The Cartagena Protocol on Biosafety (CPB), in force since September 2003, is a legally binding global protocol to the Convention on Biological Diversity (CBD).
The CPB, stated in 40 Articles and three Annexes, is the first international agreement to regulate the trade and transboundary movement of Living Modified Organisms (LMOs) resulting from modern biotechnology. So far 147 countries are parties to the CPB. Significantly, among the countries that are commercializing
and exporting GE crops, Argentina and Canada have signed the CPB, but have not yet ratified it, while Australia and the US have not even signed.
Objectives of the CPB
The main objective of the CPB is to ensure an adequate level of protection in the safe transfer, handling and use of LMOs that may have adverse effects on the conservation, sustainable use of biological diversity and the environment, to protect human health.
The CPB is not concerned with the intra-country issues related to LMOs. CPB does not cover a) the products derived from LMOs (such as paper from GE trees or seed meal, oil or sauce from GE soybean or ginned GE cotton) which cannot be used to introduce LMOs into environment, and b) the LMOs, which are pharmaceuticals that are addressed by other relevant international organizations or agreements.
The Role of CPB
The CPB assists developing countries in building their capacity for managing modern biotechnology, by creating an ‘Advanced Informed Agreement’ (AIA) procedure that requires exporters to seek consent from
importing countries before the first shipment of LMOs meant to be introduced into the environment, such as seeds for planting, fish for release and microorganisms for bioremediation. CPB established an internet-based ‘Biosafety Clearing House’ (BCH) to help countries exchange scientific, technical, environmental and legal information on LMOs, and requires bulk shipments of LMO commodities, such as corn or soybean intended to be used as food, feed or for processing, to be accompanied by documentation stating that such shipments ‘may contain’ LMOs and are ‘not intended for intentional introduction into the environment’.
The CPB ensures that the protocol does not alter the rights and obligations of governments under the World Trade Organization (WTO) or other international agreements.
The CPB a) does not address food safety issues, which are the concern of other international fora, b) does not require segregation of bulk shipments of commodities that may contain LMOs, c) does not require consumer product labeling, and d) does not subject bulk shipments of commodities to the CPB’s AIA procedure.
Advanced Informed Agreement (AIA)
AIA is CPB’s main mechanism which must be followed before the first intentional transboundary movement of an LMO into the importing country. The exporter must provide to the importing country the notification containing detailed information about the LMO, its previous ‘Risk Assessment’ and its regulatory status in the exporting country. The importing country must acknowledge receiving the information within 90 days and whether the notifier should proceed under a domestic regulatory system or under the CPB procedure.
In either case, the importing country must decide whether to allow the import, with or without conditions or deny it, within 270 days.
The AIA only applies to the first time shipments and not the subsequent shipments. LMOs not intended for release into the environment such as commodities, LMOs in transit, and LMOs destined for contained use, also do not come under the purview of the AIA.
Biosafety Clearing House (BCH)
The BCH is a website administered by the CBD Secretariat, established a) to facilitate the exchange of scientific, technical, environmental and legal information on, and experience with LMOs, and b) to
assist Parties to implement the CPB. Examples of information contained in the BCH include, a) any existing laws, regulations, or guidelines for implementation of the Protocol, b) summaries of risk assessments or environmental reviews of LMOs, and c) final decisions regarding the importation or release of LMOs.
Risk Assessment
The CPB requires that decisions on proposed imports be based on risk assessments. Risk assessments must be undertaken in a scientific manner based on recognized risk assessment techniques, relying upon the advice and guidelines developed by relevant international organizations. Lack of scientific knowledge or scientific consensus must not necessarily be interpreted as indicating a) a particular level of risk, b) an absence of risk, or c) an acceptable risk. Risks associated with LMOs or products thereof should be considered in the context of potential risks posed by the non-modified recipients or parental organisms in the receiving environment. Risk assessment should be carried out on a case-by-case basis. Nations must also take measures to prevent illegal shipments or accidental releases of LMOs.
Capacity Building
The CPB promotes international co-operation to help developing countries acquire resources and capacity to use biotechnology safely and regulate it efficiently. This is achieved by encouraging member governments to assist with scientific and technical training to promote the transfer of technology and knowledge, and financial resources. Governments are also expected to facilitate greater involvement of the private sector.
Public Awareness
Member governments must commit themselves to promoting public awareness and consultation, ensuring public access to information.
How effective is CPB?
While the CPB has not visibly achieved its intended objectives, a number of concerns have surfaced, putting in doubt the very purpose of CPB as an international instrument:
- Till the CPB came into being, only national bodies regulated biosafety issues. The stringency of the regulatory processes ranges from the very strict (US and India) to the very lax (some African countries and China). The CPB does not necessarily insist on the level of stringency of regulatory processes nor does it seek to ensure the much desired uniform global norms.
- 2. The so-called Miami Group (US and a coalition of GE-exporting countries such as Argentina, Australia and Canada) are not Parties to CPB but managed to exclude processed foods and biopharmaceuticals from its ambit. As these countries are in a big way in to commercializing GE crops, their keeping themselves out of the CPB is a matter of concern.
- Countries that are not parties to the CPB may go to WTO for dispute settlement if GE exports are not accepted, as the US has already done so against the European Union and won the case.
- CPB is not concerned with labeling GEOs and so mandatory labeling requirements for GE commodities will remain a contentious issue.
- The CPB could be used as a safe way out by countries which do not wish to import GE products.
- There has hardly been any agreement at the periodical meetings of the Conference of the Parties and Meeting of the Parties (CoP/MoP). A number of contentious issues discussed at the fourth round of the CoP/MoP held in Bonn in May 2008 did not result in any significant decisions.
The most debated issue at these meetings was the ‘Liability and Redress for Damage’ that may occur on account of LMOs. A group of 80 countries such as Malaysia, Philippines, Columbia, several African countries and India, called the ‘Like Minded Group’, pressed for a legally binding instrument based on an administrative approach with an enabling clause on civil liability, which was opposed by countries such as Japan, Brazil and Peru. Six major GE companies such as Monsanto, Dow, Bayer, Syngenta, DuPont and BASF proposed a voluntary scheme called the ‘Compact’ as an alternative. This unresolved issue is rescheduled to be discussed again at the CoP/MoP 5 to be held in Japan in October 2010, along with a number of other issues on which too there was no agreement.