acceptance. Other jurisdictions have adopted more product-based or case-by-case approaches, placing greater emphasis on proportionality, familiarity, and characteristics of the final product (Casacuberta and Puigdomènech, 2018;Gould et al. , 2022). Consequently, regulatory divergence reflects different policy priorities regarding innovation, precaution, and equity. Despite these recent advances, key issues remain unresolved, including labelling requirements, transparency of product-related information, and implications for international trade, particularly for products subject to more stringent oversight (Council of the European Union, 2025). These elements may lead to different approval timelines across jurisdictions, affecting the cost of development, innovation dynamics, and the ability of small and medium enterprises or public institutions to access markets. Although several GEd products have already reached the commercial stage (Waltz, 2022;Grinstein, 2023), their availability may still be limited by international trade challenges. 3 In biotechnology, these differences reflect the ongoing challenge of balancing safety and social legitimacy while maintaining clear and coherent regulationsry rules. Advancing toward mechanisms of regulatory convergence 4 and international cooperation has become a priority for governments, whether through the mutual recognition of product regulatory status, alignment of definitions, or adoption of product-based approaches. 5 Regulation enables both the government and various public groups to engage with biotechnology. It also facilitates innovation, making its application socially acceptable, transparent, and legitimate. As part of a broader social system, regulatory systems influence agents' behavior to ensure that they align with societal expectations (Ivanov et al. , 2025). Public perception of GEd ranges from enthusiasm for its potential benefits to rejection motivated by perceived risks. Responses are not shaped exclusively by concerns such as safety, regulation, or market control; they also reflect more deeply rooted intuitions about what is perceived as natural, acceptable, or appropriate forms of human intervention in living systems (Kuzma, 2023;Buddle et al. , 2025;Pittman et al. , 2026). In this sense, it is useful to distinguish between moral and ethical behavior. Morality refers to the set of intuitions, beliefs, and value judgments held by individuals or social groups, which are often influenced by cultural and emotional factors. Ethics involves a more explicit and structured reflection through which these judgments are examined and discussed in public and institutional settings (Bryant and Baggott la Velle, 2019c). Some reactions to GEd may arise from intuitive responses to interventions perceived as crossing certain boundaries, sometimes described as reactions of "repugnance" toward what is seen as a violation of natural or moral limits (Kass, 1997). Responses to GEd may be linked to individuals' perceptions of and interpretations of biological interventions. Differences in public perception are particularly evident when comparing biomedical and agrifood applications of GEd. For instance, 3 These challenges generate market risks for smaller-scale developers despite the reduction in entry costs offered by GEd, by reducing technical complexity and initial infrastructure requirements compared with other modern biotechnological techniques such as transgenesis (Bullock et al. , 2021;Tachikawa and Matsuo, 2023). 4 "Normative convergence represents a process whereby the regulatory requirements across countries or regions become more similar or aligned over time as a result of the gradual adoption of internationally recognized technical guidance documents, standards and scientific principles, common or similar practices and procedures, or adoption of regulatory mechanisms that might be specific to a local legal context but that align with shared principles to achieve a common goal. " (USFDA, 2021). 5 Product-based approach refers to regulatory frameworks in which oversight and regulatory requirements are determined by the characteristics of the final product, rather than by the process or technique used to obtain it (McHughen, 2016;Fernández Ríos et al. , 2025b, 2025a). psychological essentialism, the belief that organisms possess an inherent and unchanging essence, can lead to resistance toward genetic interventions, as alterations are perceived to affect the identity of the organism (Benítez Candia et al. , 2021). In this sense, perceptions that the natural world follows an intrinsic order that should not be altered may contribute to concerns about "unnaturalness" or the idea of "playing God. "In addition, emotional responses such as "disgust, " thought to have evolved as mechanisms to avoid potential threats, may intensify negative reactions to certain applications, particularly in the context of food (Curtis et al. , 2011;Tybur et al. , 2013). Recognizing this helps explain why public attitudes are not always Recognizing this helps explain why public attitudes are not always aligned with scientific assessments of risk and benefit and why certain applications may trigger strong responses, even when no clear harm has been demonstrated (Cámara et al. , 2018;Scheufele and Krause, 2019;Dawson et al. , 2022;Kuzma, 2023). Public perception regarding GEd ranges from enthusiasm for its potential benefits to rejection motivated by perceived risks. Social acceptance is not generated only through scientific literacy or knowledge (Cámara et al. , 2018;Dawson et al. , 2022). Concerns often reflect deeper values (Buddle et al. , 2025) related to health, production control, and benefit distribution. Therefore, attitudes toward GEd cannot be examined in isolation from the socio-ethical contexts in which they have meaning. Differences in public perception are evident when comparing agrifood and biomedical applications of GEd. In the biomedical domain, empirical studies have shown that social acceptance varies depending on the type of application: higher acceptance is typically associated with therapeutic uses, while heritable interventions continue to raise significant ethical concerns (Scheufele and Krause, 2019). For instance, germline GEd, foot₀ which involves interventions in oocytes, sperm, or embryos (Lezcano et al. , 2025), remains one of the most persistently debated issues and is often met with greater resistance (Singh, 2021). Even in the case of therapeutic applications, acceptance is not unconditional (Harris, 2011). Adverse outcomes reported in gene therapy trials (Henderson et al. , 2024;Kaiser, 2024;Puig-Serra et al. , 2025) appear to influence how these applications are perceived, reinforcing uncertainty and increasing ethical scrutiny. foot₁ However, these events occur within research processes involving multiple phases of clinical evaluation and under regulatory frameworks designed to assess and manage such risks. A central distinction underlying these differences lies between therapeutic and enhancement-oriented applications. Therapeutic uses are generally understood as those aimed at preventing, treating, or alleviating serious diseases and are therefore more readily associated with medical necessity and moral justification. In contrast, enhancement applications seek to modify or optimize traits beyond what is considered clinically necessary, raising concerns about social pressure, inequality, and the normalization of interventions targeting non-pathological characteristics (Harris, 2011). Some scholars consider the elimination of serious hereditary diseases an expression of responsibility toward future generations, whereas others warn that expanding permissible uses may normalize interventions aimed at modifying non-pathological traits (Pennings, 2020;Johnson and Bowman, 2022). Consequently, this debate requires distinguishing between therapeutic and enhancement applications and defining the corresponding regulatory criteria and mechanisms (Ishii, 2017;Schleidgen et al. , 2020). Moreover, advances in biomedical applications of GEd are often associated with high costs, complex infrastructure, and highly specialized clinical settings. Consequently, access is generally concentrated in high-income countries and among socioeconomically privileged groups, widening the gap between those who can benefit from cutting-edge treatments and those who remain excluded (WHO, 2021a). This raises ethical concerns regarding the balance between technological progress and distributive justice, in which exclusion translates into the inability to access potentially life-saving interventions. If such interventions are accessible only to a segment of the global population, GEd risks deepening inequalities rather than reducing them (Barlevy et al. , 2024). Differences in public perception are evident when comparing agrifood and biomedical applications of GEdAIn contrast to biomedical applications, aOn the other handHowever, agricultural innovations are more frequently debated in terms of health and environmental risks, regulatory frameworks, and market implications (Herring and Paarlberg, 2016). This is compounded by structural distrust toward actors that have historically led agricultural development (Benítez Candia et al. , 2021). These differences between biomedical and agrifood applications reflect not only the characteristics of the technologies themselves but also their intended purposes and broader context of use (Kuzma, 2023). Public responses to GEd in agri-food systems are frequently related to food safety, sustainability, perceived risks, uncertainty, and moral concernsconsiderations (Nguyen et al. , 2023). Acceptance does not alwaysnecessarily tend to increase when GEd is framed around concrete social benefits, suggesting that perceived utility is not the main driver of support (Busch et al. , 2022;Gao et al. , 2024). Risk perception is a source of resistance, especially when GEd is cognitively associated with older GMO debates or fears of unintended consequences (Atimango et al. , 2024). These concerns are often framed not only in terms of measurable risks, but also through broader questions about human intervention in food systems and the perceived integrity of natural processes. Differences in public perception are particularly evident when comparing biomedical and agrifood applications of GEd. Empirical studies in the biomedical field have shown differentiated levels of social acceptance depending on the application of GEdEmpirical studies on public perception in the biomedical field have shown differentiated levels of social acceptance depending on the application of. Higher levels of public acceptance are observed when applications are directed toward therapeutic purposes, alongside marked resistance when interventions are heritable (Scheufele and Krause, 2019). Germline GedGEd, foot₂ which pertains to interventions in oocytes, sperm, or embryos (Lezcano et al. , 2025), isone of the most persistently debated ethical issues in this field (Singh, 2021), but. e. Is it ethically legitimate to intervene in the genome to prevent serious hereditary diseases, or should such interventions be strictly limited to therapeutic purposes? Therapeutic uses are generally understood as those aimed at preventing, treating, or alleviating serious diseases and are therefore more readily associated with medical necessity and moral justification. In contrast, enhancement applications seek to modify or optimize traits beyond what is considered clinically necessary, raising concerns about social pressure, inequality, and the normalization of interventions targeting nonpathological characteristics (Harris, 2011). Some scholars consider the elimination of serious hereditary diseases an expression of responsibility toward future generations, whereas others warn that expanding permissible uses may normalize interventions aimed at modifying non-pathological traits. Consequently, this debate requires distinguishing between therapeutic interventions and enhancement-oriented applications and defining the corresponding regulatory criteria and mechanisms (Ishii, 2017;Schleidgen et al. , 2020). Aadvances in biomedical applications of GedGEd are often associated with high costs, complex infrastructure, and highly specialized clinical settings. Consequently, access is generally concentrated in high-income countries and among socioeconomically privileged groups, widening the gap between those who can benefit from cutting-edge treatments and those who remain excluded (WHO, 2021a). This raises ethical concerns regarding the balance between technological progress and distributive justice, in which exclusion translates into the inability to access potentially life-saving interventions. If such interventions are accessible only to a segment of the global population, GedGEd risks deepening inequalities rather than reducing them (Barlevy et al. , 2024). These differences between biomedical and agrifood applications reflect not only the characteristics of the technologies themselves but also their intended purposes and broader context of use (Kuzma, 2023). In contrast to biomedical applications, agricultural innovations are more frequently debated in terms of health and environmental risks, regulatory frameworks, and market implications (Herring and Paarlberg, 2016). This is compounded by structural distrust toward actors that have historically led agricultural development (Benítez Candia et al. , 2021). These differences between biomedical and agrifood applications reflect not only the characteristics of the technologies themselves but also their intended purposes and broader context of use (Kuzma, 2023). How can scientific evidence be integrated with cultural values and social expectations without undermining public legitimacy or obstructing socially valuable innovations? Previous studies have pointed toward governance models that acknowledge the dynamic nature of scientific knowledgescience and allow regulatory criteria to be revised in light of emerging evidence (Scheinerman and Sherkow, 2021;Asquer and Morrison, 2022). This adaptive governance approach (Vengadesen et al. , 2025) should not be reduced to regulatory flexibility alone, but must also reflect broader principles in decision-making, including legitimacy, transparency, consistency, and proportionality. Excessive precaution may hinder innovations with the potential to deliver significant benefits, whereas policy frameworks that are not fit for purpose (Giddings, 2024;Lubieniechi et al. , 2025) may allow actors to operate outside effective institutional oversight, thereby undermining public trust. In this sense, uncertainty should neither be treated as a reason for paralysis nor ignored in the design of governance frameworks, but rather understood as a condition that requires adaptive responses capable of incorporating new evidence over time (Asquer and Morrison, 2022). In this context, governance should be operationalized through mechanisms that reflect the diversity of GEd uses and their specific contexts of use. Rather than applying uniform schemes, proportional oversight mechanisms should be incorporated based on the characteristics and intended use of each case (Gould et al. , 2022), supported by clear and transparent criteria guiding regulatory decisionmaking. This includes considering issues of access to and distribution of benefits as well as adapting evaluation criteria to the specific context of each intervention, whether related to human health, environmental release, or potential intergenerational effects. Regulatory processes should remain consistent and predictable across comparable cases, while retaining the flexibility needed to adapt to new developments. In this sense, legitimacy does not derive from direct public participation in every decision, but from the robustness, coherence, and reliability of institutions, as well as from the consistent application of criteria in the evaluation of risks and benefits. This adaptive governance (Vengadesen et al. , 2025) should not be reduced to regulatory flexibility alone, as it requires the capacity to reflect broader social principles in decision-making, including legitimacy, transparency, consistency, and proportionality. Legitimacy does not necessarily derive from direct public involvement in every regulatory decision but rather from the robustness, coherence, and predictability of the institutions responsible for assessing risks and benefitsThe construction of public trust does not always depend on citizens' direct participation in every decision-making process but rather on the robustness and coherence of the institutions responsible for assessing the risks and benefits. Excessive precaution may prevent innovations with the potential to deliver significant benefits, whereas policy approaches that are not fit for purpose (Giddings, 2024;Lubieniechi et al. , 2025) may allow actors to operate outside effective institutional oversight, thereby undermining public trust. In this sense, uncertainty should not be treated as a reason for paralysis or ignored in the design of governance frameworks. Rather, it highlights the provisional and evolving nature of scientific knowledge and the need for approaches that can respond to new evidence over time (Asquer and Morrison, 2022). If GEd is to be aligned with principles such as justice, safety, sustainability, and social legitimacy, governance frameworks cannot be limited to the binary decisions of approval or prohibition. Instead, they should incorporate proportional oversight based on the characteristics and intended use of each application (Gould et al. , 2022), supported by clear and transparent criteria that guide regulatory decision-making. This includes considering issues of access and distribution when evaluating potential benefits and adjusting evaluation criteria according to the specific context of each intervention, whether related to human health, environmental release, or potential intergenerational effects. Simultaneously, regulatory processes should remain consistent and predictable across comparable cases. These frameworks must also retain the capacity to be revised as scientific knowledge evolves (Asquer and Morrison, 2022). In this sense, legitimacy does not derive from direct public participation in every decision but from the robustness, coherence, and reliability of the institutions, as well as from the consistent application of criteria in the evaluation of risks and benefits. Emblematic cases have exposed both the potential of GEd and the governance challenges arising from rapidly evolving technologies. In 2018, a researcher edited the genomes of human embryos to confer resistance to HIV, resulting in the birth of "CRISPR babies" (Normile, 2021;Wang et al. , 2023). The procedure was performed without the approval of a research ethics committee or an adequate oversight. This case exposed the limitations of existing oversight arrangements and the absence of robust international governance mechanisms for human germline GEdThis case revealed failures in control mechanisms and marked a turning point in discussions on the governance of human germline editing. Organizations such as the World Health Organization (WHO, 2021a, 2021b), United Nations Educational, Scientific and Cultural Organization (Amelan, 2015), and scientific academies from multiple countries have advanced recommendations and international cooperation frameworks to prevent the recurrence of similar cases in the future. In contrast, in May 2025, a successful clinical case was reported in which a child with a severe genetic disease was treated and cured using CRISPR-Cas-based therapy conducted in a regulated clinical trial under strict bioethical oversight (Ledford, 2025). This milestone demonstrates that when applied under rigorous protocols and appropriate supervision (Bloomfield et al. , 2026), GEd can create new opportunities in for precision medicine. Xenotransplantation based on GEd animal organs designed to be compatible with the human immune system is a case that lies at the intersection of medicine and animal biotechnology. Interest has grown in response to the global shortage of organs available for transplantation. Thousands of patients die annually while awaiting donors. Genome editing offers the possibility of producing "on-demand" organs through pigs engineered to reduce rejection, improve compatibility, and enhance clinical safety (Cooper, 2023;Cooper et al. , 2025). This raises ethical questions regarding the use of animals as "biological sources. " Xenotransplantation illustrates how transformative potential coexists with concerns related to animal welfare and social legitimacy. Even when technology offers critically needed medical solutions, the balance between benefits, risks, and ethical responsibilities remains a recent involving edited in 2025), editing and techniques used to enhance traits associated with and et al. , This case an international debate on the of in the between biotechnological innovation and debates GEd beyond discussions about gene (Bryant and Baggott la Velle, and Sherkow, 2021), practices (Bryant and Baggott la Velle, and limited access in countries et al. , et al. , 2024). In this sense, the of biotechnological the the values that guide and the mechanisms that confer of for more can be as as without adequate as both with scientific These are also as different regulatory reflect different for uncertainty and different of balancing innovation, precaution and equity. are also across of as biomedical and agrifood uses of GEd tend to be through different ethical and societal models that allow criteria to be as new evidence available be an approach (Vengadesen et al. , regulatory frameworks that responsible governance and scientific are not (Bloomfield et al. , 2026). from agrifood that a regulatory may not be In this the practices of countries and regions with regulatory such as the United and et al. , et al. , et al. , 2025) how frameworks can support GEd These approaches also convergence toward similar principles for evaluating such clinical including reported outcomes of gene may also influence public perceptions by to uncertainty and increasing ethical However, even in regulatory systems that ethical concerns are as the flexibility to with technological advances may with the and legitimacy of the can generate perceptions of or thereby public challenge is not to uncertainty or ethical both of which are inherent to emerging technologies. Instead, it lies in governance mechanisms that transparency, consistency, and clear criteria that rather than the legitimacy of regulatory processes (Bryant and Baggott la Velle, This is particularly when distinguishing between therapeutic enhancement-oriented uses, as each raises different ethical concerns and may differentiated regulatory approaches. responses, in are shaped not only by risk but also by social and cultural values and intuitive technological may capacity to its legitimate governance The a structured of the regulatory and cases discussed in this This illustrates the divergence in and toward as well as the levels of public acceptance between medical and agricultural applications, including resistance to germline intervention and concerns about access and it highlights cases that have shaped public such as the gene edited and these reflect the dynamic between societal and that discussions on genome editing. The was using the
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María Florencia Goberna
Ministry of Agriculture Forestry and Fisheries
Evelina Gisela Lezcano
Ibero American University
Andrés Castro Alegría
Universidad San Carlos
Frontiers in Bioengineering and Biotechnology
Ibero American University
Universidad Nacional de Asunción
Ministry of Agriculture Forestry and Fisheries
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Goberna et al. (Mon,) studied this question.
synapsesocial.com/papers/6a226694763171746d5459c5 — DOI: https://doi.org/10.3389/fbioe.2026.1832039