The ethical concerns about transgenic crops.

It is generally accepted that transgenesis can improve our knowledge of natural processes, but also leads to agricultural, industrial or socio-economical changes which could affect human society at large and which may, consequently, require regulation. It is often stated that developing countries are most likely to benefit from plant biotechnology and are at the same time most likely to be affected by the deployment of such new technologies. Therefore, ethical questions related to such biotechnology probably also need to be addressed. We first illustrate how consequentialist and nonconsequentialist theories of ethics can be applied to the genetically modified organism debate, namely consequentialism, autonomy/consent ethics (i.e. self-determination of people regarding matters that may have an effect on these people) and virtue ethics (i.e. whether an action is in adequacy with ideal traits). We show that these approaches lead to highly conflicting views. We have then refocused on moral 'imperatives', such as freedom, justice and truth. Doing so does not resolve all conflicting views, but allows a gain in clarity in the sense that the ethical concerns are shifted from a technology (and its use) to the morality or amorality of various stakeholders of this debate.

Next biotech plants: new traits, crops, developers and technologies for addressing global challenges.

Most of the genetically modified (GM) plants currently commercialized encompass a handful of crop species (soybean, corn, cotton and canola) with agronomic characters (traits) directed against some biotic stresses (pest resistance, herbicide tolerance or both) and created by multinational companies. The same crops with agronomic traits already on the market today will continue to be commercialized, but there will be also a wider range of species with combined traits. The timeframe anticipated for market release of the next biotech plants will not only depend on science progress in research and development (R&D) in laboratories and fields, but also primarily on how demanding regulatory requirements are in countries where marketing approvals are pending. Regulatory constraints, including environmental and health impact assessments, have increased significantly in the past decades, delaying approvals and increasing their costs. This has sometimes discouraged public research entities and small and medium size plant breeding companies from using biotechnology and given preference to other technologies, not as stringently regulated. Nevertheless, R&D programs are flourishing in developing countries, boosted by the necessity to meet the global challenges that are food security of a booming world population while mitigating climate change impacts. Biotechnology is an instrument at the service of these imperatives and a wide variety of plants are currently tested for their high yield despite biotic and abiotic stresses. Many plants with higher water or nitrogen use efficiency, tolerant to cold, salinity or water submergence are being developed. Food security is not only a question of quantity but also of quality of agricultural and food products, to be available and accessible for the ones who need it the most. Many biotech plants (especially staple food) are therefore being developed with nutritional traits, such as biofortification in vitamins and metals. The main international seed companies continue to be the largest investors in plant biotechnology R&D, and often collaborate in the developing world with public institutions, private entities and philanthropic organizations. These partnerships are particularly present in Africa. In developed countries, plant biotechnology is also used for non-food purposes, such as the pharmaceutical, biofuel, starch, paper and textile industries. For example, plants are modified to specifically produce molecules with therapeutic uses, or with an improved biomass conversion efficiency, or producing larger volumes of feedstocks for biofuels. Various plant breeding technologies are now used in the entire spectrum of plant biotechnology: transgenesis producing proteins or RNAi. Cisgenesis (transgenes isolated from a crossable donor plant) and intragenesis (transgenes originate from the same species or a crossable species), null segregants are also used. To date, the next generation precision gene editing tools are developed in basic research. They include: clustered regularly interspaced short palindromic repeats (CRISPR), oligonucleotide-directed mutagenesis (ODM), transcription activator-like effects nucleases (TALENs) and zinc-finger nuclease (ZFN).

Next biotechnological plants for addressing global challenges: The contribution of transgenesis and new breeding techniques.

The aim of this survey is to identify and characterize new products in plant biotechnology since 2015, especially in relation to the advent of New Breeding Techniques (NBTs) such as gene editing based on the CRISPR-Cas system. Transgenic (gene transfer or gene silencing) and gene edited traits which are approved or marketed in at least one country, or which have a non-regulated status in the USA, are collected, as well as related patents worldwide. In addition, to shed light on potential innovation for Africa, field trials on the continent are examined. The compiled data are classified in application categories, including agronomic improvements, industrial use and medical use, namely production of recombinant therapeutic molecules or vaccines (including against Covid-19). The data indicate that gene editing appears to be an effective complement to 'classical' transgenesis, the use of which is not declining, rather than a replacement, a trend also observed in the patenting landscape. Nevertheless, increased use of gene editing is apparent. Compared to transgenesis, gene editing has increased the proportion of some crop species and decreased others amongst approved, non-regulated or marketed products. A similar differential trend is observed for breeding traits. Gene editing has also favored the emergence of new private companies. China, and prevalently its public sector, overwhelmingly dominates the patenting landscape, but not the approved/marketed one, which is dominated by the USA. The data point in the direction that regulatory environments will favor or discourage innovation.

What Will Be the Benefits of Biotech Wheat for European Agriculture?

In European countries, wheat occupies the largest crop area with high yielding production. France, a major producer and exporter in Europe, ranks the fifth producer worldwide. Biotic stresses are European farmers' major challenges (fungal and viral diseases, and insect pests) followed by abiotic ones such as drought and grain protein composition. During the last 40 years, 1136 scientific articles on biotech wheat were published by USA followed by China, Australia, Canada, and European Union with the UK. European research focuses on pests and diseases resistances using widely marker-assisted selection (MAS). Transgenesis is used in basic research to develop resistance against some fungi (Fusarium head blight) while RNA interference (RNAi) silencing is used against some fungi and virus. Transgenic plants were also transformed with genes from various species for drought tolerance. The UK (mostly with transgenesis and site-specific nucleases) and France (with no transgenic tools but with MAS and site-specific nucleases) are the main countries carrying out research programs for both biotic stress and drought tolerance. Thus, few European countries used transgenesis for gluten protein composition and RNAi-mediated silencing in celiac disease. Because of vandalism field trials of transgenics dropped since 2000. No transgenic wheat is cultivated in Europe for political reasons.

Assessment of GE food safety using '-omics' techniques and long-term animal feeding studies.

Despite the fact that a thorough, lengthy and costly evaluation of genetically engineered (GE) crop plants (including compositional analysis and toxicological tests) is imposed before marketing some European citizens remain sceptical of the safety of GE food and feed. In this context, are additional tests necessary? If so, what can we learn from them? To address these questions, we examined data from 60 recent high-throughput '-omics' comparisons between GE and non-GE crop lines and 17 recent long-term animal feeding studies (longer than the classical 90-day subchronic toxicological tests), as well as 16 multigenerational studies on animals. The '-omics' comparisons revealed that the genetic modification has less impact on plant gene expression and composition than that of conventional plant breeding. Moreover, environmental factors (such as field location, sampling time, or agricultural practices) have a greater impact than transgenesis. None of these '-omics' profiling studies has raised new safety concerns about GE varieties; neither did the long-term and multigenerational studies on animals. Therefore, there is no need to perform such long-term studies in a case-by-case approach, unless reasonable doubt still exists after conducting a 90-day feeding test. In addition, plant compositional analysis and '-omics' profiling do not indicate that toxicological tests should be mandatory. We discuss what complementary fundamental studies should be performed and how to choose the most efficient experimental design to assess risks associated with new GE traits. The possible need to update the current regulatory framework is discussed.

Assessment of the health impact of GM plant diets in long-term and multigenerational animal feeding trials: a literature review.

The aim of this systematic review was to collect data concerning the effects of diets containing GM maize, potato, soybean, rice, or triticale on animal health. We examined 12 long-term studies (of more than 90 days, up to 2 years in duration) and 12 multigenerational studies (from 2 to 5 generations). We referenced the 90-day studies on GM feed for which long-term or multigenerational study data were available. Many parameters have been examined using biochemical analyses, histological examination of specific organs, hematology and the detection of transgenic DNA. The statistical findings and methods have been considered from each study. Results from all the 24 studies do not suggest any health hazards and, in general, there were no statistically significant differences within parameters observed. However, some small differences were observed, though these fell within the normal variation range of the considered parameter and thus had no biological or toxicological significance. If required, a 90-day feeding study performed in rodents, according to the OECD Test Guideline, is generally considered sufficient in order to evaluate the health effects of GM feed. The studies reviewed present evidence to show that GM plants are nutritionally equivalent to their non-GM counterparts and can be safely used in food and feed.