Regulation and Policy
Risk assessments, regulation of gene drive, and thought leadership on gene drive policy
The Anthropocene as the End of Nature? Why Recognizing Interventionism Is Key in Coming to Terms with the Anthropocene
24729K. Boersma, ENVIRONMENTAL ETHICS, 44:195-219. 2023-02-12 09:43:02.
In this article, I address and argue against the tendency to understand the anthropocene as inaugurating the end of nature. I conduct two key moves. First, by way of an engagement with the concept of anthropocene technology I explain how understanding the anthropocene as the end of nature prevents us from recognizing what the anthropocene is all about: interventionism. Secondly, I illustrate how a nondualist understanding of the human-nature relation allows us to recognize interventionism as the hallmark of the anthropocene without falling back into the hierarchical human-nature conceptions that underlie interventionism. A nondualist framework that conserves the human-nature distinction helps us in our ability to relate critically to contemporary science and technology in the anthropocene. I illustrate the conceptual narrative of the article through the specific case of gene drive technology development.
Moving beyond narrow definitions of gene drive: Diverse perspectives and frames enable substantive dialogue among science and humanities teachers in the United States and United Kingdom
24692S. Hartley, A. Stelmach, J. A. Delborne and S. K. Barnhill-Dilling, Public Understanding of Science, 2023-02-06 08:31:02.
Gene drive is an emerging biotechnology with applications in global health, conservation and agriculture. Scientists are preparing for field trials, triggering debate about when and how to release gene-drive organisms. These decisions depend on public understandings of gene drive, which are shaped by language. While some studies on gene drive communication assume the need to persuade publics of expert definitions of gene drive, we highlight the importance of meaning-making in communication and engagement. We conducted focus groups with humanities and science teachers in the United Kingdom and United States to explore how different media framings stimulated discussions of gene drive. We found diversity in the value of these framings for public debate. Interestingly, the definition favoured by gene drive scientists was the least popular among participants. Rather than carefully curating language, we need opportunities for publics to make sense and negotiate the meanings of a technology on their own terms.
Assessing potential hybridization between a hypothetical gene drive-modified Drosophila suzukii and nontarget Drosophila species
24610S. Wolf, J. Collatz, J. Enkerli, F. Widmer and J. Romeis, Risk Analysis, 2023-01-24 09:02:35.
Genetically engineered gene drives (geGD) are potentially powerful tools for suppressing or even eradicating populations of pest insects. Before living geGD insects can be released into the environment, they must pass an environmental risk assessment to ensure that their release will not cause unacceptable harm to non-targeted entities of the environment. A key research question concerns the likelihood that nontarget species will acquire the functional GD elements; such acquisition could lead to reduced abundance or loss of those species and to a disruption of the ecosystem services they provide. The main route for gene flow is through hybridization between the geGD insect strain and closely related species that co-occur in the area of release and its expected dispersal. Using the invasive spotted-wing drosophila, Drosophila suzukii, as a case study, we provide a generally applicable strategy on how a combination of interspecific hybridization experiments, behavioral observations, and molecular genetic analyses can be used to assess the potential for hybridization.
Environmental, Socio-economic, and Health Impact Assessment (ESHIA) for Gene Drive Organisms
24428isaaa Inc. and Outreach Network for Gene Drive Research, ISAAA, 2023-01-11 10:31:02.
Understanding the possible positive and negative impacts that gene drive organisms could have on the environment and people is essential before these technologies are considered for release, whether for research purposes or for use. Different impacts are assessed through different tools and methodologies. While environmental risks are evaluated through specific risk assessments, other dimensions, such as positive and negative impacts on a social, economic, and health level can be assessed through impact assessments. These environmental, socio-economic and health impact assessments can complement the information provided by environmental risk assessments.
Trust in science and scientists: Effects of social attitudes and motivations on views regarding climate change, vaccines and gene drive technology
24622H. G. W. Dixson, A. F. Komugabe-Dixson, F. Medvecky, J. Balanovic, H. Thygesen and E. A. MacDonald, Journal of Trust Research, 2023-01-10 09:31:54.
Trust in science and scientists (TSS) is an increasingly important topic with respect to how science is applied within society. However, its role regarding specific issues may vary depending upon other psychosocial factors. In this study, we investigated how trust interacts with social attitudes and motivations to shape views on scientific issues in New Zealand (N = 8,199; 74.7% New Zealand European, 55.1% female). The study went beyond TSS by including broader institutional trust alongside measures relating to support for inequality, status quo preservation and fear of the unknown. We focused on their effects on three issues: vaccines, climate change and genetic technology (gene drive). Although TSS was strongly associated with lower vaccine skepticism (B = -0.497, p < 0.01), and moderate support for gene drive (B = 0.231, p < 0.01), it had no meaningful effect on climate skepticism. Furthermore, trust differentially mediated the relationship between social motivations and responses to all three issues. Trust in science and scientists is therefore unlikely to represent a one-size-fits-all variable. We conclude that future research should consider what effects trust in institutions and TSS have with social attitudes and motivations over a range of technologies across the sciences.
Genes drive organisms and slippery slopes
24322D. B. Resnik, R. F. Medina, F. Gould, G. Church and J. Kuzma, Pathog Glob Health, 2022-12-22 08:58:12.
The bioethical debate about using gene drives to alter or eradicate wild populations has focused mostly on issues concerning short-term risk assessment and management, governance and oversight, and public and community engagement, but has not examined big-picture- 'where is this going?'-questions in great depth. In other areas of bioethical controversy, big-picture questions often enter the public forum via slippery slope arguments. Given the incredible potential of gene drive organisms to alter the Earth's biota, it is somewhat surprising that slippery slope arguments have not played a more prominent role in ethical and policy debates about these emerging technologies. In this article, we examine a type of slippery slope argument against using gene drives to alter or suppress wild pest populations and consider whether it has a role to play in ethical and policy debates. Although we conclude that this argument does not provide compelling reasons for banning the use of gene drives in wild pest populations, we believe that it still has value as a morally instructive cautionary narrative that can motivate scientists, ethicists, and members of the public to think more clearly about appropriate vs. inappropriate uses of gene drive technologies, the long-term and cumulative and emergent risks of using gene drives in wild populations, and steps that can be taken to manage these risks, such as protecting wilderness areas where people can enjoy life forms that have not been genetically engineered.
Gene editing and agrifood systems
24291FAO, FAO, 2022-12-20 09:22:56.
Gene-editing technologies represent a promising new tool for plant and animal breeding in low- and middle-income countries. They enhance precision and efficiency over current breeding methods and could lead to rapid development of improved plant varieties and animal breeds. However, as for any new technology, they have their merits and demerits. There is, as yet, no international consensus regarding if and how gene-edited organisms should be regulated, and whether their release would fall under the regulatory framework of the Cartagena Protocol on Biosafety to the Convention on Biological Diversity. This science- and evidence-based Issue Paper on gene editing and agrifood systems presents a balanced discussion of the most pertinent aspects of gene editing, including the consequences for human hunger, human health, food safety, effects on the environment, animal welfare, socioeconomic impact and distribution of benefits. Intrinsic ethical concerns and issues of governance and regulation are addressed, and the roles of the public and private sectors, alone and in partnership, are summarized. Various scenarios are also presented for how gene editing might be used in the future to help transform agrifood systems.
Exploring the value of a global gene drive project registry
24279R. I. Taitingfong, C. Triplett, V. N. Vásquez, R. M. Rajagopalan, R. Raban, A. Roberts, G. Terradas, B. Baumgartner, C. Emerson, F. Gould, F. Okumu, C. E. Schairer, H. C. Bossin, L. Buchman, K. J. Campbell, A. Clark, J. Delborne, K. Esvelt, J. Fisher, R., Nature Biotechnology, 2022-12-15 14:15:40.
Recent calls to establish a global project registry before releasing any gene-drive-modified organisms (GDOs) have suggested a registry could be valuable to coordinate research, collect data to monitor and evaluate potential ecological impacts, and facilitate transparent communication with community stakeholders and the general public. Here, we report the results of a multidisciplinary expert workshop on GDO registries convened on 8–9 December 2020 involving 70 participants from 14 countries. Participants had expertise in gene drive design, conservation and population modeling, social science, stakeholder engagement, governance and regulation, international policy, and vector control; they represented 45 organizations, spanning national and local governmental agencies, international organizations, nonprofit organizations, universities, and district offices overseeing local vector control. The workshop aimed to gather perspectives on a central question: “In what ways could a gene-drive project registry both contribute to and detract from the fair development, testing and use of GDOs?” We specifically queried the perceived purpose of a registry, the information that would need to be included, and the perceived value of a registry. Three primary findings emerged from the discussion: first, many participants agreed a registry could serve a coordinating function for multidisciplinary and multisector work activities; second, doing so may require different design elements, depending on the target end-user group and intended purpose for that group; and third, these different information requirements lead to concerns about information sharing via a registry, suggesting potential obstacles to achieving transparency through such a mechanism. We conclude that any development of a gene-drive project registry requires careful and inclusive deliberation, including with potential end-users, to ensure that registry design is optimal.
Experts urge caution over biotech that can wipe out insect pests
24153L. Fauvel, Phys Org, 2022-12-09 07:09:45.
Dozens of scientists, experts and campaigners called for a ban on the release of genetically-edited organisms into the wild, in a statement Friday warning of potentially severe risks to the world's pollinators. The appeal was launched at crunch biodiversity talks in Montreal, where delegates from almost all the world's countries were meeting to negotiate a strategy to halt human environmental destruction, which threatens the natural life support systems of the planet. A host of new genome-editing tools that modify the genetic material of living beings have emerged in recent years, and are being researched and developed largely to target insects and plants in agriculture. Supporters argue that they could help human health, agriculture and even species conservation. But their use in the wild carries "understudied risks which could accelerate the decline of pollinator populations and put entire food webs at risk," according to the letter drafted by the French non-governmental organization Pollinis.
Bioinformatic and literature assessment of toxicity and allergenicity of a CRISPR-Cas9 engineered gene drive to control the human malaria mosquito vector Anopheles gambiae
24161A. Qureshi and J. B. Connolly, Malaria Journal, 2022-12-06 07:52:06.
Population suppression gene drive is currently being evaluated, including via environmental risk assessment (ERA), for malaria vector control. One such gene drive involves the dsxFCRISPRh transgene encoding (i) hCas9 endonuclease, (i) T1 guide RNA (gRNA) targeting the doublesex locus, and (iii) DsRed fluorescent marker protein, in genetically modified mosquitoes (GMMs). Problem formulation, the first stage of ERA, for environmental releases of dsxFCRISPRh previously identified nine potential harms to the environment or health that could occur, should expressed products of the transgene cause allergenicity or toxicity. Amino acid sequences of hCas9 and DsRed were interrogated against those of toxins or allergens from NCBI, UniProt, COMPARE and AllergenOnline bioinformatic databases and the gRNA was compared with microRNAs from the miRBase database for potential impacts on gene expression associated with toxicity or allergenicity. PubMed was also searched for any evidence of toxicity or allergenicity of Cas9 or DsRed, or of the donor organisms from which these products were originally derive While Cas9 nuclease activity can be toxic to some cell types in vitro and hCas9 was found to share homology with the prokaryotic toxin VapC, there was no evidence of a risk of toxicity to humans and other animals from hCas9. Although hCas9 did contain an 8-mer epitope found in the latex allergen Hev b 9, the full amino acid sequence of hCas9 was not homologous to any known allergens. Combined with a lack of evidence in the literature of Cas9 allergenicity, this indicated negligible risk to humans of allergenicity from hCas9. No matches were found between the gRNA and microRNAs from either Anopheles or humans. Moreover, potential exposure to dsxFCRISPRh transgenic proteins from environmental releases was assessed as negligible.Bioinformatic and literature assessments found no convincing evidence to suggest that transgenic products expressed from dsxFCRISPRh were allergens or toxins, indicating that environmental releases of this population suppression gene drive for malaria vector control should not result in any increased allergenicity or toxicity in humans or animals. These results should also inform evaluations of other GMMs being developed for vector control and in vivo clinical applications of CRISPR-Cas9.
No Environmental Release of Gene Drive Organisms
24114Anonymous, STOP GENE DRIVES, 2022-11-30 09:32:55.
We urge governments to prevent the environmental release of gene drive organisms and to establish a global moratorium on the release of gene drive organisms at the UN Convention on Biological Diversity (CBD). Gene drives work against natural rules of inheritance forcing nearly 100% instead of the usual 50% of offspring to inherit their genetically engineered traits. Whereas existing biosafety systems are designed to limit the spread and persistence of living modified organisms to mitigate against adverse impacts, gene drives are intended to spread genetic modifications to alter species and ecosystems. This would undermine the integrity of the UN Cartagena Protocol and international and national biosafety systems, including the procedures for Advanced Informed Agreement (AIA) of countries and Free, Prior and Informed consent (FPIC) of Indigenous Peoples and local communities.
GMOs in Africa: Status, adoption and public acceptance
27490L. A. Gbadegesin, E. A. Ayeni, C. K. Tettey, V. A. Uyanga, O. O. Aluko, J. K. Ahiakpa, C. O. Okoye, J. I. Mbadianya, M. A. Adekoya, R. O. Aminu, F. P. Oyawole and P. Odufuwa, Food Control, 141:109193. 2022-11-01 13:46:04.
Globally, genetically modified (GM) crops contribute to food security by increasing crop yield, quality and shelf-life. The commercialisation and adoption of GM crops in many developed countries raised hope of improving food security and livelihood. Africa, a developing continent facing malnutrition, food crises and inadequate food production technologies has been slow to accept GM crops. The hesitancy to accept GM crops emanates from unfavourable policies shaped by public opinion, despite its potential for achieving the zero-hunger agenda. Impeding factors hampering the adoption of GM technology necessitate biosecurity regulations on GM crops to monitor the crop biosafety, environmental and health concerns. Herein, we reviewed GM crops status and adoption in Africa and possible constraints to their acceptance amidst some commercialised GM crops in African countries. Efforts aimed at improving GM adoption in Africa should include the provision of adequate monitoring and surveillance system, science-based policies, political will and a robust public education on GM technology.
Hurdles in responsive community engagement for the development of environmental biotechnologies
25089A. M. Normandin, L. M. Fitzgerald, J. Yip and S. W. Evans, Synthetic Biology, 7:ysac022. 2022-10-20 06:56:55.
Recent calls for engaging communities in biotechnology development do not draw enough attention to the hurdles that must be overcome for engagement strategies to effectively feed back into research design and conduct. These hurdles call into question many standard ways of operating and assessing in traditional scientific disciplines. The first steps in addressing these hurdles can be the most difficult. In reflecting on our own experiences in the early-stage development of environmental biotechnologies, we provide a set of techniques to help scientists and their collaborators learn to become more responsive to the needs and attitudes of communities with which they are engaging.Graphical Abstract
GeneConvene Global Collaborative | Laboratory Containment of Arthropods Capable of Gene Drive: Best Practices and Recommendations
23739Hector Quemada, GeneConvene Global Collaborative, 2022-10-13 14:19:28.
This webinar is presented by members of the American Society of Tropical Medicine and Hygiene's American Committee of Medical Entomologists who were involved in drafting a recent Addendum to the ASTMH's Arthropod Containment Guidelines that specifically consider arthropods with gene drive systems. https://www.liebertpub.com/doi/10.1089/vbz.2021.0035
Risk Assessment on the Release of Wolbachia-Infected Aedes aegypti in Yogyakarta, Indonesia
23707D. Buchori, A. Mawan, I. Nurhayati, A. Aryati, H. Kusnanto and U. K. Hadi, Insects, 13. 2022-10-12 08:16:52.
Wolbachia-infected Aedes aegypti is the latest technology that was developed to eliminate dengue fever. The Ministry of Research and Technology of the Republic of Indonesia (Kemenristekdikti) established an expert group to identify future potential risks that may occur over a period of 30 years associated with the release of Wolbachia-infected Ae. aegypti. The risk assessment consisted of identifying different hazards that may have impacts on humans and the environment. From the consensus among the experts, there were 56 hazards identified and categorized into 4 components, namely, ecological matters, efficacy in mosquito management, economic and sociocultural issues, and public health standards. There were 19 hazards in the ecological group. The overall likelihood in the ecology of the mosquito is very low (0.05), with moderate consequence (0.74), which resulted in negligible risk. For the efficacy in mosquito management group, there were 12 hazards that resulted in very low likelihood (0.11) with high consequence (0.85). The overall risk for mosquito management efficacy was very low (0.09). There were 14 hazards identified in the public health standard with very low likelihood (0.07), moderate consequence (0.50) and negligible risk (0.04). Lastly, 13 hazards were identified in the economic and sociocultural group with low likelihood (0.01) but of moderate consequence (0.5), which resulted in a very low risk (0.09). The risk severity level of the four components leading to the endpoint risk of “cause more harm” due to releasing Wolbachia-infected Ae. aegypti is negligible (0.01).
Points to consider in seeking biosafety approval for research, testing, and environmental release of experimental genetically modified biocontrol products during research and development
23648W. K. Tonui, V. Ahuja, C. J. Beech, J. B. Connolly, B. Dass, D. C. M. Glandorf, et al., Transgenic Research, 31:607. 2022-10-04 08:24:50.
Novel genetically modified biological control products (referred to as “GM biocontrol products”) are being considered to address a range of complex problems in public health, conservation, and agriculture, including preventing the transmission of vector-borne parasitic and viral diseases as well as the spread of invasive plant and animal species. These interventions involve release of genetically modified organisms (GMOs) into the environment, sometimes with intentional dissemination of the modification within the local population of the targeted species, which presents new challenges and opportunities for regulatory review and decision-making. Practices developed for GMOs, primarily applied to date for GM crops may need to be adapted to accommodate different types of organisms, such as insects, and different technologies, such as gene drive. Developers of new GM biocontrol products would benefit from an early understanding of safety data and information that are likely to be required within the regulatory dossier for regulatory evaluation and decision making. Here a generalizable tool drawing from existing GM crop dossier requirements, forms, and relevant experience is proposed to assist researchers and developers organize and plan their research and trialing. This tool requires considering specifics of each investigational product, their intended use, and country specific requirements at various phases of potential product development, from laboratory research through contained field testing and experimental release into the environment. This may also be helpful to risk assessors and regulators in supporting their systematic and rigorous evaluation of new biocontrol products.
Justifying an Intentional Species Extinction: The Case of Anopheles gambiae
23662D. E. Callies and Y. Rohwer, Environmental Values, 31:193-210. 2022-10-01 06:16:34.
Each year, over 200 million people are infected with the malaria parasite, nearly half a million of whom succumb to the disease. Emerging genetic technologies could, in theory, eliminate the burden of malaria throughout the world by intentionally eradicating the mosquitoes that transmit the disease. In this paper, we offer an ethical examination of the intentional eradication of Anopheles gambiae, the main malaria vector of sub-Saharan Africa. In our evaluation, we focus on two main considerations: the benefit of alleviating the malaria burden, and the loss of value that would accompany the eradication of the species. We outline a typology of the different ways in which species are valued or could be valuable, then use that typology to appraise the value of the species in question. We argue that Anopheles gambiae has minor (and redundant) instrumental value, little final subjective value and no objective final value.
Toward product-based regulation of crops
23498F. Gould, R. M. Amasino, D. Brossard, C. R. Buell, R. A. Dixon, J. B. Falck-Zepeda, M. A. Gallo, K. E. Giller, L. L. Glenna, T. Griffin, D. Magraw, C. Mallory-Smith, K. V. Pixley, E. P. Ransom, D. M. Stelly and C. N. Stewart, Science, 377:1051-1053. 2022-09-02 19:04:01.
Current process-based approaches to regulation are no longer fit for purpose Much effort has been expended globally over the past four decades to craft and update country-specific and multinational safety regulations that can be applied to crops developed by genetic engineering processes, while exempting conventionally bred crops. This differentiation made some sense in the 1980s, but in light of technological advances, it is no longer scientifically defensible. In the coming decades, innovations in genetic engineering and modern ?conventional? processes of crop development will enable use of these approaches to alter more crops and more traits. Future governance of new plant varieties and foods, regardless of the processes and techniques used to develop them, will require new, scientifically sound assessment methodologies, developed in a manner acceptable to society. Here, we provide a rationale for one governance approach that moves away from current process-based regulation and uses newly developed molecular techniques that enable detailed characterization of the new crops and foods themselves.
Call for public consultation ̶ Development of Target Product Profiles (TPPs) for Wolbachia infected Aedes aegypti population replacement intervention
23511World Health Organization, WHO, 2022-08-31 19:42:27.
WHO aims to reduce the global burden of dengue by 25% by 2030. To reach this goal, it is imperative to provide control programmes with sustainable vector control tools. Wolbachia, a symbiotic bacterium that occurs naturally in many insects, has been successfully transferred into the Aedes aegypti mosquito and has been found to reduce the transmission of the dengue virus. Some studies have also shown that this intervention could be sustained for more extended periods. The WHO Vector Control Advisory Group has assessed this intervention and confirmed its public health value for dengue control. WHO has identified a need to develop the Target Product Profiles (TPPs) of current and emerging vector control products to support their optimization. Consequently, a Technical Advisory Group (TAG) was established by WHO to define optimal and minimally acceptable characteristics for developing the TPPs. The TAG is being supported by the WHO secretariat.
ISAAA Policy Brief: Risk Assessment for Gene Drive Organisms
23562Anonymous, ISAAA, 2022-08-31 14:52:33.
Gene drive is a genetic phenomenon that occurs in nature and causes a selected trait to spread rapidly through a species via sexual reproduction over generations, potentially becoming increasingly common within a specific species. Gene drive systems are being developed in the laboratory to replicate this natural phenomenon in order to help tackle major challenges such as malaria. In this way, a desired change is passed on to up to 100% of offspring, rather than at the more usual rate of 50%. This technology is currently under research, and the risks and benefits of each potential application are being thoroughly investigated.
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