I S A A A

National Workshop on

Biotechnology After the World Summit on Sustainable Development:

The Way Forward

Workshop Report

19 February 2003

Plaza Athenee Hotel Bangkok, Thailand

Table of Contents

Background Workshop Programme Paper Presentations:

The National Biosafety Framework: Dr Banpot Napompeth Trade and Environment under the WTO: Pornvit Sila-On

Workshop Summary & Recommendations Participant List

Background The World Summit on Sustainable Development (WSSD) held in Johannesburg from 26 August to 4 September 2002, concluded with significant commitments to improve the lives of people living in poverty and to reverse the continuing degradation of the global environment. The two principal documents that emerged from the Summit- the Plan of Implementation and the Political Declaration- demonstrate that the world is re-committed to the full implementation of Agenda 21, and to achieving the widely shared goals of sustainable development.

Developments in biotechnology are contributing to these goals in ways that enhance development and protect our environment. As recognized in chapter 16 of Agenda 21, biotechnology carries significant potential for addressing many environment and development problems, including “better health care, enhanced food security, improved supplies of potable water, more efficient industrial processes, sustainable methods of afforestation and reforestation, and detoxification of hazardous wastes”.

Furthermore, Chapter 16 details action plans on the deployment of biotechnology to highlight two key aspects: taking advantage of the benefits and ensuring safety. This then, provided the overall theme for this workshop. The WSSD action plans highlighted the following needs to:

• engender public trust and confidence

• promote the development of sustainable applications of biotechnology

• establish appropriate enabling mechanisms, especially within developing countries

• enhance safety and develop international mechanisms for cooperation, and

• establish enabling mechanisms for the development and the environmentally sound application of biotechnology.

As an initial post-WSSD activity based on the foregoing highlights, ISAAA proposed to assist countries in South East Asia to begin working toward their WSSD commitment to fully implement Agenda 21 by holding workshops to review the role of biotechnology in Agenda 21 and to discuss the challenges ahead in achieving existing commitments. Building domestic capacity for research and commercial application of biotechnology is a prerequisite for developing countries to benefit from innovation in agricultural biotechnology and compete on equal terms in the global marketplace. It is hoped that these workshops will assist countries to position

themselves to take advantage of the benefits of biotechnology while at the same time providing for the safe use of the technology in accordance with the Biosafety Protocol and other international obligations. Description of Project

Four 1-day workshops were held during February - March 2003 in Indonesia, Malaysia, Philippines, and Thailand. The workshops were co-hosted with relevant national centres of excellence in each country- BIOTEC (Thailand), SEAMEO-BIOTROP (Indonesia), the Department of Agriculture Biotech Program (Philippines) and MARDI (Malaysia). Invited participants were senior-level policy makers, members of the national biosafety committees, government officials involved in biosafety regulations, industry and NGOs). The workshops aimed to: (a) discuss the action items concerning biotechnology in Agenda 21 and the

challenges that lie ahead in fulfilling these commitments; b) brief participants on the requirements of the Biosafety Protocol and the

tools available to assist countries with national implementation of their obligations;

c) compare the merits of different experiences and approaches of other developing countries in the implementation of such international agreements;

d) identify actions needed at national and international levels.

Speakers were drawn both from the international community and local national experts with strong credentials in the field.

Outcomes The outcomes of the workshop are summarised in this report. These outcomes will be fed into the ongoing debate at relevant regional and international fora. In the run-up to Cancun, it is envisaged that the workshops will provide a platform for Asian leaders to bring the Asian developing country perspective to the global debate on trade and MEAs. ISAAA hopes that this process will contribute to the establishment in Asia of appropriate national biosafety legislation that (a) is consistent with the Biosafety Protocol and (b) facilitates the growth of domestic biotechnology capacity building and investment.

Workshop Programme

08:00 Registration 08:30 Introductions Dr Randy Hautea, ISAAA Global Coordinator 08:45 Welcome Dr Morakot Tanticharoen, Director, BIOTEC 09:00 Setting the Stage: Biodiversity and Sustainable Development in

Thailand Dr Plodprasop Surasawasdee, Permanent Secretary, Ministry of Natural

Resources & Environment 09:30 Implementation of Agenda 21: Biotechnology for Sustainable

Development in Asia Mrs Muffy Koch, Director, Innovation Biotechnology, South Africa 10:00 Technology Transfer and Cooperation: Opportunities and

Obligations under the Convention on Biological Diversity Dr. Randy Hautea, ISAAA 10:30 Coffee 10:45 Cartagena Protocol on Biosafety: Fundamental Obligations and

Requirements Dr Banpot Napompeth, Chairman, National Biosafety Committee 11:15 Introduction to WTO Trade and Environment Issues Kh Pornvit Sila-on, Department of Multilateral Trade Negotiations,

Ministry of Commerce) 11:45 Implementing the Biosafety Protocol: Panel Discussion

- Current Status, Activities, and Challenges - Dr Banpot Napompeth

- Capacity Building Programs and Needs - Dr Sakarindr Bhumiratana (Senior Adviser, BIOTEC)

- Compliance with WTO Obligations - Dr Jade Donavanik, Chief Attorney, J Donavanik Law Office

13:00 Lunch

14:00 Tools for Creating an Appropriate Regulatory Environment for Biotechnology

Mrs Muffy Koch 15:00 Group Discussions: Action Plan for Implementation of Chapter 16 Facilitators: Mr. Wyn Ellis, and Dr. Margarita Escaler, ISAAA 15:45 Tea 16:00 Group Presentations & Discussion 16:30 Summary of Conclusions and Recommendations Facilitator: Mrs Muffy Koch 17:15 Closing Remarks Dr Randy Hautea, ISAAA Global Coordinator 17:30 Cocktails

National Biosafety Framework (NBF) in Thailand*

Banpot Napompeth1 and Chalinee Kongsawat2

1National Biological Control Research Center (NBCRC) Kasetsart University, Bangkok 10900, Thailand

2Thailand Biodiversity Center National Science and Technology Development Agency (NSTDA)

Bangkok 10400, Thailand Abstract It was soon after the establishment of the National Center for Genetic Engineering and Biotechnology (BIOTEC) under the National Science and Technology Development Agency (NSTDA) in 1983 that an issue on biosafety in modern biotechnology was one of the main concerns in Thailand. The commissioned status reports on the advances of biotechnology in agriculture and on the needs to develop biosafety guidelines submitted to BIOTEC in 1986 and 1990 respectively resulted in the formation of an Ad Hoc Biosafety Subcommittee under BIOTEC in 1990. The main task of the subcommittee was to develop and prepare appropriate and practical biosafety guidelines in genetic engineering and biotechnology for laboratory work and for filed work and planned releases. The guidelines were completed and finalized in 1992 and approved for voluntary implementation together with the appointment of the National Biosafety Committee (NBC) in 1993. The Institutional Biosafety Committees (IBCs) were since then proposed and installed in a number of government agencies, universities and private industry dealing with biotechnology. With the establishment of Thailand Biodiversity Center (TBC) in January 2000, NBC and its secretariat have been transferred from BIOTEC to this newly established center. TBC is also serving as the secretariat of the National Biosafety Policy Subcommittee (NBPS) under the National Committee on Conservation and Utilization of Biodiversity (NCCUB). The main duty and responsibility of NBPS is to propose appropriate and relevant policy on biosafety issues to the government through NCCUB, as well as to harmonize biosafety regulations to form a national biosafety framework (NBF). The national biosafety framework in terms of national policy framework, institutional framework, technical guidelines framework, and regulatory framework are presented and discussed. Introduction Thailand is among several developing countries in Southeast Asia which realize that modern biotechnology or genetic engineering is an important tool for supporting the economic development of the country. Such a potential of modern biotechnology has been realized and as a result the National Center for Genetic Engineering and Biotechnology (BIOTEC) has been established since 1983 under the then Ministry * Paper presented at the International Workshop on Impacts and Biosafety of Genetically Modified

Agricultural Products, Taipei, Taiwan, ROC, 9 – 14 September 2002..

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of Science, Technology and Energy which is now the Ministry of Science, Technology and Environment (MOSTE). Genetic engineering may pose some adverse effect to biodiversity, human and animal health as well as to the environment. Biosafety has thus become an important issue and both developed and developing countries need to take careful measures in the application of modern biotechnology. Issues on biosafety have been realized and priorities identified in Thailand soon after the establishment of the BIOTEC in 1983. Needs to develop biosafety guidelines have thus been identified and advocated in the status report on the advances of biotechnology in agriculture submitted to the BIOTEC in 1986. Another status report on the needs to develop biosafety guidelines was prepared and submitted to the BIOTEC in 1990. As a result, the Ad Hoc Biosafety Subcommittee was appointed Under the National Science and Technology Development Agency (NSTDA) in 1992 with a main responsibility in drafting biosafety guidelines in genetic engineering or modern biotechnology for laboratory work and for field work and planned releases. The Biosafety Guidelines in Genetic Engineering and Biotechnology for Laboratory Work and for Field Work and Planned Release were completed and finalized in 1992. The National Biosafety Committee (NBC) was then established in 1993 with its secretariat at BIOTEC. In order to expand biosafety work to other concerned institutes, the NBC encouraged and helped guide the establishment of the Institutional Biosafety Committee (IBCs) starting from 1993. There are now 9 IBCs at various universities, 4 IBCs at various government agencies, 3 IBCs at various research agencies and 1 IBC at a private industry. It was also perceived that biosafety is a cross-cutting issue and subcommittees under the National Biosafety Committee (NBC) are essential to cover a much wider scope of biosafety issue. As a consequence NBC Subcommittees on Plants, Microorganisms, Food, and Socioeconomics have been appointed. Additional NBC Subcommittees on Livestock, Fisheries, Trade and Commerce, Environment, and Laws and Regulations are in the process of appointment. With the establishment of Thailand Biodiversity Center (TBC) recommended by the Subcommittee on the Convention of Biological Diversity (CBD) in January 2000, a National Biosafety Policy Subcommittee (NBPS) was established under the National Committee on Conservation and Utilization of Biodiversity (NCCUB). The NBC and its secretariat was, as a consequence, transferred to TBC. In a situation such as this, there exists a need to install a national biosafety framework within the country embracing all bodies concerned with biosafety under a comprehensive network within the framework. The objective of this paper is to present a national biosafety framework (NBF) in Thailand showing primary, secondary and even tertiary linkage and networking so far developed and achieved in the country.

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National Policy Framework Thailand has a liberal policy for research and development using gene technology. The government fully supports development and strengthening of capacity in research and production of modern biotechnology or genetic engineering. However, the government still does not allow commercial release of genetically modified plants until proven that they are “safe”. Such a moratorium was due to the move by NGO, the organization of the Poors, to halt all field tests of genetically modified plants until the enactment of the so-called national biosafety law it claimed to be able to complete it within six months since April 2001. It is not known if that NGO should be responsible and pay for the damage done to modern biotechnology in the country. In addition the country does not have any biosafety laws per se. The existing national policy is to push the parliament to pass a biosafety law and regulation to cover genetically modified organisms (GMOs) or living modified organisms (LMOs). Such an attempt was a Ministerial Notification No.2 under the Plant Quarantine Act 1964 on May 10, 1994 enforced June 7, 1994 prohibiting the import of 40 plant species known to undergo genetic engineering or transgenesis. The Plant Quarantine Act 1964 was later amended in 1999. Since Thailand has not yet ratified the Convention on Biological Diversity (CBD), the country is not eligible to sign and ratify the Cartagena Protocol on Biosafety under the Convention on Biological Diversity. The national policy to abide and comply with with CBD thus automatically applicable to the Cartagena Protocol on biosafety. Thailand Biodiversity Center (TBC) serving as the secretariat of the National Biosafety Policy Subcommittee (NBPS) under the National Committee on Conservation and Utilization of Biodiversity (NCCUB) as well as the secretariat of the National Biosafety Committee (NBC) is in the process of being officially appointed as a National Focal Point (NFP) of the Cartagena Protocol on Biosafety, the Biosafety Clearing House (BCH), and the Intergovernmental Committee on Cartagena Protocol (ICCP) under the CBD Secretariat. TBC thus has a collaborative function with the Office of Environmental Policy and Planning (OEPP) which serves as Thailand CBD National Focal Point. Administrative-wise Thailand Biodiversity Center (TBC) is under the National Science and Technology Development Agency (NSTDA) which is an autonomous agency under the Ministry of Science, Technology and Environment (MOSTE). The Office of Environmental Policy and Planning (OEPP) is also under the MOSTE as its mandate agency. OEPP also serves as the secretariat of the CBD Subcommittee chaired by the permanent secretary of the Ministry of Agriculture and Cooperatives (MOAC) but this CBD Subcommittee is appointed by the National Environmental Committee having OEPP as the secretariat and chaired by the prime minister who assigns his duty to one of the deputy prime ministers On trade and commerce dealing with genetically modified organisms for food, feed and processing (GMOFFP), the permanent secretary of the Ministry of Agriculture and Cooperatives chaired a Subcommittee on Policies Concerning Biotech Products under the

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National Committee on International Economic Policy under the Ministry of Commerce (MOC), a representative of which is also an ex-officio member of the National Biosafety Committee (NBC) and NBC Subcommittee on Trade and Commerce. In the MOAC Permanent Secretary Office is also an internally created Natural Resources and Biodiversity Institute (NAREBI) whose function is mainly advisory and missionary. It is thus obvious that at the national level the biosafety framework has taken into account all agencies involved or likely to be involved in biosafety and modern biotechnology in Thailand. The Subcommittee on Policies Concerning Biotech Products under the National Committee on International Economic Policy, has assigned the Working Group on Measures Concerning Production and Trade of Biotech Products, to revise the draft policy on genetically modified food and agricultural product (2002-2006) in accordance to its decision on February 13, 2001. The draft consists of policies in 6 Areas as follows:

Policy on Production: Thailand has not yet produced genetically modified plants, animals and microorganisms or used genetically modified organisms in production processes for trade, unless scientifically sound evaluation has been conducted to warrant safety of such activities.

Policy on Human Resources and Technological Development: Supporting development and strengthening of capacity in research and production of genetically modified food and agricultural products to ensure self-reliance, effectiveness and competitiveness while taking into account safety of the consumers.

Promoting development of knowledge and experience for those associated with

monitoring genetically modified food and agricultural products in several areas including research, laboratory analysis, biosafety evaluation risk assessment.

Policy on Biosafety Evaluation: Biosafety evaluation and risk assessment of

genetically modified food and agricultural products are to be carried out on scientifically sound basis and in transparent manner procedures basis. Relevant agencies are requested to jointly conduct these tasks using the same measures for imported, domestically produced and exported products.

In the case where certain products may pose health risk to specific groups of

consumers, such risks must be clearly displayed on the labels. This labeling measure is applied to imported, domestically produced and exported products.

Policy on Trade: Importation and domestic distribution of genetically modified

food and agricultural products are subjected to prior biosafety evaluation and risk assessment.

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Supporting preparation for exporting genetically modified food and agricultural

products that their (bio) safety has been certified and in accordance to rules, regulations, conditions and demands of trading partner countries.

Policy on Public Relations: Collection, analyzing and promoting compilation

and dissemination of news and information on scientific issue, trade, governmental regulations and procedures and findings on genetically modified food and agricultural products in Thailand and other countries to involved parties and general public. To ensure correct understanding of the issues. These are to be carried out in an objective and transparent manner.

Policy on Participation: Supporting partnerships between public and private

sectors, both domestically and internationally, in the implementation of policies related to genetically modified food and agricultural products, and providing support to the formulation of clear guideline on international trade of genetically modified food and agricultural products. Institutional Framework At a functional level based on the national policy framework BIOTEC and TBC are the main institutions overseeing and supervising biosafety work in the country as competent national authorities in biosafety regulation on a voluntary basis having no legal mandate or authority. In order to accomplish such an objectives the composition of the National Biosafety Committee (NBC) consists of a number of ex-officio members representing respective government departments and agencies as well as scientists and experts drawn from the universities and NGO representative. Nine NBC Subcommittee have been identified. Four NBC Subcommittees on Plants, Microorganisms, Food, and Socioeconomic have been appointed while the five more NBC Subcommittee to be appointed are NBC Subcommittees on Livestock, Fisheries, Trade and Commerce, Environment, and Laws and Regulations. The philosophy behind the appointment of these nine subcommittees was to help orient the members or representatives drawn from the competent national authorities to initiate and institutionalize biosafety-related matters in their respective institutions. For example, NBC Subcommittee on Plants could be linked to Department of Agriculture, a competent national authority on transgenic plant regulation. Likewise NBC Subcommittee on Food could be linked with the Food and Drug Administration (FDA) under the Ministry of Public Health (MOPH), or NBC Subcommittee on Livestock linked with Department of Livestock Development (DOLD), Ministry of Agriculture and Cooperative (MOAC). While linkage at the NBC and NBC Subcommittee levels are both horizontal and vertical in nature, an additional horizontal link has been initiated and encouraged through the establishment of Institutional Biosafety Committees (IBCS). Since 1993 a total of 17

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IBCs has been established. Of these are 9 IBCs at various universities, 7 IBCs at various government and research agenceis, and 1 IBC with a private industry. Since their establishment TBC organized an annual NBC/IBCs workshop as a means for capacity building for IBC representatives and others interested in biosafety issues and regulations. The workshops thus organized have served as a platform upon which an exchange of ideas, progress of implementation, constraints and limitations, needs, etc. could be made and resolved. So far 12 additional institutes have expressed their interest to establish IBCs. Technical Guidelines Framework The lack of biosafety guidelines in Thailand has been made obvious by Millis (1990) during which a feasibility study was being commissioned by the MOSTE for the BIOTEC. However, researchers at various universities and research institutes receiving research grants from BIOTEC were urged and required to adopt procedures and guidelines developed elsewhere in the industrial countries and comply to those which are appropriate to the country. Before the establishment of the Ad Hoc Biosafety Subcommittee in November 1990, information about the laws and regulations, procedures, and guidelines developed in other countries have been compiled and investigated thoroughly and even translated in order to formulate the preliminary draft guidelines for further development. Thialand’s approaches to biosafety guidelines, and their implementation were summarized in Napompeth (1993, 1996, 1997). At the end of 1992 Biosafety Guidelines in Genetic Engineering and Biotechnology For Laboratory Work and For Field Work and Planned Release (BIOTEC 1996a, 1996b) were approved and recommended for implementation on a voluntary basis by all agencies concerned and involved with genetic engineering research and development as well as grant application for research in genetic engineering. It is through these available guidelines that all biosafety work dealing with risk assessment and risk management are made possible (Iamsupasit 2002; Sriwatanapongse 1998; Sriwatanapongse et al. 1996). They have served the purpose not merely for the applicators to carry out biosafety assessment in the laboratory and in the field to comply with but also to help guide additional regulations to be made by the respective competent national authorities and to help serve the harmonization of the guidelines at the regional level. After being subject to use for some time it was deemed necessary to revise these guidelines. The process of revision and simplification of the guidelines is in progress while additional guidelines for the field trials of transgenic plants have also been developed and recommended for use by Department of Agriculture (DDA) under the Ministry of Agriculture and Cooperatives (MOAC). In June 2001, the NBC Subcommittee on Food developed the Guidelines in Safety Assessment of Genetically Modified Foods which has been recommended for use by all concerned (BIOTEC 2001).

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Regulatory Framework While the exiting guidelines may be considered (a) “soft law”, the adoption of such guidelines is not mandatory nor its enforcement implemented from the legal point of view. They are not legal binding in strictest sense. Also, not being a statutory or promulgated into law the question arises on its compliance and legal enforcement. As a result the present biosafety guidelines available in Thailand may be considered voluntary until further enactment is sought and the guidelines decreed mandatory as a law (Sriwatanapongse 1998). However, there exist several laws that could be referred to in the regulation of LMOs in the country. These laws could be utilized in such a way that they could compliment the enforcement of the biosafety guidelines whenever necessary. In principle, there exists in Thailand a number of competent national authorities on biosafety in modern biotechnology. Department of Agriculture (DOA) is the competent national authority on transgenic plants and has exercised existing Plant Quarantine Act 1964 to prohibit the import of 40 plants species known to undergo genetic transformation. Department of Livestock Development (DOLD) and Department of Fisheries (DOF) are yet to make use of the existing Act under their jurisdiction to regulate transgenic animals and fish. The Food and Drug Administration (FDA) under the Ministry of Public Health (MOPH) has already prepared to enfcrce the labeling of foods derived from GMOs effective from May 2003. It is to be noted that regulations by the Department of Agriculture is for the imports of GMOs only, not enforceable for GMOs developed in the country. Ironically, at the national level for GMOs developed within the country by local researchers and scientists they are not subject to any regulation by law or the lack of it. It is, however, advised that the guidelines developed by the National Biosafety Committee be complied with through an approval by respective Institutional Biosafety Committee (IBC) with an advice and concurrence from the National Biosafety Committee (NBC) when in doubt. As a non-party to the Convention on Biological Diversity (CBD) Thailand has to comply itself with Article 24 (Non-parties) of the Cartagena Protocol on Biosafety to the Convention on Biological Diversity which states that

1. Transboundary movements of living modified organisms between Parties and non-Parties shall be consistent with the objective of this Protocol. The Parties may enter into bilateral, regional and multilateral agreements and arrangements with non-Parties regarding such transboundary movements.

2. The Parties shall encourage non-Parties to adhere to this Protocol and to contribute appropriate information to the Biosafety Clearing-House on living modified organisms released in, or moved into or out of, areas within their national jurisdictions.

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Conclusion The National Biosafety Framwork (NBF) of Thailand covering policy, institutional, technical guidelines, and regulatory framework could be abridged, summarized and presented in Figure 1. Not obvious in the framework is the components on capacity building. There exists a variety of constraints and limitation as far as the financial and human resources are concerned. As a non-party to the CBD, Thailand has deprived itself tremendously from the financial and aid privilege of being parties to the convention enjoyed by other colleagues in the Asia and Pacific Region. Thailand position on the Convention on Biological Diversity has tarnished its prestige in the global community due essentially to the lack of responsibility and ignorance of the individuals in all agencies concerned.

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Figure 1. Simplified Diagram of National Biosafety Framework in Thailand.

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References BIOTEC. 1996a. Biosafety Guidelines in Genetic Engineering and Biotechnology For Laboratory Work. National Center for Genetic Engineering and Biotechnology (BIOTEC), Bangkok, Thailand. 97 pp. BIOTEC. 1996b. Biosafety Guidelines in Genetic Engineering and Biotechnology For Field Work and Planned Release. National Center for Genetic Engineering and Biotechnology (BIOTEC). Bangkok, Thailand. 49 p. BIOTEC. 2001. Guideline in Safety Assessment of Genetically Modified Foods. National Center for Genetic Engineering and Biotechnology (BIOTEC). Bangkok, Thailand. 25 pp. Iamsupasit, N. 2002. Thailand country report on biosafety – risk assessment and management. Asia Regional Workshop on Risk Assessment and Risk Management to Implement the Cartagena Protocol. 22-24 May 2002. New Delhi, India. 9 p. Millis, N.F. 1990. Biotechnology in veterinary science: regulations in Asia and Oceania. Review on Science and Technology Office, International Epizootics 9 (3): 715-732. Napompeth, B. 1993. Biosafety regulation in Thailand. ISAAA Biosafety Workshop, April 19-23, 1993. Cisarua, Bogor, Indonesia. 11 pp. Napompeth, B. 1996. Development and implementation of biosafety regulations in Thailand. International Workshop to Follow-up on UNEP’s International Technical Guidelines for Safety in Biotechnology. October 31 – November 1, 1996. Buenos Aires, Argentina. 11 pp Napompeth, B. 1997. Status of biosafety in Thailand. Asia-Pacific Workshop on Biosafety: Environmental Impact Analysis of Transgenic Plants. July 21-26, 1997. M.S. Swanminathan Research Foundation, Mardas (Chennai), India. 19 pp. Sriwatanapongse, S. 1998. Biosafety regulation and administration: Thailand experience. The UNEP/GEF Regional Workshops on Biosafety for Asia/Pacific Region. December 7-11, 1998. New Delhi, India. Sriwatanapongse, S., Wongsasithorn, D. and S. Attathom. 1996. Management on field testing of trangenic plants: Thailand experiment. The 4th International Symposium on Biosafety Results of Field Tests of Genetically Modified Plants and Microorganisms. July 14-17, 1996. Tsukuba, Japan. 6 pp.

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1

Trade & Environment under the WTO

Presentation by Pornvit Sila-On

Department of Trade Negotiations, Ministry of Commerce

Bangkok, Thailand

19 February 2003

Trade Trade && Environment Relationship Environment Relationship ......

Conflicting Policies

Developed countries’ views

Developing countries’ views

WTO is not WEO

Coherence of Multilateral Policies

Trade Trade && Environment in the GATTEnvironment in the GATT

l Article XX of the GATT (General Exceptions)

l EMIT Group (Group on Environmental Measures and International Trade)– Relationship between GATT & MEAs– Transparency of Environmental Measures– Effects on Trade of these Measures

GATT Article XX: General GATT Article XX: General ExceptionsExceptions

Preamble : Subject to the requirement that such measures are not applied in a manner which would constitute a means of arbitrary or unjustifiable discrimination between countries where the same conditions prevail, or a disguised restriction on international trade, nothing in this Agreement shall be construed to prevent the adoption or enforcement by any contracting party of measures:

(b) necessary to protect human, animal or plant life and health;

(g) relating to the conservation of exhaustible natural resources if such measures are made effective in conjunction with restrictions on domestic production and consumption;

Environment related Environment related Agreements/Provision under WTO Agreements/Provision under WTO

1. Marrakesh Agreement Establishing the WTO2. Agreement on Agriculture3. Technical Barriers to Trade Agreement: TBT4. Agreement on the Application of SPS Measures:

SPS5. Agreement on Subsidies and Countervailing

Measures6. TRIPs7. General Agreement on Trade in Services: GATS8. Dispute Settlement Understanding: DSU

CTE’s work programme centers on 10 issues

1. MEAs and the WTO2. Environmental measures and WTO rules3. WTO rules and tax measures4. Transparency5. Dispute settlement within WTO and MEAs6. Market access7. Domestically-probited goods: DPGs8. TRIPs and the environment9. Trade in services and the environment10. NGOs and the work of the WTO

2

WTOWTO--Relevant Relevant MEAsMEAs

CITES (Endangered Species)

UNFCC (U.N. Framework on Climate Change)

CBD (Convention on Biodiversity)

Montreal Protocol (Ozone Depletion)

Basel Convention (Hazardous Waste Disposal)

Biosafety Protocol (Cartagena Protocol)

N.B. Approximately 14 out of 200 MEAs contain potential trade measures

Important Disputed Cases Related to the Important Disputed Cases Related to the Environment Environment

under under GATT / WTOGATT / WTO

- Standard not based on scientific evidence, Lacks risk assessment according to Article 5.1 of SPS

- Article 3.3 of SPS allows higher standards

Ban on Import of Beef with 6

banned hormones

Protection of Human Health /Food Safety

1996 US. vs EU(EU Beef Hormone

Case)

- Goes Against XI:1 and cannot use XX(g) as reason- Conservation not main objective of import ban

- Article XX(b) and XX(g)- Marine Mammal Protection Act (MMPA) 1972

Tuna Import Restriction

Dolphin Conservation

1992 US. vs EU(Tuna/Dolphin II)

- Measure not necessary- Disallow extraterritorial use of measure for XX(b)- No reason for use under XX(g)

- Article XX(b) and XX(g)

- Marine Mammal Protection Act (MMPA) 1972

Tuna Import Restriction

Dolphin Conservation

1991 US. vsMexico

(Tuna/Dolphin I)

RulingLegal Argument

MeasureObjectiveYear / Case

Important Disputed Cases Related to the Important Disputed Cases Related to the Environment Environment

under under GATT / WTO (2)GATT / WTO (2)

-Measure allow to be used to protect human l ives-Different treatment allow for imported product as not considered like product to Domestically produced one

-Decree No. 96-1133 of Dec. 24, 1996 of France-Article XX (b)

Ban on Asbestos import from Canada

Protection of Human Health (2,000 Lives Lost per year to asbestos explosion)

2001 EU vsCanadaAsbestos Case

-US to amend measure and related regulations due to Unjustifiable and arbitrary discrimination caused by measure

-Section 609 of US Public Law 101-162 -Article XX (b) XX (g)

Ban on Shrimp Import

Sea Turtle Conservation

1996 US. vsThailand India Pakistan ETC. (Shrimp & Turtle Case)

RulingLegal Argument

MeasureObjectiveYear / Case

Environment in the New Round of WTO Environment in the New Round of WTO NegotiationsNegotiations

lIssues to be negotiatedlStatus of negotiations

Trade and Environment in the WTO’s Doha Declaration

1. Begin Negotiations on 3 issues (Paragraph 31 of Doha Declaration)1.1 Relationship between WTO rules and trade measures of MEAs1.2 Information exchange between MEAs Secretariats and WTO, and

drafting criteria for observer status of MEAs in relevant WTO Committees

1.3 Reduction/elimination of tariff and NTBs on environmental goods & services

2. CTE carry out studies on 3 issue (Paragraph 32 of Doha)2.1 Effects of environmental measures on market access of

developing countries ’ exports2.2 TRIPS and the environment2.3 Eco-labelling

Status of NegotiationsStatus of Negotiations

l A Special Session of the Committee on Trade & Environment was established to complete negotiations on mandated issues (Para 31). To be concluded as a single undertaking by 1January 2005

l CTE regular session to report to the 5th Ministerial Conference in Cancun, Mexico (September 2003) on the desirability of negotiations on para 32 issues

l To date, there have been 4 Special Session CTE Meetings since 2002

3

Balance

Regulatory Protection

TradeLibealization

WORKSHOP SUMMARY AND RECOMMENDATIONS

• The group discussions focused on three areas: recommendations for

enabling technology transfer; actions required to enhance the existing risk assessment process, and the development of a National Biosafety Framework

• Thailand has kept up with the CBD and CPB protocol requirements and has developed the NBF and technical guidelines cost effectively.

• Development of a National Biosafety Framework was initiated in 1993 and is now in Phase 2. The NBF covers 4 points: national policy, institutional participation, technical guidelines and regulatory frameworks.

• Thailand has still to draft a legal instrument and work on the role of the public in decision making. The drafting of the regulations will offer an opportunity to review processes and make modifications as necessary.

• Thailand recognises the role of biotechnology in reaching national goals. It would be valuable to see this reflected in national policy and strategies. A national strategic programme has been suggested to stimulate technology transfer.

• Thailand has recognised the importance of IPR in stimulating innovation and technology transfer, and focused on regulations that facilitate transfer and utilization of technologies.

• Further biosafety risk assessment training is needed to increase capacity at national level. Formal recognition of the roles of scientific reviewers may help with the efficiency of the review process.

• Thailand needs a stronger developing country voice at international fora and especially in the EU. The developed world needs to acknowledge the situation in developing countries and recognize that developing countries need access to new technologies in order to advance and compete in a global marketplace.

• The workshop emphasized the need to strengthen private-public sector strategic partnerships as an effective mechanism for implementation.

Participant List

Ministry of Agriculture and Cooperatives (MOAC)

7. Mr. Sasi Jaroenpoj Department of Livestock Development, Phaya Thai Road, Bangkok 10400 1. Mr. Wichar Thitiprasert Tel: +66 2653 4444 Department of Agriculture Fax: +66 2653 4900 Agricultural Regulatory Division

Chatuchak, Bangkok 10900 8. Ms. Doojduan Sasanavin Tel: +66 2940 6670

National Bureau of Agricultural Commodity Fax: +66 2940 5687 and Food Standards (ACFS) Ministry of Agriculture & Cooperatives 2. Dr. Songkarn Chitrakon Rajdamnoen Nok Avenue Office of Biotechnology and Nuclear Technique Bangkok 10200 Department of Agriculture (DOA) Tel: +66 2629 8977 Pathumthani 12110 Fax: +66 2629 8978 Tel: +66 2904 9885

Fax: +66 2904 6885 9. Ms. Patasorn Jiravatrungsri

National Bureau of Agricultural Commodity and Food Standards (ACFS)

3. Mr. Kittisak Keeratiyaangkul Office of Biotechnology and Nuclear Technique

Ministry of Agriculture & Cooperatives Department of Agriculture (DOA) Rajdamnoen Nok Avenue Pathumthani 12110 Bangkok 10200 Tel: +66 2904 9885 Tel: +66 2629 8970 Fax: +66 2904 6885 Fax: +66 2629 8978

4. Dr. Methinee Sriwattanakul 10. Ms. Tasanee Pradyabumrung Office of Biotechnology and Nuclear Technique

National Bureau of Agricultural Commodity and Food Standards (ACFS)

Department of Agriculture (DOA) Pathumthani 12110

Ministry of Agriculture & Cooperatives Tel: +66 2904 9885 Fax: +66 2904 6885 Rajdamnoen Nok Avenue

Bangkok 10200 Tel: +66 2280 3905 5. Mr. Apichart Termvidchakorn Fax: +66 2280 1542 Department of Fisheries

Kasetsart University Campus 11. Ms. Wiboonwan Wannapolee Chatuchak, Bangkok 10900

National Bureau of Agricultural Commodity and Food Standards (ACFS)

Tel: +66 2562 0600 Fax: +66 2940 6203 Ministry of Agriculture & Cooperatives

6. Dr. Supattra Uraiwan Rajdamnoen Nok Avenue National Aquaculture Genetics Research Institute Bangkok 10200

Tel: +66 2629 8975 39 Moo1 Klongluang Pathumthani 12120 Fax: +66 2281 3958 Tel: +66 2577 5058 – 60 Fax: +66 2577 5062

Ministry Of Science and Technology (MOST) 12. Ms. Pantipa Patarat 23. Dr. Sutat Sriwatanapongsri National Bureau of Agricultural Commodity

and Food Standards (ACFS) National Center for Genetic Engineering and Biotechnology (BIOTEC) Ministry of Agriculture & Cooperatives 113 Phaholyothin Road, Klong Luang Rajdamnoen Nok Avenue Pathumthani 12120 Bangkok 10200

Tel: +66 2629 8975 Tel: +662 564 6700 ext. 3163 Fax: +662 567 6703 Fax: +66 2281 3958

24. Ms. Darunee Edwards 13. Ms. Thunyaros Sanguanhong

National Center for Genetic Engineering and Biotechnology (BIOTEC)

National Bureau of Agricultural Commodity and Food Standards (ACFS)

113 Phaholyothin Road, Klong Luang Ministry of Agriculture & Cooperatives Pathumthani 12120 Rajdamnoen Nok Avenue Tel: +662 564 6700 ext. 3163 Bangkok 10200

Tel: +66 2629 8975 Fax: +662 567 6703 Fax: +66 2281 3958

25. Dr. Nares Damrongchai Ministry of Public Health (MOPH) National Center for Genetic Engineering and

Biotechnology (BIOTEC) 14. Mr. Adisak Rujiranupong 113 Phaholyothin Road, Klong Luang National Institute of Health Pathumthani 12120 Department of Medical Science Tel: +662 564 6700 ext. 3314 Tiwanond Road, Muang Fax: +662 567 6703 Nonthaburi 11000

Tel: +66 2580 8907 26. Ms. U-Sarat Bunnag Fax: +66 2591 5449

Center for Genetic Engineering and Biotechnology (BIOTEC)

Ministry of Natural Resources and Environment (MONRE) 113 Phaholyothin Road, Klong Luang

Pathumthani 12120 15. Dr. Sirikul Bunpapong Tel: +662 564 6700 ext. 3159 Office of Environmental Policy and Planning Fax: +662 567 6703 60/1 Soi Phibunwattana 7, Rama VI Rd. Phayathai Bangkok, 10400

27. Ms. Bubpha Techapattaraporn Tel: +662 279 7180-9 ext. 286 Center for Genetic Engineering and Biotechnology (BIOTEC)

FAX: +662 271 3251

113 Phaholyothin Road, Klong Luang 16. Ms. Sita Pholpoke Pathumthani 12120 Office of Environmental Policy and Planning Tel: +662 564 6700 ext. 3131 60/1 Soi Phibunwattana 7, Rama VI Rd. Fax: +662 567 6703 Phayathai Bangkok, 10400

Tel: +662 279 7180-9 ext. 286 28. Dr. Boonyanath Nathwong FAX: +662 271 3251

Plant Genetic Engineering Unit Kasetsart University, Kamphangsaen Campus 17. Ms. Anchira Maneevong Nakhonpathom 73140 Office of Environmental Policy and Planning Tel: +663 435 1908 60/1 Soi Phibunwattana 7, Rama VI Rd. Fax: +663 435 1908 Phayathai Bangkok, 10400 Tel: +662 279 7180-9 ext. 286 FAX: +662 271 3251

35. Dr. Suwina Ratanachaiyavong 29. Dr. Chetsadaporn Pitaksutheepong Prince of Songkla University, Hadyai Campus

Plant Genetic Engineering Unit Kasetsart University, Kamphangsaen Campus

15 Karnjanavanich Road Nakhonpathom 73140 Hatyai, Songkla 90110 or Tel: +663 435 1908 P.O.Box 102, Hadyai Post Office Fax: +663 435 1908 Tel: +66 7422 2151-3

University 36. Dr. Wisa Supanpaiboon 30. Dr. Supat Attathom

Faculty of Medical Science Department of Plant Pathology, Faculty of Agriculture Kasetsart University, Kampangsaen Campus,

Naresuan University Phitsanulok, 65000 Tel: +66 5526 1000 – 4 ext. 4608 Nakorn Pathom 73140 Fax: +66 5526 1000 – 4 ext. 4758 Tel: + 66 3435 1908

Fax: + 66 3435 1908 37. Mr. Rajendra Ketkar 30. Dr. Sakol Punyim Country Manager

Institute of Molecular Biology and Genetics Monsanto Thailand Ltd. Mahidol University, Salaya 19/F SCB Park Plaza 3 East Nakon Pathom 73170 19 Rachadapisek Rd. Chatuchak Tel: + 66 2441 9003 ext. 1476 Bangkok 10900 Fax: +66 2441 9906 Tel: +662 937 8888

Fax: +662 937 8844 31. Dr. Prasartporn Smitamana

Chiangmai University, Huaykaew Road 38. Ms. Thaddao Anantachaiyong Muang, Chiangmai 50200 Regulator Affairs Executive Tel: +66 5394 4080 Monsanto Thailand Ltd. Fax: +66 25394 4666 19/F SCB Park Plaza 3 East

19 Rachadapisek Rd. Chatuchak 32. Dr. Neung Teaumroong Bangkok 10900

Institute of Research and Development Tel: +662 937 8888 Suranaree University of Technology Fax: +662 937 8844

111 University Avenue, Muang Nakhon Ratchasima 30000 Facilitators / Resource Persons Tel: +66 4422 4751 38. Dr. Plodprasop Surasawadee Fax: +66 4422 4750 Permanent Secretary

Ministry of Natural Resources and Environment 33. Dr. Rudee Suravit

Mahidol University 92 Phaholyothin7, Phaholyothin Road 198/2 Somdejprapinklao Road Ra Bangkok 10400 Bangplad, Bangkok 10700 Tel: +662 298 2000 Tel: +66 2433 7069 ext. 601, 603 Fax: +662 298 2002

34. Dr. Jisanuson Svatiwat 39. Dr. Morakot Tanticharoen

Chulabhorn Research Institute Director Vibhavadee-Rangsit Highway National Center for Genetic Engineering and

Biotechnology (BIOTEC) Bangkok 10210 Tel: +66 2574 0604 113 Phaholyothin Road, Klong Luang Pathumthani 12120 Tel: +662 564 6700 ext. 3507

Fax: +662 567 6705

40. Dr. Banpot Napompeth National Biological Control Research Center Kasetsart University P.O. Box 9-52 Bangkok 10900 Tel/Fax: +662 942 8252

41. Mr. Pornvit Sila-on

Department of Multilateral Trade Negotiations Ministry of Commerce Ratchadamneon Klang Road Bangkok 10200 Tel: +662 282 6171 ext. 1191 Fax: +662 280 1579

42. Dr. Sakarindr Bhumiratana

Senior Adviser, BIOTEC 113 Phaholyothin Road, Klong Luang Pathumthani 12120 Tel: +662 564 6700 ext. 3507 Fax: +662 567 6705

43. Dr. Jade Donavanik

Jade Donavanik Law Office 99/100 Ngamwongwan Road Chatuchak, Bangkok 10900 Tel: +662 561 4396 Fax: +662 561 4476

44. Dr. Randy Hautea

Center Director and ISAAA Global Coordinator DAPO Box 7777, Metro Manila The Philippines Tel: +632 845-0563 / 0569 / 0573 Fax: +634 9 536-7216 / +63 2 845-0606

45. Dr. Margarita Escaler Manager, ISAAA Global Knowledge Center on Crop Biotechnology

111 Arthur Road Windsor, Berkshire, SL4 1RU United Kingdom Tel: + 44 7776 303852 Fax: +44 1753 842158

46. Ms. Muffy Koch Golden Genomics cc Box 30923

Kyalami South Africa 1684 Tel: +27 11 702 1682

47. Mr. Wyn Ellis ISAAA Coordinator 178/4 Soi Apapirom Rachada Pisek Road Bangkok 10900 Tel: + 66 1 835 7380 Tel / fax: + 662 939 0018

Secretariat 48. Ms. Panatta Junchai

ISAAA (THAILAND) P.O. Box 26 Sanampao Bangkok 10406 Tel: +662 279 3741 – 2 Fax: + 662 279 3741

49. Ms. Chonnatee Rodhawand

ISAAA (THAILAND) P.O. Box 26 Sanampao Bangkok 10406 Tel: +662 279 3741 – 2 Fax: + 662 279 3741

50. Dr. Nipon Iamsupasit

Biosafety Program, National Center for Genetic Engineering and Biotechnology 113 Phaholyothin Road, Klong Luang Pathumthani 12120 Tel: +662 564 6700 ext. 3312 Fax: +662 567 6703

51. Mr. Sukun Kunawasen Biosafety Program, National Center for Genetic Engineering and Biotechnology 113 Phaholyothin Road, Klong Luang Pathumthani 12120 Tel: +662 564 6700 ext. 3374 Fax: +662 567 6703

52. Ms. Chalinee Kongsawat Biosafety Program, National Center for Genetic Engineering and Biotechnology 113 Phaholyothin Road, Klong Luang Pathumthani 12120 Thailand Tel: +662 564 6700 ext. 3318 Fax: +662 567 6703

National WorkshoponDescription of ProjectOutcomesDr Banpot Napompeth, Chairman, National Biosafety CommitteeTrade and Environment under WTO- Pornvit Sila-On.pdfMultilateral Trade Negotiations BureauBangkok, Thailand, 19 February 2003The Beginning of Trade & Environment in the GATTEnvironmental Dispute Cases in the WTOTrade and Environment: Towards achieving an Equilibrium

Participants Thailand.pdfMinistry of Public Health (MOPH)Ministry Of Science and Technology (MOST)University

Secretariat