The Cartagena Biosafety Protocol is just the beginning

The Cartagena Biosafety Protocol is just the beginning

The Cartagena Protocol on Biosafety regulates genetic engineering. It is a remarkable achievement in international law, given the determination of GMO producer/exporter countries and the biotechnology industry to block global regulation. The following article outlines the progress so far and examines the challenges ahead.

THE Cartagena Protocol on Biosafety (CPB) entered into force on 11 September 2003.
It is the first international law to specifically regulate genetic engineering, reflecting 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.

Its entry into force means that it will be legally binding in the international legal system and in the legal systems of countries that have ratified, approved, accepted or acceded to it. As of 16 January 2004, there were 79 Parties to the Protocol, including the European Community (EC). Of these, the majority are developing countries. The 1st Meeting of the Parties (MOP1) will be held in Kuala Lumpur, Malaysia from 23-27 February 2004. None of the major producer/exporter countries have ratified.

The entry into force of the Protocol is an important defining moment in global biosafety regulation. It follows years of negotiations, from when the need for a biosafety protocol to address the risks of genetic engineering was first articulated in Article 19(3) of the Convention on Biological Diversity (under which the Protocol was negotiated), to its adoption by more than 130 countries in the year 2000 in Montreal.

Article 19(3) of the CBD was itself the result of intense negotiations spearheaded by Malaysia, which raised the issue of biosafety, and Sweden, which proposed a protocol. The CBD Parties were mandated to ‘consider the need for and modalities of a protocol setting out the appropriate procedures, including in particular, advance informed agreement, in the field of the safe transfer, handling and use of any living modified organism resulting from biotechnology that may have adverse effect on the conservation and sustainable use of biological diversity’. Risks to human health were covered by Article 8(g).

For legal, commercial and political reasons, the United States was instrumental in substituting the term ‘prior informed consent’ with ‘advance informed agreement’ as well as ‘genetically modified organism’ with ‘living modified organism’. Malaysia made a written declaration on signing the CBD that the term ‘LMO’ would be understood as meaning ‘GMO’. Laws in the European Union and a number of other countries use the term ‘GMO’.

For clarity in this article we use the term ‘GMO’.

Acrimonious negotiations

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.

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 Canada, Australia, Argentina, Chile and Uruguay – the major producers of GMOs and allies) blocked agreement on provisions on the transboundary 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.

On the other hand, 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. They argued that the lack of scientific certainty and gaps in scientific knowledge underpin the Precautionary Principle already adopted in the CBD.

During the negotiations, the overwhelming majority of these countries forged 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.
Eventually the CPB excluded GMOs for food, feed or processing from the advance informed agreement (AIA) procedure that requires the prior informed consent of the importing Party before the first transboundary movement of a GMO takes place.

The AIA procedure foreseen in the Protocol will therefore only apply to first transboundary movements of GMOs destined to be released into the environment of importing Parties. For GMOs destined to be used as food, feed or processing, the Protocol only foresees an information exchange system facilitated by the Biosafety Clearing House which will be administered by the CBD Secretariat in Montreal.

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 and across national boundaries. Furthermore, mounting scientific evidence of hazards coupled with revelations of flawed approval systems in producer countries highlighted the urgent need for international regulation.

General scope

The end result is a heavily negotiated text in part, with a compromise package that was finally adopted. This 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’, not ‘genetically modified organisms’. This was contentious as such a term arguably excludes non-living modified organisms, potentially excluding all GMOs except those intended for growing in fields, GM animals and GM microorganisms.

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.

Therefore, countries should formulate national laws where the term used, whether ‘LMO’ or ‘GMO’, is clearly defined so as to be comprehensive.

The CPB primarily regulates the transboundary movement of GMOs – export and import, and other movements between countries. However its scope extends to the transit, handling, and use of all GMOs. The battle to have a comprehensive scope was crucial, as all GMOs carry similar fundamental 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 GMOs, its application to genetically engineered pharmaceuticals (e.g. GE vaccines), GMOs in transit and GMOs for contained use, is regrettably 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 GMO 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 qualifications and limitations to its application.

The AIA procedure only applies to the first transboundary movement of GMOs that are intended for intentional introduction into the environment (e.g. planting and field testing). Under the Protocol, subsequent exports will not be subject to such procedure. Unfortunately, neither the identity of the GMO 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 may be quite different from the originally approved line.

The AIA procedure does not apply to GMOs 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 GMOs 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 GMO 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 GMO 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. However, the Protocol preserves the right of Parties to take a decision on the import of these GMOs according to its domestic regulatory framework.

GMOs in transit (i.e. that are passing through the territory of a third party) and GMOs destined for contained use (defined as specific measures that limit the contact and impact of GMOs on the external environment) are excluded from the AIA procedure, although the right of a Party to regulate these GMOs is explicitly preserved.

Other key provisions

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 GMOs, information sharing, capacity building, public awareness and participation (see box).

Significance of the CPB

Despite the compromises, the CPB is still a remarkable achievement, considering that the Miami Group, and the biotech industry, did not want a legally-binding 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 ‘subsstantial equivalence’ 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.

Ongoing process

The process to prepare for implementation has been active. Three meetings of the Intergovernmental Committee of the Cartagena Protocol on Biosafety (ICCP) have been held. The ICCP process continued to further the development and interpretation of the CPB, pending the entry into force of the Protocol. Now the Meeting of the Parties will be the decision-making body to carry forward the development, interpretation and implementation of the Protocol.

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.

At the 3rd ICCP meeting in April 2002 negotiations proceeded very slowly, with some GMO producing/exporting countries attempting to delay progress, often arguing that the work of the ICCP should not ‘re-open’ agreed CPB text. Most countries however urged for moving forward by also interpreting ambiguous CPB text, as the work of the ICCP is to make progress on the CPB before it comes into force. Many countries expressed dismay that the process is lagging behind events in the real world, e.g. transgenic contamination, and widespread commercialisation and release of GMOs, some of which have entered into countries that have not approved them.

A number of 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, Latin America and the Caribbean, Central and Eastern Europe, and Asia-Pacific.

The BCH is critical in the case of GE commodities for food, feed or processing, as it is the main tool for notification of domestic approvals, triggering decision-making by other countries. It could also play a crucial role in providing critical information to countries which lack access to information and the capacity to take decisions on GMOs. Unfortunately, this process is largely driven by vested interests in facilitating the trade in GMOs, rather than by biosafety information considerations.
Experts’ group meetings on handling, transport, packaging and identification; on compliance; and on capacity building have also 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.
Further meetings on capacity building, and liability and redress were held in November and December 2002 respectively. The workshop on liability and redress saw little will on the part of exporter countries to seriously discuss the issue and to take steps towards elaborating the liability and redress regime within the stipulated time frame (4 years from MOP1).

National legislation essential

The Protocol sets minimum standards for the regulation of GMOs – 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, and which also comprehensively regulate the domestic development and use of GMOs.

As an international law that is binding on countries that are party to it, the CPB presents obligations on and opportunities for sovereign countries. As a negotiated text, many flexibilities for interpretation and implementation are available for countries to utilise, putting real biosafety at the heart of national regulation.

The CPB is really just a starting point from which provisions and parameters for risk assessment and risk management, which were watered down during the Protocol’s negotiations, can be fully implemented nationally. Actual biosafety standards still need to be established and these should be done under the CPB taking into account the latest scientific findings and knowledge, including the identification of knowledge gaps. The focus of the CPB is the transboundary aspect and this should be extended to full domestic regulation.

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, the EU’s biosafety regulatory framework (see box), the Organisation of African Unity model law on safety in biotechnology, and national biosafety laws in Norway, Denmark, Sweden and Austria.

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 or domestic development, trials and releases of GMOs, 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. The decision-making body must have the backing of local scientific capacity to screen applications and make decisions on import and domestic use. 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. Socio-economic concerns and impacts must also be an integral part of the assessment framework and the decision-making process.

The scientific body will have to evaluate the risk assessment documentation submitted by the applicant. It could also conduct its own risk assessment or instruct the applicant 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 applicant, with inevitable conflict of interest.

Furthermore, the information provided by the applicant may not be sufficient to assess the safety of the GMOs as the Protocol only specifies the minimum information required. The exporting Party (or the applicant) has no obligation to provide anything more, unless such information is specifically required in national legislation.

The Protocol does provide 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. However, there are also limitations to the tests that are available, both technical and cost-wise.

Monitoring and enforcement has to occur on different levels. Firstly, scientific (including socio-economic) 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, for example by 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. Contamination and 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 international food aid. This unfairly exploits a country’s urgent needs and temporary crisis situations. 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 effective international regulation of genetic engineering. Much more needs to be done, and countries must act to ensure that real biosafety becomes a reality.

Lim Li Lin is a researcher with Third World Network and participates actively in the Cartagena Protocol processes. Lim Li Ching is a researcher with Third World Network and the Institute of Science in Society.


Other key provisions of the Cartagena Protocol on Biosafety
Identification and segregation

The Protocol provides for GMOs to be identified as such in shipping documents. However, GMOs for direct use for food, feed or processing need only be identified as ‘may contain’ GMOs. Detailed requirements for this have to be resolved within 2 years of the entry into force of the Protocol. In effect, mandatory segregation of all such GMOs – the bulk of traded GMOs – may not be required. Mandatory segregation would severely disrupt its trade, and the Miami Group strongly opposed this.

Trade with non-parties
Parties can trade with non-Parties, as long as the trade is consistent with the Protocol’s objective. The concern is that the US, the most notable non-Party (the US is not a Party to the CBD, under which the Protocol was negotiated, and hence cannot be a Party to the Protocol), may insist on weak agreements with Parties. This will undermine the Protocol, allowing the US to enjoy the benefits of trade without the responsibility of biosafety. Moves by the US and other major exporting countries (all non-Parties except for Mexico) to make agreements on the handling, transport, packaging and identification of GM commodities are already taking place and this threatens to pre-empt decisions to be made at MOP1 in February.

Relationship with other international agreements
While this issue was deleted as a substantive provision, the language in the preamble is contradictory, on the one hand emphasising that the Protocol shall not be interpreted as implying a change in the rights and obligations of a Party under existing international agreements and on the other, stating that this is not intended to subordinate the Protocol to other international agreements. In the event of a dispute, results will depend on the forum of arbitration. The US, a non-Party, will almost certainly bring disputes to the WTO. It has already submitted a complaint to the WTO for the alleged failure by the European Union to comply with its own approvals procedure. However, they are not complaining about the EU biosafety standards as such.

Liability and redress
A system for liability and redress for damage resulting from the transboundary movement of GMOs is to be worked out within four years from MOP1 (2008) .

Socio-economic considerations
This can be taken into account when making import decisions, but is qualified by reference to consistency with other international obligations.


EU biosafety regulatory framework

THE EU has now put in place a comprehensive biosafety regulatory framework, which includes the regulation of contained use of genetically-modified microorganisms; deliberate release and placing on the market of GMOs; GM food and GM feed; traceability and labelling; and transboundary movement.

The EU Directive on the deliberate release of GMOs into the environment (Directive 2001/18/EC) has been applicable since 17 October 2002. It applies to the deliberate release into the environment of GMOs and the placing on the market of GMOs as such or in products. The Directive strengthens previous legislation, requiring more detailed pre-market scientific evaluation and risk assessment of GMOs, and specifically refers to the Precautionary Principle. Mandatory post-market monitoring and general surveillance will allow potential longer-term effects to be followed.
The Regulation on GM food and feed (Regulation (EC) No 1829/2003) applies to the evaluation, authorisation and labelling of GM food and feed. It has been in force since 7 November 2003 and will be applicable as of April 2004. This legislation extends the scope of previous regulation to now include feed produced from GMOs and all products derived from GMOs, irrespective of whether the DNA or protein is detectable. It also improves on the approvals process and can require post-market monitoring. The threshold that triggers labelling has been lowered from 1.0% to 0.9%, provided the presence of the authorised GMO in the final product is ‘technically unavoidable’.

The Regulation on traceability and labelling of GMOs and the traceability of food and feed produced from GMOs (Regulation (EC) No 1830/2003) provides a traceability framework for GMOs, GM food and GM feed. It entered into force on 7 November 2003. Traceability is defined as the ability to trace GMOs and products produced from GMOs at all stages throughout the production and distribution chains. Apart from providing the possibility of withdrawing products when problems arise, it is also important for meaningful labelling of GMOs and in addressing liability issues.

The Regulation on trans-boundary movements of GMOs (Regulation (EC) No 1946/2003) implements the EU’s obligations under the Protocol. In accordance with the Protocol’s AIA procedure, no first export of GMOs intended for deliberate release into the environment can be carried out without the prior written express consent of the importing country. The regulation recognises the flexibilities in the Protocol that preserve the right of importing countries to take (stricter) decisions according to their domestic regulatory frameworks, for GMOs intended for deliberate release and for food, feed and processing. It also recognises the right of countries to set standards for contained use and to regulate transit of GMOs. In the absence of domestic legislation, the provisions of the CPB apply and the prior written express consent provision holds.

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