A Brief Introduction to the Cartagena Protocol on Biosafety, Including the Negotiation Process, ICCP, COP/MOP and the Working Group on Liability and Redress

Article 19.3 of the Convention on Biological Diversity (CBD) provides for Parties to consider the need for, and modalities of, a protocol setting out procedures in the field of the safe transfer, handling and use of living modified organisms (LMOs) resulting from biotechnology that may have an adverse effect on biodiversity and its components. A Biosafety Working Group (BSWG) was established to this end at the second Conference of the Parties (COP-2) to the CBD. Following five years of negotiations, the Cartagena Protocol on Biosafety was agreed in January 2000. The Protocol addresses the safe transfer, handling and use of LMOs that may have an adverse effect on biodiversity, taking into account human health, with a specific focus on transboundary movements. It establishes an advance informed agreement (AIA) procedure for imports of LMOs for intentional introduction into the environment, and also incorporates a precautionary approach, and mechanisms for risk assessment and risk management. The Protocol further establishes a Biosafety Clearing-House (BCH) to facilitate information exchange, and contains provisions on capacity building and financial resources, with special attention to developing countries and those with domestic regulatory systems.

The Protocol entered into force on 11 September 2003, 90 days from the submission of the 50th instrument of ratification. At the date of entry into force, certain provisions took effect immediately, including: the obligation for prior notification of the first shipment to an importing country that is Party to the Protocol under the AIA procedure; the obligation for Parties to the Protocol to use the BCH; and the identification in the accompanying documentation of all shipments containing LMOs. As of September 2008, there were 148 Parties to the Protocol.

Negotiation Process
 
BIOSAFETY WORKING GROUP: The BSWG met six times between 1996 and 1999. Delegates used the first and second meeting to define issues and terms and to articulate positions. By the third meeting, in October 1997, delegates had produced a consolidated draft text to serve as the basis for negotiation, established two sub-working groups to address the core articles of the Protocol and also formed a contact group on institutional matters and final clauses. The fourth and the fifth meeting focused on reducing and refining options for each article of the draft Protocol. The final meeting of the BSWG (February 1999, Cartagena, Colombia) was intended to finalize negotiations on the Protocol for submission to the first Extraordinary Meeting of the Conference of the Parties (ExCOP) immediately following BSWG-6. Despite intense negotiations, delegates were not able to finalize the Protocol, disagreeing primarily over its scope, trade-related issues and treatment of LMOs for food, feed or processing (LMO-FFPs).

ExCOP: The first ExCOP (February 1999, Cartagena, Colombia), immediately following BSWG-6, sought to develop a compromise package over two days of non-stop negotiations, under the guidance of Juan Mayr, Minister of Environment of Colombia. Unable to do so, the ExCOP adopted a decision to suspend the meeting, which would be resumed based on further consultations. Outstanding issues included: inclusion of LMO-FFPs within the Protocol’s scope; the Protocol’s relation to other agreements, especially those related to trade; the application of the AIA procedure, particularly with regard to the precautionary principle; and requirements for documentation and identification.

INFORMAL CONSULTATIONS: After the meeting’s suspension, three sets of informal consultations (July 1999, Montreal, Canada; September 1999, Vienna, Austria; and January 2000, Montreal, Canada) were held under the chairmanship of ExCOP President Mayr, to address outstanding issues. These meetings included spokespersons from the five major negotiating groups: the Central and Eastern European countries; the Compromise Group (Japan, Mexico, Norway, Republic of Korea and Switzerland); the European Union; the Like-Minded Group (the majority of developing countries); and the Miami Group (Argentina, Australia, Canada, Chile, the US and Uruguay).

RESUMED ExCOP: The resumed ExCOP (January 2000, Montreal, Canada) followed the final set of informal consultations. After seven days of intensive negotiations, the meeting adopted the Cartagena Protocol on Biosafety in the early morning hours of 29 January 2000. The ExCOP also established the Intergovernmental Committee for the Cartagena Protocol on Biosafety (ICCP), under the chairmanship of Amb. Philémon Yang (Cameroon) and advisement of an ICCP Bureau, to undertake preparations for the first Meeting of the Parties (MOP). The ExCOP requested the CBD Executive Secretary to start preparatory work on the development of a BCH, and established a regionally balanced roster of experts to be nominated by governments to provide advice and support upon request.

ICCP-1: The first meeting of the ICCP (December 2000, Montpellier, France) discussed: information sharing and the BCH; capacity building; the roster of experts; decision-making procedures; handling, transport, packaging and identification (HTPI); and compliance. The meeting reflected a congenial “Montpellier Spirit” as a positive force in building confidence and political momentum. ICCP-1 concluded with recommendations for intersessional activities and synthesis reports for each substantive item to be further considered by ICCP-2.

ICCP-2: The second meeting of the ICCP (October 2001, Nairobi, Kenya) developed recommendations on: information sharing; HTPI; monitoring and reporting; capacity building; the roster of experts; guidance to the financial mechanism; decision-making procedures; liability and redress; compliance; consideration of other issues necessary for the Protocol’s implementation; the Secretariat; Rules of Procedure; cooperation with the International Plant Protection Convention; and preparatory work for MOP-1. While focusing mainly on process, ICCP-2 highlighted continued concerns regarding capacity building and information sharing as essential elements for the Protocol’s ratification and implementation at the national level.

COP-6: The sixth meeting of the COP (April 2002, The Hague, the Netherlands) adopted decisions relevant to the Protocol on: the CBD Strategic Plan; the statement to the WSSD; capacity building; the budget; and applications for CBD Secretariat observer status to the WTO Committees on Sanitary and Phytosanitary Standards and on Technical Barriers to Trade.

ICCP-3: The third meeting of the Intergovernmental Committee (April 2002, The Hague, the Netherlands) adopted recommendations on: liability and redress; compliance; information sharing; capacity building; the roster of experts; HTPI; monitoring and reporting; other issues necessary for the Protocol’s implementation; and entry into force. The most contentious issues concerned compliance, liability and redress, and documentation for LMOs for food, feed or processing, contained use and intentional introduction.

COP/MOP-1:  The first meeting of the CBD COP serving as the Cartagena Protocol MOP (February 2004, Kuala Lumpur, Malaysia) adopted decisions on: decision-making procedures; information sharing and the BCH; capacity building; HTPI; compliance; liability and redress; monitoring and reporting; the Secretariat; guidance to the financial mechanism; and the medium-term work programme. The meeting agreed that documentation of LMO-FFPs, pending a decision on detailed requirements, would: use a commercial invoice or other document to accompany the LMO-FFPs; provide details of a contact point; and include the common, scientific and commercial names, and the transformation event code of the LMO or its unique identifier. Agreement was also reached on more detailed documentation requirements for LMOs destined for direct introduction into the environment. The meeting established a 15-member Compliance Committee, and launched the Working Group on Liability and Redress (WGLR) under Article 27 of the Protocol, which requires the elaboration of international rules and procedures in the field of liability and redress for damage resulting from transboundary movements of LMOs, within four years after the Protocol’s entry into force. Jimena Nieto (Colombia) and René Lefeber (the Netherlands) were elected as Co-Chairs of the WGLR.

COP/MOP-2: At its second meeting (May/June 2005, Montreal, Canada), the COP/MOP adopted decisions on capacity building, and public awareness and participation; and agreed to establish an intersessional technical expert group on risk assessment and risk management. Parties did not reach agreement on detailed requirements for documentation of LMO-FFPs that, according to Article 18.2(a), were to be approved “no later than two years after the date of entry into force of this Protocol.”

COP/MOP-3: At its third meeting (March 2006, Curitiba, Brazil), the COP/MOP adopted detailed requirements for documentation and identification of LMO-FFPs, and considered various issues relating to the Protocol’s operationalization, including funding for the implementation of national biosafety frameworks, risk assessment, the rights and responsibilities of transit parties, the financial mechanism and capacity building.

COP/MOP-4: The fourth meeting of the COP/MOP (May 2008, Bonn, Germany) was dominated by discussions on liability and redress. While the meeting did not complete its mandate to adopt an international regime on liability and redress in the context of the Protocol, it achieved a political compromise that will pave the way towards adopting a legally binding regime, hailed by most participants as a major step forward. The compromise envisions a legally binding supplementary protocol focusing on an administrative approach but including a provision on civil liability to be complemented by non-legally binding guidelines on civil liability. The meeting also established an ad hoc technical expert group on risk assessment and risk management.

The Ad Hoc Open-ended Working Group of Legal and Technical Experts on Liability and Redress (WGLR) was established pursuant to Article 27 (Liability and Redress) of the Cartagena Protocol on Biosafety by COP/MOP-1 (February 2004, Kuala Lumpur, Malaysia). Its mandate is to: review information relating to liability and redress for damage resulting from transboundary movements of living modified organisms (LMOs); analyze issues relating to potential and/or actual damage scenarios of concern; and elaborate options for elements of rules and procedures on liability and redress. Article 27 of the Protocol requires the elaboration of international rules and procedures in the field of liability and redress for damage resulting from transboundary movements of LMOs, within four years after the Protocol’s entry into force. COP/MOP-1 elected Jimena Nieto (Colombia) and René Lefeber (the Netherlands) as Co-Chairs of the WGLR.

WGLR-1: At its first meeting (May 2005, Montreal, Canada), the Working Group heard presentations on scientific analysis and risk assessment, and state responsibility and international liability; and expanded options, approaches and issues for further consideration in elaborating international rules and procedures on liability and redress.

WGLR-2: At its second meeting (February 2006, Montreal, Canada), the Working Group focused on a Co-Chairs’ working draft synthesizing proposed texts and views submitted by governments and other stakeholders on approaches, options and issues for liability and redress; and produced a non-negotiated and non-exhaustive, indicative list of criteria for the assessment of the effectiveness of any rules and procedures referred to under Article 27 of the Protocol.

WGLR-3: At its third meeting (February 2007, Montreal, Canada), the Working Group considered a working draft text synthesizing views submitted by governments and other stakeholders on approaches, options and issues regarding liability and redress. The Co-Chairs presented the Working Group with a blueprint for a COP/MOP decision on international rules and procedures in the field of liability and redress.

WGLR-4: At its fourth meeting (October 2007, Montreal, Canada), the Working Group focused on the elaboration of options for rules and procedures for liability and redress, based on a working draft synthesizing submissions with respect to approaches and options on liability and redress. Delegates focused on streamlining options for operational text related to damage, administrative approaches and civil liability, resulting in a consolidated text to be used for further negotiations.

WGLR-5: At its fifth meeting (March 2008, Cartagena de Indias, Colombia), the Working Group continued the elaboration of options for rules and procedures for liability and redress based on a revised working draft compiled by Co-Chairs. Delegates agreed on certain core elements, including the definition of damage, and further streamlined the remaining options. The Working Group decided to convene a Friends of the Co-Chairs group immediately before COP/MOP-4 to consider outstanding issues, including standard of liability, causation and the choice of instrument.

FRIENDS OF THE CHAIR GROUP: From 7-10 May 2008, delegates convened in Bonn, Germany, for regional consultations and in the Friends of the Chair group to continue negotiating an international regime on liability and redress. In an open plenary, delegates addressed: a detailed draft of a compact proposed by six major agricultural biotechnology companies, constituting a mutually binding contract to cover actual damage to biodiversity, subject to proof of harm. Closed door negotiations were held on proposed operational texts as contained in Annex II of the WGLR report (UNEP/CBD/BS/COP-MOP/4/11). On damage, delegates agreed on one consolidated definition of damage to the conservation and sustainable use of biodiversity. The Friends of the Co-Chairs group then further refined operational texts on the elements of the administrative approach, and extensively discussed additional elements in regard to: exemptions or mitigation; limitation of liability; and coverage. The group considered whether key elements of civil liability should be determined according to domestic law, including the forms of damage to be covered, valuation of damage, and the burden of proof for causation. In closing, the group further consolidated the definition of scope and achieved a reduction of the operational text in this section from four pages to one.

COP/MOP-4: The fourth meeting of the COP/MOP (May 2008, Bonn, Germany) was dominated by discussions on liability and redress. While the meeting did not complete its mandate to adopt an international regime on liability and redress in the context of the Protocol, it achieved a political compromise that will pave the way towards adopting a legally binding regime, hailed by most participants as a major step forward. The compromise envisions a legally binding supplementary protocol focusing on an administrative approach but including a provision on civil liability, to be complemented by non-legally binding guidelines on civil liability. The COP/MOP further decided to establish a Group of the Friends of the Co-Chairs on liability and redress, in order to continue negotiations on liability and redress, and to present the outcome of their deliberations to COP/MOP-5 for its consideration.