Regulations on biosafety D 3.2 57 D 3.2.2 The biosafety protocol Since July 1996 international negotiations have been taking place to develop a biosafety protocol that was to have been concluded in February 1999. Since no consensus had been achieved by that date, adoption ofthe protocol was postponed; no date has been set for further negotiations; the only thing that is certain is that they should be scheduled before May 2000. The aim ofthe protocol is to establish rules that would guarantee an international minimum standard for biotechnology activities. The protocol would be the first agreement (binding under international law) in this field. D 22.214.171.124 Overview The legal basis for the protocol is the Convention on Biological Diversity (Section I 3). Art. 19 para 3 ofthe Convention commits the contracting parties to examine ‘the need for and modalities of a protocol setting out appropriate procedures, [...] that may have adverse effect on the conservation and sustainable use of biological diversity’. Once the expert group had completed its assessment, the second meeting ofthe Conference ofthe Parties (COP-2) in 1995 decided by Decision II/5 to deploy a working group to draw up a draft protocol. This was agreed upon in Cartagena in February 1999 (CBD/BSWG/6 /L.2/Rev.2) but was not adopted by the Extraordinary Meeting ofthe Conference ofthe Parties (ExCOP). In terms of content, the disputed point at the unfinished conference right up to the end was whether and to what degree the following areas or principles should also form part or indeed the basis ofthe protocol: – inclusion of human health as an asset to be protected, – application ofthe protective mechanisms ofthe protocol, – incorporation of socio-economic impact in a risk analysis; placing the precautionary principle at the basis of risk assessment, – the substantive form ofthe advance informed agreement (AIA) procedure. Also, no consensus was reached on the nature or scale of a liability regime in the context ofthe protocol. Experience from other internationally binding agreements has shown that resolving liability questions is difficult and involves a great deal of talk and time. For example, in the context ofthe 1989 Basel Convention on the Control of Transboundary Movements of Hazardous Wastes andtheir Disposal, the contracting parties have still not managed to establish a liability regime that has the support of all parties. To promote a swift conclusion ofthe protocol negotiations at the last, 6th meeting ofthe Biosafety Working Group, a consensus was reached that they will not begin working on the liability rules until the First Meeting ofthe Parties to the Protocol and that work should be concluded within four years. Highly controversial questions have thus been removed from the protocol negotiations and postponed. The Council would like to point out in this context that a sophisticated system of liability – in particular with regard to the preventive function it should assume – is an essential component of an effective biosafety regime. The removal of certain points so expedient for swift consensus must not be allowed to lead to a neglect of this regulatory area. At the 6th meeting ofthe Biosafety Working Group andthe 1st Extraordinary Meeting ofthe Conference ofthe Parties to the Convention on Biological Diversity that immediately followed it, in many areas no progress was made. By contrast to previous sessions, the composition ofthe interest groups had changed. Whereas up to that point the industrialized countries and developing countries (G77 and China) had been on opposing sides, now agreement on a protocol proposed by the EU and advanced with many compromise wordings foundered on a number of large agricultural exporters (Argentina, Australia, Chile, Canada, Uruguay and – although with no voting rights – the USA), even though the proposal catered to the particular interests ofthese countries. LMOs for example that are destined for direct consumption or use as fodder were to be excluded from the AIA procedure (Bai et al, 1999). And the provision that allowed importing states to refuse import, even if there was an absence of scientific certainty, was left out (Art. 8 para 7 ofthe draft protocol). It is nonetheless remarkable that a majority ofthe developing countries and take-off countries (exceptions:Argentina, Chile, Uruguay) advocated a strong biosafety regime during the formulation ofthe protocol. D 126.96.36.199 Details ofthe regulations that are still hotly disputed Including human health in the protocol as an asset worthy of protection Taking a lead from Art. 19 para 3 andthe explicitly protective purpose ofthe Convention on Biological Diversity (CBD), it is argued that the protocol
58 D The use of genetic and species diversity should only protect negative impacts on biological diversity, and not on human health. Likewise, the direct legal basis for the development ofthe protocol, the operative portion of Decision II/5 of CBD COP-2, only refers to biological diversity. However, the considerations expressed in II/5 clearly show that human health is also a concern that was shared by a majority ofthe Parties and that should be addressed by the protocol. Furthermore, Art. 19 para 3 should be read in combination with Art. 8(g) ofthe CBD. The latter provision calls for Parties to subject the use or release of LMOs to a national risk control procedure that should also consider risks to human health. From a European point of view it should be pointed out that Art. 4 ofthe Directive on the Deliberate Release into the Environment of Genetically Modified Organisms (GMOs) (90/220/EEC) obliges the European Union (EU) member states to ensure ‘that all appropriate measures are taken to avoid adverse effects on human health or the environment which might arise from the deliberate release or placing on the market of GMOs’. Furthermore, it is also conceivable under certain circumstances and on the basis of current international law to ban by national legislation the importation of genetically modified products with possible dangerous impact on human health, without violating GATT. According to Art. XX(b) of GATT it remains the right ofthe member states to issue rules to protect the life and health of people, animals and plants within their own territory even if these have the effect of restricting trade. Aware that such broadly defined terms actually invite hidden restriction of international trade, in 1994 the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS) was adopted. According to Art. 2 para 2 ofthe SPS the measures taken may only be applied in the degree necessary for protection ‘on the basis of scientific principles and [may] not be upheld without sufficient scientific evidence’. Pursuant to Art. 5 para 7 a member can in cases in which the scientific evidence in this regard is insufficient, [...] take provisional sanitary or phytosanitary measures [...]. An example that would fall under this exception to the free trade regulation could – although it is not poised for admission onto the market – be the ‘genetically modified (GM) potato’. In a much disputed experiment, a gene was inserted into potatoes that normally protects snowdrops from being eaten by insects and had proved relatively non-toxic in toxicological investigations. Time-intensive experiments that are at present not required in trials leading to commercial approval showed however that the GM potato had significant effects on the development of organs, metabolism and immune system of laboratory animals to which it was fed (Puztai, 1998; Sentker, 1999; Coghlan et al, 1999). One single experiment can certainly not be taken as sufficient scientific proof in the meaning of Art. 2 para 2 ofthe SPS, but Art. 5 para 7 SPS allows national precautionary measures in the case of a recognized, scientific, but not yet proven, risk potential. Scope of application ofthe protocol’s protective mechanisms Opinions differ, first of all, on the extent to which end products (particularly foods) into which LMOs have been processed should be included in the protocol besides ‘living’ modified organisms. Countries that want to give the protocol very narrow scope base their arguments on the wording of Art. 8(g) and 19 para 3 ofthe CBD. These provisions relate only to LMOs, that is living modified organisms. The opposite side demands an effective approach that takes account ofthe comprehensive goals ofthe Rio Summit. This stance is based on a number of scientific studies according to which, in such cases, too, a damaging impact on species diversity and human health cannot be ruled out (Henningsen, 1998b). Furthermore, it should be mentioned that both EU Directive 90/220 and German legislation treat genetically modified organisms andtheir products the same (Art. 1 para 1, 2nd indent ofthe Directive; Art. 2 para 1, No. 4 ofthe German Genetic Engineering Act). There is also lack of agreement on the issue ofthe extent to which agricultural mass-produced goods that are still living that serve as food, fodder or for further processing should fall under the scope of application ofthe protocol. Agricultural exporters issued a vehement call for these goods to be excluded. In the current draft ofthe protocol agricultural commodities are only excluded from the AIA procedure. And so, not just the processed food products are to be excluded (eg cornflakes, soya oil), but also the living products themselves (maize, soya sprouts).The danger for biodiversity is in part seen as low since the foods would not be released into the environment.The considerable danger of an unintentional release speaks crucially in favour oftheir being included however. Another question is whether agricultural commodities constitute a danger to human health.To that extent, the discussion has to be seen in the context ofthe dispute about whether human health enjoys protection under the protocol. If – as is foreseen in the draft protocol – this is affirmed, then it would be illogical to rule out genetically modified foods as a potential source of danger to human health.