EXECUTIVE SUMMARY

It is important for developing countries to regulate genetically modified organisms (GMOs). Two main motivations are that GMO regulation allows developing countries to protect consumer health and the environment and/or to harness the benefits of these new technologies. While there is agreement about the need for a GMO regulatory framework, there are differences in opinion about how strict it should be, as this is influenced by issues such as costs, perceived risks and benefits of GMO release, enforceability and credibility of the regulatory framework. Regulation of some stages or components of the process can be stricter than others. Developing countries currently lack the resources and capacity to adequately regulate GMOs, although there are notable differences between individual countries in this respect, and there is an important need for capacity building activities in this area. Methodology for risk assessment is well described, but there is disagreement whether it can be appropriately applied to GMOs, given their novelty. The social, ethical and economic aspects of GMOs are important but it is not certain that they should be included in the regulatory framework.

The risks of GMOs should be weighed against their benefits as well as the risks of alternative options. There is a strong division over whether GMOs should be regulated differently to non-GM varieties, with participants disagreeing whether it is the process (i.e. genetic modification or not) or the product (the kind of traits expressed) that should be the "regulatory trigger". Particular attention is needed for regulation of GMOs in countries that are also the centres of origin or diversity of agricultural species.

There is general consensus that harmonization of regulatory systems across countries is important (and that existing international agreements/guidelines can assist in this context), but that it should also be possible to retain some country-specific elements in the systems. Co-ordination and harmonization of GMO regulation between the different relevant government ministries within a country is also important. Developing countries wishing to establish a GMO regulatory framework can learn a lot from, but do not need to model it on, the existing regulatory frameworks in developed countries.

There is general support for involving the public in GMO regulatory processes; informing the public about GMOs (including labelling of GM products); and ensuring transparency of the regulatory processes. Monitoring implementation of a GMO regulatory framework may be especially difficult in developing countries due to lack of resources, although some issues are difficult to monitor even for resource-strong developed countries. The cost of regulation, including post-release monitoring of GMOs, is an issue of concern for developing countries, although strategies to reduce it can be considered. The question of liability is important and should be covered in the GMO regulatory framework.

These were some of the main themes and outcomes of a moderated e-mail conference entitled "Regulating GMOs in developing and transition countries", hosted by the FAO Biotechnology Forum from 28 April to 1 June 2003. About 400 people subscribed to the conference and 93 messages were posted over the 5-week period by 44 participants from 20 countries, with half of the messages coming from people living in developing countries. Most messages came from people working in research centres, universities, NGOs and as private consultants, with the remainder from people working in government bodies, UN agencies or farmers' organizations.

Complete summary document: http://www.fao.org/biotech/logs/C9/summary.htm