By: Phil Bereano and Eliott Peacock


The international movement of GMOs (genetically engineered organisms) falls under an increasing number of apparently independent legal regimes, each with somewhat different primary goals.

This policy brief explores the evolving treaty rules — in light of promoting trade, protecting the environment, safeguarding human health, and recognizing consumer interests — and the still-open issues identified.  It is not clear whether a rationally integrated international system will emerge, or if so, when and how.


Two international instruments have recently changed the playing field regarding the international regulation of genetically engineered organisms. One is the Cartagena Protocol on Biosafety, which is intended to regulate the international transfer of "living modified organisms" (LMOs). The second is a set of guidelines, the Risk Analysis Principles for Foods Derived from Biotechnology, established by a little-known United Nations body called the Codex Alimentarius Commission.

These two instruments signal attempts by the world community to establish rules governing the production, trade and use of genetically modified (GM) foodstuffs. Both agreements emphasise the rights of consumers and farmers, and the protection of ecosystems. However, it is not clear how their provisions will work alongside the free-trade rules of the World Trade Organization (WTO).

The Cartagena Protocol: a greener way

By joining the WTO, countries agree to limit their freedom to impose restrictions on foreign trade. The Cartagena Protocol, however, stresses that trade considerations need not always be given precedence over other national objectives. It recognizes that the need to protect biodiversity, the environment and human health are valid priorities in decision-making. As of 3 December 2004, some 111 countries had ratified the Protocol, which came into force on 11 September 2003.

The Protocol establishes a procedure called Advanced Informed Agreement. Under an AIA, those planning to export LMOs for introduction into the environment must notify the country to which they are being sent. That country is then entitled to authorise or refuse permission for the shipment, based on a risk assessment. Furthermore, the Protocol allows the recipient nation to invoke precautionary regulation if, in its judgment, there is not enough scientific information to make a proper assessment:

"Lack of scientific certainty due to insufficient relevant scientific information and knowledge regarding the extent of the potential adverse effects of a living modified organism on the conservation and sustainable use of biological diversity in the Party of import, taking also into account risks to human health, shall not prevent that Party from taking a decision, as appropriate, with regard to the import of that living modified organism..."

The Protocol does not specify how to resolve any conflict between its own rules allowing an importing country to control trade in LMOs and that country's obligations not to impede trade, if it is also a member of the WTO.

Its Preamble contains three intentionally conflicting provisions — that trade and the environment should be "mutually supportive"; that the agreement does not change any Party's international rights and obligations; and that the Protocol should not be interpreted as being "subordinate" to any other treaty;

In particular, the Protocol's adoption of the precautionary principle — the idea that an action should not be carried out if the consequences of it are unknown but highly likely to be negative — is claimed by trade interests to run counter to the WTO mandate.

Those involved in drafting the Protocol, along with other observers, also acknowledge that there are a number of outstanding issues relating to the oversight of genetic manipulation technologies that may cause concerns. These include:

  • "Living modified organisms" (LMOs) is a more restricted category than "genetically modified organisms" (GMOs), since it excludes those no longer alive, and their products.
  • "Intentional introduction into the environment" may not address situations where the exporter knows that some shipped modified grain, for instance, will be planted within the importing country, but does not necessarily 'intend' this to happen.
  • Many important countries are not members of the Protocol, including the largest growers and exporters of LMOs: the United States (US), Canada, Argentina and Australia.
  • The Protocol's provisions on trade in LMOs between a party and a non-party state does not require that its procedures be followed.
  • The Protocol says nothing about any regulatory oversight within a country.

Furthermore, two key issues have yet to be resolved:

  • A system for identifying and tracing LMOs in international trade must be negotiated by September 2005.
  • The parties still have to produce a system of "liability and redress" to deal with any damages LMOs cause, such as the genetic contamination of farmers' fields, by 2007.

The Codex Alimentarius: focus on food safety

Two months before the Protocol entered into force, a separate breakthrough took place. In July 2003, with the backing of all its 168 member nations, the Codex Alimentarius Commission produced the first set of international guidelines for assessing and managing any health risks posed by GM foods.

A relatively obscure United Nations agency, the Commission is charged with the key global task of setting international guidelines for food quality and safety. It was established in 1963 by the Food and Agriculture Organization (FAO) and the World Health Organization (WHO), and given the mandate of "protecting the health of the consumers and ensuring fair practices in the food trade". The Commission draws up voluntary international food guidelines through negotiations in approximately 30 committees and task forces.

The most significant element of the 2003 guidelines is that they call for safety assessments of all GM foods prior to their approval for commercial sale. This has important implications for WTO members. In 1995, the WTO had agreed that Codex norms should be the reference point for evaluating the legitimacy of food regulatory measures that are challenged as restrictions on trade. Thus, although the Codex guidelines are strictly voluntary, they have legal significance for WTO members.

The Codex Alimentarius Commission has therefore come to play a potentially significant role in defining internationally acceptable ways of regulating GMOs. For example, the European Union (EU) [1] has referenced the new Codex guidelines in its current WTO dispute with the United States, Canada and Argentina over European restrictions on GM foods.

The Codex risk assessment guidelines contain much language about the need for a "scientific" evaluation of the actual hazards presented by the new foods. But they also recommend that "risk managers should take into account the uncertainties identified in the risk assessment and implement appropriate measures to manage these uncertainties". This wording appears to acknowledge the validity of a precautionary regulatory regime, similar to that allowed for international shipments under the Cartagena Protocol.

The Codex also recognizes that Other Legitimate Factors (OLFs) — non-scientific in nature — can form a valid basis for regulations, such as using halal or kosher standards. Other provisions, within the guidelines, call for a "transparent" safety assessment, that should be communicated to "all interested parties" that have opportunities to participate in "interactive" and "responsive consultative processes" where their views are "sought" by the regulators.

These non-scientific aspects are consistent with the second prong of the Codex mandate, namely its role in deterring deceptive practices. Such practices might, for example, include selling or distributing GM foods to consumers without labelling them as such. As a top world food exporter, the United States has vigorously advocated that only "objective" and "scientific" health claims should be used as the basis for regulating GM foods. Along with industry lobby groups, it has argued that the impact of the second Codex mandate, the OLFs, and precautionary regulations of any kind should be reduced. By contrast, consumer and environmental groups are putting pressure on governments to resist accepting these views.

Too rich a mix?

It is not obvious how the Protocol, the Codex guidelines and WTO rules mesh together. Seeking a simple answer to this question assumes that the negotiation of these agreements was guided by a logical process. In fact, they were produced at different times, by delegations from different national ministries with various missions (trade, environment, food, agriculture, health, etc), and without any reference to the bigger picture. These agreements also reflect the different configurations of industry and public interest groups that helped shape them.

Thus, despite language in each of the three texts about "harmonisation", it needs to be recognised that they are separate agreements with divergent objectives, and that only through their application will countries realise the need to reconcile some of the apparent conflicts. For example, the aforementioned WTO dispute between the EU and the US, Canada and Argentina rests exclusively on a narrow interpretation of the WTO Agreement on the Application of Sanitary and Phytosanitary Measures (known as the SPS agreement). The US asserts that the SPS agreement should form the basis for evaluating the legitimacy of GM food regulations, and ignores both the new Codex guidelines and the Protocol.

The EU, however, is calling on the WTO's dispute panel to interpret and apply the WTO agreement in the light of the Codex and the Protocol. In making its defence, the EU has referenced the new Codex risk analysis principles to illustrate that its pre-market safety assessment requirements for GM foods agree with international norms, and referred to the Protocol to support its argument that the SPS agreement is inappropriate and inadequate for determining the legitimacy of GM food regulations.

Furthermore, more than 660 civil society groups and academics have voiced similar arguments, and many have submitted amicus briefs [2] in support of the EU to the WTO dispute panel. However, the decision on whether to accept such a defence will be made within the WTO dispute mechanism. At the end of the day, economic and political factors may play a determining role, rather than health or safety considerations.

In addition, environmentalists argue that the new Codex guidelines on GM foods simply underscore how easy it has been for industry to bring GM foods to market without regulatory supervision, for example in the US. This practice has been criticised by many activist organisations and a growing number of scientists, as well as several international authorities on food safety matters.

Many of these critics point out that there is virtually no peer-reviewed, published scientific research on the risks of GM food that would allow for safety claims to be tested. They argue that the lack of evidence of risk is not the same as evidence of no risk. Many civil society organisations have insisted that precautionary steps should be taken to avert potential risks. Even the WTO Appellate Body, which settles its disputes, has recognised that divergent scientific views may be considered in making assessments, such as those evaluating food risks.

Using the precautionary principle to manage risks also puts the burden of proof on those seeking to introduce the new technology. The United States and other exporters of GM foods have blocked efforts to incorporate the principle explicitly into the Codex guidelines. But some commentators and activists believe that, despite no actual mention of it in those guidelines, the precautionary principle is implicit in the document's suggestions for risk analysis because these call for the safety of a GM food to be analysed before it is produced and sold. The WTO's SPS agreement explicitly allows precautionary regulation to go forward while additional relevant scientific information is obtained.

The governments blocking the inclusion of the precautionary principle into the Codex guidelines have argued that if it were to be applied to regulating GM foods, that could be used to justify regulations intended primarily to protect domestic industries from foreign competitors — in violation of the WTO agreements. Others point out, however, that it is not the purpose of the Codex guidelines to stimulate trade, but rather, to protect consumers. The WTO is supposed to follow Codex norms, not vice versa.

Staying on track

Another concept still under negotiation in both Codex and under Article 18 of the Protocol is the 'traceability' of GM foods. The idea behind traceability is the need to keep track of information about the origins, transformation and fate of products as they move through production and commerce on their way to the market.

There are several good reasons for doing this. For example, by keeping clear records and creating a transparent system of communication, regulators would be able to respond quickly and effectively to any suspected food-related health problem, and would be able to monitor long-term health impacts. Such records would also help consumers hold industry accountable for any wrongdoing.

Given that more than half the world's population live in countries that require the labelling of GM foods, traceability provides support for information presented to the consumer, and thus encourages free choice in the marketplace. Just as some households may want to avoid buying goods made in countries that abuse human rights or have poor labour conditions, they may wish — for scientific, political or ethical reasons — to avoid consuming GM foods.

The logical endpoint of a traceability system would be the labelling of foods for consumers. Codex has the authority to recommend labelling guidelines that are objective or scientific in nature (such as the maximum amount of acid olive oil can contain and still be called "virgin") or social (such as the definitions of hallal or kosher). The question of whether consumers should be able to identify GM foods has been under negotiation in Codex for 10 years, with the debate centring on which criteria, if any, should guide labelling.

In these negotiations, most GM-food producing nations have argued that labels would suggest to purchasers that there is a difference between GM and non-GM foods, and that this would be "misleading". Most civil society organisations, however, believe that there is a difference.

At present, a battle is being fought between two labelling options within the Codex Committee on Food Labelling. One calls for all GM foods to be identified by labelling. The other, supported by the countries that export GM food, who fear a consumer backlash, proposes that GM food should only require labelling where its nutritional content, composition or intended use is no longer "substantially equivalent" to non-GM foods.

Whither GMO politics?

The political storm raging round GM foods continues to grow in intensity, largely because the economic stakes rise steadily while scientific debate remains unresolved. Given the frameworks described above, what conclusion can one draw about the prospects for adequate regulatory supervision of the technology, and for proper protection of human health and the environment?

The four countries keen to export GM crops — the United States, Canada, Argentina and Australia — are all Codex members, but none of them are (or, with the possible exception of Argentina, soon likely to be) a party to the Cartagena Protocol. Therefore, one could argue that it would be inappropriate for such countries to object about others that choose to use the Codex risk assessments, since they all voted in Codex to adopt them.

On the other hand, as the countries that signed the Protocol meet to work out the details for carrying out risk assessments under its aegis, and to set rules on traceability and liability, none of these four nations will be legally able to block action taken under the Protocol.

As a result, the Protocol is likely to lead to rules that focus on protecting biodiversity and health more than any rules devised by the WTO. On that basis, there are grounds for believing that the future will see better environmental and health protection than exists at present.

A different situation, however, is likely to unfold behind the scenes, as GM food exporters — particularly the United States — put pressure on countries, one by one, to waive their rights under international law. This has already happened with the new International Criminal Court. And it has happened in the past with GM regulation, where weak nations, such as Croatia and Thailand, have been subjected to pressure by the United States. Thus, the responses of civil society will be crucial to ensure democratic and transparent oversight of this technology.

A version of this article appeared in the April 2004 issue of Seedling magazine, published by Genetic Resources Action International (GRAIN).

Phil Bereano is Professor of Technology and Public Policy at the University of Washington, Seattle, in the US. He is on the roster of experts for the Cartagena Protocol, co-founder of the Council for Responsible Genetics, and currently represents the Washington Biotechnology Action Council and the 49th Parallel Biotechnology Consortium at international meetings.

Eliott Peacock is a Senior Research Associate of the 49th Parallel Biotechnology Consortium, and is completing an analysis of negotiation dynamics in the Codex Alimentarius Commission.


[1] Legally speaking, the dispute is between the US and the European Community (EC).

[2] An amicus brief is a technical advisory opinion submitted to a court by third parties to a dispute.

Related topics