The Cartagena Protocol on Biosafety: compliance issues ad intra and ad extra

Tackling the issue of genetically modified organisms was the Cartagena Protocol on Biosafety (CPB), adopted as a supplementary agreement to the CBD covering living modified organisms (LMOs) resulting from modern biotechnology which may have adverse effects on biological diversity, also taking into account risks to human health. Pursuant to Articles 8 (g. 17) and 19 (3-4), the parties concluded the Cartagena Protocol on Biosafety (CPB) to the CBD to address the transboundary movement, transit, handling and use of LMOs (also known as genetically modified organisms or GMOs). The Cartagena Protocol added another layer of protection, including minimising the impacts of biotechnology on the environment. The CPB expanded the main objective of the CBD, relating to ‘the conservation of biodiversity, the sustainable use of its components and the fair and equitable sharing of the benefits arising out of the utilization of genetic resources’. The protocol deals with the question of biotechnology and

the adoption of adequate measures for the conservation of the environment and, at the same time, safeguarding of human health.

There is also a relevant teleological aspect, as mentioned in Article 19(3), which stipulates:

The Parties shall consider the need for and modalities of a protocol setting out appropriate procedures, including, in particular, advance informed agreement, in the field of the safe transfer, handling and use of any living modified organism resulting from biotechnology that may have adverse effect on the conservation and sustainable use of biological diversity.[1]

The Conference of the Parties acts as well as the Conference for the Cartagena Protocol, deciding on compliance issues. Procedures and mechanisms on compliance under the Cartagena Protocol on Biosafety: The Intergovernmental Committee for the Cartagena Protocol on Biosafety and the clearinghouse mechanism.

The Cartagena Protocol provides for the Advance Informed Agreement (AIA) procedure, which places obligations on the exporters of GMOs. As a rule, a particular procedure should be followed, except in those cases in which is waived by the party of the import. For each procedure, the exporter State must provide a detailed, written description of the GMO to the importing State in advance of the first intentional transboundary shipment. In turn, the importing State must acknowledge receipt of the information within 90 days and then explicitly authorize the shipment within 270 days or state its reasons for rejecting it. Consent is not deemed implicit, so silence or the absence of a response is not equal to approval.

At the heart of this procedure lies the main goal to ensure that importing States have both the opportunity and the capacity to assess risks that may be associated with GMOs before agreeing to their import. Interestingly, a number of GMOs are explicitly excluded from this procedure: GMOs in transit, GMOs destined for contained use and GMOs intended for direct use as food or feed, or for processing. These exceptions can be further expanded by a decision of the Meeting of the Parties (MOP) to the Cartagena Protocol. This exclusion

does not, however, imply that the import of these categories of GMOs should not be regulated by States.

Additional labelling requirements have been imposed by the COP. In this sense, labels must state that the shipment in question carries GMOs, identifying the organism and providing handling and storage requirements and a contact for further information.[2] Labelling requirements have turned out to be relevant under this regimen, and they may differ slightly depending upon whether the organism is intended for contained use or is to be intentionally introduced into the destination’s environment. Further labelling requirements were imposed by the COP for GMOs’ intended for use as food, feed or for processing.n6 The COPs serving as MOPs have introduced new requirements and further regulations on the use of GMOs and labelling requirements.

Compliance under the Cartagena Protocol is also facilitated through a Biosafety Clearing-House, which fosters the exchange of scientific, technical, environmental and legal information concerning GMOs, and assists parties in implementing their commitments. The Guidelines for National participation in the Biosafety Clearing-House provide technical guidance to parties and other governments about the registration and submission of data to the Clearing-House. The COP also looked into improving the efficiency of the Clearing-House mechanism. COPs have tried to make the process available online and offline, including training for users in technological tools. Information exchange to facilitate compliance becomes even more relevant with regard to GMOs intended for direct use as feed or food, or for processing; the CPB sets up a special procedure requiring States to exchange information at an early stage through the Biosafety Clearing-House. Accordingly, States must give notice to the Clearing-House of domestic authorizations of GMOs, making available copies of domestic laws and regulations concerning them.

The approach taken to the issue aligns with the precautionary principle, following Principle 15 of the Rio Declaration. Based on this principle, States will decide whether or not to accept imports of GMOs on the basis of risk assessments, to be undertaken in a scientific manner following recognised risk

Biodiversity 265 assessment techniques.[3] Wherever there is insufficient relevant scientific information, a State may decide to apply the precautionary approach and refuse the import of the GMO into its territory (art 10.6). In the assessments, the CP also recognises the right of the importing States to take into account socioeconomic considerations, like the value of biodiversity to its indigenous and local communities, in reaching a decision on the import of GMOs.

The Cartagena Protocol focusses on international action, acknowledging that domestic measures are crucial to making its procedures effective. Civil society participation is also considered central for the operation of the regime. Parties to the protocol assume the commitment to promoting public awareness, ensuring public access to information and consulting the public in decisions concerning GMOs and biosafety. Similarly, parties should undertake national measures to prevent illegal shipments and accidental releases of GMOs, being obligated to notify affected or potentially affected States in the event that an unintentional release occurs. The COP set up a group tasked with developing rules and procedures for a liability and redress regime to deal with damages arising from transboundary GMO shipments; however, it took a while for a binding regime to be articulated.

The Nagoya-Kuala Lumpur Protocol on Liability and Redress (in force since 2018),6s another supplementary protocol under the umbrella of the CBD, allows countries to use their domestic law to seek redress under different liability (including civil liability) regimes against States.

The Cartagena Protocol brings about the question of interactions with other areas or branches of international law, particularly with regard to international trade law regarding the commercialization of biotechnology and proliferation of GMOs in areas such as the pharmaceutical sector. Other close interrelations are with the WTO’s Agreement on Sanitary and Phytosanitary Measures (1994, Annex 1A). Under this discipline, some scholars argue that free trade should prevail as a tool to advance SD. The controversial situation is given by decisions that ban GMOs as being potentially against free trade. Under the Sanitary and Phytosanitary Measures (SPS) Agreement, these decisions should be justified on principles of sound scientific knowledge based on scientific risk assessments. The focus of the Cartagena Protocol is primarily environmental protection providing for exceptions to the free trade principle, allowing States to protect biosafety by banning GMOs on the basis of the precautionary principle in those

cases in which strict scientific evidence is lacking. In terms of compliance and enforcement, any measure pertaining to these aspects will be comprised within the jurisdiction of the WTO Dispute settlement due to the absence of binding settlement procedures under the CBD and the CP. This is a quite controversial area at the intersection of both IEL and trade law.[4]

  • [1] CBD, art 19(3). 2 Cartagena Protocol on Biosafety, adopted in 2000 and entered into force in 2003; it currently has 170 Parties. 3 Kathryn Garforth, Experience with the Compliance Procedures and Mechanisms of the Cartagena & Nagoya Protocols to the CBD, Secretariat of the Convention on Biological Diversity, available at compliance_cbd.pdf accessed 1 April 2020. 4 CP, art. 7. 5 CP, art.6. 6 Ibid. 7 CP, art 7.2.
  • [2] COP1, CBD, report of the First meeting of the Conference of the Parties serving as the Meeting of the Parties to the Protocol on Biosafety (2004). 2 COP3, March 2006, CBD Report of the Third meeting of the Conference of the Parties to the Convention on Biological Diversity serving as the Meeting of the Parties to the Cartagena Protocolo on Biosafety (2006), at 60-61. 3 CPB, art. 20(1). 4 Biosafety COP-1 at 35-37. 5 Report of the Second Meeting of the Conference of the Parties to the Convention on Biological Diversity serving as the Meeting of the Parties to the Cartagena Protocol on Biosafey (2005), at 33-36. 6 Fifth Meeting of the Informal Advisory Committee of the Biosafety Clearing-House, 2009. UNEP/CBD/BS/BCH-IAC/5/2. 7 CPB, art. 11.
  • [3] CPB, art. 15. 2 CPB, art. 26.1. 3 Biosafety COP-1, at 104-105. 4 F761E2 accessed 1 April 2020. 5 The Supplementary Protocol aims to contribute to the conservation and sustainable use of biodiversity by providing international rules and procedures in the field of liability and redress relating to LMOs. 6 SPS Agreement, art 5.
  • [4] Kym Anderson and Chantal Pohl Nielsen, ‘GMOs, the SPS Agreement and the WTO’, in Anderson Kym, McRae Cheryl, and Wilson David (eds), The Economics of Quarantine and the SPS Agreement (University of Adelaide Press, 2001), pp. 305-331. 2 It entered into force on 12 October 2014, 90 days after the date of deposit of the 50th instrument of ratification. 3 Nagoya Protocol on Access and Benefit-sharing, adopted in 2010, entered into force in 2014, it currently has 85 Parties. 4 Elisa Morgera, Elsa Tsioumani, Matthias Buck, Unravelling the Nagoya Protocol: A Commentary on the Nagoya Protocol on Biological Diversity (Martinus Nijhoff Publishers 2014). 5 Elisa Morgera, ‘An International Legal Concept of Fair and Equitable Benefit-sharing’” (SSRN, 2015; published in the European Journal of International Law). 6 FAO, International Treaty on Plant Genetic Resources for Food and Agriculture (2020) available at http:Z/!ant-treaty/areas-of-work/the-multilateral-system/overview/en/ accessed 1 April 2020.