Most of the measures of the Convention on Biological Diversity (CBD) (Secretariat of the Convention on Biological Diversity, 1992) focus on the conservation of ecosystems; however, two aspects concerning the conservation of biological diversity are relevant for biosafety - the management of risks associated with LMOs resulting from biotechnology and the management of risks associated with alien species.
In the context of in-situ conservation measures, the Convention requires contracting parties “… to regulate, manage or control the risks associated with the use and release of living modified organisms resulting from biotechnology which are likely to have adverse environmental impacts that could affect the conservation and sustainable use of biological diversity …”. This provision goes beyond the general scope of the Convention in that it requires also that risks to human health are taken into account.
The Convention establishes that contracting parties have the obligation to prevent the introduction of alien species and to control or to eradicate those alien species that threaten ecosystems, habitats or species. Invasive alien species are considered as species introduced deliberately or unintentionally outside their natural habitats where they have the ability to establish themselves, invade, replace natives and take over the new environment.
The Cartagena Protocol on Biosafety (Secretariat of the Convention on Biological Diversity, 2000) was adopted by the CBD in September 2000 and came into force in September 2003. The objective of the Protocol is to protect biological diversity from the potential risks posed by safe transfer, handling and use of LMOs resulting from modern biotechnology. Risks to human health are also considered. The Protocol is applicable to all LMOs, except pharmaceuticals for humans that are addressed by other international agreements or organizations.
The Protocol sets out an Advance Informed Agreement (AIA) procedure for LMOs intended for intentional introduction into the environment that may have adverse effects on the conservation and sustainable use of biodiversity. The procedure requires, prior to the first intentional introduction into the environment of an importing party:
- notification of the party of export containing certain information;
- acknowledgement of its receipt; and
- the written consent of the party of import.
Four categories of LMO are exempted from the AIA: LMOs in transit, LMOs for contained use, LMOs identified in a decision of the Conference of Parties/Meeting of Parties as not likely to have adverse effects on biodiversity conservation and sustainable use, and LMOs intended for direct use as food, feed or for processing.
For LMOs that may be subject to transboundary movement for direct use as food or feed, or for processing, Article 11 provides that a party that makes a final decision for domestic use, including placing on the market, must notify the Biosafety Clearing-House established under the Protocol. The notification is to contain minimum information required under Annex II. A contracting party may take an import decision under its domestic regulatory framework, provided this is consistent with the Protocol. A developing country contracting party, or a party with a transition economy that lacks a domestic regulatory framework, can declare through the Biosafety Clearing-House that its decision on the first import of an LMO for direct use as food, feed or for processing will be pursuant to a risk assessment. In both cases lack of scientific certainty because of insufficient relevant scientific information and knowledge regarding the extent of potential adverse effects shall not prevent the contracting party of import from taking a decision, as appropriate, in order to avoid or minimize potential adverse effects.
Risk assessment and risk management are requirements for both AIA and Article 11 cases. The risk assessment must be consistent with criteria enumerated in an annex. In principle, risk assessment is to be carried out by competent national decision-making authorities. The exporter may be required to undertake the assessment. The importing party may require the notifier to pay for the risk assessment.
The Protocol specifies general risk management measures and criteria. Any measures based on risk assessment should be proportionate to the risks identified. Measures to minimize the likelihood of unintentional transboundary movement of LMOs are to be taken. Affected or potentially affected states are to be notified when an occurrence may lead to an unintentional transboundary movement.
The Protocol also contains provisions on LMO handling, packaging and transportation (Article 18). In particular, each contracting party is to take measures to require documentation that:
- For LMOs intended for direct use as food or feed, or for processing, clearly identifies that they “may contain” LMOs and are “not intended for intentional introduction into the environment”, and a contact point for further information;
- For LMOs destined for contained use, clearly identifies them as LMOs and specifies any requirements for safe handling, storage, transport and use, and a contact point and consignee;
- For LMOs intended for intentional introduction into the environment of the party of import, clearly identifies them as LMOs and specifies the identity and traits/characteristics, any requirements for safe handling, storage, transport and use, and a contact point, the name/address of the importer/exporter and a declaration that the movement conforms to the Protocol's requirements applicable to the exporter.
Information exchange is envisaged in the Protocol through the establishment of the Biosafety Clearing-House. The Biosafety Clearing-House is intended to facilitate the exchange of information on, and experience with, LMOs and to assist parties in implementation of the Protocol. Pursuant to Article 20, paragraph 2, it shall also provide access to other international biosafety information exchange systems. Information that parties are required to provide to the Clearing-House includes existing laws, regulations and guidelines for implementation of the Protocol; information required for the AIA; any bilateral, regional and multilateral agreements within the context of the Protocol; summaries of risk assessment and final decisions.
Public participation is specifically addressed in Article 23. Contracting parties shall:
- promote and facilitate public awareness, education and participation concerning safe transfer, handling and use of LMOs;
- endeavour to ensure public awareness and education encompasses access to information on LMOs identified by the Protocol that may be imported;
- consult the public in the decision-making process regarding LMOs and shall make decisions available to the public in accordance with national laws and regulations. Confidential information is to be respected in those activities.
Socio-economic considerations are allowed in decision-making. Contracting parties may account for socio-economic considerations arising from the impact of LMOs on biodiversity conservation and sustainable use, especially with regard to the value of biodiversity to indigenous and local communities. The parties are encouraged to cooperate on research and information exchange on any socio-economic impacts of LMOs. A process to address liability and redress for damage resulting from LMO transboundary movements is to be set up by the first meeting of parties to the Protocol.