Leveling the Field
by Lara Freeman

What is the Cartagena Protocol on Biosafety?

The Biosafety Protocol is the first international treaty governing the movement of genetically modified organisms (GMOs) across international boundaries. It entered into force for member countries on September 11th, 2003, ninety days after the fiftieth country completed the process of ratifying it. On the basis of a “precautionary approach” the protocol aims to ensure the safe transfer, handling, and use of GMOs that may have adverse effects on the conservation and sustainable use of biological diversity. The Protocol specifies a detailed plan for the import and export of GMOs, in which an exporter must provide the country of import with a detailed description of the GMO, including a risk assessment outlined by the protocol. The importer may then accept or refuse the GMO, or request additional time for consideration. The exact procedures and mechanisms for making these decisions will be addressed in the next meeting of the parties to the Protocol in February, 2004. In order to assist with the implementation of the Protocol, a Biosafety Clearing House has been established that will aid in the exchange of scientific, technical, environmental and legal information concerning GMOs.

How did the Biosafety Protocol become international law?

The Cartagena Protocol is the result of eleven years of negotiation and compromise. The Protocol was born out of Article 19 of the United Nations Convention on Biological Diversity (CBD), introduced at the Earth Summit in 1992, which calls for the establishment of an advance information agreement on the safe transfer, handling and use of living modified organisms. In December, 1996, a working group met to begin developing the Protocol; the four-year delay between the proposal and its development was due in part to the U.S.’ and the biotech industry’s denial that any legal agreement of this sort was
necessary. While the U.S. did not join other countries in support of the CBD, U.S. representatives were still invited to, and were present at, the negotiations for the Protocol. A final draft was presented at Cartagena, Colombia, in February 1999, but negotiations terminated without agreement. The majority of the countries involved supported the draft, but a small, vocal minority of GMO exporters, led by the U.S., felt that free trade, as established by the World Trade Organization (WTO), was threatened. The following year, the WTO meetings in Seattle collapsed as developing countries united against their exclusion from key trade negotiations. This collapse proved helpful for the Montreal meeting of the CBD in 2000. The time was ripe for a consensus to be reached concerning GMO trade, and for a body outside of the WTO to establish this consensus.

In January, 2000, the Biosafety Protocol was adopted as a supplementary agreement to the Convention on Biological Diversity. By June, 2001, 103 governments had signed on in support of the agreement, and in June, 2003 the government of Palau became the fiftieth nation to ratify the Protocol. With fifty states in support of the document, it entered into force as international law under the UN’s Convention on Biological Diversity 90 days later, on September 11th, 2003. Currently, sixty-five countries have ratified — or are going through the process of ratifying — the Protocol. The U.S., Canada, Australia, Argentina, Chile and Uruguay, all key agricultural GMO exporters, have yet to officially accept the agreement.

What are the successes of the Biosafety Protocol?

The agreement empowers developing and developed countries with resources and legal authority to make an informed decision concerning the trade of GMOs. In light of the bitter controversies surrounding food aid from the U.S. to Southern Africa last winter, in which leaders were forced to choose between accepting food aid containing GM maize and grains or allowing thousands of people to starve, this empowerment is timely. The Protocol will clarify the risks associated with GM crops and give developing countries the legal right to accept or reject GM foods based on these assessments.
In addition to legal empowerment, it is a victory for the international community that global institutions are seriously considering the uncertainty and potential risks to biodiversity of genetically modified organisms. The U.S. government’s policies — more favorably disposed towards agribusiness than towards environmental and health issues — have not yet acknowledged that these potential risks exist. Further, the social and economical impacts of biotechnology on small,
subsistence farmers, especially in developing countries, are acknowledged by the Protocol as vital considerations.

How does the Protocol define the “precautionary approach”?

The precautionary approach which undergirds the principles of the Protocol was originally outlined in 1992 at the Earth Summit in Rio de Janeiro as part of the Rio Declaration on Environment and Development. It states that “where there are threats of serious or irreversible damage, lack of full scientific certainty shall not be used as a reason for postponing cost-effective measures to prevent environmental degradation.” When applied to the Protocol, the precautionary approach means that an importing country with questions concerning the safety of a GMO can request further relevant information from the exporting group before accepting that GMO. Additionally, the Protocol specifically mentions that lack of scientific certainty due to insufficient, relevant, scientific information concerning the potential environmental impact of the GMO should not prevent an importing country from making a decision which will minimize potentially adverse effects on its biodiversity.

These are significant departures from the principles of current trade agreements surrounding biotechnology. The World Trade Organization’s Sanitary and Phytosanitary Agreement (SPS) requires that an importing government provide “sufficient scientific evidence” of risks before it can restrict or prohibit trade. The SPS agreement is more concerned with the removal of trade barriers than with the assessment of potentially dangerous environmental and health situations.

What Genetically Modified Organisms and products are included under the jurisdiction of the Protocol? What is left out?

The protocol divides GMOs into three categories: those intended for direct introduction into the environment; those intended for contained use; and those destined for food, feed, or processing. Shipments containing products which fall into any of these categories must clearly identify that they “may contain living modified organisms” and provide contacts for the exporting group in case further information is required. Seeds, crops, microbes, animals, and other agricultural
commodities which will be directly released into the environment are subject to the Advanced Informed Agreement (AIA) every time they cross international boundaries.

However, anything that will not come into direct contact with the environment — such as products used in a laboratory, or things in transit through a country — will not be covered under the AIA after an initial registration of the product with the Biosafety Clearing House. This means that processed foods containing GMOs — such as vitamins, vaccines, drugs, pharmaceuticals, food additives, bread, beer, canned or preserved food, adhesives, and fuel ethanol — are not included within the jurisdiction of the Protocol after an exporter informs the Clearing House of intentions to trade the GMO for direct use as food, feed, or processing across international boundaries.

What is the relationship between the Biosafety Protocol and the World Trade Organization?

One of the greatest challenges facing the implementation of the UN’s Biosafety Protocol will be determining its interaction with the rules of the World Trade Organization (WTO). Up to this point, the WTO has handled the majority of trade considerations with an aggressive free trade strategy. The events in Seattle in 1999 made it clear that, at least in the handling of GMOs and their potential threats to biodiversity and health, some issues need to be managed by another agreement. However, the Protocol remains ambiguous as to how these two international agreements will relate in practice. Though the Protocol expressly states that its purpose is not to change any existing international agreements, the precautionary approach transforms the current applications of risk assessment and the obligations of importing parties to ensure that potential risks are considered in the trade of GMOs. With this objective, the Protocol articulates that it will not be subordinate to any other international
agreements. The stipulation is, for the moment, in uncharted legal territory.

How does the Biosafety Protocol deal with the issue of liability?

While the protocol is potentially a huge success for protecting the environment and reducing the imbalances of international trade, unresolved issues remain to be addressed at the next meeting of the Congress, which will be held February, 2004 in Kuala Lumpur, Malaysia. The issue of liability is one of the thorniest of these.
In Montreal, provisions for the liability and redress of a GMO exporter to an importer, in case of an accident or unexpected damage, were so sensitive that negotiators simply left them to be dealt with in future meetings. The major exporters of genetically modified agricultural products — the U.S., Canada, Australia, Argentina, Chile and Uruguay — have severe reservations about this sort of responsibility. Rules and procedures need to be developed that hold exporters — whether they be developers, countries, or companies — accountable for any damage caused by their GMO products following release into the environment. The exporting parties need to be responsible for reparations to the importing group if there are adverse consequences to biodiversity caused by the GMO.

A solid statement on liability and redress would ensure that only safe and thoroughly tested products are delivered to countries — a consideration that is especially crucial to those countries lacking biotechnological development and the resources to repair biological harm. The protocol calls for the adoption of rules addressing this issue within four years of its entry into force.

What about enforcement of the Protocol?

At the meetings in Kuala Lumpur, the parties will also consider non-compliance and enforcement of the Protocol. The Conference will consider the development of procedures and institutional mechanisms that will encourage adherence to the provisions of the Protocol. Dispute settlement and non-compliance will also be addressed. Special attention will need to be given to trade agreements between members of the Protocol and non-members, as the Protocol declares that any trade between a member country and a non-member country must be consistent with the guidelines of the agreement.

How is the labeling of GMOs addressed in the Protocol?

Labeling of GMOs is addressed in the Protocol, but many people
are concerned that the Protocol does not go far enough. GMO
products not intended for direct use in the environment have lax labeling codes which only require a statement that the product “may contain” living modified organisms.

A coalition of negotiators representing the major GM crop exporters, led by the U.S., were adamant that products containing GM material, such as soy sauce or vitamins, don’t need to be separated from non-GM products. Consumers who wish to avoid GM products for health or religious concerns are not considered in this system, and the Protocol cannot prevent genetically modified material from entering ecosystems in other, indirect ways — such through an escape from a laboratory or research facility.

Lara Freeman is a Master of Divinity Candidate at Harvard Divinity School. With a background in human biology, she is currently pursuing study in the Religion and Ecology Program and is an intern at CRG.