With the growing influence of the biotechnology industry worldwide, Malaysia has enacted legislation to regulate the release, importation, exportation and contained use of living modified organisms and the release of products of such organisms. The objectives being to protect human, plant and animal health, the environment and biological diversity. The Act further provides that 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 full damage.
Some Key Definitions
This article aims to highlight some of the salient features of the Act. To appreciate the provisions of the Act, it is important to understand legal description given to some terms.
“Release Activity” means any intentional introduction of living modified organisms (LMOs) or products of LMOs into the environment through the activities or for the following purposes:-
- 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.
- remediation purposes.
- any other activity which does not amount to contained use.
“Contained Use” means any operation including research and development, production or manufacturing operation involving LMOs or storage of LMOs, undertaken within a facility, installation or other physical structure such that it prevents the contact and impact of the LMOs on the external environment.
“Product of such Organisms” means any product derived from a LMO or part of a LMO:-
- if the product contains detectable r DNA; or
- where the profile, characteristics or properties of the product is or no longer equivalent to its conventional counterpart irrespective of the presence of the r DNA.
To carry out the objectives, 3 administrative organs under the ministry of Natural Resources and Environment are established, namely:-
- National Biosafety Board
- Genetic Modification Advisory Committee
- Director General of Biosafety and other officers including enforcement officers.
Legislated Control Activities
The Act categories the activities involving LMOs in two separate Parts, namely:-
Part III of the act applies to release activities and import activities involving LMOs. This part applies to the importation of LMOs intended for purpose of undertaking a contained use activity.
Part IV of the Act applies to the exportation and contained use activities involving LMOs and importation of LMOs for purpose of undertaking a contained use activity.
Identification and Labeling
All LMOs, items containing LMOs and products of LMOs shall be clearly identified and labeled in a manner to be prescribed and the requirements for such identification and labeling shall be in addition to any other written law.
Confidentiality of Information
The Act recognizes confidentiality of commercial and industrial information relating to the application or notification and makes appropriate provisions to deal with that.
Liability for Non-Compliance
The Act provides several penalties for violation of the provision of the Act. Corporate offenders face heavier penalties compared to individuals.
Nothing in the Act removes civil tortious liability of offenders to third parties.
As of 18 November 2008, the Act has not come into force.
(The article is a brief summary of some key aspects of the Biosafety Act 2007 and should not be relied on for an informed view).
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[IP Advisory Service from KASS (Issue 104/2008)]