The Biosafey Protocol: What It Does and Does Not Do

By David B. Sandalow

The author is U.S. Assistant Secretary of State for
Oceans and International Environmental and Scientific Affairs

The Biosafety Protocol, adopted by more than 130 countries on January 29, 2000, in Montreal, Canada, helps build a global framework based on information-sharing and science-based decision-making to help governments manage both the benefits and the risks of biotechnology.

The Biosafety Protocol is the first international agreement to expressly recognize the potential benefits of modern biotechnology. The preamble states that "modern biotechnology has great potential for human well-being" -- a statement that is particularly significant in an environmental agreement.

Modern biotechnology has many potential benefits. For example, scientists recently discovered ways to enhance the vitamin A content of rice, offering the possibility of addressing problems related to vitamin A deficiency, including vision problems in children around the world. Modern biotechnology also offers important new tools for enhancing agricultural productivity, thereby reducing pressure on rain forests and helping to protect the environment.

Biotechnoloy has already shown that it can reduce the need for pesticides in some parts of the United States. This, of course, can lead to reduced runoff and contamination. It also helps protect human health by reducing exposure of agricultural workers to chemicals that are by definition toxic.

We had two broad objectives in the Biosafety Protocol negotiations. One was to shape an agreement that helps to protect the environment. The second was to resist proposals that would disrupt world food trade. Both of those objectives are met in the Biosafety Protocol.

The protocol establishes important new tools to help the world protect the environment. In particular, it sets up a Biosafety Clearing House -- an extremely useful central repository of information for countries wishing to assess the risks or understand the potential benefits of biotechnology. The clearing house will operate an Internet Web site that includes information on any domestic approvals of genetically modified crops. For example, if a Party to the Protocol approves a genetically modified corn for planting, it would be required to post that information with the clearing house within 15 days. The clearing house will also help exporters by providing information about the regulatory regimes that exist in countries around the world. Countries without domestic regulatory systems -- particularly emerging market nations -- can notify the clearing house that they will perform science-based risk assessments on bioengineered products within a specific timeframe, thereby providing a structure for decision-making and giving industry a level of predictability in trade that it has not previously enjoyed.

We have also ensured -- in a number of ways -- that world food trade will not be disrupted. The protocol's preamble includes an extremely important provision, the so-called "savings clause," which makes it crystal clear that the treaty does not alter -- and fully preserves -- the rights and obligations of governments under the rules of the World Trade Organization (WTO) or other international agreements. In the event an exporting country challenged the decision of an importing country not to accept a bioengineered product in the WTO, the WTO rules would apply. In other words, U.S. exporters still have the right to challenge unfair trade practices in the WTO. Making sure those rights were fully preserved was a major negotiating objective of the United States.

Under the WTO, all countries are obligated to trade fairly, in a non-discriminatory fashion, and to regulate on the basis of sound science. Nothing in the protocol changes those fundamental obligations under the WTO. Nothing about the protocol trumps or in any way changes obligations under the WTO, and nothing about the WTO trumps or changes any obligations under the protocol. They must work together and be mutually supportive.

The protocol is fully consistent with the long-standing U.S. view that the precautionary approach should be part of a science-based decision-making process, not a substitute for that process. The protocol does not allow countries to restrict imports by invoking the so-called precautionary principle, which states that potentially hazardous activities can be restricted or prohibited even before they can be scientifically proven to cause serious damage. The protocol language related to precaution states a self-evident truth: that full scientific certainty is not required for governments to act. That view has been part of the U.S. environmental regulatory process for more than a generation. We think the precautionary approach is an important part of both domestic and international efforts to protect the environment.

I also want to emphasize that nothing in the protocol requires or points to the segregation of agricultural commodities, as some governments had sought during the negotiations. The protocol does require, however, that any shipments in international trade that include bioengineered bulk commodities, such as corn or soybeans, be accompanied by documentation stating that they "may contain" living modified organisms. The protocol also establishes a three-to-five year timeline for considering more precise identification of bioengineered commodities in international trade. The outcome of that process is not prejudged.

It's worth mentioning that the protocol does not include a much more stringent requirement sought by the European Union and others that every individual strain of a bioengineered product be identified in every individual shipment. What that proposal would have meant, for example, is that U.S. corn shipments could not be gathered into large silos or barges and shipped as a bulk commodity, but instead would have had to be shipped in small packages and individual containers. That simply isn't practical without tens of billions of dollars of new investment in shipping and transportation infrastructure.

It is also important to note that the documentation issue relates entirely to shipments in international trade. The protocol does not in any way address the issue of consumer labeling, or impose any obligations with respect to what consumers see on their grocery shelves.

The protocol's requirements are more stringent for bioengeneered organisms meant to be released into the environment. That would include such things as seeds that are shipped abroad for field testing, or microorganisms that are intended to be used for bioremediation -- to soak up oil spills, for example. The protocol also requires exporters -- under a procedure called the Advance Informed Agreement -- to seek the consent of importers before shipping bioengineered organisms intended for introduction into the environment. It's essentially a notice and consent procedure where the exporter notifies the importer that these products are coming, and the importer will make decisions about the import based on a scientific risk assessment within 270 days of notification. Furthermore, genetically modified products in transit through countries or destined for contained use, such as research and development, are exempt from these advance consent requirements.

The protocol's stricter requirements for bioengineered products meant to be released into the environment are in line with our view that more stringent standards are appropriate for such products in an environmental agreement.

The Biosafety Protocol, which will enter into force after being ratified by 50 countries, was negotiated under the 1992 Convention on Biological Diversity. Since the U.S. Senate has not ratified the convention, the United States was not able to vote in Montreal and relied on its allies to speak for it in formal meetings. Also, the United States will not become a party to the Biosafety Protocol unless it ratifies the convention. It's worth emphasizing, however, that the protocol may shape arrangements with respect to the transboundary movement of bioengineered products in years ahead, and I think the United States and our exporters will be aware of that as we go forward.

In many countries, biotechnology is an extremely controversial issue. By reaching an agreement in Montreal, we have taken an important step toward depolarizing the debate about biotechnology in many places. We hope that this agreement can help contribute to a calmer, more rational discussion of these issues.

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