Keywords: Genetically modified organisms
Regulatory Provisions for Post-Release Monitoring of Genetically Modified Organisms in Africa
35497Julia Njagi, John Muriuki, Paul Mbugua, et al., Frontiers in Bioengineering and Biotechnology, 2026-03-10 09:22:44.
Genetically modified (GM) crops with improved traits such as resistance to biotic and abiotic stresses and enhanced nutritional profiles have been commercially cultivated for over three decades. Despite extensive safety data and long-term cultivation experience, concerns continue to be raised about the potential risks and benefits of genetically modified organisms (GMOs). This is particularly true for the African region, where only eight out of fifty-four countries have so far commercialized GMOs. Upon release into the environment, GM crops may interact with ecosystems in complex ways, possibly leading to unanticipated ecological effects. Consequently, post-release monitoring of GMOs is essential to identify early signs of adverse impacts, enabling timely responses such as adjustments in risk management strategies, mitigation measures, or re-evaluation of previous regulatory decisions. A supportive policy and regulatory environment are critical for facilitating the safe development, testing, and commercialization of GMOs. This study conducted a desktop review of post-release monitoring frameworks for GMOs in selected African countries, as well as interviews with key informants in countries that have commercialized at least one GMO product. The findings reveal that most sampled countries lack clearly defined environmental protection goals and specific provisions regarding the scope and duration of post-release monitoring of GMOs. Where the duration of monitoring is prescribed, it is a blanket cover for all GMOs regardless of their life cycles. Moreover, the responsibility for monitoring is often delegated entirely to the applicant, and where local institutions are involved, there is no clear coordination mechanism for data sharing. These findings underscore the need for case-by-case monitoring approaches, guided by clearly articulated national protection goals and clear roles and coordination among stakeholders to ensure the safe and responsible deployment of GMOs.
CRISPR/Cas9-germline editing of Biomphalaria glabrata: A breakthrough in genetic modification of snails that transmit schistosomiasis
35226Kouhei Oonuma et al., Science Advances, 11. 2025-10-09 10:03:53.
Human schistosomiasis remains one of the most devastating parasitic diseases worldwide, and the development of genetically modified vector snails has long been a goal in the field. Here, we report the successful creation of genetically modified Biomphalaria glabrata, an important intermediate host, using CRISPR/Cas9 gene editing. We targeted the fibrinogen-related protein 3.1 (FREP3.1) gene, confirmed stable germline transmission of the mutated gene, and established two different homozygous FREP3.1-edited lines. Disruption of the FREP 3.1 gene did not alter snail susceptibility to Schistosoma mansoni infection, possibly due to a limited role of FREP3.1 in resistance or to functional redundancy and/or compensatory expression within the highly diverse FREP gene family. Our study demonstrates successful germline editing, effective ex ovo culture of decapsulated embryos, and the generation of viable, genetically modified B. glabrata snails, thereby establishing a foundation for future genetic strategies to control schistosomiasis.
Making sex deadly for insects could control pests that carry disease and harm crops
34559Bill Sullivan, The Conversation, 2025-03-04 17:08:29.
Insects do a lot more harm than ruining picnics. Some insects spread devastating diseases, while others cause staggering economic losses in agriculture. To control some of these pests, scientists are developing males that make sex a deadly event. The stakes are high. Mosquitoes carry viruses such as dengue, West Nile and Zika, as well as parasites that cause malaria. Researchers estimate that mosquitoes have caused the deaths of 52 billion people overall – nearly half of all the humans that have ever lived. Other insects cause major crop damage, jeopardizing the food supply and driving up prices. According to the Food and Agriculture Organization of the United Nations, 20% to 40% of global crop production is lost to pests annually at a cost of US$70 billion. Pesticides have been the front-line defense against insects, but many bugs have evolved resistance to these chemicals. Some pesticides can indiscriminately kill beneficial insects, harm the environment and endanger human and animal health. Some researchers worry that certain pesticides can cause cancer or have damaging effects on human nervous and endocrine systems. I’m a microbiology researcher studying infectious disease. New solutions that do not harm humans and the environment to control disease-carrying insects and agricultural pests could lead to fewer people contracting dangerous diseases. In the past few years, a variety of genetic engineering approaches have emerged as promising tactics to combat problematic insects.
Should We Unleash GMO Mosquitoes?
34051Brooke Borel and Anna Rothschild, Entanglements, 2024-12-16 14:26:29.
In this episode of Entanglements, hosts Brooke Borel and Anna Rothschild discuss the ethics and risks of genetically modified (GMO) mosquitoes. They explore differing expert opinions, focusing on technologies like gene drives and sterile males, examining ecological and safety concerns while debating whether releasing GMO insects is ultimately beneficial.
Most advanced gene drive projects
33625Gene Drive Monitor, 2024-11-12 17:33:29.
This infographic shows the species in which a gene drive has actually been built and is at least partially functional, up to 1 March 2024. Note that gene drives have been proposed in many more species, as shown our taxonomic list of targets here. Along with gene drives it includes sex ratio distorters, a similar genetic technology that also aims to suppress or eliminate populations.
Wolbachia-based emerging strategies for control of vector-transmitted disease
32708Diego Montenegro, Gerardo Cortés-Cortés, María Guadalupe Balbuena-Alonso, et al., Acta Tropica, 260. 2024-10-22 17:28:54.
Dengue fever is a mosquito-transmitted disease of great public health importance. Dengue lacks adequate vaccine protection and insecticide-based methods of mosquito control are proving increasingly ineffective. Here we review the emerging use of mosquitoes transinfected with the obligate intracellular bacterium Wolbachia pipientis for vector control. Wolbachia often induces cytoplasmic incompatibility in its mosquito hosts, resulting in infertile progeny between an infected male and an uninfected female. Wolbachia infection also suppresses the replication of pathogens in the mosquito, a process known as “pathogen blocking”. Two strategies have emerged. The first one releases Wolbachia carriers (both male and female) to replace the wild mosquito population, a process driven by cytoplasmic incompatibility and that becomes irreversible once a threshold is reached. This suppresses disease transmission mainly by pathogen blocking and frequently requires a single intervention. The second strategy floods the field population with an exclusively male population of Wolbachia-carrying mosquitoes to generate infertile hybrid progeny. In this case, transmission suppression depends largely on decreasing the population density of mosquitoes driven by infertility and requires continued mosquito release. The efficacy of both Wolbachia-based approaches has been conclusively demonstrated by randomized and non-randomized studies of deployments across the world. However, results conducted in one setting cannot be directly or easily extrapolated to other settings because dengue incidence is highly affected by the conditions into which the mosquitoes are released. Compared to traditional vector control methods, Wolbachia-based approaches are much more environmentally friendly and can be effective in the medium/long term. On the flip side, they are much more complex and cost-intensive operations, requiring a substantial investment, infrastructure, trained personnel, coordination between agencies, and community engagement. Finally, we discuss recent evidence suggesting that the release of Wolbachia-transinfected mosquitoes has a moderate potential risk of spreading potentially dangerous genes in the environment.
Loss-of-function in testis-specific serine/threonine protein kinase triggers male infertility in an invasive moth
32506Wei, Z., Wang, Y., Zheng, K. et al., Communications Biology, 7. 2024-10-08 09:10:05.
Genetic biocontrol technologies present promising and eco-friendly strategies for the management of pest and insect-transmitted diseases. Although considerable advancements achieve in gene drive applications targeting mosquitoes, endeavors to combat agricultural pests have been somewhat restricted. Here, we identify that the testis-specific serine/threonine kinases (TSSKs) family is uniquely expressed in the testes of Cydia pomonella, a prominent global invasive species. We further generated male moths with disrupted the expression of TSSKs and those with TSSKs disrupted using RNA interference and CRISPR/Cas9 genetic editing techniques, resulting in significant disruptions in spermiogenesis, decreased sperm motility, and hindered development of eggs. Further explorations into the underlying post-transcriptional regulatory mechanisms reveales the involvement of lnc117962 as a competing endogenous RNA (ceRNA) for miR-3960, thereby regulating TSSKs. Notably, orchard trials demonstrates that the release of male strains can effectively suppress population growth. Our findings indicate that targeting TSSKs could serve as a feasible avenue for managing C. pomonella populations, offering significant insights and potential strategies for controlling invasive pests through genetic sterile insect technique (gSIT) technology.
Opinion: A cautionary tale of experimenting with genetically modified mosquitoes in Uganda
28900Barbara Ntambirweki, The Independent, 2024-02-20 14:44:38.
The Uganda Virus Research Institute is pressing forward with gene drive technology which provides a way to rapidly, permanently, and genetically modify wild animals or plants. Gene drive organisms, are a genetically modified organism (GMO) designed to spread a genetic modification through entire populations of wild or farmed species, and are promoted as a ‘solution’ to pressing problems in the fields of public health, ecology and agriculture. The capacity of gene drives to spread and persist in the environment presents novel biosafety and socio-economic concerns for both people and biodiversity. Several research projects in Africa are advancing in their experiments to develop genetically modified ‘gene drive’ mosquitoes to release into the environment as a public health intervention to combat malaria and some are already releasing GMO mosquitoes similar to those touted by Oxitec. In Africa, Burkina Faso, Ghana, Tanzania and Uganda have allowed experimentation towards gene drive in their countries where some of these are under the auspices of Target Malaria – a consortium of research institutions led by laboratories based at Imperial College in the United Kingdom funded by Bill and Melinda Gates Foundation. In Uganda, Target Malaria has entered in partnership with the Uganda Virus Research Institute and has commenced entomological mosquito collections from field sites around Kalangala and Mukono Districts.
Next-generation genetic sexing strain establishment in the agricultural pest Ceratitis capitata
27972S. Davydova, J. Liu, N. Kandul, P., W. E. Braswell, O. Akbari, S. and A. Meccariello, bioRxiv, 2023.09.29.560088. 2023-10-01 07:32:11.
Tephritid fruit fly pests pose an increasing threat to the agricultural industry due to their global dispersion and a highly invasive nature. Here we showcase the feasibility of an early-detection SEPARATOR sex sorting approach through using the non-model Tephritid pest, Ceratitis capitata. This system relies on female-only fluorescent marker expression, accomplished through the use of a sex-specific intron of the highly-conserved transformer gene from C. capitata and Anastrepha ludens. The herein characterized strains have 100% desired phenotype outcomes, allowing accurate male-female separation during early development. Overall, we describe an antibiotic and temperature-independent sex-sorting system in C. capitata, which, moving forward, may be implemented in other non-model Tephritid pest species. This strategy can facilitate the establishment of genetic sexing systems with endogenous elements exclusively, which, on a wider scale, can improve pest population control strategies like sterile insect technique.Competing Interest StatementO.S.A is a founder of Agragene, Inc. and Synvect, Inc. with equity interest. N.P.K is a founder of Synvect, Inc. with equity interest. The terms of this arrangement have been reviewed and approved by the University of California, San Diego in accordance with its conflict-of-interest policies. All other authors declare no competing interests
Transgenic approaches in medical entomology: 2022 highlights
27751M. L. Simões, Journal of Medical Entomology, tjad105. 2023-09-02 07:40:51.
Transgenesis has emerged as a powerful tool to control arthropod vectors and the diseases they transmit. Here, we highlight the latest developments on transgenic approaches in ticks, Anopheles and Aedes mosquitoes, based on recent findings and significant papers from 2022. We survey topics ranging from population replacement, population suppression, gene drive, sex ratio distortion, public engagement and capacity building, and gene editing in ticks. While presenting these advancements, we discuss the current challenges surrounding the application of arthropod transgenesis for the development of novel vector control strategies.
Baker: New tools can change mosquitoes’ DNA, but should it be done?
27597K. Baker, Fremont News Messenger, 2023-08-09 06:54:53.
Suppose Sauron — or perhaps Gandalf — were to offer you a magical golden ring with the power to rid the world of mosquitoes once and for all. And with their demise, to save countless human lives from the many diseases for which mosquitoes are the sole or primary vectors: Malaria, dengue, West Nile virus, chikungunya, yellow fever, filariasis, tularemia, encephalitis, Zika fever, Keystone Virus, Rift Valley Fever…And not just mosquitoes. From within the folds of his cloak the wizard draws out an array of equally luminous rings with the power to cure genetic disorders like cystic fibrosis, hemophilia, and Down’s syndrome, to rid cities of mice and rats, and free the world’s farms of weeds and insect pests without the use of pesticides. Would you take them? Those rings exist and are now being refined and tested in the Elvin forges of academic, commercial, and government research facilities around the world. They go by various names, but collectively may be referred to as CRISPR-Cas Genome Editing Systems.
Scientists are Gene-Editing Flies to Fight Crop Damage
26310E. Mullin, WIRED, 2023-06-28 07:28:35.
In greenhouses in Oregon last month, researchers with the US Department of Agriculture began testing one such approach: sterilized male flies. The gene-edited bugs, made by St. Louis–based biotech company Agragene, are meant to suppress wild fly populations. The idea is that if they were to be released into the environment, the sterilized males would mate with wild females, resulting in a fertility dead end. “We see this technology as being able to provide healthier fruit and vegetables without doing a lot of harm to the environment,” says Agragene CEO Bryan Witherbee. Scientists at the company used the DNA editing tool Crispr to knock out two essential genes in fly embryos—one involved in male reproduction and another with female development. As a result, only sterile males hatch while the females die. “You don’t want to release females into the population, because those are the ones that are doing the damage,” says Stephanie Gamez, director of research and development at Agragene.
Explained | The problem with India’s new guidelines on genetically modified insects
26274S. Naik, The Hindu, 2023-06-27 10:35:38.
India’s bioeconomy contributes 2.6% to the GDP. In April 2023, the Department of Biotechnology (DBT) released its ‘Bioeconomy Report 2022’ report, envisioning this contribution to be closer to 5% by 2030. This ambitious leap – of $220 billion in eight years – will require aggressive investment and policy support. But neither funding for the DBT, India’s primary promoter of biotechnology, nor its recent policies reflect any serious intention to uplift this sector. Along with more money, policies that enable risk-taking appetite within Indian scientists will be required to create an ecosystem of innovation and industrial action. Funding for biotechnology India has been stagnating for a while. Despite a slight uptick during COVID-19, when DBT led the vaccine and diagnostics efforts, funding hasn’t returned to the pre-pandemic level. The current allocation is also only 0.0001% of India’s GDP, and it needs to be significantly revised if biotechnology is to be of any serious consequence for the economy.Funding aside, biotechnology policies also need to be aligned to the economic goals set out in the Bioeconomy report. However, the language in a set of guidelines that the Indian government released recently, pertaining to genetically edited insects, indicate a problem. In April 2023, the Department of Biotechnology (DBT) issued the ‘Guidelines for Genetically Engineered (GE) Insects’. They provide procedural roadmaps for those interested in creating GE insects. They have three issues, however.
CRISPR-based gene editing of non-homologous end joining factors biases DNA repair pathway choice toward single-strand annealing in Aedes aegypti
25461K. Chae, J. M. Overcash, C. Dawson, C. Valentin, H. Tsujimoto, K. M. Myles and Z. N. Adelman, Current Research in Biotechnology, 5:100133. 2023-05-29 08:04:22.
To maintain genome stability, eukaryotic cells orchestrate DNA repair pathways to process DNA double-strand breaks (DSBs) that result from diverse developmental or environmental stimuli. Bias in the selection of DSB repair pathways, either non-homologous end joining (NHEJ) or homology-directed repair (HDR), is also critical for efficient gene editing and for homing-based gene drive approaches developed for the control of disease-transmitting vector mosquitoes. However, little is understood about DNA repair homeostasis in the mosquito genome. Here, we utilized CRISPR/Cas9 to generate indel mutant strains for core NHEJ factors ku80, DNA ligase IV (lig4), and DNA-PKcs in the mosquito Aedes aegypti and evaluated the corresponding effects on DNA repair. In a plasmid-based assay, disruption of ku80 or lig4, but not DNA-PKcs, reduced both NHEJ and SSA. However, a transgenic reporter strain-based test revealed that those mutations significantly biased DNA repair events toward SSA. Interestingly, ku80 mutation also significantly increased the end joining rate by a yet-characterized mechanism in males. Our study provides evidence that the core NHEJ factors have an antagonistic effect on SSA-based DSB repair of the Ae. aegypti genome. Down-modulating the NHEJ pathway can enhance the efficiency of nuclease-based genetic control approaches, as most of those operate by homology-based repair processes along with extensive DNA end resection that is antagonized by NHEJ.
Render pests harmless – through genetic engineering CRISPR
25160Anonymous, Breaking Latest News, 2023-05-21 08:29:03.
Whether ants or wild bees: It is undisputed that insects are indispensable for functioning ecosystems and thus for the survival of mankind. In agriculture, however, certain species can become a nuisance. Even insecticides do not always help and also harm the environment. Researchers and companies are now pursuing a new strategy: Instead of treating plants, they want to defuse the harmful insects with the help of CRISPR gene scissors. “Before CRISPR/Cas, the technology to manipulate pests simply didn’t exist,” says Peter Atkinson, an entomologist at the University of California, Riverside, who works on modifying the invasive cicada species. “We are now entering a new era in which genetic control of the problem seems quite realistic.” It would not only be an alternative to the use of insecticides, but also a strategy to strengthen crop defenses through genetic engineering.
Editorial: Genetic control of insect pest species—achievements, challenges, and perspectives
25423I. Häcker, D. Bartsch, A. Choo and F. Marec, Frontiers in Bioengineering and Biotechnology, 11. 2023-05-05 08:12:07.
Genetic control is a type ofbiological control and a promising approach to regulate insect pest populations in a species-specific manner. It is based on targeting the reproductive capacity of the target pest species to reduce population size to non-critical levels. The best known and also very successful genetic control strategy is the Sterile Insect Technique (SIT), which entails the continuous mass-release ofirradiation-sterilized males ofa given species to produce infertile matings in the field, leading to the decline in the target population over time. To date, SIT is only available for a few species, as its transfer to new target species is challenging and time consuming. Key aspects of this classical SIT and challenges in applying it to new pest species include mass rearing of target species, mass removal of female insects prior to irradiation and release, the sterilization procedure, and the biological quality control of the sterile insects produced. Besides this classical SIT strategy, current research efforts are also focused on the development of genetic control approaches based on transgenic, symbiont-mediated, or gene-drive strategies. Modern genetic technologies offer new solutions for the improvement of existing genetic control strategies and insect strains, for faster and easier transfer of existing strategies to new target species, and also for the development of new genetic control approaches. Publications within this Research Topic address pressing questions and challenges related to the genetic control of insect pests.
White-Eyed Fruit Flies: How Improvements in Gene Editing Could Aid in Pest Managemen
24752C. Bernhardt, Entomology Today, 2023-02-17 19:07:21.
The SIT involves scientists raising the target fruit fly species in the lab, sterilizing the flies by exposing them to a certain amount of radiation while they are still pupae, and releasing large amounts of the newly sterile flies into nature. When the released, sterile flies mate with wild flies, they produce infertile eggs that never hatch and, over time, this reduces—and hopefully eliminates—the population of flies. “But research shows that if you only release sterile males—instead of sterile males and females at the same time—you can more efficiently accomplish management,” says Daniel Paulo, PhD, a researcher in the Department of Plant and Environmental Protection Sciences at the University of Hawaiʻi at Mānoa. Male flies mate more often than females and don’t damage fruits in the field because they don’t lay eggs. Male-focused SIT programs also guarantee sterile males are using their energy to mate with wild-type females, not with females who were also sterilized. So, scientists target male flies with sterilization efforts by using a classic genetic method called genetic sexing, which helps create sex-specific, visible physical characteristics or markers (called phenotypes) among fruit flies. These phenotypes make it possible for scientists to tell the two sexes apart more easily and parse the males and females before sterilizing. A colony of such flies is called genetic sexing strain (GSS). A GSS requires a phenotype scientists can create by inducing a genetic change, called a mutation, that leads to a visible characteristic. Next, they link the normal, non-mutated visual marker to the male sex.
Evaluating the mating competency of genetically modified male mosquitoes in laboratory conditions
28160B. Contreras, Z. N. Adelman and K. Chae, Frontiers in Tropical Diseases, 4. 2023-02-13 12:01:23.
Efforts to eradicate mosquito-borne diseases have increased the demand for genetic control strategies, many of which involve the release of genetically modified (GM) mosquito males into natural populations. The first hurdle for GM males is to compete with their wild-type counterparts for access to females. Here, we introduce an eye color-based mating assay, in which both Lvp wild-type and kynurenine 3-monooxygenase (kmo)-null males compete for access to kmo-null females, and therefore the eye color phenotype (black or white) of the progeny is dependent on the parental mating pair. A series of tests addressed that male mating competitiveness between the two strains can significantly be influenced by adult density, light intensity, and mating duration. Interestingly, the mating competitiveness of males was not correlated with body size, which was negatively influenced by a high larval density. Lastly, this eye color-associated assay was applied to characterize GM mosquitoes in their mating competitiveness, establishing this method as a fast and precise way of benchmarking this fitness parameter for laboratory-raised males.
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.
Zombie Deer and the Scientists Behind the War on the ‘Man Eater’
24023S. Jones, NC STATE CALS News, 2022-10-24 09:52:07.
In the remote jungles of the Panama-Colombia border, sterile flesh-eating flies fall from the sky in the thousands. Released from retired military planes, they embark on a suicide mission for their species, with the sole purpose of duping their female counterparts into mating with them despite their inability to bear offspring. Before this military-like operation became the norm, the New World Screwworm (Cochliomyia hominivorax or “man-eater”) cost livestock producers millions of dollars every year as a merciless parasite. Without scientific intervention, the screwworm’s life cycle weaves a devastating tale fit for classic horror films of a bygone era. After a successful rendezvous with a male screwworm, the female screwworm spends her time drinking the sweet nectar of the forest. When she’s ready to lay her eggs, she emerges from the forest and into nearby farms and pastures on the hunt for a suitable host. Then she spots it: a blissfully grazing cow who just so happens to have a scratch on its head. She lands in the wound, lays her eggs and waits for another generation of screwworms to do its worst, which doesn’t take long. This devilish pest has completely adapted to a parasitic lifestyle, with its eggs developing in a matter of hours at the precise body temperature of a poor unsuspecting cow. “They develop at 40 degrees Celsius, which is really hot for most insects. Most flies won’t develop well at that temperature. These do, and they’re very quick,” says Max Scott, Professor of Entomology at North Carolina State University’s Department of Entomology and Plant Pathology.
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.
Researchers propose new framework for regulating engineered crops
23506North Carolina State University, Phys Org, 2022-09-01 19:29:56.
A Policy Forum article published today in Science calls for a new approach to regulating genetically engineered (GE) crops, arguing that current approaches for triggering safety testing vary dramatically among countries and generally lack scientific merit—particularly as advances in crop breeding have blurred the lines between conventional breeding and genetic engineering. Rather than focusing on the methods and processes behind the creation of a GE crop to determine if testing is needed, a more effective framework would examine the specific new characteristics of the crop itself by using so-called "-omics" approaches, the article asserts. In the same way that biomedical sciences can use genomic approaches to scan human genomes for problematic mutations, genomics can be used to scan new crop varieties for unexpected DNA changes.
Genetically Modified Mosquitoes to Fight Malaria in Nigeria, Burkina Faso, Mali and Uganda: What Legal Response?
23275O. J. L. Tung, Potchefstroom Electronic Law Journal, 25:1-42. 2022-06-07 10:05:47.
Advanced applied research on genetically modified (hereafter GM) insects is being undertaken to control insect vectors of human diseases such as mosquitoes. GM insect technologies are being developed in countries where there is a legal framework for genetically modified mosquitoes (hereafter GMM), but the beneficiaries of such insect technologies to control insect-borne diseases are most likely to be in malaria-endemic countries where the regulation of GM insect technologies is inadequate. Although no commercial release of GMM has been conducted in Africa yet, there may be prospects for the use of GMM to control malaria in malaria-endemic countries such as Nigeria, Burkina Faso, Mali and Uganda. Nigeria has the highest rate of deaths related to malaria in Africa and will potentially be targeted by companies seeking to introduce GMM as a public health tool in African countries. Research is being carried out on GMM in Burkina Faso, Mali and Uganda in collaboration with foreign companies. Whereas the control of diseases is certainly needed and there are potential public health benefits for GM insect technologies to address mosquito control, there are environmental and health concerns, and there is also the potential of the misuse of such technologies. Consequently, the use of GMM requires prior robust domestic, regional and international regulation. While the Cartagena Protocol on Transboundary Movements of Living Modified Organisms (LMOs) to the Convention on Biological Diversity (hereafter the Cartagena Protocol)and voluntary guidelines on the testing of GM mosquitoes are applicable with respect to GM insect technologies, there is a lack of international and regional guidance on the regulation of such technologies. Domestic legislation tends to focus on GM crops and is inadequate for regulating GMM. This paper discusses the legal response for the above Africancountries which may perhaps use GMM as a public health tool and makes recommendations for the necessary regulatory response
Gene Editing and Genetic Control of Hemipteran Pests: Progress, Challenges and Perspectives
22757I. D. Pacheco, L. L. Walling and P. W. Atkinson, Frontiers in Bioengineering and Biotechnology, 10. 2022-06-07 08:02:11.
The origin of the order Hemiptera can be traced to the late Permian Period more than 230 MYA, well before the origin of flowering plants 100 MY later in during the Cretaceous period. Hemipteran species consume their liquid diets using a sucking proboscis; for phytophagous hemipterans their mouthparts (stylets) are elegant structures that enable voracious feeding from plant xylem or phloem. This adaptation has resulted in some hemipteran species becoming globally significant pests of agriculture resulting in significant annual crop losses. Due to the reliance on chemical insecticides for the control of insect pests in agricultural settings, many hemipteran pests have evolved resistance to insecticides resulting in an urgent need to develop new, species-specific and environmentally friendly methods of pest control. The rapid advances in CRISPR/Cas9 technologies in model insects such as Drosophila melanogaster, Tribolium castaneum, Bombyx mori, and Aedes aegypti has spurred a new round of innovative genetic control strategies in the Diptera and Lepidoptera and an increased interest in assessing genetic control technologies for the Hemiptera. Genetic control approaches in the Hemiptera have, to date, been largely overlooked due to the problems of introducing genetic material into the germline of these insects. The high frequency of CRISPR-mediated mutagenesis in model insect species suggest that, if the delivery problem for Hemiptera could be solved, then gene editing in the Hemiptera might be quickly achieved. Significant advances in CRISPR/Cas9 editing have been realized in nine species of Hemiptera over the past 4 years. Here we review progress in the Hemiptera and discuss the challenges and opportunities for extending contemporary genetic control strategies into species in this agriculturally important insect orderr.
Evaluation of Additional Drosophila suzukii Male-Only Strains Generated Through Remobilization of an FL19 Transgene
25425A. Yamamoto, A. K. Yadav and M. J. Scott, Frontiers in Bioengineering and Biotechnology, 10. 2022-03-15 08:27:00.
Drosophila suzukii (D. suzukii) (Matsumura, 1931; Diptera: Drosophilidae), also known as spotted wing Drosophila, is a worldwide pest of fruits with soft skins such as blueberries and cherries. Originally from Asia, D. suzukii is now present in the Americas and Europe and has become a significant economic pest. Growers largely rely on insecticides for the control of D. suzukii. Genetic strategies offer a species-specific environmentally friendly way for suppression of D. suzukii populations. We previously developed a transgenic strain of D. suzukii that produced only males on a diet that did not contain tetracycline. The strain carried a single copy of the FL19 construct on chromosome 3. Repeated releases of an excess of FL19 males led to suppression of D. suzukii populations in laboratory cage trials. Females died as a consequence of overexpression of the tetracycline transactivator (tTA) and tTA-activated expression of the head involution defective proapoptotic gene. The aim of this study was to generate additional male-only strains that carried two copies of the FL19 transgene through crossing the original line with a piggyBac jumpstarter strain. Males that carried either two chromosome 3 or a singleX-linked transgene were identified through stronger expression of the red fluorescent protein marker gene. The brighter fluorescence of the X-linked lines was likely due to dosage compensation of the red fluorescent protein gene. In total, four X-linked lines and eleven lines with two copies on chromosome 3 were obtained, of which five were further examined. All but one of the strains produced only males on a diet without tetracycline. When crossed with wild type virgin females, all of the five two copy autosomal strains examined produced only males. However, the single copy X-linked lines did not show dominant female lethality. Five of the autosomal lines were further evaluated for productivity (egg to adult) and male competition. Based on these results, the most promising lines have been selected for future population suppression experiments with strains from different geographical locations.
Newer Genetic Tools, Techniques, Vectors, Promoters, and Molecular Markers for Genetic Engineering of Herbivorous Insects
25474D. D. Rani, S. Subhash, H. R. Gopalkrishna and A. K. Chakravarthy, Genetic Methods and Tools for Managing Crop Pests, 2022-01-01 08:54:42.
Insects can transmit major infectious diseases to crop plants. Recent advances in insect genomics and transformation technology provide new strategies for the control of insect-borne pathogen transmission and insect pest management. One such strategy is the genetic modification of insects with genes that block pathogen development. Another is to suppress insect populations by releasing either sterile males or males carrying female-specific dominant lethal genes into the environment. Newer genetic tools and methods are described.
Procedurally Robust Risk Assessment Framework for Novel Genetically Engineered Organisms and Gene Drives
19376Kuzma, J., Regulation and Governance, 15:1144-1165. 2021-11-29 17:13:52.
In this article, a new framework for improving risk assessments of novel genetically engineered organisms (GEOs) is developed and applied. The Procedurally Robust Risk Assessment Framework (PRRAF) provides a set of principles and criteria for assessing and enhancing risk assessment protocols for GEOs under conditions of high uncertainty. The application of PRRAF is demonstrated using the case of a genetically engineered mosquito designed to kill its wild population and therefore decrease disease transmission. Assessments for regulatory approval of this genetically engineered insect fall short of several PPRAF criteria under the principles of humility, procedural validity, inclusion, anticipation, and reflexivity. With the emergence of GEOs designed to spread in ecosystems, such as those with gene drives, it will become increasingly important for regulatory agencies and technology developers to bolster their risk analysis methods and processes prior to field testing. PRRAF can be used as a flexible guide for doing so within a variety of institutional, regulatory, and governance contexts.
Calling the latest gene technologies ‘natural’ is a semantic distraction — they must still be regulated
18752J. A. Heinemann, D. J. Paull, S. Walker and B. Kurenbach, The Conversation, 2021-09-22 13:41:22.
Legislators around the world are being asked to reconsider how to regulate the latest developments in gene technology, genome editing and gene silencing. Both the European Court of Justice and the New Zealand High Court have ruled that genome editing techniques should remain under the regulations specific to genetically modified organisms. But a few other countries, including Australia, have exempted some uses of these techniques from their regulations, based on similarities to what occurs in nature. The main argument is that the biochemical processes of editing are like the processes that cause natural mutations. The “equivalent to nature” narrative blurs the boundary between natural processes and technology.
Cas9-Mediated Gene-Editing in the Black-Legged Tick, Ixodes Scapularis, by Embryo Injection and ReMOT Control.
17197A. a. P. Sharma, Michael N. and Reyes, Jeremiah B. and Chana, Randeep and Yim, Won C. and Heu, Chan C. and Kim, Donghun and Chaverra-Rodriguez, Duverney and Rasgon, Jason L. and Harrell, Robert A. and Nuss, Andrew B. and Gulia-Nuss, Monika,, Cell Reports, 2021-08-20 20:35:08.
Despite their capacity to acquire and pass on an array of debilitating pathogens, research on ticks has lagged behind other arthropod vectors, such as mosquitoes, largely because of a lack of genetic and molecular tools. CRISPR-Cas9 is transforming non-model organism research; however, successful gene editing has not yet been reported in ticks. Technical challenges for injecting tick embryos to attempt gene editing have further slowed research progress. Herein we report a successful tick embryo injection protocol for the black-legged tick, Ixodes scapularis, the first for any chelicerate species, and the use of this protocol for genome editing with CRISPR-Cas9. We also demonstrated for the first time that the ReMOT Control technique can be successfully used to generate genome mutations outside Insecta. Our results provide innovative tools to the tick research community that are essential for advancing our understanding of the molecular mechanisms governing pathogen transmission by tick vectors as well as for understanding the underlying biology of host-vector-pathogen interactions.
‘Nigeria has capacity for safe application of modern biotechnology’
17298M. Adewale, The Guardian, 2021-06-09 11:00:41.
Director-general of the National Biosafety Management Agency (NBMA), Dr. Rufus Ebegba, has declared that Nigeria has the capacity to deploy safe biotechnology products for agricultural development and environmental safety. Ebegba, who gave the assurance at the opening of a two-day retreat on agricultural biotechnology for media practitioners and extension workers yesterday in Kano, explained that Nigeria possessed the institutional capacity and policy framework to ensure the application of modern technology, especially on agricultural production with the potential to accelerate food security and reduce import dependency. He stressed that the establishment of the NBDA, which necessitated the development of national policy on biotechnology in 2001 and the enactment of the agency, mandated to ensure the safety of modern biotechnology products, has positioned the country with the knowledge to deploy Genetically Modified Organisms (GMOs) products. Ebegba stressed that part of the core responsibility of NBDA was to ensure the regulation of biotechnology and the safety of GMO products for human health and the environment.
Next gen insect control
16960E. Unglesbee, Progressive Farmer, 2021-05-04 14:58:12.
Dubbed "self-limiting" insects by their makers, a UK-based biotechnology company called Oxitec, these insects are genetically modified (GM) with an inserted gene that permits only male offspring to survive. Once released into a pest community, the GM insects gradually lower the population, accomplishing a new type of pest control. Then, rather politely, they die off themselves. "After we stop releasing the self-limiting males, the gene declines in a population over a short period of time and within a few generations, disappears," Neil Morrison, head of agriculture programs for Oxitec, told DTN. "It's a gene that prevents survival of half its carriers -- the females -- so it's essentially programmed to decline and disappear quite rapidly." Sound too sci-fi to be real? It's actually happening right now, in the Florida Keys. After gaining EPA and state regulatory approval for the project last year, Oxitec is working with the Florida Keys Mosquito Control District to deploy the country's first largescale release of Oxitec's self-limiting Aedes aegypti mosquitoes.
Differentiated impacts of human interventions on nature: Scaling the conversation on regulation of gene technologies
18750J. A. Heinemann, D. J. Paull, S. Walker and B. Kurenbach, Elementa: Science of the Anthropocene, 9. 2021-03-17 13:35:29.
Biotechnology describes a range of human activities in medicine, agriculture, and environmental management. One biotechnology in particular, gene technology, continues to evolve both in capacity and potential to benefit and harm society. The purpose of this article is to offer a policy bridge from unproductive descriptions of gene technology to useful methods for identifying sources of significant biological and socioeconomic risk in complex food systems. Farmers and the public could be voluntarily and involuntarily interacting with new techniques of genome editing and gene silencing in entirely new ways, limiting the usefulness of previous gene technology histories to predict safety. What we believe is a more consistent, verifiable, and practical approach is to identify the critical control points that emerge where the scale effects of a human activity diverge between risk and safety. These critical control points are where technical experts can collaborate with publics with different expertise to identify and manage the technology. The use of technical terminology describing biochemical-level phenomena discourages publics that are not technical experts from contesting the embedded cultural perspectives and uncertainty in “scientific” concepts and prejudice the risk discourse by ignoring other issues of significance to society. From our perspective as gene technologists, we confront the use of pseudo-scale language in risk discourse and propose an escape path from clashes over whether risks that arise spontaneously (from nature) can be perfectly mimicked by gene technology to a discussion on how to best control the risks created by human activity. Scale is conceptually implicit and explicit in gene technology regulation, but there is no agreement about what scales are most useful to managing risk and social expectations. Both differentiated governance (risk-tiered) and responsible research and innovation models could accommodate the critical control points mechanism that we describe.
Proceedings of an expert workshop on community agreement for gene drive research in Africa – Co-organised by KEMRI, PAMCA and Target Malaria [version 1; peer review: awaiting peer review]
16224D. Thizy, L. Pare Toe, C. Mbogo, D. Matoke-Muhia, V. P. Alibu, S. K. Barnhill-Dilling, T. Chantler, G. Chongwe, J. Delborne, L. Kapiriri, E. Nassonko Kavuma, S. Koloi-Keaikitse, A. Kormos, K. Littler, D. Lwetoijera, R. Vargas de Moraes, N. Mumba, L. Muten, Gates Open Research, 2021-01-28 16:25:31.
Target Malaria, the Kenya Medical Research Institute and the Pan African Mosquito Control Association co-organised a workshop with researchers and practitioners on this topic to question the model proposed by Target Malaria in its research so far that involved the release of genetically modified sterile male mosquitoes and how this could be adapted to future studies involving gene drive mosquito releases for them to offer reflections about potential best practices. This paper shares the outcomes of that workshop and highlights the remaining topics for discussion before a comprehensive model can be design
Into the Wild: GMOs head for the forest
16115L. Sharratt, Sentinel, 2021-01-25 13:49:25.
Genetic engineering is set to leave the farm for the forest. After over twenty years of growing genetically engineered (GE or genetically modified) crop plants in North America, researchers are now proposing to plant GE trees in the forests of eastern US and Canada. This is a precedent-setting request that asks us to accept, even embrace, genetically modified organisms (GMOs) in the wild. The first genetically engineered forest tree is now being considered for release into the wild. The US Department of Agriculture is now assessing a proposal from university researchers to plant a GE American chestnut tree in forests. The researchers have genetically engineered the tree to tolerate the blight Cryphonectria parasitica that decimated American chestnut populations in Canada and the US in the 1900’s. This GE tree is engineered with a gene from wheat, key to creating the blight-tolerant trait, as well as genetic material from four other species: a plant related to mustard, two different bacteria, and a plant virus. Together, the use of this new genetic material has resulted in the “Darling 58” GE American chestnut tree.
Combining refuges with transgenic insect releases for the management of an insect pest with non-recessive resistance to Bt crops in agricultural landscapes
17006T. R. Brewer and M. B. Bonsall, Journal of Theoretical Biology, 509:11. 2021-01-21 12:35:03.
Reinforcing the high-dose/refuge strategy with releases of transgenic insects has been suggested as a method for simultaneously managing agricultural pest populations and resistance to transgenic crops. Theoretical and empirical studies have shown that these approaches can work when deployed against closed populations and the assumptions of the HDR strategy are met. However, field-evolved resistance is often linked to non-recessive resistance or refuge non-compliance, and pest management regimes are likely to take place at the landscape-level. It is therefore important to understand how effective such strategies are when resistance is non-recessive, and how they could be employed in agricultural landscapes. We developed a spatially-explicit model to investigate the efficacy of strategies combining refuges with transgenic insect releases to manage a pest with non-recessive resistance in agricultural landscapes. We compared two release strategies, area-wide releases and localised releases targeted at population hotspots, and analysed the effects of refuge and release parameters on population and resistance dynamics. Area-wide releases reliably achieved landscape-level pest eradication. Localised releases also eradicated the pest when low release thresholds were combined with high release ratios, and maintained the pest at low densities when insufficient to achieve extinction. Reinforcing refuges with localised releases also greatly enhanced the probability of resistance extinction. However, when resistance remained in the population, localised releases prevented resistance from reaching fixation rather than greatly delaying or reversing resistance evolution. Our work indicates that combining refuges with simple release policies is effective for landscape-level pest suppression when the HDR assumptions are violated, but more nuanced release strategies may be required to enhance the benefits to resistance management. (C) 2020 Elsevier Ltd. All rights reserved.
‘Clever Approach’: Scientists Create GM-Free Organisms Using Genetic Engineering
15955A. Paleja, The WIRE, 2021-01-11 17:07:06.
Farther to the north, researchers at the University of Minnesota have developed a novel way to resolve this problem. They used genetic engineering to create organisms for release that are not genetically modified. Maciej Maselko was a postdoctoral associate at the university when he was part of the study. “Slow and expensive regulatory approvals for GM insect release” inspired the team’s work, he told The Wire Science. “We looked for a way to get the benefits achieved with GM insect release but without needing to release GM insects.” He conceptualised the experiment with PhD scholar Siba Das and molecular biology professor Michael Smanski. The results were published in November 2020. In a typical control intervention, researchers release sterile male mosquitoes into the environment. These compete with wild males to mate with wild females. Mosquitoes mate only once in their lifetime. Since mating with sterile mosquitoes produces no offspring, the local mosquito population begins to fall. The methods to select these male mosquitoes to subsequently release are either labour intensive or need specialised equipment. The colony that scientists rear is also often three times larger than the number of males released. Third, a mosquito lives typically for 8-10 days. So scientists must select the males to release close to the site of intervention.
A patent review on strategies for biological control of mosquito vector
15377K. Parihar, M. Telang and A. Ovhal, World Journal of Microbiology and Biotechnology, 36:23. 2020-12-09 20:28:33.
This paper presents a comprehensive technology overview of patent documents disclosing biological agents for mosquito control. The patent analysis revealed that comparable number of patent documents were filed in two technology categories: non-recombinant agents and genetically modified (GM) agents. In the category of non-recombinant agents, toxic peptides from microbes and biological consortia seemed to be the earliest technology noted right from the year 1965 whereas the patent filings for suppression of mosquito population using genetic modification techniques have emerged from the year 2000 onwards. The United States of America is the leading patent filing jurisdiction followed by China and the Great Britain. Academic institutes have filed higher number of patent applications as compared to private companies. University of Florida was found to be the leading patent filing entity and its patents were focused on suppression of vector population using techniques such as release of insects with dominant lethal (RIDL) and RNA interference (RNAi).
GMOs: Implications for Biodiversity Conservation and Ecological Processes
15283Chaurasia, Anurag , Hawksworth, David L., Pessoa de Miranda, Manoela., GMOs: Implications for Biodiversity Conservation and Ecological Processes, 2020-12-02 16:45:05.
This book covers a broad spectrum of topics related to GMOs and allied new gene-based technologies, biodiversity, and ecosystem processes, bringing together the contributions of researchers and regulators from around the world. The aim is to offer a clear view of the benefits and effects of genetically modified crops, insects, and other animals on the soil microbiome and ecological processes. Contributors examine issues related to the development of risk assessment procedures and regulations designed to maximize benefits while minimizing risks. Beyond the scientific challenges of GMOs, the book explores the broad and contentious terrain of ethical considerations. The contributors discuss such questions as the unintended, possibly unforeseen, consequences of releasing GMOs into ecosystems, and the likelihood that the full effects of GMOs could take years, even decades, of close monitoring to become evident. The importance of developing a precautionary approach is stressed.
Genetic engineering of sex chromosomes for batch cultivation of non-transgenic, sex-sorted males
19246S. R. Das, M. Maselko, A. Upadhyay and M. J. Smanski, PloS Genetics, 16:11. 2020-11-02 22:13:55.
The field performance of Sterile Insect Technique (SIT) is improved by sex-sorting and releasing only sterile males. This can be accomplished by resource-intensive separation of males from females by morphology. Alternatively, sex-ratio biasing genetic constructs can be used to selectively remove one sex without the need for manual or automated sorting, but the resulting genetically engineered (GE) control agents would be subject to additional governmental regulation. Here we describe and demonstrate a genetic method for the batch production of non-GE males. This method could be applied to generate the heterogametic sex (XY, or WZ) in any organism with chromosomal sex determination. We observed up to 100% sex-selection with batch cultures of more than 10(3) individuals. Using a stringent transgene detection assay, we demonstrate the potential of mass production of transgene free males. Author summary In this manuscript, we describe and demonstrate in a model system a new genetic engineering approach for producing sex-sorted, non-transgenic batches of an organism with genetic sex determination. This approach could impact pest control programs using Sterile Insect Technique.
WHO Releases a Position Statement on Genetically Modified Mosquitoes for the Control of Vector-Borne Diseases
14793E. R. Fletcher, Health Policy Watch, 2020-10-19 14:56:43.
WHO announced their support for the continued investigation into genetically modified mosquitoes as an alternative to existing interventions to reduce or prevent vector-borne diseases.
Embracing Dynamic Models for Gene Drive Management
14596A. J. Golnar, E. Ruell, A. L. Lloyd and K. M. Pepin, Trends in Biotechnology, 2020-09-30 13:54:04.
We describe how quantitative tools can reduce risk uncertainty, streamline empirical research, guide risk management, and promote cross-sector collaboration throughout the process of gene drive technology development and implementation.
Responsible innovation in biotechnology: Stakeholder attitudes and implications for research policy
15225P. Roberts, J. Herkert and J. Kuzma, Elementa, 2020-09-01 21:17:09.
Using a mixed methods approach, we analyzed the attitudes of different biotechnology stakeholders, particularly those working in areas related to genetically modified organisms (GMOs) in agriculture and the environment, towards the principles and practices of RI. Homogenous focus groups (organized by stakeholder affiliation) and pre- and post-focus group surveys were used to measure attitudes towards RI. We designed the survey questions according to the Advocacy Coalition Framework (ACF) and examined the agreement of stakeholders with policy core beliefs (general principles of RI) and secondary beliefs (implementation practices of RI). Qualitative analysis of focus-groups revealed barriers for implementing RI practices.
Do Africans need genetically modified mosquitoes?
14261genetically modified, mosquito, oxitec, autocidal, SIT, perspective, malaria, gene drive synthetic, engagement,, Mail and Guardian, 2020-09-01 14:32:06.
The following is an updated version of an article I wrote for the University of Michigan Risk Science Centre a while ago:
Socrates Untenured: Ethics, Experts, and the Public in the Synthetic Age
13182C. Preston, ISSUES in Science and Technology, 2020-07-14 17:44:20.
C. Preston (2020). Three tools have transformed biotechnology over the past decade and a half. Gene reading has made it possible to quickly sequence the genome of any living creature. Gene synthesis has made it possible to construct DNA sequences in the lab from constituent chemicals. Gene editing has made it possible to place those sections into an existing DNA sequence at any point a technician chooses.
CSOs raise alarm over genetically-engineered mosquitoes in Nigeria
13179A. Oboh, Vanguard, 2020-07-11 17:41:57.
No fewer than 75 civil society organisations, CSOs, across the world have raised the alarm over moves to release genetically-modified mosquitoes in Nigeria, noting that the country was about to be used as a guinea pig for the project, which will endanger humans, biodiversity and to ecosystem balance. The CSOs noted that the shortcoming of transgenic mosquitoes was evident from the experiments done in Brazil and in Burkina Faso.
Groups warn against release of genetically-engineered mosquitoes in Nigeria
13172C. Onyesi, Daily Post, 2020-07-07 14:52:15.
C. Onyesi (2020). Daily Post. Over 75 Civil Society Organizations from Nigeria, Africa and the world have condemned moves to open the way for the release of genetically modified mosquitoes in Nigeria.
Malaria: Over 75 CSOs raise alarm over plans to release nautically engineered mosquitoes
13174News Agency of Nigeria, WorldStage, 2020-07-06 14:56:01.
Mre than 75 Environmental Civil Society Organisations from Nigeria, Africa and other countries have condemned moves to open way for release of genetically modified mosquitoes to control malaria infection. The News Agency of Nigeria (NAN), reports that at a virtual meeting of the West African Integrated Vector Management Programme, on June 6, Mr Rufus Ebegba, Vice Chairman of the Programme said: “There is the need to accelerate the development of regulatory pathways for genetically based vector control methods such as transgenic mosquitoes.”
GMO Mosquitoes to be launched in Florida
13162Administration, Editorials 360, 2020-07-01 14:38:18.
In June 2020, the Florida Division of Agriculture and Shopper Providers gave the go-ahead to a plan to launch thousands and thousands of genetically engineered mosquitoes within the Florida Keys this summer time to battle mosquito-borne diseases.1 The plan follows the EPA’s current granting of an experimental use allow (EUP) for the GMO (genetically modified organism) mosquitoes to allow them to be launched in Florida in 2020 and in Texas in 2021.2 The mosquitoes, engineered from the Aedes aegypti mosquito species,3 have been created by the U.S.-owned, Britain-based firm Oxitec, which originated as a spin-off firm from Oxford College and subsidiary of Intrexon.4 The corporate has additionally created genetically modified pink bollworm moths and GMO cabbage moths.
Nigerian government restates commitment to safety in applying modern biotechnology
13164Agencies, today ng, 2020-06-30 14:41:51.
The National Biosafety Management Agency (NBMA) has reiterated its commitment to ensure the safety of the public while applying modern biotechnology to boost food security and economic development of citizens. Dr Rufus Ebegba, Director-General, NBMA, gave the assurance at a meeting to review the National Guidelines of the Regulation of Gene Editing, on Tuesday in Abuja. Ebegba said the NBMA was amended in 2019, to include the application of gene drive, gene editing and synthetic biology and biosecurity which says: ”No person, institution or body shall carry out gene drive, gene editing and synthetic biology except with the approval of the agency,”.
Detecting the population dynamics of an autosomal sex ratio distorter transgene in malaria vector mosquitoes
13607P. Pollegioni, A. R. North, T. Persampieri, A. Bucci, R. L. Minuz, D. A. Groneberg, T. Nolan, P. A. Papathanos, A. Crisanti and R. Muller, Journal of Applied Ecology, 11. 2020-06-18 12:44:16.
A sex-distorting autosomal transgene has been developed recently in G3 mosquitoes, a laboratory strain of the malaria vectorAnopheles gambiaes.l. Following the World Health Organization guidance framework for the testing of GM mosquitoes, we assessed the dynamics of this transgene in large cages using a joint experimental modelling approach. We performed a 4-month experiment in large, indoor cages to study the population genetics of the transgene.
Beyond limits – the pitfalls of global gene drives for environmental risk assessment in the European Union
11458M. Dolezel, C. Lüthi and H. Gaugitsch, BioRisk, 15:1-29. 2020-05-04 14:58:37.
We evaluate the novel features of GDOs and outline the resulting challenges for the environmental risk assessment.
Report of the ad hoc technical expert group on risk assessment
16095Ad Hoc Technical Expert Group on Risk Assessment, Convention on Biological Diversity, 2020-04-15 15:54:41.
The Conference of the Parties serving as the meeting of the Parties to the Cartagena Protocol further decided to extend the Online Forum on Risk Assessment and Risk Management to assist the AHTEG and invited submissions of information relevant to the work of the online forum and the AHTEG from Parties, other Governments, and indigenous peoples and local communities. The AHTEG is to submit the outcomes of its work for consideration by the Subsidiary Body on Scientific, Technical and Technological Advice at its twenty-fourth meeting, prior to the tenth meeting of the Parties to the Protocol.
The value of existing regulatory frameworks for the environmental risk assessment of agricultural pest control using gene drive
8194J. Romeis, J. Collatz, D. C. M. Glandorf and M. B. Bonsall, Environmental Science & Policy, 108:19-36. 2020-03-27 20:20:04.
The application of (synthetic) gene drives is a powerful tool to control populations of insects that are agricultural pests, vectors of diseases, or a threat to biodiversity potentially leading to the local or global eradication of a species. The potential use of gene drive organisms has triggered a heated discussion regarding their environmental impacts and regulatory oversight. However, experience exists in assessing the environmental impacts of a number of established agricultural pest control methods that require the release of living organisms, that provide high levels of area-wide control and that might be irreversible. This includes classical biological control, the sterile insect technique, the incompatible insect technique that is based on the cytoplasmic incompatibility caused by Wolbachia endosymbionts, and genetically modified insects containing self-limiting traits. The different technologies are described, the regulatory practice and experience is summarized and pathways through which these control technologies could harm valued ecosystem services are presented. With a focus on the application of gene drives in agriculture, using the invasive Drosophila suzukii (Diptera: Drosophilidae) as a case study we then discuss to what extent the existing frameworks could assist the risk assessment of insects carrying gene drives. We suggest that drawing on existing practices, experiences and legislative frameworks will provide a pragmatic and proportionate approach to evaluate the environmental risks of novel solutions based on gene drive technologies.
Genetic frontiers for conservation: An assessment of synthetic biology and biodiversity conservation
16089K. H. Redford, T. Brooks, M., B. W. Nicholas and J. S. A. Macfarlane, International Union for Conservation of Nature, 2019-12-01 15:41:26.
This assessment is the beginning of a process that will lead to the development of an IUCN policy to guide the Union’s Director General, Commissions, and Members. The draft policy will be discussed in many fora before it is brought to vote at the World Conservation Congress in 2020. Far greater public attention to the topic of synthetic biology and biodiversity conservation is essential, given the potential impact of scientific discoveries and policy decisions that may be just over the horizon, and also given the need for broad partnerships to address the challenges that the conservation and synthetic biology communities will inevitably face
Two unresolved issues in community engagement for field trials of genetically modified mosquitoes
13541D. B. Resnik, Pathogens and Global Health, 113:238-245. 2019-09-25 19:32:29.
There is an emerging consensus among scientists, ethicists, and public health officials that substantive and effective engagement with communities and the wider public is required prior to releasing genetically modified mosquitoes into the environment.
Guidance for IBCs: Regulatory requirements for contained research with GMOs containing engineered gene drives
16086Office of the Gene Technology Regulator, Australian Government, Department of Health, 2019-09-01 15:35:42.
This document provides guidance for Institutional Biosafety Committees (IBCs) and researchers on the regulatory requirements for organisms containing engineered ‘gene drives’, including the physical containment (PC) level of facilities for notifiable low risk dealings (NLRDs). Gene drives are genetic elements that are favoured for inheritance, and which can therefore spread through populations at a greater rate than genes with standard Mendelian inheritance. Gene drives can only spread from sexually reproducing parents to their offspring. If gene technology is used to introduce or create a gene drive in an organism, the resulting organism will be a GMO and subject to regulation under the Gene Technology Act 2000.
Sex Sorting for Pest Control: It’s Raining Men!
17064C. Lutrat, D. Giesbrecht, E. Marois, S. Whyard, T. Baldet and J. Bouyer, Trends in Parasitology, 35:649-662. 2019-06-26 14:04:15.
In the pursuit of better pest- and vector-control strategies, attention returns to an old proven technology, the sterile insect technique (SIT) and related insect population-suppression methods. A major obstacle for any of these approaches that involves the release of sterile males is the separation of males from females during the mass rearing stage, in order to improve the cost-efficiency of these methods and to prevent the release of biting and disease-vectoring females. This review describes recent sex-sorting developments in dipteran flies with an emphasis on assessing the suitability of these methods for large-scale rearing of male vectors for mass release.
The EU regulatory framework on genetically modified organisms (GMOs)
3893Bruetschy, C, Transgenic Research, 28:169-174. 2019-01-11 00:00:00.
The European Union (EU) legislation on genetically modified organisms (GMOs) aims to ensure a high level of protection for human, animal and environmental health and a well-functioning EU internal market. The framework regulates the release of GMOs into the environment and their use as, or in, food and feed. It has three main pillars: pre-market authorisation based on a prior risk assessment, traceability and labelling. Within this legal framework, the EU has authorised the placing on the market of 118 GMOs so far. These have been obtained through long-standing techniques of genetic modification, namely transgenesis. Following the adoption of the GMO legislation, new techniques of genetic modification, including new mutagenesis techniques, have been developed, which have raised questions regarding the applicability of the GMO legislation and attracted a lot of attention from stakeholders and the general public. This article provides an overview of EU GMO legislation and implementation of the EU Court of Justice ruling on organisms obtained by mutagenesis techniques, issued in July 2018. It also updates on the recent initiatives by the European Commission and EU Member States on new developments in biotechnology. The manuscript is based on the author's contribution at the OECD Conference on Genome Editing, Applications in Agriculture, Implications for Health, Environment and Regulation held in Paris on 28-29 June 2018. It is complemented with updated information.
The Release of Genetically Engineered Mosquitoes in Burkina Faso: Bioeconomy of Science, Public Engagement and Trust in Medicine
3890Beisel, UG, J. K., African Studies Review, 62:164-173. 2019-01-08 00:00:00.
Malaria, which is transmitted by mosquitoes, continues to be responsible for a significant number of disease episodes and childhood deaths on the African continent. A variety of mosquito control strategies are currently inplace, but since case numbers are rising again, and drug and insecticide tolerance slow down progress made, there has been a push for innovative strategies. In August 2018, the National Biosafety Agency of Burkina Faso granted approval for the release of a maximum of 10,000 male Anopheles mosquitoes in experimental trials conducted by the multi-country consortium Target Malaria. These mosquitoes are rendered infertile through genetic modification, namely through “re-programming” of endonucleases that “cut through essential genes,” in this case, genes for fertility (Target Malaria 2019). The idea is that through the sterilization of male mosquitoes, the population of malaria-transmitting mosquitoes will be reduced, thereby decreasing the overall number of malaria infections.
Genetics-based methods for agricultural insect pest management
18687N. Alphey and M. B. Bonsall, Agricultural and Forest Entomology, 20:131-140. 2018-05-01 13:30:37.
Abstract The sterile insect technique is an area-wide pest control method that reduces agricultural pest populations by releasing mass-reared sterile insects, which then compete for mates with wild insects. Contemporary genetics-based technologies use insects that are homozygous for a repressible dominant lethal genetic construct rather than being sterilized by irradiation. Engineered strains of agricultural pest species, including moths such as the diamondback moth Plutella xylostella and fruit flies such as the Mediterranean fruit fly Ceratitis capitata, have been developed with lethality that only operates on females. Transgenic crops expressing insecticidal toxins are widely used; the economic benefits of these crops would be lost if toxin resistance spread through the pest population. The primary resistance management method is a high-dose/refuge strategy, requiring toxin-free crops as refuges near the insecticidal crops, as well as toxin doses sufficiently high to kill wild-type insects and insects heterozygous for a resistance allele. Mass-release of toxin-sensitive engineered males (carrying female-lethal genes), as well as suppressing populations, could substantially delay or reverse the spread of resistance. These transgenic insect technologies could form an effective resistance management strategy. We outline some policy considerations for taking genetic insect control systems through to field implementation.
The ethical implications of population suppression and the irreversibility of gene drives
14167J. Kim, International Journal of Life Sciences Research, 2018-04-01 14:11:25.
This paper aims to examine the current situation by presenting important ethical arguments that include Chardin’s principle of irreversibility and Weiss’ beliefs on intergenerational equity, ideals upheld by the United Nations
Regulating animals with gene drive systems: lessons from the regulatory assessment of a genetically engineered mosquito
13804Z. Meghani and J. Kuzma, Journal of Responsible Innovation, 5:S203-S222. 2018-01-24 15:52:57.
In this paper, we consider the question of whether the United States Food and Drug Administration is prepared to effectively regulate insects and other animals with gene drives. Given the profound impact that gene drives could have on species and ecosystems, their use is a highly contentious issue. The rigorous regulation of insects and other animals with gene drive systems is crucial.
THE NATIONAL BIOSAFETY TECHNICAL COMMISSION (CTNBio) NORMATIVE RESOLUTION No. 16, OF JANUARY 15, 2018
16083CTNBio, National Biosafety Technical Commission of Brasil, 2018-01-15 15:17:02.
Sets forth the technical requirements for submitting an inquiry to the CTNBio concerning Precision Breeding Innovation Techniques. THE NATIONAL BIOSAFETY TECHNICAL COMMISSION (CTNBio), using its legal and regulatory powers and in observance of sections XV and XVI of article 14 of Law No. 11.105 of March 24, 2005; Whereas there is a need to assess Precision Breeding Innovation (PBI) techniques, which also comprise the so-called New Breeding Technologies (NBTs) in the light of Law No. 11.105 of March 24, 2005;
Report of the ad hoc technical expert group on synthetic biology
16073Ad Hoc Technical Working Group, Convention on Biological Diversity, 2017-12-08 14:12:31.
In decision XIII/17, the Conference of the Parties to the Convention on Biological Diversity commended the work of the online forum and the Ad Hoc Technical Expert Group on Synthetic Biology (AHTEG) and welcomed the conclusions and recommendations of the report of the AHTEG as a basis for further discussion. The Conference of the Parties also considered the operational definition useful as a starting point for the purpose of facilitating scientific and technical deliberations under the Convention and its Protocols and took note of the conclusion of the AHTEG that living organisms developed through synthetic biology are similar to living modified organisms (LMOs) as defined in the Cartagena Protocol. The Conference of the Parties noted that the general principles and methodologies for risk assessment under the Cartagena Protocol and existing biosafety frameworks provide a good basis for risk assessment of living organisms developed through synthetic biology, but such methodologies might need to be updated and adapted.
SCIENTIFIC OPINION: In response to the referral of 12 October 2015 concerning use of genetically modified mosquitoes for vector control
16065High Council for Biotechnology, High Council for Biotechnology (France), 2017-05-31 13:46:03.
The Scientific Committee’s opinion describes emerging vector control techniques using GM mosquitoes, the current state of research into and development of these techniques and the outcomes of initial experiments worldwide. To date, only one technique has been developed to an operational level: Oxitec’s RIDL technique, which sets out to reduce a mosquito population by repeated mass releases of sterilising transgenic males. Two other techniques at an earlier stage of research and development are based on gene drive, seeking to spread a genetic trait in a wild population, either to make the mosquitoes incapable of transmitting pathogens (gene drive for population modification) or to eliminate the population by spreading sterility (gene drive for population elimination).
The End of the GMO? Genome Editing, Gene Drives and New Frontiers of Plant Technology
15368K. L. Hefferon and R. J. Herring, Review of Agrarian Studies, 7. 2017-01-01 21:40:33.
mprovements to agriculture will constitute one of the world’s greatest challenges in the coming century. Political and social controversies, as well as complications of plant breeding, intellectual property, and regulation, have compromised the promised impact of genetically engineered – typically transgenic – crops designated as “GMOs.” Genome editing is a new suite of molecular tools for assisting biologists identify genes that control agronomic traits such as drought tolerance and pest resistance, as well as to elucidate how expression of these genes is intertwined within the functional framework of the cell. This technology has recently gained momentum for its ability to accelerate the crop breeding process in an unprecedented fashion and expand the range of crop varieties with improved precision and lower costs. This review explains the basic concepts and provides examples of how genome editing could help address the United Nation’s Sustainable Development Goals with respect to food, agriculture, and medicine. It concludes with a discussion of the potential social impact of genome editing and gene drive. These effects are contingent on the resolution of novel ethical and regulatory challenges that add new layers of complexity to societal questions of appropriate technology, in agriculture and beyond. We expect these questions to replace the irresolvable GMO debate.
Science and Technology Committee Genetically Modified Insects
16058UK Parliament, UK Parliament, 2015-12-17 21:18:14.
The UK is a world leader in the development of this technology. The European Union’s regulatory process, however, is likely to hold back progress. There is a moral duty to test the potential of the technology. We therefore support further research and call for action to test the efficiency of the EU process via a trial which should also be used to drive public engagement. GM insect technology has already been trialled for dengue transmitting mosquitoes.
Biosafety for human health and the environment in the context of the potential use of genetically modified mosquitoes (GMMs)
16044WHO/TDR, WHO/TDR Training Manual, 2015-01-01 20:09:55.
This Training manual: Biosafety for human health and the environment in the context of the potential use of genetically modified mosquitoes (GMMs) is based on biosafety training courses on GMMs undertaken in Africa, Asia and Latin America from 2008–2011. The courses were conceived by Yeya Touré, formerly Unit Leader (Vectors, Environment and Society), WHO/TDR, Geneva, Switzerland. Brij Kishore Tyagi (Asia course coordinator and Principal Investigator of the “Biosafety Manual-GMM Project”) prepared the first draft and compiled the Manual with invaluable assistance from the late Madama Bouaré (Africa course coordinator), Maria Corena-McLeod and Ivan Velez (Latin America course coordinators), and all those involved in preparing the courses
Guidance on the environmental risk assessment of genetically modified animals
16055European Food Safety Authority, European Food Safety Authority, 2013-05-23 20:45:04.
This document describes the six sequential steps for the ERA of GM animals, as indicated in Directive 2001/18/EC: (1) problem formulation including hazard and exposure identification; (2) hazard characterisation; (3) exposure characterisation; (4) risk characterisation; (5) risk management strategies; and (6) an overall risk evaluation. The Scientific Panel on Genetically Modified Organisms of the European Food Safety Authority follows Annex II of Directive 2001/18/EC, considering specific areas of risk to be addressed by applicants and risk assessors during the ERA of GM fish, GM insects and GM mammals and birds.
Progress and prospects for the use of genetically modified mosquitoes to inhibit disease transmission
16052A. A. James, J. D. Mumford, S. L. James and Y. T. Touré, WHO/TDR, 2010-04-01 20:29:20.
The use of genetically modified mosquitoes (GMMs) for disease control has social, economic and ethical implications, so it is important that the World Health Organization (WHO) and its partners provide guidance to countries on these issues. In collaboration with the Foundation for the National Institutes of Health (FNIH), TDR has developed a series of planning meetings on Progress and prospects for the use of genetically modified mosquitoes to inhibit disease transmission. These technical and public consultations will focus on current status and planning for future development.
Directive 2009/41/EC of the European Parliament and of the Council of 6 May 2009 on the contained use of genetically modified micro-organisms (Recast) (1)
7354European Parliament,, Official Journal of the European Union L 125, 52:75. 2009-05-21 21:44:10.
Whereas: (1 )Council Directive 90/219/EEC of 23 April 1990 on the contained use of genetically modified micro-organisms (3) has been substantially amended several times (4). Since further amendments are to be made, it should be recast in the interests of clarity. (2) Under the Treaty, action by the Community relating to the environment must be based on the principle that preventive action is to be taken and must have as its objective, among other things, the preservation, protection and improvement of the environment and the protection of human health. (3) Measures concerning the evaluation and best use of biotechnology with regard to the environment are a priority area on which Community action should concentrate.
RSPM No. 27 Guidelines for Importation and Confined Field Release of Transgenic Arthropods in NAPPO Member Countries
16041NAPPPO, NAPPO Regional Standards for Phytosanitary Measures, 2007-10-22 20:04:03.
This Standard is designed to provide guidance to NAPPO member countries on the importation and confined field release of transgenic arthropods that are known plant pests or have the potential to affect plant health. This includes transgenic arthropods used for biological control and transgenic beneficial arthropods with the potential to affect plant health. Transgenic arthropod species that are not plant pests, but that may pose a phytosanitary risk because of the genetic modification may also be considered under this Standard. Transgenic arthropods that have undergone a previous pest risk analysis by the regulatory authority of the importing country and been determined not to pose a phytosanitary risk may be exempted from importation requirements under this standard.
Malaria Control with Genetically Manipulated Insect Vectors
16035L. Alphey, C. B. Beard, P. Billingsley, M. Coetzee, A. Crisanti, C. Curtis, P. Eggleston, C. Godfray, J. Hemingway, M. Jacobs-Lorena, A. A. James, F. C. Kafatos, L. G. Mukwaya, M. Paton, J. R. Powell, W. Schneider, T. W. Scott, B. Sina, R. Sinden, S. Sink, Science, 298:119. 2002-10-04 19:49:32.
At a recent workshop, experts discussed the benefits, risks, and research priorities associated with using genetically manipulated insects in the control of vector-borne diseases.
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