“The Moral Difference between Intragenic and Transgenic Modification of Plants”

Ecological scientists routinely make decisions in contexts where scientific uncertainty and ignorance constrain available evidence, yet empirical research on how they judge such situations remains limited. Understanding these decision-making processes is critical because ecological crises—such as biological invasions and chemical accidents—require rapid action despite incomplete information. Accordingly, this study aimed to examine how ecological field experts respond cognitively, emotionally, and behaviorally to different uncertainty-laden scenarios. The study involved 16 ecological field experts from a single national context (with an average experience of 22.0 years), specializing in amphibians, reptiles, freshwater fish, and birds. Data were collected using three scenario-based instruments representing increasing levels of uncertainty, risk, and urgency, and analyzed through constant comparative analysis. Four distinct decision-making types emerged: Consistent Knowledge-Seekers (25.0%), Risk-Escalating Responders (25.0%), Action-Oriented Responders (25.0%), and Policy-Focused Responders (25.0%). As risk increased across scenarios, the research orientation decreased from 93.8% to 43.8%, while the preventive/management orientation increased to 56.2%. Additionally, emotional responses intensified to 25.0% in the high-risk scenario. These findings underscore the importance of biology education in leveraging uncertainty as a learning resource and fostering students’ contextual scientific reasoning, adaptive expertise, and communication competencies. Keywords: post-normal science, scientific uncertainty, scientific ignorance, ecological experts, decision-making patterns, adaptive expertise, biology education

There has been a rapid expansion in the commercial cultivation of genetically modified crops, rising from the first plantings in 1995 to 44.5 million hectares worldwide in 2000, most of which have grown in North America. Though there are sharp divisions in opinions on benefits and risk, genetic modification (GM) does not represent a single, homogenous technology. Each application brings different potential benefits and risks for different stakeholders. This paper reviews recent scientific progress and future applications using a new typology of three generations of genetically modified organisms (GMOs) ranged against five types of scientific application. Agricultural GMOs pose a range of potential environmental and health risks. An analysis of recent independent field and scientific evidence from industrialized countries summarizes the current state of knowledge on seven types of risk that apply to all agricultural systems: (1) horizontal gene flow; (2) new forms of resistance and pest problems; (3) recombination to produce new pathogens; (4) direct and indirect effects of novel toxins; (5) loss of biodiversity from changes to farm practices; (6) allergenic and immune system reactions; and (7) antibiotic resistance marker genes. There remain highly contrasting positions taken by different stakeholders over GMOs. A review of three debates explains claims and counter-claims for (1) genetic modification as technological fix or contributor to sustainability; (2) genetic modification as driver of corporate power or friend of farmer; and (3) genetic modification as feeder of the world or eliminator of alternatives.

Final Health and Environmental Risk Assessment of Genetically Modified Maize 59122

One of the most serious issues confronting the global food system is the wastage of approximately one-third of food at various points throughout the supply chain due to environmental and economic factors. Declines in production and food quality deterioration are concerns due to less awareness of the farming community and end users about the advanced technologies. Therefore, scientists face to develop cutting-edge technology to solve these problems and feed the bulging population to prevent starvation. Genetic engineering (GE) techniques can aid in several contexts to boost crop yields and quality. Biotechnology, genetic modification, and recombinant (r) deoxyribonucleic acid (DNA) technologies are significantly beneficial in pursuing chief progress in food production and supply. This latest literature review illustrates the recent advances in GE, their sources, current trends, and future. GE foods from animals, microbes, and crop plants have altered DNA and introduced modified genetic characteristics. Genetically modified organisms (GMOs) are vital parts of the industrial food system, and most packaged foods contain GMO ingredients that received engineering for resistance to pesticides and herbicides. Several issues raise red flags concerning GMOs, including safety, effects on the environment, and ineffective usage of pesticides. Many people are anxious about GMOs; however, most do not understand the problems.

The events of 1999 highlight the importance of the need for identity preservation (IP) of products that result from genetic modification. In April of 1999, Archer Daniels Midland Co. and A. E. Staley Co. announced that they would not accept product that was not approved for export to the European Union. By the time the 1999 harvest arrived, decision makers in the grain marketing industry realized the nature of their business had dramatically changed in just one growing season. In particular, they needed to preserve the identity of all grains and oilseeds intended for European and Japanese markets. During the remainder of the 1999 growing season, consumer concern about the safety of genetically modified organisms (GMOs) increased. The need for IP represents a substantial challenge for the grain marketing system, since the system has evolved over time to handle large volumes of homogeneous product. The objective of this study is to examine the impact of IP for GMOs on the grain handling system for a typical region in the eastern corn belt.

Pharmaceutical regulation of genetically modified organisms (GMOs) is one of the critical issues for developing viral vector-based medicines. In this perspective, we introduce the recent improvement of regulatory operations in GMOs like viral vector-based products in Japan by comparing those in the United States and the European Union. The recent advancements in genetic modification and editing techniques have accelerated the development of advanced-therapy medicinal products using genetically modified viral vectors and cells.1 Despite the increase in use of GMOs/living modified organisms (LMOs) in medicine, the potential risk of GMOs/LMOs on the environment is a concern. To address internationally the environmental issues related to biological diversity, including the usage of GMOs/LMOs, 196 nations as of 2021 have concluded or signed the Convention on Biological Diversity (CBD), which is the first global agreement to cover all aspects of biological diversity. The Cartagena Protocol based on CBD aims to ensure the safe handling, transport, and use of GMOs/LMOs, produced by modern biotechnology, which may have an impact on biological diversity. The Cartagena Protocol was entered into force on September 11, 2003. The Cartagena Protocol requires the parties to consider the necessity of the standard of handling of GMOs/LMOs and, if necessary, to establish the standard. The EU countries had already established domestic laws based on Directive 2001/18/EC that addressed the handling of GMOs/LMOs for medical use before the establishment of the Cartagena Protocol. Therefore, the EU countries did not have to take any additional actions to regulate the handling of GMOs/LMOs for pharmaceuticals. In 2003, the Japanese government established the Act on the Conservation and Sustainable Use of Biological Diversity through Regulations on the Use of Living Modified Organisms,2 known as the Cartagena Act, for the handling of the GMOs/LMOs. This Act is similar to Directive 2001/18/EC and the domestic laws established in the EU countries. In contrast to the European Union and Japan, the United States is one of the few countries that have not signed the CBD and the Cartagena Protocol. The United States enacted one specific environmental law named the National Environmental Policy Act of 1969 (NEPA) that regulates all kinds of environmental assessments. For initiating clinical trials, developers should submit appropriate clinical trial-related applications (investigational new drug (IND) application in the United States, clinical trial application (CTA) in the European Union, and clinical trial notification (CTN) in Japan) to each regulatory agency. In the European Union and Japan, approval of the usage of the GMOs/LMOs in the clinical trials is also mandatory before starting clinical trials (Figure 1). The objective of the EU domestic laws is to protect humans and the environment when carrying out deliberate release of GMOs/LMOs into the environment. Thus, developers (academia and/or industry) planning clinical trials in the EU countries should submit an environmental risk assessment (ERA) of each GMO to each country where the clinical trial will be conducted. In Japan, the Cartagena Act has two types of GMO/LMO regulations, the deliberate release, with GMO/LMO-specific rules for usage (Type-1 Use Regulation (T-1R)) and containment use for closed production sites and laboratories (Type-2 Use Regulation (T-2R)). Clinical trials are within the scope of T-1R, therefore developers planning to conduct clinical trials in Japan should submit an ERA and the T-1R application for GMOs/LMOs. In the United States, the submission of an ERA is not required for IND applications. However, when GMOs/LMOs may affect the quality of the environment, the US Food and Drug Administration (FDA) will request an ERA during the review process of the IND (the Title 21 of the Code of Federal Regulations (CFR) 25.21 and 25.31). In both the European Union and the United States, applicants should submit an ERA result of GMOs/LMOs when applying for marketing authorization, and the FDA or European Medicines Agency (EMA) reviews the appropriateness of the usage of drugs in clinical practice based on the ERA result (Figure 1). In Japan, the resubmission of an ERA is not mandatory when applying for marketing authorization. If developers obtain new data that indicates the environmental risk is lower than expected, resubmission is acceptable at any time to relax the T-1R. Some clinical researchers in Japan recently commented that the Cartagena Act delays the development of medicines containing GMOs/LMOs when compared to that of the medicines regulated by the similar laws in the European Union and the United States.3 But the regulatory framework of Japan is not significantly different from that of at least the European Union (Figure 1). The Pharmaceuticals and Medical Devices Agency (PMDA) is the Japanese regulatory agency responsible for a scientific review of new drug applications and Cartagena Act-related applications. The PMDA believed that such opinions came from the differences between the scheme of the Cartagena Act implementation and the procedure of actual development of drugs, and a lack of information on the Cartagena Act applications among academia. To solve these problems, since 2019, the Ministry of Health, Labor, and Welfare and the PMDA have started to improve the implementation of the Cartagena Act to ensure faster development of drugs (Table 1). The first improvement made in 2019 was the establishment of the PMDA official consultations to address specific measures of the Cartagena Act. The consultations for the Cartagena Act were the first established at the PMDA for the environmental law, and the developers can officially discuss the Cartagena Act-related matters with the PMDA since the establishment. It takes < 3 months to complete the official consultations and for official minutes to be published. The applicant can then submit the T-1R application as soon as the issues pointed out in the consultations are resolved. The administrative processing time after the submission is officially < 6 months, and the median actual administrative processing time and total processing time in 2021 were ~ 2.7 months and < 5 months, respectively. Section 42 of the German Drug law indicates that the evaluation period of CTA for trials dealing with GMOs/LMOs is 90 days after receiving the application conforming to the regulations. Thus, the actual administrative processing time before starting clinical trials is similar between Japan and the European Union. Since 2021, the parallel application of CTN and T-1R is acceptable. Now, developers should receive the approval of the T-1R application before at least the first patient enrollment of the clinical trial in Japan. In the European Union, several countries, such as France, accept the parallel application of CTA and ERA, but some countries, such as Poland, demand the approval of usage of the GMOs in the clinical trials before submitting a CTA.4 The PMDA has published a considerable number of instructions, such as the specific descriptions of ERA for adeno-associated virus (AAV) vectors,5 to provide information about the Cartagena Act to future applicants. The specific ERA for AAV vectors includes the general information and prior knowledge about AAVs and the general principles of risk assessment for AAV vectors. The European Commission has also published specific ERA for AAV in June 2022.6 These instructions and specific descriptions will significantly reduce the burden on applicants and regulators in Japan. Because the ERA submission is not mandatory when applying for marketing authorization, the regulation of the development of gene therapy products in Japan is not more time-consuming than that in the European Union and the United States. No funding was received for this work. The authors declared no competing interests for this work.

The environmental risk assessment of the insect resistant genetically modified maize MON 89034 (Reference EFSA/GMO/BE/2011/90) has been performed by the Panel on Genetically Modified Organisms (GMO) of the Norwegian Scientific Committee for Food Safety (VKM). VKM has been requested by the Norwegian Directorate for Nature Management and the Norwegian Food Safety Authority to issue a preliminary scientific opinion on the safety of the genetically modified maize MON 89034 (Unique identifier MON-89Ø34-3) for cultivation, and submit relevant scientific comments or questions to EFSA on the application EFSA/GMOBE/2011/90. The current submission is intended to complement application EFSA-GMO-NL-2007-37, which was approved by Commission Decision 2009/813/EC of 30 October 2009, authorising the placing on the market of products containing, consisting of, or produced from genetically modified maize MON 89034 (scope import, processing, food and feed). Maize MON89034 has previously been assessed by the VKM GMO Panel in connection with EFSA´s public hearing of the application EFSA/GMO/NL/2007/37 (VKM 2008a). Preliminary health- and environmental risk assessments of several stacked events, with MON 89034 as one of the parental lines, have also been performed by the VKM GMO Panel (VKM 2009a, b, c; VKM 2010a,b).&#x0D; &#x0D; The environmental risk assessment of the maize MON 89034 is based on information provided by the applicant in the application EFSA/GMO/BE/2011/90, and scientific comments from EFSA and other member states made available on the EFSA website GMO Extranet. The risk assessment also considered peer-reviewed scientific literature as relevant. &#x0D; &#x0D; The VKM GMO Panel has evaluated MON 89034 with reference to its intended uses in the European Economic Area (EEA), and according to the principles described in the Norwegian Food Act, the Norwegian Gene Technology Act and regulations relating to impact assessment pursuant to the Gene Technology Act, Directive 2001/18/EC on the deliberate release into the environment of genetically modified organisms, and Regulation (EC) No 1829/2003 on genetically modified food and feed. The Norwegian Scientific Committee for Food Safety has also decided to take account of the appropriate principles described in the EFSA guidelines for the risk assessment of GM plants and derived food and feed (EFSA 2006, 2011a), the environmental risk assessment of GM plants (EFSA 2010), the selection of comparators for the risk assessment of GM plants (EFSA 2011b), and for the post-market environmental monitoring of GM plants (EFSA 2006, 2011c). &#x0D; &#x0D; The scientific risk assessment of maize MON 89034 include molecular characterisation of the inserted DNA and expression of target proteins, comparative assessment of agronomic and phenotypic characteristics, unintended effects on plant fitness, potential for gene transfer, interactions between the GM plant and target and non-target organisms, effects on biogeochemical processes and evaluations of the post-market environmental plan.&#x0D; &#x0D; In line with its mandate, VKM emphasised that assessments of sustainable development, societal utility and ethical considerations, according to the Norwegian Gene Technology Act and Regulations relating to impact assessment pursuant to the Gene Technology Act, shall not be carried out by the Panel on Genetically Modified Organisms. &#x0D; &#x0D; The genetically modified maize MON 89034 was developed to provide protection against certain lepidopteran target pest, including European corn borer (Ostrinia nubilalis) and Mediterranean corn borer (Sesamia nonagrioides). Protection is achieved through expression in the plant of two insecticidal Cry proteins, Cry1A.105 and Cry2Ab2, derived from Bacillus thuringiensis, a common soil bacterium. Cry1A.105, encoded by the cry1A.105 gene, is a chimeric protein made up of different functional domains derived from three wild-type Cry proteins from B. thuringiensis subspecies kurstaki and aizawai. The Cry2Ab2 protein is encoded by the cry2Ab2 gene derived from B. thuringiensis subspecies kurstaki. &#x0D; &#x0D; Molecular characterization:&#x0D; &#x0D; Appropriate analysis of the integration site, including flanking sequence and bioinformatics analysis, has been performed to characterise the transformation event MON 89034. The results of the segregation analysis are consistent with a single site of insertion for the cry1A.105 and cry2Ab2 gene expression cassettes and confirm the results of the molecular characterisation. Molecular analysis of both self-pollinated and cross-fertilised lines, representing a total of seven different generations, indicates that the inserted DNA is stably transformed and inherited from one generation to the next. No genes that encode resistance to antibiotics are present in the genome of MON 89034 maize. The molecular characterisation confirmed the absence of both the aad and nptII genes, which were used in the cloning and transformation process.&#x0D; &#x0D; Event MON 89034 and the physical, chemical and functional characteristics of the proteins have previously been evaluated by The VKM Panel on Genetically Modified Organisms, and considered satisfactory (VKM 2008a).&#x0D; &#x0D; Comparative assessment:&#x0D; &#x0D; The field trials for comparative assessment of agronomic and phenotypic characteristics of maize MON 89034 in the USA (2004-2005) and Europe (2007), have been performed in accordance with the EFSAs guidelines for risk assessment of genetically modified plants and derived food and feed (EFSA 2010, 2011a). Based on results from the comparative analyses, it is concluded that maize MON 89034 is agronomically and phenotypically equivalent to the conventional counterpart and commercial available reference varieties, with the exception of the lepidopteran-protection trait. The field evaluations support a conclusion of no phenotypic changes indicative of increased plant weed/pest potential of MON 89034 compared to conventional maize. Evaluations of ecological interactions between maize MON 89034 and the biotic and abiotic environment indicate no unintended effects of the introduced trait on agronomic and phenotypic characteristics. &#x0D; &#x0D; Environmental risk:&#x0D; &#x0D; There are no reports of the target Lepidopteran species attaining pest status on maize in Norway. Since there are no Bt-based insecticides approved for use in Norway, and lepidopteran pests have not been registered in maize, issues related to resistance evolution in target pests are not relevant at present for Norwegian agriculture.&#x0D; &#x0D; Published scientific studies show no or negligible adverse effects of Cry1A.105 and Cry2Ab2 proteins on non-target arthropods that live on or in the vicinity of maize plants. Cultivation of maize MON 89034 is not considered to represent a threat to the prevalence of red-listed species in Norway.&#x0D; &#x0D; Few studies have been published examining potential effects of Cry1A.105 and Cry2Ab toxin on ecosystems in soil, mineralization, nutrient turnover and soil communities. Some field studies have indicated that root exudates and decaying plant material containing Cry proteins may affect population size and activity of rhizosphere organisms (soil protozoa and microorganisms). However, data are only available from short term experiments and predictions of potential long term effects are difficult to deduce. Most studies conclude that effects on soil microorganisms and microbial communities are transient and minor compared to effects caused by agronomic and environmental factors.&#x0D; &#x0D; Few studies have assessed the impact of Cry proteins on non-target aquatic arthropods and the fate of these proteins in senescent and decaying maize detritus in aquatic environments. Further studies with better experimental design are needed for the assessment of the potential effects of Bt crops on aquatic organisms. However, exposure of non-target organisms to Cry proteins in aquatic ecosystems is likely to be very low, and potential exposure of Bt toxins to non-target organisms in stream ecosystems in Norway is considered to be negligible. &#x0D; &#x0D; Maize is the only representative of the genus Zea in Europe, and there are no cross-compatible wild or weedy relatives outside cultivation with which maize can hybridise and form backcross progeny. Vertical gene transfer in maize therefore depends on cross-pollination with other conventional or organic maize varieties. In addition, unintended admixture of genetically modified material in seeds represents a possible way for gene flow between different crop cultivations. The risk of pollen flow from maize volunteers is negligible under Norwegian growing conditions. &#x0D; &#x0D; In addition to the data presented by the applicant, the VKM GMO Panel is not aware of any scientific report of increased establishment and spread of maize MON 89034 and any change in survival (including over-wintering), persistence and invasiveness capacity. Because the general characteristics of maize MON 89034 are unchanged, insect resistance are not likely to provide a selective advantage outside cultivation in Norway. &#x0D; &#x0D; Since MON 89034 has no altered agronomic and phenotypic characteristics, except for the specific target pest resistance, the VKM GMO Panel is of the opinion that the likelihood of unintended environmental effects due to the establishment and survival of maize MON 89034 will be no different to that of conventional maize varieties in Norway &#x0D; &#x0D; The environmental risk assessment will be completed and finalized by the VKM Panel on Genetically Modified Organisms when requested additional information from the applicant is available.

Following the submission of application EFSA‐GMO‐RX‐013 under Regulation (EC) No 1829/2003 from Syngenta Crop Protection NV/SA, the EFSA Panel on Genetically Modified Organisms (GMO) was asked to deliver a scientific risk assessment on the data submitted in the context of the renewal of authorisation application for the insect‐resistant genetically modified maize MIR604, for food and feed uses, excluding cultivation within the EU. The data received in the context of this renewal application contained post‐market environmental monitoring reports, a systematic search and evaluation of literature, updated bioinformatic analyses, and additional documents or studies performed by or on behalf of the applicant. The GMO Panel assessed these data for possible new hazards, modified exposure or new scientific uncertainties identified during the authorisation period and not previously assessed in the context of the original application. Under the assumption that the DNA sequence of the event in maize MIR604 considered for renewal is identical to the corrected sequence of the originally assessed event, the GMO Panel concludes that there is no evidence in renewal application EFSA‐GMO‐RX‐013 for new hazards, modified exposure or scientific uncertainties that would change the conclusions of the original risk assessment on maize MIR604.

The conceptual model necessary for an assessment of biotechnology's economic benefits and costs is outlined, emphasizing the need to account for the proprietary nature of biotechnology innovations. The model is illustrated with an application to Roundup Ready soybeans. The estimated value of this innovation is sizeable, with consumers and innovators claiming the larger share of net benefits. Also, disparities in intellectual property rights protection across countries affect the distribution of benefits. Consumer resistance toward genetically modified organisms (GMOs) and the issues of labeling and market segregation complicate the economic evaluation of biotechnology innovations, and a number of related regulation and public policy issues are discussed. Emerging output-trait GMOs are potentially less controversial and may bring more benefits to all participants in the agri-food sector, but this outcome depends crucially on the development of an effective, credible, and internationally harmonized regulatory system.

While interconnected systems proliferate in nowadays computing and communications technology there are few reports investigating their security. In this paper, new efficient models are developed and evaluated for analyzing the security-related behavior of computing architectures and networks comprising complex interconnected communication systems adapted towards a generalized analysis. These models, based on Markov processes, allow calculation of critical security factors, related to intrusion detection, of such interconnected systems components and the evaluation of the associated security mechanisms. Although, at this step two interconnected systems are analyzed, the systematic model introduced allows for a generalized model of N interconnected systems. We herein show the principles of such an analysis. Security parameters calculation and Security mechanisms evaluation may support the risk analysis and the decision making process in resolving the trade-offs between security and quality of service characteristics corresponding to the complex interconnected computing and communication systems.

This exploratory study, which is based on the basic concepts of science communication, conducted in-depth interviews to examine the Chinese public's perceptions of and attitudes towards genetically modified organisms (GMOs). We found that, while scientific knowledge may to some extent be a differentiating factor in attitudes to GMOs, people are subject to significant influence from other information sources. Besides scientific knowledge and scientific literacy, the perception of risks in three dimensions—scientific uncertainty, food safety and conspiracy theories—forms an individual's affective framework for understanding GMOs. The trust framework, which is the regulating mechanism of perception and attitude, plays different roles through institutional trust and interpersonal trust. These tentative conclusions shed new light on how science communication should build the relationship between science and the public in the age of globalization and digitalization.

Genetically modified organisms (GMO) become a real constituent of our lives and nowadays, they are commonly introduced into the food chain of people and animals in some states. Among higher organisms, plants are used above all for genetic modifications; potatoes are a suitable model plants for this purpose. Nowadays, a number of various genetic modifications of potato plants are available, particularly those with increased resistance to biological agents and factors of the external environment or with improved nutritional value. Plants that produce proteins of the immune system of man or animals or substances that may be used as vaccines in human or veterinary medicine are highly important. Modified potato plants that produce biomaterials for potential applications in the industry are a significant category.

Understanding the integration of transgene DNA (T-DNA) in transgenic crops, animals, and clinical applications is paramount for ensuring the stability and expression of inserted genes, which directly influence desired traits and therapeutic outcomes. Analyzing T-DNA integration patterns is essential for identifying potential unintended effects and evaluating the safety and environmental implications of genetically modified organisms (GMOs). This knowledge is crucial for regulatory compliance and fostering public trust in biotechnology by demonstrating transparency in genetic modifications. This review highlights recent advancements in T-DNA integration analysis, specifically focusing on targeted DNA enrichment and sequencing strategies. We examine key technologies, such as polymerase chain reaction (PCR)-based methods, hybridization capture, RNA/DNA-guided endonuclease-mediated enrichment, and high-throughput resequencing, emphasizing their contributions to enhancing precision and efficiency in transgene integration analysis. We discuss the principles, applications, and recent developments in these techniques, underscoring their critical role in advancing biotechnological products. Additionally, we address the existing challenges and future directions in the field, offering a comprehensive overview of how innovative DNA-targeted enrichment and sequencing strategies are reshaping biotechnology and genomics.

New Synthesis: Chemical Ecology and Sustainable Food Production

The precautionary principle within European Union public health policy: The implementation of the principle under conditions of supranationality and citizenship