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CONSIDERATION OF THE PRIORITY CONSENSUS ELEMENTS OF THE MADRID MEETING
Delegates agreed with the Chair’s proposal that discussion of the elements of a protocol should commence with the list of items identified in paragraph 18(a) of Annex I to the report of the Madrid meeting. From the paragraph of the terms of reference on priority items, the Chair identified three priorities for initial discussion: key concepts and terms; form and scope of AIA procedures; and relevant categories of LMOs. He then invited comments on the first priority issue, key concepts and terms.
KEY CONCEPTS AND TERMS: SWITZERLAND, supported by MALAYSIA, stated that defining the ultimate purpose of the protocol is a priority. MALAYSIA identified key concepts as: LMOs are genetically modified organisms, including genetic material intended to produce LMOs and including subcellular particles such as DNA. He included the behavior of LMOs in the environment under the scope of transboundary movement.
The EU highlighted adverse effects of LMOs on biodiversity (Article 19.3), including consideration of human health, as a key issue. He noted existing EU legislation on biosafety. CHINA added the concept of release of LMOs into the environment. INDIA excluded fragments or parts of nucleic acids from the definition of LMOs, and included the use of gene products derived from LMOs. The PHILIPPINES underlined unintended movement of LMOs, and added release in centres of origin and genetic diversity to the list. He referred to the precautionary principle.
INDONESIA highlighted AIA, unintended release and liability and compensation. AUSTRALIA mentioned LMOs, transboundary movement, adverse effects and AIA. He called for careful definition of “centres of origin and genetic diversity.”
SUDAN added LMOs produced domestically, for example in fermentation, to the definition of LMOs, as well as the concept of boundaries. NIGERIA suggested utilizing previous work, including UNEP’s International Technical Guidelines for Biosafety. A coalition of biotechnology industry organizations known as the INDUSTRY GROUP, including the Biotechnology Industry Organization (BIO), the Japan Bioindustry Association (JBA), the Green Industry Biotechnology Platform (GIBIP) and the Senior Advisory Group on Biotechnology (SAGB), underlined the concept of AIA and the need to avoid undue barriers to technical cooperation and commercialization. He called for regulating the transboundary movement of only the LMOs agreed by the COP as having potentially adverse effects.
ARGENTINA suggesting using existing precedents for AIA procedures, especially Annex II of the UNEP Guidelines. ETHIOPIA noted that modern biotechnology is rapidly evolving. He stated that microbes extinct for millions of years can be resuscitated, and called for clear definitions of handling, use and disposal. He also highlighted the importance of risk assessment from an ecological point of view. NORWAY mentioned national regulations as a key concept, and suggested emphasizing those LMOs that may have adverse effects.
IRAN noted the need to classify LMOs in order to elaborate the risks of biotechnology. SOUTH AFRICA listed several concepts requiring clarification, including: biomaterial; information exchange; unjustifiable constraints to trade; and the precautionary principle as elaborated in both the UNEP Guidelines and the Rio Declaration and as distinct from the precautionary approach.
COSTA RICA disagreed with Ethiopia’s contention that LMOs could realistically be resurrected from the past. NEW ZEALAND highlighted the following priority issues requiring clarification: LMOs resulting from biotechnology; transboundary movement; centres of origin and of genetic diversity; and AIA principles and procedures. KENYA noted the importance of defining both safe transfer and safety procedures in risk management, explaining that these terms were subjective, meaning different things to different countries and regions. MOROCCO underscored the need to clarify genetically modified organisms (GMOs) that lead to the creation of multicell organisms and the identification of behaviors and characteristics of LMOs. He supported Ethiopia’s position regarding the need for a clearer definition of biotechnology, taking into account spiritual values espoused by many countries. SRI LANKA supported the EU’s intervention regarding adverse effects on conservation and sustainable use of biodiversity, human health and welfare.
POLAND suggested adopting definitions already agreed to in OECD and EC directives. TUNISIA noted the need to first define biosafety, just as biodiversity is first defined in the CBD. The Chair noted that biosafety was merely an abbreviation of “safety in biotechnology”, which was already defined in the CBD. He noted that the Working Group would benefit from a list of agreed definitions compiled from existing legal instruments or negotiated documents. He reported that the industry sector had already submitted a glossary of terms to the Secretariat and called on delegates to determine to what extent key concepts are already defined in other agreed or negotiated texts, legal instruments and soft law.
FORM AND SCOPE OF AIA PROCEDURES: The Working Group then addressed the form and scope of advance informed agreement procedures.
SWITZERLAND proposed to circulate a discussion paper that outlines how AIAs would apply to transboundary movement of LMOs, on the basis of clearly defined concepts. He noted that AIAs should be flexible, based on existing structures. Later supported by the US and NEW ZEALAND, he stated that AIAs should only apply to the initial transboundary movement of LMOs, while notification procedures could cover subsequent movements.
The PHILIPPINES noted the need to define the terms of AIA, which it considers to be interchangeable with PIC. These terms should specify: the timing and parties to the agreement; nature, source and target of information to be provided; and liability provision in case of agreement violation.
AUSTRALIA noted the need to categorize LMOs and identify risks related to each category. He called for differential treatment of LMOs commensurate with the degree of risk that triggers the AIA. He outlined several principles for AIA, including: full information for the importing country, which remains the final judge of risk assessment; efficiency to minimize costs and time delays; and consistency with the WTO. The EU underscored experience obtained from international instruments regarding chemicals, pesticides and wastes. He called for flexible and differentiated AIA and notification procedures proportional to the risks involved, dependent on the characteristics and intended use of LMOs and the circumstances of transboundary movement.
SOUTH AFRICA noted that existing mechanisms should facilitate rather than determine the formulation of AIA, which should be guided by environment, trade and human health issues. He proposed that country positions on AIA procedures should be systematically solicited for consideration at the next BSWG meeting.
MALAYSIA underlined AIA as a priority and, supported by the REPUBLIC OF KOREA, highlighted precedents on Prior Informed Consent (PIC), which he equated with AIA, under the Basel Convention on the Control of Transboundary Movements of Hazardous Waste and their Disposal. Intellectual property rights (IPR) should not run counter to objectives of CBD Article 16.5. NORWAY broadened the definition of movement to include accidental release or unintentional spread of LMOs. The MAHARISHI INTERNATIONAL COUNCIL OF NATURAL LAW PARTIES stated that development of risk categories of LMOs is unrealistic.
The REPUBLIC OF KOREA called for information sharing on safety and potential adverse effects as part of AIA. MOROCCO pointed out that the Basel Convention bans the export of certain hazardous material, and that many developing countries lack financial resources for risk assessment and management (RAM). IRAN highlighted monitoring and enforcement in a protocol, comparing biosafety to chemical safety. The M.S. SWAMINATHAN RESEARCH FOUNDATION, later supported by the GREEN INDUSTRY BIOTECHNOLOGY PLATFORM, highlighted the balance between disclosure of information for biosafety evaluation, and protection of intellectual property rights. He called AIA a priority.
The US called for information sharing on organisms raising “reasonable concern” over risks to biodiversity, and for harmonization with the WTO. ZAIRE called for regulation of transshipment of LMOs. ARGENTINA stated that the Basel Convention may not be easily adapted to a biosafety protocol format. He cautioned against impeding technology transfer. BURKINA FASO stated that the exporting country should bear all liability for use of LMOs in importing countries that had complied with protocol regulations.
SRI LANKA called for shared liability, suggesting green labeling initiatives as models for import regulation. The SENIOR ADVISORY GROUP ON BIOTECHNOLGY (SAGB) proposed that nations identify focal points for notification and evaluation of LMOs to be imported. NEW ZEALAND emphasized flexibility and harmonization with existing regimes. JAMAICA, later supported by CAMEROON, called for clarification of the responsibility of countries used in transshipment of LMOs. INDONESIA stated that the “burden of proof” should lie with the exporter and highlighted liability and compensation.
The THIRD WORLD NETWORK highlighted a case-by-case assessment of all LMOs. She identified specific guidelines on Prior Informed Consent (PIC) in the Basel Convention as a guide for practical implementation of AIA under the protocol.
The EDMONDS INSTITUTE cautioned against unintended movement. He called for continuous monitoring of all LMOs to detect adverse effects.
RELEVANT CATEGORIES OF LMOS: The Chair then asked for comments on relevant categories of LMOs. This topic is relevant to risk assessment involving LMOs, as one approach to risk assessment management (RAM) is to elaborate risk categories based on the nature of the LMO in question. However, this approach to RAM is not unanimous. There were no responses to the Chair’s call for comments on this topic.
OTHER CONSENSUS ELEMENTS OF THE MADRID MEETING: The meeting next addressed other consensus elements agreed on at the Madrid Meeting, identified in paragraph 18(a) of Annex I to the report. BRAZIL noted that the Madrid meeting agreed to items within the context of a biosafety framework rather than protocol. BRAZIL, later supported by ARGENTINA, objected to the reference to research and development in a biosafety protocol, noting that this is a matter for domestic competence. SWITZERLAND noted that a protocol should not try to elaborate details on risk assessment and management but, rather, develop general principles, which already had received support in international bodies such as the OECD.
The COUNCIL FOR RESPONSIBLE GENETICS noted that the effects of GMOs can be transboundary whether or not GMOs themselves move across borders. ARGENTINA noted that although risk assessments may be made by third parties, their adoption remains the prerogative of the recipient country. He noted the need for capacity building and training to develop mechanisms must not be imposed in a protocol. The PHILIPPINES stated that although RAM falls primarily within the competence of national authorities, international mechanisms for risk assessment and management were needed and should remain open for negotiation. He further proposed that the protocol should contain minimum standards for Environmental Impact Assessments of LMOs.
The EU stated that RAM should be based on sound scientific data and should include characteristics of LMOs and potential adverse effects on biodiversity, and characteristics of intended application and of the recipient environment. He noted that mutual acceptability of data and authorization procedures between Parties should be pursued. The US noted that the UNEP Guidelines provide a useful source of general principles regarding RAM. CANADA stated that the protocol should underscore national responsibility for RAM without specifying its methodology. COSTA RICA highlighted the need for local capacity to both conduct RAM and to benefit from biotechnology products.
AUSTRALIA stated that provision of information on LMO exports remains the responsibility of the exporting country, while final judgments based on RAM remain the responsibility of the importing country, even though the latter may require assistance. Explaining that since unintended movement could not be covered under AIA procedures, he suggested that it could be addressed outside a protocol but within an overall biosafety framework.
Regarding exchange of information, SWITZERLAND noted that the effective implementation of the protocol and AIA procedures in particular would require transparent information exchange and proposed that data on transboundary movements should be included in the CBD’s Information Clearing-House Mechanism (CHM). In this connection, he proposed adopting language from CBD Article 19.4 on information exchange. INDIA noted that LMOs are knowledge-intensive and that while most research and development (R&D) arrangements focus on finished LMOs with application for society, we cannot belittle the importance of LMOs at the research stage. SRI LANKA, underscoring the importance of human health and welfare, called for social impact assessments in addition to EIAs.
The BIOTECHNOLOGY INDUSTRY ORGANIZATION underscored the experience of the industry community in successful research and development involving LMOs, and expressed its willingness to make available its findings on biosafety and its regulation. The PHILIPPINES emphasized the importance of providing full information to the general public and local communities. He noted the need to further develop CBD Article 19.4 for the purposes of a protocol. BULGARIA called for information sharing on LMOs to raise the “comfort level” of importing countries.
TUNISIA highlighted RAM in a protocol. SWITZERLAND stated that capacity building should precede implementation. KENYA linked information exchange with capacity building, and called for public education. AUSTRALIA underlined responsibility of all Parties to ensure safe transfer. The INTERNATIONAL SERVICE FOR THE ACQUISITION OF AGRI-BIOTECH APPLICATIONS (ISAAA), supported by SUDAN and ETHIOPIA, suggested developing regional focal points in Africa for capacity building and technology acquisition, stating that the former requires the latter.
The REPUBLIC OF KOREA called for a multilateral cooperative network for information exchange and human capacity building. MOROCCO linked RAM to information exchange. CÔTE D’IVOIRE called for a regional approach to implementing a protocol, to be complemented by national and local measures. The RUSSIAN FEDERATION stated that existing channels for information exchange are sufficient, and called for capacity building for better utilization of these mechanisms.
NIGERIA recommended that the GEF should provide financial resources for the capacity building provisions of the UNEP Guidelines. The Secretariat reported that the SBSTTA-2 agenda includes capacity building for biosafety and the COP-3 agenda includes the UNEP Guidelines. He noted that COP-3 might recommend that the GEF support national implementation of the Guidelines.
ETHIOPIA, on behalf of the African Group, called for the creation of national biosafety committees and international multidisciplinary bodies as well as for public participation in decision-making. He noted the need for arbitration and emergency global response plans. The DEMOCRATIC PEOPLE’S REPUBLIC OF KOREA cautioned against complicated communication and coordination procedures that waste time and money. JAPAN stated its policy to avoid the establishment of any new international institutions for biosafety and underscored each country’s primary responsibility for implementation, while encouraging regional cooperation. SRI LANKA called for: an independent international authority with competence on biosafety; evaluation guidelines and a certification process for biosafety; and legal procedures and insurance schemes for liability and compensation.
NEW ZEALAND emphasized the importance of: flexibility through the full use of annexes; capacity building for national focal points and strengthening of regional capacities; community consultation; existing institutions such as the CBD Secretariat and the CHM as well as existing funding arrangements. CHINA called for a timetable and plan of work to guide future meetings of the BSWG. He underscored capacity building in biotechnology particularly to meet food needs in light of predicted population growth. VIETNAM stated that the protocol should be based on the precautionary principle and a case-by-case approach.
MAURITIUS distinguished capacity building in biosafety from capacity building in biotechnology, and called for reporting mechanisms on the export of LMOs and for CBD Article 14 (environmental impact assessment) to be included in a protocol. The EU cautioned against creating new structures and recommended that the administration and financing of the protocol take place within existing CBD institutions. The UK underscored the need to mobilize appropriate assistance for capacity building as essential to the urgent implementation of the UNEP Guidelines during the development of the protocol. He noted the Secretariat’s suggestion that the COP might recommend that the GEF fund capacity building for biosafety but encouraged “casting a wider net” by taking into account national, bilateral and multilateral resources as well as organizations such as UNEP, UNDP and UNIDO who are active in this area.
INDIA called for provisions on liability and insurance as well as RAM and AIA. She discouraged the proliferation of new institutions and mechanisms. MALAWI underscored the importance of public awareness and personnel training for implementation. The PHILIPPINES called for a thorough capacity building process to be instituted according to a specified timeframe. Explaining that the pace of LMO development exceeds developing countries’ ability to control them, SUDAN highlighted capacity building as critical to implementation. CAMEROON stated that information exchange requires the capacity to understand biosafety issues.