Biosafety Act 2007 · Updated to 1 May 2019 · Part III · Approval for Release and Import
18. Review of approval upon obtaining new information
Official textFrom Laws of Malaysia Online, unchanged
The Board may, in consultation with the Advisory
Board
“Board” means the National Biosafety Board established under subsection 4(1);
Committee, review any approval at any time upon obtaining new information or evidence on the living modified organisms or products of such organisms in respect of which such approval was granted.
If, on review of the approval, the Board is satisfied that there is a risk posed to human, plant or animal health, the environment or biological diversity, the Board may take any of the following actions:
biological diversity
“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;
revoke the approval;
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make a temporary cessation order;
impose additional terms and conditions;
order the approved person to make rectifications; or
make any other order as the Board thinks fit in the interest of biosafety.
Where the Board revokes an approval, the approved person shall cease all activities involving the living modified organisms and products of such organisms immediately and shall, within seven days from the date of the notification of the revocation, surrender the certificate of approval to the Board.
approved person
“approved person” means— (a) a person to whom an approval has been granted under
Where the Board makes a temporary cessation order, the approved person shall cease all activities involving the living modified organisms and products of such organisms immediately and shall, within seven days from the date of the notification of the cessation order, surrender the certificate of approval to the Board and the Board shall endorse the fact and duration of the temporary cessation on the certificate of approval and return the certificate to the approved person.
products of such organisms
“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
Where the Board imposes any additional terms and conditions the approved person shall, within seven days of the notification of the imposition of the additional terms and conditions, surrender the certificate of approval to the Board and the Board shall endorse such additional terms and conditions on the certificate of approval and return the certificate to the approved person.
Any approved 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, 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
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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);
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
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