Plenary 6 - Biosafety Act 2007 Act on Biosafety

8/9/2019 Plenary 6 - Biosafety Act 2007 Act on Biosafety

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Biosafety Act 2007:

Act on Biosaefty

Dr Chan Kok GanLLB(Hons), LLM (with Merit), MSB, CBiol, BSc (Hons), MSc,

PhD

Commonwealth Scholar, Boursier du gouvernementfranais

Senior Lecturer, ISB (Genetics & Molecular Biology)

Faculty of Science, University of Malaya

[email protected] Chan Kok Gan


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To reduce, eliminate the potential risksresulting from modern biotechnology and

its products

Many countries (eg. US, Australia,

Philippines) realise the importance ofbiosafety and regulate accordingly with

their own domestic measures

WHY BIOSAFETY?

Dr Chan Kok Gan


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$$$$$ vs. risk by biotech

Dr Chan Kok Gan


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Cartagena Protocol

of Biosafety

Msia = member

Dr Chan Kok Gan


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The Biosafety ActThe Biosafety Act

The Biosafety Act will:

complement the implementation

of the National Policy on

Biotechnology (2005) &

National Policy on Biological

Diversity (1998).

Malaysias obligation under theCartagena Protocol on Biosafety.

Boost the confidence of investors in biotech

Clear direction on regulatory framework on

LMO Dr Chan Kok Gan


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An Act to establish the National Biosafety Board; to

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 arethreats 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

connected therewith.Dr Chan Kok Gan


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ScopeScope Establishes a National Biosafety Board to regulates the release, importation,

exportation and contained use

LMOs and products thereof

Precautionary principle enshrined In line with Malaysias obligation under the

Cartagena Protocol on Biosafety

An enabling law where most of the

operational issues such as identificationand labeling will be spelt out inRegulations.

Dr Chan Kok Gan


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Main Parts of The BillMain Parts of The BillPart 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 & EmergencyResponse Plan

Part VI Enforcement

Part VII MiscellaneousDr Chan Kok Gan


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Part IPart 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


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Establish ofNBB key function is

decision making Establish GMAC to give science

based advise to assist NBB

Establish IBC R&D (BiosafetyRegulations 2009)

Based on precautionary approach

if there are threats of irreversible

damage, lack of full scientificevidence may not be used as

reason not to take action to

prevent such damageDr Chan Kok Gan


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Part IIPart II

National Biosafety Board

Dr Chan Kok Gan


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National

Biosafety

Board

SG NRE

(Chair)Min. of Agriculture

Min. of Health

Min. of Plantation

Industries &

Commodities

Min. of Domestic Trade &

Consumer Affairs

Min. of Science,

Tech. & Innovation

Not more than 4 persons knowledge/experience

in biosafety

Min. of International

Trade & Industry

DG

(Secretary)

Dr Chan Kok Gan


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Functions of NBBFunctions of NBB

to decide on all applications to monitor activitiesrelating to living modified organisms and productsof such organisms;

to promote research, development, educational and

training activities relating to biosafety;

to establish mechanisms to facilitate the collection,storage and dissemination ofdata relating to livingmodified organisms and products of such organismsand biosafety; and

where so directed by the Minister, to perform orprovide for the performance of the obligationsarising from agreements, conventions ortreatiesrelating to biosafety to which Malaysia is a partywhere such agreements, conventions or treatiesrelate to the purposes of this Act.Dr Chan Kok Gan


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Genetic Modification AdvisoryGenetic Modification AdvisoryCommittee (GMAC)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 theBoard.

The chairman of the Advisory Committee shall be appointedby the Minister.

Such number, as may be approved by the Minister, ofother members of the Advisory Committee shall beappointed by the Board.

Members of the Advisory Committee shall consist of

experts from various science-based and other relevantdisciplines.

NBB and GMAC may also form committees/subcommittees to assist in their work

Dr Chan Kok Gan


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SCOPE OF

REGULATORY ACTIVITIES

RELEASE

MODERN

BIOTECHNOLOGY

LMOs

PRODUCTS

IMPORT

EXPORT

CONTAINED USE

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Part IIIPart III

Approval for Release and Import

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Approval for Release & ImportApproval 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

Dr Chan Kok Gan


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Applicant

NBB

Complete

Public Govt. Agency GMAC

NBB

Approved

NBB

Approved PersonRelevant. Dept.

Approved

Appeal to

Minister

NO

NO

NO

YES

YES

YES

APPEAL

Dr Chan Kok Gan


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FROM BENCH TO MARKET

Commercialisation

Direct introduction to

the environment

Placing in the market

Notification

Activity canstart

NBB decision

(90 days)

Approval

Certificate of Approval is neededActivity cannot start until

decision received

NBB decision (180 days)

R&D

Contained

use

Import for

contained use

R&D

Field Trial

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Part IVPart IV

Notification for Export,

Contained Use and Import forContained use

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NotificationNotification Is required for :

Exportation (must comply with requirements ofimporting country)

Contained use

Importation for contained use

Activity can start upon receivingacknowledgement. In the parallel the Boardshall assess the notification whether theactivity 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


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Notifier

NBB

Acknowledge

Approved Person

GMAC

NBB

Action

CompleteNO

YES

YES

YES

NO

Govt. Ag

Relevant Dept.

Appeal toMinister

Approved

NBB

APPEAL

NO

YES

Dr Chan Kok Gan


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Part VPart V

Risk Assessment, Risk Management &

Emergency Response Plan

Dr Chan Kok Gan


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RA & RMRA & RM The risk assessment and risk management reports

shall be in a form prescribed by the Minister andshall contain-

an assessment of the risk and adverse effect that suchliving modified organisms and products of such organismswill have or are likely to have on the human, plant andanimal 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 suchliving modified organisms and products of such organismswill have or are likely to have on human, plant and animalhealth, the environment and biological diversity.

Dr Chan Kok Gan


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ERPERP

An emergency response plan shall

provide

safety measures and procedures for the

protection of human, plant and animalhealth, 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.Dr Chan Kok Gan


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Part VIPart VI

Enforcement

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EnforcementEnforcement

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 VIIPart 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

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RegulationsRegulations

To fully implement this Act, regulations willbe needed and the power to make regulationlies 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 publicresearch institutes (IBC)

Identification and labelling

Risk Assessment & Risk Management &ERP

Fees payable

Compounding of offencesDr Chan Kok Gan


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Dr Chan Kok Gan

Dont know

what is all

about

Biosafety?!It is fine


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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, contravene new info

request:s33 (3) (a) & (b)Dr Chan Kok Gan


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Institutional Biosafety

Committee (IBC)

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Establish and register with NBB Form

NBB/IBC/90/Form G

Provide guidance for safe use

Monitor activities dealing

Establish and monitor the implementation ofpolicies and procedures

Provide guidance to researchers on biosafety

issues

Determine biosafety levels (contained use)

IBC

Dr Chan Kok Gan


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Information verified by IBC includes:

General information about project eg. ProjectTitle, 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, Headof Organization

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IBC Risk Assessment is based on:

Risks to the health and safety of humans fromactivities 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


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ROLE OF RESEARCHERS

Ensure compliance

Self regulation through IBC - interface

assessment

Transparent and provide comprehensiveinformation

Advocate good practices

Keep records of activities

Raise awareness about importance of

biosafety

Dr Chan Kok Gan

Documents

Plenary 6 - Biosafety Act 2007 Act on Biosafety