Biosafety Protocol just Beginning
The Cartagena Protocol on Biosafety regulates genetic engineering. That there is a Protocol at all is remarkable, given the determination of GMO producer/exporter countries and the biotechnology industry to undermine international regulation. Lim Li Lin (Third World Network) and Lim Li Ching outline progress so far and alert us to the challenges ahead.
The year 2000 marked a turning point in global biosafety regulation. The Cartagena Protocol on Biosafety (CPB), the first international law to regulate genetic engineering, was adopted by more than 130 countries. This reflected a global climate of concern about the safety, health and ecological risks of genetically modified organisms (GMOs), and the wider political and socio-economic implications of corporate-driven science and technology.
The Convention on Biological Diversity (CBD), under which the CPB was negotiated, has three fundamental pillars: the conservation of biological diversity, the sustainable use of biological resources, and ensuring fair and equitable sharing of benefits arising from such use. It was opened for signature at the 1992 Earth Summit in Rio.
Even at these early stages, the risks of gene biotechnology were on the agenda. Article 19 (3) of the CBD urges that countries ‘consider the need for and modalities of a protocol including, in particular, advance informed agreement in the field of the safe transfer, handling, and use of any living modified organism resulting from biotech that may have an adverse effect on the conservation and sustainable use of biodiversity’.
The Jakarta Mandate to begin negotiations on a legally binding biosafety protocol arose from the second CBD Conference of the Parties in Jakarta in 1995.
Negotiations on the CPB concluded in January 2000 in Montreal. To-date more than 100 countries are signatories, but only 10 have ratified the Protocol, far short of the 50 ratifications required for the CPB to enter into force. Of the countries that have ratified, the majority are developing countries.
The negotiations were very difficult and divisive; although scheduled to conclude in February 1999 in Cartagena, Colombia, the talks collapsed. The US-led Miami Group (comprising also of Canada, Australia, Argentina, Chile and Uruguay - the major producers of GMOs and allies) blocked agreement on provisions on the movement of genetically engineered commodities for food, feed or for processing. The provisions would have required the prior informed consent of the importing Party before these GMOs are shipped to that country. These commodities are the bulk of traded GMOs, and the Miami Group was determined that they should be excluded from the CPB.
Conversely, developing countries felt very keenly the need to have an internationally binding legal instrument on biosafety, based on the principle of precaution, which would regulate the movement of all GMOs between countries. During the negotiations, most had consolidated into a negotiating bloc known as the ‘Like-Minded Group of Developing Countries’. As importers of GMOs, and as countries most vulnerable to their ecological and socio-economic impacts, they presented a united front.
Most developing countries have no laws or regulations on biosafety and lack the capacity, and technological and financial resources to regulate genetic engineering. As public rejection of GMOs in Europe and other parts of the world gathered momentum, the fear of becoming a dumping ground for unwanted and untested GMOs was real. It was thus imperative to place the onus on exporting countries to seek the prior informed consent of importing countries, instead of simply allowing GMOs to pass unregulated through the global market. Furthermore, mounting scientific evidence of hazards coupled with revelations of flawed approval systems in producer countries highlighted the urgent need for international regulation.
The end result is a Protocol with a heavily negotiated text, which left some serious flaws and loopholes, particularly relating to the obligation of exporters to provide full information about GMOs and to obtain the full prior informed consent of importing countries for all GMOs.
The CPB regulates genetic engineering biotechnology, not biotechnology in general. It covers ‘living modified organisms’ (LMOs), not ‘genetically modified organisms’. This was contentious as such a narrow definition excludes non-living modified organisms, potentially excluding all GMOs except those intended for growing in fields. The US had opposed the term ‘genetically modified’ and wanted to downplay semantically its connotations. And products derived from GMOs such as processed and unprocessed food and food additives would not be included, despite the fact that inserted genetic material can persist in the products, can survive passage through the gut, and enter into cells via the bloodstream. (In this article, we use ‘LMOs’ only in reference to the Protocol).
The CPB primarily regulates the transboundary movement - export and import, movement between countries - of LMOs, although its scope extends to the transit, handling, and use of all LMOs. The battle to have a comprehensive scope was crucial, as all GMOs carry the same risks and hazards, whether living or not, and regardless of whether they are used in agriculture, medicine or research, or classified as commodities or pharmaceuticals. Although the general scope of the Protocol applies to all LMOs, its application to GE pharmaceuticals (e.g. genetically engineered vaccines), LMOs in transit and LMOs for contained use, is limited.
Advance informed agreement (AIA)
The AIA procedure forms the ‘backbone’ of the Protocol. It is a procedure for obtaining prior informed consent from the importing Party before a LMO crosses national boundaries. The onus is on the exporting Party to notify and furnish relevant information to the importing Party. The latter will then make a decision based on risk assessment and the Precautionary Principle.
But there are many qualifications and limitations to its application.
· AIA procedure only applies to the first transboundary movement of LMOs that are intended for intentional introduction into the environment (e.g. planting and field testing). Subsequent exports will not be subject to such procedure. Unfortunately, neither the identity of the LMO nor its stability can be guaranteed without molecular data. Due to the uncontrollable, random nature of the genetic engineering process, each transgenic line will be distinct, even though the same materials, gene-constructs and vectors are used. Because of inherent instability, further changes may occur during cultivation, so that, in effect, the properties will be quite different from the originally approved line.
· AIA procedure does not apply to LMOs intended for direct use as food, feed or processing (these make up more than 90% of the Miami Group’s GMO exports e.g. soya, canola, maize). Hence, the bulk of LMOs are not subject to the AIA procedure. For this category, an alternative system, based on information sharing via the Internet, applies. When a country approves a LMO domestically, minimal information must be posted on the Biosafety Clearing House, administered by the CBD Secretariat. This is the extent of the obligation of the potential exporting country. Parties that may be potential importers have to initiate procedures for risk assessment and decision-making without knowing whether that LMO will ever be exported, or whether it will be exported to them. The burden of regulation has thus been shifted from exporting countries onto other countries (essentially anti-AIA), and from international to domestic regulatory procedures.
· LMOs in transit (i.e. that are passing through the territory of a third party) and LMOs destined for contained use (defined as specific measures that limit the contact and impact of LMOs on the external environment) are excluded from the AIA procedure.
Other provisions of the Protocol cover identification and segregation, trade with non-parties, relationship with other international agreements, socio-economic considerations, liability and redress, risk assessment, risk management, review of decision, unintentional and illegal transboundary movement of LMOs, information sharing, capacity building, public awareness and participation (see Box 1).
Significance of the CPB
Despite the compromises, the CPB is still a remarkable achievement, considering that the Miami Group, under the influence of the biotech industry, did not want a protocol on biosafety and strongly resisted it, attempting to water it down so as to render it meaningless.
The CPB addresses the fact that GMOs may have adverse effects on the conservation and sustainable use of biodiversity, and also on human health. For the first time in international law, GMOs are recognised as inherently different, carrying special risks and hazards, and hence need to be regulated internationally. This essentially unseats the flawed regulatory mechanism of ‘susbstantial equivalance’ that is sometimes used, in effect, to (de)regulate GMOs.
The CPB establishes the foundations of international law on the regulation - primarily of the transboundary movement - of GMOs. While many aspects of biosafety regulation are best addressed by national legislation, aspects relating to transboundary movement are difficult to regulate domestically. An international law is therefore necessary.
The Precautionary Principle (i.e. in the absence of scientific certainty, a party should err on the side of caution and restrict or ban the import of GMOs on account of their potential adverse effects) has also been reaffirmed and put into operation in the CPB decision-making procedures.
The process nevertheless continues. Two meetings of the Intergovernmental Committee of the Cartagena Protocol on Biosafety (ICCP) have been held. The ICCP process continues further development and interpretation of the CPB. Another meeting is anticipated in April 2002.
At the 1st and 2nd ICCP meetings, the substantive issues discussed were information sharing; capacity building; decision making procedures; handling, transport, packaging and identification; compliance; and liability and redress. Little progress was made to address biosafety concerns, and discussion was often limited to issues of process rather than of substance.
Three technical experts group meetings of the Biosafety Clearing House (BCH) have been held to date, and regional meetings on the BCH have been held in Africa and Latin America. Regional meetings for Central and Eastern Europe and Asia-Pacific will be held in early 2002. The BCH is critical in the case of genetically engineered commodities for food, feed or processing, as it is the main tool for notification of domestic approvals, triggering decision-making by other countries. Unfortunately, this process is largely driven by vested interests in facilitating the trade in GMOs, rather than by biosafety information considerations.
Expert group meetings on handling, transport, packaging and identification; on compliance; and on capacity building have already been held. At the meetings on the first two issues, serious disagreement hampered consensus. At the meeting on capacity building, although agreement was reached on the draft action plan, developing countries were frustrated by developed countries’ lack of real commitment, in terms of providing financial resources and speedy implementation of capacity building initiatives.
National legislation essential
The Protocol sets minimum standards for the regulation of LMOs - Parties may take action that is ‘more protective of the conservation and sustainable use of biological diversity than that called for’ in the Protocol. While strengthening the Protocol and rectifying its deficiencies should be the long-term goal, it is critical that national governments, and developing countries in particular, formulate domestic biosafety laws that improve on the scope and standards set by the Protocol.
Many countries are formulating national biosafety legislation in preparation for CPB ratification. Many have already established, or are establishing, strict and comprehensive biosafety regulation, for example, EU biosafety rules and policy (see Box 2), the Organisation of African Unity model law on safety in biotechnology, and national biosafety laws in Norway, Denmark and Sweden.
Capacity building is crucial
Capacity has to be built in developing and developed countries alike for comprehensive national biosafety regulation. A priority is the need to have full knowledge of any pending imports that are genetically engineered, and the ability to make an informed decision based on a full assessment of risks and applying the Precautionary Principle. Thus, countries need to build capacity on three key fronts: biosafety regulation, scientific capacity, and monitoring and enforcement capabilities.
Risk assessment should be required for every stage of GMO development - from research in contained conditions to field trials, to full-scale releases into the environment. Regulation should be process, rather than product, oriented. In addition to risk assessment, it is also necessary to determine if there is a need for the GMO, and if there are sustainable or safer alternatives.
Once a biosafety regulatory system is in place, countries will need to make decisions on applications to export GMOs to its country. The decision-making body must have the backing of local scientific capacity to screen applications and make decisions on import. Training and capacity building of local scientists in biosafety assessment is therefore critical. Regional and international scientific collaboration is also crucial, as is drawing on multidisciplinary and biosafety (not biotechnology) scientific expertise at all levels.
The scientific body will have to evaluate the risk assessment submitted by the exporting Party. It could also conduct its own risk assessment or instruct the exporting Party to undertake another risk assessment if not fully satisfied with that supplied. This is important, as the risk assessment would have been conducted or commissioned by the exporter, with inevitable conflict of interest. Furthermore, the information provided by the exporting Party may not be sufficient to assess the safety of the GMOs as the Protocol only specifies the minimum information required, beyond which the exporting Party has no obligation to provide. The Protocol does allow for review in light of new scientific information - the importing Party can review its decision or the exporting Party may request a review. All this requires scientific capacity.
There has to be effective national monitoring and enforcement capacity. The ability to test or the access to testing facilities is critical. Testing is the fastest, most effective way of determining non-compliance with biosafety laws.
Monitoring and enforcement has to occur on different levels. Firstly, scientific developments globally have to be monitored constantly. New evidence of actual and potential risks of genetic engineering is emerging all the time. Secondly, countries must be on the alert for GMOs that may bypass regulatory processes, entering a country inadvertently. This will entail extreme vigilance at entry points. The principle of prior informed consent, which places the onus on the exporting country to seek the approval of the importing country, must be strictly enforced. Growing consumer rejection of GMOs is raising concerns that excess and unwanted genetically engineered seeds and food are being dumped on developing countries through bilateral or food aid. This unfairly exploits a country’s urgent needs. Aid agencies should be prohibited from including genetically engineered food, seeds and crops in their projects.
In conclusion, the Biosafety Protocol is just the start of the long and difficult road to international regulation of genetic engineering. Much more needs to be done, and countries must act to ensure that biosafety regulation becomes a reality (see Box 3).
For more details, please visit the Third World Network website: www.twnside.org.sg