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Generally, Biosafety Act 2007 implements by Natural Resources and Environment for the genetic engineering development and this act is amending the Food Regulation 1985 and Food Act 1983. In 2010, there is a new biosafety act implemented which is known as Biosafety (Approval and Notification) Regulation 2010. Objective of this regulation is to give guidance by the institutional biosafety committee in term of the safe uses of modern biotechnology, and controlling activities which are related to modern biotechnology. Besides, it is also used for the establishment and monitoring for the procedure and policies implementation for the handling of living genetic modified organisms. This regulation set the requirement, procedures and application form for certificates approving any release activity or any importation of living modified organisms..
Other than that, Ministry of this department also drafting another two guidelines with the help from universities and research institutes professional. Topics covered in the two guidelines are including Setting Up an Institutional Biosafety Committee (IBC) and Contained Use Activity of Living Modified Organisms (LMOs) which are independently reviewed by a Malaysian experts who are have 30 years of experience in conducting research and development activities in modern biotechnology (MONRE, 2010). Both guidelines are useful for any organization involved in conducting research and development on modern biotechnology. The purpose implementing these guidelines is to make sure these activities comply with the Biosafety Act 2007, Biosafety (Approval and Notification) Regulation 2010 and other government related regulations and policies to ensure human health and the environment in safe condition.
Basically, the content in the "Guidelines for Institutional Biosafety Committees (IBCs): Use of Living Modified Organisms and Related Materials" including setting up of IBCs, and role of IBCs. The most important thing outlined in this guideline is discussing the process must be followed when obtaining, using, storing, transferring, destroying living modified organisms or rDNA materials (MONRE, 2010). Besides, the relevant regulatory requirement and procedures are also included in these guidelines. Other than that, these guidelines also including the 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 and spills and emergency situations, record keeping for activities and incidents, laboratory inspections and other related information.
The second guideline which is implemented by ministry of Natural Resources and Environment is "Biosafety Guidelines for Contained Use Activity of LMOs". The objective implementing this guideline is to help in identifying the BSL for containment of any LMO activity and specifying work procedures under the various containment levels (MONRE, 2010). This guideline also use for outlining the minimum requirements for setting up facilities for contained use activities of LMOs and identifying equipment requirements under the different containment levels. Basically, this guideline is explaining on the Biosafety Levels (BSL) for any containment in detail and practices for working with LMOs and products of these organisms safely. When adopting this guideline, it is require to used together with the relevant legislations, and guidelines that involve containment facilities. Disposal of LMO and related wasters, biological waste packing, labeling, and movement, treatment method for bio-hazardous waste, storage of LMOs and related materials are also including in the guideline.
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. made it mandatory to follow this act. 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 was mandatory enforced based on Biosafety Act 2007. This act is specific to those approved genetic modified food in Malaysia such as roundup ready soybean, MON 810 Bt maize, NK 603 roundup ready maize and MON 863 Bt maize. This legislation designed to protect consumer health and environment.
It is required to be identified and labeled for all of the genetic modified organisms and its products derived which are contained in the provisions of this act. Based on the act, section 61 and 69, stated that all of the living modified organisms, items and products which is containing any genetic modified organisms must have to be clearly identified and labeled in a better manner.
Different countries will have different genetic modified labeling threshold which is according to their own required criteria. For example, in European Union (EU) is still the one and only that sets the GMO threshold level of 0.9%, which is most stringent legislation globally (Heide et al., 2008). The labeling threshold level in Japan and Taiwan set at 5.0%; South Korea is 3.0%; while for Australia, New Zealand, Brazil and Saudi Arabia set at 1.0% (Viljoen et al., 2006). For Malaysia, the labeling threshold is set at 3.0% that has been approved but have not been implemented (Yoke-Kqueen et al., 2011).
Food labels provide information about the food and its contents, about the place or origin of manufacture and about how to use and store the food (Rumble et al., 2003). In another words, the purpose of the labeling is to make sure that the products that have undergone the prescribed process are properly and adequately identified so that consumers would know the contents of the product. Basically, labeling is based on the consumers' rights to provide information to consumers so that they can be more confidently while purchasing genetic modified food.
Through genetic modified food labeling, the characteristic and specialty of the particular genetic modified food can be known clearly. Without this labeling, consumers will do not know whether the food they consume is genetically modified or not. For example, the unintended effect of genetic modified organisms on new products such as allergies can be known before consumers purchase the food. In term of genetic modified food health safety issue, label on the food products that contain genetic modified organisms that a gene from a nut is used will alert consumer who is allergic to nuts. It is very important as consumers who have potentially fatal on nut allergies. Therefore, food label on the genetic modified food able to provide important information for those who are health concerns. This is a safety impact from implementing of Biosafety Act 2007.
On the other hand, genetic modified food labeling also important for industries traceability procedure. It is to help industries to identify genetic modified organisms in the genetic modified food products in all stages. If any harmful material arises from the GMO or product, the worker who is responsible can be traced and followed by action taken. Therefore, labeling allows regulators to make a connection between GMO and product from GMO to its risk assessment. It is also to allow a product recall in case existence any unexpected safety issues that arise subsequently.
Genetic modified food safety level can be increase and maintained after Biosafety Act 2007 enforced. Regarding to this act, it is control on the LMOs release activities procedures and importation of LMOs and it is also make concerns in which LMOs used for contained use and exportation. When country needs to export of LMOs, the exporters are required to follow the requirements which are set up by the importing country. In Malaysia, the applicant have to inform the Biosafety Board through notification form and submitted together with the emergency response plan, specific measure for contained use activity and such other information as specified by the Board. The board has the power to review and remark the notification at any time to make sure that there is none danger thing which is harmful to consumer health and environment. Fine or imprisonment or both enforced for those who is guilty of contravening the notification for export, contained use and import for contained use.
There is more peoples concern about the risk which is relating to the genetic modified organisms and its products. So, due to this concerns, this act is contains the provisions on the mechanisms and procedures such as risk management and risk assessment information about LMOs. This act eventually cover virtually all food imports, production and processing in the country. The act also used to assess that the products are safe to use and safe for the environment, humans and animals.
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