Rome, 12-23 November 1999
INFORMATION NOTE ON BIOSAFETY
1. This paper provides information to Conference on current activities 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. The paper also reports on developments in other intergovernmental fora relevant to biosafety in food and agriculture.
2. The 15th session of the Committee of Agriculture (COAG) considered biotechnology in relation to biosafety. COAG recommended that FAO monitor developments in the CBD negotiations, to help ensure that agricultural expertise is available to implement the Biosafety Protocol, once finalized. In this context, several countries requested FAO's help in drafting national biosafety legislation and setting up their regulatory bodies. The Committee recommended that FAO help harmonize regulations at the regional and sub-regional levels. Therefore, FAO should continue and reinforce its normative and advisory work, in coordination with other agencies.
3. COAG noted the difficulties that developing countries and countries in transition face in conducting risk-analysis in relation to genetically modified organisms. This risk analysis may call for international standard-setting and harmonization. Such harmonization is an integral part of existing pest and phytosanitary risk analysis programmes, and of risk analysis in relation to human health sanitary measures, as called for in the World Trade Organization Agreement on the Application of Sanitary and Phytosanitary Measures. Expanded risk-analysis harmonization may build on the existing programmes in Codex Alimentarius and the International Plant Protection Convention, within recognized frameworks. The Committee noted that the effort for harmonization should not duplicate the content of the Biosafety Protocol.
4. The 116th Session of Council, in considering the report of COAG, concluded as follows: "The Council appreciated the need for FAO to have a coherent programme on agricultural biotechnology to assist Member Nations in obtaining the full benefits of new developments while minimizing risks. FAO's role as a forum for the discussion of issues and for standard-setting, and as an `honest broker' of quality science-based information, through mechanisms such as the International Plant Protection Commission (IPPC) and Codex Alimentarius, was underscored in general, and in relation to biotechnology in particular."
5. FAO also provides a intergovernmental forum for the discussion of relevant issues, in the Commission on Genetic Resources for Food and Agriculture (CGRFA). In this context, Council noted that the CGRFA, at its 2001 regular session, would consider a status report on the draft Code of Conduct on Biotechnology as it relates to Genetic Resources for Food and Agriculture.
6. The 1995 Conference of Parties (COP) to the Convention on Biological Diversity in 1995 recognized the "special nature of agricultural biodiversity, its distinctive features and problems needing distinctive solutions".1 The same Conference of Parties decided to establish a negotiation process to develop, in the field of the safe transfer, handling and use of living modified organisms, a protocol on biosafety, specifically focusing on transboundary movement of any living modified organism (LMO) resulting from modern biotechnology. The primary focus of these negotiations is the adverse effects of GMOs on the conservation and sustainable use of biological diversity. The COP established an Open-ended Working Group to negotiate a Protocol on Biosafety: to date it has met six times, last in Cartagena, Colombia, in February 1999, followed by an Extraordinary Meeting of the COP.
7. The Extraordinary Session of the COP was unable to agree on a text. Still in discussion are the scope of the protocol (only LMOs or LMOs and products thereof), trade implications, the introduction of socio-economic considerations, liability, and the treatment of non-parties. The discussion reflects the difficulty to monitor and regulate an expanding technology in a single instrument. Informal consultations on reviving the negotiations took place at meetings in Montreal (June 1999) and Vienna (September 1999). The CBD will continue Informal Consultations on a Biosafety Protocol in Montreal, Canada, from 20 to 22 January 2000, followed by the Resumed Extraordinary Meeting of the COP to Finalize and Adopt a Protocol on Biosafety, from 24 to 28 January 2000.
8. The OECD coordinates a programme on the harmonization of regulatory oversight in biotechnology. The objective of the programme is to promote international harmonization in biotechnology, which will ensure that environmental health and safety aspects are properly evaluated, while avoiding non-tariff barriers to products of the technology. The major component of the programme is the development of consensus documents, which comprise technical information for use during the technical assessment of products of biotechnology, and are intended to be mutually recognized among OECD Member Countries. These documents focus on the biology of organisms (such as plants, animals, or microorganisms), or traits, and contain scientific evidence that is useful for environmental safety assessment. OECD also has further information exchange mechanisms and outreach activities with UNEP and UNIDO.
9. The main objectives of the OIE are: to inform Governments of the occurrence and course of animal diseases throughout the world, and of ways to control these diseases; coordinate, at the international level, studies devoted to the surveillance and control of animal diseases; and harmonize regulations for trade in animals and animal products among Member Countries. The OIE Standards Commission publishes the Manual of Standards for Diagnostic Tests and Vaccines. Some of the tests and vaccines described are genetically engineered. OIE has had a working group on biotechnology since 1996. It has produced several technical publications on biotechnology as it relates to animal production, risk analysis, and biologicals. It has not approved international standards on biotechnology yet.
10. 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). This Agreement concerns sanitary and phytosanitary measures:
(a) to protect animal or plant life or health from risks arising from the entry, establishment or spread of pests, diseases, disease-carrying organisms or disease-causing organisms;
(b) to protect human or animal life or health from risks arising from additives, contaminants, toxins or disease-causing organisms in foods, beverages or feedstuffs;
(c) to protect human life or health risks arising from diseases carried by animals, plants or products thereof, or from the entry, establishment or spread of pests; or
(d) to prevent or limit other damage from the entry, establishment or spread of pests.
11. The SPS Agreement recognizes international standards, guidelines and recommendations:
(a) for food safety, the standards, guidelines and recommendations established by the Codex Alimentarius Commission relating to food additives, veterinary drug and pesticide residues, contaminants, methods of analysis and sampling, and codes and guidelines of hygienic practice;
(b) for animal health and zoonoses, the standards, guidelines and recommendations developed under the auspices of the OIE;
(c) for plant health, the international standards, guidelines and recommendations developed under the auspices of the Secretariat of the IPPC in cooperation with regional organizations operating within the framework of the IPPC; and
(d) for matters not covered by the above organizations, appropriate standards, guidelines and recommendations promulgated by other relevant international organizations open for membership to all Members, as identified by the Committee.
12. 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. Codex Alimentarius provisions concerning quality and compositional requirements, labelling, nutrition and methods of analysis are relevant to the TBT Agreement.
13. The International Centre is dedicated to advanced research and training in molecular biology and biotechnology. It provides information and training on biosafety and risk assessment for the environmental release of GMOs.
14. 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 adopted by the 23rd Session of the Codex Alimentarius Commission 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".
15. 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.
16. 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.
17. 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.
18. 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.
19. 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.
20. 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.
21. 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 meeting2 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.
22. On the basis of the recommendations of COAG and Council, FAO will seek to address separately a number of issues of concern to its constituency, through a sectoral approach to harmonization of various matters regarding agricultural GMOs, in the fields of food standards, plant health, and animal health.
23. 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.
24. Harmonization might first address protocols for risk-assessment in relation to testing and release of GMOs, building on the experience in the IPPC. Biosafety, as far as food safety is concerned, is now dealt within the context of the Codex Alimentarius which covers food of all origins. The specific standard-setting roles of Codex and the IPPC in the WTO context also need to be borne in mind. It would also be appropriate to establish further linkages between Codex work on biotechnology with that being undertaken by OECD including the OECD's response to the 25th G-8 Summit's request to study the implications of biotechnology, and other aspects of food safety.
25. 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. The use of GMOs in animal vaccines and, perhaps, diagnostics appears to be covered in the OIE's standard-setting role under the WTO. Genetically modified attenuated live vaccines may also be covered by the Biosafety Protocol if adopted. 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.
26. FAO will explore the possibility of addressing animal and fisheries biosafety and GMOs, in cooperation with the OIE, recognizing that the OIE's field of activities currently only addresses the question in a very limited way.
27. The Report to the CGRFA in 2001 will include the status of the draft Code of Conduct on Biotechnology as it relates to Genetic Resources for Food and Agriculture, the outcome of the CBD Biosafety Protocol process and FAO's relevant biosafety activities in preparation for the FAO Conference later in the same year.
28. 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.
29. On many issues, cooperation will need to be developed with other agencies, but the current incomplete status of the CBD negotiations of the Biosafety Protocol means that, for the moment, this cooperation in some sectors will be on an ad hoc or ad interim basis. The Organization will continue to monitor developments in the CBD negotiations to ensure that agricultural expertise is available to implement the Biosafety Protocol, once adopted. Moreover the Organization will consider in its appropriate fora, issues of biosafety in relation to GMOs that are of relevance to food and agriculture and that are not addressed in the protocol. It will be necessary to address relevant questions of biosafety in food and agriculture on a sectoral basis within the context of the PWB 2000/2001, with a view to developing programmes and activities more systematically in the PWB 2002/2003, in the light of the outcome of the Biosafety Protocol negotiations, and of countries' needs.
1 CBD/COP Decision II/15.
2 Towards Policies for the Conservation and Sustainable Use of Aquatic Genetic Resources, Bellagio Study and Conference Center, 15 - 18 April, 1998, Bellagio, Italy.