Ir Arriba

Why is biotechnology safe?

Convention on Biological Diversity, Cartagena Protocol and Nagoya-Kuala Lumpur Supplementary Protocol: Instruments for the application of biotechnology in agriculture

Biotechnology is understood as "any technological application that uses biological systems and living organisms or their derivatives for the creation or modification of products or processes for specific uses" (Secretariat of the Convention on Biological Diversity, 2000). Based on this definition, it is clear that the human being has been developing biotechnology since the very beginnings of civilization. Within the multiple biotechnological tools, and for some decades, biotechnology has made it possible to carry out genetic modifications that overcome the natural physiological barriers of reproduction and has generated what has been known as living modified organisms (LMOs).

Much has been said about the LMOs, in particular, genetically modified (GM) crops. The results obtained in terms of technological alternatives for the controls of insects and weeds and for the generation of diverse products (among them, oils, bioplastics, vaccines, etc.) have demonstrated the relevance and potential of this type of crops. In spite of its usefulness, in order to guarantee the safety and security of GM crops, their release to the environment is regulated in the countries and this is due, to a large extent, to the instruments that have been generated within the framework of global forums such as the Convention on Biological Diversity, the Cartagena Protocol on Biosafety, and the recently approved Nagoya–Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety, among others. Thus, when talking about GM crops it is imperative to talk about their safety and the instruments that guarantee it.

The Convention on Biological Diversity (CBD), entered into force in 1993, has among its objectives "the conservation of biological diversity, the sustainable use of its components and the fair and equitable sharing of the benefits derived from the use of biological diversity, genetic resources." The regular meetings of the CBD are called Conference of the Parties (COP) and it is where topics are discussed and protocols developed.

Subsequently, the Cartagena Protocol on Biosafety (CPB) emerged, which came into force in September 2003, with the objective "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”. The regular meetings of CPB are called COP-MOPs – Conferences of the Parties that act as the Meeting of the Parties to the CPB. It is in COP-MOPs where issues regarding LMOs, such as: transit and contained use; handling, transport, packaging, and identification; unintentional and illegal transboundary movements and emergency measures; risk assessment; risk management; information sharing, confidential information, capacity building, public awareness and participation, application of the advance informed agreement procedure; notifications; decision procedures; and bilateral, regional and multilateral agreements and arrangements, between others, are discussed by CPB parties, non-parties, and observers. However, just parties take the final decisions.

The CPB requested the development of a procedure in the area of liability and redress for possible damage resulting from transboundary movements of LMOs. And from this request, the Nagoya–Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety (NKLSP) emerged, which came into force in March 2018. It is important to mention that there is a Nagoya Protocol on Access and Benefit-sharing (NPABSN), which came into force in 2014. However, it must be clarified that the NKLSP and the NPABSN are completely different protocols even though they contain the word “Nagoya” in their names.

Interestingly, the four instruments discuss biotechnology to a greater or lesser degree. And they are based on the precautionary principle, which establishes that, if an action generates serious risks for public health or the environment without having a definitive scientific proof of them, protective measures must be taken to avoid such action.

The CBD is interested in living modified organisms (LMOs) "that may have adverse effects on the conservation and sustainable use of biological diversity" - that is, not all LMOs but those that may have adverse effects; however, this clarification is often omitted. The CPB and the NKLSP are instruments that promote the safe development of biotechnology associated with LMOs. In fact, the CPB is the regulatory framework for genetically modified (GM) crops. On the other hand, the NPABSN is also incorporating biotechnology, but with regard to digital DNA sequences.

In general, the mode of action of these conventions and protocols incorporate the use of virtual forums on topics of interest. The ideas resulting from such forums constitute reference documents that serve specialized technical groups (known as AHTEG) when they hold meetings to have technical exchanges.

It is worth mentioning that when it comes to the agricultural sector, there is a significant interest from the private sector for the countries to have a strong regulatory framework with clear, predictable and functional guidelines to guarantee the safety of the processes and products. This has resulted in GM crops being considered the most analysed products when it comes to security and harmlessness, and positively impacted biodiversity, the environment, the institutions, the farmers and the consumers.

Through the years it has become evident that applying biotechnology techniques, both traditional and new, is essential to the sustainable development of the agricultural sector. Further, it behoves all the parties in the sector (developers, producer, traders, regulators and consumers) to ensure that biotechnology is safe, based on objective criteria and scientific knowledge. To achieve these goals, IICA supports its member countries to provide training, communications and support in biosafety. All of which is strengthen by the regulatory experience of the public sector and the technical and market knowledge in the private sector.

Pedro J. Rocha

International Specialist in Biotechnology and Biosafety, IICA