BIOSAFETY ACT 2007

LAWS OF MALAYSIA ONLINE VERSION OF UPDATED TEXT OF REPRINT Act 678 BIOSAFETY ACT 2007 As at 1 May 2019 2 BIOSAFETY ACT 2007 … … … 29 August 2007 Date of publication in the Gazette … … 30 August 2007 Latest amendment made by P. U. (A) 36/2019 which came into operation on … … … 16 February 2019 Date of Royal Assent 3 LAWS OF MALAYSIA Act 678 BIOSAFETY ACT 2007 ARRANGEMENT OF SECTIONS PART I PRELIMINARY Section 1. Short title and commencement 2. Act to be read together with other laws 3. Interpretation PART II NATIONAL BIOSAFETY BOARD 4. Establishment of the National Biosafety Board 5. Functions of the Board 6. Establishment of the Genetic Modification Advisory Committee 7. Board and Advisory subcommittees 8. Appointment of Director General and other officers 9. Delegation of functions of the Board Committee may establish 10. Power of Minister to give directions PART III APPROVAL FOR RELEASE AND IMPORT 11. Application of Part III committees and 4 Laws of Malaysia ACT 678 Section 12. Requirement for approval 13. Application for approval 14. Director General to refer application to Advisory Committee, etc. 15. Advisory Committee to make recommendations on application for approval 16. Approval for release and import 17. Approval to be valid for subsequent release and import 18. Review of approval upon obtaining new information 19. Circumstances where Board may make further order on approval 20. Appeal to Minister relating to approval PART IV NOTIFICATION FOR EXPORT, CONTAINED USE AND IMPORT FOR CONTAINED USE 21. Application of Part IV 22. Requirement for notification 23. Compliance with requirements of importing country 24. Submission of notification 25. Acknowledgement of submission of notification by Director General 26. Specific measures to be taken in contained use 27. Director General may require additional information 28. Director General to refer notification to Advisory Committee and relevant agency 29. Advisory Committee to make recommendations on notification 30. Board to make appropriate order on notification 31. Board may require additional information 32. Review of notification upon obtaining new information 33. Circumstances where Board may make further order on notification 34. Appeal to Minister relating to notification 35. Taking of decision by the Board or Minister Biosafety 5 PART IV RISK ASSESSMENT AND RISK MANAGEMENT REPORTS AND EMERGENCY RESPONSE PLAN Section 36. Risk assessment and risk management reports 37. Emergency response plan PART VI ENFORCEMENT 38. Enforcement officers 39. Power of investigation 40. Search by warrant 41. Search without warrant 42. Access to computerized data 43. List of things seized 44. Power to seal premises 45. Forfeiture of living modified organisms or products of such organisms, etc. 46. Cost of holding organisms, etc., seized 47. No costs or damages arising from entry, search or seizure to be recoverable 48. Obstruction of enforcement officers 49. Examination of persons acquainted with case 49A. Admissibility of statement of evidence 50. Power to require production of things related to offence 51. Enforcement officer may seek assistance to examine things related to offence 52. Power of Board to require information on living modified organisms or products of such organisms 53. Power to take sample 54. Procedure for taking sample 55. Appointment of analyst 6 Laws of Malaysia Section 56. Certificate of analysis 57. Presumption 58. Institution of prosecution PART VII MISCELLANEOUS 59. Confidential business information 60. Public disclosure 61. Identification and labelling 62. Assistance from multi-agencies in emergency 63. Service of notice 64. Offence by body corporate 65. Offence by partner, agent or servant 66. Power to compound 67. Falsification, concealment and destruction of document 68. Power of Minister to exempt 69. Power to make regulations 70. Power to amend Schedules 71. Transitional provisions FIRST SCHEDULE SECOND SCHEDULE THIRD SCHEDULE ACT 678 7 LAWS OF MALAYSIA Act 678 BIOSAFETY ACT 2007 An Act to establish the National Biosafety Board; to regulate the release, importation, exportation and contained use of living modified organisms, and the release of products of such organisms, with the objectives of protecting human, plant and animal health, the environment and biological diversity, and where there are threats of irreversible damage, lack of full scientific evidence may not be used as a reason not to take action to prevent such damage; and to provide for matters connected therewith. [1 December 2009, P.U. (B) 537/2009] ENACTED by the Parliament of Malaysia as follows: PART I PRELIMINARY Short title and commencement 1. (1) This Act may be cited as the Biosafety Act 2007. (2) This Act comes into operation on a date to be appointed by the Minister by notification in the Gazette. Act to be read together with other laws 2. (1) This Act shall be read together with any other written law relating to import and export, human, plant and animal health, the environment and biological diversity, and the provisions of this Act 8 Laws of Malaysia ACT 678 shall be in addition to, and not in derogation of, the provisions of such other written laws. (2) In the event of any inconsistencies between the provisions of this Act and any of the other written laws referred to in subsection (1) the provisions of this Act shall prevail. Interpretation 3. In this Act, unless the context otherwise requires— “release activity” means any intentional introduction of living modified organisms or products of such organisms into the environment through the activities or for the purposes specified in the Second Schedule; “modern biotechnology” means the application of— (a) in vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and direct injection of the nucleic acid into cells or organelles; or (b) fusion of cells beyond the taxonomic family, that overcome natural physiological reproductive or recombination barriers and that are not techniques used in traditional breeding and selection; “products of such organisms” means any product derived from a living modified organism or part of a living modified organism— (a) if the product contains detectable deoxyribonucleic acid (DNA); or recombinant (b) where the profile, characteristic or properties of the product is or are no longer equivalent to its conventional counterpart irrespective of the presence of the recombinant deoxyribonucleic acid (DNA); Biosafety 9 “Advisory Committee” means the Genetic Modification Advisory Committee established under section 6; “analyst” means an analyst appointed under section 55; “contained use” means any operation including research and development, production or manufacturing operation involving living modified organisms, or storage of living modified organisms, undertaken within a facility, installation or other physical structure such that it prevents the contact and impact of the living modified organisms on the external environment; “approval” means an approval granted under subsection 16(3); “biological diversity” means the variability among living organisms from all sources including, inter alia, terrestrial, marine and other aquatic ecosystems and the ecological complexes of which they are part; and includes diversity within species, between species and of ecosystems; “Director General” means the Director General appointed under subsection 8(1); “Board” means the National Biosafety Board established under subsection 4(1); “Minister” means the Minister charged with the responsibility for natural resources and environment; “approved person” means— (a) a person to whom an approval has been granted under Part III; or (b) a person to whom an acknowledgement of receipt on the submission of a notification under Part IV has been issued; 10 Laws of Malaysia ACT 678 “living modified organism” means any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology; “living organism” means any biological entity capable of transferring or replicating genetic material, including sterile organisms, viruses and viroids; “enforcement officer” means an enforcement officer appointed under subsection 8(1) and includes an officer specified in the Third Schedule and an officer authorized under paragraph 38(c); “occupier” means a person in actual occupation or having the charge, management or control of— (a) any premises; or (b) in relation to premises where different parts of which are occupied by different persons, the respective persons in occupation or control of each part; “Chairman” means the Chairman of the Board appointed under paragraph 4(2)(a); “premises” includes houses, buildings, lands, tenements, easements of any tenure, whether open or enclosed, whether built on or not, whether public or private, and whether maintained or not under statutory authority and any machinery, plant, vessel, aircraft or other vehicle. PART II NATIONAL BIOSAFETY BOARD Establishment of the National Biosafety Board 4. (1) A board by the name of the “National Biosafety Board” is established. Biosafety 11 (2) The Board shall consist of the following members who shall be appointed by the Minister: (3) (a) the Secretary General of the Ministry of Water, Land and Natural Resources who shall be the Chairman; (b) a representative from the Ministry of Agriculture and Agro-based Industry; (c) a representative from the Ministry of Health; (d) a representative from the Ministry of Primary Industries; (e) a representative from the Ministry of Domestic Trade and Consumer Affairs; (f) a representative from the Ministry of International Trade and Industry; (g) a representative from the Ministry of Energy, Science, Technology, Environment and Climate Change; and (h) not more than four other persons who have the knowledge or experience or both in any of the disciplines or matters relevant to this Act. The provisions of the First Schedule shall apply to the Board. (4) The Director General shall be the Secretary of the Board and shall carry out such duties as may be imposed by the Board. (5) The Board shall be responsible to the Minister. Functions of the Board 5. (1) The functions of the Board shall be as follows: 12 Laws of Malaysia ACT 678 (a) to decide on all applications and matters under Part III and Part IV; (b) to monitor activities relating to living modified organisms and products of such organisms; (c) to promote research, development, educational and training activities relating to biosafety; (d) to establish mechanisms to facilitate the collection, storage and dissemination of data relating to living modified organisms and products of such organisms and biosafety; and (e) where so directed by the Minister, to perform or provide for the performance of the obligations arising from agreements, conventions or treaties relating to biosafety to which Malaysia is a party where such agreements, conventions or treaties relate to the purposes of this Act. (2) The Board shall have power to do such things as the Board thinks fit to enable it to perform its functions effectively or which are incidental to the performance of its functions. Establishment of the Genetic Modification Advisory Committee 6. (1) A committee by the name of the “Genetic Modification Advisory Committee” is established. (2) The function of the Advisory Committee is to provide scientific, technical and other relevant advice to the Minister or the Board. (3) The chairman of the Advisory Committee shall be appointed by the Minister. (4) Such number, as may be approved by the Minister, of other members of the Advisory Committee shall be appointed by the Board. Biosafety 13 (5) Members of the Advisory Committee shall consist of experts from various science-based and other relevant disciplines. (6) The chair