Genetically modified (GM) plants are a remarkable example of the controversial interactions of science, society and politics, as the plants leave laboratories and enter into our everyday lives bearing their load of promises and concerns. THE CHALLENGE OF GM-PLANTS AS BIO-OBJECTS: NEW TOOLS for GOVERNANCE BACKGROUND In 2013, 175 million ha of GM crops were grown globally (11% of the earth’s cultivated area). Of these, soybean, maize, cotton and canola are the most widespread, though less grown in the EU. After productivity traits, interest lies in food quality improvement and in nutriceutical and pharmaceutical compound production. In the EU, to meet public demands for safety and to manage (perceived/true) risks, the cultivation, marketing and the traceability and labeling of the GM products are regulated (EC Reg. 2001/18, 2003/1829, 2003/1830). A case-by-case evaluation of GM plants is recommended by EFSA, while public research suffers from funding cuts. CURRENT UNDERSTANDING Currently a GMO is defined as “an organism in which the genetic material has been altered in a way that does not occur naturally through fertilization and/or natural recombination” (2001/18/EC). Use, labeling, traceability and co-existence with nonGM crops are regulated. However, there is disagreement over the ways in which the European Union’s policy on crop isolation is implemented in practice. What counts as sustainable development that enables both GM and non-GM crops to co-exist is not simply a scientific matter but is shaped by cultural and political values: the boundary between science and politics has become increasingly blurred. FUTURE TARGETS FOR POLICY The recent development of new techniques for manipulating plant genomes (NPBT) may result in a new classification of a ‘modified’ plant requiring a revision of GMO definition and regulation. Questions raised include: compared with GM plants, are NPBT plants more ‘natural’, more ecocompatible and more acceptable to consumers? How should public views and scientific discoveries be acknowledged in food policy decisions? What is the role of GM crops in the enhancement of global food security? How is it possible for policy to enable the coexistence of GM, conventional and organic crops? Where do the risk and liability for GM crops lie? KEY CHALLENGES IN CURRENT GOVERNANCE INSTRUMENTS INCLUDE 1. The definition and limits of genetic modification as a form of plant tissue needs ongoing FUTURE review as the science develops TOOLS 2. The requirement of engaging the public and the role of public views and science in decision-making not so much to do with the technology per se but with the structure of the agro-food system and how choices are made now and for the future 3. The co-existence of genetically modified, conventional and organic crops and food products needs to be defined and made workable and the interests of different groups supporting these agro-technologies recognised Novel biological materials become both recognizable and valuable through the twin processes of Bio-objectification and Bio-identification. Subsequent to these processes we encounter stabilised bio-objects that obtain the qualities of being knowable, recognizable, and transferable. GMOs pose specific regulatory challenges because they disturb conventional biological boundaries. In doing so, they create concerns (over risk) and demands (e.g. over patenting designation) that have to be resolved for their successful stabilization. The debates over GMOs illustrate how a bioobject continually crosses the boundary back and forward between safe and unsafe. The core issues are outlined below: 1. BIO-OBJECTIFICATION (i.e. the ranges of experimental work which is devoted to the exploration and fashioning of new ‘bio’, new forms of life). Possibility of living artifacts challenging the distinction between natural and unnatural plant tissues, such as debates over cis-genics How such bio-objects articulate with and depend on pesticide and herbicide systems x different variations of the same kind Which objects are distinct in kind, which are Co-existence requires identification and classification of tissue for traceability purposes 2. BIO-IDENTIFICATION (i.e. the social labour that is undertaken to ensure the (co-)relative identity of bioobjects to other forms of life is made clear) Classification of plant organisms into genetically modified and others Ownership and plant-breeders’ rights need to be clarified Implications and acceptability of bio-identification for product labeling and GMOs in the food chain Identification of GM-free zones and liability for risks incurred 3. STABILISED BIO-OBJECTS The stabilization of GMOs within different European andxother countries has not been fully secured. Pressures from the pro-GMO networks or ‘proportionate’ regulation has been met by counter arguments about unknown risks that make proportionality difficult to define. Policy has focused on providing scientific assessment but trust will only be secured by recognition of the value debates involved in GMO technologies. The work on public understanding of GMOs has concentrated on a deficit-model: such work shows that public anxieties are less to do with the science per se and more to the institutional context driving the GMO project. The current relative stability of the field can be described in the following terms reflecting differing safe/unsafe boundaries: Widely sold and used GM crops, first generation GM crops commonplace Second generation GM crops allow expansion of GMO markets for major firms Third generation GM crops producing medication for health care systems create new types of regulatory requirements: there appears to be greater acceptance of medical application of GMOs than for food Consensus on sustainable plant biotechnology yet to be secured CASE Studies GENETICALLY MODIFIED PLANTS BACKGROUND As ‘creations’ of biology innovation, GM plants bear crucial features of ‘bio-objects’: they evoke the language of the ‘unnatural’, being constructed and manipulated creatures on the fine line between ‘natural’ and ‘non-natural’/’artificial’, and having hybridity; they promise enhancement of human life quality; they challenge the conventional natural, cultural, scientific and institutional orderings; they have potential to move between domains, shifting from agriculture, nutrition, health and industry.GM food illustrates the controversial relation between the intrinsic uncertainty of the scientific approach and the demand of citizen-consumers to use products of science innovation that are known to be safe. Thus far, reluctance towards GM food has been accompanied with a higher acceptance of medical applications of biotechnology. Nowadays, nutriceutical compounds as well as medicines and vaccines can be produced by GM plants (GMO of new generations), thus challenging the boundary between agriculture and medicine and proposing a new understanding of the meaning of ‘food ‘ itself: the recursive relation between bio-objectification and bio-identification work is evident here. NEW PLANT BREEDING TECHNIQUES (NPBTS) FOR GENE TRANSFER INTO PLANTS BACKGROUND Following the increased knowledge of plant genomes, new tools for gene transfer (among these trans- and cis-genesis and genome editing) have been developed. When genes and related sequences phylogenetically close to the host species are introduced and insertion of foreign and unnecessary DNA is reduced, as in the case of cis-genesis, a different regulation from ‘traditional’ GMOs have been pursued. By stressing the origins of the gene transferred (same species or crossable vs. foreign origins), cis-genic supporters claim for the application of a product-based approach versus the technical-based approach adopted by EU regulation. In 2012, the EFSA’s GMO panel concluded that similar hazards can be associated with cis-genic and conventionally bred plants. This opinion, however, has not yet been translated into a less stringent EU regulation. Thus, a crucial question emerges: should crop plants be classified according to their properties or according to the technology used for producing them? The answer will set a precedent for future governance. GM CROPS RESISTANT TO DISEASES AND PESTICIDES: PROMISES AND CONSTRAINTS BACKGROUND Considering the environmental and economic costs of chemical use in agriculture to protect crops from (virus, bacterium and insect) diseases and weed damage, production of intrinsically resistant plants to pathogens and biocides is one of the main goals of genetic engineering in agriculture. Knowledge of disease resistance genes to be transferred has been a main effort of the recent ‘genomic era’. “More biology and less chemicals” is thus the promise of this biotech research. On the other hand, GM crops of first generation that are able to tolerate herbicides –thus allowing the use of chemicals- are also available. In both types of GM crops, field testing, the necessary final step of the research, are necessary. This is challenging in Europe, because of the time and high costs necessary to complete the assays. Moreover, social resistance, which in some Member States has resulted in vandalism against some field tests, is hindering the European research on GM crops in general and on plant resistance in particular. Regulations more responsive to the needs of research are sought by the scientific community. This is likely to be only a partial solution which will need much wider consideration of regulation and governance of the wider food production system of which GM is only a part. This would make for a more effective dialogue across different and competing interests. RESPONSIBLE RESEARCH AND INNOVATION POLICY BIO-OBJECT IMPLICATIONS The bio-objects network has identified FOUR related challenges for Issues concerning GM crops are still instantiating RRI practice in the GMO sector controversial in public and scientific Transparency: research on GMO safety should not be dependent on the positions of large corporations discussion. Whilst the majority of scientists agree on GM crops’ safety, reports on health risks associated with Engagement: redefine the issue from specific focus on GMO and open to a GMO consumption do appear. Doubts wider debate relating to food production which will foster more effective on reliability of research results and on engagement across all parties including ‘the public’ unpredicted results of the research make Gender equality: the poorest farmers of developing countries are often women: policy must address their interests in decision-making regarding GMOs people reluctant to use GM food. This makes lay people, in their safety considerations, dependent on Science education: there is a need to go beyond the deficit model which still interpretations and explanations provided predominates and examine value positions, and in particular from an ethics by scientists and the media. Accordingly, perspective to ask about risks and if decisions about future impact are made GMOs may be regarded as ‘bio-objects’ under conditions of some ignorance, what institutional structures are needed and that cross back and forward the and how should the precautionary principle be refreshed? boundaries of ‘safe/unsafe’ and of ‘well known/still to be known’. USING BIO-OBJECT FRAMEWORK in RRI POLICY MAKING THE CONCEPTS OF ‘BIO-OBJECTS’, ‘BIO-OBJECTIFICATION’ AND ‘BIO-IDENTIFICATION ‘SEEM TO BE HIGHLY RELEVANT TO POLICY MAKING. THE WAY THE WORLD IS UNDERSTOOD, CLASSIFIED AND DIVIDED INTO OBJECTS AFFECTS OUR UNDERSTANDING OF REALITY. POLICIES SELECTED DEPEND ON VIEWS ADOPTED REGARDING THAT REALITY, OR PERHAPS ’REALITIES’. THE PRACTICES OF LABELLING AND THE POLICIES ON COEXISTENCE, FOR EXAMPLE, DEPEND ON CERTAIN VIEWS REGARDING WHAT BIOLOGICAL ENTITIES COUNT AS ‘GM CROPS’. NEW APPLICATIONS, SUCH AS CIS-GENICS IN WHICH GM-TECHNOLOGIES ARE USED FOR PRODUCING PLANTS THAT COULD BE THE RESULT OF A ‘NATURAL’ BREEDING, CHALLENGE OUR VIEWS REGARDING THE CLASS OF GM CROPS. SHOULD BIO-IDENTIFICATION IN THIS CASE RELY MORE ON PROPERTIES OF THE OUTCOME OR THE PROCESS OF PRODUCTION ITSELF? THE IDEA OF BIO-OBJECTS AND BIO-OBJECTIFICATION REVEAL THE INTELLECTUAL CLASSIFICATION PROCESSES BEHIND UNDERSTANDINGS REGARDING PRODUCTS OF NEW BIOTECHNOLOGIES. THUS, THEY ARE A USEFUL TOOL FOR A BETTER, MORE OPEN AND MORE TRANSPARENT DECISION-MAKING. Case Study Authors: Lucia Martinelli, Helena Siipi and Małgorzata Karbarz, COST Action Network
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