Act of Parliament · Updated to 1 May 2019 · 7 parts
Biosafety Act 2007
Regulating living modified organisms and a national biosafety boardPart I
Preliminary
Official textFrom Laws of Malaysia Online, unchanged
This Act may be cited as the Biosafety Act 2007.
This Act comes into operation on a date to be appointed by the
Minister by notification in the Gazette.
This Act shall be read together with any other written law relating to import and export, human, plant and animal health, the environment and biological diversity, and the provisions of this Act
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shall be in addition to, and not in derogation of, the provisions of such other written laws.
In the event of any inconsistencies between the provisions of this Act and any of the other written laws referred to in subsection (1)
the provisions of this Act shall prevail.
s 3Interpretation
In this Act, unless the context otherwise requires—
“release activity” means any intentional introduction of living modified organisms or products of such organisms into the environment through the activities or for the purposes specified in the
Second Schedule;
“modern biotechnology” means the application of—
in vitro nucleic acid techniques, including recombinant deoxyribonucleic acid (DNA) and direct injection of the nucleic acid into cells or organelles; or
fusion of cells beyond the taxonomic family, that overcome natural physiological reproductive or recombination barriers and that are not techniques used in traditional breeding and selection;
“products of such organisms” means any product derived from a living modified organism or part of a living modified organism—
if the product contains detectable recombinant deoxyribonucleic acid (DNA); or
where the profile, characteristic or properties of the product is or are no longer equivalent to its conventional counterpart irrespective of the presence of the recombinant deoxyribonucleic acid (DNA);
Biosafety 9
“Advisory Committee” means the Genetic Modification Advisory
Committee established under section 6;
“analyst” means an analyst appointed under section 55;
“contained use” means any operation including research and development, production or manufacturing operation involving living modified organisms, or storage of living modified organisms, undertaken within a facility, installation or other physical structure such that it prevents the contact and impact of the living modified organisms on the external environment;
“approval” means an approval granted under subsection 16(3);
“biological diversity” means the variability among living organisms from all sources including, inter alia, terrestrial, marine and other aquatic ecosystems and the ecological complexes of which they are part; and includes diversity within species, between species and of ecosystems;
“Director General” means the Director General appointed under subsection 8(1);
“Board” means the National Biosafety Board established under subsection 4(1);
“Minister” means the Minister charged with the responsibility for natural resources and environment;
“approved person” means—
a person to whom an approval has been granted under
Part III; or
a person to whom an acknowledgement of receipt on the submission of a notification under Part IV has been issued;
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“living modified organism” means any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology;
“living organism” means any biological entity capable of transferring or replicating genetic material, including sterile organisms, viruses and viroids;
“enforcement officer” means an enforcement officer appointed under subsection 8(1) and includes an officer specified in the Third Schedule and an officer authorized under paragraph 38(c);
“occupier” means a person in actual occupation or having the charge, management or control of—
any premises; or
in relation to premises where different parts of which are occupied by different persons, the respective persons in occupation or control of each part;
“Chairman” means the Chairman of the Board appointed under paragraph 4(2)(a);
“premises” includes houses, buildings, lands, tenements, easements of any tenure, whether open or enclosed, whether built on or not, whether public or private, and whether maintained or not under statutory authority and any machinery, plant, vessel, aircraft or other vehicle.
Part II
National Biosafety Board
Part III
Approval for Release and Import
Part IV
Notification for Export, Contained Use and Import for Contained Use
Part V
Risk Assessment and Risk Management Reports and Emergency Response Plan
Part VI
Enforcement
Part VII