* For Example, Act 2007

Original Language Title: *Biosafety Act 2007

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Laws of MALAYSIA ONLINE VERSION of the PRINT TEXT that UPDATES BIOKESELAMATAN ACT 2007 Act 678 As on May 1 2015 2 BIOKESELAMATAN ACT 2007 date of Assent............ August 29, 2007, the date of publication in the Gazette......... 30 August 2007 3 laws of MALAYSIA Act 678 BIOKESELAMATAN ACT 2007 ARRANGEMENT of SECTIONS part I preliminary section 1. Short title and commencement 2. The Act should be read in conjunction with other laws 3. Interpretation of PART II of the NATIONAL BOARD of BIOKESELAMATAN 4. The establishment of the Board of the national Biokeselamatan 5. Functions of the Board 6. The establishment of the Genetic Modification Advisory Committee 7. The Board and the Advisory Committee may establish committees and sub-committees of the 8. The appointment of the Director General and other officers 9. Delegation of the functions of the Board 10. Power of Minister to give directions PART III APPROVAL for RELEASE and IMPORTS 11. Application of part III 4 laws of Malaysia ACT 678 section 12. Requirements for approval 13. Application for approval 14. The Director-General shall refer the application to the Advisory Committee, etc.
15. The Advisory Committee shall make recommendations about application for approval 16. Approval for release and imports 17. Approval shall be valid for emissions and imports the next 18. Review of approval when getting new information 19. Circumstances the Board may make further orders when approved 20. Appeal to the Minister relating to the approval of PART IV NOTIFICATION for export, the USE of CONTROLLED and the IMPORT of the CONTROLLED USE of 21. Application of part IV 22. Requirements for notification of 23. Compliance with the requirements of the importing countries 24. Submission of notification of 25. Pengakuterimaan submission of notification by the Director General 26. Specific measures to be taken in the use of controlled 27. The Director-General may require additional information 28. The Director-General shall refer to the notification to the Advisory Committee and the relevant government agency 29. The Advisory Committee shall make recommendations about 30 notifications. The Board shall make an appropriate order about notification 31. The Board may require additional information 32. Review notification when getting new information 33. Circumstances the Board may make further orders about 34 notifications. Appeal to the Minister relating to notifications 35. Decision-making by the Board or the Minister Biokeselamatan 5 part V REPORT of the RISK ASSESSMENT and RISK MANAGEMENT and EMERGENCY RESPONSE PLAN Section 36. Report of the risk assessment and risk management, 37. Emergency response plan PART VI ENFORCEMENT of 38. Enforcement officers 39. Power of investigation of 40. Search with warrant 41. A search without a warrant 42. Access to computerized data 43. List of things seized 44. Power to avoid premises 45. Forfeiture of the living modified organism or products of such organisms, etc.
46. The cost of holding organisms, etc., seized 47. There are no costs or damages arising from the entry, search or seizure can be obtained 48. Obstruction of enforcement officers 49. Examination of person who knew the case of 49A. Admissibility of statements as evidence 50. Power to require production of the object in relation to the offence of 51. Enforcement officers can get help to check things in relation to offences 52. The power of the Board to require information about the modified organisms living or such organisms products 53. Authorized to collect a sample of 54. Procedure for taking a sample of 55. The appointment of analyst 56. Certificate of analysis of 57. Assumption 6 laws of Malaysia ACT 678 Section 58. An initial prosecution PART VII MISCELLANEOUS 59. A secret business information 60. General disclosure 61. Identification and labelling of 62. Help from multiple agency emergency 63. Service of notice 64. Offences by body corporate 65. Offences by partner, agent or servants 66. Power to compound 67. Fraud, concealment and destruction of documents 68. Minister's power to make exemptions 69. The power to make regulations 70. The power to amend Schedule 71. The transitional provisions of the FIRST SCHEDULE SECOND SCHEDULE of the THIRD SCHEDULE of the 7 laws of MALAYSIA Act 678 BIOKESELAMATAN ACT 2007 an act to establish the national Biokeselamatan Board; to regulate the importation, exportation, clearance and controlled use of living modified organisms, and the release of such organisms and their products, with the aim to protect the health of humans, plants and animals, the environment and biological diversity, and if there is a threat of damage that cannot be returned as usual, lack of full scientific evidence cannot be used as a reason for not taking action to prevent such damage; and to provide for matters connected therewith.

[1 January 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 Biokeselamatan Act 2007.

(2) of this Act come into force on such date as the Minister may, by notification in the Gazette.


8 laws of Malaysia ACT 678 of the Act are to be read together with the other laws 2. (1) this Act shall be read together with any other written law relating to import and export, human health, plants and animals, the environment and biological diversity, and the provisions of this Act shall be in addition to, and not a reduction, of the provisions of any other written law.

(2) where there is any inconsistency between the provisions of this Act with any other written law referred to in subsection (1) of this Act shall apply.


Interpretation 3. In this Act, unless the context otherwise requires — "activities release" means any intentional introduction of modified living organisms or products of such organisms into the environment through activities or for the purposes specified in the second schedule;


"modern biotechnology" means the application of — (a) in vitro nucleic acid techniques, including deoksiribonukleik acid (DNA) and direct injection of rekombinan nucleic acid into cells or organelles; or (b) the merger of cells outside of the family taksonomik, which overcome natural physiological reproductive or obstacles rekombinasi and that are not techniques used in traditional breeding and selection of breed;

Biokeselamatan 9 "products of such organisms" means any products derived from modified organisms living or part of living modified organisms — (a) if the products contain deoksiribonukleik acid (DNA) rekombinan can impact; or (b) if the profile, characteristics or properties of the products was or is no longer equivalent to common products regardless of the presence of deoksiribonukleik acid (DNA) of the rekombinan;

"Advisory Committee" means the Genetic Modification Advisory Committee established under section 6;

"analyst" means a person analyst appointed under section 55;

"controlled use" means any operations including research and development, manufacturing or production operations that involve modified living organisms, or storage of living modified organisms, which is carried out in a given structure of the facility, installation or other physical structure until it prevents light touch and impact modified living organism to external environment;

"approval" means approval given under subsection 16 (3);

"biological diversity" means the keragaman between living organisms from all sources including, inter alia, land, Ocean 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 Board of the national Biokeselamatan established under subsection 4 (1);
10 laws of Malaysia ACT 678 "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 a pengakuterimaan receipt when forwarding notification under part IV was released;

"living modified organism" means any living organisms that have a new combination of genetic material obtained through the use of modern biotechnology;

"living organisms" means any biological entity that can transfer or replicating genetic material, including organisms, viruses and viroid sterile;

"enforcement officer" means a person appointed enforcement officers under subsection 8 (1) and includes an officer who is specified in the third schedule and an officer who is authorized under paragraph 38 (c);

"residents" means a person occupies with fact or in charge of, managing or controlling — (a) any premises; or (b) in relation to the different parts of the premises occupied by different people, each person occupying or controlling each Division;

"Chairman" means the Chairman of the Board appointed under paragraph 4 (2) (a);

"premises" includes land, buildings, houses, tenemen, isemen any holding, whether open or closed, whether Biokeselamatan 11 constructed on it or not, whether public or private, and whether or not maintained under statutory authority and any machinery, plant, vessel, aircraft or other vehicles.


PART II BOARD of NATIONAL BIOKESELAMATAN National Biokeselamatan Board 4. (1) a Board with the name "the national Biokeselamatan Board" was established.

(2) the Board shall consist of the following members who shall be appointed by the Minister: (a) the Secretary General of the Ministry of natural resources and the environment who shall be the Chairman;

(b) a representative of the Ministry of agriculture and agro-based industries;

(c) a representative of the Ministry of health;

(d) a representative of the Ministry of plantations industries and commodities;

(e) a representative of the Ministry of domestic trade and Consumer Affairs;

(f) a representative of the Ministry of international trade and industry;

(g) a representative of the Ministry of science, technology and innovation; and (h) not more than four other persons who have knowledge or experience or both in the 12 laws of Malaysia ACT 678 of any discipline or matter relating to this Act.

(3) the provisions of the first schedule shall apply to the Board.

(4) the Director General shall be the Secretary of the Board and shall perform the 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 are as follows: (a) to make decisions about 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 encourage research, development, education and training relating to biokeselamatan;

(d) to establish mechanisms to facilitate the collection, storage and dissemination of data relating to the modified living organisms and products of such organisms and biokeselamatan; and (e) if directed by the Minister, to carry out or provide for the implementation of the obligations arising from the agreement, Convention, or treaty relating biokeselamatan to which Malaysia into a party if agreement, Convention or treaty that related to the purposes of this Act.
Biokeselamatan 13 (2) the Board shall have power to do any of the things it thinks fit by the Board to enable it to perform its functions effectively or incidental to the performance of its functions.


The establishment of the Genetic Modification Advisory Committee 6. (1) a Committee by the name of "the Genetic Modification Advisory Committee" was established.

(2) the functions of the Advisory Committee is to provide advice on scientific, technical and other related advice to the Minister or the Board.


(3) the Chairman of the Advisory Committee shall be appointed by the Minister.

(4) such number of other members of the Advisory Committee, as approved by the Minister, shall be appointed by the Board.

(5) a member of the Advisory Committee shall consist of experts from various disciplines based on Science and other related disciplines.

(6) the Chairman and members of the Advisory Committee shall hold office for such period as may be specified in the instrument of appointment and shall be eligible for re-election.

(7) the appointment of the Chairman of the Advisory Committee may at any time be revoked by the Minister and the appointment of any member of the Advisory Committee may at any time be revoked by the Board, without giving any reason for the revocation.

(8) the Chairman of the Advisory Committee may at any time resign his Office by a written notice addressed to the Minister and a member of the Advisory Committee may 14 laws of Malaysia ACT 678 may at any time resign his Office by notice in writing addressed to the Board.

(9) If the Chairman of the Advisory Committee is not present at a meeting of the Advisory Committee, the members present may appoint one of them to chair the meeting.

(10) the Advisory Committee may invite any person to attend any meeting of the Committee for the purpose of advising it on any matter under discussion, but the person invited shall not be entitled to vote at any such meeting.

(11) subject to subsection (9) and (10), the Advisory Committee may regulate its own procedure.

(12) the Chairman and members of the Advisory Committee and any person invited to attend any meeting of the Advisory Committee may be paid such allowances and other expenses related to the work of the Committee as it deems fit by the Minister, with the agreement of the Minister of finance.

(13) without prejudice to the Minister's power to issue general instructions to the Advisory Committee under section 10, the Advisory Committee shall be responsible to the Board.


The Board and the Advisory Committee may establish committees and sub-committees 7. (1) the Board may establish any Committee, and the Advisory Committee may establish such sub-committees as it deems necessary or expedient by the Board and the Advisory Committee to assist them in carrying out their functions under this Act.

Biokeselamatan 15 (2) the Board and the Advisory Committee may appoint any person to be a member of the Committee or Subcommittee, as the case may be, established under subsection (1).

(3) a Committee or a Sub-Committee established under this section may elect any of its members to be Chairman and may regulate its own procedure.

(4) a Committee or Subcommittee may invite any person to attend any meeting of the Committee or Subcommittee for the purpose of advising it on any matter under discussion, but the person invited shall not be entitled to vote at any such meeting.

(5) members of a Committee or Sub-Committee and any person invited to attend any meeting of the Committee or Sub-Committee may be paid such allowances and other expenses related to the work of the Committee or the Sub-Committee as the Minister thinks fit, with the agreement of the Minister of finance.

(6) a member of a Committee or Subcommittee shall hold office for such period as may be specified in the instrument of appointment and shall be eligible for re-election.

(7) the appointment of any member of a Committee or Sub-Committee may at any time be revoked by the Board or Advisory Committee, as the case may be, without assigning any reason for the revocation.

(8) a member of a Committee or Sub-Committee may at any time resign his Office by a written notice addressed to the Chairman of the Board or the Chairman of the Advisory Committee, as the case may be.
16 laws of Malaysia ACT 678 (9) a Committee and Subcommittee shall be subject to and act in accordance with any instructions given to the Committee or the Sub-Committee by the Board or Advisory Committee, as the case may be, in the discharge of their functions.


The appointment of the Director General and other officers 8. (1) there shall be appointed a Director-General of Biokeselamatan and any other officers, including enforcement officers, as may be necessary for the purposes of this Act.

(2) the Director General shall have general control over the appointed under subsection (1).

(3) in fulfilling its duties, the Director-General shall act under the authority and the General instructions of the Board.


Delegation of the functions of the Board 9. (1) the Board may, subject to such conditions, limitations or restrictions as it thinks fit to impose, delegate any of its functions, with the exception of the functions under paragraph 5 (1) (a), to — (a) any member of the Board;

(b) Advisory Committee or any of its members;

(c) any other Committee established by the Board;
or (d) the Director-General.

(2) a delegation under this section shall not prevent the Board from performing or conducting himself at any time any of the functions delegated it.

Biokeselamatan 17 the power of Minister to give directions 10. The Minister may provide general instructions to the Board and the Advisory Committee in accordance with this Act, and the Board and the Advisory Committee shall, as soon as possible, implement such instructions.


PART III the APPROVAL for the RELEASE and IMPORT Application Part III 11. (1) this part shall apply to the activities of relief and import activities involving living modified organisms.

(2) Notwithstanding subsection (1), this part does not apply to the importation of modified organisms living intended for the purpose of carrying out an activity regulated uses.


Requirements for approval 12. (1) No person shall carry out any activities release, or any importation of modified organisms

life, or both without prior approval from the Board.

(2) any person who contravenes subsection (1) commits an offence and shall, on conviction, — (a) if the person is an individual, to a fine not exceeding two hundred and fifty thousand or to imprisonment for a term not exceeding five years or to both common and, in the case of a continuing offence, a further fine not exceeding ten thousand dollars for each day the offence continues after conviction;

18 laws of Malaysia ACT 678 (b) if that person is a body corporate, to a fine not exceeding five hundred thousand dollars and, in the case of a continuing offence, a further fine not exceeding twenty thousand dollars for each day the offence continues after conviction.


Application for approval 13. (1) an application for approval of any relief activities, or any importation of modified living organisms, or both must be submitted to the Director General in the prescribed manner, together with the prescribed fee, and shall be accompanied by — (a) a report on risk assessment and risk management as specified in section 36;

(b) an emergency response plan as specified in section 37; and (c) any other information as may be specified by the Board.

(2) At any time after receipt of an application made under subsection (1), the Director-General may require the applicant to provide the information, particulars or additional documents within any period specified by the Director General.

(3) if any applicant fails to provide any information, particulars or additional documents required under subsection (2), the application or the application of the body corporate shall be deemed to have been withdrawn without prejudice to a new application is made.



Biokeselamatan 19 the Director-General shall refer the application to the Advisory Committee, etc.

14. When an application for approval has been submitted in accordance with section 13, the Director General of — (a) shall refer the application to the Advisory Committee for the syornya;

(b) shall refer the application to any Department or related government agencies about specific matters; and (c) subject to section 59, shall for the purposes of disclosure to the public, invite the participation of the public, in such manner as determined by the Director General, in order to obtain their views on the application.


The Advisory Committee shall make recommendations on applications for approval, 15. (1) upon receipt of an application referred to it under paragraph 14 (a), the Advisory Committee shall evaluate the application for the purpose of making recommendations to the Board on whether or not the application should be approved, and the terms and conditions shall be imposed by the Board, if any.

(2) At any time after receipt of the application, the Advisory Committee may request information, particulars or documents from the applicant by the Director General.

(3) if any applicant fails to furnish, within any period specified by the Director-General, any information, particulars or additional documents required under subsection (2), the application or applications the Organization 20 laws of Malaysia ACT 678 of the Corporation shall be deemed to have been withdrawn without prejudice to a new application is made.

(4) as soon as the Advisory Committee to complete its evaluation of the application of this, the Advisory Committee shall submit the application to the syornya on the Board.


Approval for release and imports 16. (1) At any time after receiving the recommendation of the Advisory Committee under section 15, the Board may request the applicant to provide the information, particulars or additional documents within any period specified by the Board.

(2) if any applicant fails to provide any information, particulars or additional documents required under subsection (1), the application or the application of the body corporate shall be deemed to have been withdrawn without prejudice to a new application is made.

(3) after considering the recommendation of the Advisory Committee, reviews the relevant department or agency referred to in paragraph 14 (b), the views of the public, if any, referred to in paragraph 14 (c), and any information, particulars or additional documents provided pursuant to a request under subsection (1), the Board may approve the application by issuing a certificate of approval or reject the application.

(4) If the Board gives approval, the Board may impose such terms and conditions as the Board may think fit.

(5) the approved Person may apply to the Board to alter any terms and conditions imposed on the approval.

Biokeselamatan 21 (6) the Board may, at any time after the approval is given, requires those who passed it to provide any information, particulars or further documents as may be deemed fit by the Board.

(7) any person approved in violation of any terms and conditions imposed on the approval or failed to provide information, particulars or documents required under subsection (6) commits an offence and shall, on conviction, — (a) if the person is an individual, to a fine not exceeding one hundred thousand ringgit or to imprisonment for a term not exceeding four years or both and , in the case of an offence continues, to a fine not exceeding ten thousand more dollars for each day the offence continues after conviction;

(b) if that person is a body corporate, a fine not exceeding two hundred and fifty thousand dollars and, in the case of a continuing offence, a further fine not exceeding twenty thousand dollars for each day the offence continues after conviction.


The approval is valid for the next release and imports 17. (1) where an approval has been given to the person who passed for an activity involving the release of any living modified organisms or products of such organisms imported or modified living organisms, the approval is valid for similar relief activities in the next

involving living modified organisms or products of such organisms of the same or importation involving living modified organisms the same carried out by the person who approved it.

(2) the provisions of subsection (1) not at all free the person who passed it from complying with the law 22 laws of Malaysia ACT 678 other control organisms modified living organisms in such products or the same.

(3) in this section, "living modified organisms or products of such organisms in the same" means modified organisms living or products of such organisms described in approval and involves the same transformation event.


Review of approval when getting new information 18. (1) the Board may, after consultation with the Advisory Committee, to review any approval at any time when getting new information or evidence about the modified organisms living or products of such organisms in respect of which approval is given.

(2) If, upon review of the approval, the Board is satisfied that there is a risk posed to human health, plants or animals, the environment or biodiversity, the Board may take any of the following actions: (a) cancel the approval;

(b) make an order of termination of temporary;

(c) impose additional terms and conditions;

(d) order the person who is approved to make corrections; or (e) make such other order as it thinks fit by the Board in the interest of biokeselamatan.

(3) if the Board revokes an approval, the approved person shall stop all activities that involve modified living organisms and products of such organisms immediately and shall, within seven days from the date of notification of the revocation Biokeselamatan 23, surrender the certificate of approval to the Board.

(4) If the Board makes an order temporary termination, the person who approved it should stop all activities that involve modified living organisms and products of such organisms immediately and shall, within seven days from the date of notification of the termination of the order, deliver the certificate of approval back to the Board and the Board shall endorse or the fact and duration of temporary termination of the certificate of approval and return the certificate to the person who passed.

(5) If the Board impose such additional terms and conditions of the approved person shall, within seven days from the notification of the imposition of additional terms and conditions that, surrender the certificate of approval to the Board and the Board shall endorse or additional terms and conditions of the certificate of approval and return the certificate to the person who passed.

(6) any person who contravenes any order made by the Board under subsection (2) or contravenes subsection (3), (4) or (5) commits an offence and shall, on conviction, — (a) if the person is an individual, a fine not exceeding two hundred and fifty thousand ringgit or to imprisonment for a term not exceeding five years or to both and, in the case of a continuing offence , a further fine not exceeding ten thousand dollars for each day the offence continues after conviction;

(b) if that person is a body corporate, to a fine not exceeding five hundred thousand dollars and, in the case of a continuing offence, a further fine not exceeding twenty thousand dollars for each day the offence continues after conviction.
24 laws of Malaysia ACT 678 of the circumstances the Board may make further orders when approved 19. (1) Notwithstanding the authority of the Board to take any action under subsection 18 (2), the Board may revoke the approval, make a temporary termination order, impose such additional terms and conditions, order the person who is approved to make a correction, or make such other order as it deems fit in the interest of biokeselamatan by the Board in the following circumstances: (a) if there is a risk posed to human health , plants or animals, environmental or biological diversity;

(b) if the person who passed that fails to comply with any terms and conditions imposed on the approval;

(c) if the person who passed that fails to comply with any order made by the Board;

(d) if the person who approved it has violated any provision of this Act or any regulations made under this Act, whether or not a prosecution has been instituted against him; or (e) if the person who passed it has been convicted of an offence under this Act or any regulations made under this Act.

(2) if the Board revokes an approval, the approved person shall stop all activities that involve modified living organisms and products of such organisms immediately and shall, within seven days from the date of notification of the revocation, the approval certificate of surrender to the Board.

(3) if the Board makes an order of termination of temporary, those who approved it should stop all Biokeselamatan 25 activities that involve modified living organisms and products of such organisms immediately and shall, within seven days from the date of notification of the termination of the order, deliver the certificate of approval back to the Board and the Board shall endorse or the fact and duration of temporary termination of the certificate of approval and return the certificate to the person who passed.

(4) If the Board impose such additional terms and conditions of the approved person shall, within seven days from the notification of the imposition of the additional terms and conditions, the approval certificate of surrender to the Board and the Board shall endorse or additional terms and conditions of the certificate of approval and return the certificate to the person who passed.

(5) any person approved in violation of any order made by the Board under subsection (1) or contravenes subsection (2), (3) or (4) commits an offence and shall, on conviction, — (a) if the person is an individual, to a fine not

more than two hundred and fifty thousand ringgit or to imprisonment for a term not exceeding five years or to both and, in the case of a continuing offence, a further fine not exceeding ten thousand dollars for each day the offence continues after conviction;

(b) if that person is a body corporate, to a fine not exceeding five hundred thousand dollars and, in the case of a continuing offence, a further fine not exceeding twenty thousand dollars for each day the offence continues after conviction.





26 laws of Malaysia ACT 678 of appeal to the Minister relating to the approval of 20. (1) any person or persons approved aggrieved by any decision or action of the Board under section 16, 18 or 19 may appeal against such decision to the Minister.

(2) the Minister shall have power to confirm, reverse or vary the decision or action of the Board.

PART IV NOTIFICATION for export, the USE of CONTROLLED and the IMPORT of the CONTROLLED application of part IV USES 21. Part IV shall apply to the export of controlled activities and uses that involve modified living organisms and importation of living modified organisms for the purpose of carrying out controlled uses.


Requirements for notification of 22. (1) No person shall carry out any of the following activities without giving prior notice to the Board: (a) the export of living modified organisms;

(b) regulated uses involving living modified organisms;

(c) importation of living modified organisms for the purpose of carrying out an activity regulated uses.

(2) any person who contravenes subsection (1) commits an offence and shall, on conviction, — Biokeselamatan 27 (a) if the person is an individual, a fine not exceeding two hundred and fifty thousand ringgit or to imprisonment for a term not exceeding five years or to both and, in the case of a continuing offence, a further fine not exceeding ten thousand dollars for each day the offence continues after conviction;

(b) if that person is a body corporate, to a fine not exceeding five hundred thousand dollars and, in the case of a continuing offence, a further fine not exceeding twenty thousand dollars for each day the offence continues after conviction.


Compliance with the requirements of the importing countries 23. (1) any person who intends to export the modified living organisms shall comply with the requirements of the importing countries about the importation of living modified organisms and shall inform the Board of the requirements, if any, and its compliance or compliance body corporate with the requirements in the prescribed manner and accompanied by the prescribed fee.

(2) information provided under subsection (1) is sufficient notification for the purposes of paragraph 22 (1) (a).

(3) compliance with subsection (1) not at all free the person from complying with any other written law regulating the export and foreign trade.


24. notification forwarding Notifications required under paragraph 22 (1) (b) and (c) shall be submitted to the Director General in accordance with the form of 28 laws of Malaysia ACT 678 and the prescribed manner together with the prescribed fee and accompanied by the following documents: (a) an emergency response plan as specified in section 37;

(b) in relation to an activity that involves the controlled use of modified living organisms, specific measures to be taken; and (c) any other information as may be specified by the Board.


Pengakuterimaan submission of notification by the Director-General of 25. (1) the Director General shall issue a pengakuterimaan acceptance notifications submitted under subsection 23 (1) and section 24 and the person to the pengakuterimaan issued may be carried out in relation to the notification and can continue to carry out the activities subject to any order made by the Board under subsection 30 (3).

(2) Pengakuterimaan issued under subsection (1) is not entirely absolve that person from compliance with the other written laws governing the modified organisms living and pengimportannya.


Specific measures should be taken in controlled uses 26. (1) any person approved to carry out an activity controlled use shall take any measures specifically referred to in paragraph 24 (b) and as approved by the Board.

Biokeselamatan 29 (2) any person approved in violation of subsection (1) commits an offence and shall, on conviction, — (a) if the person is an individual, a fine not exceeding two hundred and fifty thousand ringgit or to imprisonment for a term not exceeding five years or to both and, in the case of a continuing offence, a further fine not exceeding ten thousand dollars for each day the offence continues after conviction;

(b) if that person is a body corporate, to a fine not exceeding five hundred thousand dollars and, in the case of a continuing offence, a further fine not exceeding twenty thousand dollars for each day the offence continues after conviction.


The Director-General may require additional information 27. (1) At any time after receipt of a notification made under subsection 23 (1) and section 24, the Director-General may require the person who passed it to provide information, particulars or additional documents.

(2) if any person who approved failed to provide any information, particulars or documents required under subsection (1), pengakuterimaan issued to him or to the body corporate under section 25 shall be deemed to have been withdrawn without prejudice to submission of a new application.


The Director-General shall refer to the notification to the Advisory Committee and the relevant government agency 28. When a notification diaku thank properly in accordance with section 25, the Director General shall refer 30 laws of Malaysia ACT 678 the notification to the Advisory Committee and any other relevant government agencies about specific things.


The Advisory Committee shall make recommendations about notification


29. (1) Upon receipt of the notification under section 28, the Advisory Committee shall evaluate the notification for the purpose of making recommendations to the Board on whether or not activities relating to the notification should continue, and the terms and conditions shall be imposed by the Board, if any.

(2) At any time after receipt of the notification, the Advisory Committee may request information, particulars or additional documents through the Director-General.

(3) if any person who approved failed to provide any information, particulars or documents required under subsection (2), pengakuterimaan issued to him or of bodies corporate under section 25 shall be deemed to have been withdrawn without prejudice to submission of new notifications.

(4) upon making an assessment of the notification, the Advisory Committee shall submit syornya about the notification to the Board.


The Board shall make an appropriate order about 30 notifications. (1) At any time after receiving the recommendation of the Advisory Committee and reviews the relevant government agency referred to in section 28, the Board may request information, particulars or additional documents through the Director-General.

Biokeselamatan 31 (2) if any person who approved failed to provide any information, particulars or additional documents required under subsection (1), pengakuterimaan issued to him or of bodies corporate under section 25 shall be deemed to have been withdrawn without prejudice to submission of new notifications.

(3) when considering the recommendation of the Advisory Committee under subsection 29 (4), the Board may not make the order, issue order the cessation of, impose any terms and conditions, order the person who passed it to make corrections or make such other order as it thinks fit by the Board in the interest of biokeselamatan.

(4) the Board shall make its decision under subsection 30 (3) within ninety days from the date of receipt of the notification and notify its decision in writing to the person who passed.

(5) If the Board issue a cessation order, those who approved shall stop all activities that involve modified living organisms immediately and shall, within seven days from the date of notification of the termination order, surrender pengakuterimaan receipt notification issued to him or of bodies corporate under section 25 to the Board.

(6) any person approved in violation of any order made by the Board under subsection (3) or contravenes subsection (5) commits an offence and shall, on conviction, — (a) if the person is an individual, to a fine not exceeding one hundred thousand ringgit or to imprisonment for a term not exceeding four years or to both and, in the case of a continuing offence, a further fine not exceeding ten thousand dollars for each day the offence continues after conviction;

32 laws of Malaysia ACT 678 (b) if that person is a body corporate, a fine not exceeding two hundred and fifty thousand dollars and, in the case of a continuing offence, a further fine not exceeding twenty thousand dollars for each day the offence continues after conviction.


The Board may require additional information 31. (1) the Board may, at any time, after the exercise of its powers under subsection 30 (1), require the person who passed it to provide any information, particulars or additional documents as may be deemed fit by the Board.

(2) any person who passed that fails to provide any information, particulars or documents required under subsection (1) commits an offence and shall, on conviction, — (a) if the person is an individual, to a fine not exceeding one hundred thousand ringgit or to imprisonment for a term not exceeding four years or to both and, in the case of a continuing offence, a further fine not exceeding ten thousand dollars for each day the offence continues after conviction;

(b) if that person is a body corporate, a fine not exceeding two hundred and fifty thousand dollars and, in the case of a continuing offence, a further fine not exceeding twenty thousand dollars for each day the offence continues after conviction.


Review notification when getting new information 32. (1) the Board may, after consultation with the Advisory Committee, to review any notification at any time upon receipt of information or new evidence about 33 Biokeselamatan modified organisms living in relation to the notification.

(2) upon review, if there is a risk posed to human health, plants or animals, the environment or biodiversity, the Board may take any of the following actions: (a) make an order of termination;

(b) impose additional terms and conditions;

(c) order the person who passed it to make corrections; or (d) make any other order as it thinks fit by the Board in the interest of biokeselamatan.

(3) if the Board makes an order termination, the person who approved it should stop all activities that involve modified living organisms immediately and shall, within seven days from the date of notification of the termination order, surrender pengakuterimaan submission notification issued under section 25 to the Board.

(4) any person approved in violation of any order made by the Board under subsection (2) or contravenes subsection (3) commits an offence and shall, on conviction, — (a) if the person is an individual, to a fine not exceeding one hundred thousand ringgit or to imprisonment for a term not exceeding four years or to both and, in the case of a continuing offence, a further fine not exceeding ten thousand dollars for each day the offence continues after conviction;

34 the laws of Malaysia ACT 678 (b) if that person is a body corporate, a fine not exceeding two hundred and fifty thousand dollars and, in the case of a continuing offence, a further fine not exceeding twenty thousand dollars for each day the offence

It continues after conviction.


Circumstances the Board may make further orders about 33 notifications. (1) Notwithstanding the authority of the Board to take any action under subsection 32 (2), the Board may make an order of termination, impose such additional terms and conditions, order the person who passed it to make corrections, or make such other order as it thinks fit by the Board in the interest of biokeselamatan in the following circumstances: (a) if there is a risk posed to human health , plants or animals, environmental or biological diversity;

(b) if the person who passed that fails to comply with any terms and conditions imposed on the notification;

(c) if the person who passed that fails to comply with any order made by the Board;

(d) if the person who approved it has violated any provision of this Act or any regulations made under this Act whether or not prosecutions have been instituted against him; or (e) if the person who passed it has been convicted of an offence under this Act or any regulations made under this Act.

Biokeselamatan 35 (2) if the Board makes an order of termination, those who approved shall stop all activities that involve modified living organisms immediately and shall, within seven days from the date of notification of the termination, surrender pengakuterimaan submission notification issued under section 25 to the Board.

(3) any person who contravenes any order made by the Board under subsection (1) or contravenes subsection (2) commits an offence and shall, on conviction, — (a) if the person is an individual, to a fine not exceeding one hundred thousand ringgit or to imprisonment for a term not exceeding four years or to both and, in the case of a continuing offence, a further fine not exceeding ten thousand dollars for each day the offence continues after conviction;

(b) if that person is a body corporate, a fine not exceeding two hundred and fifty thousand dollars and, in the case of a continuing offence, a further fine not exceeding twenty thousand dollars for each day the offence continues after conviction.


Appeal to the Minister relating to the notification of 34. (1) any person or persons approved aggrieved by any decision of the Board relating to the notification may appeal against such decision to the Minister.

(2) the Minister shall have power to confirm, reverse or vary the decision of the Board.


36 laws of Malaysia ACT 678 decision-making by the Board or Minister 35. The Board or the Minister shall not be prevented from making decisions, appropriate, under part III or part IV, if there is a lack of scientific certainty due to information and scientific knowledge related to insufficient with respect to the extent of the potential adverse effects of living modified organisms or products of such organisms against human health, plants and animals, the environment and biological diversity and may also take into account socio-economic considerations.


SECTION V REPORTS on RISK ASSESSMENT and RISK MANAGEMENT and EMERGENCY RESPONSE PLAN report of the risk assessment and risk management 36. (1) report of risk assessment and risk management shall be in the form prescribed by the Minister and shall include — (a) a risk assessment and adverse effects of living modified organisms and products of such organisms is or is likely to have on the health of humans, plants and animals, the environment and biological diversity; and (b) the measures proposed to be taken to prevent, reduce or control the risks and adverse effects of living modified organisms and products of such organisms is or is likely to have on the health of humans, plants and animals, the environment and biological diversity.

Biokeselamatan 37 (2) Notwithstanding any report of risk assessment and risk management, submitted by an approved person, the person who approved it shall comply with the management measures minimum risk as determined by the Board, after consultation with the Advisory Committee.

(3) when the approval or pengakuterimaan obtained from the Board, the person who approved it shall, in carrying out relief, importation or use of controlled relating to approval or pengakuterimaan, as the case may be, — (a) enter into the design, construction and operation, whichever the case may be, the release, imports or uses controlled measures proposed in the report risk management people approved it; and (b) carry out and comply with, to the satisfaction of the Board, management measures minimum risk referred to in subsection (2).

(4) any person approved in violation of subsection (3) commits an offence and shall, on conviction, — (a) if the person is an individual, a fine not exceeding two hundred and fifty thousand ringgit or to imprisonment for a term not exceeding five years or to both and, in the case of a continuing offence, a further fine not exceeding ten thousand dollars for each day the offence continues after conviction;

(b) if that person is a body corporate, to a fine not exceeding five hundred thousand dollars and, in the case of a continuing offence, a further fine not 38 laws of Malaysia ACT 678 exceeding twenty thousand dollars for each day the offence continues after conviction.


Emergency response plan 37. (1) an emergency response plan shall provide — (a) measures and safety procedures for the protection of human health, plants and animals, the environment and biological diversity against injury or damage caused directly or indirectly by living modified organisms or products of such organisms; and (b) all necessary measures need to be taken in the event of an emergency.

(2) any person who fails to take approved

measures necessary in an emergency in accordance with the emergency response plan is guilty of an offence and shall, on conviction, — (a) if the person is an individual, a fine not exceeding two hundred and fifty thousand ringgit or to imprisonment for a term not exceeding five years or to both and, in the case of a continuing offence, a further fine not exceeding ten thousand dollars for each day the offence continues after conviction;

(b) if that person is a body corporate, to a fine not exceeding five hundred thousand dollars and, in the case of a continuing offence, a further fine not exceeding twenty thousand dollars for each day the offence continues after conviction.



PART VI ENFORCEMENT 39 Biokeselamatan enforcement officers 38. The following officers may exercise powers under this part: (a) a Board enforcement officers;

(b) the officer specified in the third schedule; and (c) any other officer of the Board or any other public officer authorized in writing by the Board.


Power of investigation of 39. (1) an enforcement officers shall have all the powers necessary to carry out an investigation under this Act or any regulations made under this Act.

(2) an enforcement officer shall, when requested, stating his position, and submit to the person against whom he is acting or from whom he requested any information, authority card as directed by the Board that carried by the officer.

(3) in any case in relation to the Commission of an offence under this Act or any regulations made under this Act, any enforcement officers conducting investigations can perform all or any of the special powers in relation to police investigation in the case can capture provided by the criminal procedure code [Act 593].

40 laws of Malaysia ACT 678 (4) of this section shall not be deemed to limit or prejudice any of the same powers granted to any person under any other written law.


Search with warrant 40. (1) if it appears on a person's Magistrate, based on information given in writing and after such inquiry as he may deem necessary, that there is reasonable cause to believe that in any premises there is or has been any violation of this Act or any regulations made under this Act, the Magistrate may issue a warrant to authorise any enforcement officers called it , at any reasonable time either on the day or night and with or without assistance, to enter the premises, if necessary by force, and there — (a) a search and seize any products suspected organisms or organism is modified living organisms and their products or such, or books, documents, computerized data, apparatus, equipment, devices, machinery, vehicle, article or thing including in digital form reasonably believed to be, give evidence of a violation of this Act or any regulations made under this Act;

(b) take samples of any organisms or products is suspected of living modified organisms or products of such organism or thing found in the premises for the purpose of ascertaining, by testing or otherwise, whether any offence under this Act or any regulations made under this Act has been committed;
and (c) make copies of or take extracts from any books, documents, computer data or anything Biokeselamatan 41 including in digital form, or make a copy of a computer data backup or things included in digital form, for the purposes of the investigation.

(2) where, by reason of the nature, size or its recoverable amount, it is not practical to transfer any organisms or products that are suspected to be a living modified organisms or products of such organisms, or books, documents, computerized data, apparatus, equipment, devices, machinery, vehicle, article or thing including in digital form that is seized under subsection (1), enforcement officers shall be, with any reasonable way , avoid the suspected organisms or products is modified living organisms or products of such organisms, or books, documents, computerized data, apparatus, equipment, devices, machinery, vehicle, article or thing including in digital form in the premises or container which organisms or products of such organisms suspected is a modified living organisms or products of such organisms, or books, documents, computerised data , apparatus, equipment, devices, machinery, vehicle, article or thing including in digital form, found.

(3) it shall be an offence if any person without a valid power break, interfere with or damage lak referred to in subsection (2) or transfer any products or organisms suspected is a modified living organisms or products of such organisms, or books, documents, computerized data, apparatus, equipment, devices, machinery, vehicle, article or thing including in digital form that dilak or attempting to do so.

(4) any person who contravenes subsection (3) commits an offence and shall, on conviction, to a fine not exceeding one hundred thousand ringgit or to imprisonment for a term not exceeding one year or to both.

(5) any enforcement officer entering any premises under this section may bring with him any person and other equipment as it appears to him necessary.
42 laws of Malaysia ACT 678 (6) any enforcement officers can be in exercise of its powers under this section, if required to do so — (a) break open any door or in the premises and get into the premises;

(b) forceful entry into the premises and every part of the premises;

(c) remove by force any barriers to entry, search, seizure and transfer as he is empowered to carry it out; and (d) detain every person found in the premises until the completion of the premises searched.

(7) subject to any other written law,

in exercise of powers under this section, an enforcement officers shall also have the power to stop, catch or detain any vessel, aircraft or other vehicles.


Search without warrant 41. If any enforcement officers in any of the circumstances referred to in subsection 40 (1) has reasonable cause to believe that by reason of the delay in obtaining a search warrant under section of that investigation will be affected or evidence of the Commission of an offence is likely to be interrupted, transferred, damaged or destroyed, the enforcement officers can get into the premises and conduct in the , above and in respect of premises that all the powers provided for in section 40 in a way that fully and adequately as if he is authorized to do so by a warrant issued under that section.

Biokeselamatan 43 access to computerised data 42. Any enforcement officers conducting a search under section 40 or 41 shall be given access to computerised data either stored in a computer or otherwise, and for the purpose, shall be given a password, encryption, encrypting code code, software or hardware to be and any other means required to enable computerised data understandable.


List of things seized 43. (1) where any organisms or products is suspected of living modified organisms or products of such organisms, or books, documents, computerized data, apparatus, equipment, devices, machinery, vehicle, article or thing including in digital form seized under this part, the officer shall seize provides a list of the suspected organisms or products is modified living organisms or products of such organisms , or books, documents, computerized data, apparatus, equipment, devices, machinery, vehicle, article or thing including in digital form, seized.

(2) the residents of the premises searched, or any person on his behalf, shall in all circumstances be allowed to be present during the search, and a copy of the list prepared and signed under this section shall be submitted to the population or the person upon his request.

(3) where the premises were unoccupied, officers seize shall whenever possible affixing a list of organisms or products is suspected of living modified organisms or products of such organisms, or books, documents, computerized data, apparatus, equipment, devices, machinery, vehicle, article or thing including in digital form, seized it in conspicuous place in the premises.


44 the laws of Malaysia ACT 678 authorized to seal the premises of 44. In exercise of the powers under section 40 or 41, one enforcement officers can help avoid any premises on a temporary basis.


Forfeiture of the living modified organism or products of such organisms, etc.

45. (1) any organisms or products that are suspected to be a living modified organisms or products of such organisms, or books, documents, computerized data, apparatus, equipment, devices, machinery, vehicle, article or thing including in digital form seized in exercise of any power conferred under this Act shall be dilucuthakkan.

(2) an order for forfeiture of any organisms or products that are suspected to be a living modified organisms or products of such organisms, or books, documents, computerized data, apparatus, equipment, devices, machinery, vehicle, article or thing including in digital form referred to in subsection (1) shall be made by the Court before prosecution therefor has been made if it is proved to the satisfaction of the Court that an offence under this Act or any regulations made under this Act has been committed and that organisms or products suspected the modified organisms living or such organisms, products or books, documents, computerized data, apparatus, equipment, devices, machinery, vehicle, article or thing including in digital form, is the matter or has been used in the Commission of the offence, though none has been convicted of the offence.

(3) if there is no prosecution in respect of any organisms or products is suspected of living modified organisms or products of such organisms, or books, documents, computerized data, apparatus, equipment, devices, machinery, vehicle, article or thing including in digital form, seized at Biokeselamatan 45 exercise any of the powers conferred under this Act, a notice must be delivered to the address last known to the person from whom the organisms or products suspected the organism living modified organisms or products
so, or books, documents, computerized data, apparatus, equipment, devices, machinery, vehicle, article or thing including in digital form were seized.

(4) the notice referred to in subsection (3) shall indicate that — (a) no prosecution in respect of the suspected organisms or products is modified living organisms or products of such organisms, or books, documents, computerized data, apparatus, equipment, devices, machinery, vehicle, article or thing including in digital form; and (b) organisms or products is suspected of living modified organisms or products of such organisms, or books, documents, computerized data, apparatus, equipment, devices, machinery, vehicle, article or thing including in digital form, shall be taken and deemed to have been dilucuthakkan at the end of a period of one calendar month from the date of delivery of the notice unless before that date a claim is made in the manner specified in subsection (5) , (6) and (7).

(5) any person who asserts that he is the owner of the suspected organisms or products is modified living organisms or products of such organisms, or books, documents, computerized data, apparatus, equipment, devices, machinery, vehicle, article or thing including in digital form referred to in subsection (3) and that the organisms or products that is suspected to be modified organisms living or products of such organisms , or books, documents, computerized data, apparatus, equipment, devices, machinery, vehicle, article or thing that

including in digital form, can not dilucuthakkan can 46 laws of Malaysia ACT 678 give personally or by his agent authorized in writing notice to enforcement officers who in his possession organisms or products is suspected of living modified organisms or products of such organisms, or books, documents, computerized data, apparatus, equipment, devices, machinery, vehicle, article or thing is included in digital form , held that he was demanding the suspected organisms or products is modified living organisms or products of such organisms, or books, documents, computerized data, apparatus, equipment, devices, machinery, vehicle, article or thing is included in digital form.

(6) on receipt of the notice under subsection (5), the enforcement officer shall refer the claim to a Magistrate of the first Class to get the decision.

(7) a magistrate to whom a matter is referred under subsection (6) shall issue a summons requiring the person who pointed out that he is the owner of the suspected organisms or products is modified living organisms or products of such organisms, or books, documents, computerized data, apparatus, equipment, devices, machinery, vehicle, article or thing is included in digital form and the person from whom the suspected organisms or products is modified living organisms or products of such organisms , or books, documents, computerized data, apparatus, equipment, devices, machinery, vehicle, article or thing is included in digital form seized appear before him, and when they attend or they default to appear, but the delivery of summons accordingly has been proved, the Magistrate shall proceed with examination of the matter, and when proven that an offence under this Act or any regulations made under this Act has been committed and that the suspected organisms or products is a modified organisms living or
such organisms, products or books, documents, computerized data, apparatus, equipment, devices, machinery, vehicle, article or thing is included in digital form, is the matter or has been used in the Commission of that offence, shall order that the suspected organisms or products is 47 Biokeselamatan modified organisms living or such organisms, products or books, documents, computerized data, apparatus, equipment, devices, machinery, vehicles , the thing or the thing included in digital form dilucuthakkan or may, in the absence of such evidence, ordered the release of the suspected organisms or products is modified living organisms or products of such organisms, or books, documents, computerized data, apparatus, equipment, devices, machinery, vehicle, article or thing is included in digital form to the person entitled to it.

(8) If an order of forfeiture made by the Court under subsection (2) or (7) or if no claim is made under subsection (5), enforcement officers shall dispose of the suspected organisms or products is modified living organisms or products of such organisms, or books, documents, computerized data, apparatus, equipment, devices, machinery, vehicle, article or thing is included in digital form , in accordance with any instructions issued by the Director General and any costs incurred for disposal shall be borne by the owner of the suspected organisms or products is modified living organisms or products of such organisms, or books, documents, computerized data, apparatus, equipment, devices, machinery, vehicle, article or thing is included in digital form.

(9) If any organisms or products is suspected of living modified organisms or products of such organism seized in exercise of the powers conferred under this Act is of the type that easily destroyed or according to tabiinya lekas is damaged or if the care of organisms or products is suspected of living modified organisms or products of such organisms involves unreasonable expense or harm people , enforcement officers can dispose of organisms or products is suspected of living modified organisms or products of such organisms according to the instructions issued by the Director General and any costs incurred for disposal shall be borne by the owner.

48 laws of Malaysia ACT 678 (10) any organisms or products is suspected of living modified organisms or products of such organisms, or books, documents, computerized data, apparatus, equipment, devices, machinery, vehicle, article or thing is included in digital form, which dilucuthakkan or deemed to have been dilucuthakkan under this section shall be the property of the Federal Government.

(11) the Director General or a person enforcement officers acting in good faith in the exercise of powers under this section shall not be liable to any person for any deterioration, depreciation or damage, whatever the reason, the quality of any products or organisms is suspected of living modified organisms or products of such organisms, or books, documents, computerized data, apparatus, equipment , devices, machinery, vehicle, article or thing is included in digital form that is seized under this Act.


The cost of holding organisms, etc., seized 46. If any of the suspected organisms or products is modified living organisms or products of such organisms, or books, documents, computerized data, apparatus, equipment, devices, machinery, vehicle, article or thing including in digital form, seized under this Act held in the custody of the Federal Government pending the settlement of any proceedings in respect of an offence under this Act or any regulations made under this Act , the costs of holding the suspected organisms or products is modified living organisms or products of such organisms, or books, documents, computerized data, apparatus, equipment, devices, machinery, vehicle, article or thing is included in the form of digitalnya, in custody shall be obtained as a civil debt due to the Federal Government from the owner.




Biokeselamatan 49 no costs or damages arising from the entry,

search or seizure can be obtained 47. No person shall, in respect of any entry or search, or seizure of any organisms or products is suspected of living modified organisms or products of such organisms, or books, documents, computerized data, apparatus, equipment, devices, machinery, vehicle, article or thing including in digital form, seized in exercise of any power conferred by this Act, be entitled to the cost of admission, search , or the seizure or to any damages or other relief unless the entry, search or seizure is made without reasonable cause.


Obstruction of enforcement officers 48. Any person who mengamang, prevent, thwart or interfere with, or refuse to provide access to any premises to, one enforcement officers in carrying out its duties under this Act commits an offence and shall, on conviction, to a fine not exceeding one hundred thousand ringgit or to imprisonment for a term not exceeding one year or both of each.


Examination of person who knew the case 49. (1) an enforcement officers making an investigation under this Act or any regulations made under this Act may examine orally any person who expected to find out the facts and circumstances of the case.

(2) such person shall be bound to answer all questions relating to the case submitted to it by the enforcement officers, but he can refuse to answer any question that the answer may disclose it to a criminal charge or penalty or forfeiture.
50 laws of Malaysia ACT 678 (3) a person who makes a statement under this section shall be legally bound to state the truth, whether or not the statement was made wholly or partly to answer that question.

(4) an enforcement officers examining a person under subsection (1) shall first inform that person of the provisions of subsection (2) and (3).

(5) a statement made by any person under this section shall, whenever possible, reduced to writing and signed by the person making it or affixed with cap head jarinya, as the case may be, after — (a) the statement was read out to him in the language of the statement made by him; and (b) he is given the opportunity to make any corrections he wanted.


Admissibility of statements as evidence 49A. (1) except as provided in this section, no statement made by any person to an enforcement officers during an investigation made under this Act or any regulations made under this Act may be used as evidence.

(2) when any witness called for prosecution or for the defence, other than the accused, the Court shall, at the request of the accused or the Prosecutor, referring to any statement made by the witness to an enforcement officers during an investigation under this Act or any regulations made under this Act and may then, if the Court thinks fit in the interest of Justice, direct that the accused be given a copy of the statement and the statement can be used to challenge the credibility of the witness Biokeselamatan 51 according to manner provided by Act Description 1950 [Act].

(3) if the accused has made a statement during an investigation, the statement is admissible as evidence in support of his defence during the trial.

(4) no nothing in this section shall be deemed to apply to any statement made during a parade cam or included in section 27 or paragraph 32 (1) (a), (i) and (j) of the description of 1950.

(5) when any person is charged for any offence in connection with the manufacture or the contents of any statement made by him to an enforcement officers during an investigation made under this Act or any regulations made under this Act, the statement can be used as evidence in the prosecution case.


Power to require production of things in relation to offences 50. (1) any enforcement officers may, by notice in writing, require any person to produce to him the suspected organisms or products is modified living organisms or products of such organisms, or books, documents, computerized data, apparatus, equipment, devices, machinery, vehicle, article or thing including in digital form, which the enforcement officer reasonably believes was used in the Commission of an offence under this Act or any regulations made under this Act as in the possession, custody or control of that person or in that person's power to produce.

(2) an enforcement officer shall have the authority to detain any suspected organisms or products is modified living organisms or products of such organisms, or books, documents, computerized data, apparatus, 52 laws of Malaysia ACT 678 fittings, devices, machinery, vehicle, article or thing including in digital form, which is submitted to it under subsection (1) for the purposes of the investigation.

(3) the provisions on forfeiture in section 45 shall apply, mutatis mutandis, in respect of any organisms or products is suspected of living modified organisms or products of such organisms, or books, documents, computerized data, apparatus, equipment, devices, machinery, vehicle, article or thing including in digital form that is detained under subsection (2).

(4) any person who fails to produce any organisms or products is suspected of living modified organisms or products of such organisms, or books, documents, computerized data, apparatus, equipment, devices, machinery, vehicle, article or thing including in digital form, as required by an enforcement officers under subsection (1) commits an offence and shall, on conviction, — (a) if the person is an individual , to a fine not exceeding one hundred thousand dollars and, in the case of a continuing offence, a further fine not exceeding ten thousand dollars for each day the offence

continues after conviction;

(b) if that person is a body corporate, a fine not exceeding two hundred thousand dollars and, in the case of a continuing offence, a further fine not exceeding twenty thousand dollars for each day the offence continues after conviction.


Enforcement officers can get help to check the object in relation to the offence of 51. A power amplifier can help any person to inspect any organisms or Biokeselamatan 53 suspected products is modified living organisms or products of such organisms, or books, documents, computerized data, apparatus, equipment, devices, machinery, vehicle, article or thing including in digital form, seized or detained under this Act, if the person has the necessary credentials to check the suspected organisms or products is modified living organisms or products of such organisms , or books, documents, computerized data, apparatus, equipment, devices, machinery, vehicle, article or thing including in digital form, for the purposes of an investigation under this Act or any regulations made under this Act.


The power of the Board to require information about the modified organisms living or products of such organisms 52. (1) the Board may require any person carrying out any activities that involve modified living organisms or products of such organisms to provide to the Board information relating to the composition and use of any living modified organisms or products of such organisms.

(2) any person who fails to provide any information relating to the composition and use of any living modified organisms or products of such organisms required under subsection (1) commits an offence and shall, on conviction, — (a) if the person is an individual, to a fine not exceeding one hundred thousand dollars and, in the case of a continuing offence, a further fine not exceeding ten thousand dollars for each day the offence continues after conviction;

(b) if that person is a body corporate, a fine not exceeding two hundred thousand dollars and, in the case of a continuing offence, a further fine not 54 laws of Malaysia ACT 678 exceeding twenty thousand dollars for each day the offence continues after conviction.


Authorized to collect a sample of 53. (1) an enforcement officers can request, choose, take or get a sample of any organisms or suspected products or contains a modified living organisms or products of such organisms for the purposes of analysis — (a) on payment, from any person that sells such products or organisms, or from an agent or pekhidmatnya or agents or servants of the body corporate; or (b) without payment, from any manufacturer or importer of the organism or such products or from agents or pekhidmatnya or agents or servants the body corporate.

(2) the sample requested, selected, taken or obtained under subsection (1) shall be accepted in any court.

(3) any person who refuses to comply with any request made by an enforcement officers under subsection (1) commits an offence and shall, on conviction, — (a) if the person is an individual, to a fine not exceeding one hundred thousand dollars and, in the case of a continuing offence, a further fine not exceeding ten thousand dollars for each day the offence continues after conviction;

(b) if that person is a body corporate, a fine not exceeding two hundred thousand dollars and, in the case of Biokeselamatan 55 a continuous offence, liable to a fine of not more than a further twenty thousand dollars for each day the offence continues after conviction.


Procedure for taking a sample of 54. (1) if intended for submission of any sample for any organisms or suspected products or contains a modified living organisms or products of such organisms for analysis of enforcement officers who purchase or otherwise acquire such sample shall notify the seller, manufacturer or importer or agent or pekhidmatnya or agents or servants the body corporate from whom the organism or the products purchased or otherwise acquired that he means the sample is analyzed by an analyst.

(2) the Procedure for taking and dealing with the sample shall be as prescribed by the regulations.


Appointment of analysts 55. The Board may appoint any qualified person to be the analyst for the purpose of carrying out an analysis under this Act.


Certificate of analysis of 56. (1) a certificate signed by an analysis analyst shall, upon submission by the Prosecutor in any proceedings under this Act or any regulations made under this Act, be sufficient evidence of the facts stated in the certificate unless the accused requires that the analyst called as a witness, that in that case he shall 56 laws of Malaysia ACT 678 give a notice in writing to the Prosecutor not less than three clear days before the commencement of the trial it.

(2) if the public prosecutor intends to give in evidence any certificate referred to in subsection (1) he shall deliver a copy of the certificate to the accused not less than ten clear days before the commencement of the trial.


Assumption is 57. If evidence or a certificate of analysis given by an analyst stating that organisms or products of any kind produced before the Court is a modified living organisms or products of such organisms, the Court shall presume that such products or organisms are modified organisms living or products of such organisms, unless the contrary is proved.


An initial prosecution 58. No prosecution in respect of any offence under this Act or any regulations made under this Act shall be instituted except by or with the written consent of the public prosecutor.


PART VII MISCELLANEOUS a secret business information


59. (1) any person who makes an application under section 13 or who submit a notification under subsection 22 (1) may apply to the Director General Biokeselamatan 57 that kept confidential any information trade and industry relating to the application or notification, as the case may be.

(2) the Director General may authorize confidentiality based on the criteria in subsection (3) and if the confidentiality of the information cannot be allowed announced.

(3) the Director General shall consider the claim for confidentiality in accordance with the following criteria: (a) that the information is not generally known among, or readily accessible by, any person within that normally deal with the kind of information to be used as secret;

(b) that the information has commercial value because it is secret; and (c) that reasonable measures have been taken to withhold that information.

(4) except for the purposes of this Act or for the purpose of any civil or criminal proceedings under any written law or if otherwise permitted by the Director General, as the case may be — (a) no member of the Board or Advisory Committee, or any Committee or committees are noticeably, as the case may be;

(b) No person attending any meeting of the Board or Advisory Committee, or any Committee or committees are noticeably, as the case may be; or (c) the Director General and any officer appointed under subsection 8 (1) 58 laws of Malaysia ACT 678 either during the term of Office or during the period of her employment or thereafter, disclose any information it considers while performing his duties for which confidentiality has been granted under subsection (3).

(5) any person who contravenes subsection (4) commits an offence and shall, on conviction, to a fine not exceeding ten thousand ringgit or to imprisonment for a term not exceeding one month or to both.


Exposure to General 60. (1) subject to the discretion of, the public can have access to any information relating to any application for approval, the approval given or notification, which is not granted confidentiality under subsection 59 (2), in such manner as the Board may think fit.

(2) any decision made under part III and part IV shall be available to the public in such manner as the Board may think fit.


Identification and labelling of 61. All living modified organisms, containing details of the modified living organisms and products of such organisms shall be identified and labeled clearly in such manner as shall be determined and the requirements for the identification and labelling that is in addition to any other written law.






Biokeselamatan 59 help from multiple agency emergency 62. (1) the Director General shall submit the emergency response plans submitted under paragraph 13 (1) (b) and 24 (a) to all related agencies for appropriate action.

(2) in the event of any emergency involving any living modified organisms or products of such organisms, the Director General may seek the assistance and cooperation of the relevant agencies in carrying out any emergency measures including measures provided in the emergency response plan.

(3) any costs incurred by any agencies in carrying out any emergency measures shall be ditangggung by the person who approved it.

(4) no anything in this section can free up or be deemed to release people who approved of any of its obligations or the obligations of the body corporate to take all necessary measures in the event of any emergency.


Service of notice 63. (1) any notice required to be given or served under this Act can be delivered with personally or by registered post an acknowledgement, unless there are other forms of delivery specified — (a) in the case of a company incorporated in Malaysia, to the address of the registered office of the company;

(b) in the case of a company incorporated outside Malaysia, either to the individual authorized to receive service of process under the companies Act 1965 [Act 125], or to the address filed with the Registrar of companies or the registered office of the company, in wherever it is; or 60 laws of Malaysia ACT 678 (c) in the case of an individual or group of persons, to address business or private individual or group that the person last known.

(2) if the person to have addressed a letter registered with acknowledgement of receipt containing any notice to be given under this Act to be notified of the fact that there is a registered letter Acknowledgement that is being menunggunya in a post office, and those that refused to ignore or take the registered letter, such notice shall be deemed to have been duly delivered to him at the date she was told the same.


Offences by body corporate 64. If a body corporate commits an offence under this Act or any regulations made under this Act, then any person who at the time of the Commission of the offence was a Director, Manager, Secretary or other similar officer of the body corporate or is purporting to act on any such property, or by any other means or up to any extent is responsible for the management of any Affairs of the body corporate or assist in the management of such — (a) may be charged in separately or in association in the same proceedings with the body corporate;
and (b) if the body corporate is found to have committed the offence, shall be deemed to have committed the offence unless, having regard to the type of functions on the properties and all the circumstances, he proves — (i) that it was committed without his consent or knowledge, pembiarannya;
61 Biokeselamatan and (ii) that he took all reasonable precautions and exercise due diligence to prevent the Commission of the offence; and


(c) shall, on conviction, be liable to penalties applicable to an individual.


Offences by partner, agent or servants 65. Any person who should be liable to any penalty under this Act or any regulations made under this Act for any act, omission, neglect or default if an Act, omission, neglect or default is done by himself may be subject to the same penalty if the Act, omission, neglect or default committed by the partner, agent or pekhidmatnya unless he is proved — (a) that the Act of , omission, neglect or default is done without his consent or knowledge, pembiarannya; and (b) that he took all reasonable precautions and have carried out due diligence to prevent the Act, omission, neglect or default of that.


Power to compound 66. (1) the Board may, with the consent of the Prosecutor, make an offer in writing to compound any offence under this Act or any regulations made under this Act, and the Minister may determine as error can compound by regulations made under this Act, by accepting from the person who committed such offence reasonably suspected of such amount, not exceeding fifty per cent of the amount of the maximum fine for 62 laws of Malaysia ACT 678 of the offence for which that person should imposed or if he or it has been convicted of that offence, within the time stated in the offer.

(2) an offer under subsection (1) may be made at any time after the offence, but before any prosecution for him started, and if the amount specified in the offer is not paid within the time stated in the offer or within such extended period as may be allowed by the Board, a prosecution for the offence may be commenced at any time after that to the person to whom the offer is made.

(3) where an offence has been compounded under subsection (1), no prosecution shall be instituted in respect of the offence against a person to whom an offer to compound is made.

(4) any money received by the Board under this section shall be paid into and form part of the Federal Consolidated Fund.


Fraud, concealment and destruction of documents 67. Any person, with intent to deceive, in respect of a document to be shown or presented under any provision of this Act or any regulations made under this Act, who makes or causes to be made a false entry, leaving from make, or cause to be omitted, any entry, or change, making the draw, hide or destroy, or cause to be modified, made the draw , hidden or destroyed, any entry, falsify a document, or use or hold in his possession a false document, purporting to be a legal document, amend any entries made in any document, or remove or use a document that is false or incorrect, in whole or in part, or Biokeselamatan 63 misleading, commits an offence and shall, on conviction, — (a) if the person is an individual , a fine not exceeding two hundred and fifty thousand ringgit or to imprisonment for a term not exceeding five years or to both; or (b) if that person is a body corporate, to a fine not exceeding five hundred thousand dollars.


Minister's power to make exceptions 68. The Minister may, on the recommendation of the Board, exclude from the application of any or all of the provisions of this Act any person, class of persons, activities, activity, category modified living organisms or products of such organisms.


The power to make regulations 69. (1) the Minister may, after consultation with the Board, make any regulations necessary or expedient to carry out the provisions of this act better.

(2) without prejudice to the generality of subsection (1), regulations may be made for the following: (a) the methods to be followed and information, including detection methods and samples be supplied in an application for an approval under section 13;

(b) the certificate of approval given under subsection 16 (3);

64 the laws of Malaysia ACT 678 (c) the methods to be followed, information and reports to be supplied in the produce a notification under subsection 22 (1);

(d) form pengakuterimaan acceptance issued under section 25;

(e) report of the risk assessment and risk management reports including periodic reports by those who passed on the monitoring and assessment of risks;

(f) the emergency response plan;

(g) the procedure to be followed in appeals made to the Minister;

(h) activities of controlled use of any research and development carried out by the Institute for public research and trainees;

(i) procedures take and deal with the sample;

(j) the identification and labelling of the living modified organism, the item contains modified living organisms and products of such organisms;

(k) the compounding of offences;

(l) fees payable under the Act;

(m) such other matters as it considers expedient or necessary by the Minister for the purposes of this Act.

(3) regulations made under this section may provide that any person who contravenes any of the provisions of these regulations commits an offence and shall, on conviction, — Biokeselamatan 65 (a) if the person is an individual, to a fine not exceeding one hundred thousand ringgit or to imprisonment for a term not exceeding six months or to both and, in the case of a continuing offence, a further fine not exceeding ten thousand dollars for each day the offence continues after conviction;

(b) if that person is a body corporate, a fine not exceeding two hundred thousand dollars and, in the case of a continuing offence, a further fine not exceeding twenty thousand dollars for each day the offence continues after conviction.


The power to amend Schedule 70. The Minister may, after consultation with the Board, through the

order published in the Gazette amend the Schedule to this Act.


Transitional provision 71. (1) any person who, at the date of coming into operation of this Act, undertake an activity to which this Act applies shall, within three months from the date of coming into operation of this Act, make an application for approval under section 13 or forward a notification under subsection 22 (1), as the case may be.

(2) on receipt of an application for approval or submission of notification under subsection (1), the Director General shall issue a receipt to the person pengakuterimaan.

(3) pending the determination of the application or notification pursuant to part III or part IV, as the case may be, that person may continue to carry out such activity.

66 laws of Malaysia ACT 678 FIRST SCHEDULE [Subsection 4(3)] PROVISIONS RELATING to alternate members of the BOARD 1. (1) the Minister may, in respect of each Member of the Board other than the Chairman and the Member appointed under paragraph 4 (2) (h), appoint an alternate member to attend, in lieu of the Member, Board meetings the Member could not attend for any reason.

(2) when attending meetings of the Board, one alternate member shall for all purposes be deemed to be members of the Board.


The term of Office 2. (1) subject to such terms and conditions as may be specified in the instrument of appointment, a member of the Board other than the Chairman shall, unless he sooner resigns or clear his Office or his appointment is sooner revoked, hold office for a term not exceeding three years and are eligible for re-election.

(2) an alternate member shall, unless he first put his membership or clear membership or his appointment is sooner revoked, cease to be an alternate member when the Member in respect of which he is the alternate cease to be a member of the Board.


Revocation and resignation of 3. (1) the appointment of any member of the Board other than the Chairman may at any time be revoked by the Minister without assigning any reason for the revocation.

(2) a member of the Board other than the Chairman may at any time resign his Office by giving notice in writing addressed to the Minister.

Biokeselamatan 67 vacation of Office 4. (1) the Office of a member of the Board shall be vacated: (a) if he dies;

(b) if there has been proved against him, or if he has been convicted on a charge in respect of — (i) an offence involving fraud, dishonesty or moral turpitude;

(ii) an offence under any law relating to corruption; or (iii) any other offence punishable with imprisonment (whether imprisonment only, or in addition to a penalty or in lieu of a fine) for more than two years;

(c) if he becomes bankrupt;

(d) if he is of unsound mind or otherwise is unable to meet its obligations;

(e) if he fails to attend meetings of the Board three times consecutive-also without the permission of the Chairman or in the event the Chairman, without the consent of the Minister;

(f) if his resignation is accepted by the Minister; or (g) if his appointment is revoked by the Minister.

(2) if any person cease to be a member of the Board by reason of any of the provisions of subparagraph (1), another person shall be appointed to replace the place.


Temporary exercise of functions of the Chairman 5. (1) if the Chairman is for any reason unable to perform the functions of the Chairman or during any period of vacancy 68 laws of Malaysia ACT 678 of the Chairman, the Minister may appoint any member of the Board to undertake the functions of the Chairman.

(2) until such appointment under subparagraph (1) is made or, if no such appointment or absence of the Chairman at any meeting of the Board, the members present shall appoint one of them to be the Chairman for the purpose of the meeting.
(3) a member appointed under subparagraph (1) or (2), as the case may be, shall, during the period that he perform the functions of the Chairman under this section are deemed to be Chairman.


6 meeting. (1) the Board shall meet at least six months at a time and at the place determined by the Chairman.

(2) at least fourteen days notice in writing of a meeting shall be given to members of the Board.

(3) every Member of the Board present shall be entitled to one vote.

(4) where on a questions for a decision by the Board there is a number of votes equal, then the Chairman shall have a casting vote.

(5) the Chairman and four other members present at the meeting of the Board shall form a quorum.


The Chairman of the Advisory Committee shall be present at meetings of the Board 7. (1) the Chairman of the Advisory Committee or his representative shall be present at every meeting of the Board, but its presence does not constitute a quorum for the meeting and he shall not be entitled to vote at the meeting.

Biokeselamatan 69 (2) if the Chairman of the Advisory Committee or his/her representative attend the meeting of the Board he shall be paid such fees as determined by the Board.


The Board may invite others to attend meetings 8. (1) the Board may invite any person to attend any meeting or deliberation of the Board for the purpose of advising it on any matter under discussion but that person shall not be entitled to vote at the meeting or deliberation.

(2) any person invited under subparagraph (1) may be paid such fees as determined by the Board.


Disclosure of interest 9. A member of the Board who has, directly or indirectly, by himself or through his partner, any interest in any matter under discussion by the Board, shall disclose the fact of his interest and the kind of interest, and the disclosure shall be recorded in the minutes of the Board and the Member cannot be present in any deliberation or decision of the Board relating to the matter.


Minutes 10. (1) the Board Secretary shall maintain minutes of all

meetings of the Board in a proper form.

(2) minutes made of meetings of the Board shall, if duly signed, is admissible in evidence in all legal proceedings without further proof.

(3) every meeting of the Board in respect of the proceedings thereon: such has been made shall be deemed to have been duly convened and held and all members at a meeting duly qualified to act.


70 laws of Malaysia ACT 678 Allowance 11. The Chairman and members of the Board shall be paid such allowances as determined by the Minister, with the agreement of the Minister of finance.


Procedure 12. Subject to this Act, the Board shall regulate its own procedure.


Seal 13. (1) the Board shall have a common seal bearing a sign approved by the Board and such seal may be broken, changed, altered and made anew as the Board may think fit.

(2) until a seal is provided by the Board, a stamp bearing the words "National Example Board" or "Board" may be used by the national Biokeselamatan and shall be deemed to be the common seal of the Board.

(3) the common seal shall be kept in the custody of the Director-General or any other person authorized by the Board, and shall be authenticated by the Director General or a person authorized or by any officer authorized by one of them in writing; and all deeds, documents and other instruments purporting to be sealed with the seal, and certified as aforesaid, shall, be deemed to have been validly executed, until the contrary is proved.

(4) any document or instrument which, if executed by a person not being a body corporate is not required in order to be sealed, can be executed in the manner similar by the Board; and any document or instrument may be executed on behalf of the Board by any of the officers or servants of the Board authorized generally or specially by the Board for that purpose.

(5) the common seal of the Board shall be officially and judicially noticed.
Biokeselamatan 71 Validity of acts and proceedings 14. No act done or proceeding taken under this Act may be questioned on the ground that — (a) any vacancy in the membership of, or there is a defect in the establishment of, the Board;

(b) any breach by any member of the Board in respect of the provisions of paragraph 9; or (c) any omission, defect or ketidakaturan that are not touching the merits of it.


The Board should devote time to the business of the Board 15. Every Member of the Board should devote time to the business of the Board as may be necessary to meet their obligations effectively.


SECOND SCHEDULE [section 3] confirmation of RELEASE 1. The purpose of research and development in all experiments the field 2. Supply or offer to supply for sale or put on the market 3. Offer as a gift, prize or item free of charge 4. Disposal of 5. The purpose of recovery 6. Any other activities to use controlled 72 is about addressing laws of Malaysia ACT 678 THIRD SCHEDULE [section 38] ENFORCEMENT OFFICERS 1. Any police officer of Inspector not meteoric as provided for in the Police Act 1967 [Act 344] 2. Any officer Inspector Department of agriculture as defined in section 2 of the plant quarantine Act 1976 [Act 167] 3. Any authorized officer as defined in section 2 of the Food Act 1983 [Act 281] 4. Any customs officer as defined in section 2 of the Customs Act 1967 [Act 235] 5. Any officer of the port as defined in section 2 of the Merchant Shipping Ordinance 1952 [Ord. 70/1952] 6. Any fishery officer as defined in section 2 of the Fisheries Act 1985 [Act 317] 7. Any authorized officer as defined in section 2 and appointed under section 53 of new plant variety protection Act 2004 [Act 634] 8. Any veterinary authority as defined in section 2 of the Act 1953 [Act 647] 73 laws of MALAYSIA Act 678 BIOKESELAMATAN ACT 2007 LIST AMENDMENT of laws that amend the short title effect from-No-74 laws of MALAYSIA Act 678 BIOKESELAMATAN ACT 2007 LIST SECTION AMENDED Section Power amend with effect from-no-