Risk Assessment and Risk Management

Articles 15 and 16 of the Cartagena Protocol on Biosafety (BSP) outline requirements that relate to risk assessment and risk management of living modified organisms (LMOs):

  • Article 15 requires Parties to decide on the import of LMOs for intentional introduction into the environment (e.g., seeds for planting) in accordance with scientifically sound and evidence-based risk assessments. The general principles, methodological steps, and points to consider when conducting such risk assessments are set out in Annex III of the BSP.
  • Article 16 of the BSP requires Parties to adopt measures and strategies for managing and controlling any risks identified by the risk assessment, and for preventing unintentional transboundary movements of LMOs. The aim is to prevent any adverse effects of LMOs on the conservation and sustainable use of biological diversity. Click here to access more information about risk assessment under the BSP.

The Global Industry Coalition (GIC) continues to have significant concerns with the ongoing negotiations on risk assessment and risk management of LMOs under the Protocol. In particular, how gaps in existing guidance are identified and selected for further consideration, in the absence of consensus by the Parties that such work is justified. Parties to the Protocol will consider proposed recommendations for a path forward on risk assessment during the 9th meeting of the Parties to the Cartagena Protocol on Biosafety taking place 17-29 November 2018 in Sharm El-Sheikh, Egypt. The proposed recommendations continue the inefficient and unproductive work that has occurred on this issue since 2004, using the same mechanisms that have not led to beneficial outcomes for the Parties. The GIC is firmly of the view that the Parties should discontinue this repetitious work and instead recommend work on developing objective and agreed-upon criteria to determine whether further work on risk assessment is warranted. An appropriate mechanism for this activity is an online forum that would allow for the participation of a wide spectrum of experts to engage and support outcomes fully-informed by appropriate expertise.

More information on the GIC’s views on this debate can be found here.

In addition, the GIC notes that existing guidance documents and well-established methodologies on risk assessments for LMOs that are consistent with the principles of Annex III of the Protocol are readily available through the Biosafety Clearing-house and other websites. These are equally applicable to every current and realistically foreseeable LMO. Parties looking for guidance in conducting LMO risk assessments may find the following materials useful:

  • The accumulated practical experience of conducting risk assessments at national levels;
  • Existing guidance materials;
  • Established risk management practices from countries with experience of LMOs and environmental releases.

The GIC has created a list of links to these documents here.

Please click here for the GIC’s views on risk assessment and risk management issues related to gene drives and living modified fish.