Comparative regulatory approaches for new plant breeding techniques - Workshop Proceedings

The JRC-IPTS organized a workshop on "Comparative approaches for new plant breeding techniques" in September 2011. In this workshop, the regulatory framework for biotechnology derived crops with specific focus on approaches for new plant breeding techniques in Argentina, Australia, Canada, the European Union, Japan and South Africa was presented by experts from these countries. Additionally, experts discussed approaches and decisions for specific groups of new plant breeding techniques. Whereas, in Canada products derived through biotechnology are treated as any other novel products (plants with novel traits, PNTs), specific biotechnology or GMO legislation was introduced in the other five countries. Experience with the regulation of crops obtained by new plant breeding techniques is very limited globally. While initial decisions have already been taken in a few countries, discussions have only just started in others. Deviating decisions (between countries and between techniques) have to be expected.JRC.J.4-Agriculture and Life Sciences in the Econom

Comparative Regulatory Approaches for new Plant Breeding Techniques

When the first transgenic plants reached the stage of commercialisation, the existing legislation was regarded as insufficient to regulate these new crops in many countries and governments introduced biotechnology or GMO (genetically modified organisms) legislation in the 1980s or 1990s. In the meantime new plant breeding techniques (NPBTs) which deploy biotechnology have been developed and in countries where GMOs are regulated under specific legislation the question arises if these NPBTs should be classified as techniques of genetic modification. In 2010 the Joint Research Centre (JRC) carried out a study on "New plant breeding techniques: state-of-the-art and prospects for commercial development" which covered the following techniques: zinc finger nuclease (ZFN) technology, oligonucleotide directed mutagenesis (ODM), cisgenesis, intragenesis, RNA-dependent DNA methylation (RdDM), grafting on GM rootstock, reverse breeding and agro-infiltration. From a survey which was carried out in the framework of this study, it appears that all seven NPBTs are already adopted by breeders and that the most advanced crops are close to commercialisation. Two of the fields covered by the JRC study are specifically relevant for the discussion of the classification of the techniques under the GMO legislation and for the risk assessment: An evaluation of the changes in the genome of crops obtained through NPBTs shows that besides the intended changes in the genome also unintended changes have to be expected. An investigation of the analytical possibilities for crops produced with NPBTs revealed that for most of the techniques identification of the genetic modification currently is not possible. As a follow-up of the 2010 study, the IPTS organised a workshop in September 2011 to discuss the regulatory approaches for biotechnology derived crops with specific focus on NPBTs in six countries/regions (Argentina, Australia, Canada, the European Union, Japan and South Africa). Whereas, in Canada products derived through biotechnology are treated as any other novel products (plants with novel traits, PNTs), specific biotechnology or GMO legislation was introduced in the other five countries/regions. The presentations and discussions during the workshop showed that also regulatory approaches for crops obtained by new plant breeding techniques differ from country to country. The Canadian regulatory process does not need to be changed or specifically adapted for crops derived through NPBTs. In the EU and Argentina groups of experts started to evaluate whether new techniques constitute genetic modification. In Australia, the Office of the Gene Technology Regulator encourages developers to contact them with specific cases where the regulatory status is not clear. The Office has given advice on a few occasions on the interpretation of legislative provisions relevant to NPBTs. In Japan, officials from several ministries responsible for regulating GMOs meet for the purposes of consulting and coordinating their activities under the national biotechnology legislation including issues relating to NPBTs. The South African participant in the workshop stated that initial considerations concerning NPBTs have started following the invitation to the JRC workshop In the workshop, decisions and preliminary considerations were discussed for four groups of NPBTs: (i) mutagenesis, (ii) cisgenesis/intragenesis (iii) transgenic construct driven breeding and (iv) others (agro-infiltration and grafting on GM rootstock). Deviating decisions have to be expected in the countries represented in the workshop depending on the regulatory approaches and specifically on the different GMO definitions and their interpretation.JRC.J.4-Agriculture and Life Sciences in the Econom

Comparative regulatory approaches for groups of new plant breeding techniques

This manuscript provides insights into ongoing debates on the regulatory issues surrounding groups of biotechnology-driven “New Plant Breeding Techniques” (NPBTs). It presents the outcomes of preliminary discussions and in some cases first decisions taken by regulators in the following countries: Argentina, Australia, Canada, EU, Japan, South Africa and USA. In the light of these discussions we suggest in this manuscript a structured approach to make the evaluation more consistent and efficient. The issue appears to be complex as these groups of new technologies vary widely in both the technologies deployed and their impact on heritable changes in the plant genome. An added complication is that the legislation, definitions and regulatory approaches for biotechnology-derived crops differ significantly between these countries. There are therefore concerns that this situation will lead to non-harmonised regulatory approaches and asynchronous development and marketing of such crops resulting in trade disruptions.JRC.J.4-Agriculture and Life Sciences in the Econom

Deployment of new biotechnologies in plant breeding

The Institute for Prospective Technological Studies (IPTS) and the Institute for Health and Consumer Protection (IHCP) of the European Commission's Joint Research Centre (JRC) conducted a study on "New plant breeding techniques: State-of-the-art and prospects for commercial development". This paper summarises the main results of this project. It reviews the state-of-the-art of research and development of new plant breeding techniques, maps the patent activities in the EU and the USA, highlights the commercial pipeline, discusses drivers and constraints for further commercial adoption of these technologies and finally shows the difficulties for identifying crops produced by the new plant breeding techniques.JRC.J.4-Agriculture and Life Sciences in the Econom

New plant breeding techniques. State-of-the-art and prospects for commercial development

Harmonised EU legislation regulating organisms produced by modern bio-techniques (GMOs) goes back to the year 1990 and the definition of GMOs was not up-dated since. During the last decade new plant-breeding techniques have been developed. The Institute for Prospective Technological Studies (IPTS) of the Joint Research Centre (JRC) of the European Commission in cooperation with the JRC's Institute for Health and Consumer Protection (IHCP) has reviewed the state-of-the-art of these technologies, their level of development and their current adoption by the breeding sector and prospects for a future commercialisation of crops based on them. The technologies discussed included cisgenesis, intragenesis (technologies using transformation with genetic material restricted to the species' own gene-pool), emerging techniques to induce controlled mutagenesis or insertion (ODM, Zinc Finger Nuclease technologies 1-3) and other applications such as grafting on GM rootstocks or reverse breeding. The following methods were used in the study: literature and patent searches, search in a database of field trials, a survey directed to plant breeders and a workshop with participants from public and private sector. Additionally challenges for the detection of these techniques were evaluated. The study showed that the development of these techniques is differently advanced. Technical advantages, but also challenges for the commercialisation (technical constraints, acceptance and regulation) have been identified.JRC.J.4-Agriculture and Life Sciences in the Econom

Strategies and other policy initiatives dedicated to the bioeconomy in the EU and some other countries

The collection includes datasets compiling information on bioeconomy policy strategies and initiatives at the national, regional and macro-regional level.JRC.D.1-Bio-econom