The Biosafety Protocol: An Analysis

Transcription

1 The Biosafety Protocol: An Analysis 20 th March 2000 Peter Hardstaff Trade Policy Officer RSPB The Lodge Sandy Bedfordshire SG19 2DL UK Tel: The author would like to acknowledge the advice and comments of Matthew Stillwell of the Centre for International Environmental Law. Responsibility for the content of this report lies with the Author.

2 Contents: 1.Executive summary 2 2. Background 3 3. Why have a Biosafety Protocol? 4 4. What is the Biosafety Protocol? 4 5. What does the Biosafety Protocol allow/ 5 require contracting parties to do? 6. What is the Status of the Protocol in 10 international law? 7. What does this all mean? Key actions for governments 16 1

3 1. Executive summary The Biosafety Protocol is an international agreement (reached in Montreal, January 2000) aimed at regulating the transboundary movement of Living Modified Organisms (LMOs, or living GMOs ). The very existence of the Protocol is a landmark achievement given the hard line taken in the negotiations by six LMO exporting countries (known as the Miami Group ). This hard line was a reflection of the politically sensitive nature of the key issues in the negotiations (e.g. the use of the precautionary principle and the relationship between environment agreements and WTO rules) as well as the political differences over the GMO issue more broadly. The Protocol contains a number of significant positive developments in the international regulation of LMOs such as the following: It permits importing countries to take precautionary decisions on many LMO imports and enhances the status of the precautionary principle in international law. It is, in itself, recognition that GMOs are different from non-gmos and thus require special regulations. It includes a rigorous process of Advanced Informed Agreement (AIA) for LMOs intended for introduction into the environment including a clause enabling importing countries to require the exporters to pay for risk assessments. However, deep political divides on a number of issues resulted in the Protocol containing a number of flaws such as the following: LMO commodity exports are not included in the full AIA procedure. A different, and less rigorous, AIA process has been set up for commodities. LMO commodity exports are subject to different and less rigorous documentation (i.e. labelling) requirements than LMOs for intentional introduction into the environment. LMO products (e.g. GM Soya milk) and most LMO pharmaceuticals for humans are exempted from the Protocol. LMOs in transit (i.e. moving through a country en route to another country) and LMOs destined for contained use are not included in the Protocol s AIA procedures. The final text of the Protocol also leaves a number of issues unresolved, including the following: The establishment of a legal liability regime is deferred until a later date. The establishment of dispute settlement procedures is deferred until a later date. The relationship between the Protocol and WTO rules is still unclear; meaning a successful WTO challenge of a government implementing the Protocol is still possible (although unlikely). The status of non-parties to the Protocol and the ability of Parties and non-parties to enter into bilateral deals may allow the USA, for example, to use its political muscle to chill full and effective implementation of the Protocol. The segregation of different LMO commodities will not happen as a direct result of the Protocol s identification and documentation procedures (as is the case with LMOs intended for introduction into the environment), although segregation may still happen in some cases due to the commodity AIA process. Governments should now undertake the following actions: Sign the Biosafety Protocol at the May 2000 Conference of the Parties to the Convention on Biological Diversity in Nairobi (or as soon after as possible) and ratify the Protocol as soon as possible. Transpose the Protocol s provisions into national legislation as soon as possible. 2

4 Provide technical and financial assistance to help poorer countries with implementation. Seek a formal clarification that implementing the Biosafety Protocol cannot be overruled by the WTO. Work on developing a legal liability regime and dispute settlement process under the Protocol as soon as possible. 2. Background Negotiations on the Biosafety Protocol were initiated at the Rio Earth Summit in 1992 when 175 Governments signed up to the Convention on Biological Diversity (CBD) and agreed to develop a Biosafety Protocol for the safe handling, transfer and use of Living Modified Organisms (LMOs) 1. Three years later, in 1995, the negotiation process was started and in February 1999 the signatories to the CBD convened in Cartagena (Colombia), to agree the Protocol. At Cartagena, a draft text was produced that was weaker than many Governments would have liked on a series of issues. However, this draft Protocol was eventually backed by most developing countries (known as the Like-Minded Group ), the European Union, the Compromise Group 2 and the Central and Eastern European countries (CEE). Despite this momentum, the Cartagena negotiations failed because the six countries that control the world market in GM crops still opposed the draft Protocol on the grounds that it constrained free trade. These states are known as the Miami Group (USA, Canada, Argentina, Uruguay, Australia and Chile). Two further meetings were held during 1999 to gauge whether the political will existed to reach an agreement, and to pinpoint the key areas of dispute. The decision was taken to reconvene the Extraordinary Conference of the Parties in January 2000 (in Montreal) to try and conclude the negotiations. Before the start of the Montreal meeting, the Chair of the negotiations 3 produced a so-called nonpaper attempting to find a form of words on the most contentious issues that, if not acceptable, would at least provide a basis on which to re-start negotiations. The issues addressed in this paper included the scope of the Protocol (what areas it should cover and what, if anything should be exempted from it) and the relationship between the Protocol and other international agreements (the proposed savings clause ). The paper also addressed how to set up different procedures for dealing with LMO commodities (i.e. LMOs for food, feed and processing such as LMO Soya exported for animal feed or for processed food) than those for dealing with LMOs for intentional introduction into the environment (i.e. LMOs to be released/planted into the environment such as LMO maize for planting). After a long and difficult week of negotiations, it transpired that the crunch issues on the final day were: the savings clause, the precautionary principle and the documentation requirements (i.e. labelling) for commodity exports. Agreement was reached on the first two of these issues in the early hours of Saturday 30 th January and, at around 5 o-clock that morning, a compromise on LMO commodity export documentation was also reached and the Protocol was finally agreed. This briefing is an attempt to describe and interpret the main points 4 of the Protocol and explain their ramifications. Given the complex nature of international law, this briefing cannot be seen as in any way definitive, but rather an initial interpretation of a new multilateral environmental agreement. 1 Living Modified Organisms (LMOs) are defined as: any biological entity that possesses a novel combination of genetic material obtained through the use of modern biotechnology and is capable of transferring or replicating this genetic material. In other words, living GMOs (e.g. GM plants, seeds, bacteria, animals etc.). 2 Switzerland, Japan, Norway, Mexico, Republic of Korea, New Zealand. 3 Colombian Environment Minister Juan Mayr Maldonado. 4 Note: Not every article of the Protocol has been described and analysed in this briefing. 3

5 3. Why have a Biosafety Protocol? Subject to their rights and obligations under existing international agreements (e.g. the rules of the World Trade Organisation), countries are - without a Biosafety Protocol - already able to take decisions based on risk assessments concerning whether or not to import LMOs. However, genetic modification is a new and highly specialised field of technology that carries with it particular threats and opportunities. This demands that more specific regulations than those currently existing in international law are drawn up so that countries can act within these to effectively protect the environment. Also, many countries have yet to develop the domestic regulatory capacity to deal with such a complex issue. International agreements can provide a sound legal basis for this development and can provide some of the resources to achieve this. Agreement on a Biosafety Protocol is therefore an important step in enabling countries to effectively protect the environment. Such an international agreement can also provide a more predictable regulatory framework around the world that can benefit exporting companies. 4. What is the Biosafety Protocol? The Biosafety Protocol is an international agreement aimed at regulating the transboundary movement of Living Modified Organisms (LMOs) that could adversely affect biodiversity. In essence, it aims to achieve this goal by setting up an Advanced Informed Agreement (AIA) procedure that allows an importing country to undertake a risk assessment of, and then take a decision on, imports of an LMO before the importation commences. More specifically, the objective of the Protocol states that: In accordance with the precautionary approach contained in Principle 15 of the Rio Declaration on Environment and Development, the objective of this Protocol is to contribute to ensuring an adequate level of protection in the field of the safe transfer, handling and use of living modified organisms resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health, and specifically focusing on transboundary movements (Article 1). Article 4 (Scope) states that the Protocol applies to the transboundary movement, transit, handling and use of all LMOs that could adversely affect biodiversity, taking also into account the risks to human health. However, exempted from the whole Protocol in a subsequent Article are LMO pharmaceuticals for humans that are covered by other relevant international agreements or organisations 5 (Article 5). Exempted from the Protocol s AIA procedure (but not from the rest of the Protocol 6 ) are LMOs for transit (i.e. those being transported through a country en-route to another) and LMOs destined for contained use 7 (Article 6). The Party of import decides on acceptable standards for contained use (Article 6.2). 5 For example, World Health Organisation (WHO) regulations. 6 For example, the Protocol s accidental release and legal liability provisions (Articles 17 and 25). 7 According to the Protocol, Contained use means any operation, undertaken within a facility, installation or other physical structure, which involves living modified organisms that are controlled by specific measures that effectively limit their contact with, and their impact on, the external environment. 4

6 Products of LMOs (such as milk made with GM Soya) are not mentioned in Article 4 (Scope) and so are not covered by the Protocol 8. Also, the Meeting of the Parties to the Protocol 9 is empowered to identify LMOs that are not likely to have adverse impacts on biodiversity in order to exempt them from the Protocol s AIA procedures (Article 7.4). While it is clear that LMO pharmaceuticals for humans not dealt with in other international processes and LMO pharmaceuticals for animals are covered by the scope of the Protocol, it is not clear exactly how the Protocol s AIA procedures will apply to them 10. Presumably, if these pharmaceuticals are deemed products of LMOs then they are not covered by the Protocol at all. Article 7 (AIA) concerns LMOs for intentional introduction into the environment, so applying the AIA procedure to these pharmaceuticals may depend on whether, for example, injecting an animal with an LMO drug can be considered as intentional introduction into the environment. Therefore, what the Protocol s AIA procedures clearly do cover are LMOs for intentional introduction 11 into the environment (e.g. LMO seeds for planting) and LMO commodities (i.e. seeds for food, feed or processing) that are deemed likely to have an adverse impact on biodiversity. To facilitate the AIA process, the Protocol requires the establishment of a Biosafety Clearing House to be run by the Secretariat to the CBD. The Clearing House is to serve as a central point through which information relevant to the Protocol can be gathered and disseminated (Article 20). The Protocol also requires Parties to identify a national focal point to liaise with the Secretariat and other Parties on Biosafety issues, and a competent national authority to administer the provisions of the Protocol (Article 19). Once the Protocol has come into force 12, the Conference of the Parties to the CBD will serve as the Meeting of the Parties to the Biosafety Protocol, where further decisions on rules and implementation can be taken (Article 29). 5. What does the Biosafety Protocol allow/require contracting parties to do? Introduction As already mentioned, the main aim of the Protocol is to establish a process of Advanced Informed Agreement (AIA) for LMOs. However it was not possible to establish one procedure to cover all LMOs. The Miami Group of countries opposed the application of the full AIA procedure to commodities (for food, feed or processing) because, it argued, this would unnecessarily disrupt the international commodity trade. A compromise was therefore reached on applying different AIA procedures and different notification (labelling) requirements to LMOs for intentional introduction into the environment and LMO commodities. LMOs for intentional introduction into the environment 8 Exports of LMO products, such as GM Soya Milk, are therefore treated differently to exports of LMO commodities (e.g. Soya intended for processing into products) and exports of LMOs intended for intentional introduction into the environment (e.g. Soya seeds for planting on farms). 9 The Conference of the Parties to the Convention on Biodiversity serves as the Meeting of the Parties to the Protocol once the Protocol has come into force. 10 Articles 4, 5 & 6 (concerning scope and exemptions) and Article 7 (concerning the AIA procedure) do not provide a clear indication of whether and how the Protocol s AIA procedures apply to these types of LMOs. 11 Also known as deliberate release. 12 The Protocol comes into force 90 days after the 50 th state has ratified it. 5

7 The AIA procedure applies, prior to the first intentional transboundary movement of living modified organisms for intentional introduction into the environment of the Party of import (Article 7.1). The exporter (i.e. company), or the Party of export (i.e. government), is required to provide written notification to the Party of import of its wish to export (Article 8.1). It is required to supply a range of information (set out in Annex I of the Protocol) with this notification. The Party of export must legally require itself or the exporting company to ensure that the information is accurate (Article 8.2). Within 90 days of receiving the notification, the Party of import must acknowledge receipt, state whether the information is adequate and state whether it intends to proceed according to its own domestic regulations (which must be consistent with the Protocol) or whether it intends to use the procedures set out in the Protocol to reach a decision (Articles ). Failure to respond to the notification does not imply consent to the import (Article 9.4). The Protocol does not state what happens next if an importing Party fails to respond to the notification. Within this same 90 day period, the Party of import must also inform the exporter either: (a) that it can proceed with the export without further consent after a further 90 days have elapsed, or; (b) that it can only proceed once written consent has been given (Article 10.2). If option (b) is chosen, the Party of import has a further 180 days 13 in which to communicate in writing its decision both to the exporter and to the Biosafety Clearing House (Article 10.3). The decision of the importer must be based on a risk assessment (Articles 10.1 and 15.2). This must be conducted in accordance with the risk assessment procedures that are set out in Article 15 and Annex II of the Protocol (Article 15.1). The importer may require the exporter to carry out the risk assessment and may require the exporter to pay for the risk assessment 14 (Articles 15.2 and 15.3). This is potentially significant as it goes some way to placing the burden of proof (i.e. that an LMO poses an acceptably low risk of adverse impacts on biodiversity) onto the exporters. Also significant is that importers are allowed to take precautionary decisions. As well as mentioning the Precautionary Principle (i.e. Principle 15 of the Rio Declaration) in its preamble and objectives, the Protocol - in its decision-making procedure - also states that; Lack of scientific certainty due to insufficient relevant scientific information and knowledge regarding the extent of the potential adverse effects of a living modified organism on the conservation and sustainable use of biological diversity in the Party of import, taking also into account risks to human health, shall not prevent that Party from taking a decision, as appropriate, with regard to the import of the living modified organism in question as referred to in paragraph 3 above, in order to avoid or minimize such potential adverse effects (Article 10.6). What this basically means is that an importer can impose a precautionary ban or conditions on the import of an LMO for intentional introduction if the evidence on potential adverse impacts presented in the risk assessment is felt to be incomplete. For example, a precautionary ban could be imposed on a particular type of LMO seeds if there was some, although not necessarily conclusive, evidence of potential adverse environmental impacts from growing the GM crop. On the face of it, the Protocol s definition only applies to uncertainty regarding the extent of impacts (i.e. how bad they are) and does not specifically allow precautionary action where uncertainty exists 13 A total of 270 days from when the notification is first received. 14 The Protocol places no cost-ceiling on this. 6

8 on the nature of the potential impacts (i.e. what the impacts actually are). However, it is difficult at this stage to know what impact such semantics will have on real world decision-making. In addition, the use of the words insufficient relevant scientific information in this definition may be interpreted as meaning that there will be a point at which sufficient information will come into existence. This definition also does not take into account cases where there is a lack of scientific consensus. That said, the risk assessment procedure set out in Annex II does state that, Lack of scientific knowledge or scientific consensus should not necessarily be interpreted as indicating a particular level of risk, an absence of risk, or an acceptable risk (Annex II paragraph 4). The Protocol states that the decision of the importer can be any one of the following: (a) Unconditional consent to the import (no reasons are required to be given); (b) Consent to the import with specific conditions attached (with reasons for this decision and also information on how the decision applies to subsequent imports); (c) Prohibition of the import (with reasons for this decision); (d) A request for further relevant information (with reasons for this decision); (e) Notification to the exporter that more time is required for the decision, and specification of how much more time is needed (with reasons for this decision) (Article 10.3). If the importing Party does not respond within 270 days of receipt of the original notification, this does not imply consent to the import (Article 10.5). Again, the Protocol does not state what happens next if an importing Party does fail to respond. LMOs intended for food, feed or processing ( commodities ) The AIA procedure for commodities starts when a Party domestically approves an LMO 15 that might be exported as a commodity (Article 11.1). Within 15 days of this domestic approval, the Party must make this decision known through the Biosafety Clearing House (which will most likely take the form of a web site). Those Parties that don t have access to the Internet can, in advance, inform the Secretariat of the CBD that they wish to be sent written copies of such domestic approval notifications. Parties may request additional information from the notifying authority. All importing Parties can then choose to take a decision based on their own domestic regulations (details of which they must have already made available to the Biosafety Clearing House). These regulations must be consistent with the objective of this Protocol (Article 11.4). The Protocol does not make it clear whether all importing Parties must take a decision after the exporter has notified the Clearing House of the domestic approval, or whether importing Parties can wait to take a decision prior to the first import to them. There is no specific requirement in this part of the Protocol for bilateral notification. Also, no time frame for this decision is specified in the Protocol. This could well turn out to be fertile ground for disagreements on interpretation. A Party that is a developing country or economy in transition is allowed, in the absence of its own domestic regulations, to declare through the Biosafety Clearing House that its decision prior to the first import of an LMO commodity will be taken using a risk assessment (according to the risk assessment procedure laid out in Annex II of the Protocol) (Article 11.6). This decision must be made within 270 days (Article 11.6). The Protocol does not specify when the 270 days start but it is likely that it means 270 days from when the exporter notifies the Biosafety Clearing House of the domestic approval. This means that all these countries have to undertake a risk assessment procedure at the 15 The following procedure does not apply when a Party domestically approves an LMO to be grown in a field trial (i.e. when an LMO field trial is approved, the Party does not have to submit information to the Clearing House. The rest of the AIA procedure is therefore not initiated in such cases). 7

9 same time regardless of whether they are likely to receive LMO commodity exports in the near future. Failure to respond within 270 days does not imply either consent or refusal to the import, unless otherwise specified by the Party (Article 11.7). Again, the Protocol makes no mention of what will happen next if an importing Party does fail to respond to the notification. The importing Party has the same recourse to the Precautionary Principle as in the case of LMOs for intentional introduction into the environment (Article 11.8). The Party of import does not have the right to ask the exporter to carry out, or pay for the risk assessment for an LMO commodity. This is a significant difference from the way in which LMOs for intentional introduction are treated in the Protocol. Further provisions related to the AIA procedure Socio-economic considerations Parties are allowed to take socio-economic considerations into account when reaching decisions on imports of LMOs (Article 26.1). However, this must be consistent with their international obligations (i.e. WTO rules) and must comprise only those socio-economic considerations arising from the impact of LMOs on biodiversity (Article 26.1). This is different from, and potentially weaker than, being able to consider the potential knock-on effects on biodiversity of changes in socioeconomic conditions created by the introduction of LMOs into a society. Also, there is no direct link between this Article and the risk assessment procedure elaborated in Article 15 and Annex III. That said, there is nothing in international law stopping a country from assessing socio-economic impacts to aid decision-making, although the decision will have to be in accordance with what is said in Article 26. Reviews A Party of import can, in light of new evidence, review a decision at any time (Article 12.1). Also, an exporting Party can request an importing Party to review a decision in light of changed circumstances or new evidence that could affect the risk assessment (Article 12.2). The importer has to respond to such a request within 90 days and provide a reason for its decision (Article 12.3). After the first LMO import, a Party of import may, at its discretion, require a risk assessment for subsequent imports of LMOs 16 even if they are exactly the same LMOs previously imported (Article 12.4). Handling, transport, packaging and identification The Protocol requires that all LMOs are handled, packaged and transported under conditions of safety, taking into account relevant international rules and standards (Article 18.1). LMOs for intentional introduction into the environment have to be accompanied by documentation that, clearly identifies them as living modified organisms; specifies the identity and relevant traits and/or characteristics, any requirements for the safe handling, storage, transport and use, the contact point for further information and, as appropriate, the name and address of the importer and exporter; and contains a declaration that the movement is in conformity with the requirements of this Protocol applicable to the exporter (Article 18.2c). In contrast, LMO commodities only have to be accompanied by documentation that states that they may contain LMOs and specifies a contact point for further information. Two years after the Protocol comes into force (i.e. in about 3-4 years time), the Meeting of the Parties to the Protocol will take a decision on more detailed notification requirements for commodities (Article 18.2a). 16 This applies to LMO commodities or LMOs for intentional introduction into the environment. 8

10 LMOs destined for contained use have to be accompanied by documentation that: identifies them as LMOs; specifies requirements for safe handling, storage, transport and use; and identifies a contact point and the individual or institution to which the LMO is being sent (Article 18.2b). The Meeting of the Parties to the Protocol is, at an unspecified point, to consider whether and how to develop agreed international standards for identification, handling, packaging and transport practices (Article 18.3). Risk management Parties are required to establish and maintain appropriate mechanisms, measures and strategies to regulate, manage and control risks identified in the risk assessment to the extent necessary to prevent adverse effects of LMOs on their own biodiversity (Articles 16.1 and 16.2). This Article is not formally part of the AIA procedure 17 so it is likely that it can be applied to LMOs in transit and LMOs for contained use 18 as well as to LMO commodities and LMOs for intentional introduction. Parties are also to try and ensure that, any living modified organism, whether imported or locally developed, has undergone an appropriate period of observation that is commensurate with its life-cycle or generation time before it is put to its intended use (underlining added) (Article 16.4). Simplified procedure Parties of import are allowed to specify in advance cases where transboundary movement can take place immediately or cases where LMO imports are exempted from the AIA procedure (Article 13). Bilateral agreements Parties are allowed to enter into bilateral, regional and multilateral agreements concerning LMO exports/imports as long as they are consistent with the objectives of the Protocol and do not provide for weaker biodiversity protection than that provided by the Protocol (Article 14). The Protocol will not affect exports/imports of LMOs taken under such agreements (Article 14.3). Trade with non-parties to the Protocol This Article is particularly important given that the USA has still not ratified the CBD and therefore, until it does, cannot ratify the Protocol, meaning that for the foreseeable future it will be a non-party. The Protocol states that; 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 (Article 24.1) (underlining added). This means that Parties are obliged to trade with non-parties in a manner that is consistent with the objective of the Protocol (i.e. regulating LMOs to conserve biodiversity) but do not have to adhere to its specific provisions. Parties can also negotiate bilateral agreements with non-parties that will be unaffected by the Protocol (Article 14.3). This could result in less stringent protection, especially if the non-party (e.g. the USA) has the political and economic clout to put pressure on the Party to make a bilateral deal that involves weaker regulations than those permitted by the Protocol but is still consistent with the Protocol s objectives. 17 Article 7 (Application of the Advanced Informed Agreement Procedure) states that the AIA procedure is set out in Articles 8,10 and 12. This suggests that Article 16 (Risk Management) is not formally considered as part of the AIA and thus applies to those LMOs that are, in Article 6, only exempted from the AIA procedures (i.e. LMOs for transit and contained use). 18 Assuming that the importing Party has undertaken a risk assessment first. 9

11 Capacity Building The Parties are required to co-operate in the development and/or strengthening of human resources and institutional capacities in biosafety for the effective implementation of the Protocol (Article 22.1). The needs of developing country Parties for financial and technical help shall be taken into account in achieving this objective (Article 22.2). Financial Mechanisms and Resources The Meeting of the Parties to the Protocol is to consider how to use the financial support mechanisms of the CBD to achieve the capacity building objectives in Article 22 (Article 28). The financial support mechanism of the CBD is essentially the Global Environment Facility (GEF). Compliance The Meeting of the Parties to the Protocol is, at its first meeting, to consider and approve cooperative procedures and institutional mechanisms to promote compliance with the Provisions of this Protocol and to address cases on non-compliance (Article 34). These procedures and mechanisms are to be separate from, and will not affect, the dispute settlement mechanisms of the CBD. Accidents, illegal trade and adverse impacts from LMOs Unintentional movements Parties are required to take appropriate measures to prevent unintentional transboundary movements (Article 16.3). If something happens that leads, or may lead, to an unintentional transboundary movement of an LMO that is likely to have significant adverse effects on biodiversity, Parties are required to immediately notify and consult with potentially affected states (Article 17). Illegal transboundary movements Parties are required to adopt domestic measures aimed at preventing and, if appropriate, penalising illegal transboundary movements of LMOs (Article 25.1). Parties affected by illegal LMO movements are allowed to request the Party of origin to dispose of the LMO at its own expense (Article 25.2). Liability and redress The Meeting of the Parties to the Protocol will, at its first meeting, adopt a process aimed at formulating an international liability and redress regime for damage resulting from transboundary movements of LMOs. It shall endeavour to complete this process within four years (Article 27). 6. What is the status of the Protocol in international law? Signature, ratification and withdrawal The Protocol is open for signature from the 15 th -26 th May in Nairobi (COP 5 of the Biodiversity Convention) and then from 5 th June 2000 to 4 th June 2001 at the UN headquarters in New York (Article 36). The Protocol will come into force 90 days after the 50 th state has ratified (i.e. gained domestic parliamentary consent for) the Protocol (Article 37.1). It is expected that it may take up to two years before this happens. For states that ratify subsequently, the Protocol will come into force 90 days after they ratify (Article 37.2). A Party may indicate its wish to withdraw from the Protocol 10

12 any time two years after the Protocol has entered into force for that Party (Article 39.1). The Party can then withdraw one year after it has given written notification of its wish to do so (Article 39.2). The Biosafety Protocol and the WTO An ongoing debate during the negotiations concerned the status of the Protocol in relation to other international agreements, most obviously the rules of the World Trade Organisation (WTO), and in particular the WTO s Agreement on Sanitary and Phytosanitary Measures (SPS) 19. This relationship is important because the two agreements may be deemed to overlap in their coverage. For example, both concern the use of risk assessments in determining the safety of seed commodity imports. However, the SPS Agreement is essentially deregulatory in its objective (it imposes disciplines on national regulations in order to promote trade) as opposed to the primarily regulatory objective of the Biosafety Protocol (that encourages countries to develop national regulations to protect the environment). This means that their detailed provisions differ 20 and a question arises over which agreement should prevail in the event of a conflict. Any potential for conflict, either through formal recognition that the WTO rules take precedence or through lingering doubt over the relationship between the two agreements, could be used by LMO exporters to chill the implementation of the Protocol. It was therefore essential in Montreal to clarify the relationship between the Protocol and the WTO, and to ensure that the Protocol would exist as the guiding standard for trade in LMOs. However, due to persistent pressure from the Miami Group, this was not adequately achieved. The Miami Group wanted a savings clause that would have specifically subordinated the Protocol to other agreements (i.e. the WTO s SPS rules). The other negotiating groups objected to such a clause. The end result, as perhaps would be expected from such an impasse, is essentially a fudge. The compromise reached concerning the relationship between the agreements comprises the following three lines in the preamble of the Protocol: The Parties to this Protocol......Recognizing that trade and environment agreements should be mutually supportive with a view to achieving sustainable development, Emphasizing that this Protocol shall not be interpreted as implying a change in the rights and obligations of a Party under any existing international agreements, Understanding that the above recital is not intended to subordinate this Protocol to other international agreements.... There is no way to stop a WTO member from initiating a dispute in the WTO. However, the preambular wording quoted above is not in itself enough to ensure that a Party that is implementing measures in compliance with the Protocol could not be successfully challenged under WTO rules. The second paragraph above originates from the proposed text of the savings clause and suggests that the Biosafety Protocol should not affect the rights and obligations that states have under WTO rules. In other words, the savings clause proponents would argue that this second paragraph states 19 The SPS Agreement concerns animal and plant life and health (e.g. food and hygiene standards). 20 Two obvious areas where the two agreements differ is in their different language on the Precautionary Principle and in the ability of importers to require exporters to pay for risk assessments in the Protocol, which is not the case under the SPS Agreement. 11

13 that the Biosafety Protocol is subordinate to the WTO rules 21. The third paragraph then cancels this out by saying that the second paragraph is not intended to subordinate the Protocol to WTO rules! This means that we are effectively left with the first paragraph that states that trade and environment agreements should be mutually supportive. The question is; how will this be interpreted if there is a dispute? At the outset, it is important to recognise that, in the event of a dispute over LMOs concerning WTO rules, a WTO Dispute Panel would find it politically very difficult to refuse to proceed with the case, especially given that there is no dispute settlement procedure under the Protocol (at least for the foreseeable future). The key questions are therefore: 1) Will a Panel take the provisions of the Biosafety Protocol into account in its ruling and will these be interpreted as being mutually supportive with WTO rules? 2) If there is a conflict between the provisions, which agreement will take precedence in international law? A state making a complaint to the WTO would be arguing that its rights, most likely under the SPS Agreement, have been infringed. The defendant would be arguing that it is implementing the Protocol and that this measure is either not inconsistent with WTO rules, should be exempt under Article XX of the WTO rules 22, or takes precedence over the SPS rules in international law. The Panel would find it difficult to ignore the Biosafety Protocol in its ruling. Firstly, because Article 3.2 of the WTO Dispute Settlement Understanding requires Panels to apply customary rules of interpretation of public international law when interpreting WTO rules, and secondly because WTO case law has been established (i.e. through a previous WTO Appellate Body ruling) stating that WTO rules must not be interpreted in clinical isolation from other international laws 23. Arguably, in a dispute concerning LMOs and WTO rules, a Panel could interpret WTO rules in light of those in the Protocol to ensure that the two are mutually supportive and that the WTO rules do not conflict with the provisions of a much more recent and more carefully tailored agreement on LMOs that has received broad international consensus. More problematic is if a Panel deems that a Party s implementation of a provision in the Protocol is in conflict with a provision in the WTO rules. The defendant could argue for an Article XX exception under WTO rules, and its case would be strengthened by the very existence of the Protocol. The measure in question would still have to pass the WTO s tests of not constituting arbitrary or unjustifiable discrimination or a disguised restriction on international trade (Article XX, GATT 1994). However it could be argued that implementing a measure consistent with a Protocol agreed by over 130 countries can hardly be characterised as arbitrary, unjustifiable or a disguised restriction on trade. If however, the measure in question did not qualify for an Article XX exemption under WTO rules, the Panel would then have to decide, using the preamble to the Biosafety Protocol, the Vienna 21 It should be noted that, the fact that this language was moved out of an operational provision and into the preamble; that it is further softened by paragraphs one and three; and that it is hard to know exactly what it means on its own, makes it unclear how it is intended to operate in practise. 22 Article XX of the WTO rules (a.k.a GATT 1994) concerns exemptions for reasons such as protecting animal or plant life/health. 23 World Trade Organisation. (1996). United States - Standards for Reformulated and Conventional Gasoline: Report of the Appellate Body (WT/DS2/AB/R). 29 April Geneva. World Trade Organisation. 12

14 Convention on the Law of Treaties 24 and the WTO rules, what the relationship between the Protocol and WTO rules is, and which provision should take precedence. Generally speaking, preambular text is interpreted in international law as a statement of intent that is not normally binding but is used to provide interpretative context for those ruling on a dispute. A WTO Dispute Panel could see the words mutually supportive in the preamble to the Protocol as meaning the Parties to the Protocol think it should be equal to (rather than overriding or being subordinate to) the WTO rules. The Protocol itself therefore does not help establish its primacy over WTO rules in the event of a clash between the two. The Vienna Convention on the other hand states that, where there are treaties covering the same subject matter, the later treaty prevails in the event of a conflict (Article 30.3). Also, a general customary rule of international law is that the more specific treaty should take precedence over a more general treaty. In both cases the Biosafety Protocol should take precedence as it is more recent and more specific. However, a problem may arise if the actual provision under dispute in the Biosafety Protocol is less specific than the WTO rules (e.g. it is an enabling provision rather than a requirement). In this case, the more specific provision (i.e. the WTO rule) may be deemed to take precedence, even if it is less recent. A further complication is the status of non-parties to the Protocol. According to the Vienna Convention, if there is a dispute concerning two treaties on the same subject matter between a state that is Party to both and a state that is Party to one, then the treaty to which both States are parties governs their mutual rights and obligations (Article 30.4b, Vienna Convention on the Law of Treaties). This suggests that the WTO rules will take precedence in a dispute where both states are members of the WTO but only one is a Party to the Protocol (e.g. in a case involving the USA and a Party to the Protocol). A further complication still is that the Vienna Convention requires states that have signed a treaty but not ratified it to refrain from acts which would defeat the object and purpose of the treaty 25 (Article 18 of the Vienna Convention). Although the USA has signed but not ratified the Vienna Convention, it has publicly stated that it will be bound by the Convention s provisions. This means that in the likely event that the USA signs but does not ratify the Biosafety Protocol, it is required not to do anything that would defeat the object of this treaty 26. However, the USA could still make a complaint to the WTO and argue that this is not inconsistent with the purpose of the Protocol, especially given that the two agreements are mutually supportive. Finally, it is worth noting that a very real problem for a WTO Dispute Panel is whether, politically and legally, the WTO can actively say that its own rules are trumped by another agreement. This is perhaps unlikely. What all this points to is continued confusion because the legal relationship between the agreements is not resolved in the preamble to the Protocol. In the event of a WTO dispute: WTO Panels will almost certainly decide to rule on a dispute; they will most likely take into account the existence of the Biosafety Protocol; and, depending on the particular circumstances of the case, the measure could be deemed to mutually support WTO rules or be in conflict with them. In cases of conflict, the measure could either qualify for an Article XX exemption or, if not, the Biosafety Protocol could either take precedence over, or be overridden by, WTO rules - again depending on the details of the case. This situation is not satisfactory as it could undermine both the legitimacy of the multilateral trading system (through further high profile environmental disputes) and sustainable development (through 24 As already mentioned, Article 3(2) of the WTO Dispute Settlement Understanding (DSU) requires the WTO to apply customary rules of treaty interpretation - such as the Vienna Convention on the Law of Treaties - when interpreting WTO rules. 25 Unless the State has clearly stated its intention not to become a Party (i.e. not to ratify). 26 Put simply, the objective of the Protocol is effective LMO regulations to conserve biodiversity. 13

15 attacks on a strong and predictable framework to regulate the transboundary movement of LMOs). The legal relationship between the agreements therefore needs further clarification to ensure that the WTO does not override the Biosafety Protocol. 7. What does this all mean? Introduction Given the strong opposition of the Miami Group to rigorous LMO regulation, the fact that a Protocol has been agreed at all is a landmark achievement. The Protocol contains a number of significant positive developments in the international regulation of LMOs. That said, the hard line of the Miami Group resulted in a number of important weaknesses in the agreement and left some key issues unresolved. Positive outcomes The status of the precautionary principle has been enhanced in international law. Countries can, to some degree, take precautionary decisions concerning LMO imports and the description of the Precautionary Principle in Article 10.6 of the Protocol is an improvement on the definition in Article 5.7 of the WTO s SPS Agreement. It is therefore a positive development in the ongoing process of operationalising the Precautionary Principle in law. The very existence of the Protocol is recognition that genetically modified organisms are different from non-gmos and require special treatment. This weakens the argument used by GMO proponents that GMOs are substantially equivalent to (i.e. almost exactly the same as) their non-gm counterparts and thus should be treated the same in international law. A rigorous AIA procedure was agreed for LMOs for intentional introduction into the environment. Parties of import can require the exporter to carry out or pay for risk assessments. The Protocol makes some provision for financial resources to enable capacity building in developing countries. The negotiating process was a boost for developing country co-operation. The Like Minded Group was a very significant force in the negotiations and showed that developing countries support the development of effective Multilateral Environmental Agreements (MEAs). This Protocol may boost the status of the Convention on Biological Diversity and may allow further important Protocols such as on recognising traditional and indigenous rights over biological resources to be negotiated under the CBD. Unfortunate failures LMO commodities are not covered by the full AIA. The provisions relating to commodities are also vague in places and may therefore be more likely to lead to disputes. LMO commodities should have been covered by the full AIA procedure because, although they are not intended for introduction into the environment, commodities for food, feed and processing will almost certainly find their way into the natural environment. For example, the distribution of animal feed is not so tightly controlled by farmers as to prevent any seed escaping into the natural world and, as the Like-Minded Group negotiators pointed out, it is possible that seed intended as a commodity may well end up being planted. As some have commented, the LMO itself has no way of knowing whether it was intended as a commodity or whether it was intended for intentional introduction. 14

16 The documentation requirements for commodities (i.e. may contain LMOs) means no automatic segregation for LMO commodities. This will have an impact on the traceability of particular LMOs meaning, for example, that if adverse impacts do occur as a result of an LMO commodity import it will be extremely difficult and perhaps impossible to establish liability. Products of LMOs (e.g. Soya milk) are not included in the Protocol at all. Inclusion of products could have brought all GMO regulation under one international framework. Pharmaceuticals for humans are effectively exempted from the Protocol. LMOs in transit and LMOs for contained use are exempted from the Protocol s AIA procedures. There is an over-reliance in the Protocol on domestic regulations. The Protocol also contains many enabling provisions that may be deemed weaker than requirements concerning similar subjects in other international agreements. Unanswered questions The Protocol takes some first tentative steps towards establishing an international liability regime but, if the experience of the Basel Convention on Hazardous Waste is anything to go by, it will take many years before agreement is reached (if at all). For the foreseeable future therefore, exporters will not, in practice, be responsible for what happens once the LMO has legally entered the Party of import. No dispute resolution mechanism has been established. This further increases the likelihood of disputes over interpretation or implementation being taken to the WTO. However, there is a commitment to establish a mechanism in the future. Parties are allowed to take into account socio-economic considerations arising from impacts on biodiversity. Given the hard-line opposition of the Miami Group to the inclusion of socio-economic concerns, the very mention of socio-economic consideration in the Protocol is, in itself, a kind of success. However, it is a little unclear what additional impact the socio-economics provisions will have on decision-making given that biodiversity impacts on their own are already enough to take action on LMO imports. Can there be a successful WTO challenge? It is impossible to be certain. What we do know is: that a Party implementing the Protocol can be challenged in the WTO; that, politically, a WTO Panel is likely to feel compelled to interpret international law as meaning that it has jurisdiction to make a ruling; that the Panel will almost certainly take the Protocol into account in the case; and that the outcome will depend on factors such as the status of the complainant (Party or non-party to the Protocol) and the measures that are being disputed. This uncertainty over the possibility of a successful WTO challenge, could be used (by LMO exporters) as a constant threat that could undermine the effective implementation of the Protocol. Not only could the Protocol be undermined, but also the legitimacy of the WTO itself could be further eroded if it is seen to be being used deliberately to undermine effective LMO regulation. With this in mind, it would be politically difficult, and potentially self-destructive, for a WTO Panel to rule against a measure that is being implemented under the Biosafety Protocol. That said, it would be politically difficult for a WTO Panel to judge that another agreement overrides its own rules. The uncertainty, and the damage that this could do both to the WTO and the Biosafety Protocol means that it is still important to work for a formal clarification that implementing the Biosafety Protocol cannot be overruled by the WTO. 15