Regulations on biosafety D 3.2 55 tions a milder measure might be intensified monitoring of products from the country in question. It should be considered that such trade restrictions might be in conflict with the WTO/GATT trade regime. Its Committee on Trade andthe Environment (CTE) does, however, indicate that possible disputes between member states of a multilateral environmental agreement that provides explicitly for trade measures (as is the case with CITES) should be solved in that forum and not through the WTO arbitration procedure (WTO, 1996). Public impact and awareness-raising The concept behind CITES has not proved successful in all cases (WBGU, 1995a). Despite its limited approach andthe difficulties in implementation, however, it makes an important contribution to the global system to protect species diversity, andthe scope it does offer should continue to be used and expanded. In particular, by categorizing various species in Appendix I, the public has become sensitized to the problem of extinction. The trade ban on ivory was discussed in detail in the press and in many cases substitute products have been found, for example synthetic materials instead of leopard skin for coats or substitute materials for ivory (Sand, 1997). This type of public impact could be promoted through targeted publicity work and increased transparency (Section I 3.3).A meaningful supplement for directing economic use beyond the conservation approach of CITES is sustainable tourism (eg sustainable safaris, national parks; Section E 3.7). Species conservation can be linked to economic benefits for local communities in those cases. D 3.2 Regulations on biosafety D 3.2.1 Why do we need international regulations on biosafety? Great expectations are being attached to genetic engineering – particularly in the area of agriculture and food. There is a hope that this new branch ofthe economy will create additional jobs and secure economic growth. Developing countries should benefit from the new technology as a component of effective poverty reduction strategies, or yield increases through genetically engineered herbicide resistance or saline and drought tolerance (Henningsen, 1998a). Biotechnology, in particular release experiments with genetically modified organisms (living modified organisms, LMOs), are however associated with certain risks (naturalizing of transgenic plants andtheir uncontrolled spread, negative secondary effects, impact on foods). In its risk report the Council assigned certain transgenic plants in this area of application of genetic engineering to the Pythia risk class (WBGU, 2000a). Characteristic of this risk class is the high degree of uncertainty both with regard to the probability of occurrence andthe scale of damage. In neither case do we have sufficient certainty of assessment. Risk awareness developed first of all in the industrialized countries. New biotechnological methods were developed in those countries and that is also where there was the first need for release experiments and, consequently, the first political debates and legislative procedures. The national regulations turned out to vary greatly; but they all have in common the fact that there is a bureaucratic procedure that has to be gone through with a duty to acquire information that must be submitted at high costs as a prerequisite for approval (Dederer, 1998). There is a certain incentive to implement such experiments and tests in countries where such rules are not in place. In some cases firms have carried out such release experiments without sufficiently informing the countries in question and thus have ‘exported’ the risks associated with the tests. Generally, the countries that were affected were those that, as a result of a lack oftheir own biotechnology industry, saw no reason to act to put regulations in place. Risks were therefore exported from industrialized countries to developing and take-off countries without the latter being sufficiently included in the resultant new insights into patent protected products. The danger of insertion of transgenic elements into the environment is high, particularly in those regions where there are species-related wild plants. Several crop species, such as maize, potato and tomato, but also certain species of cotton, originated in the countries of South and Central America. Despite that fact, insect-resistant and herbicide-resistant cotton were tested by the Calgene company in Bolivia and Argentina (1991) and genetically manipulated tomatoes that are able to delay their maturing process (Flavr Savr) were tested in Chile and Mexico (1990 and 1991) (Shiva et al, 1996; GRAIN, 1994). However, biotechnology and genetic engineering are among the key technologies ofthe coming decades. Within the industrialized countries there is, therefore, competition for the best sites for biotechnological and genetic research.The legal frameworks represent one ofthe main competitive factors in that context (Dederer, 1998). Insofar, there is the danger, given the (still) deficient knowledge of potential damage, of underestimating the risks in order not to create competitive disadvantages for one’s own
56 D The use of genetic and species diversity industry in the area of biotechnology, or prevent a business drain. Box D 3.2-1 gives an overview of existing international regulations affecting biosafety. A binding protocol under international law on biosafety is therefore necessary for the following reasons: • A protocol would have the advantage of harmonizing existing national legislation and thus particularly in terms ofthe assessment procedures, creating an easily understood minimum standard that would rule out site advantages at the cost of biological diversity or human health. • Developing countries could be protected against the risk of becoming the testing and experimental ground, without sufficient safety precautions, for genetically manipulated varieties from industrialized countries (Graziano, 1996; Hunter et al, 1998). • The impact of release often cannot be limited to one national territory; an international agreement with a common protection standard would provide the neighbouring states with greater security. • The codification by means of a binding document under international law would send a strong political signal with regard to the importance ofthe topic in hand (cf Montreal Protocol on Protection ofthe Ozone Layer). Box D 3.2-1 Biological safety in existing international law Soft-law regulations There are currently no comprehensive arrangements under international law addressing the issues surrounding biosafety; there are however various ‘guidelines’ initiated by international organizations that regulate aspects of biosafety on a voluntary basis. • Codex Alimentarius: the Codex Alimentarius Commission (CAC) was established in 1962 by the FAO and WHO to create a programme to establish food standards. The Commission now comprises 162 states. The aim ofthe programme is to guarantee consumer protection in the area of food and creation of fair standards in the trade in food (Art. 1 a CAC).To fulfil these tasks, the CAC drafts standard or has these drawn up by suitable organizations (Art. 1 c). These food standards form a collection, the Codex Alimentarius, which is published and adapted to developments (Art. 1 d, e).They have no binding power on member states, but are considered internationally recognized recommendations (Decision ofthe General Assembly 39/248). Under that aspect, genetically treated foods also fall under the general protective regimen ofthe Codex, but the latter does not contain specific regulations governing genetic modification. For many governments, the Codex Alimentarius is primarily an interesting instrument for breaking down non-tariff trade barriers; therefore, the reduction of trade barriers has moved more and more to the forefront ofthe Commission’s work over the last few years (Merkle, 1994). • UNIDO (United Nations Industrial Development Organisation) Voluntary Code of Conduct: The UNIDO secretariat developed a Code of Conduct for the release of organisms into the environment. The Code contains recommendations to national legislators to create laws according to which when geneticall modified organisms are released the responsible national authorities should be involved. Simple notification is sufficient, however, no approval is required (Shiva et al, 1996). • Code of Conduct for biotechnology:The Commission for Genetic Resources for Food and Agriculture that was formed in 1983 at the FAO conference and now has 158 members developed a Code of Conduct governing the use of biotechnology. A preliminary draft was divided into four Chapters, Chapter 3 focussing amongst other things on the concerns surrounding biosafety issues. In 1993 the Commission stopped its work on this area ofthe Code since biosafety issues fall more under the auspices ofthe CBD. The recommendation was made that the drafts drawn up so far should be seen as suggestions for future regulations (Shiva et al, 1996; FAO CL 103/Rep). • UNEP International Technical Guidelines for Safety in Biotechnology: Under Decision II/5, in which the Second Conference ofthe Parties to the CBD in 1995 commissioned a working group to draw up a biosafety protocol, the urgency of creating binding rules for the safe use of biotechnology was underlined. These guidelines were to serve as orientation until the protocol was adopted.They contain the parameters of existing protective provisions and, above all, regulations in the area of risk management, information exchange and capacity building. • Chapter 16 of AGENDA 21 is dedicated to the environmentally sound use of biotechnology and calls above all for the development of risk assessment and management rules for all areas of biotechnology. Binding regulations under international law • Art. 19 Paragraph 4 CBD: This provision in the Convention on Biological Diversity, that prescribes that the exporting states have a duty to provide information with regard to the possible adverse impact ofthe use of living modified organisms, is binding under international law. • The International Plant Protection Convention (IPPC): This Convention entered into force in 1952, currently has 106 members and was revised in 1979, 1983 and 1997. The aim ofthe Convention is to prevent and contain epidemic plant diseases. In this connection the member states may, pursuant to Art. 4, impose import restrictions and bans with regard to certain plant varieties.Within its protective scope, the Convention is also applicable to genetically modified plants, ie also to seeds. Since, however, the purpose ofthe IPPC is to prevent the spread of plant epidemics, the measures mentioned above could only be used if this danger were impending and emanated from a genetically modified plant (Shiva et al, 1996; FAO, 1998a).