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ASIA

Asean

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

ASEAN Guidelines on Risk Assessment of Agriculture-related Genetically Modified Organisms (1999)


Y




Y

Y


Y

Y




Selected Legal Annotations and Comments

The objective of the non-binding Guidelines is to ensure a common framework for a science-based assessment of risks associated with the transboundary movement of agriculture-related GMOs.

Each Member Country is to designate a National Authority on Genetic Modification (NAGM), the main responsibility of which is to review and approve on a case-by-case basis proposals for release of agriculture-related GMOs in the respective Countries (art.4.2 (a)).

The proponent is to notify the NAGM of information necessary for risk assessment and safety prior to the release, as specified in Annex 2. The NAGM is to appoint a panel of scientific experts that is tasked with conducting the risk assessment using criteria based on degree of scrutiny, as defined in Annex 3. The NAGM is to decide on the recommendations issued by the panel within a timeframe (art.6).

A register of approved GMOs is to be kept by the ASEAN Secretariat. The Secretariat will inform the NAGMs of all Member Countries and make the basis for approval available (art.7).

China

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Safety Administration Regulation on Genetic Engineering of 24 December 1993

Y









Y

Y



Selected Legal Annotations and Comments

The Safety Administration Regulation on Genetic Engineering has been published by the State Science and Technology Commission. It is the body responsible in China for genetic engineering safety work. The regulation is aimed at strengthening safety control of genetic engineering work on recombinant DNA technology, while guaranteeing public health and preventing environmental damage (art.1). The regulation establishes a procedure in order to review the preliminary risk assessment performed by the institutions carrying out genetic engineering work. A national safety committee is set up to supervise and coordinate tasks (art.4).

Potential risk levels in genetic engineering are determined through four safety classes. The relevant Ministries formulate technical and environmental standards for each class (art.7).

Risk assessment is to be conducted by the institutions carrying out genetic engineering work. The evaluation targets different components that are indicated for each activity to be performed. For instance, according to article 11 the safety control for the release of GMOs is to be focused on the purpose of the release, ecological conditions of the site, release methods, monitoring means and control measures.

Once the safety of the project has been evaluated and the safety class determined, the proponent institutions are required to apply to relevant administrative departments at different levels for approval (art.13).

Approval is to be issued prior to the beginning of the project once the accuracy of the safety evaluation of the project has been established and no threat to the public health and ecological environment is uncovered by the safety control measures (art.18). The safety control measures are to be formulated and implemented by the institutions carrying out the project in accordance with the safety class (art.19).

A set of rules is established to attribute legal responsibilities to the different institutional levels in cases where the regulations are violated (art.26-29).

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Safety Administration Implementation Regulation on Agricultural Biological Genetic Engineering of 10 July 1996

Y








Y

Y

Y



Selected Legal Annotations and Comments

The Safety Administration Implementation Regulation on Agricultural Biological Engineering has been reviewed and passed at the Conference of the Standing Committee of the Ministry of Agriculture. It is implemented through the Safety Administration Office for Agricultural Biological Genetic Engineering that has been established by the Ministry of Agriculture (art.5).

The regulation covers agriculture organisms the genome constitution of which has been mutated through genetic engineering technologies. Agriculture organisms encompass plants and animals related to agricultural production, plant-related micro-organisms, veterinary micro-organisms, aquatic animals and plants (art.3). As with the 1993 Safety Administration Regulation on Genetic Engineering (see above), this regulation establishes a system of prior approval from administrative departments at different levels for institutions carrying out genetic engineering work.

According to potential risk levels, four safety classes are established and certain procedures are associated with each class in order to guide the safety evaluation and class determination to be carried out by the institutions. In particular, the following steps are required: (1) class determination of recipient organism; (2) determination of the impact of genetic manipulation on safety class; and (3) determination of the safety class of GMOs (art.7).

An application procedure similar to the 1993 Regulation is set out to review the safety evaluation performed by the responsible institutions in accordance with the above mentioned criteria. In particular, the application must include an evaluation of the GMO’s impact on human health as well as an indication of the ecological characteristics of the release site that may cause further propagation of the GMO to other organisms in the environment (art.16.3 and art.16.4).

Likewise, provisions on safety control measures and on legal responsibilities are set out.

According to potential risk levels, four safety classes are established and certain procedures are associated with each class in order to guide the safety evaluation and class determination to be carried out by the institutions. In particular, the following steps are required: (1) class determination of recipient organism; (2) determination of the impact of genetic manipulation on safety class; and (3) determination of the safety class of GMOs (art.7).

An application procedure similar to the 1993 Regulation is set out to review the safety evaluation performed by the responsible institutions in accordance with the above mentioned criteria. In particular, the application must include an evaluation of the GMO’s impact on human health as well as an indication of the ecological characteristics of the release site that may cause further propagation of the GMO to other organisms in the environment (art.16.3 and art.16.4).

Likewise, provisions on safety control measures and on legal responsibilities are set out.

Indonesia

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Ministerial Decree on the Provisions on Biosafety of Genetically Engineered Agricultural Biotechnology Products (1997)

Y




Y

Y



Y

Y



Y

Selected Legal Annotations and Comments

The Indonesian Ministry of Agriculture is responsible for implementing the decree. The decree’s intent is to regulate and supervise the use of “genetically engineered agricultural biotechnology products” (GEABP) (art.2(1)) and “to ensure the safety and health of humans, biosafety and the environment related to the use of GEABPs (art.2(2)). It applies to (1) transgenic animals and fish and materials originating from them, (2) transgenic plants and their parts and (3) transgenic micro-organisms (art.4). The decree applies to the following uses: science, research, breeding, production and distribution including trading (art.9(2)).

The use of GEABP must meet general and category-specific requirements (arts. 10-33) enumerated in the decree. For example, in general, both domestic and foreign GEABPs must “pay attention to and take into consideration” religious, ethical, socio-cultural and aesthetic norms (art.9(1)). How this is actually ensured is unclear. The more specific requirements enumerated relate to information that is to be supplied in an application to the Ministry of Agriculture for use, such as information on the organism’s characteristics and potential threats to the environment. Written applications must be made to the Ministry of Agriculture (art.34). The category of organism determines the agency within the Ministry that reviews the application.

Upon receipt, the application is forwarded to and reviewed by a “biosafety commission” (art.35(1)). The biosafety commission assists the Minister of Agriculture in compiling and determining biosafety policy for the use of a GEABP (art.1(13)). A “biosafety technical team” assists the biosafety commission in evaluating the risks and appropriateness of a particular GEABP’s use (art.1(14)) by undertaking a technical study (art.35(2)) and submitting a subsequent report to the biosafety commission (art.35(3)). On the basis of the report the biosafety commission submits considerations or recommendations to the appropriate ministerial agency (art.35(4)). The responsibilities of the biosafety commission and the biosafety technical team are to be enumerated in a subsequent (and unavailable) decree (art.37). The biosafety technical team’s evaluation report is used “as consideration” by the biosafety commission in its recommendation to the particular competent agency within the Ministry to either approve or deny the application (art.39(1)). The commission’s recommendations are to be used as the basis of the agency’s determination (art.(39(2)). Denials are to be accompanied by a rationale (art.39(3)). There do not appear to be any provisions for public participation, though another law may apply.

The successful applicant has a number of rights and obligations. For example, commercial confidentiality is available to the applicant over the GEABP, but it appears to be limited to situations where the approval has been issued (art.40(1)). Confidentiality is extended to the application by the agency reviewing the application (art.40(2)). No criteria are provided in either case for reviewing claims to confidentiality. GEABPs that are destined for production and/or distribution activities must be labelled (art.41(1)). The label must be fashioned so “a person could know that the commodity concerned is a GEABP” (art.41(1)). The label is to be pasted on the packaging for the GEABP commodity concerned (art.41(2)). “When the GEABP causes biosafety harm”, the person who holds the approval is obligated to participate in the steps to “overcome” the harm (art.42). Finally, the person holding the approval is obliged to submit a periodic report every six months or any time there is an “event of biosafety harm” (art.43). The oversight agency appears to be responsible for monitoring the use (art.44(2)).

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Food Act (1996)


Y

Y


Y

Y


Y

Y

Y


Y

Y

Selected Legal Annotations and Comments

The Food Act addresses GM food in a handful of specific articles. It states that food development is carried out to fulfil the basic needs of mankind which is provided on a “fair and equal basis based on self-determination and not contradictory to the conviction of the community” (art.2). The Act also states that among the objectives regulating, developing and supervising food are ensuring its availability and fulfilling safety, quality and nutritional requirements in the interest of human health (art.3(a)). Any materials used as a food additive and for which the human health impacts are unknown must be first examined for safety (art.11). Use of such material production or process activities may only be carried out after approval from the government and subject to regulations.

The Act makes specific reference to genetic engineering in article 13. Persons who produce food or use foodstuffs, food additives or “other auxiliary material” in the “production activity or process of food” derived from genetic engineering must have the food examined before it is circulated (art.13(1)). The government is to set requirements and principles for research, development and use of the genetic engineering method in the food production activity or process (art.13(2)). It will also lay down requirements to test food derived from the genetic engineering process. These provisions build on the more general provisions for contaminated food. A person is prohibited from circulating (1) food containing materials which are toxic, dangerous or which may harm or endanger human health or life, and (2) food containing materials prohibited from use in food production or processes (arts.21(a) and ©).

Pre-packaged food to be traded, either produced within Indonesia or imported, must have a label (art.30(1)). Among other things, the label shall contain information on “halal” (allowable for Muslim consumption; relatedly but not required for listing is “haram” (forbidden)) (art.30(2)(e)). The government may determine other information to be included in or withheld from the label (art.30(3)). Persons are prohibited from providing untrue or misleading information through the label (art.33). A person making a claim about a food’s acceptability to the requirements of a religion or belief through a label or advertisement is responsible for the correctness of the statement based on the religion or belief (art.34(1)).

Food imports are prohibited where the food does not fulfil the requirements of the Act (art.36). The government may require that the imported food (1) has been examined and approved in the country of origin for safety by an authorized agency, (2) is supported by documents evidencing test results and (3) be tested in Indonesia determine safety, quality or nutrition before circulation (art.37). Food importers are responsible for the safety, quality or nutrition of the food (art.38). The government may require food exports to be tested before circulation for safety, quality, label requirements or nutrition content (art.39).

Liability attaches to a business venture or the individual within the business (art.41(1)). Any natural person whose health is harmed as a direct consequence of consuming processed food is entitled to file a claim of indemnity against the responsible business venture or individual (art.41(2)).

The Act provides the “community” with the opportunity to participate in realizing the protection of any natural person consuming food (art.51). The community may submit “problems, inputs and/or the solution for matters in the field of food” in the framework of improving and upgrading the food system (art.52). It is unclear how participation is to be realized. The extent to which this means the public can participate in regulatory decision-making is also unclear. No criteria are provided on the extent to which governmental decision-makers must consider the comments and other inputs that are provided.

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Consumer Protection Act (1999)



Y



Y



Y





Selected Legal Annotations and Comments

The Consumer Protection Act does not make specific reference to genetically engineered products. It does, however, demonstrate some consumer protection principles that could be extended to genetically engineered products. The Act applies to all “goods” (anything that can be moved, used up or otherwise) and which can be traded, applied or used by consumers (art.1(4)). Consumer protection is based on the principles of consumer benefit, justice, balance, security and safety and legal certainty (art.2). Consumer protection is to be inter alia premised on a consumer protection system built additionally upon legal certainty, information transparency and access to information (art.3(4)). Consumers have enumerated rights including inter alia the (1) right to comfort, security and safety in using goods and services and the (2) right to correct, clear and honest information about the condition and guarantee of goods and services (art.4©). Business agents have enumerated obligations including inter alia (1) providing correct, clear and honest information about the condition and guarantee of goods and services and providing information about uses, as well as (2) guaranteeing the quality of goods or services provided. In addition, business agents are prohibited from producing or trading in goods and services which inter alia: (1) do not fulfil or conform to the standard required; (2) do not conform to the promise stated in a label or description; (3) do not comply with production requirements as permitted by “halal”; and (4) do not have a specified label (art.8(1)(a), (f), (h) and (i)). Liability attaches to business agents for losses and other damages suffered (art.19(1)). Every disadvantaged consumer may sue a business agent through an assigned dispute settlement agency (set up by the government - art.49) or through a judicial process (art.45). A national agency of consumer protection is established. Its regulatory powers are unclear (art.31). Finally, the government shall recognize non-governmental institutions for consumer protection, which fulfil enumerated criteria (art.44).

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Food Labels and Advertising (Reg. 69/1999)














Selected Legal Annotations and Comments

This regulation has provisions related to labelling of products derived from biotechnology. Primary source materials were unavailable for analysis.

Philippines

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Executive Order Constituting the National Committee on Biosafety (No. 430) (1990)












Y


Selected Legal Annotations and Comments

Executive Order 430 creates a national committee on biosafety (NCBP) that is attached to the Department of Science and Technology (sect.1). The NCBP has a multidisciplinary membership including various scientists, a social scientist, citizens and representatives from various governmental agencies (sect.2). The functions of the NCBP include inter alia (1) identifying and evaluating potential hazards related to initiating genetic engineering experiments, the introduction of new species and GMOs and recommending risk minimization measures; (2) formulating and reviewing national biosafety policies and guidelines; (3) formulating and reviewing national policies and guidelines on risk assessment; (4) publishing the results of internal deliberations; holding public deliberations on proposed national policies, guidelines and other biosafety issues; and (5) assisting in the formulation of laws (sect.4). The Department of Science and Technology provides the NCBP’s secretariat (sect.4).

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Philippine Biosafety Guidelines (1991)

Y




Y


Y


Y

Y


Y


Selected Legal Annotations and Comments

The National Committee on Biosafety (NCBP) formulated the Guidelines. The Guidelines reflect various national policies on biosafety. The Guidelines apply to all public and private, national or international research, production and manufacturing institutions engaged in genetic engineering. The Guidelines also cover the importation or introduction and/or breeding of plant pests and potentially harmful micro-organisms. The NCBP must review and approve any work covered by the Guidelines. Institutions and involved scientists have the primary responsibility to enforce biosafety rules and regulations and this is accomplished through institutional biosafety committees and biosafety officers. The NCBP has the power to impose sanctions on erring personal and institutions. Monitoring is the institution’s responsibility. Pest monitoring is the Government quarantine service’s responsibility.

All institutions engaged in genetic engineering are to create institutional biosafety committees (IBCs) (sect.B). IBCs have the responsibility to evaluate and monitor the biosafety aspects of their institution’s biological research. IBC need to have the collective expertise to supervise and assess planned field releases. The Guidelines outline additional expertise to be represented on IBCs (sect. B, para 1.1). IBCs may have consultants on call that are knowledgeable in a variety of issues, including standards of professional conduct and practice and community attitudes (sect. B, para 1.2). Among its functions an IBC is to review work conducted or sponsored by the institution and recommend research proposals (sect. B, para. 2.1). Reviews are to include holding discussions on the comparative ecological, economic and social impacts of alternative approaches to attain the purposes of the genetic engineering product or services (sect. B., para. 2.1.3). An IBC should also formulate and adopt emergency plans and notify the NCBP about significant problems (sect. B, paras. 2.4 and 2.5).

Procedurally, IBCs review proposals made by the principal investigator (sect. C, paras. 1.1 and 1.3). The IBC assesses the project and sends the proposal and its evaluation to the NCBP for its assessment (sect. C, para. 1.3). A guiding principle for approval is provided: “Genetic manipulation of organisms should be allowed only if the ultimate objective is for the welfare of humanity and the natural environment and only if it has been clearly demonstrated that there is no existing or foreseeable alternative approaches to servicing the welfare of humanity and the natural environment. The use of domestic animals in tests involving products of genetic engineering is subject to approval of IBC and NCBP” (sect. C, para 1.4). Commercially sensitive information may be indicated as such for the IBC/NCBP and members of both bodies are to sign “deeds of confidentiality” (sect. C. para. 1.8).

The NCBP conducts a biosafety assessment on the proposal (sect. C, para. 2.1). The risk assessment is to be based on the characteristics of the biological product and on the process by which it was obtained. A working group is formed to assess the proposal based on Procedures for Evaluation (included in the Guidelines as sect. 3; these vary depending on the organism) and submits recommendations to the NCBP (sect. C, para. 2.2). The assessment is sent to the IBC and any appropriate regulatory agencies (sect. C, para. 2.3). No member of the NCBP shall vote when deliberations involve projects in which he or she has an interest (sect. A para. 1.4).

Procedures are also provided for introductions, movement and field releases of regulated materials covered by the Guidelines. Import permits are required from relevant regulatory agencies. The import application must respond to all information enumerated in the Guidelines. Applications for importation of organisms modified by DNA techniques are to be referred to the NCBP by the regulatory agency involved. The Philippines Department of Agriculture recently issued an Administrative Order (No. 08, Series of 2002) on importation and release of plants and plant product derived from the use of modern biotechnology. A specific approval process of products for direct use as food or feed is established.

Confidential information in the application can be so indicated. NCBP reviews the application and if approved issues appropriate conditions. The denied permits may be appealed. The introduction and movement of GMOs within the Philippines must comply with packaging and container requirements. After movement from quarantine to research facility, no further movement may be made without authorization. Release into the environment requires a permit. An IBC endorsed application and release procedure is submitted to the NCBP for review. The application addresses all information enumerated in the Guidelines. Where other permits are required they are to be co-ordinated with the NCBP. A public notice and comment period is also required before the NCBP authorizes any field test proposal. A Public Information Sheet (PIS) is to be maiden available to the public and a time framework is set out for comments and response.

Periodic reports are required if the permit is granted. The government’s quarantine services monitor the progress of the work and report any significant outcome to the IBC for remedial action.

The Guidelines do not appear to apply to commercial releases.

Thailand

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Biosafety Guidelines in Genetic Engineering and Biotechnology (1992, revised in English 1996)

Y






Y

Y

Y

Y



Y

Selected Legal Annotations and Comments

Thailand does not have in place comprehensive laws to address biosafety. Other laws apply in part but a set of guidelines is the primary instrument applicable. The guidelines consist of two parts. One part comprises the Guidelines in Genetic Engineering and Biotechnology for Laboratory Work for “viroids, viruses, cells or organisms, carrying novel genetic material which are either improbable to arise naturally or are potentially detrimental towards public safety and environmental health”. The second part, described here, comprises the Guidelines in Genetic Engineering and Biotechnology for Field Work and Planned Release for plants and micro-organisms. Both parts have common structure and content. For example, work related to GMOs is classified according to level of risk and safety. Three categories exist: (1) work bearing no risk; (2) work bearing low risk; and (3) work with high risk. Risk management and control is proportional to the organism/risk category at issue. Institutional arrangements in monitoring and control are also similar. For example, three groups of personnel and organizations are involved: (1) principal investigators and researchers; (2) institutional biosafety committees (IBC) and (3) the National Biosafety Committee (NBC). The Guidelines are considered “soft law based on voluntary action”. However, the Plant Quarantine Act prohibits GMO imports without a permit from the Department of Agriculture and when imports are allowed this can only be for experimental purposes.

According to the Guidelines, the fieldwork and release guidelines are meant to complement the guidelines on laboratory work because a natural extension of laboratory work is field-testing. Field-testing is meant to (1) confirm laboratory observations; (2) gather information on, for example, stability and gene expression under field conditions; (3) assess viability and (4) assess adaptive or evolutionary potential. In general, only GM plants that do not have a history of safe fieldwork require a preliminary risk assessment to determine the full range of possible environmental effects (sect. 2.1.3). Similar requirements apply to micro-organisms (sect. 2.2.3).

In terms of institutional review, distinctions are made based on a history of prior fieldwork. For example, an institutional biosafety committee must evaluate the sufficiency of biosafety provisions where experimental plants and micro-organisms have a history of prior fieldwork (sects. 3.1.1 and 3.2.1). Work can begin only upon IBC endorsement. The IBC must also forward the proposal to the NBC for information. Where a plant or micro-organism has no history of prior fieldwork, the work must proceed “under the advice, counsel and direction of the IBC and the NBC. Committee recommendations are to be grounded on biosafety concerns. Consent must be directly granted by the NBC (sects. 3.1.2 and 3.2.2).

In January 1993, a national biosafety committee (NBC) was established under the National Centre for Genetic Engineering and Biotechnology (BIOTEC). BIOTEC was originally established in 1983 under the Ministry for Science, Technology and Energy and then was moved under the National Science and Technology Development Agency as an autonomous centre. The NBC has general responsibilities to inter alia (1) ensure that genetic manipulation work adheres to the Guidelines; (2) review and direct research methodologies; (3) recommend appropriate experimental conditions; and co-ordinate public information and education on biosafety issues and on proposed national policies (sect. 4.1.1). In the context of field research, the NBC inter alia (1) provides advice to Institutional Biosafety Committees; (2) suggests practical alternatives to high risk field procedures; and (3) protects and restricts access to commercially significant information (sect. 4.1.2). The NBC has direct responsibility for evaluating and endorsing enumerated proposals (sect. 4.1.3).

IBCs must be established by all institutions, whether public or private, engaged, or with the intent to engage, in the purchase, construction, propagation or field release of GMOs or components (sect. 4.2). Smaller institutions with less capacity to establish their own IBC may request work with non-affiliated IBCs, upon notification of the NBC. In general, an IBC must be formally endorsed by the NBC (sect. 4.2.1) and is to be composed of no less than five members (e.g. with backgrounds in evaluation, ecology, engineering and biosafety (officer)). The IBC should also consider establishing relationships with people knowledgeable inter alia with ethics and community attitudes (sect. 4.2.2). In general with regard to field research, the IBC is to inter alia (1) assess all projects referred to it; (2) undertake risk assessment in co-operation with the research teams as necessary; and (3) suggest practical alternatives to any high-risk laboratory procedures (sect. 4.2.4).

The guidelines also address movement of regulated materials within or between institutions (sect. 5.1). Exports of regulated materials are to be in compliance with international postal requirements and other national requirements (sect. 5.3). Finally, the guidelines apply sanctions even though they are to be voluntary (sect. 6). For example, scientists and institutions failing to enforce the provisions or intent of the Guidelines may be penalized through, for example, the withdrawal of government research grants and incentives. Scientist may be held accountable for all consequences resulting from failure or negligence in complying with the national biosafety guidelines.

Apparently, Thailand does not have food safety laws in place for genetically modified foods, though the government has committed to labelling by the end of 2001 (Greenpeace, 2001).

Instrument

Application

Biotech Product Movement

Oversight Mechanisms

Environment and Human Health?

Food Safety?

Consumer Protection?

Traceability?

Labelling?

Commerce/ Marketing?

Transport?

Export?

Import?

Safety Assessment?

Cross-sectoral Coordination/ Advice?

Stakeholder Participation and other information-related considerations?

Other Considerations (e.g. socio-economics or ethics)?

Plant Variety Protection Act (1999)

Y









Y




Selected Legal Annotations and Comments

New plant varieties under the Act cannot be registered when they have severe adverse impacts, directly or indirectly, on the environment, health or public wealth (sect. 13). New plant varieties derived from genetic modification may be registered only upon “a successful result of a safety appraisal” on environment, health or public welfare conducted by the Department of Agriculture or another agency designated by the Plant Variety Protection Commission in accordance with a ministerial regulation.


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