New Breeding Techniques: which risks? And which regulation should be applied to them?

          

     

     

     

     

    New Breeding Techniques (NBTs): which risks? And which regulation should be applied to them?

    Research Paper written by Stefano Mori and Antonio Onorati

    for Centro Internazionale Crocevia

    February 2017

    ABSTRACT

    GMOs’ producers always faced difficulties in setting down roots in the European territories. Most of EU Member Countries and public opinion never agreed on the introduction of GMOs on the European fields. This is the reason why cultivation in European Union is very limited. Social movements and producers’ organizations have historically fought against agro-business and seeds’ industries. The limitation of GMO cultivation in EU represent a great achievement for civil society, since nowadays it is authorized in 10 Member States out of 28. However, the power of lobbies of agro-business push Governments in support the agro-industry model of production. Since 2007 many constituencies interested in GMOs production, want to exclude the products of new breeding technologies from European GMO legislation. These technologies are known as “New Breeding Techniques (NBTs)”. This text analyses what is the difference between the technologies used for NBTs products and those used for GMOs products. Moreover it will be analysed the process of legislation that is trying to regulate NBTs in Europe. Lastly it showcases the need to elaborate a more stringent legislation.

    INTRODUCTION

    GMOs production is one of the biggest economic opportunities for Transnational seeds Companies (TNCs). For this reason, its regularisation is a pressing concern, discussed for many years and still present in many political agendas. Since this paper is focused on European GMOs regulation, firstly it is important to acknowledge how EU defines the products of GMOs techniques. The official definition is at it follows:

    “it has become possible to modify the genetic make-up of living cells and organisms using techniques of modern gene technology; the genetic material is modified artificially to give it a new property (e.g. a plant’s resistance to a disease, insect or drought); such organisms are called GMOs”[1].

    However, over the last 5-10 years there have been rapid developments in genetic engineering techniques. Meanwhile, deeper and more complex changes occurred in the genetic makeup and metabolic pathways of living organisms. Consequently, two new fields of genetic engineering overlap with each other: synthetic biology and the so-called New Breeding Techniques (NBTs). Their main species and traits are similar to those recalled by the GMOs: the tolerance to herbicides, fungal resistance, drought resistance or scab-resistance. The advances in genetic engineering rose new issues and problems to be addressed at political level, since the TNCs are trying to make pressure in order to exclude NBTs from the actual European legislation on GMOs.

    The aim of the research paper is to analyse – using the great work done by many different organisations – NBTs, starting from the concerns about GMOs and the uncertainty of their principles.

    Then, it will be highlighted the reason why genetic engineering is still developing and why industries are investing in R&D of this field.

    Finally, the “traditional” GMOs techniques will be compared to NBTs techniques, also from a legislative perspective: which are the GMOs European regulations and their relations with NBTs.

    • WHAT ARE THE GENES AND THE DNA? THE “CERTITUTED” OF THE GMOs

    Among genetic scientists, there is an ongoing conceptual debate. On one hand, some scientists support that life can be influenced only by innate characteristics; so life is destined to follow an hereditary programme. On the other hand, other scientists give an added value and an important role to the history of the organisms, influenced by time flow and interactions with the environment. After the re-discovery of Mendel’s book, in 1900, the major part of genetic engineers shared a univocal view on genetic resources: humans’ characteristics are determined just by stable hereditary factors that are combined randomly generation after generation. In other words, physical aspects are determined by this combination. However, the Mandelian thesis also includes the random determination of the personal characteristics of a person, instead of being influenced by human interactions. Taking it to the extreme, life quality could be bettered just through a selection of the best genetic heritage, and not through more equal social rules or public services. Genetic engineering represent an accelerated process of the natural selection of the best combination of genetic heritage. For example the targeted selection and modification of genes can be applied to human beings, but also to animals, plants and bacteria. These techniques take into account a “mendelian” vision in genetic. Therefore, if it is assumed that genes are independent each others, and they are enough to define the characteristics of living beings, the outcomes of modifications will be totally predictable and they will not carry risks that can arise from unpredictable interactions between the new selected gene and the genetic heritage; or, between the new resulted organism and the environment.

    However, this vision has to be deepened. The “mendelian” vision is based on an assumption which is not generally assumed by all and there is no evidence that proves it. It has to be noted that the predictability of the outcomes at mid- and long- term are based on a narrowed vision of the world. It is a knowledge based on a part of a global system, but it is assuming that this particular part can control the entire system. Hence, as it happens in other scientific sectors, a limitless progress based on the omnipotence of human knowledge can be dangerous and unpredictable in results.

    The opposite mindset is carried on by another intellectual tradition, named “real socialism”[2]. It argues that the organisms are determined by the environment around them, so also by the interactions with other human beings. The real socialism emphasizes the capacities of the human beings to shape other persons and themselves as they wish. In this case the prevision of the outcomes of the modified organisms are not related to knowledge on genes, while they are determined by a knowledge plan related to the action of the persons (Buiatti, 1995).

    Biology has never taken such as extreme positions, however it makes understand that scientists somehow are guided by different visions, that often involve extra-scientific world. So, the presence of two way of thinking biology and the human beings has always existed especially since the genetic engineering started to work effectively. Goldschmidt and Mc Clintock – belated Nobel Prize in 1981 – highlighted the strong and dangerous instability of the genetic material, after the discovery of the existence of genes able to “jump” from one side to another of the genome, disabling or modifying the expression of the genes near or inside those in which they install themselves. One of the most remarkable exponents opposed to “mendelian” theories, is Luigi Cavalli-Sforza[3]. In his works, he explained how the genes are transmitted to the next generation, and how this transmission is linked to the experiences and influences had from the environment. Every single cell of a living being is a calculator that elaborates the information contained in the DNA, in order to build more complex structures. Those cells need energy to do so, which is taken from outside the organism. For example, if a men is tall and strong, but the food is scarce during the adolescence, he will never grow so much tall, nor  so much strong. In the early phases of a living being, the zygote can build the entire organism alone. Then, when the organism grows, different types of cells will serve for specific function, even if they all belong to the same DNA. Depending on the task of each cell, some genes can switch on and other can be silenced naturally. Each cell acquires its final characteristics interacting with the environment. Hence, our activities, or pathogens, or the alimentation, can modify the way in which the cells are working. These changes are not modifying the DNA sequencing, but they are transmitted to the daughter cell jointly with DNA of the mother cell. If this process involve the reproductive cell, the changes can be transmitted at least for some generations. The science that explain this process is named epigenetics. It reveals how elastic are the cells, and that in general, everything that is learnt can be transmitted (Cavalli-Sforza, 2012).   

    Despite this and other discoveries, since the ‘50s and ‘60s the common thinking is aligned with the positivism – coming from the “mendelian” way of thinking. It argues that the organisms and their history can be understood simply reading the information written in the DNA. Since the discovery of the DNA (1953), the molecular biology strengthened its efforts in reading and modifying the DNA, carrying new and rapid techniques. Genetic engineering is a consequence of this fast development of this science. In few years it introduced the modifications of organisms through interventions on the genetic material.

    So, genetic engineering is based on the assumption that DNA includes all the information of an organism. It means that the organism can be modified in any part of its genetic heritage in order to achieve the best characteristics of a certain living being. However, as theorized by Cavalli-Sforza (among others), the characteristics of an organisms are located in the DNA, but also in other parts of the genome, and the effects of a modification are unpredictable.

    • HOW CAN BE THE GMOs SO PERFECT AND PREDICTABLE?

    After presenting the two mindsets that borrow political and cultural implications, it is important to analyse technically, why GMOs pillar – the “mendelian” DNA assumption – is not as solid as it is considered. The discussion on the genome is central in this debate. In modern molecular biology and genetics, the term “genome” – which indicates the set up of genes of an organism – has two definitions. On one side it defines the data that are in the gene, which are responsible for the development and the functioning of an organism. On the other, it is the genetic material of an organism and it consists of DNA, which is the chemical structure in which the data are “written”. The two definitions are not carrying the same meaning: DNA is not composed only by genes, because it includes also extra-genomic material. The composition of the genome has been deeply studied and the outcomes showed that the relation between the genomic DNA and the total DNA varies a lot. In human beings it is around 3%, in other organisms, such as the fish fugu rubripes it’s around 70%[4].

    About the definition of the term “gene”, there is no clarification. It is commonly used to say that it is a part of DNA, even if nobody can say precisely that genes can be found in a particular position or another, and neither how the genes’ shapes are. An historian of biology, Allen Garland, tried to define a story of the genes, since the discovery of their existence until the last theories on genes. In 1978, in his book Life Sciences in Twentieth Century he said:

    “The hereditary particles preformed, has been defined with different wordings: “factors”, “genes”, “elementary characters” and similar. But what lost on many who were engaged in, between 1900 and 1910, were the basilar distinction between the hereditary particle itself and the trait, conveyed by the particle, that would manifest itself in the adult age”. (Garland, 1985).

    The distinction described by Garland carried to the abandon of the identification of the hereditary particles with the adult trait already formed, while it favoured a new conception that recognizes that they were units that control the functional processes. However, if it was recognized only the potential outcome of the adult character, there was the question on the process involved to get to that outcome.

    In synthesis, the term “gene” has been introduced in the deterministic view of human sciences, without any clue on the factors that cause the creation of genes. So it has been thought its existence as an unknown consequence of a known effect – which in this case is the trait. As theorized by Steven Rose[5], it is possible that genes are the outcome of a combination of nucleosomes[6]. However, there is no unique vision on the composition of the genes. For these reasons, it can be argued that genetic engineering bases its follow-ups on a wrong principle, which is not generally accepted by all genetic sciences. The common genetic engineering is based on the assumption that a gene taken away from another organism, will be the same and will keep the same function if it is inserted in another organism. The concern that comes from this assumption is the effect of this practice: an insertion of a gene will not carry unexpected effects in the interactions between the gene inserted and the pre-existing genes, but it will have effects in the interaction with the whole organism, other living beings – humans or not –, or other ecosystems.

    However, it is well known that human beings are made of different components linked among themselves and structured in networks. It is foreseeable that a change in a component of this structure is able to change also the interaction with other components, without a precise prediction on how it will change the whole organism.

    Despite the concerns coming from different scientists working in the genetic issues, the deterministic approach advanced in a strengthened way. The identification of the genes in a common language was necessary in order to apply the techniques of genetic engineering. For this reason, it has been invented the genome sequencing. It figures out the order of DNA nucleotides which are considered the basis of the genome that makes up an organism’s DNA. The human genome is made up of over 3 billion of these genetic letters. Sequencing the genome does not immediately lay open the genetic secrets of an entire species. Even with a rough draft of the human genome sequence in hand, much work remains to be done. Scientists still have to translate those strings of letters into an understandable genome works: what the various genes that make up the genome do, how different genes are related, and how the various parts of the genome are coordinated. They have to figure out what those letters of the genome sequence meaning.

    Today, DNA sequencing on a large scale – the scale necessary for ambitious projects such as sequencing an entire genome – is mostly done by high-tech machines. The first techniques used for sequencing the genome were highly costly and as consequence had limited access: the cost for a genome sequencing of a human being, were between 10 and 25 million US dollars. From the industrial side there was a need to find cheaper and faster techniques. Consequently, the research agencies started from big projects that aimed to sequence the complete genome of a thousand of different living beings. In 2007, thanks to new techniques, scientists succeeded to sequence the genome of a person in two months, costing around one million US dollars[7]. This discoveries opened the path for new techniques, easier and faster, such as the pyrosequencing or the resequencing, which are methods more accessible and adaptable to small organisms.

    Thanks to these techniques, it has been easier for the genetic engineering to produce new GM plants, inserting the external gene where they wanted. The laboratory outcomes has always been predicted, but actually the results are not immediate and in practice the resulting plants did not follow the predictions. The aim of GM plants is to increase the productivity even in difficult environmental situations, such as the areas hit severely by the climate change. In reality no GM plants ever ensured an economic success, while it is increasing the requests for patents of conventional varieties obtained with the support of molecular markers[8], that accelerate the selection of the “best” genes. The technical failure of the GMOs comes from the unexpected outcomes of the introduction of an external gene in a system – like a plant – which is alive and interactive with other genes and the environment. The introduction of a gene produces effects that are not as predictable as the deterministic view of genetic engineering is used to claim.

    • GMOs DEVELOPMENT RESEARCHES ARE JUSTIFIED BY THE MARKET

    The general thought is that the biggest and strongest companies of seeds of the world are based in North America. However, many dominant seeds industries are present in Europe as well. The data from the European’s Parliament internal policies department support this view. In 2012, the value of the EU seed market reached around € 7 billion. Today the EU market represents 20% of the global seeds market. It ranks n°3 after the United States (27%) and China (22%), well ahead of the fourth market (Brazil, 6%).

    Figure 1. Sizes of Domestic Seed Markets in the World (in € million)

    New Breeding Techniques: which risks? And which regulation should be applied to them?

    Source: PolDep B elaboration based on data received from the International Seed Federation. The data includes field crops, vegetable and flower seeds for planting, which are sold to end users. Seed potatoes are not included. Market values were converted from US dollars to euros using annual exchange rates retrieved from the Eurostat database.

     

    In an expanding world seeds market (+76%), the EU market grew by +45% between 2005 and 2012[9]. Moreover, to underline the fact that few countries are controlling the market, it is useful to say that a group of five EU Member States (France, Germany, Italy, Spain and the Netherlands) represents two thirds of the EU market.

    What is still more concerning is the data related to the concentration of seeds market in the hands of few companies. At the moment, 5 European companies own the 95% of vegetable seeds market[10]. The consolidation of seed giants is dependent on a complex of factors. One of the ways to expand control over the market is to invest in the hybridisation of certain crops, or in biotech products protected by patents. Generally, private companies working with varieties designed for industrial-scale production such as F1 hybrids need on average between 7 and 15 years to breed a new variety and place it on the market. Indeed, if they are not backed up with public funds, actors need to invest considerable time and money to enter into the sector. This creates a barrier impeding access to newcomers (Mammana, 2014). As a consequence the biggest seeds companies acquire know-how and market power through mergers and acquisitions of smaller local and seeds companies around the world. For example, the French Limagrain group, has acquired 14 large seeds companies in the last 15 years. These acquisitions are the results of bilateral agreements that limit the competition on the seed market, putting the market in an oligopoly. A single company may own a large number of brands, giving farmers the illusion of having the opportunity to buy from different companies. For instance, Monsanto owns SEMINIS and DE RUITER in the vegetable seeds market, and DEKALB and ASGROW in the agricultural seeds market. As far as LIMAGRAIN is concerned, it owns HM CLAUSE and VILMORIN. Cross-licensing agreements, in particular for transgenic seeds traits have created a network of relationships between seeds companies (EC, 2013). These agreements have increased with the development of adding multiple transgenes in crops. As stated by MONSANTO in its 2012 annual report:

    “With the exception of competitors in our Seminis and De Ruiter vegetable seed business, most of our seed competitors are also licensees of our germplasm or biotechnology traits”.

    When a high level of concentration is reached, the largest companies are able to ensure stable profits by ceasing to compete on the basis of price. In this way they are able to simply raise prices or restrict output, giving the orientation of the market.

    • DIFFERENCE BETWEEN GMOs AND SYNTHETIC BIOLOGY, THE CREATION OF NEW BREEDING TECHNIQUES

    The R&D institutes involved in GMOs studies are trying to strengthen their work in order to get techniques that have to be easy in the application and cheap. Synthetic biology is one of those techniques. It is a discipline that lies in the middle between the molecular engineering and biology. It was born at the beginning of the XXI Century in the United States, within the Universities of biological engineering. This particular study aims to redraw the metabolic and genetic schemes of the living beings, in order to create new synthetic organisms to be applied in the fields.

    However, it is not a part of GMO techniques. In genetically modified organisms there is just the introduction of one single gene or two in the whole genome, such as those resistant to pesticides or herbicides. The rest of the cells keep functioning as before. While in the synthetic organisms, the whole genome is almost completely changed. For this reason, when some organism is obtained through synthetic biology, some researchers refer to a “synthetic life”.  Part of this synthetic life is represented by last innovation in the field of genetic engineering: the New Breeding Techniques (NBTs).

    Over the last 5-10 years there have been rapid developments in genetic engineering techniques. The main species and traits of the products obtained by NBTs are similar to those recalled by the ones obtained by GMOs: tolerance to herbicides, fungal resistance, drought resistance or scab-resistance. However, NBTs are more advanced because they open the possibility for seven different genetic variations divided in four groups:

    • Targeted mutagenesis (ZFN 1 and 2 technology and ODM).
    • Targeted introduction of new genes (ZFN 3 technology and cigenesis/intragenesis).
    • Gene silencing (RdDM).
    • Improvement of selection (agroinfilitration).

    In practice, the technical advantages – recalled by seed industries but not recognized by any institutions – of NBTs are represented by a site specific and targeted changes in the genes, and by the fact that commercialized crops “will not contain an inserted transgene”. Moreover big corporations argue that with NBTs there will be also economic advantages thanks to a faster breeding process and lower production costs. Finally, R&D institutes say that final products obtained by  NBTs are in most cases indistinguishable from traditionally bred plants, due to the fact that there is no introduction of other genes of other animal or plants in an already existing organism, there is just an adjustment – always made in laboratory – that allow the plant to grow faster and to be more productive.

    However, from a scientific point of view, those supporting NBTs claim that those techniques are very precise, while actually they have off-target effects with unpredictable consequences. The so promoted precision of these techniques is actually a very imprecise notion and does not equate to predictability. For this reason, NBTs bring risks and uncertainty as GMOs do, such as the potential environmental and health impacts of RNA dependent DNA methylation (RdDM). Moreover there are also new risks of unintended effects coming from the use of gene editing techniques such as ZFN and ODM. It can be said that there is a scientific case for classifying all these techniques as GM and regulating their use with the same rigour provided for GM techniques.

    What is more concerning for farmers – and especially for farmers’ seeds systems – is the similarity of products obtained by NBTs and those that carry primitive traits of the plants. Although this similarity with plants that can be found in nature, the plant obtained by NBTs can be patented. In other words, after the mapping of the genome of a plant or an animal, and having identified the interested gene to be transferred to a local variety found in the fields or in wild nature, the outcome of this process is considered as an invention[11]. Therefore the “invention” can request the patenting of that new variety through a normal industrial patent. The European Directive 98/44 on patentability, transcribed in the Regulations of the European Patent Office (EPO) also allows patenting:

    1. products that come from essentially biological processes (whole plants and/or components);
    2. biological materials (genetic information, proteins …) obtained by non-essentially biological but not distinct traits of native processes;
    3. any kind of biological material isolated from its natural environment.

    This means that the Directive 98/44 allows patenting on any plant that contains the “natural” equivalent of the biological material patented – such as gene, genetic traits, etc. This framework does not protect a technique, a process, a biological material or any product. It allows patenting the genetic information, meaning a series of plants or animals very different each other, that cannot be reduced to a single plant variety or one animal species: all might contain one similar genetic information and express a hereditary character or function associated with this specific genetic information – which stands for the resistance to an insect or herbicide, precocity, nutritional quality, taste, etc. So, varieties breeders and peasants will not be owners of those patents, but if they work or cultivate that plants, they will face great difficulties in demonstrating that they did not use the patented plants, but natural vegetables before the planned modification of the gene and patented. In this sense, they could be accused of theft and forgery. Within this patenting framework, seeds industries will have an exclusive monopoly for the commercial utilization of those seeds.

    • GMOs AND NBTs LEGISLATION – EUROPEAN CASE STUDY

    In EU legal framework, GMOs food and feed are considered under three directives and two regulations[12], which ensure that the development of modern biotechnologies – and in this specific case the GMOs – take place in safe conditions. The reason of these rules is based on the precautionary principle – which is in opposition to the substantial equivalence principle in action within the USA legislation on GMOs – which is applied in risk management. If an action or a policy has a suspected risk of causing harm to the population, or to the environment, in the absence of scientific consensus – which will have to consider if the action or policy is harmful or not – , the burden of proof, that is not harmful, falls on those taking an action that may or may not be a risk. So, based on this pillar, the EU legal framework protect human and animal health and the environment by introducing a safety assessment of the highest possible standards at EU level before any GMO is placed on the market. Moreover EU rules ensure clear labelling to be placed on GMO products that are commercialized, in order to enable consumers – as well as professionals – to make an informed choice. Finally, the EU framework ensures the traceability of GMOs placed on the market addressing restricted rules.

    Since the advent of NBTs, seeds companies tried to exclude those products obtained by NBTs from the GMOs legislation put in place in EU. They claim that NBTs should not fall under the scope of the directive on GMO seeds, because plant products that result from NBTs do not differ from plants obtained by means of conventional breeding – such as sexual crossing or – also –  mutagenesis[13]. The actual concern is that all these techniques are ready to be commercialized and to be used. For this reason, great pressure is made by TNCs towards European Commission, to allow the entry into the market of these new products. An intense lobbying action has been carried on also by the US Government during the TTIP (Transatlantic Trade and Investment Partnership) negotiation, where they tried to push the NBTs outside the GM rules: the US mission also warned the EU Commission on TTIP that “different regulatory approaches between governments to NBT classification would lead to potentially significant trade disruptions”. The lobbying action was carried by the US government pushed by GMO companies, which often turns to the US trade representative for help with overseas markets. However, at the moment there is not sufficient information to properly assess the risks. For this reason the decision of European Commission weather new plant breeding techniques should be considered GMOs has been delayed.

    Recently, the last happening regarding NBTs has involved European Union, the French Government and the French social movements. The French State Council – the most important French administrative court – emanated in a report its decision regarding the complain made by a large group of French organizations, such as Confederation Paysanne and le Reseau Semence Paysannes on the nature of the mutagenesis (corresponding to ZFN 1 and 2 technologies, and ODM), against the French Government’s decisions on that issue. The State Council, answering to the complaining, due to the fact that the products obtained by mutagenesis are still under the study of European Union – so there is no clear classification – decided to transfer the case to the European Union Court of Justice, asking for four preliminary questions:

    1. The French State Council asked if the organisms obtained through mutagenesis have to be considered under the directive 2001/18/EC on the deliberate release of GMOs into the environment.
    2. If the same organisms are instead considered under the directives 98/95/CE and 98/96/CE concerning the marketing of seeds and on the common catalogue of varieties of agricultural plant species.
    3. It also asked if the directive (EU) 2015/412, regarding the possibility for the Member States to restrict or prohibit the cultivation of GMOs in their territory, can be applied also to mutagenesis technique.
    4. The last preliminary question posed by the State Council regards the validity of the directive on the “new breeding techniques”, which is posed in doubt due to the precautionary principle.

    This action, pushed by the French farmers organizations, is a great achievement for all European farmers, and it doesn’t regard only the complaints to the French Government positions which wanted to exclude the mutagenesis from the GM rules without having any scientific proof, but it regards also a reanimation of the discussion on the validity of the considerations made by the EU on that issue. Indeed, the EU, trying to exclude the NBTs from the GM rules, did not take into account the precautionary principle. And for this reason, also in this situation, the French State Council asked to the European Court of Justice to implement the precautionary principle.

    • CONCLUSION

    This success is a first step towards a fair regulation for all the farmers in order to ensure their freedom in the application of a certain production model. The introduction of these new techniques without specific regulation, will led to an interaction between the traditional crops and the GM crops, due to natural causes – such as wind or bees. It should be underlined also that the NBTs are an invention of the big corporations that lead the international market. However, those who are feeding the planet are the small-scale producers: around 70% of the food production[14] – for human consumption and not for other scopes – is supplied by them. So, the NBTs represent another tool for the agro-industry to make the prices of food always more competitive in international market and to own all the production basis tools – such as patented seeds. Keeping this path, will led to a situation in which the farmers will not be able to be free anymore to produce what they want in the way they want.

    In conclusion, patenting seeds has failed as a tool to promote and protect innovation in agriculture and it represents the wrong system for promoting innovation in breeding. The only consequence that the patents can bring is the risk of hyper ownership in genetic resources. At the same time it is obvious after this paper that the NBTs should follow the case by case procedure following the GMOs system, even if they are techniques – like reverse breeding – that produce non transgenic plants at the end of the process. There are many other sciences or techniques that are innovative and are more reliable, adapted to organic and less costly – such as agroecological processes.

     

     

     

     

    BIBLIOGRAPHY

    • Buiatti M., “Da Mendel all’Ingegneria Genetica”, La Scuola, 1995, Brescia.
    • Cotter J., Zimmermann D., Bekkem H., Application of the EU and Cartagena definitions of a GMO to the classification of plants developed by cisgenesis and gene-editing techniques, Greenpeace, July 2015.
    • Directorate-general for internal policies of the European Parliament, The EU Seed and Plant Reproductive Material market in perspective: a focus on companies and market shares, November 2013, Brussels.
    • Dulbecco R., Enciclopedia del Novecento. Il Supplemento, Enciclopedia Treccani, 1998.
    • ECVC, In Order to Stop the Theft of Agricultural Biodiversity Patents on Native Traits Should Be Banned, September 2016.
    • European Commission, Commission staff working document impact assessment accompanying the document proposal for a regulation of the European Parliament and of the Council on the production and making available on the market of plant reproductive material, May 2013, Brussels.
    • European Parliament, The EU Seed and Plant Reproductive Material (PRM) market in perspective: a focus on companies and market shares, Directorate-general for internal policies of the European Parliament, November 2013, Brussels.
    • European Seed Association, At the crossroads – what future for plant breeding in Europe?
    • Garland A., “Life Science in the Twentieth Century”, Cambridge Studies in the History of Science, 1978.
    • Greenpeace, CEO, Gene Watch UK, Commission fails to regulate new GMOs after intense US lobbying, 21st April 2016.
    • Joint Position, New techniques of genetic engineering IFOAM EU Group, Friends of the Earth Europe, Slow Food, Greenpeace, Reseau Semences Paysannes, ECVC, Arche Noah, Gene Watch UK, GM Freeze, TestBiotech, CEO, IG Saatgut, BUND, Global 2000, EcoNexus, GMWatch, March 2016.
    • Joint Position, Open letter to the Commission on new genetic engineering methods, EcoNexus, CEO, Friends of the Earth Europe, Gene Watch UK, Greenpeace, TestBiotech, ECVC, European Beekeeping Coordination 27th January 2015.
    • Mammana I., Concentration of Market Power in the EU Seed Market, Study commissioned by the Green/EFA Group in the European Parliament, January 2014, Brussels.
    • Onorati A., Mobilizing Agro-Food Expertise – Innovative teaching in a multicultural environment, Uni Cassino, 6th October 2015.
    • Press release, La Corte di Giustizia Europea dovrà decider se gli organismi ottenuti per mutagenesi siano soggetti alle attuali leggi relative agli OGM, (transl. The European Court of Justice will decide weather the organisms obtained through mutagenesis will be subjected to the actual GMOs regulations), Centro Internazionale Crocevia, Associazione Rurale Italiana, 4th October 2016.
    • Richard A.Steinbrecher, Genetic Engineering in Plants and the “New Breeding Techniques (NBTs)” inherent risks and the need to regulate, EcoNexus, December 2015.
    • Steven Rose, “The Chemistry of Life”, Penguin, 1966.
    • UNHR, The Right to Adequate Food, Fact Sheet n°34, April 2010.

    JOURNAL

    • Cavalli-Sforza, Quando l’ apprendimento può essere trasmesso, journal article from “La Repubblica”, 22 April 2012.

    WEBSITES

    [1] European Commission: http://ec.europa.eu/food/plant/gmo/index_en.htm.

    [2] The “real socialism” approach to biology emphasized the importance of human capacity in modifying human characters or also animals and plants. The most remarkable example is the Russian movement called Lysenkoism, which had the pretension to modify the genetic heritage of animals and plants, just modifying the environment surrounding them.

    [3] Luigi Luca Cavalli-Sforza is an Italian population geneticist, who has been a professor at Stanford University USA) since 1970. While he is best known for his work in genetics, he also initiated the sub-discipline of “cultural anthropology” known alternatively as co-evolution, gene-culture co-evolution, cultural transmission theory or dual inheritance theory. The publication Cultural Transmission and Evolution: A Quantitative Approach (1981) made use of models from population genetics and infectious disease epidemiology to investigate the transmission of culturally transmitted units. This line of inquiry initiated research into the correlation of patterns of genetic and cultural dispersion.

    [4] Dulbecco R., Enciclopedia del Novecento. Il Supplemento, Enciclopedia Treccani, 1998.

    [5] Steven Rose, “The Chemistry of Life”, Penguin, 1966.

    [6] A nucleosome is a basic unit of DNA packaging in eukaryotes, consisting of a segment of DNA wound in sequence around eight histone protein cores. This structure is often compared to thread wrapped around a spool.

    [7] In May 2007, during a ceremony held at Baylor College of Medicine, 454 Life Sciences founder Jonathan Rothberg presented James D. Watson with a digital copy of his personal genome sequence on a portable hard drive. Rothberg estimated the cost of the sequence—the first personal genome produced using a next-generation sequencing platform—at $1 million. Watson’s genome sequence was published in 2008.

    [8] A molecular marker is a molecule contained within a sample taken from an organism (biological markers) or other matter. It can be used to reveal certain characteristics about the respective source. DNA, for example, is a molecular marker containing information about genetic disorders, genealogy and the evolutionary history of life.

    [9] Directorate-general for internal policies of the European Parliament, The EU Seed and Plant Reproductive Material market in perspective: a focus on companies and market shares, November 2013, Brussels.

    [10] European Commission, Commission staff working document impact assessment accompanying the document proposal for a regulation of the European Parliament and of the Council on the production and making available on the market of plant reproductive material, May 2013, Brussels. Page 32.  http://ec.europa.eu/dgs/health_consumer/pressroom/docs/proposal_aphp_ia_en.pdf.

    [11] A patent is a legal title that can be granted for any invention having a technical character provided that it is new, involves an ‘inventive step’, and is susceptible to industrial application. A patent can cover how things work, what they do, what they are made of and how they are made. Anybody can apply for a patent. It gives the owner the right to prevent others from making, using or selling the invention without permission. Patents encourage companies to make the necessary investment for innovation, and provide the incentive for individuals and companies to devote resources to research and development. Currently, (technical) inventions can be protected in Europe either by national patents, granted by the competent national IP authorities in EU countries or by European patents granted centrally by the European Patent Office. (https://ec.europa.eu/growth/industry/intellectual-property/patents_it).

    [12]Directive 2001/18/EC; Regulation (EC) 1829/2003; Directive (EU) 2015/412; Regulation (EC) 1830/2003; Directive 2009/41/EC

    [13] See the paragraph below for last contestation to mutagenesis in France.

    [14] UNEP (January, 2011), Towards a Green Economy: Pathways to Sustainable Development and Poverty Eradication – A Synthesis for Policy Makers, France.