Categories
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GMAC
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Subcommitee for Labelling of GMOs
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Subcommittee for Public Awareness
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Subcommittee for Release of Agriculture-related
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General Position Regarding GM Microorganisms
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GMAC Assessment On Local Field Trials
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Release Applications
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Subcommittee for Research on GMOs
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Research Proposals
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Safety Review Required For Start-Up Companies That Works With Cell-Based Companies As Well As Companies Utilising GM Microbial Fermentation To Produce Food Products
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GMAC
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What is Singapore’s position on labelling of GM food?
You can find Singapore’s current position on labelling of GM food at the following page: Labelling on Genetically Modified Food, Singapore Food Agency
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How do I stay updated on the public events that GMAC is organising?
Information regarding any public events will be put up on GMAC website and also on GMAC Students Challenge Facebook page. Members of the public who are interested in our events and activities are encouraged to visit these sites regularly, to check for updates.
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What other efforts has the Subcommittee made to reach out to the public?
Other than events, the Subcommittee also produces collaterals for public distribution. The Subcommittee had formulated, published and distributed an educational brochure [Important Facts You Need to Know about GM Food] in all 4 languages commonly used in Singapore – English, Mandarin, Tamil, and Malay. This is in order to help members of public understand the complex technology in simpler terms. Other forms of outreach include publications of articles in local newspapers and magazines.
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What sort of activities does the Subcommittee organise?
Some of the past events that the GMAC Subcommittee on Public Awareness had organized include talks, seminars and public forums on issues relating to gene technology. These were sometimes organised in collaboration with other local and overseas organizations.
The Subcommittee also reaches out to the Singapore student population through the annual GMAC Students Challenge where students from secondary schools in Singapore pit against each other with their creative efforts in depicting topics relating to GM technology
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What does the GMAC Subcommittee on Public Awareness do?
The GMAC Subcommittee on Public Awareness is tasked with the responsibility to disseminate information that is objective, factual and scientific, so that members of the public can make educated, rational decisions on GM technology and its products.
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What is the safety review required for start-up companies doing research using genetically modified microbes in fermentation as a processing aid to produce food products?
The safety review should cover the potential safety, health and environmental risks and also include measures to prevent worker ill health, accidental release of GM microorganisms and chemicals, etc.
The companies are advised to look through GMAC’s research guidelines, and to submit the proposal form for research involving GM microbes. The GMAC subcommittee for Research will then review the proposal to ensure that the prescribed safety guidelines are adhered. More details can be found here.
For applications on the release of GM microorganisms, kindly submit a dossier including the section on Appendix 1 Questionnaire for Risk Assessment of Genetically Modified Organisms (GMOs) Related to Agriculture of the Singapore Guidelines on the Release of Agriculture-Related GMOs. The Guidelines can be found here. (The guidelines are currently undergoing revision.)
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What is the safety review required for start-up companies doing research on cell-based food products (using genetically modified cells), and/or in the future preparing to sell these products in Singapore?
GMAC has published two sets of guidelines that cover different phases of GM product development: The research guideline covers Singapore based GM research and development while the release guideline covers commercial release of GMOs and GMO-related products. For a Singapore based GM product, it should be documented from the R&D stage. Both sets of guidelines can be found on GMAC’s website.
Application to the GMAC subcommittee for Research is required for the initial stages when the companies are involved in manipulation of GM cells to prepare cell-based food products. The companies are advised to look through GMAC’s research guidelines, and to submit the proposal form for research involving GM cells. The GMAC subcommittee for Research will then review the proposal to ensure that the prescribed safety guidelines are adhered.
For companies which intend to commercially release the cell-based food products, the regulatory agency Singapore Food Agency (SFA) should be the first point of contact. SFA will then contact GMAC if advice or safety review is required by GMAC’s Subcommittee for Release of GMOs and products derived from GMOs. The companies are advised to look through GMAC’s release guidelines. Food traders may also refer to SFA’s requirements related to food additives and novel foods on SFA’s website.
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What should be the rightful composition of an IBC?
For details about IBC composition, you may to refer to Section 5.2 of the Singapore Biosafety Guidelines for Research on GMOs here. You may also wish to visit the webpage of the MOH Biosafety Branch for detailed information regarding the composition of the IBC here.
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What should I do if there is no IBC in my institution/organization?
It is recommended that you set up your own IBC as the main biosafety committee overseeing biosafety issues at your premises. During the period of establishing your own IBC, it may be appropriate for your organization to consult an existing IBC in another Singapore-based outside your premises. But we would like to highlight that this is not to be considered as a permanent arrangement. The presence of an IBC is crucial to the implementation and day-to-day enforcement of the Singapore Biosafety Guidelines for Research on GMOs and other biosafety regulations and guidelines.
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To whom should I submit the proposal form?
The proposal form should be submitted to your IBC for its review and approval prior to submitting it to GMAC for review.
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How should I classify my project if the GM work to be undertaken potentially falls within two categories?
In this case, we will recommend that the applicant submit his/her research proposal under the higher classification of the two. When the review panel sees it appropriate, the classification may be maintained or downgraded accordingly. The applicant and the IBC will be informed about this in the endorsement to be returned after GMAC’s completion of assessment.
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I have a problem classifying my project. What should I do?
You may wish to consult your IBC and/or the GMAC Secretariat for further clarifications on the rightful classification of your project.
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How can I be sure that the information will stay confidential?
All members of the GMAC Subcommittee for Research on GMOs are required to sign a confidentiality agreement before undertaking their duties as member of the review panel.
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Who assesses these forms?
Review panels comprising members of the Subcommittee on Research for GMOs will assess the forms.
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What kind of information is required for the scientific assessment of these proposal forms?
Information required for GMAC’s scientific assessment includes details pertaining to the gene modification process such as the identity of the transgene(s), host/vector systems to be used etc. For more details, you may refer to the proposal form available for download here.
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What purpose does the review of research proposals by GMAC serve?
The GMAC subcommittee reviews the proposals involving GMO work from all the research establishments based in Singapore to ensure that the prescribed safety guidelines are adhered to while planning (and future execution of) the research projects. The Institutional Biosafety Committees (IBC) also are required to ensure safety within their respective Institutions.
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What kind of applications does it review and endorse?
The GMAC Subcommittee on Research for GMOs reviews and provides endorsements for research proposals within Singapore involving genetic manipulative work or GMOs, and to provide expert advice for the risk assessment of these.
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What is the “Singapore Biosafety Guidelines for Research on GMOs”?
The Singapore Biosafety Guidelines for Research on GMOs was drawn up with the objective of ensuring the safe containment, handling and transport of GMOs used in research in Singapore. It is the first and only set of biosafety standards designed specifically for laboratory/facilities involved in GM work.
This set of Guidelines was drawn up in consultation with the local regulatory agencies and other stakeholders, in addition to references made to other relevant international guidelines, regulations and publications including those from Australia, the United States and the World Health Organization (WHO).
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What does the GMAC Subcommittee on Research do?
The terms of reference for the GMAC Subcommittee on Research are to:
– Establish issues concerning the biosafety of research involving genetic modification or genetically modified organisms (GMOs) for the creation of an enabling environment for biotechnology R&D;
– Deliberate on the policy, scientific and economic aspects of biosafety safeguards covering GMOs for research purposes;
– Formulate recommendations regarding the Singapore Biosafety Guidelines for Research on GMOs. These will include recommendations for the establishment and review of guidelines for physical and biological containment for GMOs in R&D activities; and
– Evaluate submitted research proposals involving genetic manipulative work or GMOs and to provide expert advice for the risk assessment of these. -
If GMAC’s outcome of the environmental risk assessment is that the local farming of the gene-edited crop has an impact on Singapore’s environment, what will be GMAC’s recommendations?
When an issue of concern is identified by GMAC, this will be communicated to the applicant, who then has to come up with solutions to mitigate the concerns. The onus is on the company to propose the solutions to mitigate the concerns. (Similar to GM crop applications, GMAC will then provide endorsement when members are satisfied with the applicant’s responses to their concerns.)
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Will GMAC not support the local farming of the gene-edited crop if it has an impact on Singapore’s environment?
An environmental risk assessment needs to be conducted for gene edited crop with potential impact on environment.
Evaluation of environmental impact will take multiple factors into consideration such as its potential to outcompete plants in nature, possible gene flow to compatible weeds and potential harm to other animals. NParks will also participate in environmental impact evaluation of GM plants, if necessary. GMAC will work with them to make a joint recommendation/decision.
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What is the safety review required for companies that want to conduct local field trials on food crops developed using gene editing?
The safety review to be conducted by these companies should include the potential safety, health and environmental risks and measures.
The Subcommittee for Release of GMOs and GMO-Related Products will perform environmental risk assessment if companies want to use food crops developed using gene editing for local field trials.
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What is the safety review required for start-up companies doing research using genetically modified microbes in fermentation as a processing aid to produce food products?
The safety review should cover the potential safety, health and environmental risks and also include measures to prevent worker ill health, accidental release of GM microorganisms and chemicals, etc.
The companies are advised to look through GMAC’s research guidelines, and to submit the proposal form for research involving GM microbes. The GMAC subcommittee for Research will then review the proposal to ensure that the prescribed safety guidelines are adhered. More details can be found here.
For applications on the release of GM microorganisms, kindly submit a dossier including the section on Appendix 1 Questionnaire for Risk Assessment of Genetically Modified Organisms (GMOs) Related to Agriculture of the Singapore Guidelines on the Release of Agriculture-Related GMOs. The Guidelines can be found here. (The guidelines are currently undergoing revision.)
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What is the safety review required for start-up companies doing research on cell-based food products (using genetically modified cells), and/or in the future preparing to sell these products in Singapore?
GMAC has published two sets of guidelines that cover different phases of GM product development: The research guideline covers Singapore based GM research and development while the release guideline covers commercial release of GMOs and GMO-related products. For a Singapore based GM product, it should be documented from the R&D stage. Both sets of guidelines can be found on GMAC’s website.
Application to the GMAC subcommittee for Research is required for the initial stages when the companies are involved in manipulation of GM cells to prepare cell-based food products. The companies are advised to look through GMAC’s research guidelines, and to submit the proposal form for research involving GM cells. The GMAC subcommittee for Research will then review the proposal to ensure that the prescribed safety guidelines are adhered.
For companies which intend to commercially release the cell-based food products, the regulatory agency Singapore Food Agency (SFA) should be the first point of contact. SFA will then contact GMAC if advice or safety review is required by GMAC’s Subcommittee for Release of GMOs and products derived from GMOs. The companies are advised to look through GMAC’s release guidelines. Food traders may also refer to SFA’s requirements related to food additives and novel foods on SFA’s website.
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What is GMAC’s position on the local use of GM microorganisms that are used as production organisms in the production of food substances (such as enzymes, food proteins etc.), but are not part of the final food product themselves?
GM microorganisms and chemicals used in the production of food substances may affect the health and safety of workers involved in the production process and environmental contamination if not properly handled. These potential safety, health, and environmental risks (i.e. accidental release of the GM microorganism, prevention of workers’ exposure to GM microorganisms) should be identified and adequately mitigated.
If the GM microorganism does not get into/remain in the finished food product, but is only used during the manufacture of the food item as a ‘processing aid’, the food itself will not be subject to GMAC review. However, the food product may need to be reviewed by other government bodies such as SFA under other regulations. Food traders may refer to SFA’s requirements related to food additives and novel foods on SFA’s website.
For applications on the release of GM microorganisms, kindly submit a dossier including the section on Appendix 1 Questionnaire for Risk Assessment of Genetically Modified Organisms (GMOs) Related to Agriculture of the Singapore Guidelines on the Release of Agriculture-Related GMOs. The Guidelines can be found here. (The guidelines are currently undergoing revision.)
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How many rounds of clarifications will the review panel take in the entire assessment process?
The number of rounds of clarifications required differs from case to case. On average, the number of clarifications required for individual assessment ranges from one to three.
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How long will the review process take?
The time taken to evaluate each application differs from case to case. This is mainly due to the varying number of rounds of clarifications required by the Subcommittee regarding each individual application.
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What kind of information is required for the scientific assessment of the applications meant for release in Singapore?
For applications on the release of GMO-related health product, kindly submit a dossier following the EU guidelines for Environmental Risk Assessment to the GMAC for review. The checklist of items required for Environmental Risk assesment can be found here. For applications on the release of agriculture-related GMOs, kindly refer to Appendix 1 Questionnaire for Risk Assessment of Genetically Modified Organisms (GMOs) Related to Agriculture of the Singapore Guidelines on the Release of Agriculture-Related GMOs. The Guidelines can be found here.
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What kind of applications does it review and endorse?
The Release Subcommittee scientifically reviews applications involving the intentional release of GMOs into the environment for purpose of planting, commercial sale or clinical trials and provides its findings to relevant authorities for their considerations for the (GMO) final approval.
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What does the GMAC Subcommittee on Release do?
The GMAC Release Subcommittee has been tasked specifically to: To draft revisions of the Singapore Guidelines on the Release of Agriculture-Related GMOs, when necessary, for GMAC’s approval;
– To designate the various agencies (ie. SFA, NEA, MOH, NParks) to implement the Guidelines using
their existing legislation;
– To assess the risks associated with the release of GMOs and GMO-related products or recommend to GMAC
to appoint an expert panel if necessary;
– To make recommendations to GMAC on the approval for release of GMOs and GMO-related products; -
Who does GMAC partner with, in its work?
GMAC works very closely with regulatory agencies such as the Singapore Food Agency, the Ministry of Health, the National Environment Agency and the Ministry of Manpower.
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What is the role of GMAC?
The objective of GMAC is to ensure public safety while maintaining an environment that is conducive for commercial exploitations of GMOs and GMO-derived products. Specifically, it falls within the responsibilities of GMAC to: Advise and recommend for approval, or otherwise, the research and development, production, use and handling of GMOs;
– Advise and recommend for approval, or otherwise, the research and development, production, use
and handling of GMOs;
– Review, monitor and advise on matters related to the release of GMOs into the environment;
– Inform the public, where deemed necessary, on planned releases of GMOs;
– Establish mechanisms for exchange of information with overseas agencies and to facilitate the harmonization of guidelines with regional and international authorities; and
– Facilitate public education and create awareness on GM issues. -
When was GMAC established?
GMAC was established in April 1999 under the purview of the Ministry of Trade and Industry, Singapore
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What is GMAC?
GMAC is a non-regulatory multi-agency advisory body established by MTI (with an independent website) that has been tasked to monitor and to provide scientifically-sound advice on the research and development, production, release, use and handling of genetically modified organisms (GMOs) in Singapore.