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National and International regulations on GMOs

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Biovigilance and biosecurity are the watchwords of national and international regulations in terms of GMOs. Word to Éric Schoonejans from the Ministry of Ecological Planning and Sustainable Development.

One of the main conditions necessary to ensure an assessment based on scientific excellence, multidisciplinarity and the independence of experts is to separate the risk management bodies from the bodies responsible for evaluation. One of the ways to implement this separation is to entrust the evaluation to expert commissions of various disciplines, scientifically recognized, responsible for the evaluation of genetically modified organisms (GMOs), on a case-by-case basis, and separated from the structures. in charge of decisions and risk management.

Beyond these existing elements of consensus on the environmental risk assessment of genetically modified organisms (GMOs), the following four points should be highlighted:

  • the scope of implementation of the environmental impact;
  • better transparency of information and procedures;
  • the necessary development of biovigilance and traceability of GMOs;
  • the need for coherence in the development of international standards with the biosafety protocol, particularly with respect to countries with developing capacities.

Furthermore, it is important to better study, not only the medium and long-term consequences of the use of genetically modified plants (GMPs) in agriculture , but also to study further the potential benefits and potential risks of biotechnology. . In particular, this concerns the analysis of the legitimacy and acceptability of these technologies, as well as the study of the socio-economic impacts of the use or non-use of these innovations. The General Commission of the Plan submitted a report on this theme on September 26, 2001.

The broad scope of environmental impact

In the context of the global use of biotechnology, the environment should be considered broadly, in the sense of the Convention on Biological Diversity , and include both the “natural” (as opposed to domesticated or exploited) the agronomic environment, even that of the local populations.

It is therefore necessary to take into account, beyond the classical assessment of environmental risk (the potential adverse effects on the natural environment and human health), the agronomic environment and agricultural practices, at the level of the major regions and regions. subregions, as at the local level, in the context of the environmental impact assessment of genetically modified plants.

Such potential impacts – positive or negative – of GMOs on the environment, in the broad sense, can not be easily identified today because they have not been scientifically evaluated so far. For example, there is little scientifically based information on both the positive and negative impacts of GMPs on the wider environment, compared to traditional equivalents and all other available technical solutions.

In particular, the question of the coexistence of different types of agriculture (GMO, non-GMO, traditional agriculture, organic farming , etc.) and the maintenance of the freedom of choice of consumers, users and all operators in general is an equally central issue for the identification of environmental impacts, understood in a broad sense.

It is now necessary to study and evaluate the appropriate and sustainable conditions for the coexistence of different types of agriculture, as well as the potential impact of GMOs on the multiple functions of agriculture. Similarly, the positive or negative impact of using GM crops (Genetically Modified Plant) on the diversity of cultivated or wild species must be taken into account.

For this, a diversification of criteria and methods of evaluation is necessary, as well as the development of appropriate scientific skills.

The necessary development of biovigilance and traceability of GMOs

Current methods of prior evaluation, as identified by the experts themselves, are limited. There is the need to complement this assessment with monitoring devices, but also to broaden the evaluation perspective to indirect and more general consequences of the use of GMPs (for example, the assessment of changes in use of pesticides ).

For this, it is necessary to implement in a systematic and coordinated way a sustainable and global vigilance to complete the evaluation a priori, in particular to follow the environmental aspects.
This post-market biovigilance is necessary to confirm the risk analysis, including the identification of potential uncertainties, and to identify possible unintended effects that can not be foreseen in the screening assessment.

It allows for the consideration and integration of the more systemic and global dimension of the negative or positive environmental impact, linked for example to the very large scale culture of GMPs or their association.
The collection of information related to this vigilance, through possible surveillance networks or national observatories, could be the subject of national, regional or even regular international summaries, and are in any case essential to advance the evaluation a priori.

Prior evaluation and biovigilance must feed each other and be linked to the documentary traceability of GMOs as an indispensable tool for implementation.

Indeed, the development of the traceability of GMOs is necessary in order to be able to ensure the effective monitoring, and to allow the taking of proportionate risk management measures, or even the withdrawal of the market, in case of difficulty or unexpected adverse effect .

Finally, traceability, like biovigilance, are essential contributions to the transparency and trust of citizens and consumers.

Through a transmission of documents that trace the presence of GMOs throughout the agri-food sectors, the ability to know if a GMO is present in a product, and if so, which one, is essential for the free choice of consumers, and for any economic operator or user of GMOs, in particular to be able to put in place an informative, reliable and effective labeling for these products.

The necessary coherence of the development of international standards with the biosafety protocol, and the evaluation of GMOs in countries with developing experience or capacities

1.) The binding international framework

The current multiplication of the countries in which GMOs are used, and the global issues that GMOs raise, require the development of international and harmonized standards, capable of dealing with issues that go beyond national jurisdictions; however, the multiplication of international places where GMO issues are dealt with greatly diminishes the impact and sustainability of the recommendations that emerge from them; moreover, this multiplication does not favor the necessary coherence and the effective follow-up of standards, recommendations and more generally current activities.

On the other hand, the specificity of the European Union has led to the development of a binding regulatory framework for GMOs which is increasingly detailed at Community level, with certain rules requiring national transposition, but also more and more rules. direct application. This is an achievement that the Member States, as well as the candidate countries that are now accession countries, must integrate into their national framework and implementation framework for GMOs.

The Treaty ( the Cartagena Protocol on Biosafety) adopted in Montreal in January 2000 is the international platform for GMO issues. Its objective is to help ensure an adequate level of protection for the safe transfer, handling and use of GMOs, and specifically regulates international trade in GMOs. To date, it is the only multilateral instrument that will probably be binding very soon, and which deals explicitly with GMOs and environmental security.

As a result, the very active preparatory work for the rapid and complete operational implementation of the biosafety protocol, as soon as it came into force, which began in Montpellier in December 2000, draws on the contributions of all the countries and must remain the international reference forum for GMO environmental safety issues.

It should be recommended that future work on GMOs of international organizations ( OECD , International Plant Convention, FAO , WTO, Aarhus Convention , UN-ECE, etc.) be focused, and to add value, because of the specificity of the organization. It is also necessary that they be coherent and mutually supportive with those of the biosafety protocol, and that they take due account of the binding provisions of the protocol.

In particular, it should be recommended that technical standard-setting work developed in appropriate fora (eg environmental assessment standards for GMOs developed within the International Plant Protection Convention for all strictly phytosanitary issues associated with GMOs) make a valuable contribution to the effective and rapid implementation of the Protocol, in particular through its global information base on GMOs (Biosafety Clearing House) or by contributing to coordinated capacity building programs.

2.) Developed and Developing Countries: Experiences from Different Countries and Regions

One of the key factors in the exercise of identifying potential impacts on the environment is, in the current state of knowledge, the level of significant scientific uncertainty for certain potential impacts, and even more so if they are deferred or long-term, which precludes a closed list of these impacts.

Moreover, today it is not possible to generalize the evaluation criteria, nor the familiarity gained, whereas 99% of commercially grown PGM acreage in some countries consists of only four field crops ( corn , soybeans , cotton, rapeseed), and two characters ( resistance to insects and tolerance to herbicides totals).

There is therefore a strong need for better knowledge, both for potential benefits and for potential risks, relating to the diversity of all the conditions of use and to the multiplicity of different environments considered or possible, in particular with regard to tropical regions and developing countries.

The acquired knowledge must also be systematically placed in a case-by-case evaluation framework, where each GMO has its own specificities and where general conclusions, or even the identification of systemic impacts, can never be associated with GMOs in general. .

The basic facts of the global food challenge – satisfactorily feeding 9 billion people in 2050 – a doubling of current food production – are well-known.

However, is it not appropriate to stand out from sometimes advanced visions that would see either developed countries feed the planet or GMOs alone represent a credible solution to this challenge? It is necessary to recall with force the preliminary necessity to put in place in all the countries the social, economic and political conditions of the development in order then to be able to identify the technical innovations desirable to support this development.

These desirable techniques are potentially very varied and can also largely rely on more traditional techniques such as for plants, good agricultural practices, agronomy or rural sociology.


Today, both at European and international level, standards are strengthening and multiplying to frame these new technologies that are GMOs. The resulting obligations are more and more detailed and binding, and require ever increasing resources and capabilities.

It must be seen as a legitimate desire of the legislator to ensure a better level of protection of the environment and public health with regard to GMOs.

But we must also see the need to take into account the level of acceptability of these innovations for society.
No risk does not exist. Therefore, after the risk assessment stage, when the risk has been identified by the evaluator, however small, and preventive measures are proposed to circumscribe, the decision of the evaluator follows. Risk Manager and the terms and conditions that he will eventually apply.

However, the authority in charge of risk management, who will take this step, will only decide what level of risk it considers acceptable to society. In a context of low level of social acceptability, the level of risk determined to be acceptable will be very low.

In such a context, it is necessary that the legislative framework is rigorous and exhaustive, in order to allow a better confidence in the evaluation of the GMOs, and from there, a better potential acceptability.

It may also be necessary to consider complementing the evaluation criteria with rigorous and scientific consideration, not only of the potential risks, but also of the potential benefits. The determination of the acceptable level of risk, so that it is consistent, should integrate these different elements in order to be able to judge the balance for the citizens between the costs and the benefits of the envisaged measure.

In order for the public to trust these assessments, they must be transparent and independent, and recognized as such. It is also essential to put in place the conditions for access to reliable, comprehensive and recognized information by consumers.

That is why, in Europe today, labeling and traceability are at the heart of the regulatory framework for GMOs, as this labeling is a  sine qua non of trust in finding consumers through access to free choice that they claim, rightly so.

Dr. Kanika Singla

Ph.D., IARI Postdoctoral Scholar, UC Berkeley

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