National Implementation of the Cartagena Protocol on Biosafety: Some Key Issues

National Implementation of the Cartagena Protocol on Biosafety: Some Key Issues

Lim Li Lin, Third World Network

The UN Cartagena Protocol on Biosafety (CPB) is the 1st and only international law on genetic engineering/genetically modified organisms. It entered into force on 11 September 2003. Currently, there are around 120 Parties. Most of the Parties are developing countries, with the majority from Africa and small-island developing states. The 1st Meeting of the Parties (MOP) was held in Kuala Lumpur from 23-27 February 2004. The 2nd Meeting of the Parties was held in Montreal from 30 May-3 June 2005, and the 3rd Meeting of the Parties will be held in Curitiba, Brazil from 13-17 March 2006.

For the 1st time in international law, it is recognized that GMOs (genetically modified organisms) are inherently different from other naturally occurring organisms, and that there are risks and hazards associated with and inherent to genetic engineering and GMOs. As a result, GMOs need to be regulated internationally, based on the Precautionary Principle. The CPB also recognizes that GMOs may have biodiversity, human health, and socio-economic impacts.

Risk assessment for the impacts on biodiversity and human health is an essential and critical component of the international regulatory system. Socio-economic impacts arising from the use of GMOs are also recognized and may be taken into account and risk assessed. The crucial importance of centres of origin and genetic diversity of plant and animal genetic resources is acknowledged, and due regard for the risks posed by GMOs in these centres is one of the underlying concerns in the CPB.

The CPB also recognizes the special needs and vulnerabilities of developing countries.

These issues and concerns at the global level are important and significant at the national level. The Like-Minded Group of Developing Countries (of which Malaysia was a part of) actively promoted a strong and legally binding international framework for the regulation of GMOs. The on-going negotiations in the subsequent Meetings of the Parties are critical for the further development, interpretation, and implementation of the CPB.

During the negotiations of the CPB, the Miami Group (US, Canada, Australia, Argentina, Chile and Uruguay) which consists of some of the main producers and exporters of GMOs were a very powerful negotiating bloc. They were a strong voice for the biotech industry, and negotiations were very difficult and divisive. The negotiations drew the line between those countries that were clearly promoting the interests of the biotech companies, and those developing countries that were fighting for the interest of the environment, health, and small farmers, in accordance with the principle of precaution.

Other negotiating groups were the European Union, the Central and Eastern European countries, and the Compromise Group (comprising Norway, Switzerland, Mexico, South Korea, Japan, New Zealand and Singapore)

The Cartagena Protocol on Biosafety is an international instrument that deals mainly with the transboundary movement (import and export) of GMOs. In the CPB, the AIA (advance informed agreement) procedure, more commonly known as the “prior informed consent” procedure governs the international transboundary movement of GMOs for intentional introduction into the environment. This procedure essentially establishes the principle that there should be no export of GMOs unless the importing country approves its transboundary movement.

In other words, the CPB recognizes the right of countries to say “no”. Instead of passing through global markets unregulated, countries now have an international right to be notified that a GMO is going to be shipped to them, and this must be accompanied by information disclosure.

This means that the burden is now shifted to the countries that are producing and exporting GMOs to notify and obtain the permission of importing countries before transboundary movement can take place. A risk assessment and decision making based on the Precautionary Principle are critical components of the process.

The Precautionary Principle is established as the critical decision-making tool. It remains a challenge for any country to operationalise this principle. What is the result of precautionary decision making?

It is also important to note that the CPB’s scope extends to all GMOs, whether or not classified as GMOs for deliberate release into the environment, commodities for food, animal feed or for processing, GMOs in agriculture, GM pharmaceuticals, GMOs in industrial use, GM trees, GM animals etc. This is a reflection of the concern of the developing countries about the possible impacts of any final product of genetic engineering. It is also significant because the methods and techniques for genetic engineering are the same in GMOs for agriculture, and GM pharmaceuticals for example. There are the same inherent risks and hazards due to the process of genetic engineering.

Importantly, it also reflects that the critical distinction to be made in regulation, is not what the intended use of the GMO is, for example, “for food, feed or for processing”. As was argued by the chief negotiator of the Like-Minded Group of Developing Countries, in many developing countries, a seed is a seed is a seed. It does not matter what the exporter/producer intends it to be used for. It may only be intended for animal feed, for example, but when it is present in a developing country in particular, there is a high chance that a seed will be planted.

The Starlink scandal where a GMO that was only approved for animal feed was found in food across the US, and the contamination of native varieties of maize in Mexico shows us that contamination will happen. In Mexico, the GM maize imports from the US were supposed to be for “food, feed or for processing”, and their food aid from the US also probably contained GM maize.

GM pharmaceuticals for humans are not covered by the CPB if they are “addressed by other relevant international agreements of organizations”. It is open to interpretation as to whether GM pharmaceuticals for humans are indeed “addressed” by any international agreements or organizations.

In the CPB, certain categories of GMOs are excluded from the AIA procedure (All GMOs are covered by the scope of the CPB). These are “LMO-FFPs”, which are GMOs for food, animal feed and for processing, GMOs in transit, and GMOs destined for contained use.

National implementation is an obligation on countries that are Parties to the CPB. It is important to recall that the CPB is a negotiated international law framework that sets minimum standards for national biosafety implementation. This is clearly established in Article 2 (4):

“Nothing in this Protocol shall be interpreted as restricting the right of a Party to take action that is more protective of the conservation and sustainable use of biological diversity than called for in this Protocol, provided that such action is consistent with the objective and the provisions of this Protocol and is in accordance with that Party’s other obligations under international law.”

Sovereign countries are free to interpret, and implement the CPB in a more comprehensive way, and with higher standards. The CPB primarily deals with the transboundary movement of GMOs. In national legislation on biosafety, countries also need to regulate the research, field trials, etc. Any international law that is negotiated is the lowest common denominator that is able to reflect agreement by all Parties. It is in national implementation that countries are able to reflect their concerns, and put in place strong and robust legislation.

The worst-case scenarios, and the “what-if” questions must be asked when designing any regulation. If these problems cannot be prevented, or dealt with satisfactorily by national legislation, then there should be no approvals or releases. This is because the environmental damage is irreversible if the GMO concerned is problematic.

What is then important in regulation is the critical distinction between what is in “contained use” and what is “released”. GMOs are self-replicating organisms that cannot be recalled once they are released into the environment. Any regulation must be careful to define “contained use” very strictly, i.e. containment that is truly contained, for example in laboratory conditions where there is no possibility of contact with the external environment. Whatever is not “contained” is thus a “release”.

Nevertheless, the possibility of an accident or accidental release from containment cannot be ruled out. There is good reason to regulate “contained use” as strictly as “release”. In addition, policy supervision over research that usually begins in “contained use” is critical, as by the time considerable resources have been spent developing a GMO, the push for eventual commercialization is very great, sometimes even at the expense of biosafety.

Monitoring for environmental/ecological effects and effects on human and animal health are also critical if releases are approved and GMOs are planted and eaten in the country, for example. It is important that this is worked in as part and parcel of the risk assessment and when making decisions, as this is the true cost and responsibility of releasing a GMO. It should not just be considered as something to put in place once a release has taken place.

Other important provisions in the CPB include liability and redress, public participation in decision making, risk assessment and risk management, review of decisions that have been taken, unintentional transboundary movements and emergency measures, illegal transboundary movement of GMOs, identification of transboundary shipments, and information sharing.

The issue of liability and redress is critical, and this will be negotiated over the next four years. The next working group meeting is in February 2006, and the negotiations are supposed to conclude in 2008). It is very important to have an international liability and redress regime in place, given the difficulties of international law in trying to sue a biotech company in the US for example, if something goes wrong and there are negative health, environment or socio-economic impacts.

Unintentional and illegal releases of GMOs are also important to monitor. The capacity of any country to detect and enforce such releases is critical for compliance with national legislation, and for safety. If this capacity does not exist, countries must proceed with caution in allowing the domestic development of GMOs, and must be vigilant if GMO imports are allowed into the country. Even if a country does not allow GMOs to enter into their territory, this may happen accidentally or illegally, and the capacity to detect and enforce urgently needs to be built.

In such situations, emergency measures need to be taken. It is critical for countries to evaluate whether or not they know what to do, and whether the damage is repairable. All these are important factors to consider before any approvals or releases are authorized.

The issue of identification of GM commodity shipments is still being negotiated. A decision on this issue (article 18.2(a)) was supposed to have been reached at MOP 2 in June 2005. However, no agreement was reached because New Zealand and Brazil blocked consensus on this issue. Negotiations on this will continue at MOP 3 in March 2006.

This issue is critically important because clear and strict rules on identification of GM commodities will mean that countries which are producing and exporting GMOs may be compelled to segregate GM commodities and test shipments before they are exported. Currently, this is not being done, and contaminated commodity shipments have been exported all over the world.

It is often said that biosafety regulation is like trying to regulate what cannot be regulated. It is very important to understand that we do not know the risks of GMOs. Risks are defined as the consequence of a negative impact, multiplied by the likelihood if it happens. It should not be confused merely with the likelihood of something happening.
A risk can be very great if the consequence is catastrophic, even though the likelihood of it happening is small. It needs to happen only once. At this point in time, not enough research has been done to know what the negative impacts may be or even what the likelihood of it happening is. But early warnings are starting to emerge with new scientific evidence, from biosafety research and field monitoring, of environmental and health hazards.

In addition, it is critically important to consider before approving or releasing GMOs, whether or not we know what to do if something goes wrong. Can the negative impacts be reversed? Is remediation possible? Is co-existence possible? Is contamination inevitable? If these are questions that cannot be answered, then the Precautionary Principle dictates that there should be no releases or approvals until independent biosafety research has shown that these GMOs are safe beyond reasonable doubt.

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