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Biosafety Acts and Regulations

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Biosafety is concern for all humanity�

Every individual has a responsibility and a role to play in making sure that biohazards and living modified organisms do not negatively impact biodiversity and human health

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CARTAGENA PROTOCOL ON BIOSAFETY

The Protocol is an international legally binding treaty which sets procedures and mechanisms to be applied in the transboundary movements of Living Modified Organisms (LMOs)

LMOs

The Protocol does not apply to other products of biotechnology.

The protocol entered into force in 11 Sept 2003 with 170 parties (as 2015) including Malaysia.

Living organisms that possesses a novel combination of genetic material obtained through the use of modern biotechnology (genetic modification)

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The Cartagena Protocol establishes rules and procedures to regulate the movements of LMOs from one country to another.

Some of the measures include:-

Risk Assessment – scientific, case by case
Safe handling, transport, packaging and proper

identification of LMO shipments

Public Awareness and participation
Compliance procedures and mechanisms
Liability and redress
Information sharing through Biosafety Clearing-House (BCH)

http://bch.cbd.int/

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CARTAGENA PROTOCOL ON BIOSAFETY AND BIOSAFETY ACT- COMPLIMENTARY LEGAL INSTRUMENTS

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Country A

Country B

Malaysia

Domestic Law Biosafety Act 2007

Transboundary movement - CPB

The Cartagena Protocol on Biosafety (CPB) regulates movement of LMOs from one country to another country
Locally, the Biosafety Act regulates modern biotechnology activities

Domestic Law Biosafety Act

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Biosafety Act 2007 and GMO Products in Malaysia

The Biosafety Act 2007 is drafted to be in line with the National Biological Diversity Policy (1998) and the National Biotechnology Policy (2005) and covers only modern biotechnology activities.

Department of Biosafety Malaysia (under Ministry of Natural Resources and Environment (NRE)) is responsible for implementation and enforcement of Biosafety Act

The Biosafety Act 2007 established a process to vet all applications for direct release of living modified organisms (LMOs) into the environment to ensure that the particular LMO is safe.

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In the Act, there are two different scopes of activities dealing with LMOs

(i) deals with release activities (R&D, placing in the market; offer as gift, prize or free item, disposal and remediation purposes) and importation of LMOs

(ii) concerns in which LMOs used for contained use and exportation.

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MALAYSIA’S PROTECTION GOAL

OBJECTIVE OF THE BIOSAFETY ACT 2007

To establish the National Biosafety Board (NBB); to regulate the release, importation, exportation and contained use of living modified organisms (LMO) & the release of products of such organisms, with the objectives of protecting human, plant and animal health, the environment and biological diversity

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Any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology

LMO (INTerpretation in biosafety act)

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Derived from LMOs or part of LMOs
Contains detectable recombinant DNA; or
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

PRODUCTS

(INTerpretation in biosafety act)

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[Covers laboratories, Animal Unit, Growth Room, Glasshouse and Bioreactor Facility…]

Any operation including R&D, production or manufacturing operation involving LMOs, or storage of LMOs, undertaken within a facility, installation or other physical structure such as it prevents contact and impact of the LMOs on the external environment

CONTAINED USE

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Includes:

R&D purposes in all field experiments
Supply or offer to supply for sale or placing on the market
Disposal
Etc.

RELEASE

(INTerpretation in biosafety act)

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PENALTY �Non-compliance to get approval from NBB for release and contained use activities involving LMO/products

It is mandatory to get an approval from the National Biosafety Board (NBB) to conduct modern biotechnology activities and handle LMO and its products.
Any non-compliance can result in a penalty under the law.

Where such person is an individual :

a fine not exceeding RM250,000 or to imprisonment for a term not exceeding 5 years or to both;
continuing offence, further fine no exceeding RM10,000 for each day

Where such person is a body corporate :

a fine not exceeding RM500,000;
continuing offence, further fine no exceeding RM20,000 for each day

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Malaysia Biosafety Clearing House (BCH)

http://www.biosafety.nre.gov.my/

- The Malaysia's National BCH is a gateway for all information related to biosafety in Malaysia.

# Please visit this site for any updates on biosafety regulatory instruments, administration of the Biosafety Act, capacity building activities and other biosafety related resources.