BIOSAFETY ISSUES RELATED TO BIOTECHNOLOGY FOR SUSTAINABLE
AGRICULTURE AND FOOD SECURITY
This paper provides information on current activities of FAO in particular in relation to standard setting in the field of Biosafety. In this paper, biosafety is considered in relation to the use of genetically modified organisms (GMOs) in food and agriculture. In agriculture, (including animal husbandry, fishery and forestry), the concept of biosafety involves assessing and monitoring the effects of possible gene flow, competitiveness and the effects on other organisms, as well as possible deleterious effects of the products on health of animals and humans. Policy decisions taken in regard to biosafety may have long-term implications for the sustainability of agriculture and food security.
Within the WTO, biosafety in relation to GMOs appears to fall chiefly under the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement). There are also implications for GMOs in standard-setting under the Agreement on Technical Barriers to Trade (TBT Agreement). This Agreement covers a large number of technical measures that seek to protect consumers from economic fraud and deception and measures concerning human, animal and plant life and health not covered by the SPS Agreement, and the environment.
INTERNATIONAL STANDARD SETTING WITHIN THE FRAMEWORK OF FAO
FOOD STANDARDS: THE CODEX ALIMENTARIUS COMMISSION
The purpose of the Codex Alimentarius Commission is to protect the health of consumers, to ensure fair practices in food trade, and to promote coordination of all food standards work undertaken by international governmental and non-governmental organizations. The Commission's Medium-term Objectives include inter alia "consideration of standards, guidelines or other recommendations as appropriate for foods derived from biotechnology or traits introduced into foods by biotechnology on the basis of scientific evidence and risk-analysis and having regard, where appropriate, to other legitimate factors relevant for the health protection of consumers and promotion of fair practices in food trade".
The 23rd Session of the Codex Alimentarius Commission (June/July 1999) established an Ad Hoc Intergovernmental Task Force on Foods derived from Biotechnology to fulfil these objectives, which will take full account of the work of national authorities, FAO, WHO, other international organizations and other relevant international fora. The Task Force will submit a preliminary report to the Codex Alimentarius Commission in 2001, and a full report in 2003. The Codex Committee on Food Labelling is also working on the development of recommendations for the labelling of foods obtained through biotechnology.
It should be noted that Codex standards apply to all types of foods, and, for this reason, Codex will need to deal with foods of plant, animal and fish origin. The impact of feeding GMO plants to animals, and the nature of the resulting foods from these animals will also need to be addressed.
PHYTOSANITARY STANDARDS: THE INTERNATIONAL PLANT PROTECTION CONVENTION (IPPC)
The IPPC's purpose is common and effective action to prevent the introduction and spread of pests of plants and plant products, and the promotion of appropriate control measures. It covers both cultivated and wild plants; the direct and indirect effects of pests; and the prevention of the introduction and spread of weeds, and their control. The IPPC also covers the movement of biological control agents, and other organisms of phytosanitary concern claimed to be beneficial. The IPPC provides the global standard setting mechanism for phytosanitary measures. It may be concerned with evaluating the potential "pest" characteristics (including weediness) of GMOs, that is, whether a GMO may be detrimental to plant life or health.
At the second meeting of the Interim Commission on Phytosanitary Measures (ICPM) in October 1999, a number of members gave high priority to standard setting in relation to GMOs in particular to risk assessment and testing and release of GMOs. They indicated that this could be addressed within the framework of the IPPC. Others advocated a more cautious approach while some indicated the need to give sufficient priority to development of standards for plant quarantine. The ICPM decided that an exploratory working group would address the issues of biosafety in relation to GMOs and of invasive species and report back to the 3rd meeting of the ICPM in April 2001.
THE COMMISSION ON GENETIC RESOURCES FOR FOOD AND AGRICULTURE (CGRFA)
Since 1989, the CGRFA has regularly considered reports on technical and policy issues regarding biosafety, within the context of biotechnology as it relates to genetic resources for food and agriculture. In 1991, it requested the preparation of a draft Code of Conduct on Biotechnology, with the aim of maximizing the positive effects, and minimizing the possible negative effects of biotechnology. The draft Code of Conduct, drawn up following a survey of over 400 international experts, contained four modules, one of which was on biosafety. In 1993, noting that the CBD was considering the development of a biosafety protocol, the CGRFA recommended that FAO participate in this work, in order to ensure that the aspects of biosafety relevant to genetic resources for food and agriculture were appropriately covered. The biosafety component of the draft Code of Conduct was forwarded to the Executive Secretary of the CBD, at the request of the CGRFA, as an input to the biosafety protocol.
The CGRFA has suspended work on the draft Code of Conduct pending the completion of the negotiations for the revision of the International Undertaking on Plant Genetic Resources. The Eighth Session of the CGRFA, in April 1999, noting that the negotiations for the revision of the International Undertaking were expected to be completed during 2000, requested a report on the status of the draft Code of Conduct, at its Ninth Session, in 2001.
GMOS IN FISHERIES
The fishery sector has recognized that GMOs are a diverse class of organisms that share many common features with introduced or alien species. FAO's Regional Fisheries bodies have adopted, in principle, codes of practice on the use of introduced species and GMOs, produced by FAO's European Inland Fishery Advisory Commission (EIFAC) and the International Council for the Exploration of the Sea (ICES). The general principles in such codes of practice, which include general principles for environmental assessment, contained use, advanced notification and the application of the Precautionary Approach, have been incorporated into the FAO Code of Conduct for Responsible Fisheries. FAO continues to work with regional bodies, professional fishery associations and national governments in the harmonization and refinement of these codes, and in methods for appropriate risk assessment. A recent international meeting 1 convened by FAO and the International Centre for Living Aquatic Resources Management (ICLARM) on developing policies for aquatic genetic resources recognized "that in the formulation of biosafety policy and regulations for living modified organisms, the characteristics of the organisms and of potentially accessible environments are more important considerations than the processes used to produce those organisms". In terms of aquatic animal health and quarantine, FAO and OIE are working together. According to the SPS agreement, the accepted international standards governing the movement of aquatic animals are those of OIE. FAO closely collaborates with OIE in providing assistance to developing countries to improve their capacities in the effective application of these standards.
FOR THE NEAR FUTURE
In view of the importance of harmonizing regulations at the regional and sub-regional levels related to the testing and release of GMOs, FAO will continue to strengthen its normative and advisory work, in coordination and cooperation with other relevant organizations.
Recent advances make it likely that a diverse set of GMO-based technologies, and transgenic animals, will be brought into agricultural production environments (including for modified milk) in the near future. This will require more systematic consideration of the biosafety questions involved. At the international level, there are as yet no immediately relevant instruments. There is an evident need for harmonization over a wider range of biosafety issues involved within animal agriculture, beginning with systematic consultation among the relevant international organizations.
In terms of technical advice and capacity-building, FAO will: advise member governments on regulatory issues (including in the context of implementing the Biosafety Protocol, if adopted); advise on harmonization at regional and international levels; offer legal advice for the establishment of any regulatory bodies required; assist in establishment of the capacity for risk assessment; and seek to mobilize extra-budgetary funds and to cooperate with other relevant organizations. Member countries have also requested FAO's assistance in establishing and implementing regulations regarding the quality and safety of foods derived from biotechnology; in this context, existing regulatory instruments elaborated by national food safety authorities should also be considered.
1 Towards Policies for the Conservation and Sustainable Use of Aquatic Genetic Resources, Bellagio Study and Conference Center, 15 - 18 April, 1998, Bellagio, Italy.