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The Biosafety Protocol and the Future of Biosafety

Carmelo Ruiz-Marrero
Americas Policy Program, Center for International Policy (CIP), 25 September 2008

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."

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."


However, the Protocol and its enforcement have been bogged down by an impasse on the twin issues of liability and redress. Article 27 of the Protocol provides for "liability and redress for damage resulting from transboundary movements of living modified organisms."

According to the Network for a GMO-Free Latin America (RALLT, for its Spanish acronym) this is essential because it prevents the Protocol from becoming a mere text of directives with no legally binding power.12 A binding liability regime implies, among other things, assessing the damages caused by the products of genetic engineering, who will be liable for these damages and losses, how the victims will be compensated, and how the affected environment will be restored.

RALLT holds that the binding clause is essential if the Protocol is to fulfill its stated purpose. The Protocol's text says it aims at "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."

"Developing countries had always argued that if GMOs are as safe as industry and the producing countries claimed they were, then they need not have to be concerned about strong liability and redress provisions, which would give more confidence in their products," according to Lim Li Lin.13 "In fact, the inclusion of substantive liability and redress provisions in the Biosafety Protocol was seen as critical to its success, and during the negotiations, many delegates supported the NGO campaign, 'No Liability, No Protocol' and later, 'No Liability, No Biosafety'."

Liability and redress have been contentious issues since the Protocol was conceived in the 1990s. During the negotiations that led to its final version, the Like-Minded Group and the Miami Group were deadlocked on this particular area until the Like-Minded Group agreed to postpone the discussion and return to the issue after the Protocol came into force.14 Article 27 thus states that at the first MOP meeting work would begin toward establishing a mechanism for liability and redress and this work should conclude in four years.

Who's Responsible? Seeking Binding Liability

The first MOP took place in 2004, so a liability and redress regime should have been agreed upon by the time of the 2008 MOP in Bonn. But such was not the case. Going into the Bonn meeting, agreement still seemed unlikely. After the 2004 MOP, a Working Group on Liability and Redress was formed and held five meetings in which no progress was made.

The last meeting, a last ditch attempt to arrive at an agreement, was held in the Colombian city of Cartagena in March 2008, only two months before the Bonn MOP, co-chaired by the chiefs of the Colombian and Dutch delegations. In order to facilitate the negotiation, a group of Friends of the Co-Chairs was formed.

During the Friends meeting, six biotechnology corporations proposed a contractual compensation agreement, which they called a Compact. They claimed it was an alternative to the difficult negotiations, which some observers had begun to think of as doomed.

"The Compact is an agreement among its corporate members to provide recourse for 'actual' damage to biological diversity if their products are the cause," explains Lim Li Lin.15 "The terms and conditions, and its governance are defined by the members of the Compact. States become 'third party beneficiaries' if they consent, and if their claim is allowed."

Many delegates and civil society observers were distressed at this industry initiative. "The Compact is proposing to redefine the roles of States and the corporations," according to Lim Li Lin. "The corporations are attempting to create legal rights and obligations, and States are allowed, as third parties, to attempt to enforce those rights."

The non-governmental organization (NGO) sector roundly condemned the Compact and released a statement to that effect. "The industry would become at the same time defendant and judge of the liability claims for damage," and the privatization of international law would set "a bad precedent within the whole UN system."16 The NGOs called for the Compact to be "dismissed with the contempt that it deserves."

In spite of the efforts of the Friends of the Co-Chairs, the negotiators left Cartagena with no agreement to bring to the Bonn MOP. During the Bonn meeting Malaysia tried to break the stalemate with the formation of a Like-Minded Friends Group. Eventually over 80 countries joined this group, whose compromise proposal tried to reach some sort of legally binding liability regime while also taking in consideration the objections of countries like Japan, that were dead set against liability and blocking the negotiations.

The only countries that would not accept even this proposal were Japan, Peru, Paraguay, and Brazil. At this point in the negotiations the Peruvian delegation said it did not see the need for negotiation since "biotechnology has no risks." According to RALLT, it later turned out that Peru's negotiator was a biotechnology industry representative.17 RALLT also denounced that the Paraguayan delegation was closely advised by Argentina's ministry of agriculture. Argentina, as said before, is a Miami Group Member, a non-party to the Protocol, and the world's second largest producer of GM crops.

There is no doubt that Argentina's government, beholden to the GM crop agroexport model, has played a major role in undermining biosafety and furthering the interests of the biotechnology industry in international negotiations, such as the Bonn COP-MOP. According to the Grupo de Reflexión Rural, an Argentina-based NGO, Moises Burachik, the leader of Argentina's delegation in Bonn, was not a public servant but a corporate lobbyist.18

When the Bonn meeting ended without agreement, participants decided to hold two more negotiating meetings on liability and redress before the next MOP in 2010. Mexico has offered to host one of them.

Whither Biosafety?

"We can't help but see this as a failure, since undoubtedly the message that the (Bonn) MOP sends the biotech industry is that they will enjoy at least for this period, impunity in their actions; and that the strategy of contamination can still be used," said RALLT looking back on Bonn.

The "strategy of contamination" according to NGOs and scientists in several countries (SEE SIDEBAR), consists of planting - legally and illegally - extensive fields of GM crops so that eventually natural biodiversity will be lost to genetic contamination, and the issue of conserving biodiversity will no longer be relevant.

RALLT added that the lack of progress toward biosafety regulation "indicates that governments do not acknowledge the existing evidence of multiple harms derived from the utilization of GMOs, and what's more grave, of the potentiality for even broader consequences in the future ... The industry presence, which in this MOP was evidently stronger than in Curitiba, indicates that the private sector has redoubled its efforts to guarantee the cooptation of the environs of multilateral negotiation."19

According to Ethiopian scientist Tewolde Egziabher, one of the leaders of the Like-Minded Group, "It is not surprising that the process of negotiating (the Protocol) has been very divisive. It is equally not surprising that it satisfies nobody completely. Time will show whether negotiating it has set a good precedent to ensure the safety of emerging new technologies."20

"The Protocol is just a start of the long and difficult road to effective international regulation of genetic engineering," says Lim Li Lin. "Much more needs to be done, and countries must act to ensure that real biosafety becomes a reality."21


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) [http://www.foe.org/new/releases/1104gmcrops.html], 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 [http://www.organicexcellence.com/email-newsletters/environmental-issues-in-news-august-2005.php] 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 [http://www.gmcontaminationregister.org/], 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 [http://www.scidev.net/en/news/mexico-confirms-gm-maize-contamination.html] found that as many as 95% of the corn fields in the states of Oaxaca and Puebla had GM contamination.

End Notes

1. Ruiz-Marrero, Carmelo, "Latin America: The Downside of the GM Revolution," Americas Policy Program Special Report (Washington, DC: Center for International Policy, December 3, 2007) found at: http://americas.irc-online.org/am/4786.

2. International Service for the Acquisition of Agri-Biotech Applications, "Global Status of Commercialized Biotech/GM Crops: 2007" (Executive Summary), http://www.isaaa.org/resources/publications/briefs/37/executivesummary/default.html.

3. Cartagena Protocol on Biosafety home page: http://www.cbd.int/biosafety/.

4. Lim Li Lin, "Cartagena Protocol on Biosafety," Biosafety First: Holistic Approaches to Risk and Uncertainty in Genetic Engineering and Genetically Modified Organisms, Lim Li Ching and Terje Traavik, eds., Tapir Academic Press, 2007.

5. Egziabher, Tewolde B. G., "The Cartagena Protocol on Biosafety: History, Content, and Implementation from a Developing Country Perspective," Biosafety First, Lim Li Ching and T. Traavik, eds.

6. Egziabher.

7. Convention on Biological Diversity web page: http://www.cbd.int/.

8. Lim Li Lin, "Cartagena Protocol on Biosafety," Biosafety First, Lim Li Ching and T. Traavik, eds.

9. Myhr, Anne Ingeborg, "The Precautionary Principle in GMO Regulations," Biosafety First: Holistic Approaches to Risk and Uncertainty in Genetic Engineering and Genetically Modified Organisms, Lim Li Ching and Terje Traavik, eds., Tapir Academic Press, 2007.

10. Text of the Rio Declaration, http://www.un.org/documents/ga/conf151/aconf15126-1annex1.htm.

11. Myhr.

12. RALLT, Bulletin #293, "Un Fracaso a Medias: Dos AÒos M·s Para Completar el RÈgimen de Responsabilidad y Compensación en el Protocolo de Cartagena," 2008, http://www.biodiversidadla.org/layout/set/print/content/view/full/42557.

13. Lim Li Lin, "Progress After Tough Talks on Liability Regime for GMOs," South-North Development Monitor, May 23, 2008, http://www.biosafety-info.net/article.php?aid=520.

14. Egziabher.

15. Lim Li Lin, "Progress After Tough Talks on Liability Regime for GMOs."

16. Ibid.

17. RALLT.

18. Grupo de Reflexión Rural, "A Propósito de La Reunión de La Mop4 en La Ciudad de Bonn en Alemania," May 25, 2008, http://horizontesurblog.blogspot.com/2008/05/apropsito-de-la-reunin-de-la-mop4-en-la.html.

19. RALLT.

20. Lim Li Lin, "Cartagena Protocol on Biosafety," Biosafety First, Lim Li Ching and T. Traavik, eds.

21. Egziabher.

Carmelo Ruiz-Marrero is a Puerto Rican independent environmental journalist and environmental analyst for the Americas Policy Program (www.americaspolicy.org), a fellow of the Oakland Institute, a senior fellow of the Environmental Leadership Program, and founder/director of the Puerto Rico Project on Biosafety (bioseguridad.blogspot.com). His bilingual web page (carmeloruiz.blogspot.com) is devoted to global environment and development issues.

To reprint this article, please contact americas@ciponline.org. The opinions expressed here are the author's and do not necessarily represent the views of the CIP Americas Policy Program or the Center for International Policy.


Chapela, Ignacio & David Quist, "Transgenic DNA Introgressed into Traditional Maize Landraces in Oaxaca, Mexico," Nature, 2001.

Hilbeck, Angelika, "GMOs and the Environment: What are the Issues?" Presentation at the Institute for Gene Ecology, University of Tromso, Norway, July 31, 2008. Biosafety First: Holistic Approaches to Risk and Uncertainty in Genetic Engineering and Genetically Modified Organisms, Lim Li Ching and Terje Traavik, eds., Tapir Academic Press, 2007.

Pusztai, Arpad and Susan Bardocz, "Potential Health Effects of Foods Derived from Genetically Modified Plants - What are the Issues?" Biosafety First, Lim Li Ching and T. Traavik, eds.

Smith, Jeffrey, "Genetic Roulette: The Documented Health Risks of Genetically Engineered Foods," Yes! Books, 2007. For More Information

Fueling the Debate: Agrofuels, Biodiversity, and Our Energy Future

Latin America: The Downside of the GM Revolution http://americas.irc-online.org/am/4786

Synthetic Biology's Role in Agrofuels http://americas.irc-online.org/am/5194