BIOSAFETTY ACT 2007

1 Main Elements
1.1 Establishment of NATIONAL BIOSAFETY BOARD (NBB) - Decision
making

1.2 Establish Genetic Modification Advisory Committee (GMAC) - To give

science based advise

1.3 Based on precautionary approach -if there are threats of irreversible

damage, lack of full scientific evidence may not be used as reason not
to take action to prevent such damage

1.4 Operational issues such as application process will be spelt out in

Regulations

2 Purpose
2.1 National Policy on Biotechnology (2005) and aNational Policy on
Biological Diversity (1998)

2.2 Malaysia’s obligation under the CPB to have a domestic regulatory

framework

2.3 Boost the confidence of investors in biotech

2.4 clear direction on regulatory framework

2.5 Not intended to disrupt R&D

3 Objective
3.1 To establish the National Biosafety Board

3.2 to regulate the release, importation, exportation and contained use of

living modified organisms, and the release of products of such
organisms

3.3 protecting human, plant and animal health, the environment and
biological diversity
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4 Concern
4.1 Impact to the environment –gene flow, weediness

4.2 Impact on non target organism or indirect effects

4.3 Evolution of resistance (resistant pests)

4.4 Allergenicity & toxicity

4.5 Source of the gene –can cause disease, toxic, other negative impact

4.6 Herbicide/Insecticide tolerance

5 Main Item
5.1 Living Modified Organism - LMO
5.1.1 any living organism that possesses a novel combination of genetic
material obtained through the use of modern biotechnology

5.2 Product
5.2.1 Derived from LMOs or part of LMOs

5.2.2 Contains detectable recombinant DNA

5.2.3 Profile, characteristic or properties of the product is or are no longer

equivalent to its conventional counterpart irrespective of the presence of
the recombinant DNA

6 Activity
6.1 Notification
6.1.1 Activity can start after receiving acknowledgement from Dept of Biosafety

6.1.2 Type

 Exportation of living modified organisms

 Contained use involving living modified organisms

 Importation of living modified organisms for purposes of

undertaking a contained use activity

6.1.3 Part of Requirement

Emergency Response Plan

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6.2 Approval
6.2.1 Activity can start only after getting Certificate of Approval

6.2.2 Type

 Release

 Import

6.2.3 Part of Requirement

 Risk Assessment

 Risk Management

 Emergency Response Plan

6.3 Offence
6.3.1 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

6.4 INSTITUTIONAL BIOSAFETY COMMITTEE (IBC)

7 Modern Biotechnology
7.1 Scope
7.1.1 ALL INSTITUTES & PERSONS INVOLVED

7.1.2 ALL STAGES OF R&D AND RELEASE

7.1.3 ALL TYPES OF ORGANISM

7.1.4 ALL ACTIVITIES

 RELEASE

o R&D purposes in all field experiments

o Supply or offer to supply for sale or placing on the market

o Offer as gift, prize or free item

o Disposal

o Remediation purposes
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o Any other activity which does not amount to contained
use

 IMPORT

 EXPORT

 CONTAINED USE

o Any operation including R&D, production or

manufacturing operation involving LMOs, or storage of
LMOs

o within a facility, installation or other physical structure

o prevents contact and impact of the LMOs on the external

environment

7.2 Application
7.2.1 in vitro nucleic acid techniques, including recombinant deoxyribonucleic
acid (DNA) and direct injection of the nucleic acid into cells or organelles

7.2.2 fusion of cells beyond the taxonomic family

7.3 Non-Application
7.3.1 products of such organisms which are pharmaceuticals and addressed by
relevant international treaties or organizations, or regulated under any
other written laws relating to pharmaceuticals

7.3.2 techniques and contained use activities in relation to living modified

organisms as specified in the FIRST SCHEDULE