Biosafety Act 2007:

Act on Biosaefty

Dr Chan Kok Gan

LLB(Hons), LLM (with Merit), MSB, CBiol, BSc (Hons), MSc, PhD
Commonwealth Scholar, Boursier du gouvernement français

Senior Lecturer, ISB (Genetics & Molecular Biology)

Faculty of Science, University of Malaya
kokgan@um.edu.my
Dr Chan Kok Gan
 WHY BIOSAFETY?
To reduce, eliminate the potential risks
resulting from modern biotechnology and
its products

Many countries (eg. US, Australia,

Philippines) realise the importance of
biosafety and regulate accordingly with
their own domestic measures
Dr Chan Kok Gan
$$$$$ vs. risk by biotech

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Cartagena Protocol
of Biosafety

M’sia = member
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 The Biosafety Act

• The Biosafety Act will:

– complement the implementation
of the National Policy on
Biotechnology (2005) &
National Policy on Biological
Diversity (1998).
– Malaysia’s obligation under the
Cartagena Protocol on Biosafety.
– Boost the confidence of investors in biotech
– Clear direction on regulatory framework on
Dr Chan Kok Gan
LMO
 to
An Act to establish the National Biosafety Board;
regulate the release, importation,
exportation and contained use of
living modified organisms, and the
release of products of such
organisms, with the objectives of
protecting human, plant and animal
health, the environment and
biological diversity, and where there are
threats of serious damage, lack of full scientific
evidence may not be used as a reason not to take action
to prevent such damage; and to provide for matters
Dr Chan Kok Gan
connected therewith.
 Scope
Establishes a National Biosafety Board
to regulates the release, importation,
exportation and contained use
LMOs and products thereof
Precautionary principle enshrined
In line with Malaysia’s obligation under the
Cartagena Protocol on Biosafety
An enabling law where most of the
operational issues such as identification
and labeling will be spelt out in
Regulations.

Dr Chan Kok Gan

 Main Parts of The Bill
Part I Preliminary

Part II National Biosafety Board

Part III Approval for Release & Import
Part IV Notification for Export, Contained
Use and Import for Contained use
Part V Risk Assessment & Risk
Management & Emergency
Response Plan
Part VI Enforcement
Part VII Miscellaneous
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 Part I

Preliminary

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Came into force 1- Dec- 2009 (Gazette)

Inconsistencies between provision of

this Act and any other written laws, this
Act prevails

Interpretations and definitions

Used Cartagena Protocol on Biosafety

Dr Chan Kok Gan

• Establish of NBB – key function is
decision making
• Establish GMAC to give science
based advise – to assist NBB
• Establish IBC – R&D (Biosafety
Regulations 2009)
• 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
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 Part II

National Biosafety Board

Dr Chan Kok Gan

 SG NRE DG
(Chair) (Secretary)
Min. of Agriculture

Min. of Science,
National Tech. & Innovation
Min. of Health
Biosafety
Board
Min. of Plantation Min. of International
Industries & Trade & Industry
Commodities

Not more than 4 persons

– knowledge/experience
Min. of Domestic Trade &
in biosafety
Consumer Affairs

Dr Chan Kok Gan

 Functions of NBB
• to decide on all applications to monitor activities
relating to living modified organisms and products
of such organisms;
• to promote research, development, educational and
training activities relating to biosafety;
• to establish mechanisms to facilitate the collection,
storage and dissemination of data relating to living
modified organisms and products of such organisms
and biosafety; and
• where so directed by the Minister, to perform or
provide for the performance of the obligations
arising from agreements, conventions or treaties
relating to biosafety to which Malaysia is a party
where such agreements, Dr Chanconventions
Kok Gan or treaties
relate to the purposes of this Act.
 Genetic Modification Advisory
Committee (GMAC)
• GMAC is formally establish as advisory body
– The function of the Advisory Committee is to provide scientific,
technical and other relevant advice to the Minister or the
Board.
– The chairman of the Advisory Committee shall be appointed
by the Minister.
– Such number, as may be approved by the Minister, of
other members of the Advisory Committee shall be
appointed by the Board.
– Members of the Advisory Committee shall consist of
experts from various science-based and other relevant
disciplines.
• NBB and GMAC may also form committees/
subcommittees to assist in their work
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 SCOPE OF
REGULATORY ACTIVITIES
RELEASE

LMOs
IMPORT
MODERN
BIOTECHNOLOGY
EXPORT

PRODUCTS
CONTAINED USE

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 Part III

Approval for Release and Import

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Approval for Release & Import
• Release includes
– R&D purpose in all field experiments,
– market,
– gift, prize or free item
– Disposal
– Remediation purpose
• A fee is charged
• Not applied for importation for contained use
• Approval Decision can be reviewed
• Appeal to Minister
• Offense punishable

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 Applicant APPEAL

NBB

NO
Complete Appeal to
YES Minister

Public Govt. Agency GMAC NO

Approved
YES
NBB
NBB
NO
Approved
YES

Relevant. Dept. Approved Person

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 FROM BENCH TO MARKET
R&D R&D Commercialisation
•Contained •Field Trial • Direct introduction to
use the environment
•Import for • Placing in the market
contained use

Notification Approval
• Activity can Certificate of Approval is needed
start Activity cannot start until
• NBB decision decision received
(90 days) NBB decision (180 days)

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 Part IV

Notification for Export,

Contained Use and Import for
Contained use

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 Notification
• Is required for :
– Exportation (must comply with requirements of
importing country)
– Contained use
– Importation for contained use
• Activity can start upon receiving
acknowledgement. In the parallel the Board
shall assess the notification whether the
activity relating to the notification can
continue and must decide within 90 days
• Notification Decision can be reviewed
• Offense punishable
• Appeal to MinisterDr Chan Kok Gan
 Notifier APPEAL

NBB

YES NO
Complete
Appeal to
GMAC Govt. Ag YES Minister
NBB Acknowledge
NO
Approved
YES
NO YES
Action Approved Person NBB

Relevant Dept.
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 Part V

Risk Assessment, Risk Management &

Emergency Response Plan

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 RA & RM
• The risk assessment and risk management reports
shall be in a form prescribed by the Minister and
shall contain-

– 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.

Dr Chan Kok Gan

 ERP
• An emergency response plan shall
provide–
– safety measures and procedures for the
protection of human, plant and animal
health, the environment and biological
diversity against harm or damage caused
directly or indirectly by living modified
organisms or products of such organisms;
and

– all necessary measures to be taken in the

event of an emergency.
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 Part VI

Enforcement

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 Enforcement
• Enforcement officer of the board
• Officers specified in Third Schedule
(eg. Customs, DOA, Fisheries, Police)
• Any other officer of the Board or any
public officer authorised by the board
in writing

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 Part VII

Miscellaneous

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• Confidential Business Information
(amendments made)
• Public Disclosure
• Labelling & Identification
• Assistance from multi-agency –
emergency
• Power to compound
• Transitional Provisions
• Power to make regulations

Dr Chan Kok Gan

 Regulations
• To fully implement this Act, regulations will
be needed and the power to make regulation
lies with the Minister.
• Among the regulations needed [ 69(2)]
– Manner and info for approval and notification
– Certificate of approval
– Contained use for teaching, R&D by public
research institutes (IBC)
– Identification and labelling
– Risk Assessment & Risk Management &ERP
– Fees payable
– Compounding of offences
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Don’t know
what is all
about
Biosafety?!
It is fine
Dr Chan Kok Gan
•Approval for release & import: s12(2) (a) & (b) RM250k – 500k,
5 yrs, approved person contravene approval, s16(6) (a) & (b)

•Review of approval after obtaining new info’, contravene order of

Board: s18(6) (a) & (b), Board requests further order but
contravene: s19 (5) (a) & (b)

•Notification of export & import for contained use: s22(2) (a)

& (b), contravene specific measure: s26(2) (a) & (b)

•Contravene order on notification: s30(6) RM100k– 250k, 4 yrs

•Approved person failed to provide additional info’: s31(2) (a) & (b)
•Board made further order on notification after obtaining new info’,
make new order but contravene: s32(4) (a) & (b)
•Board made further order on notification,
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request: s33 (3) (a) & (b)
Institutional Biosafety
Committee (IBC)

Dr Chan Kok Gan

 IBC
• Establish and register with NBB – Form
NBB/IBC/90/Form G
• Provide guidance for safe use
• Monitor activities dealing
• Establish and monitor the implementation of
policies and procedures
• Provide guidance to researchers on biosafety
issues
• Determine biosafety levels (contained use)

Dr Chan Kok Gan

Information verified by IBC includes:
• General information about project eg. Project
Title, Names of Principal Investigators, Objective
of project
• Description LMOs
• RA & RM, and ERP of project
• If the information is complete?
• Biosafety assessment of project done?
• Statutory Declaration Applicant, IBC Chair, Head
of Organization

Dr Chan Kok Gan

IBC Risk Assessment is based on:
• Risks to the health and safety of humans from
activities associated with genetic modification

• Risks to the health and safety of humans from

an unintentional release of the LMOs

• Risks to the environment from an unintentional

release of the LMOs

Dr Chan Kok Gan

 ROLE OF RESEARCHERS

• Ensure compliance
• Self regulation through IBC - interface
assessment
• Transparent and provide comprehensive
information
• Advocate good practices
• Keep records of activities
• Raise awareness about importance of
biosafety

Dr Chan Kok Gan