New molecular biology technologies

The terms “new molecular biology techniques” (NMTs), or else “new breeding techniques” (NBTs) outline a broad range of technologies that are in some cases clearly different from classical genetic engineering.

In classical genetic engineering, whole genes or gene constructs of an organism can be inserted into the genome of another organism. This enables a trait of the first organism, e.g. resistance to a certain pathogen, to be transferred to the second organism. This happens in an undirected manner i.e. the gene or gene construct is inserted randomly into the genome at a position that cannot be determined in advance.

However, some NMTs, such as genome editing, emulate molecular mechanisms as they happen naturally in living cells. Such mechanisms are for example the switching on and off of genes or in-cell repair systems that correct any mistakes that occurred during the copying of the DNA. No new and foreign genes or gene constructs are added to the plant’s genome, in contrast to classical genetic engineering. Instead, specific parts of the existing genetic material is “rewritten”. Individual DNA building blocks (nucleotides) are switched off, cut out, recombined or added. Natural mutations occur in a similar fashion. The large difference to classical genetic engineering consists in the process. Instead of being undirected, the process is targeted to trigger a certain effect. In plant breeding for example, existing traits can be modified, resulting in the development of varieties with new traits.

Some of the fields that NMTs are used in include basic research, human and animal healthcare, plant and animal breeding and the production of food additives. The field of NMTs is flourishing in scientific research. Genome editing is growing particularly rapidly. NMTs have the potential to radically change biotechnology, biomedicine and basic research in life sciences.

Evaluating and dealing with the new breeding techniques

The use of NMTs raises numerous technical, legal and ethical questions. There are controversies on how to evaluate and deal with the new breeding techniques.

The European Court of Justice (ECJ) issued an important ruling on 25 July 2018 to classify/categorise NMTs:

  • Organisms obtained by directed mutagenic techniques/methods (classical mutagenisis or certain new molecular biology techniques) are to be regarded as genetically modified organisms (GMOs) within the meaning of Directive 2001/18/EC, Art. 2 No. 2.
  • Organisms obtained through the techniques of classical mutagenesis are exempted from EU genetic engineering law based on the so-called mutagenic exemption of Art. 3 (1) of Directive 2001/18/EC in conjunction with Annex 1B. The mutagenic techniques/methods to obtain such organisms have been used in a range of applications and are deemed to have a long safety record (recital 17 of Directive 2001/18/EC). This applies, for example, to mutagenesis through radiation or chemicals, a technique that has been used since the 1930s. Pursuant to the judgment by the European Court of Justice, however, the exemption does not apply to organisms obtained using new molecular biology techniques.

This decision has resulted in a number of implications, many of which are hotly debated. On the one hand, researchers rightly ascribe great innovative potential to the NMTs, in particular with a view to the future global challenges such as climate change and world food security. On the other hand, EU genetic engineering law, in line with the ECJ's binding interpretation, stipulates that these technologies must be applied very restrictively.

Organisms obtained by NMTs require approval in accordance with EU genetic engineering law in order to be placed on the market in Europe. For some organisms obtained through NMTs, there are currently no reliable analytical methods to clearly detect and identify them, which means that not all genetic changes can be clearly traced back to NMTs, classical mutagenesis/breeding or natural mutation. The enforcement authorities could thus be faced with difficulties when inspecting seeds, agricultural commodities, food and feed, in particular with regard to GMO trace contamination that may stem from non-approved GMOs obtained through NMTs.

Currently, there are discussions at national and European level on whether to amend the genetic engineering law from around 20 years ago in order to achieve an adequate and differentiated regulation of NMTs.

Technical and socio-ethical dialogue: The BMEL has started comprehensive consultations

The Federal Ministry of Food and Agriculture (BMEL) has started comprehensive consultations to launch an open and transparent exchange with different stakeholders from society that represent different positions and interests on how to deal with NMTs, for it is vital to exercise great care, make appropriate assessments and then to act on this basis.

NMTs have the potential to speed up and expand breeding worldwide. NMTs are already being applied in many areas of research and development around the globe. The first products obtained through these methods have already been marketed in third countries. Many hopes are pinned on NMTs, in particular with regard to a sustainable and adaptive agricultural sector and its contribution to food security for our growing world population. The technologies also raise questions regarding security issues and the identifiability of the organisms they have changed. Many stakeholders are therefore concerned about the NMTs’ progress.

  • 2019 Forum on NMTs – Prospects for dealing with new molecular biological techniques
    Around 120 experts from research, policy-making, the business sector and society discussed the present legislation and two more regulatory options for NMTs at the "2019 Forum on NMTs – Prospects for handling new molecular biological technologies" (Forum NMT 2019 – Perspektiven für den Umgang mit neuen molekularbiologischen Techniken) on 7 June 2019. Dealing with NMTs requires legally certain rules on research, application and transparency that also take account of environmental and social aspects. The participants had lively discussions in small groups and in the plenary on different regulatory options for NMTs. The diverse and very controversial discussion demonstrated, however, how important the discussion process with all advocacy groups was in order to address unanswered questions on the use of NMTs.
    The forum aimed to initiate and maintain the dialogue and to come up with societally acceptable solutions, even after the ruling of the ECJ of 25 July 2018 on NMTs.
  • 2017 consultations: In 2017, the BMEL initiated consultations on NMTs to foster interdisciplinary exchange on these technologies. Three events took place in 2017, each of them setting a different focus on how to deal with NMTs.
    • Almost 200 interested guests took part in the kick-off event at the BMEL in spring 2017. The event discussed key questions on applying genome editing in theory and practice. The focus was on research aspects, different points of view from stakeholders and a discussion on genome editing at the interface of research and society.
    • In summer 2017, the dialogue was continued with an event entitled “Criteria for a responsible handling of genome editing”. The programme was divided into three different subject areas: impact assessment of technology; biodiversity issues and ecological retinity; and socioeconomic challenges. 120 guests had in-depth discussions on these topics, which had been selected based on feedback from the kick-off event.
    • The consultations were concluded by a third event in autumn 2017 on expanding knowledge and concretising and specifying results. Some of the topics the third event, entitled “Shaping innovation responsibly” focused on included the current state of play of the scientific discussion, the standpoints of the developing countries and consumer communication.

You can find the summaries of the consultation events on the German page.

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