biosafety Committee (IBC) of the proposed project. If the institution does not have an IBC, scientists should notify the NBC by submitting a description of the proposed work before commencement.
B Forms for IBC notification for exempted work may be devised by IBCs. A sample of such a form is shown in Appendix 4.
C Any substantive change in experiments already granted a "Special Exemption" which may affect the exemption status requires a new proposal form to be submitted to the IBC for notification. If the IBC endorses the change in the proposed work, it will send it on to the NBC.
2.2. Category 2
Experiments which involve a low level of hazard to laboratory personnel, the community or the environment.
Such work requires at least C1 or, in the case of work with whole plants or animals, PH1 glasshouse or C1 animal physical containment. Some work may require additional precautions or a higher level of containment because the donor DNA or its components are by their nature hazardous or infectious. Other work may require special containment features; the housing of transgenic animals is an example. Procedures for C1 and other containment levels are in Appendices 9-19.
The IBC and the investigator should identify all potential sources of hazard and their nature and determine any additional procedures and conditions appropriate for work in this category.
The following subcategories of work must be described in proposals submitted to the IBC for determination of the appropriate working and containment conditions, and may begin only after IBC assessment and approval. The IBC should subsequently forward the proposal and assessment forms to the NBC for information.
The following types of experiments are classified as Category 2 work:
A Genetic manipulation work involving whole animals (including non-vertebrates, but excluding microorganisms). Genetic manipulation of the genome of the oocyte or zygote or early embryo by any means to produce a novel whole organism (Appendix 15).
B Genetic manipulation work involving the production of modified whole plants. Note that the investigator needs to submit a supplementary information form for work involving whole plants (Appendix 8).
C Work with non-approved host-vector systems, i.e., other than those listed in Appendix 3. Work with approved host-vector systems, where the gene inserted:
·  is a pathogenic determinant;
·  is uncharacterized DNA from microorganisms able to cause disease in humans, animals or plants;
·  encodes a protein involved in regulating cellular growth (for example, an oncogene).
2.3. Category 3
Work which may involve a hazard to researchers, the community, the environment or, in the case of human gene therapy, to the patient, or work for which the nature or the degree of hazard may be uncertain.
The level of physical containment required will vary according to the nature of the work and its assessed hazard. In some cases, C1 may be considered sufficient, while in others higher containment levels may be necessary. This category of work requires assessment by the NBC which must then advise the IBC.
The following types of experiments fall into Category 3:
A Work with toxin producers: Work with DNA encoding a toxin for vertebrates having a LD50 of less than 100 µg/kg. (Appendix 5). Work involving high-level expression of toxin genes even if the LD50 is greater than 100 µg/kg. Work with uncharacterized DNA which may include toxin sequences from toxin-producing organisms.
B Experiments involving viral vectors whose host range includes human cells and which contain one or more inserted DNA sequences coding for a product known to play a role in the regulation of cellular growth or to be toxic to human cells (special conditions for working with viral vectors encoding oncogenes are contained in Appendix 6).
C Experiments using, as host or vector, microorganisms which are able to cause disease in plants, humans or animals, except for those listed as approved hosts or vectors (Appendix 3). Included in this subcategory are experiments using defective vector-host virus combinations which have the potential to regenerate a non-defective recombinant virus.
D Introduction of genes determining pathogenicity in microorganisms other than the approved hosts listed in Appendix 3.
E Cloning or transfer of complete viral genomes, viroids or of fragments of a genome capable of giving rise to infectious particles pathogenic to humans, animals or plants. Generally, work involving less than two-thirds of the complete viral genome, or work with a genome lacking gene activity for a vital component of replication or packaging not supplied by the experimental system would fall outside this subcategory.
F Experiments involving recombinations between whole viral genomes, viroids and/or complementary fragments of such genomes where one or more fragments contain virulence or pathogenic determinants. This subcategory includes experiments which alter host ranges of pathogens or which may increase their virulence or infectivity.
G All proposals for human gene therapy work.
H Any experiment to inject a fragment or the whole genome of a virus into an embryo to produce a transgenic animal secreting or producing infectious viral particles (Appendix 15).
I Experiments not falling into Category 1, 2 or 3 but which fall under the scope of the Guidelines as defined in Section 1.
CHAPTER 3
ROLES AND RESPONSIBILITIES
Roles and responsibilities of various regulatory authorities.
In order to oversee and review the safety aspects of genetic manipulation work and biotechnology, three levels of regulatory authorities with specific roles and responsibilities are established:
·  the National Biosafety Committee (NBC)
·  Institutional Biosafety Committees (IBCs)
·  Principal Investigators
3.1. The National Biosafety Committee
The National Biosafety Committee was established by the Minister of Science, Technology and the Environment on 22 January 1993 according to the recommendations of the National Committee for Genetic Engineering and Biotechnology, which has established guidelines for regulation and/or advice in biotechnology and genetic engineering work so that potential risks and hazards to the community and the environment can be prevented.
3.1.1. Roles of the National Biosafety Committee
A Maintain an overview of the biosafety factors associated with innovative genetic manipulation techniques.
B Identify and keep under review classes of work which have an undefined risk level.
C Alert regulatory authorities to the existence of risk factors.
D Provide specialist technical advice on specific biosafety matters to organizations using these techniques and to regulatory agencies.
E Prepare or, as appropriate, assist with the preparation of codes, standards or guidelines for the assessment and management of biosafety risk factors, whether for the Committee's own overseeing activities or to assist regulatory agencies.
F Participate in public discussions on the biosafety of these techniques.
G Liaise with agencies overseas to ensure that, as far as practicable, Thai guidelines and regulations are in harmony with international practice.
3.1.2. Responsibilities of the National Biosafety Committee
With regard to the administration of these Guidelines, NBC will:
A Provide advice to Institutional Biosafety Committees (IBCs) on Category 3 proposals (Chapter 2).
B Provide advice on any other category of proposal if such advice is sought by IBCs.
C Inspect and certify C2 and C3 laboratories and facilities, facilities with C1-LS (large scale) and C3-LS containment levels and plant and animal facilities with equivalent levels.
D Provide signs for facilities, proposal forms, IBC assessment forms, copies of Guidelines to IBCs.
E Refer matters concerning the safety of genetic manipulation to relevant government agencies, institutions and firms, where appropriate.
F Protect information which may have a commercial significance. If investigators wish to restrict access to such information, they must mark each of the relevant pages of the proposal "Confidential".
3.1.3. Certification of C2, C3 and PH2 Laboratories
C2 and C3 laboratories (including animal containment facilities with these levels) and PH2 facilities are certified by the NBC. Following receipt of the report, the NBC will ether certify the laboratory or advise the IBC of any problems preventing certification. After certification of a C2, C3 or PH2 laboratory, the IBC must undertake regular inspections as required for C1 laboratories. In addition, the NBC reserves the right to inspect laboratories and facilities at any time without notice.
3.1.4. Secretariat Contact
The National Biosafety Committee's postal address is:
National Centre for Genetic Engineering and Biotechnology,
Ministry of Science, Technology and the Environment,
Building Rama VI, Bangkok 10400, THAILAND.
Telephone: (066)-2-2452498-9. Facsimile: (066)-2-2464850.
3.2. Responsibilities of Institutions
Any institution, firm or organization which conducts genetic manipulation work, undertakes importation of organisms arising from such work or produces such organisms or plans to release such organisms into the environment or for sale is required to set up an Institutional Biosafety Committee (IBC), provide such resources and facilities as are necessary for safe work in laboratories and for the IBC to undertake its duties adequately and ensure by recruitment procedures and other measures that adequate supervision of work takes place. Institutions may consider making compliance with these Guidelines a term of employment contracts, where appropriate. Institutions conducting large-scale or industrial-scale work should have a Biological Safety Officer (BSO).
The National Biosafety Committee recognizes the difficulties that small institutions and small firms have in setting up an IBC. These firms may choose the option of being supervised by the nearest IBC or by an IBC in the same province. Such arrangements need to be formalized between the institutions concerned and notified to NBC. A representative member of the smaller institution needs to liaise closely with, or be a member of, the IBC.
The responsibilities of institutions are:
·  To review the qualifications and experience of personnel involved in research proposals, to ensure that they are adequate for good microbiological practice and for the supervision of junior personnel.
·  To maintain a register of approved projects on genetic engineering and their assessment and projects exempted under section 2.1 of these Guidelines.