Generally, Ministry of Natural Resources and Environment implemented Biosafety Act 2007 which is an amendment to the Food Regulation 1985 and Food Act 1983 for the purpose of development of genetic engineering. In 2010, Biosafety (Approval and Notification) Regulation, was implemented. The main purpose of implementing this regulation is to give guidelines based on the safety uses of modern biotechnology and involved with controlling activities which is related in this field. Besides, it is also used for procedure and policies implementation establishment and monitoring for the handling of genetic modified organisms. The requirement, procedures and application form for the certificates approving any release activity or importation of living modified organisms are set following this regulation.
Other than that, this department also drafting another two biosafety handling guideline with the help from universities and research institutes expertise. Both guidelines are useful for any research and development organization that focusing in the modern biotechnology field. The purpose of implementing this guideline is to ensure that activities related to genetic modified organisms is comply with the Biosafety Act 2007 and Biosafety (Approval and Notification) Regulation 2010 and including other government regulation policies which related to human health and environment safety.
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The "Guidelines for Institutional Biosafety Committees (IBCs)" contains guidelines for the use of living modified organisms and related materials, setting up of IBCs and role of IBCs. The main focus of this guideline is regarding the process to be followed when obtaining, using, storing, transfering, destroying living modified organisms or rDNA materials (MONRE, 2010). This guidelines also include regulatory requirement, procedures, responsibilities of the biological safety officer and researcher, IBC membership, scope of reviews done by IBC on projects, manuals, procedures, training, personnel notification sequence and actions required for reporting of incidents, laboratory inspections and other related information.
The second guideline which is also implemented by the same ministry is known as "Biosafety Guidelines for Contained Use Activity of LMOs". This guideline aids in identifying Biosafety Level for containment of LMO activity and work procedures under various containment level (MORNE, 2010). Besides that, it also contains regulation about minimum requirements for facilities associated with LMOs activities including equipment requirements. Basically, this guideline is focusing on Biosafety Level of any activities associated with LMOs such as waste, labeling, treatment method of bio-hazardous waste and the storage of LMOs.
3.2 Enforcement involved
The enforcement officer carry out investigation under this act to make sure that any activities relating to importation, exportation and contained use of living modified organisms. The enforcement officer can be done in several ways which are including search the applicant for seize any organisms or product with or without warrant. Besides, they would conducting a searching by access into the computerized data for such purpose, and any necessary password, encryption or decryption code, shall be provided. Living modified organisms or the products from such organisms may forfeiture if necessary for future analyzed. Under this law, it is mandatory to label any food or products that contain genetic modified material. It is to protect consumer health and environment. It is also able to ensure the quality of genetically modified products.
4.2 Genetic Modified Products Safety Level Increase
Genetic modified food labeling is required for all food containing genetic modified organisms or its product following the enforcement of Biosafety Act 2007. The example of approved genetic modified food in Malaysia are roundup ready soybean, MON 810 Bt maize, NK 603 roundup ready maize and MON 863 Bt maize. These materials are subjected to the enforcement of this regulation. According to this act, anything containing genetic modified organisms or products derived from genetic modified organisms under this act are required to be identified and labeled. This act is enforced to protect consumer health and environment. Section 61 and 69 of this act stated that all living modified organisms, items and products which contain any genetic modified organisms must have to be clearly identified and labelled in a proper manner.
Food label is a useful tool that provides information about the contents and ingredients of the food, its manufacturer, uses and storage method (Rumble et al., 2003). The purpose of labelling is to ensure that the food products are labelled adequately and easy to be identified according to its prescribed process to notify consumer regarding information about the food. Consumer possess rights to know about the contents of the food especially those contains genetic modified materials or ingredients that is produced from genetic modified organisms so that they can choose to buy or not to buy.
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The genetic modified food labeling is important to reveal the characteristic of the genetic modified material or its derivatives. Consumer needs to know whether the food is genetic modified or not as there is some safety issues regarding genetic modified materials. These safety issues are much related to human health such as allergenicity, antibiotic resistance and toxicity (Beever and Kemp, 2000). These safety issues have not yet been resolved as it effects are in the long term basis. Consumer is notify through the labelling to avoid any unintended effect of genetic modified materials before they purchase the food product. For example, a food that contains ingredients in which gene derived from nuts may cause allergies to person allergic to nut. In this case, the food may not contain nuts but its ingredient is genetically modified and contains gene from nut. Therefore, the genetic modified labelling is essential to notify the consumer regarding this material. The safety impact is the main effect of the enforcement of this act.
Apart from that, genetic modified food labelling is also important for industries traceability plan. Current food safety policy is focusing on traceability along the food supply chain. The enforcement of this regulation acts as supplement to this food safety policy to help increase the safety level of ingredients or materials involved along the food chain. The food industries are able to identify and track and trace back if their products contain genetic modified materials. Corrective action can be taken immediately if any harmful material arises from the genetic modified materials. Therefore, regulators can carry out risk assessment by linking genetic modified materials information with product safety in the food chain. Product recalls can also be carried in case of any unexpected safety issues that arise subsequently.
The implementation of Biosafety Act is also associated with the control of LMOs release activities procedures, uses, importation and exportation of LMOs. Importers are required to follow the requirements set by Malaysia if they are exporting to our country. National Biosafety Board is responsible to approve or regulate activities related to LMO and its products. Applicant of such activities are required to inform the board via notification form and submit emergency response plan as well as specific measure for contained use and any other related information. The board is authorized to review and remark the notification to ensure consumer health and environment are protected from any danger. Any party that is found guilty are subjected to fine or imprisonment or both.
As the society is moving to become more health conscious, consumers are concern about the risk relating to genetic modified organisms and its products. Due to this arising concern, the act contains the provisions on the procedures such as risk assessment and risk management about LMOs and covers all food imports, production and processing that involved LMOs. Safety level of food products can be increased through the implementation of this act to protect human, animals, and the environment
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