miércoles, octubre 01, 2008


The Biosafety Protocol and the Future of Biosafety

Carmelo Ruiz-Marrero | September 25, 2008

Americas Policy Program, Center for International Policy (CIP)

More than a decade after the commercial introduction of genetically modified (GM) crops and foods, the controversy surrounding them only seems to grow, as documented in recent Americas Policy Program reports.1 What are the environmental and socioeconomic impacts of these crops? Are they safe for consumption?

These questions are especially relevant for Latin America, as it is the biggest GM-producing and exporting region in the world after the United States and Canada.2 Argentina and Brazil are, respectively, the second and third biggest producers of GM crops in the world, Paraguay ranks seventh, and Uruguay ninth. Argentina alone accounts for 19% of the world's total acreage planted in genetically modified crops.

What methodological tools exist to assess the risks of this new technology? Such methods, procedures, and lines of research have been gradually developed over the last two decades and are collectively known as "biosafety."

Biosafety—not to be confused with "food safety" or "biosecurity"—is a new and growing field dedicated specifically to addressing safety concerns raised by genetic engineering and GM organisms. It acknowledges that GM organisms are essentially different from their non-GM counterparts and that they therefore present unique and unprecedented hazards that call for appropriate safety assessment.

These concerns are addressed at the international level by the United Nations Biosafety Protocol, known also as the Cartagena Protocol.3 "For the first time in international law, there is an implicit recognition that GMOs are inherently different from naturally occurring organisms, and carry special risks and hazards, hence the need to have a legally binding international instrument," says Lim Li Lin, coordinator of the Third World Network's Biosafety Programme.4 "The Protocol recognizes that GMOs may have biodiversity, human health, and socio-economic impacts, and that these impacts should be risk assessed or taken into account when making decisions on GMOs."

The Protocol, signed by 147 countries as of summer 2008, was adopted in 2000 after years of contentious negotiations and entered into force in September 2003.5 Its ratification was achieved through the efforts of developing country delegations, organized as "the Like-Minded Group."

On the opposing side, the country delegations that did not want a legally binding protocol and were hostile to the very idea of biosafety, was "the Miami Group." This small but powerful group was led by the United States and included Argentina, Chile, and Uruguay. None of the Miami Group members have signed the Protocol.6

To sign on to the Protocol, countries must also be members of the UN Convention on Biodiversity (CBD), an international agreement for the protection and sustainable use of biodiversity signed by 191 countries as of summer 2008.7 The Convention was signed into existence at the UN Conference on Environment and Development, also known as the Earth Summit, which took place in Brazil in 1992. The Untied States has refused to sign either the CBD or the Protocol, but a number of GM crop producers have, including Brazil.8

The Protocol is negotiated regularly in sessions known as the Meeting of Parties (MOP). The MOPs take place right before the bi-annual CBD meeting, known as the Conference of the Parties (COP), which is why both events are known jointly as COP-MOPs. The most recent COP-MOP meetings took place in Curitiba, Brazil (2006) and Bonn, Germany (2008). The next one will be in Nagoya, Japan, in 2010.

The Protocol and the field of biosafety are based on the precautionary principle, a scientific concept that is meant to help with the protection of human health and the environment in the face of factors of risk and uncertainty. The principle holds that when society is weighing risks caused by human activities (such as the introduction of new technologies), lack of scientific certainty shall not be used as an excuse for not taking preventive action to protect human health and the environment.9 This principle is referred to in Article 1 of the Protocol and in Principle 15 of the Rio Declaration,10 a consensus document produced at the Earth Summit.

The Protocol puts the burden of proof on the promoters of new technologies rather than on those who express misgivings and warn about dangers. "Within the general use of technology it has been those who claim an existence of yet unproven effects who have had the burden of demonstrating that the activity in question is causing harm to health or the environment," says Anne Ingeborg Myhr of the Norwegian Institute of Gene Ecology.11 "With the employment of the precautionary principle, the burden of proof is shifted to the proponent who now needs to demonstrate that the activity is necessary and that it will not harm health or the environment. This is reflected in the Cartagena Protocol."

However, neither the Rio Declaration nor the Protocol mentions the words "precautionary principle." In both instances the U.S. delegation and its allies (in the case of the Protocol, the Miami Group) succeeded in blocking any mention of it, replacing it instead with the more ambiguous term "precautionary approach."

Thus, Principle 15 of the Rio Declaration reads: "In order to protect the environment, the precautionary approach shall be widely applied by States according to their capabilities. 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."

Furthermore, the Miami Group was able to eliminate any reference to genetically modified organisms and substitute them with the more vague term "living modified organisms."

SIDEBAR: Are Genetically Modified Products Safe or Not?

In spite of the assurances of the biotechnology industry and the U.S. Food and Drug Administration (FDA), to this day GM foods have not been proven to be safe. The FDA does not carry out its own studies on GM products. All it does is accept studies submitted by the biotech companies about their GM products. Most of these studies are confidential business information, and thus not subject to public scrutiny.

"Consultation with the FDA on GM food safety is a voluntary exercise, in which the agency receives summaries without data and conclusions without foundation," says researcher Jeffrey Smith in his book Genetic Roulette. "If the company claims that its foods are safe, the FDA has no further questions. Thus, GM varieties that have never been fed to animals in rigorous safety studies and probably never fed to humans at all are approved for sale in grocery stores."

The FDA "almost totally relies on voluntary notification by the biotechnology companies that they carried out their own safety assessment of the GM crops they want to release commercially," according to Hungarian scientists Arpad Pusztai and Susan Bardocz. "The FDA has no laboratory of its own and never underwrites the safety of GM crops/foods."

The agency carried out its own tests on GM foods only once. The now declassified documents of this inquiry show that staff scientists were divided over the safety of these products and that some of them openly expressed major misgivings about them. Nevertheless the FDA approved GM foods for consumer use.

The published scientific literature on the human health implications of GM foods consists of hardly more than 20 studies, an alarmingly low number. In a study published in Nutrition and Health, I. F. Pryme and R. Lembcke observe that studies on GM foods that are not funded by industry tend to find problems with serious human health implications while the industry-funded ones never find any problem. "Safety Testing and Regulation of Genetically Engineered Foods," a report by William Freese and David Schubert (Biotechnology and Genetic Engineering Reviews, 2004), concludes that the evaluation process for GM foods in the United States is not effective, as it is based on poor research and erroneous assumptions.

The few instances in which safety tests of GM foods carried out by industry have become public have given plenty of reason for concern. An internal Monsanto report leaked in 2005 revealed that rats fed the company's Mon 863 genetically modified corn had major health problems, including abnormally high white blood cell counts, liver necrosis, reduced kidney weight, and high blood sugar.

The genetic engineering issue is further complicated by the fact that its products are living organisms, which can—unlike the products of other technologies—reproduce and spread, in the case of plants by seeds or pollen. This process is known as genetic contamination. In the words of Swiss agricultural biologist Angelika Hilbeck, the "release of self-reproducible biological organisms is potentially irreversible and adds a dimension in complexity to previous technology introductions."

The GMO Contamination Register, an information service set up by Greenpeace International and Genewatch UK, has reported 142 instances of genetic contamination worldwide since 1996. Brazil is one of nine countries that have reported over five contamination incidents.

The furtive presence of GM corn in Mexico, where it is prohibited by law, was first reported in Nature magazine by University of California scientists Ignacio Chapela and David Quist in 2001. Pro-industry scientists and think tanks undertook a major campaign to discredit the Chapela-Quist findings, but in 2002 a study commissioned by the Mexican government found that as many as 95% of the corn fields in the states of Oaxaca and Puebla had GM contamination.

The Protocol's preamble reads: "In accordance with the precautionary approach contained in Principle 15 of the Rio Declaration on Environment and Development, the objective of this Protocol is to contribute to ensuring 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 also into account risks to human health, and specifically focusing on transboundary movements."

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