Biosafety is defined as the need to protect human health and the environment from the possible adverse effects of the products of modern biotechnology. Biosafety is a preventive approach to avoid the loss of biological integrity that might happen greatly. It is strongly associated with several fields such as ecology, agriculture, medicine, chemistry and exobiology.
In agriculture, biosafety plays the role of minimizing the risk of alien viral or transgenic genes and the occurrence of food bacterial contamination. In medicine, biosafety refers to organs or tissues of biological origin or genetic therapy products, virus, levels of lab contaminant protocols. Biosafety in these various fields require the application of precautionary principle and new up-to-date information focused on the biological nature of these threatened organisms.
Biosafety level refers to the level of the biocontainment precautions required in the isolation of harmful biological agents in an enclosed facility. Biosafety level is defined from the lowest biosafety level 1 to the highest at level 4, indicating rising order of danger. These biosafety levels are also known as BSL1 through BSL4, with one anomalous level BSL3-ag for agricultural hazards that is between BSL3 and BSL4.
1.1 Reasons for Establishment of Biosafety Control
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The establishment of biosafety control is due to the heightened global environmental awareness and concern over the fast pace of ecological degradation. This resulted in the international community to put more effort on pushing the protection of the environment higher up the political agenda, leading to the formation of the Cartagena Protocol on Biosafety.
Since Malaysia is paying more attention on biotechnology field as it could be one of the new income sources, biosafety and the safe transfer, handling and use of Living Modified Organisms (LMOs) has undoubtedly become increasingly important. It is believed that biotechnology techniques have the potential in improving quality and nutritional value as well as increasing the variety of food available for human consumption. Besides, it is able to increase the efficiency of food production, processing, distribution and waste management. Therefore, Malaysia has great responsibility to make sure that the nation's biological resources are well safeguarded. At this point, biosafety control is important in ensuring the potential adverse impact that might be brought by modern biotechnology at minimum level. It is of utmost importance to make sure that modern biotechnology is handled in a way that posed no any negative impacts on biodiversity and human health.
Biosafety control is important for the development of the effective mechanisms in identifying any possible biosafety and biosecurity threats rapidly. Early detection of these biosafety and biosecurity threats is able to protect nations in the region from possible bio-disasters. It is undeniable that infectious diseases in this era spread widely without considering geographic and political boundaries. The outbreak of diseases such as Nipah disease, SARS and H1N1 caused a large number of death cases around the world. Therefore, countries around the world should have effective biosafety control. Necessary efforts are needed in strengthening the management and controlling the usage of biological materials, agents and pathogens in various processes, from storage and usage to export.
1.2 Biosafety Issues and Efforts of Malaysia in Them
The most recent biosafety issue in Malaysia is the release of genetically modified male Aedes aegypti mosquitoes OX513A (My1) into our environment. These mosquitoes were developed by Institute for Medical Research (IMR) in a joint research with Oxitec Ltd., a UK-based biotech company. This project gained the approval from Malaysia's National Biosafety Board in October 2010. This Genetic Modify Technology is creating the opportunities for the genetically modified male Aedes mosquitoes to mate with female mosquitoes. The difference between normal male Aedes mosquitoes and these genetically modified is that their off-springs will have shorter lifespan where they die before becoming adults. The Consumers' Association of Penang (CAP) and Sahabat Alam Malaysia called on the National Biosafety Board to reconsider the approval for the field release of genetically modified mosquitoes. The approval of this project had raised the fear in public. It is feared that the outcome will be unpredictable and the release of these mosquitoes will be impossible and difficult to monitor, contain, mitigate and reverse. Besides, this issue also raised concern on the possibility of the introduction of other insects that might be more dangerous than Aedes aegypti into the ecological niche left by the mosquitoes. This is exceptionally true when the genetically modified Aedes aegypti succeed in suppressing wild populations, resulting in introduction of Aedes albopictus that transmits both chikugunya and dengue.
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The outbreak of severe infectious diseases in Malaysia can also be considered as biosafety issue. Diseases such as SARS, Nipah virus and Avian flu are some example of diseases that spread in Malaysia. The outbreak of these diseases had a dramatic effect on part of economic activity in Malaysia. The effects on travel and tourism industry are more obvious as these diseases are mainly spread by person-to-person contact. Restaurants, entertainment and retail trade have also been hard hit because people fear of getting these diseases at public places.
Transgenic crops are plant that involves the insertion of a gene or genes artificially instead of the plant acquiring them through pollination. Biosafety concerns on transgenic crops arose from horizontal gene transfer, genetic contamination and transfer of allergens and toxins from one life form to another and creation of new toxins and allergenic compounds. Malaysia had approved several transgenic products. They are Roundup Ready Soybean, Roundup Ready Maize, MON 810 YieldGard Maize against Corn-Borer and MON 863 YieldGard Rootworm++ Maize. Some of these products such as Roundup Ready Soybean and Roundup Ready Maize are genetically modified to be resistant to herbicide. The others are made to be resistant to insects attack. Another product approved is Ice-Structuring Protein (ISP) which is a copy of a protein found in ocean pout (fish). This product is used to control ice crystal size, shape and growth in the preparation of ice-cream in one food industry at Malaysia.
Another effort that Malaysia put on biosafety issue is on the establishment of Plant Biotech Facility (PBF) at University of Malaya (UM). Plant Biotech Facility, a transgenic greenhouse allows Malaysia to step into another milestone in the biotechnology field. It was built for research in plant biotechnology, complying with the international biosafety standards according to the Physical Containment Level 2 of the Australian Office of the Gene Technology Regulator (OGTR) Guidelines for Physical Containment Facility. This Plant Biotech Facility consists of office space and greenhouse facilities where it can be divided into an ante room and three greenhouses. Ante room which is an airlock entry point to the greenhouse area from the office space, is equipped with stainless steel hand washbasins, emergency shower, eye wash area and a room for autoclave purpose. Every greenhouse possess Environmental Control System (ECS) to ensure that the temperature and humidity level are both set at a level enabling provision of optimal growth conditions for temperate and tropical plants.
The Ministry of Natural Resources and Environment (NRE) and United Nations Development Programme - Global Environment Facility Project (UNDP-GEF) jointly conducted various workshops. They are Genetic Modification Advisory Committee (GMAC) Workshop, Workshop on Management of Containment Facilities, Workshop on GMO Detection and Analysis, Sabah and Sarawak Stakeholders' Workshop on Biosafety and Public Awareness Initiative Workshop. These workshops are organized for various purposes ranges from creating public awareness on biosafety to the specific one such as building capacity to enable effective implementation of the Biosafety Act.
The Ministry of Natural Resources and Environment (NRE) and United Nations Development Program (UNDP) in collaboration with other partners organized a series of risk assessment workshops. Risk assessment workshop on transgenic crop plants, risk assessment workshop on transgenic trees, risk assessment workshop on transgenic microbes and risk assessment workshop on transgenic insects were few workshops that were held. The main purpose of these workshops to be held is to build capacity among the regulators and scientists to get involved in science based risk assessment and management effectively. Another objective of these workshops was to review the current model of risk assessment and facilitate decision making process under the Biosafety Act 2007. As these workshops involved participants from local universities, research institutes and government agencies who are conducting research and development on genetically modified organisms, it is possible to promote cooperation and networking in risk assessment and risk management by exchanging information, expertise, training materials and risk assessment tools.
2.0 Biosafety Act Malaysia 2007
Biosafety Act Malaysia 2007 is an act that amending the Food Regulation 1985 and Food Act 1983. In recent year of 2010, there is a new biosafety act implemented which is known as Biosafety (Approval and Notification) Regulation 2010. With the establishment of National Biosafety Board (NBB) to regulate the activity of releasing, importation, exportation and contained use of living modified organisms (LMOs) and the products of these organisms as well. This is to protect human, plant and animal health, the environment and biological diversity. This regulation set the requirement, procedures and application form for certificates approving any release activity or any importation of living modified organisms.
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This act is started to enter force of Malaysia on 1 Dec 2009. It is in line with Malaysia's obligation under Cartagena Protocol on Biosafety which is an enabling law where most of the operational law such as identification and labeling will be spelt out in the regulations. It will complement the implementation of the National Policy on Biotechnology (2005) and National Policy on Biological Diversity (1998).
Main parts of Biosafety Act Malaysia as such:
National Biosafety Board
Approval for Release and Import
Notification for Export, Contained Use and Import for Contained Use
Risk Assessment& Risk Management & Emergency Response Plan
2.1 National Biosaferty Board
National Biosafety Board is established as a body corporate which is consists of one representative from each of the Ministries as below :
Ministry of Agriculture and Agro-based Industry
Ministry of Health
Ministry of Plantation Industries and Commodities
Ministry of International Trade and Industry
Ministry of Science, Technology and Innovation
Ministry of Domestic Trade and Consumer Affairs.
the Secretary General of Ministry of Natural Resource and Management
four or less than four other persons who have the knowledge or experience or both in any of the disciplines or matters relevant to this Act.
The chairman of the board normally is the Secretary General of Ministry of Natural Resource and Management. The establishment of this board is to decide all the applications to monitor activities which are related to living modified organisms and products of such organisms. In addition to this, it is playing a role to establish mechanism to help in the collection, storage and dissemination of data related to living modified organisms and product of such organisms and biosafety. Meanwhile, this board is important to promote all the biosafety- related research, development, educational and training activities in order to update and increase the knowledge of Malaysia community on biosafety. The authority of making decision on all applications and matters under Part III and IV of this act is belongs to this board as well. The board is responsible to the Minister and directed by Minister to perform or provide for the performance of the obligations arising from agreements, conventions or treaties relating to biosafety to which Malaysia is a party where such agreements, conventions or treaties relate to the purpose of this Act.
Under National Biosafety Board, there is a committee with the name of "Genetic Modification Advisory Committee" (GMAC) is established. The establishment of this advisory body is for the purpose of providing scientific, technical and advice or to assist the Minister or Board. As the selection of chairman of the board, the chairman of the Advisory Committee is selected by the Minister while the other members of the Advisory Committee are selected by the Board. Members of this committee should consist of experts from various science-based and other relevant disciplines as well. Under the Board and Advisory Committee, the Advisory Committee can establish subcommittee as the Board and Advisory Committee think necessary to assist them in the performance of their functions under this Act. The Minister may give general directions to the Board an Advisory Committees consistent with this Act, and the Board and Advisory Committee shall response to such directions as soon as possible. In the recent Biosafety Regulation 2009, Institutional Biosafety Committee (IBC) is established and register with NBB.
2.2 Biosafety Hazardous Material Control
A guideline has published from Ministry of Science, Technology and the Environment of Malaysia (MOSTE), "National Guidelines For The Release of Genetically Modified Organisms (GMOs) Into The Environment" is to provide guidance on the handling of genetic modified organism and its products producer and it is set for the regulatory element for biotechnology. This guideline is to ensure that all the GMO regulators have knowledge about the safety and risk about the genetic modified products so that they able to familiar with the appropriate procedure while handling of GMOs and its products. Basically, all of the genetic modified organisms and its product derived at all level of research and development, trans-boundary movement, handling, use, release and transfer in the market of the GMOs and its product are covered in this guideline. Besides, through this guideline, it also highlight on the biosafety issues in term of biotechnology field, for example risk management, assessment and monitoring.
3.0 Regulatory control for GMO/ GMO products
3.1 Risk Assessment and Risk Management
For food industries who producing food originated from GMOs, they should include risk assessment and risk management report as required by Ministry when apply for approval. Assessment of risk and adverse effect of living modified organisms and products from living modified organisms on human being, plant and animal health, environment and biological diversity should be well documented.
Methods to be taken to avoid, reduce and control the risks and adverse effects of GMOs and products from GMOs should be proposed by applied industry. Risk assessment and risk management reports which handed out by the approved industry should meet the minimum risk management requirements as determined by the National Biosafety Board with consultation with Genetic Modification Advisory Committee.
An appropriate emergency response plan shall be prepared by the food industries where it should cover safety measures and procedures for the protection of human, plant and animal health, the environment and biological diversity from harm or damage caused by directly or indirectly by GMOs or products from GMOs. All necessary measures to be taken in case of emergency occurred should be included as well.
Any industry who offends the above requirement is committed to an offence and on conviction, be liable:-
for individual, to a fine not more than RM 250,000 or to imprisonment for a term not more than 5 years or to both. In the case of continuing offence, to a further fine not more than RM 10,000 for each day during the offence continue after conviction;
for body corporate, to a fine not more than RM 500,000 and in the case of continuing offence, to a further fine not more than more than RM 20,000 for each day during the offence continue after conviction
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.
3.3 Regulation of Activities Relating to Genetically Modified Organisms
In Malaysia, any individual or company that interested in research, produce, import or export, release or place on market any genetically GMOs or any GMOs product or deal with any GMOs or GMOs product in any manner, they must have the approval from the Authority by submit an application in writing to the Authority. Without the approval, any activities that relating to GMOs are not allow to undergo. But activities that relates to any gene therapy for improving human characteristic for nonmedical reasons or uses any GMOs or GMOs product that against the morality and ethical values of Malaysia are not allow applying for approval. As Islam is the official religion, GMOs that are import as food is needed HALAL certification to prove that it is HALAL.
In the application letter, it should include name of the GMOs, exact conditions of use, and type of expected use which include industry, agriculture, trades or consumers use. If it is a GMOs product, it should include product name and name of genetically modified organism contained therein, specificity of the product, name of the manufacturer and distributor and address, the type of environment or the geographical areas of the country for which the product is suited, proposed packaging to avoid release of the GMOs during transportation and storage, proper product labelling and risk assessment and management report.
If the request for approval is for the purposes of research and development, it needed addition document which include the recommendations of the relevant institutional Biosafety committee. Other than that, a clear description of the steps to implement the project, the place where and the purpose for which the GMOs or the GMOs product is planned to be developed, used, kept or marketed needed to be stated, it also including detailed instructions for the use and a proposed labelling and packaging. The monitoring and evaluation that will be made at the end of each step and the method of disposing off any waste is also needed together with a clear environmental monitoring plan. At last, a declaration confirming that the information provided is true and correct is needed. For any person or company that intends to export GMOs shall comply with the requirements of the importing country and they shall inform the Board of the requirement.
3.4 Packaging and Labeling
Transgenic crops and genetically modified (GM) foods are now growing to be an important issue around the world. One of the most common concerns related to these GM foods/ foods derived from GMOs, is the labeling of these food products. There are continuous discussion and debates on whether, why and how to label these GM food products.
In USA, labels are use to provide meaningful information and to instruct the consumer. Any further misleading / unnecessary information is believed to make the consumer confused and unable to choose wisely. If GM food products do not differ from their traditional compositions in terms of nutrition or safety, labeling is said to be unnecessary and sometimes misleading. In the European Union, the question is not whether to label these GM food products, but regarding how to label them. The main objectives of labeling are :
to provide sufficient and accurate information related to health and safety
to protect consumers and industry from deceptive packaging and labeling practices
to promote fair competition
Every GM food products will only be labeled after the GMOs being identified for its safety to use/consume by the regulatory authorities. The GMO have to go through risk assessment before it is allowed into the market.
GM food that is not equivalent to the similar existing food and food ingredients require to be labeled. The label must provide information on the properties ie composition, nutritional value and intended use, making it different from the similar existing food and food ingredients. Information on way to storage, preparation or cooking should be presented on the label as well. The threshold level is determined to be more than 3% of the total ingredient content.
Biosafety Act 2007 :Section 61 : All living modified organisms, items containing living modified organisms 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.
Biosafety Act 2007 :Section 69 : the Act sets out that regulations may be prescribed, including for the identification and labeling of living modified organisms, items containing living modified organisms and products of such organisms. No regulations on labeling have been drafted to date.
The Malaysian Ministry of Health has proposed mandatory labeling requirements for GM foods in Regulations enacted under the Food Act 1983. The proposed regulations are intended to provide consumers with proper information via labeling, as to tell whether a package contains GM food or ingredients as well as whether the product is derived from GMOs. In some cases, the label will require information of the origin of the inserted gene.
4.0 Impact of this Act to food industry
In order to comply with Biosafety Act Malaysia, any application for the approval of release or import of live modified organisms or both of them requires risk assessment and risk management report, emergency response plan together with the approval fees. Regarding to this, experienced expertises are employed to write the risk assessment and risk management report on troubleshooting studies and analysis of data recorded on production outputs and inputs. This in turns increases wage payment of a food company to hire these personnel. In additional to this, GMOs are patented which means royalties. This indicates that high cost of royalty payments plus agrichemical is further increases the costs of production of GM food.
Furthermore, the safety of GM food is always a concern of public. To assess the safety level of GM food products, safety tests technology which demands high cost is needed. Detection of GMOs, compositional, nutritional and allergenicity analysis on GM food product are conducted to identify the presence of all possible GMOs and to assess nutritional composition, potential harm from the product. They are conducted in the purpose to provide safety measures and procedures that should be taken during the emergency incident of the food product as well. The employment of researchers to conduct the analysis and the using of safety tests technology will in turns increase financial burdens of food industry. The implementation of various safety tests indicates that expenses of food companies on controlling of GM food safety is higher than those expenses of controlling of safety of non GM food product.
If the food production industry is required to label GM foods, factories will need to segregate two processing streams for GM and non GM food and monitor the production lines accordingly to avoid contamination. These steps will causes additional costs to the industries and these costs will pass along to consumers in the form of higher prices.
4.2 Strengthen Human Expertise
In the process of determining whether a food product is HALAL is not just to ensure that a product is pork free. The HALAL principle truly applied from farm to table. HALAL certification requires the examination of the entire food process, from farming, slaughtering, raw ingredients, cleaning process, processing, until transportation and distribution. GMOs product especially food poses new challenges for HALAL certification. Therefore, expert Muslim scholars are needed by the food industry to ensure the product is HALAL.
Malaysia is a multi-racial country with the population of Muslims, Buddhists and Hindus. As we know, Muslims are not allow to consume pork, alcohol and the meat of animals that have not been slaughtered according to Islamic law. However, Hindus cannot eat beef and a lot of Hindus and Buddhist are vegetarians. Labelling of GMOs products is important to inform the Malaysia consumers of the contents of products and enables them to make better choices based on their religious, ethical or moral beliefs and health concerns. Therefore, it is important to ensure a proper labelling and scholars from different religious are needed to advise the food company.
An environmental monitoring plan is needed if GMOs are use for the purpose of research by food company. The environmental monitoring plan is designed to provide an independent evaluation of the impact GMOs to the environment and the public during their research. The major components of the environmental monitoring program are sample collection, data analysis, and interpretation. Data collected is use to verify compliance with appropriate standards so that it can provide the public with reliable data regarding the environmental impact. Experienced field sampling staff and association with professional laboratories is needed for certified testing practices in order to produce accurate environmental monitoring reports.Â
If a company needed to use GMOs as a part for their research and development, monitoring and evaluation are needed to be made at the end of each step. It requires the project manager and the project team to inspect every step to ensure its alignment with the project scope. An important element is the collection and analysis of data that measure the quality of the raw ingredients, equipments, manufacturing processes and end product. Exponent statisticians are needed to help companies by developing good data collection and analysis techniques during the design, development, and production stages.
In the risk management reports, it must include the troubleshooting studies.Â If a problem is identified in the end of the line of GMOs product production line, a troubleshooting study can be conducted to determine whether changes in certain inputs are associated with the output variables. Statistical regression techniques can detect relationship between raw materials or process attributes and end of the line product outcomes. Results of troubleshooting analyses help in suggesting food company with corrective actions to solve the problems. Experienced exponent statisticians have to be hired by the food company to assist them in evaluating available alternatives to solve the problem.
4.3 Increase Reliability of Testing Method
Industry can get any needed information relating to biosafety from Biosafety Act 2007. Food industry managements are provided with information related to biological or genetic materials and the detection methods. With reliable and legal information sources, related food industries can select the best detection methods for their products. For example, maize related products producers can use the suggested detection method to differentiate between MON810 and MON863 maize. By this, the company can avoid from producing and selling products of the wrong genetically modified event by accurately selecting the needed DNA. Protein-based screening method and DNA-based detection methods are common methodology used for analysis of genetically modified product. However, there are cases in United State demonstrate that protein-based method unable to provide necessary information to distinguish between modified events. Other new developed methods include microassays, mass spectrometry and surface plasmon resonance.
4.4 Requirement of labeling of LMOs products
Some food industries tend to avoid label their products due to several reasons. Any dangers or risks arise from genetically modified products have been eliminated through regulatory schemes, restrictions and prohibitions. Hence, food industries think labeling is unnecessary and it only burdens them. Food industries also claim that they able to conceal information such as trade secret from the public by eliminating the action of labeling. They also worry that labeling could be misinterpret by society as warning label which imply genetically modified foods are less safe or nutritious than their conventional counterparts.
However, food industries are required to label and identify their products clearly if they are from living modified organisms or contained living modified organisms in order to comply with Biosafety Act 2007. Purpose of labelling on product is to protect consumer from food safety problems. Message of health effects such as allergies from products can be delivered to individual with legitimate health concerns. For example, products contained gene from nuts will not be chose by consumers who allergic to nuts. Generally, nutrient contents of genetically modified products are different with normal product. Labelling is needed to inform consumer about the changes and potential health effects from the modified foods. Consumer may be avoid to select milk from GMO-fed cow if they doubt on the safety of the products. Useful information on label is provided to consumer who practices certain lifestyles and religious beliefs that impose strict dietary observances. For examples, a vegan will not choose plant food with animal gene and a Muslim will not choose food contained swine gene as well after reading label on products.
4.5 Establishment of Institutional Biosafety Committee (IBC)
When a food industry carry out modern biotechnology research and development, Institutional Biosafety Committee shall be established in order to ensure research methodologies adopted or applied are comply with the Biosafety Safety Act 2007. Objective of establishing IBC include:
guiding on biosafety policies and issues in the use of LMO research such as safety of laboratory workers
assess and monitor activities in LMOs research
ensure proposed risk assessment, risk management and emergency response plan are sufficient
adopt and implement emergency response plan which cover accidental spills and personnel contamination resulting from LMOs research
review the policy and procedure routinely and modify when necessary
Development of standard operating procedures (SOP) or preparation of biosafety manual describe potential biohazards and precautions to be taken should be carried out before beginning the research involving LMOs. Laboratory workers should be familiar with the procedures and practices. When performing research, principal investigators shall limit access to the laboratory when research in progress. Laboratory worker who handles LMOs materials shall be provided personal protective equipment. More important aspect needed to be considered is LMOs materials are kept secure all the time.
Training of laboratory workers with guidance of NBB should be organized by food industry to ensure they have enough experience in Biosafety and Good Laboratory Practices. Knowledge in managing accidents in facility and reporting accidents should be learned by laboratory workers. Inspection on laboratory and review of biosafety manual is routinely carried out by IBC.
4.6 Increased Consumer Confidence to GM Food Product
Consumer confidenceÂ is anÂ economic indicatorÂ which measures the degree of optimism thatÂ consumersÂ feel about the overall state of the product that they buy. Consumers prefer products not just because it is good in price, but they would rather prefer one which is safe, with quality and lastly will lead to a positive end experience. As we know, there are certain health risks surrounding the consumption of GMOs product which has attracted great concerns from publics. There is a possibility that introducing a gene into a organism may cause an allergic reaction to an individuals and have harmful effects on humans. Proper labelling help to inform consumers that a particular product has such modifications and caries such health risks, if the consumers are strongly concerned about GMO products, they can be sure with what they are eating. Labelling also gives consumers the choice to avoid GMO products if they think these unknown risks that maybe cause by the GMOs product are intolerable.
Consumers always questioned the validity of risk assessments, health and environmental risks, especially focusing on long-term effects. But GMOs products that are currently on the international market have all passed risk assessments conducted by national authorities and are not likely to present risks for human health. The main focus of the authorities is on the assessment of risks of GMOs product to consumer health. The authority also taking into account health and environmental risks, as well as control and trade related issues. Therefore, any GMOs product that approved by the authority can be trusted by the consumer.
A precise traceability mechanism is important to ensure an effective and successful labelling strategy for GMOs products. Traceability helps in identify where GM ingredients are in the food chain. Regulatory and scientific that able to map out GMOs products from fields to tables may increase the public confidence regarding food safety. By providing information about improved traceability methods can help in increasing consumer confidence and trust in GMOs products.
4.7 Increased Safety Level of GM food Product
Genetic modified food safety level can be increased and maintained with the enforcement of Biosafety Act 2007. This Act covers the controlling on the LMOs release activities procedures, importation of LMOs, LMOs for contained use as well as exportation. When country needs to export products of LMOs, the exporters are required to follow the requirements which are set by the importing country. In Malaysia, the applicant have to inform the National Biosafety Board through a notification form and submitted together with the emergency response plan, specific measure for a contained use activity and such other information as specified by the Board.
The increasing safety level of GM food product is due to the inclusion of risk assessment and risk management in Biosafety Act 2007. Food organization that produces GM food must take an initial risk assessment of the LMO material. Risks and adverse effects that GM food accidentally or unintentionally affects other living organisms' health (consumer), environmental and biological diversity are assessed. This is in connection with the efforts of Institutional Biosafety Committee (IBC) which is established by the organization to assess and determine the appropriate level of perceived risk, biosafety contaminant levels of LMO from GM food. With the combination of these, the safety level of GM food is more likely to be identified at first stage.
Along with this, the measurement to avoid, reduce or control the risks and adverse effects that presented in the GM food should be taken as required in this Act. It is required in emergency response plan of the Act that in any event of emergency, safety measure and procedures are required to protect consumer's health and the environment and biological diversity from harm or damage. Related to this, aspects such as nature of the inserted DNA sequences, sources of the inserted DNA sequence, hosts and vectors to be used, agent characteristic, type of manipulation planned and containment conditions to be implemented such as risk assessment and management and emergency response plan for the LMO of the food are examined . IBC is thus responsible to report to National Biosafety Board (NBB) regarding any non-compliance of Biosafety Act Malaysia 2007. The board has the power to review and remark the notification at any time to make sure that there is no danger thing which is harmful to consumer health and environment. Fine or imprisonment or both will be liable for those who found guilty of contravening the notification for export, contained use and import for contained use. Through systematic inspection plans and strict enforcement , GM food safety level is being improved gradually.
4.8 Increase Food Industries Competitiveness
Malaysia is both a major food importer and major supplier for palm oil exportation. There are several impact of Biosafety Act 2007 concerning GMOs which include importation of foods, halal certification, seed for plantation agriculture, and the need to certify exports.
Biotechnology in Malaysia is getting important and the government has decided to make our country a major player in biotechnology and is providing fund to promote biotechnology. GM technology in correlation with Biosafety Act 2007 is one of the strategies being taken to increase industrial competitiveness. Currently, three GM crops are close to commercial release, they are GM rice resistant to virus, GM maize and GM oil palm for faster ripening. GM foods will have higher levels of vitamins, minerals, biological active phytochemicals, and other nutrients. Many allergens will be eliminated. GM foods can be said to have better nutrition compare to those existing similar foods. This phenomenon will enhance positive competition in the food industries.
Biosafety Act 2007 of Malaysia requires labeling for GM foods and foods containing GMOs. Food manufacturers who have successfully comply with this regulation own the priority in attracting the consumers to buy their products comparing to those who fails to label accordingly. Consumer's confidence on GM foods relies in the capability of the food producers to ensure the safety of GM foods via honest labeling and quality control management.
This act comprises of regulations for both the enforcement authorities and also the food producers. The invention of GM foods increases the variety of foods with better nutrition to the community. The food industries in Malaysia are responding positively towards GM products and thus creating various products derived from GMOs and GM crops. Ability to correctly label GM foods or GM derived foods according to Biosafety Act 2007 will be a factor in the increased competitiveness among food industries, as well as the consumer loyalty.
4.9 Increase Biosafety Awareness among Food Producers / Manufacturers
Biosafety refers to the rules and procedures designed to reduce and eliminate the potential risks resulting from the applications of modern biotechnology and its products so that it is safe for human, plant and animal health, and the environment.
Under Biosafety Act 2007, all GMOs and products containing GMOs have to be labeled. The failure to do so will lead to fine and imprisonment to the food manufacturers. With implementation of this act, the safety of consumers will be further enhanced, because all GM foods have to be approved prior to the release into the market. All the food producers involving in production of food containing GMOs have to comply with this act.
Therefore, the biosafety awareness of food producers must be up to certain level to avoid punishments and also to ensure that the GM food products are safe for consumption. This in turn will have the impact of increasing biosafety awareness among food producers which is crucial to run their business accordingly and smoothly.
4.10 Increase the capacity in risk assessment
In food industry, the implementation of Biosafety Act will increase the capacity in risk assessment as a result of the capacity building activities. These capacity building activities are held because it is doubted that the food manufacturers know how to implement it effectively since it is still a new thing. After these capacity building activities, food industry is capable of assessing and managing risks associated with the transboundary movement of LMOs. The increase in capacity in risk assessment is achieved through the strengthening of national biosafety framework with the necessary regulations, enhanced technical capacity and enforcement and monitoring capacities as well as systematic information and coordination network.
In recent years, genetic modified technology has become more important tools to meet the food volume that require by many developing countries especially in Asia where food security problem become uncontrollable. Many countries were finding other alternative to raising their productivity to solve their food security problem, one of the solutions is through planting of genetic modified food.
Nowadays, the Malaysian government is getting alert and well concern about the development of genetic modified organisms and its products. The government is keeping effort to ensure health safety of GM food consumers through establishment of Biosafety Act 2007 .As a result of enforcement of this act on 1 December 2009 any adverse genetic modified products effect occurred on human health and the environment is under control. This act is complies with the other guideline and law which is relevant with this act. Biosafety Act 2007 covered almost all of the activities aspect that relating to living modified organisms (LMO) such as products of such organism release, importation, exportation and the contained use. The establishment of this Act is able to give big impacts to industries especially food manufacturing industries. It is give a clear direction to the industry regulator regarding to the genetic modified organisms or its product regulatory procedure. Under this act, the management of related food industries on their GM food product and documentation of database of GMOs are more efficient and systematic.