INSTITUTIONAL BIOSAFETY COMMITTEE (IBC), UMS

Introduction and Background
The use and research activities involving modified living organisms through recombinant processes may pose huge biosafety risks to human, animal, environmental and biodiversity if these activities are not closely controlled and monitored.

In line with this, the Malaysian Biosafety Act 2007 was enacted with the establishment of the National Biosafety Board (NBB). NBB is mandated with the responsibility of controlling activities relating to the release, import, export and controlled/regulated usage of Genetically Modified Organisms (GMOs) in Malaysia to minimize its impact towards the human and environment.

According to the Biosafety Act 2007, all organizations in Malaysia which are involved in the use and research of GMO research/recombinant DNA are required to comply with this Act regardless of the source of sponsorship/funding.

Action can be taken to organizations that do not comply with this Act which include, among others, suspension or termination of research at the organization. Legal action can also be imposed to organizations in which these research activities are carried out (in Section VI, Malaysian Biosafety Act 2007).
Biosafety Act 2007 and Biosafety Regulation (Approval & Notification) 2010
NBB has the authority to instruct the involved organizations to form a committee that oversea the use of recombinant DNA as stated in Section 7 (1) of the Malaysian Biosafety Act 2007.

It is mandatory for the committee, to be known as the Institutional Biosafety Committee (IBC), to be established by the organisations that carry out use and research on GMO/recombinant DNA. The IBC aims to be the center of networking between NBB and those organizations involved, other than helping NBB to monitor the use of GMO research / recombinant DNA.
UMS Institutional Biosafety Committee (UMS IBC) was established in 2011 under Regulation 5 of the Biosafety Regulation (Approval & Notification) 2010 of Biosafety Act 2007. The UMS IBS was formally registered with the National Biosafety Board on 5th October 2011.

The function and objectives of UMS IBC are:
  • To accord relevant exposure to GMO researchers in UMS on the importance of biosafety issues pertaining to the use of GMO/recombinant DNA directly relating to their research, health of their workers and the safety of the community.
  • To review and monitor the research activities of GMO carried out at the university to ensure compliance with the Biosafety Act.
  • To receive applications for any GMO research to be carried out at the university.
  • To review and decide on all applications for GMO research and to advise the researchers accordingly on their application with regards to compliances to stated guidelines.
  • To monitor the physical infrastructure, working procedures, training and expertise of staff involved in the approved GMO research.
  • To report to the Vice Chancellor on any significant issues on GMO use in UMS or on non-complying researchers on the set guidelines.
  • To become the contact point between the National Biosafety Board Malaysia (NBB) and UMS.
  • To report on all GMO research applications received from UMS researchers to the NBB.  

The members are UMS researchers who have relevant expertise in the field of recombinant DNA and/or biosafety. Members are appointed by UMS based on recommendation by the Deputy Vice Chancellor (Research & Innovation), UMS.

IBC members are not permanent positions and opportunity is given to UMS researches to contribute. The IBC Chair notifies NBB of changes in IBC membership as and when they occur. Such notice should include a revised list of members, contact details and background information on each new member.

Current UMS IBC members:

No.

List of members

Designation in IBC, UMS

Department / Agency

1

Prof. Dr. Vijay Kumar, FASc.

Chairman

Professor of Molecular Genetics

Biotechnology Research Institute (BRI)

2

Assoc. Prof. Dr. Kenneth F. Rodrigues

Biosafety Officer

Deputy Director (R&I), Biotechnology Research Institute

3

Assoc. Prof. Dr. Cahyo Budiman

Member

Biotechnology Research Institute

4

Assoc. Prof. Dr. Teoh Peik Lin

Member

Biotechnology Research Institute

5

Assoc. Prof. Dr. Azwan Awang

Member

Dean, Faculty of Sustainable Agriculture

6

Dr. Mohammad Tamrin bin Mohammad Lal

Member

Deputy Director (R&I), Borneo Marine Research Institute

7

Dr. Fong Siat Yee@Alison

Member

Faculty of Medicine and Health Sciences

8

Dr. Mohd. Khalizan bin Sabullah

Member

Faculty of Science and Natural Resources

9

Mdm. Salmi Afidah Shabuddin (Ts.)

Secretariat

Biotechnology Research Institute

Application to Conduct Recombinant DNA / Modern Biotechnology Research at UMS

Register Your Activities

Research activities that involved in the use and research of GMO research/recombinant DNA specifically involving modern biotechnology are required to registered via google form develop by IBC, UMS as follow:

https://bit.ly/3AhTImD

IBC, UMS will advice and guide researchers accordingly with regards to compliances to Biosafety Act 2007 guidelines. 

Notification For Contained Use

Definition of Contained Use

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.

Application for contained use may involve the following:

  1. Application to export of living modified organisms
  2. Contained use involving living modified organisms
  3. Importation of living modified organisms for purposes of undertaking a contained use activity

Submission of notification

The notification shall be submitted to the Director General through the Institutional Biosafety Committee in the prescribed form and accompanied by the following documents:

  1. An emergency response plan
  2. Specific measures for the contained use activity (regulation + IBC)
  3. Such other information as may be specified by the Board
  4. Compliant with requirements of importing country (export)
Notification Process
Image

Application to Conduct Recombinant DNA / Modern Biotechnology Research at UMS

Approval

All release and import of LMOs and products of such is prohibited unless approved by the National Biosafety Board. The release activities as spelt out in the 3rd schedule in the Act are:

  1. Research and development purposes in all field experiments
  2. Supply or offer to supply for sale or placing on the market
  3. Offer as gift, prize or free item
  4. Disposal
  5. Remediation purposes
  6. Any other activity which does not amount to contained use
Approval Process

An application for approval must be completed and submitted to the Director General (DG), Biosafety Department, Ministry of Environment & Water in the prescribed manner, together with the prescribed fees, and be accompanied with:

 

Upon receiving the application, the DG shall

 

GMAC shall forward its recommendation whether the application should be approved and the terms and conditions to be imposed by the NBB, if any, after the assessment.

 

After having considered the recommendations of the GMAC, the comments of the relevant department or agency, the views of members of the public, if any, and any additional information, the NBB may grant the application by issuing a certificate of approval or refuse the application.

If you have any questions, please contact:

Assoc. Prof. Dr. Kenneth F. Rodrigues (e-mail: kennethr@ums.edu.my) or

Mdm. Salmi Afidah Shabuddin (e-mail: salmi@ums.edu.my)

UMS Institutional Biosafety Committee,

Biotechnology Research Institute,

Universiti Malaysia Sabah