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Opinion on the Regulation of Targeted Mutagenesis in Plant Breeding

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Opinion adopted by the Academy of Agriculture of France and the Academy of Technology on
July 7, 2016

Since the early 1990s techniques of induced mutagenesis targeted by biotechnological processes have been developed.

Targeted mutations obtained are of great interest for plant breeding as they can accelerate the creation of varieties of interest and therefore reduce costs associated with it.

In a regulatory landscape still confused at the European level, and in the absence of hindsight on concrete data from the field, the two French Academies in their opinion voted on July 7, 2016 call public authorities permit the development of the experiments in progress, including field experiments, and to use their results in order to prepare a regulatory framework which incorporates both biomonitoring and technical advances that these new technologies may provide.


I) Explanatory memorandum

Historically the Academy of Agriculture has been very early interested in advances in plant breeding and contributes to debates of society in science and technology. Since its creation the Academy of Technology has been interested in the evolution of techniques of the genome modification applied to the case of crop improvement in breeding programs. Its Committee of Biotechnology, in particular, follows the progress of molecular biologists in this field. 

It also watched attentively the successive regulatory and legal changes to varieties authorization procedures resulting from this work, both at the European Commission and national level. It will be recalled that in 2013 the Academy of Technology has partnered with the Academy of Sciences and the Academy of Agriculture to exchange their member expertise on the subject. Following this joint work the three Academies organized on November 19, 2013 a symposium open to discuss with a wider audience of advanced Genetically Modified Plants (GMP) in the world, the benefits and limits that could be allocated to them and the state of the French and European regulations. 

Anxious to bring their expertise to the greatest number, the Academies, following this conference, wrote a widely circulated opinion that concluded with these words: "To move forward in this debate, the academies require that scientific issues and agricultural affecting the GMP are thorough on an objective basis. This involves restoring the freedom to conduct research and testing, including field testing and long-term, under existing regulations.”

The Biotechnology Commission supported the publication in 2014 of a book "Ten Questions to Bernard Le Buanec on the Subject of GMOs" that answers the many questions asked by the public. The Academy of Agriculture working group on genetically modified plants also published in 2015 a book "Plants Genetically Modified, Threat or Hope" edited by Jean- Claude Pernollet.

At the end of 2015 a new working group was set up within the Commission of Biotechnology of the Academy of technologies to work on "New technologies and agriculture" which was associated the Academy of Agriculture. At the Academy of Agriculture working group "New Biotechnology for Food and Agriculture" examines the use of new biotechnologies, including those regarding changes to the genome. The joint working group of the two Academies brings together experts from the biotechnology of the Academy of Technology Commission as well as many of those of the Academy of Agriculture. It is therefore natural that the question posed by the availability of new techniques for genome modification without "foreign" DNA input as a selection tool in plant breeding process should be addressed. Several academic reports were considered, including in particular the report published by EASAC, the European Association of Academies of Sciences, that also published the same year by the German academies, which Acatech, our sister Academy and finally very recently, one of three American academies.

It seems important that the issue of access to new technologies for genome modification, targeted mutagenesis, is studied and discussed taking good account of the evolution of techniques and the benefits they bring in many applications derived progress facts in the life sciences (See Technical Appendix). Their low cost and ease of implementation would allow their use by many breeding companies regardless of their size, for public research laboratories, contributing to maintaining the diversity of plant breeding stakeholders. However their use in Europe, both in the field of research and in agricultural production, will depend on regulations that will be applied to them. It is important that the European Commission and its Member States quickly specify the status of these technologies in the plant area to avoid any uncertainty that might penalize the research, innovation and European agriculture in a socio-economic context increasingly globalized.

It is in this context that the two academies now offer the advice below. This is in line with the response of the French government in the issue of December 12, 2015 the member Brigitte Allain asked the Ministry of Ecology, Sustainable Development and Energy on the new plant breeding techniques: "It should ensure that the decisions taken at European level are proportionate to the risks and challenges of these techniques and take into account the purpose of the applications that can be developed with these techniques. Analysis of HCB (French biosafety committee) shows that the regulation of GMOs should not apply to some new techniques. The French government will also be alert to the legal certainty of decisions taken at European level.”

This joint approach, to the field of plant breeding, does not exclude a broader joint reflection on the uses of these new techniques in the modification of animal genomes.

II) Opinion of the Academies of Agriculture of France and Technology on the regulation of targeted mutagenesis by editing the genome of plants

1) Since the early 1990s the techniques of induced mutagenesis targeted by biotechnological processes have been developed: they involve meganucleases, ODM (Oligonucleotide Directed Mutagenesis), ZFN (zinc finger nucleases), TALE nucleases (Transcription Activator-Like Effector nucleases) and the CRISPR system (Clustered Regularly Interspaced Short Palindromic Repeat) associated with a nuclease.

2) Targeted mutations obtained are of great interest for plant breeding as they allow to accelerating the creation of varieties of interest and therefore reducing costs associated with it. They also contribute to increase the genetic diversity of varieties created.

3) In the regulatory framework still confused at the EU level, and in the absence of hindsight on concrete data from the field, the two French Academies call on public authorities to permit the development of current experiments including field experiments and use the results in order to prepare a regulatory framework that incorporates both biomonitoring and advanced techniques and technical advances that these new technologies may provide.

From the perspective of both these French Academies, techniques of targeted mutagenesis can, in principle, be excluded from the techniques regulated by the European Directive 2001/18/EC on the deliberate release of genetically modified organisms into the environment, according to its Annex 1B.

Download Opinion on the Regulation of Targeted Mutagenesis in Plant Breeding adopted by the Academy of Agriculture of France and the Academy of Technology on July 7, 2016