Considerations for safety in biotechnology induced industrialized countries to develop national biosafety regulations. Lack of such regulations has raised concerns about developing countries becoming testing grounds for biotechnological R&D. This fear led to a proposal to include biosafety provisions in the Convention on Biological Diversity (CBD). However, opinions on content and scope of such a binding international protocol still differ, as became clear during the two meetings of the Biosafety Working Group.

In Agenda 21, the action programme adopted in Rio de Janeiro in June 1992 by the United Nations Conference on Environment and Development (UNCED), adequate safety and border-control procedures are seen as a precondition for the community at large to benefit from biotechnology. In 1995, the Conference of the Parties (CoP) to the CBD established the Open-ended Ad Hoc Working Group on Biosafety (Biosafety Working Group) to develop a draft international protocol on biosafety.
In its first meeting in Denmark in July 1996, the Biosafety Working Group meeting was limited to definitions and formulation of country positions. In its second meeting in Montreal, Canada, from 12 to 16 May 1997, the Working Group attempted to provide detailed descriptions of the possible core elements of the protocol.
Both the meetings revealed a number of differences of opinion on the core issues, which generally coincide with the division between countries that have been applying modern biotechnology for some years now and countries that have not. The first group of countries including Canada, Japan, United Kingdom and USA, has acquired experience with their respective national biosafety regulations. Biotechnology in these countries is mainly driven by the private sector which has invested considerable amounts in biotechnology R&D and would like to reap the benefits from its investments. Only a biosafety protocol that will not form an undue burden on biotechnology activities in these countries will be acceptable.
The group of countries with little or no experience with biosafety regulations are counting on the international protocol to ensure protection against any adverse impact of biotechnologically altered organisms from foreign countries. A internationally agreed detailed instrument could overcome the inadequacy of their domestic regulatory system. They thus emphasise the need for transparency and consideration of liability and compensation issues.

Scope of the biosafety protocol
Not surprisingly, one of the first issues is the objective of the biosafety protocol. Based on the mandate of the Biosafety Working Group the objective of the protocol could be to establish an efficient and effective framework for the development of international cooperation aimed at ensuring safe transfer, handling and use of organisms modified by biotechnology. The protocol will especially focus on 'transboundary' (i.e. across national borders) movements of any biotechnologically altered organism that may have an adverse effect on the conservation and sustainable use of biological diversity.
This mandate was a consensus reached at the second CoP meeting in Jakarta, Indonesia, broadly between two different views. On the one hand, a number of countries, including the Group of 77 and China, called for a protocol that covers R&D, transfer, handling, use and disposal involving any biotechnologically altered organism that may adversely affect the conservation and sustainable use of biological diversity. As stated before, most of the countries of this group lack adequate R&D capacities in modern biotechnology, and have not developed national biosafety regulations yet. They wish to be protected by an international instrument from any harm from imported modified organisms. Environmental non-governmental organizations (NGOs), such as the Third World Network and Greenpeace International, call for a moratorium on the release of genetically modified organisms until a legally-binding protocol is concluded. In other fora, some African countries have proposed a moratorium as well.
On the other hand, most industrialized countries preferred to restrict the protocol to the transboundary movement aspects. These countries have national biosafety regulations in operation, to which transboundary movements could be an interesting complement. They consider R&D, domestic handling, use and disposal a matter of national sovereignty, not to be regulated by an international protocol.

LMOs, biodiversity and socio-economics
In existing regulations, the range of modified organisms to be regulated can be specified primarily on the basis of the risks posed by the organisms (product-based system) or on the basis of the type of technology used (process-based approach). In the product-based systems such as the US biosafety regulation, the key factor is that the organism is a (plant) pest or derived from a (plant) pest. In the process-based regulatory systems such as the European Union (EU) biosafety regulation, the concern stems from the fact that some biotechniques combine heritable genetic material in ways that do not occur naturally. These systems, therefore, provide lists of such biotechniques including essentially recombinant DNA techniques.
In a process-based approach, regulations refer to 'genetically modified organisms' or 'genetically engineered organisms'. For the biosafety protocol within the CBD the term 'living modified organisms' (LMOs) has been accepted. This term refers to living organisms "resulting from biotechnology that may have an adverse effect on the conservation and sustainable use of biological diversity" (Article 19.4 of the CBD). This means that elements of both the process-based system (resulting from biotechnology) and product-based system (organisms that may affect biological diversity) are combined.
Potential adverse effects of LMOs on the conservation and sustainable use of biological diversity may occur when inserted genes are unstable; resistant LMOs affect non-target species; LMOs transfer inserted genes to wild relatives or to other unrelated organisms e.g. through vector-mediated horizontal gene transfer and recombination; LMOs replace indigenous species; or, LMOs have adverse effects on ecosystem processes, e.g. on plant nutrient cycles. Methods to quantify these adverse effects need to be agreed upon as well as the lower limit of the adverse impacts that will trigger the regulatory process.
In order to be clear and specific about which LMOs to regulate, a number of countries, including EU member countries, Australia and Malaysia support the view that agreed lists of potentially harmful LMOs should be created. These countries generally use lists in their own biosafety regulations. LMOs could possibly be classified according to their level of potential risk. Such lists should facilitate the development of management strategies proportionate to the risks. This system would fit the provision of deregulation and/or notification in the USA, i.e. the possibility of excluding from the requirement of risk-assessment studies certain groups of no-risk or low-risk LMOs that have become sufficiently familiar.
Other countries and some NGOs, however, oppose the creation of such lists of high-risk and low-risk LMOs. They stress that the biosafety risk of an LMO varies according to the intended use and the environment in which it is applied. An LMO which is found harmless in one country, and is therefore deregulated, may prove harmful in another country, and vice versa. Consequently, an assessment of biosafety risks of LMOs can never be based on the characteristics of the organism, its parents and the vectors alone. Because of this opposition, the EU member countries nuanced their position towards a combination of lists of LMOs and the identification of categories of environments and intended uses based on potential risks.
It should be noted, however, that lists of LMOs and their risks will be compiled anyway as part of the general information exchange in the Advance Informed Agreement (AIA) procedure put forward in the CBD, or within the clearing house mechanism established by the CBD. If the lists are accepted and developed, countries or regions will have to develop the capacity required to review LMOs in the light of intended uses and their specific environments.
Although it is generally agreed that the use of some LMOs may interfere with traditional production systems and lead to substitution of export crops from the South, and thus increasing unemployment, a number of industrialized countries are opposed to the inclusion of socio-economic aspects in the regulatory process. Some countries perceive this attitude as hypocritical since, for example, the EU partly based its ban of a recombinant bovine growth hormone on socio-economic impact studies (see also Monitor No. 27). A number of countries, including member states of the EU, would favour a separate agreement on socio-economic considerations. Human health and ethical factors are other elements that could be considered in the decision about which LMOs should be regulated by the protocol. Existing regulations however, do not provide guidance on how to assess socio-economic and ethical factors in the context of an international protocol on biosafety.

Transboundary movement of LMOs
Transboundary movement, which is the main focus of the biosafety protocol, can occur deliberately or unintentionally by air, ground or water. An important difficulty in defining the scope of the protocol is the definition of the limits of 'transboundary movements' and their effects. The definition can also include the impacts of LMOs after these have been received by the importer (which would enable the inclusion of socio-economic aspects in the protocol); transboundary consequences even if the LMO itself did not cross the border; or long term effects of, in particular, unintended transboundary movements. Once LMOs are in widespread agricultural and/or commercial use, unintended transfer across national boundaries can occur. A solution to problems of unintended transfer lies in making comprehensive risk assessments, i.e. not confined to national or regional boundaries as is the case in current biosafety assessments. The feasibility of such risk assessments and the practicalities of post-commercialisation monitoring of LMOs are questionable.

Advance informed agreement procedures
Advance informed agreement (AIA) procedures are one of the main procedures of the protocol. The scope of AIA procedures will probably extend to the organisms and activities covered by the protocol itself. Mainly based on experience with their national regulations, a number of countries including EU member countries, Norway and Switzerland consider that an AIA procedure involving a reply from the importing country within a specified time frame (the so-called explicit procedure) should apply only to an initial transboundary movement of LMOs. Subsequent movements, and LMOs for use for R&D under contained conditions, could be dealt with by a prior or simultaneous notification (i.e. an announcement of the transfer to the competent authority in the importing country without any need for a reply). However, other countries fear that notification provisions and implicit AIA procedures (for which lack of reply means agreement) may enable unauthorized introductions of LMOs and compromise the effectiveness of an AIA procedure.
Another issue is which information should be provided by the exporting country. Some of the information needed for a well informed risk assessment and management is considered confidential. Some countries, e.g. Marshall Islands, believe that exporters may use confidentiality as an argument to hide useful information. To avoid this situation, Malaysia, among other countries, suggests a provision in the protocol on how to handle confidential information.

Risk assessment and management
Negotiators of the biosafety protocol generally consider risk assessment and management as the key to safety in biotechnology. Most countries without national biosafety regulations favour the inclusion of detailed risk assessment and management mechanisms in the protocol for the sake of transparency, consistency and comparison. Other countries, such as Colombia, New Zealand, Switzerland and the USA, consider the establishment of risk assessment and management mechanisms a national matter since it has to take into account local conditions including, according to some, socio-economic and ethical considerations. Therefore, they support only minimum standards or general principles, such as the principles described in the UNEP International Technical Guidelines for Safety in Biotechnology as opposed to legally binding provisions. As a way to foster consensus, some proponents of a detailed protocol suggest that detailed risk assessment and management methods be referred to in an annex to the protocol.

Liability and compensation
A number of countries demanded provisions on liability and compensation in the biosafety protocol in Montreal. They not only emphasized the perceived magnitude of potential risks posed by LMOs, but also that such an arrangement would strengthen the observance of the protocol. These countries refer to principles accepted in the Rio Declaration on liability and compensation for adverse effects of environmental damage caused by activities within one country's jurisdiction or control to other areas. Provisions on liability may decrease public biosafety concerns by providing reassurance that when damage occurs, compensation will be available for those affected.
The inclusion of liability and compensation into the protocol requires agreement on a number of core issues such as the definition of damage; the definition of the scope of the activities to be covered by the liability regime, in particular the limits of the concept 'transboundary movement'; the time scale taking into account the potentially long period between the introduction of the LMO and the occurrence of damage; and monitoring and compliance mechanisms.
The opponents of the inclusion of the issues of liability and compensation in the protocol claim that the CoP should address these issues under Article 14 of the CBD because consideration of these issues in the framework of the biosafety protocol might prejudice the discussions by the CoP. Some of the opponents consider the issues to be a national concern.

Implementation mechanisms
A general agreement exists about the implementation mechanisms to be established:

• national focal points to serve as an interface with government's capacities for risk assessment and management;
• mechanisms to oversee the protocol;
• financial resources to implement activities relating to safety in biotechnology.

Director, Biodiversity and Biotechnology Programme, International Academy of the Environment, 4, Chemin de Conches, CH-1231 Conches, Geneva, Switzerland. Phone (+41) 22 789 1311; Fax (+41) 22 789 2538; E-mail kalemani.mulongoy@iae.unige.ch

Sources
P. Chasek, D. McGraw and D. Putterman (1996), "Summary of the First Meeting of the Open-ended Ad Hoc Working Group on Biosafety." Earth Negotiations Bulletin. Vol. 9, No.48.

C. Carpenter, M. LL, D. Davenport and E. Gardner (1997), "Report of the Second Meeting of the Open-Ended Ad Hoc Group on Biosafety." Earth Negotiations Bulletin. Vol. 9, No 67.

K.J. Mulongoy (ed.) (1997), Transboundary Movement of Living Modified Organisms Resulting from Modern Biotechnology: Issues and opportunities for policy-makers. Geneva, Switzerland: International Academy of the Environment.