Contaminate or Save: The Consequences of Using GMOs
The historical prerequisite for the need to regulate the circulation of GMO products, the use of GMOs and the general requirements for their creation or production was the creation of the first successful genetically engineered organism by Herbert Boyer and Stanley Cohen in 1973. Scientists have developed a method that can very accurately cut a gene from one organism and implant it into another. Using this method, they transferred a gene that encodes antibiotic resistance from one strain of bacteria to another, which gives recipients antibiotic resistance. A year later, Rudolf Jaenisch and Beatrice Mintz used a similar procedure in animals, introducing foreign DNA into mouse embryos.
This new technology has opened up countless opportunities for research. However, right after its development, the media, government officials, and scientists have begun to worry about the potential impact on Earth’s ecosystems and human health. Until mid-1974, there was a general moratorium on genetic engineering projects.
During the Asilomar Conference of 1975, scientists, lawyers, and government officials discussed the safety of genetic engineering experiments for three days. Finally, the participants concluded that it is necessary to allow the introduction of genetic engineering projects, subject to specific guidelines. For example, the conference defined safety and restriction rules to reduce the risks of each experiment. Besides, they obliged the scientific supervisor of each laboratory to provide sufficient security for their researchers and to inform the scientific community of important developments. They expected that the established guidelines would be flexible and refined during the development of science.
Each legal system has its own approach to the definition of genetically modified organisms, to the term used for such organisms, and to the regulation of their regime. For example, the US, the EU, and South Korea have different approaches to GMOs, both legally and administratively. Particularly noticeable is the gap between the two major developed countries — the US and the EU. Such different approaches depend on the value of biotechnological development and the protection of human security and the environment for the country. The US emphasizes the positive aspects of biotechnology and international trade rules that focus on free trade. On the other hand, the EU underlines the risk of GMOs’ development and the need for regulation under international environmental law, focusing on human health and the environment.
Each country also has its own political and economic interests in GMOs. Speaking of economic power, the US is the largest GMO exporting country in the world. Studies have shown that political power influences the regulation of GMO circulation between developed and developing countries. Developing countries’ GMO policies can be affected by such developed countries as the US and the EU.
Considering the theories concerning the regulation of GMOs, there are two main approaches. One such approach concerns the risk of GMOs, while the other encourages the use of GMOs.
The European Union has created a legal framework to ensure that the development of modern biotechnology, and in particular GMOs, takes place in safe conditions. Legal framework aimed to:
1) Protect human and animal health and the environment by implementing a safety assessment to the highest possible standards at the EU level before any GMO is placed on the market.
2) Introduce a harmonized procedure for risk assessment and authorization to place GMOs on the market that is effective, time-limited, and transparent.
3) Provide clear labeling of GMOs placed on the market to allow consumers, as well as professionals (such as farmers and feed operators) to make informed choices.
The cultivation of GMOs in the EU is limited because of stakeholders’ concerns about the negative impact on the environment, agricultural land, and biodiversity. Under the current legal regime, EU Member States may restrict or prohibit the cultivation of GMOs in their territories by applying the safeguard provisions of Directive 2001/18/EC, or by using notification procedures under the rules of internal market regulation.
In 2011, the Court of Justice of the European Union issued a preliminary ruling in the case, which is a model precedent for bringing biotechnology companies to justice for the release of GMOs into the environment, which harms individuals. In the instant case, the Court upheld the right to compensation for a German beekeeper who had brought a criminal case against the federal state of Bavaria when Monsanto corn (MON810), which had been cultivated for research purposes on sites belonging to the Land of Bavaria, contaminated its honey. The court found that the beekeeper had suffered economic losses without being able to sell his product and that he should get compensation.
FAO has hosted several conferences within the Biotechnology Forum on Food and Agriculture. For example, the Seventh Conference, which took place from May 31 to July 6, 2002, focused on the potential importance and influence of genes from genetically modified crops, forest trees, fish or animals on non-genetically modified populations, focusing on attention to developing countries. This issue has been repeatedly raised by participants in previous e-Conferences organized by the FAO Forum. At that point, the question of the potential importance and consequences of transgene transplantation from GM crops to traditional varieties has come to the fore, especially after reports of transgenic material in maize crops grown in Oaxaca, southern Mexico.
As for environmental impact, there were discussions on two major issues at this conference. The first issue on the agenda was the impact of genes of genetically modified organisms on biodiversity. It was argued that, first, genes of genetically modified organisms could have a severe effect on the genetic diversity of domestic populations and, second, that other factors (such as the introduction of invasive alien species) may have an even more significant impact on biodiversity. There were differences of opinion: some viewed such negative factors as a minor problem, while others paid much attention to them because the risks of using GMOs are not visible, so not all people are aware of their possible magnitude. The second issue was the environmental impact of specific transgenes — in particular, those that are now used to create plant resistance to herbicides and insects. It was believed that the spread of these transgenes to non-target plants may or may not have had a negative environmental impact (in particular, mention was made of genetically modified herbicide-resistant rapeseed in Canada). This also includes those transgenes that can be used in the future. Because different transgenes can cause various environmental problems in different environments, it has been suggested that the ecological effects of transgenes on the environment will be considered on a case-by-case basis.
Genetic engineering has been and remains one of the most controversial areas of international and national law regulation since its inception and emergence. Attempts to regulate genetically modified organisms have taken place at international and regional levels. At the international level, the Cartagena Protocol on Biosafety, based on the precautionary principle, is one of the first legally binding international agreements governing the transboundary movement of GMOs. In addition to the Biosafety Protocol, international standards were established within the framework of the FAO, WTO, and the EU. However, at the international and national levels of legal regulation, there are still inconsistencies regarding the content and practice of implementing these standards.
The international legal regulation of the impact of GMOs on human health and the environment is imperfect since states interpret differently the same rule of law. Thus, in order to achieve the goal pursued by international law in the field of biotechnology, namely, biosafety and consumer and environmental protection against the risks and potential harm of GMOs, the international community should establish mandatory standards for the use and marketability of GMOs, taking into account the needs of developing countries.
Another critical point is the improvement of the information system for consumers and the population, especially the population of developing countries, most of which have no specific position on GMOs. Developing countries may be (and some have already been) in a situation where GMOs are being trafficked into the country. In most of these countries, there is no legislation governing GMOs, and some developed countries use such loopholes to export GM products to these countries without registration.
A remarkable achievement of international law is the creation of a mechanism for the protection of indigenous peoples’ traditional knowledge and rights. This was achieved through the adoption by the General Assembly of the Declaration on the Rights of Indigenous Peoples, the International Covenant on Genetic Resources of Plants for Food and Agriculture, the Convention on Indigenous and Tribal Peoples in Independent Countries and the Nagoya Protocol to the Convention on Biological Diversity.
The issue of GMO labeling and labeling requirements in different countries is essential. Since GM products are in circulation in the international market, labeling requirements should be standardized. The problem of inconsistencies in labeling requirements in different countries, in particular between the EU and the US, can create barriers to trade and complicate international legal regulation.
Finally, it is important to overcome the scientific uncertainty about GMO safety. According to biological scientists, we can see the consequences of using GMOs in 35 years from the beginning of the mass use of such products.
