Final Draft

May 3, 2000

Emily A. Berger

All 135 countries participating in talks on biosafety in Montreal, Canada adopted the first Protocol to the Convention on Biological Diversity on January 29, 2000. The Cartagena Protocol on Biosafety (Biosafety Protocol), named in honor of the Colombian city which hosted the early negotiations, is the first binding public international law to regulate genetic engineering. It spelled out new rules regulating the transboundary movement of genetically modified organisms (GMOs), referred to as living modified organisms (LMOs) in the protocol.

Introducing into one species the genetic material from one or more of the estimated ten to one hundred million other species on the planet produces a genetically modified organism. This procedure is often done to introduce desired traits, such as internal protection from insects or disease, tolerance to certain chemicals, improvement of food quality, or production of additional products. Many people believe that GMOs require regulation, as they may cause unnecessary risks to the environment, human health, and biodiversity.

The final agreement comes a year after talks in Cartagena and eight years after its origination at the 1992 United Nations Conference on Environment and Development (Earth Summit) in Rio de Janeiro. The agreement collapsed in February 1999 primarily because of opposition from the United States, Canada, and other agricultural exporters in support of free trade with few restrictions. In the wake of this failure, the polar interests of the six grain-exporting nations making up the Miami Group and the more than 100 developing countries forming the Like-Minded Group have stalled all other attempts to agree.

Before it can be implemented, 50 countries that have already signed the United Nations Convention on Biological Diversity must ratify the Biosafety Protocol. The United States had no official standing in Montreal because the United States Senate has not ratified the convention. The United States is therefore not technically bound to honor the Biosafety Protocol. Nevertheless, United States industry will have to comply with the rules of the Biosafety Protocol when exporting to nations that have ratified the treaty.

The United States should reverse its position and adopt the Biosafety Protocol. Additionally, political leaders from the United States and around the world should fight to create domestic laws that fill in the gaps left in the Biosafety Protocol. The agreement is an international one, and it covers only the transboundary movements of GMOs. To that end, it covers only a small portion of the health and environment issues that the global economy will face in the future.

Although the Biosafety Protocol is not comprehensive, it is an international legal framework that complements the rights of the sovereign nations. The World Trade Organization should recognize the value of a treaty that 135 nations have signed and resist restricting their sovereignty in the interest of freer trade. By adopting the Biosafety Protocol, these nations have voiced their concern for their global environment and for public health, and their voice should be heard.

The Convention on Biological Diversity (CBD) became a cause celebre of environmental organizations at the 1992 Rio Earth Summit. The Earth Summit was convened to develop ways to halt environmental degradation and to promote sustainable development. In an effort to find a way for countries to work together to encourage sustainable development and to slow the destruction of biodiversity, the members of the Earth Summit introduced the CBD.

The drafting of the CBD began years before it was opened for signature at the Earth Summit. In 1989, the United Nations Environment Programme (UNEP) set up an Ad Hoc Group of Legal and Technical Experts. This Group later became known as the Intergovernmental Negotiating Committee for the CBD, and it negotiated the CBD in five sessions in Nairobi between July 1991 and May 1992. The CBD was adopted May 22, 1992, and took effect on December 29, 1993. Currently, 175 countries have ratified it.

The CBD represents an international effort to curb the extinction of plants and animals. Unlike other treaties that require no more than adherence to general principles, the CBD adopts an ecosystem approach under which parties must agree to actual duties and obligations. The principle aims of the CBD are the conservation and equitable and sustainable use of biological diversity and the transfer of biotechnology expertise from industrialized to developing countries. The CBD has recognized the need to preserve biodiversity for its "intrinsic value" beyond its "ecological, genetic, social, economic, scientific, education, cultural, recreation, and aesthetic values."

The CBD mandated biosafety negotiations by calling upon its Parties to consider the need for and content of a Protocol to the CBD to address the safe transfer, handling, and use of living modified organisms derived from modern biotechnology "that may have adverse effect on the conservation and sustainable use of biological diversity." Pursuant to this provision, the Conference of the Parties (COP) to the CBD established an Open-ended Ad Hoc Group of Experts at its first meeting to consider the need for a protocol. The second meeting, held in 1995 in Jakarta, Indonesia, set up a Working Group on Biosafety to negotiate the protocol. This group was established after intense debates on the scope and elements of the protocol.

The Working Group met six times over almost three years to work on the protocol. At the end of its sixth and last meeting, its Danish Chairman, Veit Koester, produced the Cartagena version of the protocol in an effort to consolidate the drafts of the many different governments involved. The Parties never actually negotiated that draft of the protocol. The Working Group was thereafter dissolved on February 22, 1999. The Extraordinary Meeting of the Conference of the Parties, chaired by Colombian environment minister Juan Mayr Maldonado, took over the negotiations of the protocol at that time.

On July 1, 1999, delegates at an informal CBD meeting in Montreal confirmed their political will to proceed with negotiations. By September, the consultations included exploration of areas of possible agreement in Vienna. In January 2000, the Extraordinary Meeting of the COP resumed in Montreal. The concluding talks there used the Cartagena version of the protocol to start negotiations for core provisions. The final draft was adopted at the close of this meeting.

The Biosafety Protocol is an addition to the UN Convention on Biological Diversity and deals with the potential dangers of the release of organisms created by gene splicing into the ambient environment. The Biosafety Protocol was designed to provide for an "adequate level of protection in the field of the safe transfer, handling and use of living modified organisms resulting from modern biotechnology that may have adverse effects on the conservation and sustainable use of biological diversity, taking into account risks to human health and specifically focusing on transboundary movements."

The Biosafety Protocol covers neither products derived from GMOs nor pharmaceuticals for humans that other relevant international agreements or organizations address. Genetically modified vaccines and insulin are among those GMOs that are pharmaceuticals for humans. According to growing scientific literature, these types of GMOs have environmental and health risks. Relinquishing jurisdiction "from a legally binding international agreement to [] a non-legally binding standard-setting organisation" permits there to be a much lower obligation on Parties with respect to GMOs that are pharmaceuticals for humans.

The Biosafety Protocol is an environmental agreement and does not address food safety. Three major programs regulating food safety already exist: the Codex Alimentarius Commission [hereinafter Codex], the International Plant Protection Convention, and the Office Internationale Des Epizooties. That may be part of the reason why food safety was not addressed. Nevertheless, those programs have not fully addressed food safety concerns. Codex, a subsidiary body of the World Health Organization and the United Nations Food and Agriculture Organization, for example, has recently assumed a new importance that could downgrade domestic food safety regulations.

The World Trade Organization (WTO) Agreement on the Application of Sanitary and Phytosanitary Measures [hereinafter Agreement], intended in part to encourage nations to support the development of international food safety standards and to adopt those standards domestically, designated Codex as one of the primary sources of recognized international food standards. Domestic regulatory requirements based on Codex standards are generally presumed to be consistent with the Agreement, but regulatory requirements that exceed Codex standards may be challenged before the WTO as trade barriers. As one commentator so aptly stated, "The danger lies in the fact that, whenever a Codex standard is more tolerant ... than a national standard, consumers in that country face an increased risk that the national standard will be lowered to prevent a trade controversy." Thus, had the Biosafety Protocol addressed food safety concerns as they related to GMOs, the agreement would! likely have faced similar challenges and would have added little more to the present programs.

The Final Draft of the Biosafety Protocol defines the import and export procedures for GMOs. Countries that consider genetically altered seeds, microbes, crops, or animals to be a threat to their environment or public health can now refuse to import them. The Biosafety Protocol requires the exporting party to notify some "competent national authority" of the importing party of any intentional transboundary movements of GMOs not intended for direct use as "food or feed, or for processing." The importing party must acknowledge receipt of this notification within 90 days. Nevertheless, the failure of the importing party to provide notification does not constitute implied consent to an intentional transboundary movement.

The Biosafety Protocol provides that governments signal whether or not they are willing to accept imports of GMOs by communicating their decision via the Internet-based Biosafety Clearing-House. If a Party lacks the facilities to access the Clearing-House, it has the burden of informing the Clearing House before any notification issues arise. Then, relevant information must be provided in writing to the national focal point of that Party, which must make its decisions under domestic law.

The implementation of the Clearing-House has weakened the Biosafety Protocol. This method of notification hinders developing countries with little or no access to high technology. It further shifts the burden of financial and procedural initiatives to the importing Parties

The precautionary principle and labeling were at the center of the final debates leading up to the signing of the Biosafety Protocol. The Like-Minded Group of developing countries, the European Union, and the Compromise Group -- Norway, Switzerland, Japan, Mexico, South Korea, and Singapore -- called for a strong Biosafety Protocol at every stage of the negotiations. These groups argued that the agreement should allow governments to put the interest of their people ahead of the interests of free trade.

The Biosafety Protocol "marks the first time that nations have agreed on an attempt to prevent environmental problems before they begin." Prior to the signing of the Biosafety Protocol, governments could only block imports of GMOs if there was actually scientific evidence that GMO crops used in food production could be dangerous. The Biosafety Protocol itself allows governments to block imports of GMOs if there is "reasonable doubt" that they could endanger either public health or the environment. In other words, the Biosafety Protocol invokes the precautionary principle in an international setting.

The Miami Group -- the United States, Canada, Australia, Argentina, Chile, and Uruguay -- had been against imposing the precautionary principle. As the producers of most of the world’s GMOs, the Miami Group created a strong barrier to completing a successful agreement. Initially, the Miami Group had even objected to including the word "health", arguing that such language should not appear in the biodiversity agreement. Eventually, it yielded and approved of the use of such language in the Biosafety Protocol.

The agreement also permits the labeling of products derived from the biotech organisms and allows countries to block entry of GMOs. Under the treaty, shipments that contain GMOs must be clearly labeled. Seed companies and farmers need not necessarily segregate their GMO seeds from traditional varieties, however.

The Europeans, the last to yield ground on the labeling issue, conceded that it was not reasonable to ask farmers to segregate and label bulk products such as corn and soybeans. The European Union had already established a labeling system for genetically modified products. On March 30, 2000, Mexico’s Senate voted unanimously to require labeling of foods that contain genetically modified ingredients. According to the Biosafety Protocol, countries or regions like the European Union and Mexico, which have established labeling systems, will be able to keep their regulations, while developing nations will receive help in setting up their own regulatory systems.

More than one-half of the soybeans and one-third of the corn grown in the United States last year contained modified genes. In addition, approximately sixty percent of packaged foods sold in the United States contain genetically altered ingredients. The other members of the Miami Group also grow large quantities of these products, do not currently have domestic labeling requirements, and would have to output great time and expense to label them. The Miami Group succeeded in crafting the agreement so that genetically modified products need only have documentation saying that shipments "may contain" GMOs.

Stricter Advanced Informed Agreement (AIA) procedures will apply to the first intentional transboundary movement of seeds, live fish, and other GMOs that are to be released into the environment. For these GMOs, the exporter must provide detailed information to each importing country in advance of the first shipment, and the importer must then authorize shipment. The aim of this notification process in to ensure that importing countries have both the opportunity and the capacity to assess risks involving genetically modified products. The Like-Minded Group of developing countries had promoted the application of this type of advanced informed notification to the first transboundary movement of all GMOs.

The final agreement provided for further action at future dates. Detailed requirements for the specification of the identity of the modified organisms and any unique identification to be placed on them must be set forth no later than two years after the Biosafety Protocol is put into force. The terms of the protocol call for an agreement on a liability and compensation system to be set forth within four years after the Biosafety Protocol takes effect. Some environmental groups are hoping that companies exporting GMOs will be held strictly liable under the agreement in the event that problems arise. They also hope that exporters will be required to provide adequate compensation for any damages to health or the environment.

France will host a meeting to prepare for the first meeting of the Parties to the Biosafety Protocol by the end of 2000. Procedures for the segregation and identification of GMOs, along with the procedures for establishing a system of redress, are expected to be on the agenda. Neither a liability and compensation system nor requirements for more specific labeling are expected to be discussed at that time, however.

Once 50 countries ratify the treaty and the Biosafety Protocol goes into effect, a new round of negotiations on more specific labeling requirements will begin. Genetically modified crops can have unforeseen implications. Some claim that the GMOs currently being developed by multinational companies could have devastating effects for farmers and rural communities in developing countries. The identification of these GMOs may affect the implementation of stricter labeling requirements.

Ratification of the Protocol is needed as soon as possible. The agreed text will be opened for signature at UNEP Headquarters in Nairobi from May 15 to 26, 2000, and in New York from June 5, 2000 to June 4, 2001. It is the 5th session of the Conference of the Parties to the Convention on Biological Diversity. The Protocol will then enter into force 90 days after 50 countries have ratified it.

Due to a lack of democracy in Seattle, among other reasons, the WTO failed to launch a new round of trade talks. The biotech issue is probably moot at the WTO, at least for the time being, because of the collapse of the Seattle meeting. However, an in-depth analysis of the joint proposal of the United States, Canada, and Japan submitted prior to finalization of the Biosafety Protocol to the WTO "to examine approval processes" for GMOs, will be necessary to determine what the future may hold. New proposals to the WTO could weaken the Biosafety Protocol as Multilateral Environmental Agreements (MEAs) employ trade restrictions in varying forms against non-parties, making them susceptible to challenge as a violation of the General Agreement on Tariffs and Trade’s (GATT) Most Favored Nation principle.

The relationship between the World Trade Organization and the Biosafety Protocol was "deliberately left vague." Under the provisions of the Biosafety Protocol itself, the agreement and the WTO are to be mutually supportive. At the same time, the agreement states that the Biosafety Protocol is not to affect the rights and obligations of governments under existing international agreements. The outcome of a biotech trade dispute that goes to the WTO for resolution following implementation of the Biosafety Protocol is unpredictable.

The agreement contains a "savings clause," which emphasizes that the new protocol doesn’t override rights and obligations under other international agreements, such as those under the WTO. Some environmentalists worry that exporting countries could take advantage of the savings clause by challenging the WTO to ignore the Protocol altogether. Nevertheless, European diplomats have stated that the WTO cannot ignore the Biosafety Protocol if a country follows the rules set forth in the agreement and block an import accordingly. Indeed, the problem may not necessarily be that the WTO will ignore the Biosafety Protocol, but rather that free trade interests will likely prevail over the global environment and public health in a dispute before the organization.

Provisions about the relationship between the Biosafety Protocol and the WTO are in the protocol’s preamble. Because of this fact, Matthew Stilwell, managing attorney of the Center for International Environmental Law believes that the relationship of the Biosafety Protocol to the WTO is indeed unclear. The relationship would have been clearer had it been set out in one of the Articles. Preambular language is less binding than provisions in the operational chapters.

The WTO itself has determined that the exceptions clauses contained in Article XX of the GATT "allow a WTO Member legitimately to place its public health and safety and national environmental goals ahead of its general obligation not to raise trade restrictions or to apply discriminatory trade measures." In fact, the WTO asserts that "cooperative, multilateral action under an MEA" is its preferred approach for governments to take in tackling transboundary or global environmental problems. There has been no problem to date in the WTO over the use of trade measures applied pursuant to MEAs, but that is most likely due to the fact that there are very few MEAs that contain trade provisions at all.

The history of the WTO is a long one. In an effort to discourage governments from engaging in policies which put imports from foreign countries at a disadvantage relative either to domestically produced goods or goods produced in other foreign countries, the post-Second World War planners established the GATT. Two of the primary rules promoting this objective were the "Most Favored Nation" provision and the "National Treatment" provision. By 1994, the eight-year long Uruguay Round of the GATT negotiations created the WTO to make dispute settlement panel decisions binding on contracting parties.

The parties to the WTO do not have veto power over the acceptance of panel reports. Unless disapproved by a consensus of the member nations, a panel decision will be automatically adopted within 60 days. Thus, these GATT/WTO panel decisions can directly limit States’ behavior. The establishment of the WTO "represents the farthest reach to date of efforts to cede sovereignty from nation-states to international institutions."

The dominant view of state sovereignty is that States should be left free to regulate all matters of human activity within their territories. The limited mission of the WTO threatens the sovereignty not only of the member nations, but particularly, the sovereignty of their states or provinces and leaves no room for each state to choose its own level of ecological welfare. Before the United States had committed to joining the WTO, Ralph Nader summarized the arguments against the WTO as follows:

Similar concerns for United States sovereignty are at the heart of a bill that was introduced by then-Senator Dole that would require the review of any WTO panel decision that was adverse to the United States. Under the Dole Bill, the United States would cease to be a member of the WTO if a review Commission determined that three panel reports were wrongly decided.

In 1996, a WTO ruling allowing for the importation of a lower standard of Venezuelan gasoline than was required in the United States set a dangerous precedent. Two years earlier, Congress had stated that the domestic policy was to use only Reformulated Gasoline (RFG) as required by the Clean Air Act. Venezuela prevailed in its appeal to the WTO, stating that Congressional action violated the GATT. This type of action is a "direct attack on the sovereignty" of nation-states.

The Tuna-Dolphin panel decision is another good example of the GATT’s threat to national democracy and sovereignty. Before the decision in that case, the citizens of the United States spoke through members of Congress to protect dolphins from the risk of extinction. At that time, however, a movement for the globalization of free trade was underway, and the United States, and its citizens, were forced to yield to foreign trade interests.

The environmental decision was subjected to the review of an international trade panel not elected by those citizens. This panel decided that the decision of Congress lacked justification for choosing the protection of dolphins over the ease of trade. Thus, the panel decided to overrule the democratically elected body of the United States. The decision "practically eliminated the possibility of using Article XX of the GATT to justify environmental regulations that affect trade." In sum, the lack of a coherent effort within the major multinational agreements, and the accompanying reliance on dispute resolution remedies, may eventually eliminate the ability of member States to enforce their own standards or even other agreements.

In undermining national or state sovereignty, the approach of the WTO could also undermine the standards adopted by individual national governments. It is true, however, that very few nations have actually taken the lead in establishing strong domestic policy regarding GMOs. The United States has allowed GMOs to be used and tested with very little regulation. The European Union has taken the most care to regulate GMOs domestically. The European Parliament recently introduced a proposal that invokes the precautionary principle and requires risk assessment. Many observers expressed disappointment with the strength of the proposal, however.

Even if one nation were to adopt extremely strict standards, such a unilateral approach "would very likely be completely ineffective at stemming the long-term tide towards environmental degradation." A multilateral regime is the only solution for regulating a global environment. MEAs, such as the Biosafety Protocol, provide a better alternative for solving global environmental problems than do the decisions of the WTO, and they do so without restricting national sovereignty.

The WTO has failed to define its relationship to MEAs. The WTO’s Committee on Trade and the Environment (CTE) was not able to reach consensus on the standards that should apply in construing MEAs in light of WTO objectives. The CTE was able only to assert that both the WTO and MEAs were worthy of respect and that international cooperative action was preferable to unilateral environmental policy.

If a government were to lodge a WTO complaint about an MEA, the ensuing litigation could harm not only the MEA, but also the WTO. As one commentator has aptly noted, "[i]f the World Trade Organization were to rule, for example, that ... some .... popular agreement violated the provisions of the trade agreements, popular acceptance of the World Trade Organization would probably decline." The Biosafety Protocol can coexist with the WTO if the organization can agree to recognize it and other MEAs like it that have several signatories, clear objectives, and the reasonably effective means necessary to satisfy indispensable environmental objectives. The WTO should not be permitted to overrule the Biosafety Protocol following its ratification because the sovereign states will have made the decision to implement its directives, favoring health, safety, and environment over free trade.

Political leaders should exert themselves and establish domestic laws that fill in the gaps of the Biosafety Protocol. As it stands, the Biosafety Protocol only focuses on some aspects of the transboundary movements of GMOs. It is not comprehensive in scope, and it does not cover all the necessary aspects of biosafety regulation. Companies exporting GMOs should be held strictly liable in the event that problems arise as a result of their exportation. Exporters should also be required to provide adequate compensation for any damages that their GMOs cause to health or the environment.

Countries have always had the sovereign right to regulate GMOs at the national level. The Biosafety Protocol has established an international legal framework to complement the rights of the sovereign nations. Additionally, it fulfills the environmental objective of using multinational action over unilateral action to preserve the global environment.

The WTO should recognize the value and authority of MEAs, especially ones like the Biosafety Protocol that have several signatories, clear objectives, and the reasonably effective means necessary to satisfy indispensable environmental objectives. If the WTO truly values multinational action over unilateral action, it should respect the opinions of the sovereign nations and appreciate their cooperative effort. The Biosafety Protocol is an excellent remedy for global environmental problems, and it operates without restricting national sovereignty.