THE CARTAGENA PROTOCOL ON BIOSAFETY (CPB)
The CPB is a legally binding (to those countries that have ratified it), international agreement, supplemental to the Convention on Biological Diversity (CBD), with the OBJECTIVE to protect the world’s biological diversity from the potential risks associated with the transfer, handling and use of living modified organisms (LMOs), that result from modern biotechnology. It therefore focusses on potential environmental impacts and does not address food safety issues directly - although potential risks to human health may be taken into account. Currently, 170 countries are party to the Protocol.
The CPB focuses on the transboundary movements, i.e. imports and exports, of LMOs to ensure the countries involved have access to the information needed for making informed decisions about the use of LMOs. The term “LMO” (in contrast to GMOs) is used in the Protocol to stress the fact that it does not apply to the non-living products derived from LMOs, e.g. the lint from GM cotton or breakfast cereal containing GM maize, as these products can per definition not have an environmental impact. It also excludes LMOs, which are pharmaceuticals for humans that are regulated by other relevant international agreements or organisations.
The Protocol promotes biosafety by establishing rules and procedures for the safe transfer, handling and use of LMOs and facilitates information sharing, including:
1) Procedures for moving LMOs across borders.
2) Risk assessment procedures.
3) The biosafety clearing house.
4) Capacity building.
5) Public awareness.
1. Procedures for moving LMOs across borders
Considering the CPB’s focus on transboundry movement the procedures it establishes for regulating the movement of LMOs across international borders are of its most important interventions. Two key procedures are relevant in this regard:
Advanced Informed Agreement (AIA)
The AIA procedure applies to the first transboundary movement of a LMO intended for the intentional introduction into the environment, e.g. field trials, of the importing Party and consists of four main components:
(i) Notification by the exporting Party.
(ii) Acknowledgment of receipt of notification by the importing Party.
(iii) Mandatory decision process - based on risk assessment.
(iv) Opportunity for review of decisions.
LMOs intended for direct use as food, feed or for processing (LMOs-FFP)
Based on the lower potential environmental risks associated with LMOs-FFP, e.g. agricultural commodities, the Protocol has established a simplified procedure for the regulation of their transboundary movement. Under this procedure Parties that decide to place LMOs-FFP onto the market are required to make public their decision by entering it into the Biosafety Clearing-House (BCH). Potential importing Parties then have the opportunity to assess and decide on the matter, based on their domestic regulatory frameworks, where after they are required to communicate their decision on the BCH.
These procedures and requirements are designed to provide importing Parties with the necessary information needed for making informed decisions about whether or not to accept LMO imports and for handling them in a safe manner. Parties to the Protocol must also ensure that LMOs are handled, packaged and transported under conditions of safety. Furthermore, the shipment of LMOs subject to transboundary movement must be accompanied by appropriate documentation specifying, among other things, the identity of the LMO and contact point for further information.
2. RISK ASSESSMENT
1. The Protocol requires that decisions on proposed imports be based on formal risk assessments.
2. Risk assessments must be undertaken in a scientific manner based on recognised risk assessment techniques, taking into account advice and guidelines developed by relevant international organisations.
3. Lack of scientific knowledge or scientific consensus must not necessarily be interpreted as indicating a particular level of risk, an absence or risk, or an acceptable risk.
4. Risks associated with LMOs should be considered in the context of the risks posed by the non-modified recipients or parental organisms in the likely potential receiving environment.
5. Risk assessment should be carried out on a case by case basis.
3. BIOSAFETY CLEARING HOUSE (BCH)
The BCH (http://bch.biodiv.org) is an accessible, online information portal established by the CPB to:
Information is not limited to existing laws, regulations, or guidelines related to the implementation of the Protocol, but also include summaries of risk assessments an environmental reviews of LMOs and final decisions regarding the importation or release of LMOs.
4. CAPACITY BUILDING
The Protocol promotes international co-operation to help developing countries acquire resources and capacity to use biotechnology safely and regulate it efficiently. It does this by encouraging member governments to assist with scientific and technical training to promote the transfer of technology, knowledge and financial resources. Governments are also expected to facilitate greater involvement of the private sector.
5. PUBLIC AWARENESS
Parties to the Protocol must commit themselves to co-operating with other member countries to promote public awareness, ensuring public access to information and public consultation. Final decisions must be made accessible via the BCH. The Protocol recognises that national measures are important to make its procedures effective. Parties must also take measures to prevent illegal shipments or accidental releases of LMOs.
Please refer to the CPB’s website for more detailed information: https://bch.cbd.int/protocol
11 September 2018 marked the 15th anniversary of the entry into force of the Cartagena Protocol on Biosafety
At its 15th anniversary, a number of key successes achieved under the Biosafety Protocol are to be noted such as the a fully operational Biosafety Clearing-House (BCH) as well as regional and numerous national BCH websites through which Parties and other stakeholders exchange a wealth of information on biosafety. The recent entry into force of the Nagoya-Kuala Lumpur Supplementary Protocol on Liability and Redress is another noteworthy milestone to be celebrated at the Biosafety Protocol’s 15th anniversary.
Other important developments towards more effective biosafety systems are also to be noted. For example the growing experience by Parties in carrying out risk assessments and managing risks associated with the use, handling and transboundary movement of living modified organisms (LMOs). Parties have also made important progress in the context of public awareness, education and public participation at the national level. At the Protocol’s 15th anniversary, the instrumental role of the Compliance Committee in supporting Parties to implement the Biosafety Protocol and comply with their obligations should also be marked.