1.1

These Guidelines are established to ensure the safe movement and use in Singapore of agriculture-related GMOs.

1.2

These Guidelines provide a common framework for:
(a) assessment of risks of agriculture-related GMOs to human health and the environment; and

(b) approval mechanisms for their release in Singapore.

1.3

These Guidelines address issues related to food safety based on the concept of substantial equivalence.

SCOPE OF GUIDELINES

Covers release of agriculture-related organisms with genetic material that has been altered in a way that is unlikely to occur naturally by mating or natural recombination.

3.1

For purposes of these Guidelines, the following terms shall be defined as follows:

•	"Agriculture-related organisms" refers to animals (including fish and invertebrates), plants, microorganisms and vaccines used in cultivation, farming, agronomy, husbandry and horticulture or as food.
•	"GMAC" refers to the Genetic Modification Advisory Committee of Singapore.
•	"Proponent" refers to any person, firm, company, institution or organisation planning to release agriculture-related GMOs into Singapore.
•	"Release" means the deliberate introduction of agriculture-related GMOs into the open environment for field trials or commercial use in Singapore
•	"Risk" is defined as the magnitude and likelihood of adverse effect.
•	"Substantial equivalence" embodies the concept that if a new food or food component is found to be substantially equivalent to an existing food or food component, it can be treated in the same manner with respect to safety (i.e. the food or food component can be concluded to be as safe as the conventional food or food component).

4.1

The Committee shall consist of representatives from national agencies:

•	Agency for Science, Technology & Research (A*STAR)
•	Agri-Food and Veterinary Authority of Singapore (AVA)
•	Attorney General’s Chambers (AG Chambers)
•	Consumers Association of Singapore (CASE)
•	Institute of Molecular and Cell Biology (IMCB)
•	Ministry of Health (MOH)
•	Nanyang Technological University (NTU)
•	National Institute of Education (NIE)
•	National Parks Board (NParks)
•	National University of Singapore (NUS)

4.2

The Terms of Reference of GMAC are as follows:

•	To advise and recommend for approval, or otherwise, the research and development, production, use and handling of GMOs
•	To monitor the control of release of GMOs into the environment
•	To review proposals related to the release of GMOs into the environment. GMAC may establish sub-committees of experts in specific areas to assess the risks involved
•	To provide advice on matters related to the release of GMOs
•	To inform the public, where deemed necessary, on planned release of GMOs
•	To establish mechanisms for exchange of information with overseas agencies and to facilitate the harmonisation of guidelines with regional and international authorities
•	To develop and approve biosafety guidelines for the research and development, production, use and handling of GMOs
•	To create public awareness on GMO and GMO-related issues

5.1

All agriculture-related GMOs brought into Singapore by the Proponent for release should comply with existing national and international regulations.

A.

Before the release of any agriculture-related GMOs in Singapore, the Proponent is required to submit a proposal to the GMAC. The Proponent should consult GMAC to determine the appropriate approval process for the agriculture-related GMOs and the specific information necessary for an assessment.

B.

The correspondence address of the GMAC Secretariat is as follows:

5.4

The proposal should consist of information specified in Section 8.

6.1

The GMAC will forward the proposal to the Sub-Committee. The Sub-Committee may either endorse/reject the proposal or appoint the relevant agency or an expert panel to evaluate the proposal within 90 days. The panel of experts will review and assess the risks associated with each stage of the release using the questionnaire and risk assessment criteria as attached as Appendix 1 and Appendix 2. The agency/expert panel will submit their recommendations to the Sub-Committee within 90 days.

6.2

No Proponent or any agent representing the Proponent may review his own proposal.

6.3

The GMAC will decide on the recommendations of the Sub-Committee within 60 days. The GMAC can request further information/clarification from the Proponent should the need arise.

6.4

The GMAC will decide on the release on a case-by-case basis. The GMAC will either:

i)	endorse the release of the agriculture-related GMOs,
ii)	endorse the release of the agriculture-related GMOs under specified conditions,
iii)	require the Proponent to submit additional information which the GMAC deems necessary to complete the assessment, followed by decision (i) or (ii).

7.1

A register of approved agriculture-related GMOs in Singapore will be set up and updated by the GMAC Secretariat. Once the GMOs under consideration have been granted approval for release, the GMOs shall be registered with the GMAC Secretariat.

7.2

The evaluation, approval and registration in Singapore is summarised in the Flow Chart as appended in Appendix 3.

8.1

The Proposal should include, on the cover page, the title of the project, the address of the institution/organisation/registered company, name and telephone number of a contact person.

8.2

The Proponent is required to disclose the necessary information for risk assessment and safety as specified in Appendix 1. All Core Questions under Section A of Appendix 1 must be answered in detail, with relevant supporting documents included (e.g. data of field trials or laboratory tests). In addition, information on the specific agriculture-related GMOs should be given based on the classification of the GMO under Sections B-K.

8.3

The broad classifications of information that are required include:

Section A : Core Questions

•	Species of organisms
•	Eventual use of GMO
•	Location for release
•	Habitat and ecology
•	Genetics of the GMO
•	Data from contained work and other studies
•	Experimental procedures, monitoring and contingency planning
•	Other assessments

Section B: Plants

Section C: Microorganisms living in or on animals

Section D: Microorganisms as vaccines

Section E: Microorganisms not falling into Sections C or D

Section F: Animals (vertebrates, not including fish)

Section G: Fish and aquatic organisms such as crustaceans

Section H: Invertebrates

Section I: Organisms for biological control

Section J: Organisms for bioremediation

Section K: Organisms to be consumed as food

8.4

The Risk Assessment Criteria is appended in Appendix 2.

9.1

The Proponent shall inform the GMAC of any information in their proposal which the Proponent wishes to keep confidential. The GMAC shall take steps to preserve the confidentiality of such information.

9.2

It is the responsibility of the Proponent to obtain the necessary patents for the Proponent's agriculture-related GMOs for the protection of the Proponent's intellectual property.

10.1

The Proponent is responsible for ensuring that GMAC's requirements are complied with in the release of agriculture-related GMOs. The Proponent shall appoint/designate a qualified project supervisor familiar with the requirements and ensure that all persons or agents involved in the release are made aware of and directed to comply with the requirements and recommendations made by the GMAC.

10.2

The Proponent is required to disclose all relevant information to the GMAC, including all previous approvals or refusals for release in other countries.

10.3

The Proponent shall proceed with the release only when the proponent has received official approval from the GMAC.

10.4

The Proponent shall continually collect information and perform post-release monitoring relating to the agriculture-related GMOs and their application(s). The Proponent shall report to the GMAC immediately if new information regarding risks to environment or human health is found. The GMAC reserves the right to recall any agriculture-related GMOs approved for release in its respective country based on its assessment of new information.

10.5

Upon completion of the field trials or the commercial release of the GMO, the proponent is required to submit a report.

11.1

Due to the rapid changes in technology and the range of agriculture-related GMOs being developed, these Guidelines shall be periodically reviewed and updated as deemed necessary