Biotechnology and Biosafety

Biotechnology and Biosafety

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By Carmelo Ruiz Marrero

New technologies often have great potential and promise much, but they must also be properly evaluated to ensure that they are safe, as well as environmentally and socially sustainable. - Martin Khor, Third World Network

New technologies often have great potential and promise much, but they must also be properly evaluated to ensure that they are safe, as well as environmentally and socially sustainable. - Martin Khor, Third World Network

Genetically modified foods (also known as transgenic or GM) have been on our tables since the mid-1990s. Are they safe to eat? What environmental impacts do GM crops have? The answers to these questions are in controversy. How can they be found out then? What methodological tools exist that can reliably address the questions posed by the products of genetic engineering? Such methods, procedures, and lines of research have been in development in the last two decades and are collectively categorized under the term biosafety.

Last July, a group of 40 public servants, activists and academics from numerous countries, including Rwanda, Iran, Cuba, China, Mozambique, Guyana, Nepal, Palau, Jordan, Indonesia, Chile, Honduras, Sudan, Puerto Rico and Many others, we met at the Institute for Genetic Ecology (GenØk) at the University of Tromsø, in the far north of Norway for a two-week international course on biosecurity.

Among the faculty and presenters were several of the most internationally recognized experts in biology, modern biotechnology and biosafety, who came from the United States, New Zealand, Italy, Hungary, Malaysia, Austria and Switzerland, among other locations. The lingua franca of the course was English, but in the spare time there was a lot of conversation in Norwegian, Spanish and Portuguese, and also a bit of Chinese, Arabic and French.

The course, which is offered every summer, was conceived with the purpose of training citizens from various sectors, such as civil society, the scientific community and the public service, to approach the issue of biosafety in an intelligent and well-informed way and to make a contribution significant to the global debate on biotechnology. Scholarships for the course are generally reserved for applicants from low-income countries because the economic limitations of these nations put them at a great disadvantage vis-à-vis the great powers that dominate the field of biotechnology and because most of these countries enter to the biotechnology debate not as producers but as importers of GM products.

They're safe?

To this day, GM foods have not been shown to be safe. The US federal agency FDA, which is supposed to control food and drugs, does not conduct its own studies on GM products. The studies that the agency uses are carried out by the companies that produce them themselves, and are usually classified as confidential information (If they are so secure, why confidentiality?).

The FDA "relies almost entirely on voluntary notification from biotech companies that they have conducted their own safety assessment of the GM crops they want to market," warn Hungarian scientists Arpad Pusztai and Susan Bardocz, who are part of the GenØk faculty. . “The FDA does not have its own laboratory and never, in fact, guarantees the safety of GM foods and crops. It only accepts assurances from biotech companies that their product is safe. "

The report Safety Testing and Regulation of Genetically Engineered Foods, by William Freese and David Schubert (Biotechnology and Genetic Engineering Reviews, 2004) concludes that the process for evaluating transgenic foods in the United States is not effective, as it is based on poorly done research and wrong premises. According to Wolfanberger and Phifer (Science, 2000), the most pertinent questions about the environmental safety of GM crops have not yet been asked, and Snow et. al (Ecological Applications, 2005) produced a long list of important questions that regulatory authorities should ask before releasing GM crops into the environment. Very few of these questions have been addressed in the data that companies submit to the FDA.

According to Pusztai and Bardocz, publicly available scientific data on transgenics is so scarce that it is impossible to establish and reproduce conclusions based on evidence obtained through experiments. “It also doesn't help much that the data obtained by biotechnology companies is rarely published and therefore not available to most scientists. In the few cases where the results of companies' own risk assessments have been made public and have revealed statistically significant differences between GM and non-GM crop / food, the biotech industry has denied that these differences are biologically significant. . ”For more information on the dangers of GM products I refer you to my article“ Are GMOs Safe? ” (

The Cartagena Protocol

The transboundary movement of GM organisms and products is regulated by the Biosafety Protocol, also known as the Cartagena Protocol. “For the first time in international law there is an implicit recognition that genetically modified organisms (GMOs) are inherently different from organisms of natural origin, and they bring special risks and dangers, and therefore they need to have a legal instrument with the force of law, ”says Lim Li Lin, a biosafety expert at the Third World Network and a GenØk professor. "The Protocol recognizes that GMOs can have impacts on biodiversity, human health and socioeconomic nature, and that these impacts must be subject to risk assessments or taken into consideration when making decisions about GMOs."

The Protocol, which has already been signed by over 140 countries, was ratified in 2000 after years of contentious negotiations and entered into force in September 2003. The ratification of this treaty was achieved through the joint efforts of delegations from developing countries. development that formed the Grupo de Igual Parecer (Like Minded Group). On the side opposing the regulation of GMOs was the so-called Miami Group. This small but powerful group was led by the United States delegation and included other GMO exporting countries such as Canada, Australia, Argentina, Chile and Uruguay.

For a country to be a signatory to the Protocol, it must also sign the United Nations Biodiversity Convention, an international agreement for the protection and sustainable use of biological diversity already signed by 191 countries. The United States has refused to sign the Protocol and the Convention, but other GMO producing countries have signed both, including Brazil, China, India and South Africa.

The delegates of the signatory countries of the Protocol meet approximately every one and a half to two years for a negotiating session of several days, known as the Meeting of the Parties (MOP). MOP always takes place right after the bi-annual meeting of the Convention on Biodiversity, known as the Conference of the Parties (COP). That is why these meetings are known as the COP-MOPs. There have been four COP-MOP meetings, in Malaysia in 2004, in Canada in 2005, in Brazil in 2006 and in Germany in 2008. The next COP-MOP will be in Japan in 2010.

The holistic view

The Protocol is based on the Precautionary Principle, a scientific concept formulated to assist in decision-making regarding human health and environmental protection against risk factors and uncertainty. This principle holds that in the face of risks presented by human activities (such as the introduction of new technologies), the lack of scientific certainty should not be used as an excuse for not taking preventive actions to protect human health and the environment. In addition, it puts the weight of doubt on the proposing party; meaning that the sectors that protest and question do not have to demonstrate with total certainty that the activity in question is harmful. On the other hand, the proposing party must satisfactorily demonstrate that its activity is harmless.

The United States government and broad business sectors reject the precautionary principle for this allegedly imposing too much precaution and therefore unnecessary and unjustifiable obstacles to scientific activity and economic development. As a counterpart, they propose the concept of substantial equivalence, which makes up the official FDA policy on genetically modified foods. In short, what this concept postulates is that if a food has the same (or similar) compositional and nutritional qualities as its non-GMO counterpart, then it does not pose any novel risks and can therefore be marketed without further testing.

Supporters of the precautionary principle argue that such a position is absurd and has no scientific defense, and point to the case of mad cow disease. Using the concept of substantial equivalence, this disease is undetectable, since a beef that suffers from it has the same biochemical components (such as amino acids and nucleic acids) as a healthy beef. However, it would not occur to anyone with two fingers of a forehead that eating meat from one of these cows makes no difference as eating meat from the other.

According to Kuiper et al (Nature, 1999) the application of substantial equivalence does not constitute a valid risk assessment. And Millstone et al (Nature, 1999) argue that the chemical similarity between GM foods and their non-GM counterparts is not evidence that they are safe for consumption. According to Bardocz and Pusztai, substantial equivalence, while it can be useful as a starting point for biosafety research, in itself does not establish at all whether a transgenic food is safe or not.

The precautionary principle is based on a holistic conception of nature. Holism is an interdisciplinary vision that conceives all natural systems as an integrated whole that cannot be understood if its components are studied separately. In other words, the whole is not the same as the set of its parts.

"The holistic concept is approached by including all areas of potential risk (human, animal or ecosystem health; sociocultural; cultural; ethical, etc.) in the same conceptual framework", explain the scientists of GenØk Lim Li Ching and Terje Traavik. "In addition, it integrates legal, regulatory and policy issues, as well as public participation, thus providing a solid foundation on which genetic engineering and transgenic organisms can be evaluated."

The holistic vision is emerging as an alternative to reductionism, which is the concept that has guided genetic engineering since its inception. In the reductionist vision it is postulated that every system can be known and understood by studying its parts. Is holism necessarily better than reductionism, or vice versa? According to D. Quist, K. Nielsen, and T. Traavik, holistic models and methods will not replace reductionist ones but will complement them. “If you are holistic all the time, you will probably make little progress. If you are reductionist all the time, you can really go wrong, "said Peter J. Schei, director of the Fridtjof Nansen Institute in Norway, in his presentation at GenØk. According to Schei, it is necessary to balance both perspectives.

It was an empowering and inspiring experience to be able to share for two weeks with committed professionals from all over the world to discuss a matter as important as biosafety on good grounds. It was established in the course that questions about GM products do not constitute opposition to all biotechnology, as some allege. It is simply a call to the industry and government authorities to show that they know what they are doing and not to expose the public's health to unnecessary risks. We are hopeful that this course will result in follow-up events at the regional level, for example in the Caribbean. For more information:

Carmelo Ruiz Marrero, Special for Clarity. Ruiz Marrero is the author of Balada Transgénica and director of the Puerto Rico Biosafety Project.

Video: President, Nigerian Biotechnology and Biosafety Consortium NBBC on Science Communication (May 2022).


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