Term Paper on Modern Biotechnology & International Regulation

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Products derived from modern biotechnology are subject to a growing array of international institutional oversight, both technology based and sector or product based. Over recent years, several new instruments have been elaborated that address biosafety, while existing institutions and regimes have also turned their attention to the development of specific standards on genetically modified organisms (GMOs) or the derivatives of such organisms.

These developments present both a safeguard and a challenge for developing countries. On the one hand, internationally agreed rules and standards aim to ensure that developing countries do not become “testing” or “dumping” grounds for potentially harmful technologies and products.

Negative experiences in relation to hazardous wastes and chemicals have given rise to a cautious attitude on the part of many developing countries when faced with new applications of biotechnology. On the other hand, the international instruments pose implementation and capacity challenges.

In addition, the instruments themselves, being the subject of intense international debate and controversy, incorporate certain “negotiated ambiguities” that suggest that implementation will have to be mediated through further international negotiation. Given the range of applicable instruments, multiple fora exist within which these further negotiations may occur.

Far from setting out a clear “rule -based” system, the current international institutional framework presents developing countries with a series of policy choices that need to be worked out in specific legal and political contexts, including food aid; debt; trade and investment; development assistance; multilateral environmental agreements (MEAs); and World Trade Organization (WTO) membership and the post-Doha negotiations.

In developed countries, GMOs have been the subject of intense policy debate, both within and between States. Significant claims have been made about the capacity of modern biotechnology to contribute to food security, in particular, by increasing agricultural production in developing countries and by enhancing the nutritional value of basic foods.

At the same time, serious concerns have been expressed about the potential impacts of GM crops on the environment and on human health as well as about their potential socio-economic impacts.

With respect to the latter, there are concerns about the potential distributive impacts of GMOs, for instance, under what conditions would GM seeds be made available to farmers and to what restrictions would they be subject; what impact might GMOs have on traditional varieties of crops relied upon by farmers in developing countries and how would they affect centres of origin and centres of diversity of agricultural biodiversity; and what impact might the introduction of GMOs in developed countries have on commodity exports from developing countries?

While scientific opinion regarding the extent of any environmental and health risks remains divided, research has given rise to concerns about a number of potential risks associated with the release and use of GMOs.

These risks tend to fall into a number of categories, including:

(1) The potential impacts of GMOs on non-target species, such as beneficial insects or birds;

(2) The potential for cross-pollination between GM and non-GM (and organic) crops or between GM crops and wild plants-“genetic drift” or “genetic pollution”;

(3) The introduction of non-native or “exotic” species into the environment with the potential displacement of native species, for example, the spread of GMOs as weeds or “volunteers”;

(4) The indirect effects on the environment, for example, through changed agricultural practices, particularly changes in herbicide and pesticide spraying; and

(5) The potential effects on human health, for example, through the consumption of food produced using genetically modified crops and their derivatives.

Two principal areas of concern relate to allergenicity of foodstuffs as a result of introduced proteins and the potential transfer of antibiotic resistance, as a result of the use of antibiotic resistance marker genes in the production of GMOs.

With regard to human health and environmental concerns, most developing countries have tended to emphasize their lack of capacity to assess and manage the risks associated with GMOs. These concerns were strongly expressed during the negotiation of the Cartagena Protocol on Biosafety (Biosafety Protocol).

Developing countries were, on the whole, strongly in favour of the adoption of the Protocol, and they supported a stringent safety assessment and advance informed agreement procedure, the incorporation of the precautionary principle, the possibility to take socio­economic considerations into account when deciding whether to allow imports of a specific GMO, and the primacy of the Protocol over relevant WTO obligations.

While developing countries were attracted to the potential of modern biotechnology to contribute to food security needs, during the debate over the regulation of GMOs and particularly during the Biosafety Protocol negotiations, they tended to stress issues of uncertainty, capacity, social and economic concerns, and priorities relating to food security and the protection of human health and the environment.

In discussions on the labelling of GM food, India, for example, has expressed support for the labelling of all foods derived from modern biotechnology, irrespective of differences with other foods, in order to ensure consumer information and allow consumer choice. By contrast, in discussions in the WTO, developing countries have tended to express concerns about the effect of non-tariff barriers on market access for their goods.

Thus, they have been concerned not to expand the discussion of trade and environment issues in the WTO in a manner that might increase the possibility of unilateral trade-related environmental measures by developed countries, and they have been supporters of the harmonization of international standards, coupled with enhanced participation of developing countries in international standard-setting bodies and capacity building for the implementation of international standards.

Market access concerns have been at the heart of the positions put forward by many developing countries in discussions in the WTO on trade and environment, on technical barriers to trade and on sanitary and phytosanitary measures, and in the context of the Agreement on Agriculture. These positions may seem difficult to reconcile.

To some degree, they may simply be reflective of the different, and often inconsistent, approaches adopted by trade, environment, or agriculture ministries. However, they also represent a more complex reaction to the introduction of a relatively new technology, the benefits and risks of which remain uncertain, and about which gaps in knowledge still exist in relation to the long-term impacts on the environment and on human health and in relation to the potential socio -economic impacts.

Term Paper # 1. International Law and Policy Framework:

International instruments of relevance include the Biosafety Protocol, the International Plant Protection Convention (IPPC) and the Codex Alimentarius. Disciplines on domestic regulation are imposed principally by relevant WTO agreements, particularly the General Agreement on Tariffs and Trade (GATT),the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement),and the Agreement on Technical Barriers to Trade (TBT Agreement).

During the Biosafety Protocol negotiations, there were frequent references to relevant WTO agreements and an attempt to adopt provisions that were prima facie compatible with WTO requirements. In negotiations in the Codex Alimentarius, similar references to the WTO requirements are found.

Discussions on traceability and labelling of GMOs in the Codex may well impact upon future negotiations on the identification and documentation requirements for agricultural commodities under Article 18 of the Biosafety Protocol, and each of these in turn may be subject to consideration within the WTO.

And within the WTO itself, internal coherence poses a challenge as related issues are taken up in different committees and negotiating groups. With relatively little capacity for preparation and participation in these processes, some developing countries can find their interests profoundly affected by rules adopted in processes in which they have played little role.

Law and Institutions:

International institutions have been active in efforts to harmonize approaches to sanitary and phytosanitary regulation and risk assessment between countries in order to minimize trade barriers while allowing countries to apply safety standards. There has been growing activity in the area of international policymaking on modern biotechnology.

New instruments have been developed, and existing instruments and organizations have turned their attention towards the development of sectoral rules and/or standards applicable to GMOs. The result is a complex framework of relevant international rules and standards, many of which are still under development.

There processes are supplemented by numerous international workshops, symposia, and training courses, which are sponsored by governments, international organizations, the private sector, and non-governmental organizations (NGOs).

Thus, one challenge for national policymakers lies simply in keeping up with the international policymaking processes, with all that this implies in terms of human and financial resources, information exchange, preparation for negotiations, and problems of national-level coordination of policy across the relevant fora, for example, among trade, environment, agriculture, and science and technology ministries.

The basic tension inherent in policymaking in biotechnology and biosafety is reflected in Agenda 21. Agenda 21 recognized the potential benefits of biotechnology in contributing to enhanced food security through sustainable agricultural processes.

Among other things, it sought to promote activities to enhance biosafety regulation and international mechanisms for cooperation, as well as enabling mechanisms for the development and environmentally sound application of biotechnology.

In particular, Agenda 21 called for the further development of internationally agreed principles on risk assessment and management of all aspects of biotechnology. It also called for the promotion of the development and application of biotechnologies, with special emphasis on developing countries.

In this regard, it noted that the accelerated development and application of biotechnologies, particularly in developing countries, will require a major effort to build up institutional capacities at the national and regional levels.

In developing countries, enabling factors such as training capacity, know-how, research and development facilities and funds, industrial building capacity, capital (including venture capital), protection of intellectual property rights, and expertise in areas including marketing research, technology assessment, socio-economic assessment and safety assessment are frequently inadequate.

Since Agenda 21, significant developments have occurred in relation to the development of internationally agreed principles on risk assessment and the management of biotechnology. In addition, other developments have occurred that impact on the regulation of biotechnology at the national level.

The three instruments or sets of instruments are:

(1) The 1992 Convention on Biological Diversity (CBD) and the 2000 Biosafety Protocol;

(2) The IPPC;

(3) The Codex Alimenatarius; and

While the primary focus and objective of each of the instruments differs, each represents an effort towards international harmonization of standards and procedures in relation to modern biotechnology. Among these instruments, the Biosafety Protocol and the WTO agreements are presently of primary potential relevance for the movement of GMOs and agricultural biotechnology into developing countries for research and development, field trials, and/or commercial cultivation.

The other instruments are considered briefly, given their ongoing work to generate international standards and guidelines of relevance to GMOs and the status of such standards within the WTO’s SPS and TBT Agreements.

1. The Convention on Biological Diversity and the Biosafety Protocol the CBD, which was adopted in 1992, Specifically Addresses Biosafety in Two Articles:

Article 8 (on in-situ conservation) and Article 19 (on the handling of biotechnology and the distribution of its benefits): Article 8(g) requires Parties, as far as possible and as appropriate, to regulate, manage, or control risks associated with the use and release of living modified organisms resulting from biotechnology that are likely to have adverse environmental impacts that could affect the conservation and sustainable use of biological diversity, taking also into account the risks to human health.

Article 19(4) addresses the trans-boundary movement of GMOs and requires a Party that provides GMOs to another party to provide any available information about the use and safety regulations applicable to those organisms, as well as any available information on the potential adverse impact of the specific organisms concerned to the Party into which they are to be introduced. Article 8(g) and Article 19(4) are binding upon all states Parties to the CBD regardless of whether or not they become Parties to the Biosafety Protocol.

Article 19(3) provides a specific legal basis for the mandate to negotiate the Biosafety Protocol, requiring parties to the CBD to “consider the need for and modalities of a Protocol setting out appropriate procedures, including, in particular, advance informed agreement, in the field of the safe transfer, handling and use of any living modified organism resulting from biotechnology that may have adverse effect on the conservation and sustainable use of biological diversity.” In 2000, the Parties to the CBD adopted a more specific agreement on biosafety under the enabling provision in Article 19(3), the Biosafety Protocol.

The objective of the Biosafety Protocol is: In accordance with the precautionary approach contained in Principle 15 of the Rio Declaration on Environment and Development… 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 trans-boundary movements.

An Intergovernmental Committee for the Cartagena Protocol (ICCP) was established to prepare for entry into force of the Protocol, and it adopted a series of recommendations for consideration of the first meeting of the Parties. The focus of the Protocol is on the trans-boundary movement of GMOs (referred to as “living modified organisms” (LMOs) in the Protocol).

The central procedural mechanism set out in the Protocol to regulate the trans-boundary movement of living modified organisms is advance informed agreement (AIA). The AIA procedure essentially requires that before the first trans-boundary movement of a GMO subject to the AIA procedure, the party of import is notified of the proposed trans-boundary movement and is given an opportunity to decide, within 270 days, whether or not the import shall be allowed and upon what conditions.

This decision must be based upon a risk assessment, carried out in a scientifically sound manner, in accordance with Annex III and taking into account recognized risk assessment techniques.

Article 15 sets out the risk assessment requirements in more detail. Annex III of the Biosafety Protocol contains guidance on the objective of risk assessment, the general principles of risk assessment, the methodology to be applied, and several points to consider in risk assessment.

The Protocol recognizes that risk assessment must be environment specific, that is, it must consider the risks associated with the release and use of the GMO in the environmental conditions into which it is to be introduced. Where there is a lack of scientific certainty about the extent of the adverse effects of a LMO, a Party may take precautionary action to avoid or minimize the potential adverse effects.

The Party of import may also take into account certain socio-economic considerations, pursuant to Article 26 of the Protocol, in reaching a decision on the proposed import. However, any such consideration must also be consistent with that Party’s other international obligations.

In addition, the Biosafety Protocol contains certain obligations regarding public awareness and participation. The obligation to involve the public in decision-making on GMOs is qualified by a reference to national laws and regulations. The Protocol also provides for the protection of confidential information.

The AIA procedure only applies to the first trans-boundary movement of a particular GMO into a country for intentional introduction into the environment (for example, for open field trials or for commercial growing).

Central to the Biosafety Protocol negotiations were attempts by the biotechnology industry and by the Miami Group to carve out an exemption from the procedural rules for agricultural commodities. As a result, separate, and less onerous, provisions apply to the import of LMOs intended for direct use as food or feed or for processing (LMO-FFPs).

This procedure, which essentially comprises a multilateral information exchange mechanism, centres on the biosafety clearing-house (BCH), which was established under Article 20 of the Biosafety Protocol.

On the one hand, Parties that authorize potential LMO- FFPs at the domestic level inform other parties through the BCH; while, on the other hand, Parties that require advance notification and approval before the import of an LMO-FFP into their territory alert other Parties and exporters to this fact through the BCH.

The distinction between the treatment of LMOs and LMO-FFPs in the Protocol is curious, insofar as it was widely recognized during the negotiations that although LMO-FFPs were not intended to be introduced into the environment of the Party of import, they may in practice be released into the environment given the lack of adequate control on the ground-the introduction into the environment could happen accidentally, through spillage during transport, or intentionally, where grains are used as seeds in the receiving country.

The import and export provisions of the Biosafety Protocol are backed up by requirements, setting out what information must be provided in documentation accompanying trans-boundary movements of GMOs. This information is intended to provide a means to identify and track trans-boundary movements of GMOs; provide information to the Party of import at the border; and offer a contact point for further information about the consignment in question. The specific requirements vary according to the intended use of the GMOs in question.

The Protocol does not prohibit trade in LMOs between Parties and non-Parties, but it requires that such trans-boundary movements be carried out in a manner “consistent with the objective” of the protocol. This was the subject of significant debate during the Protocol negotiations since one of the major exporters of GMOs, the United States, is presently unable to become a party to the Biosafety Protocol as it has not yet ratified the CBD.

Provisions on capacity building and financial resources are incorporated into the Biosafety Protocol and are subject to further elaboration. In relation to capacity building, it is notable that during the negotiations developed countries were concerned to limit any obligations in this regard to capacity building in biosafety rather than to biotechnology as such.

Developing countries, on the other hand, sought more extensive commitments extending to biotechnology per se. A compromise was adopted referring to capacity building in “biosafety, including biotechnology to the extent that it is required for biosafety”. The Biosafety Protocol does not contain specific provisions relating to the settlement of disputes arising under it.

Instead, it relies on the relevant provisions of the CBD, which provide for optional judicial or arbitral settlement or compulsory (at the request of one party), but non-binding, conciliation. In this respect, the Protocol is significantly weaker than the WTO agreements. The Protocol also provides for the establishment of a non­compliance procedure.

2. International Plant Protection Convention:

The IPPC is aimed at achieving international cooperation in controlling pests of plants and plant products (including grains) and in preventing their international spread, particularly their introduction into endangered areas. The convention, which was originally adopted in 1951, was revised in 1979 and again in 1997. The 1997 convention introduces significant changes, particularly with respect to the elaboration and adoption of international phytosanitary standards, and explicitly reflects WTO principles.

Phytosanitary measures are to be technically justified on the basis of conclusions reached using an appropriate pest risk analysis or other comparable evaluation, and they are not to be applied in such a way as to constitute either a means of arbitrary or unjustified discrimination or a disguised restriction, particularly on international trade.

The 1997 version of the convention is not yet in effect, with the amendments that it introduces requiring ratification by two- thirds of the parties to the IPPC. The 1997 IPPC incorporates a process for the development of international standards for phytosanitary measures. Pending the entry into force of the 1997 IPPC, an Interim Commission on Phytosanitary Measures (ICPM) has been established.

The ICPM has established a working group to develop a detailed standard specification on plant pest risks associated with LMOs/products of modern biotechnology. Thus, there is some subject matter overlap between the development of a standard for plant pest risks under the IPPC and the procedures and guidelines established under the Biosafety Protocol, although the subject matter of the Protocol is broader.

The ICCP has urged the ICPM to ensure that the standards to be developed are in harmony with the objective and all relevant requirements of the Biosafety Protocol. International standards adopted under the IPPC are the standards, guidelines, and recommendations recognized as the basis for phytosanitary standards applied by WTO members under the SPS Agreement.

While the IPPC does not explicitly refer to food security, it seeks to control the introduction and spread of pests of plants and plant products that may threaten food crops. The changes introduced in the 1997 IPPC suggest that this control is increasingly to be achieved through international harmonization of phytosanitary standards, developed through the Committee on Phytosanitary Measures within the FAO.

However, Contracting Parties retain the sovereign right to regulate the entry of plants and plant products into their territory, for example, through import controls, quarantine and inspection requirements, and movement restrictions, subject to the conditions laid down in the IPPC.

Article III of the 1997 IPPC states that, nothing in the convention shall affects the rights and obligations of the contracting parties under relevant international agreements. It seems clear that rights established under the IPPC are to be exercised in accordance with obligations under the WTO.

In some respects, this approach seems to suggest an inversion of the WTO/IPPC relationship. The IPPC contains a conciliation based dispute settlement procedure, whereby a committee of experts can be established to look into technical aspects of a dispute between two Contracting Parties and make recommendations.

This procedure is stated to be complementary to, and not in derogation of, dispute settlement procedures provided for in other international agreements dealing with trade measures. Materials produced by the IPPC Secretariat suggest that the committee of expert’s procedure in the IPPC may generate useful findings for WTO dispute settlement and that the IPPC Secretariat could provide technical background to the WTO’s dispute settlement processes and nominate experts for WTO panels. A subsidiary body on dispute settlement has been established by the ICPM.

3. Codex Alimentarius:

The Codex Alimentarius Commission is a FAO/World Health Organization (WHO) body that elaborates standards, general principles, guidelines, and recommended codes of practice in relation to food safety. The Codex has underway a number of relevant processes addressing principles of risk assessment for genetically modified foods and related labelling and other issues.

A Task Force on Foods Derived from Biotechnology has elaborated a set of .Draft Principles for the Risk Analysis of Foods derived from Modern Biotechnology for consideration by the Codex Alimentarius Commission in 2003.

The Codex Committee on Genial Principles has undertaken work on Draft Working Principles for Risk Analysis to guide work within the framework of the Codex itself. This addresses, inter alia, issues of scientific uncertainty and incomplete scientific data in the standard- setting process.

The same Committee has also commenced work on draft principles of risk analysis for food safety, which are intended to provide guidance to governments. It has held discussions on traceability or product tracing, and is to develop a definition of this concept for Codex purposes.

The Committee on General Principles is also considering a Draft Revised Code of Ethics for International Trade in Foods, which may provide further scope for the consideration of food security issues within the Codex. The Committee on Food Labelling is drawing up proposed draft guidelines for the labelling of food and food ingredients obtained through certain techniques of genetic modification/genetic engineering.

Other work of potential relevance to modern biotechnology is taking place in the Committees on Food Import and Export Inspection and Certification Systems and on Methods of Analysis and Sampling. As with the IPPC standards, national sanitary and phytosanitary measures that conform to the Codex standards, recommendations, or guidelines are deemed necessary and presumed to be consistent with the WTO SPS Agreement.

Stakes within the Codex are higher since the adoption of the WTO agreements, as governments seek to have their own national approaches reflected in international standards that will benefit from a presumption of WTO consistency. The proper relationship between work in the Codex and relevant WTO rights and obligations is now a prominent feature of Codex debates.

The plethora of Codex committees and other bodies, as well as the working practices of the Codex Alimentarius have tended to limit meaningful participation by developing countries in its work. Efforts have begun to enhance developing country participation in the standard setting process.

Term Paper # 2. Legal and Political Interactions:

Legal interactions arise as the scope and applicability of each instrument may overlap to some degree and issues of legal compatibility arise, as well as issues of “institutional economy” in terms of avoidance of duplication. Political interactions arise as links are built between the political and administrative institutions of the various bodies in an effort to mediate the substantive overlaps.

i. WTO and MEAs:

The relationship between the Biosafety Protocol and the WTO is part of a more wide-ranging discussion on the relationship between the WTO agreements and MEAs, which focuses on how MEAs that require or authorize trade measures relate to the relevant WTO rules. While no dispute has yet been brought to the WTO in relation to such measures, it is clear that such concerns now influence the negotiation of MEAs, as the Biosafety Protocol negotiations themselves illustrate.

The broader WTO/MEA relationship is currently being addressed within the WTO’s CTE. While, this issue has been on the CTE’s agenda for several years, discussions so far have been general and inconclusive. At the fourth ministerial meeting in Doha, the CTE received a specific and renewed mandate to address the MEA question.

Paragraph 31 of the Doha Ministerial Declaration provides:

With a view to enhancing the mutual supportiveness of trade and environment, they agree to negotiations, without prejudging their outcome, on:

i. The relationship between existing WTO rules and specific trade obligations set out in multilateral environmental agreements (MEAs). The negotiations shall be limited in scope to the applicability of such existing WTO rules as among Parties to the MEA in question. The negotiations shall not prejudice the WTO rights of any Member that is not a party to the MEA in question;

ii. Procedures for regular information exchange between MEA Secretariats and the relevant WTO committees, and criteria for the granting of observer status;

iii. The reduction or, as appropriate, elimination of tariff and non-tariff barriers to environmental goods and services.

This text in itself hints at some of the controversies that have dogged the WTO/MEA relationship. The reference to “mutual supportiveness” is now familiar, having been used in the text of the Protocol itself as well as in other MEAs and recently in the WSSD Plan of Implementation. Yet the practical implications of the term remain unclear.

Paragraph 31(i) makes clear that any WTO outcome on the MEA relationship will preserve the position of non-parties to an MEA (for example, for the foreseeable future, the position of the United States in respect of the Biosafety Protocol). And subparagraph (ii) reflects the difficulties that have arisen for MEA secretariats in securing observer status in relevant WTO bodies.

For example, the CBD Secretariat has been mandated by its Conference of the Parties (COP) to seek observer status in the Council to the Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS Agreement),the Committee on Agriculture, and in relation to the protocol, the SPS and TBT Committees.

WTO members have engaged in a prolonged debate over the applicable criteria for observer status, which is linked to broader considerations of external transparency, and influenced by the strong “member-driven” nature of the WTO.

In relation to the post-Doha negotiations on the WTO/ MEA relationship, MEA secretariats were only in early 2003 granted ad hoc observer status in the special negotiating sessions of the CTE, although without prejudice to the broader question of observer-ship in the Doha negotiations for intergovernmental organizations, including MEAs, which remains under discussion in the WTO General Council and the Trade Negotiations Committee.

ii. Negotiation and Evolution of the Biosafety Protocol:

In the context of the broader WTO/MEA debate, and given the significance of international trade in GMOs and GM commodities, the negotiations of the Biosafety Protocol were permeated by concern and debate about the potential relationship between the Protocol and the relevant WTO agreements.

The two sets of agreements both potentially address the same subject matter, namely the trans-boundary movements of GMOs, but in the context of different objectives. Concerns therefore arose as to whether the agreements might impose conflicting obligations upon countries that were both WTO members and parties to the Biosafety Protocol. This concern was acute because of the trade measures inherent in the AIA procedure in the Protocol as well as in other aspects of the Protocol, such as identification requirements.

In the event that such a conflict between treaty provisions arose, there would also be a question as to which agreement would prevail between countries that are parties to both. Under international treaty law, the general position is that, as between countries that are both parties to agreements on the same subject matter (such as Parties to the Biosafety Protocol and members of the WTO), the treaty that is later in time would prevail.

In addition, it is generally accepted that under customary international law, the more specific treaty will prevail. Other concerns relate to the fact that not all countries trading in GMOs are likely to become parties to the Biosafety Protocol, raising potential issues of uneven international commitments.

During the Protocol negotiations, discussion focused on whether to include specific language addressing the relationship between the Protocol and the WTO. Proposals from most developing countries favoured explicitly giving primacy to the Biosafety Protocol.

The Miami Group of countries favoured a “savings clause,” which would have specifically preserved rights and obligations under existing international agreements. Others favoured silence on this issue, allowing for the operation of general rules of international treaty law.

iii. WTO and International Standards:

Under the SPS Agreement, if domestic SPS measures conform to standards or guidelines promulgated under the Codex Alimentarius, the IPPC, or the International Office of Epizootics, they are deemed to be necessary to protect human, animal, or plant life or health and (rebuttably) presumed to be consistent with the relevant provisions of the SPS Agreement and the GATT 1994.

In any event, members are required to base their SPS measures on such standards where they exist, unless they can provide scientific justification for a higher level of protection. The SPS Agreement may identify other relevant international organizations that are open to the membership of all members the standards, guidelines, or recommendations of which will be presumed to be consistent with the SPS Agreement and the GATT.

So far, no additional organizations have been so identified. In contrast to the SPS Agreement, the TBT Agreement does not identify specific international standard setting organizations in this regard, but rather defines an “international body or system” as “a body or system whose membership is open to the relevant bodies of at least all Members.”

Thus, in principle, the Biosafety Protocol could potentially be considered to be the source of international standards for the purposes of the TBT Agreement-for example, in relation to the identification requirements for shipments of GMOs.

For the present, the status of the Protocol under the SPS Agreement can be contrasted with that of the Codex and the IPPC. For the time being at least, the Biosafety Protocol’s relationship with the WTO can be characterized primarily as part of the broader trade and environment relationship rather than as an aspect of the relationship between the WTO and the constellation of international standard-setting bodies.

This relationship has practical implications, for example, with respect to observer status. At the same time, the role of the Codex and, to a lesser extent, the IPPC, is considered by some to have changed the nature of these bodies, resulting in the politicization of what were previously narrower technical fora.

As the significance of the role of the Codex standards in the WTO has been more fully understood, demands have grown for greater participation in the Codex by governments and civil society and for greater transparency in its work. Given the privileged status that the Codex standards have under the SPS Agreement, some commentators have cast them as now being, in practice, “binding,” although this view does not seem to be supported by the WTO Appellate Body.

Some concerns have been voiced that, given this status, developing countries participating in the Codex may seek to lower Codex standards in light of concerns about market access for their goods. The SPS Committee has adopted procedures to monitor the use of international standards.

The TBT Committee has adopted a decision on the Principles for the Development of International Standards, Guides and Recommendations with Relation to Articles 2.5 and Annex 3 of the TBT. This decision sets out certain additional criteria to determine whether or not an international standard can be used as a basis for TBT compliance, including transparency, openness, impartiality and consensus, effectiveness and relevance, coherence, and the development dimension.

Concerns have been expressed that the TBT Committee may have in effect trespassed into the areas of competence of other international bodies. Other analysts have suggested, however, that ” the purpose of the decision was not to dictate to other international organizations how they should proceed but rather to encourage the participation of members in the law making (standard setting) bodies to which the TBT seems to have lent certain quasi-legislative authority.”

iv. Political and Administrative Interaction:

While the instruments and agreements are all relevant to GMO regulation, they each have different mandates and objectives. In the interests of coordination, a range of political and administrative interactions between the various instruments has developed.

This interaction ranges from cross-representation as observers in negotiating fora, through administrative interactions and cooperation between secretariats, including information exchange, to the possibility of input into dispute settlement processes. There was a degree of political interaction between the WTO and the Biosafety Protocol during the Protocol negotiations.

At this time, the CBD Secretariat was invited to brief an informal meeting of the SPS Committee on developments in relation to the Protocol, even though the CBD Secretariat did not have observer status in the Committee.

The WTO Secretariat was present as an observer at the later sessions of the Open-Ended Ad Hoc Working Group on Biosafety (BSWG) as well as at the sessions of the Extraordinary Meeting of the Conference of the Parties (ExCOP), which negotiated the Biosafety Protocol.

However, it has been noted that although a representative of the WTO addressed the Protocol negotiators, and informal consultations were established between the convention Secretariat and the WTO, this interaction had little impact on the negotiations, and the WTO departments dealing with issues specific to the Protocol were absent.

The Protocol negotiations may also, paradoxically, have received a fillip from the failure of the WTO Ministerial Conference, which was held in Seattle in December 1999, shortly before the final negotiating session for the Protocol was scheduled to resume.

The Seattle meeting had before it two proposals to establish a working group on biotechnology within the WTO, and it was widely considered that if these proposals had been taken up, the Biosafety Protocol negotiations, which had been suspended in February 1999, would have been sidelined.

The failure of the Seattle ministerial meeting is generally credited with giving fresh impetus to the Protocol negotiations, in part by emphasizing the urgent need to address biosafety issues through an environmental agreement lest the issue be subsumed in the trade negotiations agenda, and in part by making negotiators keen to avoid successive failures in multilateral negotiations.

The CBD Secretariat has been requested by the Parties to the CBD to seek observer status in various WTO committees, including the CTE, the SPS Committee, the Committee on Agriculture, and the TRIPs Committees. While observer-ship for MEAs in the CTE has been granted, even this status has proved to be contentious with respect to the negotiating sessions of the CTE in relation to the post Doha negotiations on the WTO and MEAs, on the grounds that negotiations should not be open to observers.

Until the decision in early 2003 to admit MEA observers on an ad hoc, meeting-by-meeting basis, interactions on the post-Doha negotiations had taken place in information exchange sessions and in regular meetings of the CTE.

Observer status in relation to other relevant committees has proven to be even more difficult to achieve. By contrast, given their special status under the SPS Agreement, the Codex Alimentarius, the IPPC, and the International Office of Epizootics are granted observer status in the SPS Committee. The observer status controversy in the WTO stands in contrast to the relatively open admission of observers in most MEAs.

There exist possibilities for involvement of other organizations and conventions in the WTO dispute settlement should a dispute on GMOs arise. Article 11(2) of the SPS Agreement refers to the possibility of seeking advice or establishing advisory technical experts groups in disputes involving scientific or technical issues.

In fact, panels in the early SPS cases have sought advice, where relevant international bodies, such as the Codex, have been asked for input regarding appropriate experts. Article 11(3) of the SPS Agreement also preserves the right to use the dispute resolution procedures of other organizations or agreements (including the CBD).

There also exists a more general right of panels to seek information in Article 13 of the DSU, which could be utilized to obtain input from other international organizations and agreements addressing GMOs in the event of a dispute on this issue. Administrative interactions between the various bodies have also been established.

For example, the IPPC and the CBD Secretariat have agreed a memorandum of understanding to facilitate cooperation regarding the work being carried out under the Biosafety Protocol and the ICPM’s work on plant pest risks of GMOs. This device has been used frequently by the CBD to promote cooperation with conventions and organizations dealing with related subject matter.

Many of the international bodies relevant to the GMO regulations also participate in the Inter-Agency Network on Safety in Biotechnology. This network was initially composed of a number of intergovernmental agencies working in the field: the Consultative Group on International Agricultural Research (CGIAR), the CBD, the FAO, the International Centre for Genetic Engineering and Biotechnology (ICGEB), the International Office of Epizootics, the Organization for Economic Co-operation and Development, the UNCTAD BioTrade Initiative, the UN Development Programme, the UN Industrial Development Organization, the FAO/WHO Codex Alimentarius Commission, and the WTO.

The purpose of the network is to exchange information and facilitate cooperation. It issues a newsletter describing the various activities of the organizations and is meant to hold regular meetings. However, it is already notable that at the first meeting at least not all relevant intergovernmental organizations were involved.

For example, the UN Environment Programme (UNEP) and the Global Environment Facility (GEF) were not represented, despite an ongoing capacity-building program on biosafety. Moreover, in keeping with other UN attempts at synergy and promoting inter linkages between intergovernmental organizations; there is no sign as yet that the Inter-Agency Network on Safety in Biotechnology is intended to go beyond information exchange and general coordination by seeking a rationalization of goals and activities.

v. WTO and Domestic Biosafety Measures:

The relative lack of experience with GMOs worldwide, and the fact that countries are at very different stages in terms of their research and development into, and acceptance and use of, GMOs, suggests that countries regulating GMOs may well reach different conclusions about the appropriate level of protection to be achieved for the environment or for human health; about the acceptable levels and types of risk; about the interpretations of what constitutes risk and of the available scientific evidence; about the workability and effectiveness of risk management measures; and about the significance of socio-economic factors in reaching decisions on the import and use of GMOs.

Discussions between WTO members on GMO regulation have taken place in the SPS and TBT Committees under the transparency provisions of these agreements. However, at the time of writing, no disputes involving GMOs have been decided by a panel or the Appellate Body.

Before May 2003, only one request for consultations had been made in relation to trade restrictions on GMOs, and it resulted in resolution without recourse to a panel. However, in May 2003, requests for consultations were submitted by the United States, Canada and Argentina in respect of approval processes for GMOs applied by the European Communities. Several other WTO members, sought to join these consultations.

Existing GATT/WTO case law on the relevant agreements may provide some guidance as to how a panel or the Appellate Body may assess domestic biosafety measures that are justified on environmental or health grounds. Measures taken in relation to imports of GMOs or their products could potentially fall under the GATT, the TBT Agreement, or the SPS Agreement, and any challenge of such a measure would likely raise alternative arguments under each agreement.

Although the relationship between the GATT, the SPS Agreement, and the TBT Agreement has yet to be fully explored by the WTO dispute settlement system, it appears that the three agreements were designed to work in a hierarchy that allows the most specific agreement to have priority.

The main distinction between each agreement is the extent to which it either identifies specific policy objectives behind the measures that it regulates or singles out the specific category of measures that it regulates. The TBT and the SPS Agreements were adapted to “further the objectives” and to “elaborate rules for the application of the provisions” of the GATT.

These more specific agreements could arguably be applied in the place of the GATT to any measures that fell within their defined scope. The TBT Agreement specifically provides that it will not apply to sanitary and phytosanitary measures as defined in the SPS Agreement, while the SPS Agreement clarifies that it will not affect the rights of members under the TBT Agreement with respect to non-SPS measures. For example, it would appear that a mandatory GMO labelling scheme, because it is a technical regulation, would be analyzed under the TBT Agreement.

However, if the scheme were being applied for one or more of the health and food safety-related objectives set out in the SPS Agreement, it would then fall exclusively within the scope of that agreement. Which WTO agreement will apply to a measure will therefore depend, in part, on the objectives invoked to justify it.

In this sense alone, it may be difficult to predict with certainty the outcome of a particular dispute on GMOs. An analysis of the relationship between the WTO agreements and any trade related measure taken in accordance with the Biosafety Protocol must, therefore, begin with an understanding of the policy objective behind the measure. What, in other words, is the risk that the measure is designed to protect against?

In the case law under the SPS Agreement to date, the Appellate Body has addressed and clarified a number of aspects of the agreement. For example, the WTO Appellate Body has reaffirmed that countries retain the sovereign right to establish their own appropriate level of protection of human, animal, and plant health, which may be “zero risk”. While the appropriate level of protection is an objective, the SPS measure is an instrument selected to attain or implement that objective.

The Appellate Body has strongly underscored the requirement for domestic SPS measures to be based on risk assessment and has explored the relationship between risk assessment, the appropriate level of protection, and the measure applied to achieve that level of protection.

In addition, it has elaborated the meaning of science-based risk assessment and considered the factors to be taken into account in risk assessment. It has also considered the appropriate role of the WTO panels in evaluating whether measures that are the subject of complaint meet the requirements of the SPS Agreement.

A risk assessment within Article 5.1 of the SPS Agreement must:

i. Identify the diseases (or pests) whose entry, establishment or spread a Member wants to prevent within its territory, as well as the potential biological and economic consequences associated with the entry, establishment or spread of these diseases;

ii. Evaluate the likelihood of entry, establishment or spread of these diseases (or pests), as well as the associated potential biological and economic consequences; and

iii. Evaluate the likelihood of entry, establishment or spread of these diseases (or pests) according to the SPS measures which might be applied.

“Likelihood,” in this case, corresponds to “probability,” and it is insufficient merely to demonstrate the “possibility” of entry, establishment, or spread of pests or diseases. The risk evaluated in the risk assessment must be an ascertainable risk rather than a theoretical uncertainty.

While panels and the Appellate Body have characterized scientific risk assessment as a process characterized by systematic, disciplined and objective enquiry and analysis, that is, a mode of studying and sorting out facts and opinions, “the Appellate Body has also indicated that the list of factors to be taken into account in risk assessments under Article 5.2 of the SPS Agreement is not necessarily a closed list”.

It has suggested that risk assessment might incorporate qualitative as well as quantitative analysis and that “the risk is to be evaluated in a risk assessment under Article 5.1 is not only risk ascertainable in a science laboratory operating under strictly controlled conditions, but also risk in human societies as they actually exist, in other words, the actual potential for adverse effects on human health in the real world here people live and work and die”.

“It is not necessary that a member that adopts an SPS measure carries out its own risk assessment, however; it may be justified on the basis of an assessment carried out by another member or by an international organization”. Moreover, risk assessment need not necessarily rely solely on the majority view in the scientific community, but it can set out divergent views, which may in themselves reflect a state of scientific uncertainty.

There will be “scientific justification” for an SPS measure, within Article 3.3 of the SPS Agreement, if there is a “rational relationship” between the SPS measure and the risk assessment that is, the results of the risk assessment must “sufficiently warrant” or “reasonably support” the SPS measure at stake-and this relationship will be assessed on a case-by-case basis.

According to the Appellate Body, it operates as a qualified exemption from the obligation under Article 2.2 of the SPS Agreement not to maintain SPS measures without sufficient scientific evidence. In Japan – Measures Affecting Agricultural Products (Japan – Varietals), the Appellate Body confirmed that the four requirements set out in Article 5.7 are cumulative.

Thus, a member may adopt an SPS measure provisionally only if this measure is:

(i) Imposed in respect of a situation where “relevant scientific information is insufficient”; and

(ii) Adopted “on the basis of available pertinent information.”

And it may only maintain such a measure if it:

(i) “Seeks to obtain the additional information necessary for a more objective assessment of risk”; and

(ii) “Reviews the… measure accordingly within a reasonable period of time.”

The obligation actively to seek additional information is one of the more apparent points of difference between the SPS Agreement and the Biosafety Protocol. With respect to this obligation, the Appellate Body has observed that the SPS Agreement does not set out explicit requirements regarding the additional information to be sought or a specific procedure for collecting such information, nor does it specify the results to be achieved.

However the information sought must be “germane to conducting risk assessment.” What constitutes a “reasonable period of time” for Article 5.7 “has to be established on a case by case basis and depends on the specific circumstances of each case, including the difficulty of obtaining the additional information necessary for the review and the characteristics of the provisional SPS measure”.

In EC Measures Concerning Meat and Meat Products (Hormones) (Meat Hormones case), in which the EC did not seek to rely explicitly on Article 5.7 on the basis that the measure in question was not provisional, the Appellate Body noted that the precautionary principle is reflected in other provisions of the SPS Agreement that allow members to set their own level of protection and that “representative governments commonly act from perspectives of prudence and precaution where risks of irreversible, e. g. life-terminating, damage to human health are concerned.” 

The panels and Appellate Body have also addressed the issue of burden of proof in SPS cases and the proper role of the panels in assessing domestic SPS measures (the “standard of review”). The onus is on a complainant to make a prima facie case that the SPS measure at issue is inconsistent with a provision of the agreement-that is, that it is maintained without sufficient scientific evidence.

Once this case is made, the burden of proof moves to the defending member to counter or refute the claimed inconsistency. The standard of review goes to the extent to which the panels can undertake their own review of whether the member’s risk assessment justifies a particular SPS measure and to what extent they should show deference to members. This issue goes to the crux of current debates over the role of the WTO in relation to national environmental and human health measures.

The Appellate Body has observed that the standard of review must reflect the balance established in the SPS Agreement between the jurisdictional competences conceded by Members to the WTO and the jurisdictional competences retained by the Members for themselves.

“According to the Appellate Body, in accordance with the DSU, panels must undertake an objective assessment of the facts,” and thus the applicable standard is neither one of de-novo review nor one of “total deference.” The level of protection selected by a member is not of itself subject to review by the WTO panels or the Appellate Body, rather it is the extent to which a measure designed to achieve that level of protection meets the other requirements of the SPS Agreement and other WTO rules that may be reviewed.

SPS measures challenged in the WTO to date have been found wanting, either on the basis that they were not based on a proper (or any) risk assessment or on the basis that a country implementing a provisional measure did not fulfill all the requirements under Article 5.7 of the SPS Agreement.

Nonetheless, the approach taken by the Appellate Body suggests that there would be scope to defend a trade-based biosafety measure designed to address ascertainable environmental and health risks.

However, the emphasis on the risk assessment procedure in the SPS Agreement, and now in the Biosafety Protocol, emphasizes the need for regulatory and administrative procedures capable of collecting or generating, and assessing, information on which to base domestic regulatory measures.

In this regard, Charnovitz has noted that “the SPS Agreement-which was largely initiated by the US government, favours those countries that have a surfeit of administrative procedures. Governments that can produce a voluminous risk assessment, show that it was considered by regulators, and document each step of the regulatory process will probably do better as SPS defendants than countries with thinner regulatory structures”.

If a domestic biosafety measure does not fall within the SPS Agreement, it may be assessed under the TBT Agreement. The TBT Agreement applies to all measures affecting the trade in any products that are technical regulations or technical standards as long as these measures do not fall under the SPS Agreement.

These measures may include trade restrictions on products containing certain substances. There has so far been little analysis of the TBT Agreement in case law, although the Appellate Body has observed that it imposes obligations on members that seem to be “different from and additional to, the obligations imposed on Members under the GATT 1994.”

In relation to a GATT analysis, a central aspect of any dispute in relation to GMOs may be whether or not they are deemed “like” their non- GM counterparts. Case law on Article III.4 of the GATT has identified four general criteria in analyzing “likeness” for the purposes of the like products test.

These are:

(i) The properties, nature, and quality of the products;

(ii) The end-uses of the products;

(iii) Consumers’ tastes and habits-more comprehensively termed consumers’ perceptions and behaviour with respect to the products; and

(iv) The tariff classification of the products.

In EC – Measures Affecting Asbestos and Asbestos- Containing Products, the Appellate Body emphasized that these criteria are simply tools to assist in the task of sorting and examining the relevant evidence. They are neither a treaty-mandated nor a closed list of criteria that will determine the legal characterization of products.

The Appellate Body also found in this case that health risks associated with a product may be pertinent in an examination of “likeness” under Article III.4, as were consumer tastes and preferences, including as they relate to health risks. If a domestic biosafety measure were to be assessed under the GATT, it is likely that the country imposing it would seek to justify it under paragraphs (b) or (g) of Article XX, the general exceptions provision.

The member defending the measure bears the burden of provisionally justifying it under one of the policy objectives enumerated in the subparagraphs of Article XX, including showing it as being necessary to the protection of “human, animal or plant life or health” (Article XX(b)) and, under certain conditions, related to the conservation of natural resources (Article XX(g)).

If a member succeeds with its provisional justification, it must then demonstrate that the measure is not being applied in an arbitrary or unjustifiable manner and is not a disguised restriction on trade. Measures taken under the Biosafety Protocol to regulate GMOs that “may have adverse effects on the conservation and sustainable use of biological diversity, taking also into account risks to human health,” would appear, as a general matter, to be necessary or related to the objectives of the protection of human, animal, or plant life or health or of the conservation of natural resources.

The GATT and WTO panels and the Appellate Body have elaborated on the interpretation of Article XX (b) and (g) in case law. In relation to Article XX (b), according to the Appellate Body, a measure would not be considered necessary if an alternative measure, which the member could reasonably be expected to employ and which is not inconsistent with other GATT provisions, is available to that member.

“By the same token, in cases where a measure consistent with other GATT provisions is not reasonably available, a Member is bound to use, among the measures reasonably available to it, that which entails the least degree of inconsistency with other GATT provisions”.

The question of whether a particular measure meets this “least degree of inconsistency” test will require a case by case analysis. The Appellate Body has held that when determining whether a less trade restrictive measure was “reasonably available,” it will assess the extent to which the measure “contributes to the realization of the end pursued.”

“It has also observed that “the more vital or important the common interests or values” pursued by the measure, the easier it would be to accept as, “necessary” measures designed to achieve those ends.” The international recognition, in the Biosafety Protocol, of the special character of GMOs and of the need to protect biological diversity, may provide relevant evidence of “common interests and values.”

3. Socio-Economic Considerations:

Despite the intensity of international activity, there are still significant gaps in the international framework on modern biotechnology. The emphasis both in the norms adopted to date and in those under development remains on technical and procedural requirements for harmonizing risk assessment procedures in relation to risks to human health and to the environment posed by GMOs.

Developing countries have emphasized the need to address impacts of modern biotechnology more broadly, for example, by considering socio-economic issues, liability and redress, as well as technology transfer. These have been addressed only partially and in ambiguous terms to date.

Much of the debate around the role of biotechnology in promoting food security in developing countries has focused on socio-economic impacts, in particular, on the conditions under which GMOs might be made available (for example, licensing arrangements and impacts on the ability of farmers to save and re-use seed) and on the potential impacts of GM crops on traditional crop varieties.

Concerns have also been expressed that developments in modern biotechnology could give rise to substitutions of crops traditionally exported from developing countries, thus
reducing export revenues. In some circumstances, the potential impacts of a particular GMO upon biological diversity, plant or animal life or health, or human health may give rise directly to related food security or socioeconomic concerns.

In others, socio-economic concerns not specifically related to direct impacts on biodiversity or health might be raised by the potential use of GM crops. Thus, food security concerns related to the use of GMOs in agriculture might emanate directly from concerns about environmental/biodiversity or human health risks associated with a GMO, from concerns about potential impacts on other agricultural crops, or from broader concerns about socio-economic impacts in regard to food production patterns and access to seeds and so on.

In some respects, international agreements and instruments that have been adopted to date on biotechnology may constrain the consideration of some of these broader concerns, with their emphasis on “science- based” decision-making procedures.

This section examines the way in which socio-economic considerations have thus far been integrated into the international regulatory framework for GMOs and the opportunities that have arisen to expand the role of food security concerns into domestic decision-making on GMO imports and use.

Given the extent to which socio-economic issues have been raised in the debate, it is perhaps surprising that the role and impact of socio-economic considerations in decision making on imports and the use of GMOs remains relatively undefined in international instruments.

While it is recognized that decisions on imports of GMOs should take into account the assessment of risks on human health, on the environment, and on plant health, little detailed prior evaluation of the potential socio-economic impacts of the use of a specific GMO in the country concerned has been provided for.

Yet if modern biotechnology is to be promoted as a tool to contribute to food security, it would seem logical to undertake a specific analysis of potential food security and other socio-economic impacts before the technology or specific products are introduced.

Such an analysis could reasonably incorporate not only the potential impacts on agricultural productivity but also the broader distributive impacts. As observed above, food security is not express by mentioned in the Biosafety Protocol, although it was raised as a concern in discussions concerning socio -economic considerations.

During the negotiation of the protocol, many developing countries proposed that socio-economic considerations should be part of the risk assessment procedure. The original draft Protocol submitted by the African group contained extensive provisions on socio-economic considerations.

An early proposal listed the parameters of a risk assessment to include the following socio-economic considerations:

i. Anticipated changes in the existing social and economic patterns; possible threats to biological diversity, traditional crops or other products, and, in particular, farmers’ varieties and sustainable agriculture;

ii. Impacts likely to be posed by the possibility of substituting traditional crops, products, and indigenous technologies through modern biotechnology outside of their agro-climatic zones;

iii. Anticipated social and economic costs due to the loss of genetic diversity, employment, market opportunities, and, in general, means of livelihood of the communities;

iv. Disruptions to social and economic welfare; and

v. Possible effects contrary to the social, cultural, ethical and religious values of communities.

The remit of this proposal was unacceptable to most developed countries, although some, such as Norway, were prepared to see socio-economic concerns reflected in the Biosafety Protocol in some way. Other countries, such as Bolivia and Mexico, emphasized the importance of economic impacts on centres of origin and genetic diversity.

Early in the Protocol negotiations, in preparation for the second meeting of the BSWG in 1997, the Secretariat was asked to prepare a bibliography on potential socio-economic impacts of biotechnology but further studies were not conducted as part of the negotiation process.

While the Biosafety Protocol does address socio­economic considerations in Article 26, it remains unclear how far this provision goes in meeting broader concerns that have been raised around biotechnology products, such as ethical concerns and issues of property rights or local preferences. The scope of Article 26 remains to be defined, both in national legislation and in practice, and perhaps in further elaboration by the meeting of the Parties to the Protocol.

While Article 26 would appear to extend to the impacts on local crop varieties used by indigenous and local communities (and potentially to related, but indirect, impacts), it is more debatable whether it would extend to more general socio-economic impacts of the use of GMOs in a country-for example, such as what happens to local/national food production patterns as a whole and how this affects different groups.

In addition, the phrase “consistent with their international obligations” indicates that a country’s conduct in relying upon Article 26 can be tested against other applicable international agreements, including WTO agreements. The lack of data and analysis on the socio­-economic impacts of modern biotechnology makes it difficult to foresee the impact of Article 26.

Some parallels may perhaps be seen with the provisions of the TRIPS Agreement and the CBD on intellectual property rights. At the time of the negotiation of the TRIPS Agreement, little analysis was available on the inter-linkages between biological diversity and intellectual property rights. Subsequent attempts to raise these issues within the CBD itself have been inconclusive, but they have prompted calls from the COP to the CBD for case studies and analysis of the interrelationship.

In addition to Article 26, there are other provisions in the Biosafety Protocol that may support the consideration of food security concerns within the context of decision­ making on imports of GMOs. For example, in general terms, during the AIA procedure, Parties are to consider the potential impacts of the GMO on biological diversity in their territory.

Under these provisions, Parties may consider in the context of risk assessment the possible impact of introduced GMOs on other agricultural and non- agricultural biological diversity. The preamble to the Biosafety Protocol refers to the importance of centres of origin and centres of genetic diversity.

Information on such centres is also to be provided in notifications under the AIA procedure and in relation to LMO-FFPs and to be taken into account in the risk assessment process. These types of considerations have been of particular concern in the recent case of apparent “contamination” of traditional maize varieties in Mexico with the Bt. gene.

Finally, Article 16(5) of the Protocol, which provides for collective action by Parties in relation to certain GMOs or traits, may provide some scope for action related to food security concerns where these concerns arise out of adverse effects of LMOs on the conservation and sustainable use of biological diversity or risks to human health.

Given the lack of firm guidance on the scope of acceptable socio-economic considerations, it is difficult to predict how governments will implement Article 26. Stabinsky notes that as both quantitative and qualitative data are used in social impact analysis and that to an extent it is therefore subjective, “any [social impact assessment] is likely to be highly contested, in particular when the benefits and costs of the impacts are not evenly distributed, and a finding goes against the interests of either the major beneficiaries or those bearing the largest burdens of impact.”

The factors enumerated in Article 5.3 are:

“The potential damage in terms of loss of production or sales in the event of the entry, establishment or spread of a pest or disease; the costs of control or eradication in the territory of the importing Member; and the relative cost-effectiveness of alternative approaches to limiting risks.” During the negotiation of the SPS Agreement, there was debate over whether “other economic considerations and genuine consumer concerns” should be a factor in risk assessment.

The TBT Agreement, in Article 2.2, requires that technical regulations imposed by members are not prepared, adopted, or applied with a view to, or with the effect of, creating unnecessary obstacles to international trade and are not more restrictive than necessary to fulfill a legitimate objective.

A non-exhaustive list of legitimate objectives is provided, including national security requirements, the prevention of deceptive practices, the protection of human health or safety, animal or plant life or health, or the environment. A more appropriate route for accommodating socio-economic concerns may be through provisions of the WTO agreements on special and differential treatment or through enhancing the assessment of broader development implications of the agreements.

In this regard, certain debates and proposals in the context of the Agreement on Agriculture negotiations may be instructive, along with the declarations and objectives of other international policy fora.

Codex Alimentarius principles on the elaboration of food standards also provide for the consideration of certain “other legitimate factors relevant for the health protection of consumers and for the promotion of fair practices in food trade”. Such factors may be identified in the risk management process, but are not to affect the scientific basis of risk analysis.

The Codex Alimentarius Commission has stated that the feasibility of risk management options due to the nature and particular constraints of the production or processing methods, transport and storage, especially in developing countries, may be considered; and that concerns related to economic interests and trade issues in general should be substantiated by quantifiable data.

In its fourth session, the Codex Task Force on Foods Derived from Biotechnology considered possible future work on such foods within the Codex. Among the proposals for future work were discussions of broader issues related to genetically modified food such as ethics and socioeconomic considerations; other legitimate factors related to modern biotechnology; and special needs of developing countries.

Economic impacts of plant pests have been considered in the IPPC, and in 2003 the Interim Commission on Phytosanitary Measures adopted guidance on the term “potential economic importance”. Other international processes have provided alternative fora for countries to raise socioeconomic concerns, including food security, associated with biotechnology.

However, these processes have to date generated incomplete or non-binding outcomes. For example, the (CGRFA) draft 1993 Code of Conduct for Biotechnology appears to contain a more wide ranging concept of socioeconomic considerations than either the Biosafety Protocol or the SPS Agreement.

The aim of the code was to maximize the positive effects and minimize the possible negative effects of biotechnology. Work on the draft code was suspended pending the completion of the Biosafety Protocol and the revision of the International Undertaking on Plant Genetic Resources.

Article 8 of the draft code, on prevention and mitigation of possible negative effects provides:

In order that they can act to foresee and prevent possible negative socio-economic effects of agro and food biotechnologies, Governments and international organizations should develop, as part of their procedures for Technology Assessment, monitoring and assessments of the socio-economic impacts of biotechnologies, in particular on developing countries and local communities.

Governments should consider the establishment of mechanisms to provide technical and financial assistance to affected farming communities and countries to mitigate adverse socioeconomic effects due to particular developments in biotechnology. Further, Article 10 provides for research on criteria and indicators of the contribution of biotechnology to sustainability in agriculture and the use of plant genetic resources, noting that such criteria should include both scientific and socio-economic aspects.

The status of the draft code was reviewed at the most recent session of the CGRFA in October 2002. A number of FAO members had supported continued work on the code, notwithstanding the adoption of the Protocol and the International Treaty on Plant Genetic Resources, suggesting a wide range of possible issues that could be addressed, such as the socio-economic impacts of biotechnological advances on agricultural practices and food security, ethical issues, the substitution of traditional agricultural products, the control of the global agro-food system, liability issues, and incentives to promote appropriate biotechnologies. Some FAO members and stakeholders opposed further development of the code.

More generally, issues regarding biotechnology are being debated in other international fora concerned with food security, the right to food, and ethics in food and agriculture. These for encompass a range of bodies concerned with issues of human rights, ethics, and equity.

Such initiatives, while not solely focused on the role of biotechnology in contributing to food security, can provide useful inputs to broaden the debate. They include the work of the UN Special Rapporteur on the Right to Food, appointed by the Commission on Human Rights, and the FAO Panel of Eminent Experts on Ethics in Food and Agriculture.

The special rapporteur has criticized the emphasis on free trade and biotechnology as key ways of reducing hunger in the final declaration of the World Food Summit: Five Years Later and has recommended that alternative policy options be given greater attention at the international level.

The declaration called on the FAO, in conjunction with the CGIAR and other international research institutes, to advance agricultural research and research into new technologies, including biotechnology. The comments of the special rapporteur on GM food aid provoked strong criticism from the United States.

The biotech debate may also feature on the agenda of the newly created Intergovernmental Working Group, which was established by the FAO Council as a subcommittee of the Committee on World Food Security to craft voluntary guidelines to support member states efforts to achieve the progressive realization of the right to adequate food.

This action is intended to follow up paragraph 10 of the Declaration of the World Food Summit: Five Years Later. The issues of biotechnology and biosafety did not feature as prominently as might have been expected in the formal outputs of the WSSD in 2002, although they were the focus of significant debate and discussion at events taking place around the summit.

The WSSD Plan of Implementation invites all states that have not already done so to ratify the CBD and the Biosafety Protocol and calls for enhanced scientific and technical cooperation on biotechnology and biosafety, including exchanging experts, training human resources, and developing research-oriented institutional capacities.

Some countries have already sought to accommodate in their national legislation socio – economic concerns associated with modern biotechnology and have thus adopted national regulations on biotechnology/biosafety, which go beyond environmental and health risks to also address socio-economic and/or ethical concerns.

Consideration for the approval of deliberate releases of GMOs into the environment takes into account whether the release represents a benefit to the community. EC Directive 2001/18 on the Deliberate Release into the Environment of Genetically Modified Organisms recognizes that member states may take into consideration ethical aspects when GMOs are deliberately released or placed on the market as or in products.

However, the directive does not accord a specific role to ethical issues in the risk assessment and decision-making process-this being within the preserve of the member states.

The directive also provides for consultation of an Ethics Committee. The first report on the operation of the directive, which is due in 2003, will include an assessment of the socio-economic implications of deliberate releases and placing on the market of GMOs.

The New Zealand Act on Hazardous Substances and New Organisms also requires as part of the approval process for release of a GMO, information on potential socio-economic impacts, including its impacts on indigenous communities, culture, and traditions.