Biosafety Act 2007 · Updated to 1 May 2019 · Part V · Risk Assessment and Risk Management Reports and Emergency Response Plan
36. Risk assessment and risk management reports
Official textFrom Laws of Malaysia Online, unchanged
The risk assessment and risk management reports shall be in a form prescribed by the Minister and shall contain—
Minister
“Minister” means the Minister charged with the responsibility for natural resources and environment;
an assessment of the risk and adverse effect that such living modified organisms and products of such organisms will have or are likely to have on the human, plant and animal health, the environment and biological diversity; and
the proposed measures that shall be undertaken to prevent, reduce or control the risks and adverse effect that such living modified organisms and products of such organisms will have or are likely to have on human, plant and animal health, the environment and biological diversity.
Notwithstanding any risk assessment and risk management reports submitted by an approved person, the approved person shall comply with the minimum risk management measures as may be determined by the Board, after consultation with the Advisory
approved person
“approved person” means— (a) a person to whom an approval has been granted under
Committee.
34 Laws of Malaysia ACT 678
Upon obtaining an approval or an acknowledgement from the
Board, the approved person shall, in the course of undertaking the release, import or contained use activity relating to the approval or acknowledgement, as the case may be,—
Board
“Board” means the National Biosafety Board established under subsection 4(1);
incorporate into the design, construction and operation, whichever is applicable, of the release, import or contained use activity the proposed measures in the risk management reports of the approved person; and
carry out and comply with, to the satisfaction of the Board, the minimum risk management measures referred to in subsection (2).
Any approved person who contravenes subsection (3) commits an offence and shall, on conviction, be liable—
where such person is an individual, to 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, to a further fine not exceeding ten thousand ringgit for each day during which the offence continues after conviction;
where such person is a body corporate, to a fine not exceeding five hundred thousand ringgit and, in the case of a continuing offence, to a further fine not exceeding twenty thousand ringgit for each day during which the offence continues after conviction.
Terms defined in s 3
Advisory Committee
Defined · s 3“Advisory Committee” means the Genetic Modification Advisory Committee established under section 6;
approved person
Defined · s 3“approved person” means— (a) a person to whom an approval has been granted under
biological diversity
Defined · s 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;
Board
Defined · s 3“Board” means the National Biosafety Board established under subsection 4(1);
contained use
Defined · s 3“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;
Minister
Defined · s 3“Minister” means the Minister charged with the responsibility for natural resources and environment;
products of such organisms
Defined · s 3“products of such organisms” means any product derived from a living modified organism or part of a living modified organism— (a) if the product contains detectable recombinant deoxyribonucleic acid (DNA); or (b) where the profile, characteristic or properties of the product is or are no longer equivalent to its conventional counterpart irrespective of the presence of the recombinant deoxyribonucleic acid (DNA); Biosafety 9