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CISDL’s recent biosafety research has focused on the implementation of biosafety measures, both in the context of the Cartagena Protocol on Biosafety and beyond. A team of CISDL researchers has provided technical and legal support, as part of the United Nations Environment Programme / Global Environment Facility (UNEP-GEF) project on the Development of National Biosafety Frameworks including serving as resources persons in sub-regional workshops, developing analytical tools and resource materials for use by UNEP-GEF Project participant countries, and reviewing National Biosafety Frameworks (NBFs) and national draft laws for countries in Africa, Central Asia, the Middle East, Latin America and the Caribbean, and the Pacific Islands. CISDL’s efforts focus on providing legal and technical advice to the UNEP-GEF Biosafety Project on the implications of the Cartagena Protocol, and assisting developing countries with the development of new NBFs, especially regulatory regimes. The CISDL team, from Africa, Latin America, Canada and Europe, reviews and provides advice on draft biosafety policies and laws for each country’s regulatory regime. The team considers the implications of the draft policy and law for the proposed administrative system to handle notifications or requests for authorisations, systems for monitoring and enforcement, and mechanisms for public participation. The CISDL works with UNEP and national experts to identify any gaps in these components of each country’s draft NBF in relation to national needs and priorities, and the country’s obligations as a Party to the Cartagena Protocol, and makes recommendations on how best to address these gaps in preparing the final draft of the NBF. Members of the Biodiversity Programme have conducted research on biosafety for decision-makers including case studies of innovations in biosafety law, socio-economic considerations, the regulation of genetically modified food aid, and possible future trends in biosafety. A Working Paper on ‘Innovations in Biosafety Law’[www.cisdl.org/pdf/Biosafety_WP.pdf] was released during the special guest reception hosted by CISDL and the UNEP-GEF Biosafety Development Project in June 2005. On the basis of CISDL’s biosafety experience, we prepared a ‘Biosafety Scoping Study’ for IDRC, released in July 2005. 3.2 Recent CISDL Events on Biosafety Montreal, July 29, 2005 Today, CISDL releases a scoping study that examines the current context for biosafety and how this has been applied in the development of new national biosafety regulatory regimes. In conducting the study, CISDL consulted with a wide range of experts to develop priorities for research on the legal aspects of biosafety. The study concludes with three recommendations pertaining to biosafety governance, capacity building and research. The CISDL Biosafety Scoping Study was made possible by funding from the International Development Research Centre, Ottawa, Canada, and the United Nations Environment Program - Global Environment Facility's project on the Development of National Biosafety Frameworks.
Montreal, June 2, 2005 During the very successful special guests reception attended by over 75 representatives of developing and developed countries, CISDL released a Biosafety Working Paper which contains leading research and analysis in English and French on biosafety and the Biosafety Protocol, innovations in biosafety law, and pressing sustainable development questions in biosafety law and policy. Research on the areas covered in the Working Paper will continue and the authors look forward to engaging with others in the field on these topics. The Working Paper can be downloaded through the link below. Montreal | June 2, 2005 On the evening of June 2, the United Nations Environment Programme - Global Environment Fund Biosafety Project and the CISDL are hosting a special reception at the McGill University Faculty Club, providing CISDL members, partners, and associates from around the world with the opportunity to gather as a large group. Dr. Christopher Briggs (UNEP-GEF Biosafety Project) and Hon. Judge Charles Gonthier (CISDL, McGill Law Faculty/McCarthy Tetrault) will host this event. During the reception, the CISDL will present to its esteemed colleagues the release of a CISDL Biosafety Law Working Paper (to be posted on the CISDL website as well) and the Canadian Launch of ‘Sustainable Justice: Reconciling Economic, Social & Environmental Law’ (Martinus Nijoff, 2004). 3.3 Recent CISDL Publications on Biosafety During the CISDL and UNEP-GEF Biosafety Reception in June 2005, the Biodiversity Programme released a working paper on ‘Innovations in Biosafety Law’. The paper compiles CISDL’s recent experiences with biosafety law and includes chapters in both English and French. It covers the background to biosafety and the Biosafety Protocol, progress on biosafety through National Biosafety Frameworks, case studies of innovations in biosafety law, pressing sustainable development questions in biosafety law and policy (including socio-economic considerations and food aid), and future trends in biosafety. On the basis of CISDL’s international experience with biosafety, members of the Biodiversity Programme compiled a ‘Biosafety Scoping Study’ for IDRC in April 2005. The Scoping Study sets the context for the current state of biosafety law, both as it has developed into the Cartagena Protocol on Biosafety and international and national fora. The Study presents certain trends in the development of national biosafety frameworks in developing countries and sets out a series of key biosafety research questions for the future and some recommendations. It also includes a case study on the development of Costa Rica’s biosafety regulatory system, an overview of some biosafety capacity-building projects and a bibliography of biosafety resources. Members of the Biodiversity Programme prepared a legal brief ‘When Biosafety Becomes Binding: Marking the Entry into Force of the UN Cartagena Protocol on Biosafety’ for a legal experts panel held in partnership with the Secretariat of the Convention on Biological Diversity in September 2003. The brief includes an overview of biosafety and the Cartagena Protocol including the two decision-making procedures under the Protocol. It addresses two key considerations for decision-makers: precaution and sound science, and decision-making under the Advance Informed Agreement procedure. It also includes three brief case studies describing the design of different national biosafety regulatory frameworks. The legal brief was subsequently developed into a book chapter and published in M.C. Cordonier Segger & C.G. Weeramantry, Sustainable Justice: Reconciling Economic, Social and Environment Law (Leiden, The Netherlands: Martinus Nijhoff Publishers, 2004). The legal brief also served as the foundation for more in-depth analysis of key considerations in biosafety decision-making and socio-economic considerations in particular. A working paper on ‘Socio-Economic Considerations in Biosafety Decision-Making: An International Sustainable Development Law Perspective’ has been drafted. The working paper was discussed during an IUCN-IDRC meeting on biosafety held in Colombo, Sri Lanka in October 2004 and is being prepared for publication. The working paper examines the linkages between biosafety and the principles of international sustainable development law, discusses possible socio-economic considerations and when and how they can be taken into account in the biosafety decision-making process. The paper also analyses the relationship between socio-economic considerations in biosafety and international human rights law, especially the right to food. It is anticipated that this analysis will be expanded in the future to include other areas of human rights as well as international economic and environmental law. 3.4 Thanks The Biodiversity Programme is very grateful for the contributions of our funders to our biosafety research – the International Development Research Centre in Ottawa, Canada and the United Nations Environment Programme – Global Environment Facility’s Project on the Development of National Biosafety Frameworks . 3.5 Sustainable Development Law on Biosafety Article 19.3 of the Convention on Biological Diversity [www.biodiv.org] required the Parties to the Convention to consider the need for a protocol relating to biosafety. The Parties agreed on the need for a protocol at their second meeting in 1995 and negotiations began the following year. After a difficult negotiating process, the Cartagena Protocol on Biosafety was concluded in January 2000 and it entered into force in September 2003. The Protocol sets out procedures for handling two categories of living modified organisms. These are the Advance Informed Agreement procedure (Articles 7-10) which applies to “the first intentional introduction into the environment of the Party of import” (Art. 7.1), and the procedure for Living Modified Organisms intended for Direct Use as Food or Feed, or for Processing (Article 11). The Protocol also includes provisions on risk assessment (Article 15 and Annex III) and risk management (Article 16), handling, transport, packaging and identification (Article 18), confidential information (Article 21), capacity-building (Article 22), public awareness and participation (Article 23), socio-economic considerations (Article 26), and liability and redress (Article 27). Many of the details of these provisions require elaboration by the Meeting of the Parties to the Protocol. There are other international agreements and bodies that also impact the field of biosafety. The World Trade Organization and in particular, the Agreement on the Application of Sanitary and Phytosanitary Measures (SPS Agreement) and the Agreement on Technical Barriers to Trade (TBT Agreement), include rules affecting how countries can implement biosafety rules and make biosafety decisions. The SPS Agreement has two objectives: “to (i) recognize the sovereign right of Members to provide the level of protection of human, animal or plant life or health they deem appropriate, and (ii) to ensure that sanitary (human and animal health) and phytosanitary (plant health) measures do not represent unnecessary, arbitrary, scientifically unjustifiable or disguised restrictions on international trade” (Baumüller 18). The Agreement recognizes that measures that conform with international standards will be presumed to be consistent with the Agreement and GATT 1994. It refers, in particular, to three other international standard-setting bodies: the Codex Alimentarius, the International Office of Epizootics (now the World Organization for Animal Health), and the International Plant Protection Convention. The Agreement allows members to provisionally adopt precautionary SPS measures where scientific evidence is insufficient (Article 5.7). How to reconcile this provision with the allowances for precautionary decision-making in Articles 10(6) and 11(8) of the Biosafety Protocol is still unresolved. Several WTO disputes have interpreted the precaution standard in Article 5.7 of the SPS Agreement including the EC-hormones and Japan-apples decisions.. In addition, the ongoing EC-Biotech dispute is expected to interpret various provisions of the SPS Agreement including Article 5.7 when the panel issues its report, anticipated for October 2005. The TBT Agreement sets rules for the technical regulations, voluntary standards, and conformity assessment procedures relating to the international trade in all products that members can adopt. A TBT measure may include labeling requirements (Annex I, definition 1, ‘Technical regulation’) and the Agreement requires that ‘like’ products be treated alike (Article 2.1). Article 2.1 has been interpreted in numerous disputes including EC-Asbestos and It is at issue again in the EC-Biotech dispute. 3.6 For Further Resources Pew Initiative on Food and Biotechnology International Centre for Trade and Sustainable Development: page on EU-Biotech case Heike Baumüller, Domestic Import Regulations for Genetically Modified Organisms and their Compatibility with WTO Rules: Some Key Issues (Winnipeg: International Institute for Sustainable Development, August 2003), online: Trade Knowledge Network Commission for Environmental Cooperation, Secretariat Report, Maize &Biodiversity: The Effects of Transgenic Maize in Mexico (Commission onEnvironmental Cooperation: Montreal, 2004) online: CEC A. Cosbey & S. Burgiel, The Cartagena Protocol on Biosafety: An Analysis of Results (2000), online: International Institute for Sustainable Development Ruth Mackenzie et al., An Explanatory Guide to the Cartagena Protocol on Biosafety, IUCN Environmental Policy and Law Paper no. 46 (Gland, Switzerland: IUCN, 2003). Nuffield Council on Bioethics, The Use of Genetically Modified Crops in Developing Countries (London: Nuffield Council on Bioethics, 2004), online: Nuffield Council on Bioethics Suman Sahai, Genetically Modified Crops: A Resource Guide for the Asia Pacific (New Delhi: Gene Campaign, 2004). Secretariat of the Convention on Biological Diversity, The Cartagena Protocol on Biosafety: A Record of the Negotiations (Montreal: Secretariat of the Convention on Biological Diversity, 2004), online: Convention on Biological Diversity PROCEDURAL ASPECTS OF DEVELOPING ISDL REGIMES
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