Biosafety Committee

Institutional Biosafety Committee (IBC)

Introduction

Under the Ministry of Natural Resources and Environment (NRE), all institutions/universities involved in research dealing with GMO must comply with the Biosafety Act 2007 and Biosafety (Approval and notification) Regulation 2010 and other related government regulations and policies to safeguard human health and the environment. For this purpose, Institutional Biosafety Committee UM is formed and registered with National Biosafety Board (NBB) in May 2011.

The responsibilities of the IBC include but are not limited to, the following :

To provide guidance for safe use of modern biotechnology;
To monitor activities dealing with modern biotechnology;
Establishing and monitoring the implementation of policies and procedures for the purpose of handling living modified organisms; and
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 institutional biosafety committee is established.

In order to comply with the Biosafety Act 2007 and Biosafety (Approval and notification) Regulation 2010, any release activity , contained use activity and importation/exportation of GMOs must get approval/notification from National Biosafety Board (NBB) through Institutional Biosafety Committee (IBC).

Release Activity

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

Application

Apply to release activities and import activities involving living modified organisms.
Not apply to the importation of living modified organisms intended for purposes of undertaking a contained use activity.

Application for Approval

An application for the approval of any release activity, or any importation of living modified organisms, or both shall be submitted to the Director General through the institutional biosafety committee in the prescribed manner, together with the prescribed fees, and shall be accompanied with :

(a) a risk assessment and a risk management report

(b) an emergency response plan

Certificate of Approval

The Board may grant the application by issuing a certificate of approval or refuse the application.
The Board may impose such terms and conditions as the Board thinks fit.

Validity

Approval shall be valid for the subsequent similar release activity involving the same living modified organisms or products of such organisms or importation involving the same living modified organisms undertaken by such approved person.
“Same living modified organisms or products of such organisms” means the living modified organisms or products of such organisms as described in the approval and involving the same transformation event.

Fees

Fee paid for the application shall not be refunded if the application is treated as withdrawn.

Release activity	Fees (RM)
(a) supply or offer to supply for sale or placing on the market;	5000
(b) offer as gift, prize or free item;	5000
(c) disposal;	5000
(d) remediation purposes;	5000
(e) any other activity which does not amount to contained use except for commercial field release.	5000
Research and development purposes in all field experiments per release site –
Less than 5 ha	100
5 ha – 10 ha	250
More than 10 ha	500

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

1. Apply to exportation 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.

Submittion 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).

Acknowlegment

The Director General will issue an acknowledgement of receipt and the person to whom such acknowledgement is issued may undertake the activities relating to the notification and may continue to undertake such activities subject to any order made by the Board.
The acknowledgement issued shall in no way absolve the person from complying with other written laws governing such living modified organism and its importation.

Exemption

The First Schedule of the Biosafety (Approval and Notification) Regulations 2010 allows exemptionsfor some types of techniques and contained use activities in relation to LMO posing a very low risk (i.e.contained research activities involving very well understood organisms and processes for creating and studying LMO):

Exempted activities should be carried out under conditions of standard laboratory practice.
Appropriate biosafety levels as according to Second Schedule of the Biosafety (Approval and Notification) Regulations 2010 should be used for the exempted activities and personnel should have appropriate training.
Principal Investigators who believe that the work falls into any of the exemptions should nevertheless notify their IBC of the proposed project.
The IBC may review all submitted research projects to determine their exemption or non-exemption status.

Notification Process

Contained use activities which are exempted from the notification

Biosafety (Approval and Notification) Regulations 2010 (page 20-27)

Risk Assessment and Risk Management

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.
Example of risk assessment matrix can be downloaded here.

Emergency Response Plan

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.

BSL

1. Biosafety Guidelines for Contained Use Activity of Living Modified Organism (LMO)

2. Classes of Activity Involving Modern Biotechnology:

Class	Description
BSL1	Activities of no or negligible risk, for which containment level 1 is appropriate to protect human health and the environment.
BSL2	Activities of low risk, for which containment level 2 is appropriate to protect human health and the environment.
BSL3	Activities of moderate risk, for which containment level 3 is appropriate to protect human health and the environment.
BSL4	Activities of high risk, for which containment level 4 is appropriate to protect human health and the environment.

LMO RESEARCH NOTIFICATION

Dear Campus Community,

Greetings from the Institutional Biosafety Committee (IBC),

In conjunction with the enforcement of Biosafety Act 2007 and Biosafety (Approval and Notification) Regulation 2010, we would appreciate researchers to notify us on any activity or research involve in Living Modified organism (LMO). This includes:

1) Genetic Modification of Microorganisms
2) Genetic Modification of Plants
3) Genetic Modification of Animals
4) Genetic Modification of Arthropods
5) Genetic Modification of Aquatic Organism

Thank you.

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Last Updated on August 27, 2023

Biosafety Committee

Institutional Biosafety Committee (IBC)

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