Malaysia: Biosafety Act 2007 & Biosafety (Approval and Notification) Regulations 2010

  • General Information

The Malaysian Government is aware of the potential hazards and risks of modern biotechnology towards the human and environmental safety and protection of biodiversity, thus, there is a need to accelerate investments in biotechnology. On 11th September 2003, Malaysia adopted the Cartagena Protocol on Biosafety (CPB), which is a supplement to the Convention on Biological Diversity (CBD) whereby this protocol is a multilateral environmental agreement that is intended to contribute to the safe transfer, handling, and use of living modified organisms (LMOs) that may have adverse effects on biological diversity and to human health [1][2]. Following this adoption, later in 2007, the Biosafety Act was approved by the Malaysian Government and entered into force on 1 December 2009 which aims to establish the National Biosafety Board. The task is given to the Department of Biosafety (JBK), Ministry of Natural Resources and Environment (NRE)[3][4]. The Act is drafted to be in line with the National Biological Diversity Policy (1998), the National Biotechnology Policy (2005) and the Food Regulations; but covers only the modern biotechnology activities and the need to protect human health and the environment from the possible adverse effects of the biotechnology products [5][6]. 

Following the obligation under CBD and the enforcement of Biosafety Act 2007, the National Biosafety Board (NBB) was established on 15 March 2010. NBB is the decision-making body to:

  • decide on all applications and matters under Approval for release into environment and import, contained use and exportation of LMOs;
  • monitor activities relating to LMOs and products of such organisms;
  • promote research, development, educational and training activities relating to biosafety;
  • establish mechanisms to facilitate the collection, storage and dissemination of data relating to LMOs 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, conventions or treaties relate to the purposes of this Act [7].

This Act also stated the establishment of the Genetic Modification Advisory Committee (GMAC) in May 2010 as to provide scientific, technical and other relevant advice to the Minister or NBB, and gives recommendations to the NBB [4] [6] [7].

The main function of this Act is to regulate the release, importation, exportation and contained use of LMOs, and the release of products of such organism, and with the objectives of protecting human, plant and animal health, the environment and biological diversity and where there are threats of irreversible 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 [7]. LMOs are defined as any living organism that possesses a novel combination of genetic material obtained through the use of modern biotechnology. While, the products are recognized as:

  • 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 [7].

Upon consultation between the Minister and NBB with regards to the Act, the Biosafety (Approval and Notifications) Regulations came into operation on 1 November 2010 [8]. The regulations are the key to ensuring the environmental and human safety of LMOs and giving the public confidence in LMO products by established the Institutional Biosafety Committee (IBC).  IBC are registered with the NBB and are obligated to report to the NBB. The responsibilties of IBC are: 

  1. to provide guidance for safe use of modern biotechnology;
  2. to monitor activities dealing with modern biotechnology;
  3. establishing and monitoring the implementation of policies and procedures for the purpose of handling LMOs; and
  4. determining the classes of Biosafety Levels for contained use activity for the purpose of modern biotechnology research and development undertaken within a facility where the IBC is established [8]

As described in these regulations, the activities covered include the approval, certification and notification of any release and importation of LMOs and LMO products. However, these regulations shall not apply to:

  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; and
  2. techniques and contained use activities in relation to LMOs as specified in the First Schedule of these regulations [8].
  • Contact Details

Department of Biosafety
Ministry of Natural Resources and Environment
Level 1, Podium 2, Wisma Sumber Asli
No. 25, Persiaran Perdana
Precinct 4, 62574 Putrajaya
MALAYSIA.
Tel: +603 8886 1580 / 1579
Fax: +603-8890 4935
Website: http://www.biosafety.nre.gov.my/

References:

  1. Convention on Biological Diversity. Background. Last accessed on 13 March 2013 at http://www.cbd.int/biosafety/background/default.shtml
  2. Secretariat of the Convention on Biological Diversity. Nagoya – Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety. Last accessed on 13 March 2013 at http://bch.cbd.int/protocol/cpb_publications.shtml
  3. Ministry of Natural Resources and Environment, Malaysia. Department of Biosafety. Last accessed on 8 February 2013 at
    http://www.nre.gov.my/English/Pages/Department%20of%20Biosafety.aspx
  4. Convention on Biological Diversity. 2011. Biosafety Protocol News. Last accessed on 25 February 2013 at http://bch.cbd.int/protocol/outreach/newsletter/bpn-09.pdf
  5. Department of Biosafety, Ministry of Natural Resources and Environment. Malaysia Biosafety Clearing House. Last accessed on 8 February 2013 at http://www.biosafety.nre.gov.my/
  6. Convention on Biological Diversity. 2012. Malaysia’s Current Status and Experiences Gained with the Identification and Documentation of LMOs. Last accessed on 21 February 2013 at http://bch.cbd.int/forum/art18/customs%20officers/asia/malaysia.pdf
  7. Institutional Biosafety Committee, Universiti Putra Malaysia. Biosafety Act 2007. Last accessed on 8 February 2013 at
    http://www.osh.upm.edu.my/ibc/doc/LAMPIRAN%203/biosafety-act2007.pdf
  8. Institutional Biosafety Committee, Universiti Putra Malaysia. Biosafety Regulations 2010. Last accessed on 8 February 2013 at
    http://www.osh.upm.edu.my/ibc/doc/LAMPIRAN%203/biosafety%20regulations%202010.pdf