Keywords: Policy
Ifakara’s Transmission Zero team convenes stakeholders to review project progress
35524Ifakara Health Institute, 2026-03-19 09:32:34.
The Transmission Zero Program’s team at the Ifakara Health Institute hosted key stakeholders from government and research institutions in Dar es Salaam on March 17-18, to review progress and strengthen collaboration on the Transmission Zero project, an international research programme working to develop innovative genetic tools to stop malaria transmission. The project is African-led by Scientists from Ifakara Health Institute in collaboration with Imperial College London in the United Kingdom, National Institute for Medical Research in Tanzania and Swiss Tropical and Public Health Institute in Switzerland. This collaborative model is paramount in ensuring sustainable capacity strengthening through infrastructure development, and knowledge and technology outputs. The meeting brought together members of the National Biosafety Committee (NBC) and ministerial authorities, and representatives from the International Union for Conservation of Nature (IUCN) to discuss program progress, challenges and considerations for introducing the program at scale.
African scientists lead in Malaria research
35518Florian Jamax, Daily News, 2026-03-16 09:10:40.
For decades, African scientists have contributed essential data to global scientific research. Increasingly, however, they are no longer just contributors. Across the continent, researchers are assuming leadership roles, designing studies, building advanced laboratories and shaping research priorities that address Africa’s most urgent health challenges. This shift marks a significant transformation in the global scientific landscape. African institutions are developing the expertise and infrastructure required to lead high-impact studies from within the continent. Rather than relying solely on external partnerships, local scientists are defining research questions and creating solutions aligned with regional public health priorities. A major scientific breakthrough published in the journal Nature in late 2025 illustrates this transition. Beyond its immediate research findings, the study symbolised the growing capacity of African science to lead complex research addressing diseases that disproportionately affect the continent.
Equatorial Guinea’s high-tech push to end malaria by 2030
35501Ronald Musoke, The Independent, 2026-03-10 09:39:41.
In the humid equatorial belt of Central Africa; where dense forests, heavy rains and winding rivers create ideal breeding grounds for mosquitoes, malaria has long been a stubborn public health adversary. For Equatorial Guinea, the disease has shaped health outcomes, economic prospects and daily life for decades. Now the small oil-rich nation is attempting something few countries in malaria-endemic regions have managed: complete elimination. Speaking during a virtual press briefing held on Feb. 26, hosted by the Addis Ababa-based Africa Centres for Disease Control and Prevention, Equatorial Guinea’s Minister of Health, Social Welfare and Health Infrastructure, Mitoha Ondo’o Ayekaba, laid out an ambitious national strategy known as Vision 2030. The goal is simple but formidable—eradicate malaria across the country within the next five years. The plan builds on two decades of progress on Bioko Island and introduces a new phase of intervention combining vaccines, advanced surveillance, cutting-edge vector control and emerging technologies such as genetically modified mosquitoes. “This is a historic transition from advanced malaria control to full national elimination,” Ayekaba said. But the path from control to eradication will test the limits of science, policy and community engagement.
Emerging trends in genome editing of wild animals
35453Blix, T., Myhr, A.I., Transgenic Research, 35. 2026-02-06 09:37:20.
Globally, nearly one million species are currently threatened with extinction, highlighting the need for more efficient solutions to biological conservation. Genome editing, which allows for faster and more precise changes in genomes, is a promising technique for boosting populations through facilitated adaptation, management of invasive or pathogenic populations, and potentially even facilitating the revival of extinct species. These approaches belong to a new field of research termed conservation biotechnology, which places a great responsibility on researchers and decision makers to ensure sustainability. In this paper, we have mapped the emerging trends in genome editing of wild animals. Current projects primarily focus on population control and de-extinction, with fewer initiatives aimed at preserving threatened species. We then explore four critical dimensions of conservation biotechnology: the technology itself, new perspectives on conservation practices, research organization, and governance and policy. Despite its potential, key questions remain—particularly whether genome editing can increase genetic diversity without causing unintended non-target impacts. Genome editing also provokes new perspectives on conservation practices where ecosystem-wide impact assessment, case-by-case evaluations, and post-release monitoring needs to be prioritized. Furthermore, conservation biotechnology is heavily funded through private funding showing varying stakeholder interest, which can lead to untraditional and less transparent research processes. Stakeholders, including local and indigenous people, are only to a certain degree involved, which may weaken inclusion of local knowledge and monitoring efforts. Finally, concerning governance and policy, there is an urgent need to develop more adequate regulation of conservation biotechnology, as environmental release of genome-edited animals challenges definitions and guidelines in current nature protection laws and GMO regulations. Based on our analysis, we outline key points for further investigation toward a more sustainable approach to conservation biotechnology.
Precision pest management: Genome editing tools, specifically CRISPR/Cas9 and future prospects
35424Ankush Saini, Neha Sharma, Nidhi Sharma, et al., Pesticide Biochemistry and Physiology, 218. 2026-02-03 15:42:17.
The growing resistance to synthetic insecticides and Bt toxins, alongside persistent crop losses despite heavy pesticide application, highlights the urgent need for safer, sustainable and efficient pest management strategies. This review presents genome editing as a precise and versatile approach to reduce pest impact by altering fertility, feeding patterns or vulnerability, while protecting beneficial organisms. Among the genome editing tools, CRISPR/Cas9 (Clustered Regularly Interspaced Short Palindromic Repeats/CRISPR-associated protein 9) is one of the most promising genome editing techniques in insects. It facilitates targeted functional studies, integration with RNAi and dual-expression systems and gene drive applications. Deployment is envisioned in two phases, initial laboratory modification followed by regulated field release, with a strong emphasis on biosafety through terminator genes, marked individuals for gene flow monitoring, optimized dosages, stringent screening and long-term ecological surveillance, along with transparency and adherence to international safety protocols. Significant challenges encompass delivery efficiency, identification of edits, off-target mutations, dose-related efficacy and sterility, unstable transmission and resistance development. Innovations such as base and prime editing minimize unintended mutations by circumventing double-stranded breaks (DSBs), while paratransgenic strategies targeting gut symbionts offer supplementary avenues; plant-mediated insect gene editing emerges as a promising frontier. Overall, carefully regulated trials aligned with policy frameworks and stakeholder involvement are vital to assess effectiveness in natural environments and achieve targeted, dependable and ecologically responsible pest control.
Controversial genetically modified mosquito release paused after backlash in Qld
35305Brandon Long, Australian Broadcasting Corporation, 2025-12-05 17:32:24.
A plan to release genetically modified (GM) mosquitoes in Queensland has been paused, with the organisation behind the idea withdrawing its licence application. Oxitec Australia — a partnership between Australia's CSIRO and US biotech firm Oxitec Ltd — aimed to sell its so-called "friendly" mosquitoes to reduce the spread of diseases like dengue. The plan received backlash from scientists, health experts, and the public, but CSIRO said the step back was not due to concerns about the technology. "This decision was not related to concerns about the technology itself, rather a determination made around the early stage of the company and the necessary financial requirements of holding a licence," a CSIRO spokesperson said.
Malaria Know More: Behind the Science of Gene Drive with Krystal Birungi
35271Malaria No More, 2025-10-29 17:39:23.
Congratulations on being named a 2025 Goalkeepers Champion by the Gates Foundation! What does this acknowledgement mean to you personally and professionally as an advocate for malaria elimination? BIRUNGI: It was pretty exciting and also very validating. Malaria has been around for so long that, for many people, it can seem like it’s no longer a big deal. It’s incredible how it can be glossed over that we’re losing over half a million people a year to a disease that we’ve been fighting for decades. You don’t often get recognized for work in this field, so it means a lot to have something I’m working towards be acknowledged. I was also delighted that this brought such a large platform to the fight against malaria. It has helped draw more attention to what we’re doing, why we’re doing it, and the potential it holds to defeat the disease. This year’s Goalkeepers event and being named a champion, is something I’m incredibly grateful for – not just for myself, but for the impact that it can have for malaria.
Reactions as IUCN Congress votes to adopt Policy on Synthetic Biology, rejects genetic engineering moratorium
35245EnvironNews Nigeria, 2025-10-15 09:12:00.
Following the vote at the IUCN World Conservation Congress, members have rejected a moratorium on genetic engineering of wild species (Motion 133) and adopted the IUCN Policy on Synthetic Biology (Motion 087), a move observers see as a signal of support for a science-based, case-by-case approach to innovation in conservation. The Outreach Network for Gene Drive Research has welcomed the outcome as a vote of confidence in scientific collaboration and evidence-led policymaking. In a statement, the Outreach Network for Gene Drive Research said: “As a coalition that champions the value of responsible research, we welcome the adoption of IUCN’s Policy on Synthetic Biology as a constructive, balanced and science-based approach towards the potential application of this emerging field for conservation. “The escalating biodiversity crisis poses a grave threat to the future of all life on earth, with more than a million species at risk of extinction. Synthetic biology, including genetic engineering, offers new hope for solutions that can rise to the scale and urgency of the challenge.
Should genetically modified wildlife be banned? Scientists weigh the risks
35235Mariana Lenharo, Nature, 2025-10-10 16:01:10.
The global conservation community is debating whether to ban the release of genetically modified organisms into the wild. Dozens of non-governmental organizations have called for a moratorium on field applications of synthetic biology — a technology being studied as a tool to fight diseases, control pests and help endangered species — saying that the approach has unpredictable consequences. But some researchers argue that an outright ban is too restrictive, and could have negative consequences for human health and biodiversity. A proposal for a ban will face a vote next week at a congress of the International Union for Conservation of Nature (IUCN) in Abu Dhabi. The IUCN brings together governments and civil-society organizations to guide global conservation policy. Although decisions made by its members are not legally binding, they do influence legislation in many countries, says biologist Piero Genovesi, head of the Wildlife Service at the Italian Institute for Environmental Protection and Research in Rome. If members vote in favour of the proposed ban, it “could have stronger impacts in areas like Europe or Australia, where there are many lines of research focused on developing new tools based on synthetic biology for improving the efficacy of conservation action”, Genovesi says. He is among more than 240 scientists who have so far signed an open letter asking IUCN members to reject the moratorium.
Engineered Gene Drives
35221Convention on Biological Diversity, 2025-10-05 20:11:01.
This page is dedicated to living modified organisms containing engineered gene drives and was developed further to decision CP-10/10 of the Conference of the Parties serving as a meeting of the Parties to the Cartagena Protocol on Biosafety (COP-MOP).
From fear to leadership: Africa must embrace innovation instead of blocking it
35187Patricia Nanteza, The Observer, 2025-09-27 08:47:22.
In Burkina Faso, the Target Malaria project, a global research consortium aiming to use genetically modified mosquitoes to combat malaria, has faced a major setback. On August 18, 2025, judicial police raided the Research Institute in Health Sciences (IRSS), a key partner in the project. This raid, which scientists described as “brutal” and “humiliating”, involved sealing off offices and laboratories and treating researchers like criminals, searching even their vehicles for mosquitoes! This event occurred just one week after the project had celebrated a milestone on August 11, releasing about 16,000 genetically modified male mosquitoes in the village of Souroukoudingan, the first such release in Africa. The raid prompted Burkina Faso to announce the immediate suspension of all project activities. The Target Malaria project aims to combat malaria by using a gene drive to spread desirable genetic modifications in mosquitoes. The goal is to reduce the number of female Anopheles gambiae mosquitoes, as they are the ones that transmit malaria to humans. This can be achieved by introducing genes that produce enzymes which disrupt specific genes, such as those controlling fertility or sex determination. Since the genetic changes are self-sustaining and inheritable by a high percentage of offspring, the intervention offers a potentially cost-effective and sustainable solution for malaria control. For a country that records over 40,000 deaths from malaria each year, this pause was more than just a political decision – it was a health crisis delayed. The suspension, which followed years of preparation and a previous release of sterile mosquitoes in 2019, was a sobering reminder that Africa, while being the continent most affected by malaria, can also be the first to step back from promising innovations.
Target Malaria activities suspended in Burkina Faso
35087Target Malaria, Target Malaria, 2025-08-28 18:52:04.
The National Biosafety Agency (ANB) and the National Environmental Assessment Agency (ANEVE) responded favourably in July 2025 to the authorisation request submitted by the Target Malaria Burkina Faso team based at the Institute of Health Sciences Research (IRSS) to conduct controlled releases of non gene drive genetically modified male bias mosquitoes. As part of this process, the Ethics Committee for Health Research (CERS) also issued its approval. In addition to the regulatory authorisations obtained from the ANB and ANEVE, the project received agreement from the communities of the field sites to proceed with the activities in their villages. On 11 August 2025, one small scale release of non gene drive genetically modified male bias mosquitoes took place successfully, in accord with terms and conditions of the ANB and ANEVE permits. On 18 August, the national authorities requested the Target Malaria team at IRSS to suspend all their activities. The IRSS team complied with the request. On 22 August, the Ministry of Higher Education, Research and Innovation issued a communiqué informing “the Burkinabè public that it has terminated all the activities of the project Target Malaria on its territory”. The IRSS team, as part of the Target Malaria project, has operated since 2012 in compliance with the national laws of Burkina Faso. We have engaged actively with the national authorities and stakeholders of Burkina Faso and remain ready to cooperate.
Burkina Faso says no to Bill Gates’ plan of creating modified species of mosquitoes
35044Chinedu Okafor and BI Africa Contributor, Business Insider Africa, 2025-08-24 17:02:25.
In a statement published on Friday, officials urged Target Malaria, the initiative's principal NGO, to halt "all activities" in the nation. “All samples will be destroyed according to a strict protocol,” Samuel Pare, chief official at the higher education and research ministry, said in a Friday statement. The move is part of a larger crackdown on foreign-backed NGOs functioning under the present junta. The research, which began in Burkina Faso in 2019, released its first swarm of genetically modified male mosquitoes in the hamlet of Bana, a tiny settlement of around 1,000 people in the country's west. These mosquitoes were developed to limit the reproductive rate of malaria-carrying female mosquitoes, with the long-term objective of reducing the transmission of the illness that kills hundreds of thousands of people each year in Africa. Since its first release, the program has expanded its study to other locations, most recently unleashing new batches of mutated mosquitoes only days before the government's abrupt order to suspend operations. As reported by Bloomberg, campaigns in Africa accuse Target Malaria researchers of worsening the spread.
EPA assessing risk of releasing genetically engineered mosquitoes
35046Gary West, Capital Press, 2025-08-22 17:02:34.
The Environmental Protection Agency has convened a scientific panel to help assess whether genetically engineered mosquitoes could pose a risk to humans. In a paper released Aug. 21, the EPA said that as science advances it expects more proposals to control mosquitoes by releasing males with an implanted trait that prevents their offspring from surviving. Male mosquitoes don’t bite humans, only female mosquitoes bite. But if a female mosquito picks up the genetic flaw, such as a new protein, the protein could be passed onto humans, according to the EPA. The EPA expects the number of genetically engineered female mosquitoes to be low, and it hasn’t determined whether the proteins would be hazardous to humans. But it’s looking to identify the best way to confirm a female mosquito’s salvia doesn’t have novel proteins. The test will help the EPA to assess the risk of exposure to humans. “Female mosquitoes bite humans as a means of reproductive survival and, as a result, this interaction results in a plausible pathway of exposure to novel proteins,” the EPA stated.
Is Gene Drive Research Losing Traction?
35023Gregory C. Lanzaro and Ana M. Kormos, The American Journal of Tropical Medicine and Hygiene, 2025-08-12 16:18:27.
Significant progress has been made in developing gene drives, especially for mosquito vectors of malaria. It is widely agreed that a critical next step in advancing this technology is to evaluate it through small-scale field trials. However, obtaining permission to move forward with these trials has stalled, threatening this potentially transformative line of research. In this paper, roadblocks delaying progress are identified from the perspective of a developer group tasked with translating this technology to the field. We suggest that groups engaged in long-running discussions about risk and the formulation of a global regulatory framework are hindering progress. This is because these groups conflate large-scale deployment with small-scale trials, which have very different risk landscapes. Here we argue that confined field trials are essential for accurately assessing risk and should be conducted soon, with regulation by authorities in the country in which they will be conducted.
Create legal path for gene drive mosquitoes, experts say
34919Samwel Doe Ouma, The Star, 2025-06-23 10:42:22.
As Africa continues to shoulder the global burden of malaria, scientists and policy experts say gene drive technology could offer a groundbreaking solution. But without clear regulatory frameworks and strong community engagement, its deployment could be delayed, risking further loss of life and economic productivity. During the Evidence for Development (EVI4DEV) Conference in Nairobi, hosted by the African Union Development Agency (AUDA-NEPAD), the Science for Africa Foundation (SFA), and the African Institute for Development Policy (AFIDEP), experts called for urgent policy harmonisation and public dialogue to enable the safe rollout of gene drive technology. “Malaria is an African problem, we need to find our own tools to address malaria problems,” said Dr Barbara Glover from AUDA-NEPAD, South Africa. “Africa should be able to innovate new technologies and solutions for African problems.” Gene drive technology targets malaria-transmitting mosquitoes by altering their genetic makeup, specifically the Anopheles gambiae species, to pass on traits such as infertility, reducing mosquito populations over time. The approach, being developed under the Target Malaria consortium, has shown promise in laboratory settings but has not yet been tested in the field. “Gene drives systems promote the biased inheritance of specific genes from one generation to the next,” explained Dr Wiltshire Johnson of AUDA-NEPAD. “Gene drive is deployed when a causal pathway initiated by release of a gene drive system in target mosquito vector species, leading to its transmission to subsequent generations, its increase in frequency and spread in target mosquito populations, its simultaneous propagation of a linked genetic trait aimed at reducing vectorial capacity of plasmodium and reduced vectorial capacity for parasites in target mosquito populations resulting in decreased malaria incidence and prevalence.” Johnson emphasised the urgency of adopting innovative tools amid increasing resistance to existing malaria interventions such as insecticides and drug treatments. “Malaria still kills 600,000 people, causes reduction of 25 percent GDP in Africa countries,” he said. “Even with existing traditional Malaria control tools starting to fail or are showing signs of failure... the deployment and use of gene drive technology will help in solving the malaria problem.”
Rollins presses ahead with latest initiative on New World screwworm
34924HPJ staff, High Plains Journal, 2025-06-19 14:41:39.
U.S. Secretary of Agriculture Brooke Rollins on June 18 announced an $8.5 million sterile New World screwworm fly dispersal facility in south Texas and a five-pronged plan to enhance the U.S. Department of Agriculture’s ability to detect, control and eliminate the pest. In a media release, the USDA noted actions are necessary to finish the fight against NWS and protect the United States. NWS is a devastating pest that causes serious and often deadly damage to livestock, wildlife, pets, and in rare cases, humans. While NWS has been eradicated from the U.S. for decades, recent detections in Mexico as far north as Oaxaca and Veracruz, about 700 miles away from the U.S. border, led to the immediate suspension of live cattle, horse and bison imports through U.S. ports of entry along the southern border on May 11. “The United States has defeated NWS before and we will do it again,” Rollins said. “We do not take lightly the threat NWS poses to our livestock industry, our economy, and our food supply chain. The United States government will use all resources at its disposal to push back NWS, and today’s announcement of a domestic strategy to bolster our border defenses is just the beginning. We have the proven tools, strong domestic and international partnerships, and the grit needed to win this battle.”
The state of regulatory and governance frameworks for gene drives outside of Africa
34865African Genetic Biocontrol Consortium, YouTube, 2025-05-26 21:12:33.
Regional and global perspectives on gene drive regulation. Discussion on the state of regulatory and governance frameworks for gene drives outside of Africa, covering regional priorities and challenges.
Global and regional updates on gene drive governance; AUDA-NEPAD update on regional work
34860African Genetic Biocontrol Consortium, YouTube, 2025-05-26 21:04:00.
AUDA-NEPAD update on regional work. Presentation on AUDA-NEPAD’s initiatives and progress in governance and capacity-building efforts related to synthetic biology, particularly on gene drives.
Economic evaluation of Wolbachia deployment in Colombia: A modeling study
34812Shepard, D.S., Lee, S.R., Halasa-Rappel, Y.A., Rincon Perez, C.W., Harker Roa, A., PLoS One, 20. 2025-05-04 15:55:06.
Wolbachia are bacteria that inhibit dengue virus replication within the mosquito. A cluster-randomized trial in Indonesia found Wolbachia reduced virologically-confirmed dengue cases by 77.1%. Previous models predicted Wolbachia to be highly cost-effective in Indonesia, Vietnam, and Brazil. To inform decisions about future extensions in Colombia, we performed economic evaluations of potential Wolbachia deployments in 11 target cities. We assembled the numbers and distribution by severity of reported dengue cases from Colombia’s national disease surveillance system and the health service provision registry (RIPS). An epidemiological panel of three experts estimated the shares of dengue that were non-medical, under-reported, or misreported as another disease. We determined costs (in 2020 US dollars at market prices) of treating dengue illness from the benchmark insurance tariff and RIPS data on treatment services per symptomatic dengue case. Our central estimates projected 10 years of efficacy and focused on Cali, the target city with the highest number of dengue cases. For Cali, we estimated a net health-sector savings of US$4.95 per person and averting 369 disability-adjusted life years (DALYs) per 100,000 population. From a societal perspective, at 10 years Wolbachia deployment is expected to have highly favorable benefit-cost ratios, with benefits per dollar invested of US$5.50 in Cali and US$4.68 over all target cities. Over 10 years, Wolbachia is highly beneficial on economic grounds, and almost universally cost saving. The Wolbachia program’s economic benefits exceeded its costs in all 11 cities. The program’s savings in healthcare costs alone would more than offset deployment costs nationally and in 9 of 11 target cities. Wolbachia is likely to be the most cost-effective or cost-saving dengue control option in municipalities with both high incidence of dengue and high population density, whereas areas with high dengue incidence but low population density should consider vaccination.
World Malaria Day: Renewing our commitment to end malaria in Africa
34791Damaris Matoke-Muhia, Outreach Network for Gene Drive Research, 2025-04-23 10:14:29.
As the world marks World Malaria Day this week, we are reminded that malaria remains one of the oldest and deadliest diseases in human history. Despite decades of global effort, it continues to claim half a million lives each year. The overwhelming majority of these deaths occur in sub-Saharan Africa, where it is estimated that one person dies of the disease every minute. This year’s World Malaria Day theme: Malaria Ends with Us: Reinvest, Reimagine, Reignite is a reminder that we must renew our commitment to end malaria and rethink our approach to fighting the disease. The malaria burden in Africa remains unacceptably high. The impact of the disease extends beyond health. Malaria strains healthcare systems, reduces productivity, and hinders economic development. In many African countries, malaria-related absenteeism and healthcare costs place a significant burden on families and communities. Over the past two decades, significant progress has been made in the fight against malaria. Control programs involving the distribution of insecticide-treated bed nets, indoor residual spraying, and artemisinin-based combination therapies have resulted in a decline in malaria infections and deaths. But several challenges now threaten these gains. Insecticide resistance is rising, making it harder to control mosquito populations with the tools we have relied on for decades. Antimalarial drug resistance is emerging in some regions, complicating treatment. Urban malaria is becoming a growing concern, in part due to the spread of species such as Anopheles stephensi, a mosquito native to parts of South Asia and the Arabian Peninsula, which has been detected in several African countries. Climate change is shifting transmission dynamics, altering mosquito habitats and infection patterns, bringing malaria to new areas and intensifying the burden of the disease in regions where it was already present. By the 2030s, it is estimated that an additional 147 to 171 million additional Africans could be at risk of malaria.
Experts: One Health approach to help combat zoonotic diseases in Africa
34728Milliam Murigi, People Daily, 2025-03-31 16:41:28.
If African countries are to successfully combat zoonotic diseases, human health, animal health, and environmental health must be treated as one interconnected system. This was revealed in Accra, Ghana, during the second global congress on new and emerging genetic biocontrol technologies. Speaking during the meeting, Misheck Mulumba, the congress president said that, there is no way Africa is going to win this fight if different departments keep seeing rise of zoonotic diseases as a problem for one department and not their mandate. “It is important that different practitioners in all the three departments to work together to combat these infections. These three departments should stop pointing fingers but should instead work together to solve the problems the continent has,” Mulumba said noting Africa must embrace One Health approach. One Health approach is a collaborative, multisectoral, and trans disciplinary strategy that recognizes the interconnection between human health, animal health, and the environment. It emphasises that diseases affecting humans often originate from animals and are influenced by environmental factors, making it essential for experts from different fields such as medicine, veterinary science, environmental science, and public health to work together to prevent and control health threats. With 75 per cent of emerging and reemerging diseases originating from animals, Mulumba notes, it’s clear that tackling these infections requires a collaborative approach. Apart from that, the continent needs to invest in rapid detection, response, and control mechanisms to curb disease outbreaks before they escalate into global health emergencies.
AUDA-NEPAD launches the 2nd edition APET report on gene drives for malaria control and elimination
34657Charles Mugoya, Target Malaria, 2025-03-25 09:09:33.
With support from the African Union Development Agency (AUDA-NEPAD), the African Union published its 1st APET report in 2018 which noted that that, while the existing mosquito control interventions have significantly reduced the burden of malaria across Africa, complementary new interventions were very much needed to drive the residual burden towards zero and eventually achieve malaria elimination on the continent. African countries were urged to invest in the development and regulation of gene drive technology, whose greatest and most urgent application will be in malaria control and elimination. To this end, African Union (AU) held a Summit in Addis Ababa from 10 -15 February 2025 in which, AUDA-NEPAD took the opportunity to organize a side event to launch the 2nd APET report. The report provides very useful insights on genetically based vector control tools in general and gene drive in particular. The 2nd APET edition report comprises 9 sections that convey messages to update a diverse community of stakeholders on progress and current state of research and development efforts with recommendations for gene drive technology advancement.
Gene drives. Technologies for spreading genetic modifications in populations. TAB-Fokus
34652König, H., Kolleck, A., Sauter, A., TAB-Fokus, 48. 2025-03-21 07:04:16.
Gene drives have the potential to help solve major challenges, including the fight against invasive species or vector-borne diseases such as malaria. These hopes are offset by technical and scientific challenges as well as environmental risks. The policy brief TAB-Fokus no. 48 on the opportunities and risks of a technology for spreading desirable traits in populations summarises the most important results of the TA project for the German Bundestag on four pages (and is also available as a web version - see relation in KITopen). Detailed results can be found in the final report - see relation in KITopen).
Ghana committed to exploring gene drive to combat malaria – Minister
34638Ghana News Agency, 2025-03-20 14:31:41.
Ghana has expressed interest in exploring gene drive technology as a new approach to combatting malaria. The country is open to adopting technology that is cost-effective, efficient, harmless and has the potential to significantly reduce malaria transmission, especially in areas where traditional control methods have failed. Dr. Ibrahim Murtala Muhammed, the Minister of Environment, Science, and Technology gave the assurance in an interview with journalists after opening the Second Global Genetic Biocontrol Congress in Accra. Scientists, researchers, and stakeholders from 25 institutions drawn from 15 countries are participating in the conference on the theme: “Harnessing genetic biocontrol potential solutions in changing climate.” Describing Malaria as a “serious threat,” Dr. Muhammed said the burden of malaria on Africa’s economy was high as the continent spent millions of dollars on malaria control. He said Ghana would adopt emerging technologies to help support disease prevention including those that affect crops “as long as it does not affect our survival as human beings.” People who are against GMO have several cultural issues and social issues. But the question is, is it the way to go now?
Ghana hosts 2nd Global Congress on new, emerging genetic biocontrol technologies
34634Ama Kudom-Agyemang, EnviroNews Nigeria, 2025-03-13 14:22:11.
From Monday, March 17 to Thursday, March 20, 2025, Ghana is hosting a gathering of science, health and communication experts to deliberate on and contribute to innovative scientific exploits for Africa’s health sector. The over 150 African national and international professionals from scientific institutions, academia, pharmaceuticals, biotechnology researchers, development and clinical organisations as well as science communicators would be brainstorming on new and emerging genetic biocontrol technologies that can tackle vector-borne diseases such as malaria, by sharing experiences and lessons across diverse disciplines related to genetic biocontrol technologies. The four-day gathering is the 2nd Global Congress in Africa on new and emerging genetic biocontrol technologies. The 1st Global Congress was held in Nairobi, Kenya in August, 2023. Ghana’s National Biosafety Authority (NBA) and the African Genetic Biocontrol Consortium (The Consortium) are jointly organising this 2nd Congress on the theme: “Harnessing genetic biocontrol potential solutions in a changing climate.”
Gene drive modified mosquitoes offer new tool for malaria elimination efforts
34615Conrad Duncan, Imperial, 2025-03-13 11:59:36.
Transmission Zero, a research team from Imperial College London in partnership with the Ifakara Health Institute and the National Institute of Medical Research in Tanzania, has developed genetic technology which renders a mosquito unable to transmit the malaria parasite and has a gene drive that ensures that future generations are also resistant to the parasite. The technology could significantly reduce the malaria burden in high-risk countries, saving hundreds of thousands of lives each year, especially among children – who are disproportionately at risk from the disease. The work of Transmission Zero has been highlighted in a new Global Development Hub STEM for Development Impact Memo authored by Professor George K. Christophides, Professor of Infectious Disease and Immunity at Imperial, Dr Nikolai Windbichler, Reader in Genetics at Imperial, and Dr Dickson Wilson Lwetoijera, Principal Research Scientist at Ifakara Health Institute in Tanzania. Professor Christophides from Imperial’s Department of Life Sciences said: “The solutions we currently have for malaria are not enough – we need something new. “Our technology is equitable, it offers hope in the fight against malaria and doesn’t present economic or social barriers to malaria intervention access.”
2nd Edition Report: Gene Drives for Malaria Control and Elimination in Africa
34579African Union High-Level Panel on Emerging Technologies, APET Secretariat, 2025-03-12 16:43:52.
Malaria continues to impose a significant economic and public health burden on Africa. In 2021, the continent accounted for 95% of the global 247 million new malaria cases and 96% of the 619,000 malaria-related deaths. Notably, over three-quarters (77%) of these deaths occurred among children under the age of five. At present, ten countries—Burkina Faso, Cameroon, the Democratic Republic of the Congo, Ghana, Mali, Mozambique, Niger, Nigeria, Uganda, and the United Republic of Tanzania—have been classified as High Burden, High Impact (HBHI) nations, collectively contributing to 68% of all malaria cases and 70% of malaria-related fatalities globally. Furthermore, approximately 1,031,000,000 individuals across Africa are estimated to be at risk of contracting malaria. Extensive studies have consistently demonstrated a strong correlation between economic development rates and the burden of malaria, underscoring malaria’s role as a critical impediment to economic progress. The direct economic costs of malaria are substantial, placing immense strain on the limited resources of the affected African nations. Countries severely burdened by malaria exhibit Gross Domestic Products (GDPs) that are up to five times lower than those of malaria-free nations. The annual economic growth loss in endemic countries is estimated at 1.3%, equating to as much as US$12 billion in lost productivity. Moreover, malaria contributes to between 5-8% of school absenteeism among African children and causes an additional 2.4 to 6.5 days of absenteeism per student. The costs associated with malaria prevention and treatment further highlight the economic challenge. The annual cost of protecting one individual against malaria ranges from US$1.18 to US$5.97 through vector control measures. Diagnosis costs have a median of US$6, while treatment costs for each case vary depending on severity, ranging from US$9 to US$89.93. As such, malaria remains the foremost public health priority in Africa, with the costs of treatment and disease prevention far exceeding the financial capacities of most African governments. A further pressing concern is the recent introduction and establishment of Anopheles stephensi, a species of mosquito that poses a significant threat to the Horn of Africa and beyond. This invasive species, which tends to bite outdoors, could exacerbate the existing malaria burden and undermine the gains made in malaria control over the past two decades. The global response to malaria control heavily relies on donor funding, which is currently only sufficient to meet half of the required global funding targets. This reliance on external financing is unsustainable and highly vulnerable to shifts in political priorities in donor countries. Approximately a quarter of the global malaria funding is directed to Africa for the provision of insecticide-treated nets, rapid diagnostic tests, and medicines, while national funding should cover the operating costs of the broader health sector. Existing malaria control measures, including the use of Long-Lasting Insecticidal Nets (LLINs), Indoor Residual Spraying (IRS), and Larval Source Management (LSM), have demonstrated limited effectiveness, especially against the newly introduced invasive mosquito species. This underscores the necessity for the development and adoption of innovative mosquito control approaches, such as Attractive Targeted Sugar Bait (ATSB), Endocticides, Improved Housing, Sterile Insect Technique (SIT), and Paratransgenesis. Research into these methods is ongoing, and their potential for improving malaria control strategies is considerable. To supplement existing malaria control efforts, innovative technologies like Gene Drive present promising long-term solutions to protect the most vulnerable populations and address the malaria burden in Africa. The African Union (AU) has recognised the potential of Gene Drive technology and has endorsed its development, with support from the African Union Development Agency (AUDA-NEPAD). This initiative aims to foster conducive environments for research, develop regulatory frameworks, and engage stakeholders across African Union Member States, ensuring a collaborative approach to the ongoing fight against malaria.
Wolbachia-Based Approaches to Controlling Mosquito-Borne Viral Threats: Innovations, AI Integration, and Future Directions in the Context of Climate Change
34249Branda, F., Cella, E., Scarpa, F., et al., Viruses, 16:1868. 2025-01-13 14:55:50.
Wolbachia-based mosquito control strategies have gained significant attention as a sustainable approach to reduce the transmission of vector-borne diseases such as dengue, Zika, and chikungunya. These endosymbiotic bacteria can limit the ability of mosquitoes to transmit pathogens, offering a promising alternative to traditional chemical-based interventions. With the growing impact of climate change on mosquito population dynamics and disease transmission, Wolbachia interventions represent an adaptable and resilient strategy for mitigating the public health burden of vector-borne diseases. Changes in temperature, humidity, and rainfall patterns can alter mosquito breeding habitats and extend the geographical range of disease vectors, increasing the urgency for effective control measures. This review highlights innovations in Wolbachia-based mosquito control and explores future directions in the context of climate change. It emphasizes the integration of Wolbachia with other biological approaches and the need for multidisciplinary efforts to address climate-amplified disease risks. As ecosystems shift, Wolbachia interventions could be crucial in reducing mosquito-borne diseases, especially in vulnerable regions. AI integration in Wolbachia research presents opportunities to enhance mosquito control strategies by modeling ecological data, predicting mosquito dynamics, and optimizing intervention outcomes. Key areas include refining release strategies, real-time monitoring, and scaling interventions. Future opportunities lie in advancing AI-driven approaches for integrating Wolbachia with other vector control measures, promoting adaptive, data-driven responses to climate-amplified disease transmission.
Kenya Set to Introduce GMO Maize After Public Consultation Period
34217Martin Olage, Mwakilishi, 2025-01-07 20:44:12.
The National Biosafety Authority (NBA) has completed a month-long public consultation regarding the potential market introduction of Genetically Modified (GM) maize, specifically known as BT Maize. This consultation, initiated in mid-December after an official notice on December 6, 2024, gathered feedback from Kenyan citizens as part of its due diligence process. This initiative follows a licensing request made by the Kenya Agricultural and Livestock Research Organisation (Kalro) and the African Agricultural Technology Foundation (AATF). The organizations aim to bring BT Maize—developed by Bayer Company and licensed to the TELA Maize project—into the market. This genetically modified maize is engineered to resist pests such as stem borers and fall armyworms, potentially decreasing the reliance on chemical insecticides in agriculture. Historically, Kenya has cultivated genetically modified crops for non-food purposes, including BT Cotton. The NBA has been active in conducting field trials with various GM crops: these include water-efficient maize in Makueni, enhanced maize suited for African agricultural conditions in Kitale, and virus-resistant sweet potatoes and cassava in Kakamega and Thika. Current trials are also evaluating GM potatoes in Nakuru and Kiambu, along with the cultivation of purple gypsophilia flowers in Naivasha. Kalro and AATF advocate that BT Maize presents a vital solution for minimizing crop damage caused by pests. They stress that the maize contains specific genes sourced from Bacillus thuringiensis, effectively targeting particular lepidopteran pests.
Healthcare delivery in Africa still a big challenge, health experts warn
33880KBC News, 2024-12-10 16:59:08.
The adoption or harnessing of emerging technologies in the healthcare system in Africa to improve healthcare delivery remains low. It is reported that while the continent forms 18% of the global population, Africa accounts for 25% of the global diseases. Though there are already efforts by various member states to harness emerging technologies in healthcare, there are still barriers that need to be addressed to fully leverage the potential of emerging technologies to revolutionize healthcare systems across the continent. It is on this backdrop that regional economic communities (RECs) from East Africa, West African Health Organizations COMESA and Intergovernmental Authority on Development, gathered in Nairobi for a two-day forum to address challenges facing the countries in the region in the adoption of the emerging technologies in the health sector.
Navigating biosafety regulatory frameworks for genetic engineering in Africa: a focus on genome editing and gene drive technologies
33383Tilahun Rabuma, Felix Moronta-Barrios, Wendy Craig, Frontiers in Bioengineering and Biotechnology, 12. 2024-11-04 16:05:02.
Genome editing and gene drive technologies are increasingly gaining attraction in Africa, with researchers exploring their potential applications in agriculture, health and the environment. Acknowledging that robust regulatory frameworks are crucial in facilitating the development and utilization of these technologies, informed decision-making is, however, being impeded by the fragmented information availability and readiness of regulatory authorities on the continent. This study investigates the regulatory frameworks governing genome editing and gene drive technologies in African countries, identifies common regulatory challenges and proposes actionable solutions. Primary data were collected through questionnaires and complemented by analyzing existing biosafety regulations from online databases and scientific literature. Our findings suggest that while a few African countries have recently updated their regulatory frameworks, many are still under discussion. Challenges to development and implementation include limited resources, expertise, awareness, and public resistance. The findings underscore the urgent need for further development in regulatory capacities. By shedding light on these challenges, our study could provide African regulators with valuable insights to guide the formulation of effective regulatory frameworks. Such frameworks are essential for harnessing the potential of genome editing and gene drive technologies while safeguarding human health and the environment in Africa.
Exploring new tools to fight vector-borne diseases: research and governance implications
32541Alekos Simoni, Outreach Network for Gene Drive Research, 2024-10-08 12:24:29.
I recently had the honor and pleasure of attending an event co-organized by the Outreach Network for Gene Drive Research at the European Parliament in Brussels, and delivering a presentation on our work at Target Malaria to develop new genetic tools to reduce malaria transmission in Africa. The event was an opportunity to discuss advancements in the development of gene drive technologies and governance implications related to these new tools. With climate change creating favorable conditions for the spread of disease-carrying mosquitoes, and challenges such as drug and insecticide resistance threatening the efficacy of current interventions, a global, coordinated response is needed to tackle vector-borne diseases. In this context, gene drive technologies could offer a promising addition to existing approaches. MEP Charles Goerens opened the session by highlighting the global burden of vector-borne diseases, such as malaria and dengue, which cause over 700,000 deaths every year. He stressed the importance of innovation to address global health challenges and the critical role of the European Parliament in ensuring responsible oversight of new tools, such as gene drive technologies.
Bill Gates’ Efforts To Eradicate Malaria And The Economic Impact Of Ridding The Globe Of This Disease
31585Kaili Killpack, Yahoo Finance, 2024-09-17 10:18:40.
In a compelling drive to eradicate one of the world’s deadliest diseases, Bill Gates is leveraging his substantial influence and resources to tackle malaria with renewed vigor. His foundation's recent initiatives are centered around a multi-faceted approach that blends cutting-edge technology with grassroots interventions. Gates highlights the strategic investment in next-generation mosquito control methods, such as genetically modified insects that target and disrupt malaria transmission. This ambitious endeavor is complemented by an increased focus on innovative treatments and vaccines, aiming to outpace the disease's adaptability. Gates’ commitment underscores a broader global effort to turn the tide against malaria, demonstrating that through a combination of scientific innovation and dedicated funding, the fight against this ancient scourge is on the brink of a transformative breakthrough.
A bumpy road ahead for genetic biocontainment
28833George, D.R., Danciu, M., Davenport, P.W. et al, Nature Communications, 2024-01-23 18:15:26.
The environmental release of bioengineered organisms is increasingly being suggested for a variety of applications, including bioremediation, biosequestration, bio-mining, environmental biosensing and conservation. The objectives of many environmental release applications shift the goals of biocontainment from preventing organism spread outside of closed spaces (e.g., laboratories or bioreactors) to managing the persistence of engineered organisms and their genetic material in open, dynamic environments. In the scientific literature, discussions of environmental release are often accompanied by calls for robust “intrinsic biocontainment”, where containment mechanisms are genetically engineered into the organism to limit and control its spread and persistence. A number of intrinsic biocontainment approaches have so far been proposed, and can be grouped into two overarching strategies. First, gene-flow barriers attempt to limit the spread of genetic material through lateral gene transfer, which refers to the ability of cells to directly exchange DNA molecules with one another or absorb DNA from external environmental sources. This can be accomplished through conditional lethality strategies (such as toxin anti-toxin systems or targeted DNA degradation), or through limiting plasmid replication or deleting natural competence genes from target cells. Second, strain/host control strategies seek to prevent survival and growth of engineered microbes outside specific environmental conditions using growth restriction and fitness control strategies such as metabolic auxotrophy, kill switches, and conditional essentiality. Over the past decade, researchers and developers have expanded the technical toolkit of intrinsic biocontainment techniques, with new approaches using orthogonal sequences, synthetic auxotrophy, CRISPR-based kill switches, sequence-entanglement, and “cell-free” systems.
Consultation on a draft National Gene Drive Policy Guide
28786Commonwealth of Australia (Department of Health and Aged Care), National Gene Technology Scheme, 2024-01-02 13:43:01.
The term gene drive is used to describe organisms which have been genetically modified to increase the rate for a particular trait to spread through a sexually reproducing population, spreading the genes or traits through a species at a faster rate than normal inheritance. An example might be a trait to increase likelihood of offspring to be female and thereby suppress the population of the targeted pest species. The concept of a gene drive is not a new one; these dominant genes – sometimes called selfish genes – are abundant in nature. However, GM gene drive organisms have the potential to be useful for addressing some of the environmental, agricultural, and public health challenges currently faced by Australia, such as conserving native populations, controlling significant exotic pests, or providing public health benefits. As an evolving technology, gene drives may pose risks that are not yet fully understood, including the potential to alter the ecosystem in unpredictable ways. These risks should be acknowledged and managed in a structured and systematic way if Australia wishes to be a future beneficiary of this technology. The Third Review (the Review) of the National Gene Technology Scheme (Scheme), endorsed by all Australian governments on 11 October 2018, recommended “clarifying, and where necessary strengthening, the mechanisms for regulating the environmental release of GM gene drive organisms in Australia” (Recommendation 7b). Review Recommendation 7b and development of the National Gene Drive Policy Guide (Policy Guide) cannot be considered in isolation.
Bioinformatic and literature assessment of toxicity and allergenicity of a CRISPR-Cas9 engineered gene drive to control Anopheles gambiae the mosquito vector of human malaria
27626A. Qureshi and J. B. Connolly, Malaria Journal, 22:234. 2023-08-14 10:10:18.
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, (ii) 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.
Proposed Changes to the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines)
27609National Institutes of Health, Federal Register, 2023-08-10 08:09:09.
The National Institutes of Health (NIH) seeks input on a proposal to revise the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines) to include specific considerations and requirements for conducting research involving gene drive modified organisms (GDMO) in contained research settings. NIH is proposing to update the NIH Guidelines to clarify minimum containment requirements, propose considerations for performing risk assessments, and define additional institutional responsibilities regarding Institutional Biosafety Committees (IBCs) and Biosafety Officers (BSOs). The proposed revisions are specific to GDMO research subject to the NIH Guidelines, conducted in contained settings and are consistent with the recommendations of the NIH Novel and Exceptional Technology Research Advisory Committee report, Gene Drives in Biomedical Research (NExTRAC Report). NIH does not currently support research involving potential field release of GDMOs and the NIH Guidelines pertain to contained research; accordingly, no changes regarding potential field release are being proposed in this Notice. NIH is also proposing revisions to the NIH Guidelines to harmonize with the Biosafety in Microbiological and Biomedical Laboratories (BMBL), 6th edition regarding the Risk Group (RG) categorization of West Nile Virus (WNV) and Saint Louis Encephalitis Virus (SLEV).
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.
Requirements for market entry of gene drive-modified mosquitoes for control of vector-borne diseases: analogies to other biologic and biotechnology products
26281S. L. James, H. Quemada, M. Q. Benedict and B. Dass, Frontiers in Bioengineering and Biotechnology, 11:1205865. 2023-06-08 10:56:02.
Gene drive-modified mosquitoes (GDMMs) are proposed as new tools for control and elimination of malaria and other mosquito-borne diseases, and promising results have been observed from testing conducted in containment. Although still at an early stage of development, it is important to begin now to consider approval procedures and market entry strategies for the eventual implementation of GDMMs in the context of disease control programs, as these could impact future research plans. It is expected that, as for other types of new products, those seeking to bring GDMMs to market will be required to provide sufficient information to allow the regulator(s) to determine whether the product is safe and effective for its proposed use. There already has been much emphasis on developing requirements for the biosafety components of the "safe and effective" benchmark, largely concerned with their regulation as genetically modified organisms. Other potential approval requirements have received little attention, however. Although GDMMs are expected to be implemented primarily in the context of public health programs, any regulatory analogies to other public health products, such as pharmaceuticals, vaccines, or chemical pesticides, must take into account the characteristics of live mosquito products. Typical manufacturing standards related to product identity, potency or quality will need to be adapted to GDMMs. Valuable lessons can be drawn from the regulatory approval processes for other whole organism and genetically modified (GM) organism products. Supply chain requirements, such as scale of production, location and design of production facilities, and methods of distribution and delivery, will be dependent upon the characteristics of the particular GDMM product, the conditions of use, and the region to be served. Plans for fulfilling supply chain needs can build upon experience in the development of other live insect products for use in public health and agriculture. Implementation of GDMMs would benefit from additional research on enabling technologies for long-term storage of mosquito life stages, efficient mass production, and area-wide delivery of GDMMs. Early consideration of these practical requirements for market entry will help to mitigate downstream delays in the development of these promising new technologies.
An economic evaluation of Wolbachia deployments for dengue control in Vietnam
25418H. C. Turner, D. L. Quyen, R. Dias, P. T. Huong, C. P. Simmons and K. L. Anders, PLOS Neglected Tropical Diseases, 17:e0011356. 2023-05-30 07:56:11.
INTRODUCTION: Dengue is a major public health challenge and a growing problem due to climate change. The release of Aedes aegypti mosquitoes infected with the intracellular bacterium Wolbachia is a novel form of vector control against dengue. However, there remains a need to evaluate the benefits of such an intervention at a large scale. In this paper, we evaluate the potential economic impact and cost-effectiveness of scaled Wolbachia deployments as a form of dengue control in Vietnam-targeted at the highest burden urban areas. METHODS: Ten settings within Vietnam were identified as priority locations for potential future Wolbachia deployments (using a population replacement strategy). The effectiveness of Wolbachia deployments in reducing the incidence of symptomatic dengue cases was assumed to be 75%. We assumed that the intervention would maintain this effectiveness for at least 20 years (but tested this assumption in the sensitivity analysis). A cost-utility analysis and cost-benefit analysis were conducted. RESULTS: From the health sector perspective, the Wolbachia intervention was projected to cost US$420 per disability-adjusted life year (DALY) averted. From the societal perspective, the overall cost-effectiveness ratio was negative, i.e. the economic benefits outweighed the costs. These results are contingent on the long-term effectiveness of Wolbachia releases being sustained for 20 years. However, the intervention was still classed as cost-effective across the majority of the settings when assuming only 10 years of benefits. CONCLUSION: Overall, we found that targeting high burden cities with Wolbachia deployments would be a cost-effective intervention in Vietnam and generate notable broader benefits besides health gains.
Gene Drives as Interventions into Nature: the Coproduction of Ontology and Morality in the Gene Drive Debate
25114K. Boersma, B. Bovenkerk and D. Ludwig, NanoEthics, 17:4. 2023-04-22 10:10:41.
Gene drives are potentially ontologically and morally disruptive technologies. The potential to shape evolutionary processes and to eradicate (e.g. malaria-transmitting or invasive) populations raises ontological questions about evolution, nature, and wilderness. The transformative promises and perils of gene drives also raise pressing ethical and political concerns. The aim of this article is to arrive at a better understanding of the gene drive debate by analysing how ontological and moral assumptions are coproduced in this debate. Combining philosophical analysis with a critical reading of the gene drive literature and an ethnographic study of two leading research groups, the article explores the hypothesis that the development of and debate about gene drives are characterized by a particular intervention-oriented mode of coproduction. Based on the results of this exploration, we highlight the need for a broadening of the perspective on gene drives in which empirical, moral, and ontological concerns are addressed explicitly in their interplay rather than in (disciplinary) isolation from each other.
Defining transformation events for gene drive in species complexes
25001J. B. Connolly, IOBC-WPRS Bulletin, 163:8-20. 2023-04-13 15:11:40.
Engineered gene drives (EGDs) that allow the super-Mendelian inheritance of genetic traits could one day be used to reduce the vectorial capacity of Anopheles species that transmit human malaria in Africa. Many Anopheles species belong to complexes of closely related sibling species that can produce fertile interspecific hybrid females. In cases where the genomic target locus of the EGD is conserved amongst sibling species from the same complex as the released target species, it would therefore be plausible that the EGD could be vertically transmitted from the target species to sibling species by interspecific mating. To differentiate genetically modified organisms, the term ‘transformation event’ is used, based on the specific genomic location of the transgenic construct, as a result of random genomic integration. In contrast, an EGD is generated via its precise and reproducible insertion in its specific genomic target locus. These considerations pose two key questions for the use of EGD in species complexes: (i) what does the definition of “transformation event” mean in the context of vertical gene drive transfer of the EGD to sibling species in species complexes and (ii) does de novo transformation of an EGD into a sibling species constitute the same transformation event as introgression by backcrossing into a sibling species of an EGD that had been originally transformed in the target species? While definitions of the term transformation event that have been provided by national and intergovernmental organisations are somewhat ambiguous, they do provide scope for broad interpretation of vertical gene drive transfer of a specific EGD to different sibling species of the target species as the same transformation event. There also appears to be some consensus that definitions of transformation event support the notion that de novo transformations of an EGD in sibling species constitute the same transformation events as introgression by backcrossing into sibling species of an EGD that had been originally inserted in the target species.
Convention on Biological Diversity Process
34382GeneConvene Global Collaborative, 2023-04-11 13:11:27.
The image describes organizational elements and hierarchy within the United Nations system to situate the activities undertaken for the implementation of the Convention on Biological Diversity (CBD, effective Dec 1993) and its supplementary treaty the Cartagena Protocol on Biosafety to the CBD (effective Sept 2003). It also outlines the two yearly cycle of events and workflow via meetings such as the COP (Conference of the Parties) and MOP (Meeting of the Parties) organized by the CBD Secretariat to support representatives of Parties, non-Parties, non-governmental organizations and other associated organizations, and observers to discuss past work and establish future areas/programs of work related to the implementation of the treaties.
A gene drive is a gene drive: the debate over lumping or splitting definitions
24910S. L. James, D. A. O'Brochta, F. Randazzo and O. Akbari, Nature Communications, 2023-03-29 12:22:20.
Gene drive technologies are being considered as a new approach to address a variety of currently intractable global problems, including to prevent disease transmission, reduce crop loss, and preserve biodiversity1. There are some outside the genetics research community who argue that wide use of the term “gene drive” to encompass selfish genetic elements found either in extant organisms (natural gene drives) or assembled in the laboratory (synthetic gene drives) will discourage the necessary scrutiny of risks that may be associated with the introduction of synthetic gene drives into free-living populations of target organisms2,3. Here we argue that the current definition is both scientifically sound and promotes good governance.
Evolution driven by genetic engineering should be known as ‘genetic welding’ to draw scientific and ethical scrutiny
24940S. Moore, AZO Life Sciences, 2023-03-29 10:13:27.
The advent of CRISPR-Cas9 technology has been revolutionary, but it has also been highly controversial. In an opinion paper published in the journal Trends in Genetics, evolutionary geneticist Asher Cutter highlights the importance of coining the term ‘genetic welding’ for the anthropogenic manipulation of genetic drive made possible by tools such as CRISPR-Cas9. Separating this process from other processes that influence evolution might be fundamental to ensuring proper consideration is given to the potential future outcomes of genetic welding.
Regulatory and policy considerations for the implementation of gene drive-modified mosquitoes to prevent malaria transmission
24859S. L. James, B. Dass and H. Quemada, Transgenic Research, 32:17. 2023-03-15 15:00:05.
Gene drive-modified mosquitoes (GDMMs) are being developed as possible new tools to prevent transmission of malaria and other mosquito-borne diseases. To date no GDMMs have yet undergone field testing. This early stage is an opportune time for developers, supporters, and possible users to begin to consider the potential regulatory requirements for eventual implementation of these technologies in national or regional public health programs, especially as some of the practical implications of these requirements may take considerable planning, time and coordination to address. Several currently unresolved regulatory questions pertinent to the implementation of GDMMs are examined, including: how the product will be defined; what the registration/approval process will be for placing new GDMM products on the market; how the potential for transboundary movement of GDMMs can be addressed; and what role might be played by existing multinational bodies and agreements in authorization decisions. Regulation and policies applied for registration of other genetically modified organisms or other living mosquito products are assessed for relevance to the use case of GDMMs to prevent malaria in Africa. Multiple national authorities are likely to be involved in decision-making, according to existing laws in place within each country for certain product classes. Requirements under the Cartagena Protocol on Biodiversity will be considered relevant in most countries, as may existing regulatory frameworks for conventional pesticide, medical, and biocontrol products. Experience suggests that standard regulatory processes, evidence requirements, and liability laws differ from country to country. Regional mechanisms will be useful to address some of the important challenges.
Engagement on risk assessment for gene drive mosquitoes by EFSA and Target Malaria
24794S. Hartley, A. Kokotovich, Y. Devos and J. Mumford, Environmental Science and Policy, 142:183-193. 2023-02-27 11:12:07.
As engineered gene drive technologies continue to advance, many actors are actively considering how environmental risk assessments (RAs) for gene drive organisms should be conducted, and how stakeholder engagement opportunities should be provided. There is, however, a lack of clarity concerning what constitutes engagement on gene drive RA and, furthermore, what forms of engagement already exist around gene drive RA. To address this gap, we reflect on the actions of a risk assessor (the European Food Safety Authority, EFSA) and a gene drive developer (Target Malaria) to understand: 1) the RA-related decisions that each are making concerning gene drive technology for mosquitoes and other harmful insects, 2) the existing role of engagement in those decisions, and 3) the implications for our understandings of engagement and RA. We found, first, that both EFSA and Target Malaria have already made many RA-related decisions, even though any preparation and evaluation of a formal RA for gene drive mosquitoes remains far off. This finding supports the idea that gene drive RA involves multiple processes and decisions in different forms across the entire technology and regulatory development process. Second, we found that both EFSA and Target Malaria have already integrated engagement into their respective RA-related decisions in different ways, reflecting their different roles. We conclude by considering how EFSA and Target Malaria could improve their existing RA-related engagement by explicitly considering disciplinary diversity and worldview diversity in their related decision making.
Review of gene drive modelling and implications for risk assessment of gene drive organisms
24722J. L. Frieß, C. R. Lalyer, B. Giese, S. Simon and M. Otto, Ecological Modelling, 478:110285. 2023-02-13 09:34:10.
Synthetic gene drive (GD) systems constitute a form of novel invasive environmental biotechnology with far-reaching consequences beyond those of other known genetically modified organisms (GMOs). During the last 10 years, the development of GD systems has been closely linked to mathematical modelling which can provide feedback on how to achieve gene drive spread but also may be used to predict the ecological consequences of a gene drive release. GMOs, thus also GD systems, need to pass an environmental risk assessment (ERA) prior to a release into the environment. Models in this respect may play an important role because a release of GD organisms, even at a small scale, may not be reversible. In our review, we analyse the scope and structure of existing models to examine how they may assist the ERA. Our analysis reveals that a majority of models so far are deterministic, non-spatial and not tailored for a specific target organism. Models often use simplified assumptions on the biology of the species and seem to be made to test the effectiveness of the drive. Few models go beyond this and verify whether model predictions may be realistic under field conditions. We identified four advanced models that we judged to be the most ecologically realistic and compared the implemented parameters with ERA requirements by the European Food Safety Authority (EFSA) and World Health Organization (WHO) for genetically modified insects and mosquitoes. Although a number of abiotic and biotic factors are already considered in these models, mating-related factors and traits relevant to the interactions between the GMO and target organisms and with other species are largely excluded. Overall, our results show that biological and ecological realism are still poorly realized in current models and that most models aim to predict efficacy rather than ecological effects. Given the complexity of natural ecosystems, it may not be possible to compile a single model to cover all complexities. Thus, models should be further developed with the purpose to assist specific questions related to the risk assessment of GDs. Moreover, uncertainty will be a key issue for any model used in RA and we see the need to improve this aspect when modelling gene drives.
Social justice environmental activists move to block gene editing to control invasive species and promote biodiversity. Here’s why they’re misguided
24701S. Smyth, Genetic Literacy Project, 2023-02-07 12:46:02.
Control of invasive species has been extremely difficult with eradication virtually impossible. To control invasive plant species, chemicals are commonly used while in some instances removal of plants by hand, as Shiva advocates, is undertaken. Efforts to control invasive animals include poisoning and shooting. Needless to say, these ‘control techniques’ are inefficient and often harmful to the applicators. Advances in genetics potentially offer new solutions, using gene editing technology to create sterile populations. Sterility is a natural trait in mammals, which can be induced into invasive animals as a means of population control. Invasive pests can be captured, gene-edited to confer sterility in future generations and then released back into the wild. The offspring will gradually without the use of chemicals or hand labor contribute to reduced populations. Applying gene editing technologies is not an instantaneous solution, but they may be part of a long-term strategy.
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.
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.
East African policy dialogue on research of genetically modified mosquitoes for malaria control and elimination
24112C. Mugoya, Target Malaria, 2022-12-02 09:27:43.
The East African Community Secretariat, in collaboration with the East African Health Research Commission; NEPAD, AFIDEP and IFAKARA Health Institute recently convened an East African regional dialogue in Dar es salaam, Tanzania from 17-19 November 2022 to deliberate the way forward on the legal and regulatory frameworks guiding research on genetically modified mosquitoes to solve the problem of malaria in the East African region. The dialogue was attended by legislators from the seven countries of the East African Community partner states – Kenya, Uganda, Tanzania, Burundi, DR Congo, Rwanda and South Sudan, policy makers, government officials, and health experts including biotechnology/biosafety regulators.
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.
Influence of public hesitancy and receptivity on reactive behaviours towards releases of male Wolbachia-Aedes mosquitoes for dengue control
23860M. O. Lwin, Z. Ong, C. Panchapakesan, A. Sheldenkar, L. T. Soh, I. Chen, X. Li, W. Niah, K. Vasquez, S. Sim and L.-C. Ng, PLOS Neglected Tropical Diseases, 16:e0010910. 2022-11-11 10:06:20.
Singapore, a highly urbanized Asian tropical country that experiences periodic dengue outbreaks, is piloting field releases of male Wolbachia-carrying Aedes aegyptimosquitoes with the aim of suppressing urban populations of the primary dengue vector Aedes aegypti. This study proposes and assesses a model to explain the roles of hesitancy and receptivity towards Project Wolbachia–Singapore in influencing reactive mosquito prevention behaviors (reactive behaviors) towards the release of Wolbachia-Aedes mosquitoes for residents living in the release sites. Interestingly, both hesitancy and receptivity predicted greater instances of reactive behaviors. The model also examines the roles of general knowledge about Wolbachia technology, perceived severity of mosquito bites, perceived density of mosquitoes, and social responsibility as predictors of hesitancy, receptivity, and reactive behaviors towards the release of Wolbachia-Aedes mosquitoes. Hesitancy towards the project mediated the effects of general knowledge, perceived severity of mosquito bites, and perceived density of mosquitoes on reactive behaviors towards the releases, although receptivity towards the project did not. Having less knowledge about Project Wolbachia–Singapore was associated with higher hesitancy towards the project and higher likelihood of performing reactive behaviors towards the releases. Individuals who perceive mosquito bites to be more severe and think that there are more mosquitoes in their living environments were also more likely to be hesitant about the project and practice reactive behaviors. However, both hesitancy and receptivity towards the project mediated the effect of social responsibility on reactive behaviors. Receptivity towards the project was driven by social responsibility, which was also associated with reduced hesitancy towards the project. Our findings suggest that, to address the hesitancy reported by a minority of participants, future outreach efforts should focus on strengthening the public’s sense of social responsibility
WORLDWIDE: EXPERTS ON GENE DRIVES
23840Stop Gene Drive, STOP GENE DRIVES, 2022-11-07 09:51:54.
We are travelling the world speaking to some of the world’s leading thinkers, activists and academics on the impact of gene drives. We interviewed more than 20 experts from around the world
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.
Ethics of gene drive mosquitoes for malaria elimination
24071A. J. Roberts, McMaster University, 2022-10-24 10:34:04.
This thesis is concerned with presenting analyses regarding key ethical issues regarding and arising from the development and potential use of gene drive modified mosquitoes for the purpose of malaria elimination. Each of the chapters constituting this thesis offers a rigorously researched analysis which attempts to answer questions thus far unanswered in the academic literature. Chapter one explores whether the development and use of this technology can be fairly considered unethical in principle; concluding it cannot be. Chapter two explores the appropriate relationship between this technology and the precautionary principle, a prominent regulatory and governance principle which has been invoked as ostensible support for an indefinite global moratorium on all gene drive technology. The chapter concludes that the precautionary principle, at least as articulated by UNESCO, does not provide justification for a global moratorium on gene drive technology. In fact, the precautionary principle is likely unfit as a regulatory norm for some kinds of gene drive products and purposes. Chapter three was co-authored with Delphine Thizy, Global Stakeholder Engagement Manager for Target Malaria, one of the leading consortiums working on research and development of gene drive biotechnology for malaria control. Together we articulate the ethical principles selected to guide Target Malaria’s stakeholder engagement, as well as provide the rationale for their selection and expound upon some early lessons from their implementation. Chapter four offers an analysis with the goal of locating the ethically appropriate locus of political organization from which to seek permission for a gene drive modified organism release into the shared environment. The chapter considers the appropriateness of each of the following levels of political organization: consent of individuals, local communities, nation states, and international governance institutions. The conclusion arrived at, with some caveats, is that such a decision is most appropriately issued by a nation state.
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
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.
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.
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.
Infravec2 guidelines for the design and operation of containment level 2 and 3 insectaries in Europe
23469E. Pondeville, A.-B. Failloux, F. Simard, P. Volf, A. Crisanti, R. E. Haghighat-Khah, N. Busquets, F. X. Abad, A. J. Wilson, R. Bellini, S. Marsh Arnaud, A. Kohl and E. Veronesi, Pathogens and Global Health, 2022-08-22 07:08:22.
With the current expansion of vector-based research and an increasing number of facilities rearing arthropod vectors and infecting them with pathogens, common measures for containment of arthropods as well as manipulation of pathogens are becoming essential for the design and running of such research facilities to ensure safe work and reproducibility, without compromising experimental feasibility. These guidelines and comments were written by experts of the Infravec2 consortium, a Horizon 2020-funded consortium integrating the most sophisticated European infrastructures for research on arthropod vectors of human and animal diseases. They reflect current good practice across European laboratories with experience of safely handling different mosquito species and the pathogens they transmit. As such, they provide experience-based advice to assess and manage the risks to work safely with mosquitoes and the pathogens they transmit. This document can also form the basis for research with other arthropods, for example, midges, ticks or sandflies, with some modification to reflect specific requirements.
Environmentally appropriate vector control is facilitated by standard metrics for simulation-based evaluation
23443V. N. Vásquez, M. R. Reddy and J. M. Marshall, Frontiers in Tropical Diseases, 3. 2022-08-17 08:44:11.
As anthropogenic factors contribute to the introduction and expansion of new and established vector species, the geographic incidence of mosquito-borne disease is shifting. Computer simulations, informed by field data where possible, facilitate the cost-effective evaluation of available public health interventions and are a powerful tool for informing appropriate policy action. However, a variety of measurements are used in such assessments; this can complicate direct comparisons across both vector control technologies and the models used to simulate them. The expansion of biocontrol to include genetically engineered organisms is now prompting additional metrics with no analogy to traditional measurement approaches. We propose Standard Entomological Metrics (SEMs) to facilitate the model-based appraisal of both existing and novel intervention tools and define two examples: Suppression Efficacy Score and Time to Reduction Target. We formulate twelve synthetic case studies featuring two vector control technologies over three years of observed daily temperature in Cairns, Australia. After calculating Suppression Efficacy Score and Time to Reduction Target results, we apply these example outcomes to a discussion of health policy decision-making using SEMs. We submit that SEMs such as Suppression Efficacy Score and Time to Reduction Target facilitate the wholistic and environmentally appropriate simulation-based evaluation of intervention programs and invite the community to further discussion on this topic.
Natural selfish genetic elements should not be defined as gene drives
23435M. A. Wells and R. A. Steinbrecher, Proceedings of the National Academy of Sciences, 119:e2201142119. 2022-08-16 07:53:39.
Gene drives are increasingly discussed in the political realm,and how the term is defined therefore has important impli-cations. The opinion piece from Alphey et al. (1) identifies alack of consensus on the definition and makes explicitchanges in how the terminology is being used by someresearchers. As such it is a timely invitation for debate.The definition of the term“gene drive”Alphey et al. (1)propose would include naturally occurring selfish geneticelements (SGEs) and natural processes causing biasedinheritance. We disagree with this aspect of the proposal,which does not reflect the original use of the term, whichrelated to engineered system
What do we mean by “Target Organism” in Target Malaria’s gene drive research?
23336J. B. Connolly, Target Malaria, 2022-07-27 08:46:32.
In the wild and in laboratory settings, sibling mosquito species can successfully mate to produce viable offspring, regardless of whether they are vectors or not. Importantly, females, but not males, of these offspring can be fertile. Nonetheless, the likelihood of finding such hybrid mosquitoes in field samples varies greatly between different combinations of species. According to some field studies, typically, only about 0.1% of mosquito collected in the wild could be An. gambiae s.s./An. coluzzii hybrids. In addition, some species that do not overlap geographically, and therefore would not come into direct contact, cannot produce hybrids in the field. This includes An. melas, which is found along the coast of West Africa, and An. bwambae, which is restricted to hot springs in the Toro District of Uganda. This means that the gene drive could eventually transfer to all sibling species of the complex, both by direct hybridisation between geographically-overlapping species and, indirectly, by transferring from one species to another overlapping ones like stepping-stones until the gene drive was transferred to all species of the complex, including to the likes of An. melas and An. bwambae
Gene Drive in Species Complexes: Defining Target Organisms
23207J. B. Connolly, J. Romeis, Y. Devos, D. C. M. Glandorf, G. Turner and M. B. Coulibaly, Trends in Biotechnology, 2022-07-12 06:21:17.
Engineered gene drives, which bias their own inheritance to increase in frequency in target populations, are being developed to control mosquito malaria vectors. Such mosquitoes can belong to complexes of both vector and non-vector species that can produce fertile interspecific hybrids, making vertical gene drive transfer (VGDT) to sibling species biologically plausible. While VGDT to other vectors could positively impact human health protection goals, VGDT to non-vectors might challenge biodiversity ones. Therefore, environmental risk assessment of gene drive use in species complexes invites more nuanced considerations of 'Target Organisms' and ‘Non-Target Organisms' than for transgenes not intended to increase in frequency in target populations. Incorporating the concept of ‘Target Species Complexes’ offers more flexibility when assessing potential impacts from VGDT.
Larval mosquito management and risk to aquatic ecosystems: A comparative approach including current tactics and gene-drive Anopheles techniques
23152R. K. D. Peterson and M. G. Rolston, Transgenic Research, 2022-07-07 09:39:09.
Genetic engineering of mosquitoes represents a promising tactic for reducing human suffering from malaria. Gene-drive techniques being developed that suppress or modify populations of Anopheles gambiae have the potential to be used with, or even possibly obviate, microbial and synthetic insecticides. However, these techniques are new and therefore there is attendant concern and uncertainty from regulators, policymakers, and the public about their environmental risks. Therefore, there is a need to assist decision-makers and public health stewards by assessing the risks associated with these newer mosquito management tactics so the risks can be compared as a basis for informed decision making. Previously, the effect of gene-drive mosquitoes on water quality in Africa was identified as a concern by stakeholders. Here, we use a comparative risk assessment approach for the effect of gene-drive mosquitoes on water quality in Africa. We compare the use of existing larvicides and the proposed genetic techniques in aquatic environments. Based on our analysis, we conclude that the tactic of gene-drive Anopheles for malaria management is unlikely to result in risks to aquatic environments that exceed current tactics for larval mosquitoes. As such, these new techniques would likely comply with currently recommended safety standards.
Public perspectives towards using gene drive for invasive species management in Australia
23100A. Mankad, E. V. Hobman and L. Carter, CSIRO, 2022-06-30 07:55:31.
Many pest animal species live and reproduce in high numbers across Australia. This includes animal species, such as cane toads, feral cats, foxes, rodents, wild pigs, wild rabbits. These species significantly damage Australia’s agricultural industries, natural landscapes, and biodiversity. For example, feral cats kill an estimated 1.8 billion Australian animals every year. Feral animals can also carry livestock diseases and cause significant damage to land and native vegetation. This results in agricultural production losses of more than $800 million per year. Sites of cultural significance to Indigenous peoples are also at risk to pest incursions. Adding further complexity, current methods of pest control being used to manage local landscape, such as baiting, trapping and shooting, are labour-intensive and expensive. They also have animal welfare implications and are considered ineffective at scale. Genetic technologies that are developed using synthetic biology have the potential to reduce or in some cases eliminate populations of invasive pests in parts of Australia. But there are multiple social, cultural and institutional considerations to understand before genetic technologies could feasibly be integrated with current pest management practices.
Public deliberation and the regulation of gene drive in the USA
23131W. F. West, L. W. Buchman and R. F. Medina, Science and Public Policy, scac032. 2022-06-27 10:41:33.
Gene drive is a new form of biotechnology designed to bias the inheritance of selected traits in animal or plant species that reproduce sexually and have relatively short reproductive cycles. Unlike traditional breeding techniques and other forms of biotechnology, gene drive is designed to spread in wild populations. As such, the prospect of its application raises ecological and socioeconomic concerns that the current system of biotechnology regulation in the USA is ill-equipped to address. Foremost among the proposals for reform is the need for deliberative participation in decision-making by stakeholders representing a broader range of interests and analytical perspectives. As appealing as they are in the abstract, these recommendations overlook both practical and political challenges to democratic governance in administration that have received little attention.
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
Who decides whether to use gene drives against malaria-carrying mosquitoes?
22730T. H. Saey, ScienceNews, 2022-06-03 08:12:18.
The gene drive interferes with the insects’ ability to reproduce. It wiped out captive populations of mosquitoes in eight to 12 generations (SN: 10/27/18, p. 6) in a small lab study. In 2021, the technology worked in the large cages in Terni, Italy, too. Within as little as five to 10 years, this gene drive could be ready to test in the wild. The first experimental release could be rolled out in Burkina Faso, Mali, Ghana or Uganda. In those locations, researchers are working with a nonprofit research consortium called Target Malaria to develop the gene drive carriers along with other genetically engineered mosquitoes to fight malaria. This research is driven by the idea that every tool available must be used to fight malaria, which sickened close to 241 million people in 2020 and killed 670,000 worldwide, mostly in Africa. Children 5 years old and younger accounted for about 80 percent of the continent’s malaria deaths, the World Health Organization says. Because of malaria’s huge toll, large investments have been made to fight the disease, yielding preventive drugs, insecticide-treated bed nets and even malaria vaccines — one was recently recommended for use in sub-Saharan Africa (SN: 12/18/21 & 1/1/22, p. 32). These efforts are helping. But mosquitoes are developing resistance to insecticides, and some anti-malaria drugs may no longer work well.
Exploring value change
25095T. E. de Wildt and V. J. Schweizer, Prometheus, 38. 2022-06-01 10:02:19.
This article aims to explore the use of cross-impact balances (CIB) to identify scenarios of value change. The possibility of value change has received little attention in the literature on value-sensitive design (VSD). Examples of value change include the emergence of new values and changes in the relative importance of values. Value change could lead to a mismatch between values embedded in technology and the way they are currently considered in society. Such a mismatch could result in a lack of acceptability of technologies, increasing social tensions and injustices. However, methods to study value change in the VSD literature are rare. CIB is a scenario tool that can study systems characterized by feedback loops that are hard to describe mathematically. This is often the case when aiming to define values and their relationships. We demonstrate the use of CIB to identify scenarios of value change using two cases: digital voice assistants and gene drive organisms. Our findings show that CIB is helpful in building scenarios of value change, even in instances where the operationalization of values is complex. CIB also helps us to understand the mechanisms of value change and evaluate when such mechanisms occur. Finally, we find that CIB is particularly useful for social learning and explanatory modelling. CIB can therefore contribute to the design of value-sensitive technologies.
The principles driving gene drives for conservation
22295S. Hartley, R. Taitingfong and P. Fidelman, Environmental Science and Policy, 135:36-45. 2022-05-04 08:30:40.
Gene drive technology is an emerging biotechnology with the potential to address some of the most intractable global biodiversity conservation issues. Scientists are exploring potential gene drive applications for managing invasive species and building resilience in keystone species threatened by climate change. The possibility to use gene drive for these conservation purposes has triggered significant interest in how to govern its development and eventual applications. This includes a plethora of documents prescribing governance principles, which can be a sensible response to the governance gap created by emerging technologies and help shore up legitimacy. We conducted qualitative documentary analysis to examine the range and substance of principles emerging in the governance of conservation gene drive. Such analysis aimed to better understand the aspirations guiding these applications and how scientists and other experts imagine their responsibility in this field. We found a collection of recommendations and prescriptions that could be organised into a set of seven emerging principles intended to shape the governance of gene drive in conservation: broad and empowered engagement; public acceptance; decision-making informed by broad ranging considerations, state and international collaboration; ethical frameworks; diverse expertise; and responsible self-regulation by developers. We lay bare these emergent principles, analyzing the way in which they are valued, prioritized, and their strengths and weaknesses. By identifying these prescriptive principles, stakeholders can further interrogate their merits and shortcomings and identify more concrete ways that governance frameworks might embody them.
The Financialisation of Malaria in Africa: Burkina Faso, rogue capital & GM/gene drive mosquitoes
22066S. Mentz-Lagrange and S. Swanepoel, African Centre for Biodiversity, 2022-04-28 07:02:28.
This paper seeks to understand the financialisation of malaria as a vehicle for rogue capital in a context of a weakened state (through capture, corruption and coups) and the power that limits effective interventions. It shows how malaria, along with other diseases, is increasingly financialised – financial markets, institutions, actors and motives play a pivotal role in disease response. Country and donor funds are invested into research and development non-profit organisations, for example, that partner with market actors (such as pharmaceutical companies) to bring the product to market. Patents are sought and royalties procured from the sale of the product to country governments. These royalties are then accumulated by the research and development company, using vehicles such as endowment funds, for example. It show cases Burkina Faso as a real-world example of how rogue capital can enter a country and experiment with patented products, with impunity and no fear of accountability. It also illustrates how both historical and modern factors create conducive conditions for philanthrocapitalists such as the Bill and Melinda Gates Foundation and the companies they fund, to exploit Africa as a living laboratory. The outcomes of risky experimental research such as genetically modified (GM) and gene drive mosquitoes is not yet known. What is known is that it is Africans who bear the consequences – not the owners of the technologies foisted on the continent.
Governing Gene Drive Technologies: A Qualitative Interview Study
23410N. de Graeff, K. R. Jongsma, J. E. Lunshof and A. L. Bredenoord, AJOB Empirical Bioethics, 13:107-124. 2022-04-04 12:10:12.
Gene drive technologies (GDTs) bias the inheritance of a genetic element within a population of non-human organisms, promoting its progressive spread across this population. If successful, GDTs may be used to counter intractable problems such as vector-borne diseases. A key issue in the debate on GDTs relates to what governance is appropriate for these technologies. While governance mechanisms for GDTs are to a significant extent proposed and shaped by professional experts, the perspectives of these experts have not been explored in depth.Methods A total of 33 GDT experts from different professional disciplines were interviewed to identify, better understand, and juxtapose their perspectives on GDT governance. The pseudonymized transcripts were analyzed thematically.Results Three main themes were identified: (1) engagement of communities, stakeholders, and publics; (2) power dynamics, and (3) decision-making. There was broad consensus amongst respondents that it is important to engage communities, stakeholders, and publics. Nonetheless, respondents had diverging views on the reasons for doing so and the timing and design of engagement. Respondents also outlined complexities and challenges related to engagement. Moreover, they brought up the power dynamics that are present in GDT research. Respondents stressed the importance of preventing the recurrence of historical injustices and reflected on dilemmas regarding whether and to what extent (foreign) researchers can legitimately make demands regarding local governance. Finally, respondents had diverging views on whether decisions about GDTs should be made in the same way as decisions about other environmental interventions, and on the decision-making model that should be used to decide about GDT deployment.Conclusions The insights obtained in this interview study give rise to recommendations for the design and evaluation of GDT governance. Moreover, these insights point to unresolved normative questions that need to be addressed to move from general commitments to concrete obligations.
UC Davis — Malaria Gene Drive Feasibility Analysis
21563Good Ventures, Good Ventures, 2022-03-31 12:24:36.
Open Philanthropy recommended a grant of $10,248,967 over three years to UC Davis to support subsequent stages of a feasibility analysis of a potential test of gene drives for malaria control on the adjoining West African islands of São Tomé and Príncipe. The work, led by Dr. Greg Lanzaro and colleagues, will focus on a potential gene drive application that would reduce or inhibit the ability of mosquitoes to transmit the malarial parasite, without impacting the size of the mosquito population on the islands. As part of the preliminary feasibility analysis, which Open Philanthropy supported in February 2020, Dr. Lanzaro’s team developed working relationships with local communities, established an ethics advisory board, developed a communication plan, and conducted appropriate safety tests.
Opening up, closing down, or leaving ajar? How applications are used in engaging with publics about gene drive
21287A. W. Russell, A. Stelmach, S. Hartley, L. Carter and S. Raman, Journal of Responsible Innovation, 2022-03-22 12:32:50.
Public engagement and responsible innovation are strongly emphasised in gene drive research, together with the goal of addressing societal challenges, notably, malaria and environmental conservation. We aim to explore whether public engagement is used to ‘open up' or ‘close down' opportunities to shape gene drive research. Drawing on interviews with gene drive developers and stakeholders, we investigate how the public communication of gene drive is conceived. We find that traditional closing-down tendencies remain, but that there are new and encouraging opening-up approaches. Consistent with responsible innovation thinking, these frame gene drive as multifaceted, context-dependent and requiring deeper deliberation. We also identify a third ‘leaving ajar’ approach that seeks to engage with and respond to local communities and modify technological applications to be more acceptable. Innovation system constraints may well temper current aspirations to open up; framing public conversations around understandings of public good could offer a way forward.
The power of gene editing
20973The Economist, The Economist, 2022-03-17 07:27:42.
Technologies such as genetic modification and ‘CRISPR’ will cure hereditary diseases, produce disease-resistant crops and enable the breeding of malaria-free mosquitos. But advances bring ethical and practical dilemmas. Genetically modified food is banned in the EU, and doctors worry that screening for genetic diseases may pave the way for more controversial uses, such as creating so-called designer babies. This film looks at the risks and rewards of gene editing.
Could species-focused suppression of Aedes aegypti, the yellow fever mosquito, and Aedes albopictus, the tiger mosquito, affect interacting predators? An evidence synthesis from the literature
20971J. A. S. Bonds, C. M. Collins and L.-C. Gouagna, Pest Management Science, 2022-03-16 07:20:33.
The risks of Aedes aegypti and Aedes albopictus nuisance and vector-borne diseases are rising and the adverse effects of broad-spectrum insecticide application has promoted species-specific techniques, such as sterile insect technique (SIT) and other genetic strategies, as contenders in their control operations. When specific vector suppression is proposed, potential effects on predators and wider ecosystem are some of the first stakeholder questions. These are not the only Aedes vectors of human diseases, but are those for which SIT and genetic strategies are of most interest. They vary ecologically and in habitat origin, but both have behaviourally human-adapted forms with expanding ranges. The aquatic life stages are where predation is strongest due to greater resource predictability and limited escape opportunity. These vectors' anthropic forms usually use ephemeral water bodies and man-made containers as larval habitats; predators that occur in these are mobile, opportunistic and generalist. No literature indicates that any predator depends on larvae of either species. As adults, foraging theory predicts these mosquitoes are of low profitability to predators. Energy expended hunting and consuming will mostly outweigh their energetic benefit. Moreover, as adult biomass is mobile and largely disaggregated, any predator is likely to be a generalist and opportunist. This work, which summarises much of the literature currently available on the predators of Ae. aegypti and Ae. albopictus, indicates it is highly unlikely that any predator species depends on them. Species-specific vector control to reduce nuisance and disease is thus likely to be of negligible or limited impact on non-target predators
Regulation of genetically engineered (GE) mosquitoes as a public health tool: a public health ethics analysis
20480Z. Meghani, Globalization and Health, 18:21. 2022-02-21 08:33:18.
In recent years, genetically engineered (GE) mosquitoes have been proposed as a public health measure against the high incidence of mosquito-borne diseases among the poor in regions of the global South. While uncertainties as well as risks for humans and ecosystems are entailed by the open-release of GE mosquitoes, a powerful global health governance non-state organization is funding the development of and advocating the use of those bio-technologies as public health tools.
A preliminary framework for understanding the governance of novel environmental technologies: Ambiguity, indeterminateness and drift
20412F. Rabitz, M. Feist, M. Honegger, J. Horton, S. Jinnah and J. Reynolds, Earth System Governance, 12:100134. 2022-02-16 16:13:59.
We propose a conceptual framework to explain why some technologies are more difficult to govern than others in global environmental governance. We start from the observation that some technologies pose transboundary environmental risks, some provide capacities for managing such risks, and some do both. For “ambiguous” technologies, potential risks and risk management capacities are uncertain, unknown or even unknowable. Governance systems are indeterminate towards ambiguous technologies, as existing norms, rules, scripts and routines do not imply default solutions under institutional focal points. Indeterminateness can lead to institutional drift, with risks accordingly remaining unmitigated and risk management capacities remaining unexploited. We use the cases of solar geoengineering, gene drive systems and bioinformatics for illustrating this framework. As technological ambiguity may often be irresolvable, we conclude that it might force us to confront the limits to anticipatory global decision-making on matters of long-term environmental sustainability.
Gene Editing Is Popular, But Controversial, Research Are
20387Relias, RELIAS MEDIA, 2022-02-01 09:18:26.
Gene drive research carries great potential for controlling insect vectors of devastating diseases, but there are multiple unresolved ethical concerns. Unanticipated “downstream” effects on ecosystems, or in organisms that carry the gene drive machinery, are possible. To help researchers balance risks and benefits for society and humanity, scientists involved in the Controlling and Countering Gene Editing in Mosquitoes research project developed a code of ethics for gene drive research. Today, gene drive researchers are focused on diseases that mosquitoes carry. The goal is to make a mosquito that cannot infect a person with malaria. “All of a sudden, it’s become a very hot research area. With the discovery of CRISPR, everybody wants to apply CRISPR to everything. But here is an area where it actually makes sense,” says lead author George J. Annas, JD, MPH, director of the Center for Health Law, Ethics, and Human Rights at Boston University.
Gene Drives in the U.K., U.S., and Australian Press (2015–2019): How a New Focus on Responsibility Is Shaping Science Communication
20217A. Stelmach, B. Nerlich and S. Hartley, Science Communication, 10755470211072245. 2022-01-25 16:28:49.
Gene drive is a controversial biotechnology for pest control. Despite a commitment from gene drive researchers to responsibility and the key role of the media in debates about science and technology, little research has been conducted on media reporting of gene drive. We employ metaphor and discourse analysis to explore how responsibility is reflected in the coverage of this technology in the U.S., U.K., and Australian press. The findings reveal a rhetorical strategy of trust-building by evoking the moral attributes of gene drive researchers. We discuss the implications of these findings for the communication of new technologies.
Ethical Considerations for Gene Drive: Challenges of Balancing Inclusion, Power and Perspectives
20139A. Kormos, G. C. Lanzaro, E. Bier, V. Santos, L. Nazare, J. Pinto, A. A. dos Santos and A. James, Frontiers in Bioengineering and Biotechnology, 2022-01-21 13:24:13.
Progress in gene-drive research has stimulated discussion and debate on ethical issues including community engagement and consent, policy and governance, and decision-making involved in development and deployment. Many organizations, academic institutions, foundations, and individual professionals have contributed to ensuring that these issues are considered prior to the application of gene-drive technology. Central topics include co-development of the technology with local stakeholders and communities and reducing asymmetry between developers and end-users. Important questions include with whom to conduct engagement and how to define community acceptance, develop capacity-building activities, and regulate this technology. Experts, academics, and funders have suggested that global frameworks, standards, and guidelines be developed to direct research in answering these important questions. Additionally, it has been suggested that ethical principles or commitments be established to further guide research practices. The challenging and interesting contradiction that we explore here is that the vast majority of these conversations transpire with little or no input from potential end-users or stakeholders who, we contend, should ultimately determine the fate of the technology in their communities. The question arises, whose concerns regarding marginalization, disempowerment, and inequity should be included in discussions and decisions concerning how inequities are perceived and how they may be addressed? At what stage will true co-development occur and how will opinions, perspectives and knowledge held by low-income country stakeholders be applied in determining answers to the questions regarding the ethics being debated on the academic stage? Our opinion is that the time is now.
IMPACTOS AMBIENTAIS DA TÉCNICA DE GENE DRIVE PARA O CONTROLE DE EPIDEMIAS: ALCANCES E LIMITES DO PRINCÍPIO DA PRECAUÇÃO
23875N. R. Furtado, PERI Revista de Filosofia, 13. 2022-01-19 09:24:19.
The paper discusses the application of the precautionary principle in the management of environmental risks arising from the use of gene drives to control epidemics. Gene drives consist of a technique for creating genetically modified organisms, which are released into an ecosystem with the aim of spreading certain genetic elements and prevailing over native organisms. Among the possible uses of this technique are the control of epidemics. Despite its benefits, assessing the impact of gene drives on the environment proves to be a challenge. In the field of biotechnology, the socalled precautionary principle was formulated as a strategy to ground decisions whose consequences are uncertain. However, its application raises discussions about the ability to prevent damage from new technologies. Its critics argue that the precautionary mentality could lead to inaction, obstructing scientific development. Thus, this article highlights the contributions of such principle to guide the use of gene drives, while reflecting on its limits, confronting it with an alternative risk management model: the proactionary principle.
Insect Allies – Assessment of a Viral Approach to Plant Genome Editing
20036K. Pfeifer, J. L. Frieß and B. Giese, Integrated Environmental Assessment and Management, 2022-01-12 09:38:06.
The DARPA program Insect Allies has already sparked scientific debate concerning technology assessment-related issues, among which the most prevalent is that of dual use potential. As apart from the issues concerning peaceful applications, the technology also provides the blueprint for a potential bioweapon as further evidenced by a recent publication. However, the combination of a virus-induced genetic modification of crop plants in the field using genetically modified insect vectors poses an increased risk potential in comparison to the hitherto existing use of genetically modified organisms. The technology's high depth of intervention enables a number of sources for hazard and a by trend high exposure, but it is also encumbered with notable deficits in knowledge. These issues call for a thorough technology assessment. This article aims to provide an initial characterization from a technology assessment perspective, focusing on potential sources of risk for this novel invasive environmental biotechnology at an early stage of research and development. This article is protected by copyright. All rights reserved.© 2022 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals LLC on behalf of Society of Environmental Toxicology & Chemistry (SETAC).
The Need for a Tiered Registry for US Gene Drive Governance
20003K. L. Warmbrod, A. L. Kobokovich, R. West, G. K. Gronvall and M. Montague, Health Security, 2022-01-10 10:08:26.
A great deal of attention has been focused on the potential risks of gene drives, the kinds of biosafety protections they may require, and how they may be reversed; however, less attention has been paid to the systems that would be useful to have in place in the future, when multiple gene drives may be fielded in multiple species, environments, and countries.4-7 The need for coordinated governance of these technologies will become more pressing as gene drive technologies advance and more drives are created to address other vector-borne diseases like the West Nile virus, agricultural pest management, or invasive species. Gene drives carry different inherent risks compared with other genetically modified organisms (GMOs). Existing governance mechanisms for traditional GMOs are insufficient for oversight of gene drives, which require different systems to assess their usefulness and safety. To address the needs for enhanced oversight, we propose a tiered registry system, similar to the clinical trials databases, which can provide government officials, researchers, biotechnology companies, and the public with useful information about ongoing gene drive research or previously released gene drives. Such a resource would enable scientists to confirm that new gene drives would not interfere with existing drives, provide the public with the information needed to make informed decisions concerning consent for release of gene drives, provide researchers with technical information needed to prevent collisions of independent projects modifying the same organism, and provide regulators with information critical for effective oversight. We propose that the US government should implement such a registry for gene drives in the United States, which does not have a robust gene drive regulatory system in place and is not party to the international treaty most relevant for international gene drive regulation, the Convention on Biological Diversity.8 In this commentary, we describe current efforts to safely regulate gene drive and similar genetic technologies worldwide and how the United States could build a tiered registry database that is specifically designed to regulate such technologies throughout a drive's life cycle.
An Introduction to Containment Recommendations for Gene Drive Mosquitoes and the Laboratory Rearing of Genetically Engineered Mosquitoes in Africa
20044S. Higgs, Vector-Borne and Zoonotic Diseases, 2022-01-06 10:04:57.
The prospect of using genetically engineered arthropods to reduce the incidence of vector-borne diseases either indirectly by suppressing vector populations or directly by replacing wild-type vector species with less competent ones has long been discussed; however, only in the past few years has this become feasible. The advent of CRISPR/Cas9-based gene drive and its application to mosquitoes have been a critical factor in bringing the dream to reality, but with opportunity also comes responsibility. Safe and secure handling of genetically engineered arthropods under laboratory/insectary conditions was considered in the original and revised ACGs, and under field conditions by Benedict et al. (2008). Although not discussed in these ACGs, hence the need for this addendum, Benedict et al. (2018) discussed containment and management of gene drive arthropods as distinct from genetically modified mosquitoes under laboratory conditions. A prerequisite for the application of engineered mosquitoes for mosquito-borne disease control is the rearing of these mosquitoes in countries where releases will ultimately occur. In 2018, three companion articles were published in VBZ that discussed this very issue (Mumford et al. 2018, Quinlan et al. 2018a, 2018b), with James et al. (2020) discussing efficacy and safety criteria for advancing gene drive-modified mosquitoes to field testing. In this issue of VBZ, we publish two highly relevant articles that coincidentally, although submitted independently, are complementary.
Information Sharing in Senegal on the Gene Drive Technology as a potential Complementary Tool for Malaria Vector Control
19902AUDA-NEPAD, AUDA-NEPAD, 2022-01-04 08:23:49.
AUDA-NEPAD in partnership with the National Biosafety Authority (Autorité Nationale de Biosécurité (ANB) in Senegal organized an Information sharing meeting on the gene drive technology as a complementary tool for malaria vector control, from 22-23 December 2021, in Somone, Senegal. The key objective of the meeting was to discuss the opportunities offered by gene drive technology for malaria control, based on the current state of art of knowledge and experiences from countries that are testing this approach. Sixty people, including key stakeholders from relevant institutions in Senegal and experts from Burkina Faso and Mali took part in the meeting. In his opening remarks, Mr. Ousseynou Kassé, Executive Director of ANB thanked AUDA-NEPAD for the support provided in the organization of this meeting. He also thanked the experts from Burkina Faso and Mali who came to share their experiences on the subject. “We started the discussions on the Gene Drive approach some years ago at the COP-MOP meeting held in Mexico and we continued it in the past years in the sub-region. Recently we were in Accra twice to discuss the same topic ahead of the next COP-MOP meeting”, he said. Mr. Yero Dé, Chairperson of the Orientation Council of ANB, highlighted that the meeting seeks to improve stakeholders’ understanding of the gene drive technology as a novel malaria control approach. “We need to consider adopting this new approach through an open discussion on how this technology could be used in the health sector and in particular in malaria control and elimination. Malaria mortality rate is very high in most of our countries and the efforts deployed so far to control the disease face important challenges, including the resistance of the vector to the current treatments”, he further stated.
Stakeholder Views on Engagement, Trust, Performance, and Risk Considerations About Use of Gene Drive Technology in Agricultural Pest Management
19900C. L. Goldsmith, K. E. Kang, E. Heitman, Z. N. Adelman, L. W. Buchman, D. Kerns, X. Liu, R. F. Medina and A. Vedlitz, Health Security, 2021-12-31 08:17:50.
Gene drive is an experimental technique that may make it possible to alter the genetic traits of whole populations of a species through the genetic modification of a relatively small number of individuals. This technology is sufficiently new that literature on the understanding and views of stakeholders and the public regarding the use of gene drive organisms in agricultural pest management is just beginning to emerge. Our team conducted a 2-pronged engagement process with Texas gene drive agricultural stakeholders to ascertain their values, beliefs, and preferences about the efficacy, safety, and risk management considerations of gene drive technology as a potential tool for agricultural pest management. We found that a majority of stakeholders support gene drive research and its potential use for managing agricultural pests. Our work with stakeholders confirms both their willingness to be engaged and the importance they place on stakeholder and public engagement regarding these issues, as well as the need to address these issues before use of gene drive as a pest management mechanism will be accepted and trusted.
Facilitating the Conversation: Gene Drive Classification
19766J. Overcash and A. Golnar, Health Security, 2021-12-29 13:09:10.
Gene drives are an emerging technology with tremendous potential to impact public health, agriculture, and conservation. While gene drives can be described simply as selfish genetic elements (natural or engineered) that are inherited at non-Mendelian rates, upon closer inspection, engineered gene drive technology is a complex class of biotechnology that uses a diverse number of genetic features to bias rates of inheritance. As a complex technology, gene drives can be difficult to comprehend, not only for the public and stakeholders, but also to risk assessors, risk managers, and decisionmakers not familiar with gene drive literature. To address this difficulty, we describe a gene drive classification system based on 5 functional characteristics. These characteristics include a gene drive's objective, mechanism, release threshold, range, and persistence. The aggregate of the gene drive's characteristics can be described as the gene drive's architecture. Establishing a classification system to define different gene drive technologies should make them more comprehensible to the public and provide a framework to guide regulatory evaluation and decisionmaking.
Integrated Management of Malaria Vectors in Africa
19971R. Mbabazi, K. Maredia, B. B. El-Sayed, A. K. Babumba, M. Savadogo and O. Akinbo, Genetically Modified and other Innovative Vector Control Technologies, 2021-12-21 11:36:56.
Malaria disease is a major public health burden in Africa. The control of malaria vectors is a critical component for prevention, management, and eradication of malaria disease. This chapter presents information on the current status of malaria vector control in Africa with emphasis on integrated vector management (IVM) programs. The chapter highlights innovative and emerging technologies such as sterile insect technique, gene drive, Wolbachia-based biological control, and other technologies for malaria vector control in Africa which can be integrated into IVM programs. The chapter also provides global resources on malaria vector management programs.
Laboratory Biosafety in Handling Genetically Modified Mosquitoes
19963J. Charles, Genetically Modified and other Innovative Vector Control Technologies, 2021-12-21 11:19:52.
One of the novel approaches in controlling vector-borne diseases is to release genetically modified mosquitoes in nature. Trial studies are done in different phases by the researches, both in the laboratory and in the fields. Before a GM mosquito is validated to be ready for field release, the same has to rigorously go through several phase studies, and Phase I being the laboratory is the most significant to set the future of the GM mosquito for future investigations. Though the risk of handling GM mosquitoes in laboratory is low, nevertheless there is a prescribed list of DOs and DON’Ts, and the laboratory workers are needed to strictly follow the SOPs or basic principles of biosafety like handling administrative controls, using biosafety equipment, wearing personal protective equipment, etc. The laboratory also should have a proper design as per the risk assessment. Accordingly, the biosafety laboratories (BSL) are classified into four types: type 1, 2, 3 and 4. The risks are assessed as per the factors in the host, vector and donor sequences and the environmental factors and their activities in such environments. As GMMs are of low risk, BSL 1 and 2 are enough for their manipulation, but occasionally BSL 3 may be needed. There may be chances of spillage on the working surfaces during manipulation of the genes which can be remedied by the spill management protocols. Biological wastes may be generated in all areas of manipulation. These can be properly treated by either chemical disinfection or autoclaving and disposed of by incineration. These wastes should be segregated in colour-coded bags before disposal. There may be some risks while transporting GMMs to distant places. They should be packed securely in triple-layer pack and sent for disposal following IATA and other road rules. For each process of the manipulation of gene, a separate standard operating procedure (SOP) should be maintained which has to be updated whenever any change in the procedure is made.
Safety Assessment of Novel Genetic Technologies for Vector Control: National and International Perspectives
19961V. Ahuja, Genetically Modified and other Innovative Vector Control Technologies, 2021-12-21 11:15:26.
Novel genetic technologies provide an alternative approach for control of vectors particularly those carrying deadly pathogens. Genetic control technologies aim to either suppress target populations or modify the vector by introducing a heritable factor that reduces or blocks their ability to transmit the diseases. These technologies are thus referred to as population suppression or population modification approaches. Both these approaches offer significant advantages for vector control; however, there are associated biosafety concerns related to possible ecosystem interactions. Therefore, extensive testing on a case-by-case basis is required before these can be used as a public health intervention. This paper provides details of the international initiatives towards development of guidelines and status of regulations in India.
Measuring Public Attitudes to Releases of Transgenic Mosquitoes for Disease Control, with Special Reference to Dengue and Malaria
19958L. A. De Las Llagas and M. S. T. Gunigundo, Genetically Modified and other Innovative Vector Control Technologies, 2021-12-21 11:10:05.
Since the advent of DDT in public health and agriculture, science leaped forward with revolutionary technology such as gene drive or editing, thus making it possible to develop alternative approaches to address vector-borne diseases. However, their utilization and sustenance in public life are dependent on public attitude, i.e., societal awareness and social acceptance. In the face of strong skepticism against genetically modified organisms in both developed and developing countries, public acceptance is therefore a requirement (Boete and Beisel 2013, and Bohannon 2002, as cited in De Souza et al. Understanding the requirements and factors necessary for the acceptance of genetically modified mosquitoes as a potential malaria control tool in Ghana: a questionnaire survey, AsPac J Biol Biotechnol 21(3):76–88, 2013).
Arthropods of Medical Importance: Need for Genetic and Other Innovative Vector Control Technologies, with Emphasis on Eco-biosocial and Environmental Considerations.
19923B. K. Tyagi, Genetically Modified and other Innovative Vector Control Technologies, 2021-12-21 09:22:08.
Among the world’s known vector groups, viz. arthropods, snails and rodents, the most important vectors originate from arthropods, the jointed legs. Arthropods are doubtlessly regarded as the most dominant creatures on the Earth due largely to their remarkable structural and behavioural diversity, besides humongous species preponderance. Of course, some of these arthropods are serious pests and/or vectors of human and animal diseases—deadly, debilitating and economy destructing. According to an estimate, arthropod species make approximately 80% of the global biological diversity. Born some 350–400 million years ago, they have of course achieved, to the utter envy of all other animal forms, a formidable genetic diversity and robustness so much so that they have virtually captivated pivotal human attention for centuries. They serve as a spectacular model of bioprospecting or laboratory experiments mostly because they are found in abundance, breed prodigiously and are exceptionally easier to culture or cultivate. For the aforesaid reasons, arthropods are also the easy target for genetic manipulations such as the transgenesis (using the release of insect carrying dominant lethal (RIDL) gene system or gene drive-based genome editing, e.g. CRISPR/Cas9, to suppress or replace the vector population) or paratransgenesis (e.g. deploying endosymbiont Wolbachia-induced cytoplasmic incompatibility for replacing natural vector population). In particular, the advent of CRISPR technology has excited the potential to engineer new game-changing technologies and innovative systems that can be used to control wild populations of mosquitoes. Two developments of particular interest are a self-limiting system termed precision-guided sterile insect technique (pgSIT) and a homing-based gene drive (HGD). The unique features of these systems can make them valuable tools to control vector mosquitoes in the future. All these biotechnological advancements in vector control are designed to fit well in the multi-methodical integrated vector management (IVM) strategy.
Genetically Modified and other Innovative Vector Control Technologies
19912B. K. Tyagi, SpringerLink, 2021-12-21 08:48:19.
This book comprehensively covers the latest development in developing and deploying the genetically modified vectors, particularly Anopheles and Aedes mosquitoes responsible for transmitting malaria parasites and dengue viruses, the most deadly and/or debilitating among all the vector-borne diseases. It is considered timely and commensurate to bring about a book dealing with the various ecological, biological and social as well as regulatory aspects for the deployment of genetically modified vectors in special context with the biosafety of humans, his associates, and the environment. Written by an array of specialists and experts in various subjects of genetically modified organisms, this book centrally addresses the (i) basic principles of the genetic manipulation of vectors and they are potential impact on human and the environment, (ii) ecological, biological, ethical, legal and social implications of the use of genetically modified vectors, (iii) identification of potential hazards; assessment and management of risks for human and environment; risk/benefit analysis, (iv) principles and practices for the assessment and management of biosecurity and biosafety in laboratories (and in the field), (v) guiding principles for creation and management of institutional or national biosafety review boards and ethics review committees, and (vi) development and application of a biosafety regulatory framework and its related legal principles at national levels for securing the development and use of vector control methods based on genetic modification strategies.
Safe Application of Genetically Modified Mosquito (GMM) to Combat Dengue and Chikungunya Depends on Socioeconomic Status and Social Acceptance in the Developing Countries: A Comprehensive Analysis
19898M. N. Islam, Genetically Modified and other Innovative Vector Control Technologies, 2021-12-21 08:16:32.
The emerging and re-emerging vector-borne diseases are a serious public health problem throughout the world. It has been observed that more than 100 countries and approximately half of the world’s population are at risk on vector-borne diseases (VBDs). The global burden of the vector-borne diseases is unacceptably high. It alludes toward their functional inappropriateness, untimeliness, and irrelevance in controlling vectors and vector-borne diseases. Modern technologies, coupled with other appropriate ones within the precincts of integrated vector management (IVM), can tide over this situation posed by conventional, mostly insecticide-based, methodologies. A lot of challenges, obstacles, and interruptive factors have warranted urgent deployment of new approaches for the control of VBDs keeping in mind the inbuilt ethical, social, and regulatory issues. Genetically modified mosquito (GMM) technology is a complex and highly sophisticated biotechnological intervention for suppression of vector populations. Wolbachia-associated sterile insect technique (SIT) has been proved highly significant and effective for replacement of mosquito populations. Adopting a highly sophisticated GMM technology to suppress or replace the mosquito populations’ density is a big question in developing countries because their priority is directed to foremost fulfill the basic human rights to sustain. Yet, notwithstanding foreseeable bottlenecks, of paramount importance is the need to deploy GMM technology with due consideration to socioeconomic factors and availability of advanced biotechnological facilities during the application of GMM in the developing countries.
Malaria vector control tools in emergency settings: What do experts think? Results from a DELPHI survey
19785C. Boete, S. Burza, E. Lasry, S. Moriana and W. Robertson, Conflict and Health, 15:11. 2021-12-20 14:16:22.
Background The use and implementation of novel tools for malaria control such as long lasting impregnated bednets (LLINs) and Indoor Residual Spraying (IRS) over the last decade has contributed to a substantial reduction in malaria burden globally. However numerous challenges exist particularly in relation to vector control in emergency settings. This study seeks to explore expert opinion on the utility of existing tools within the emergency context setting and to better understand the attitude towards emerging and innovative tools (including Genetically Modified Mosquitoes) to augment current approaches. Methods 80 experts in the field of malaria and vector control were invited to participate in a two-round Delphi survey. They were selected through a combination of literature (academic and policy publications) review and snowball sampling reflecting a range of relevant backgrounds including vector control experts, malaria programme managers and emergency response specialists. The survey was conducted online through a questionnaire including the possibility for free text entry, and concentrated on the following topics: Utility and sustainability of current vector control tools, both in and outside emergency settings Feasibility, utility and challenges of emerging vector control tools, both in and outside emergency settings Current and unmet research priorities in malaria vector control and in malaria control in general. Results 37 experts completed the first round and 31 completed the second round of the survey. There was a stronger consensus about the increased utility of LLIN compared to IRS in all settings, while insecticide-treated covers and blankets ranked very high only in emergency settings. When considering the combination of tools, the ones deemed most interesting always involved LLINs and IRS regardless of the setting, and the acceptability and the efficacy at reducing transmission are essential characteristics. Regarding perceptions of tools currently under development, consensus was towards improvement of existing tools rather than investing in novel approaches and the majority of respondents expressed distrust for genetic approaches. Conclusion Malaria vector control experts expressed more confidence for tools whose efficacy is backed up by epidemiological evidence, hence a preference for the improvement rather than the combination of existing tools. Moreover, while several novel tools are under development, the majority of innovative approaches did not receive support, particularly in emergency settings. Stakeholders involved in the development of novel tools should involve earlier and raise awareness of the potential effectiveness amongst a wider range of experts within the malaria community to increase acceptability and improve early adoption once the evidence base is established.
New Arthropod Containment Recommendations Provide Essential Guidance for Safety of Gene Drive Research
19467S. James and D. O’Brochta, The American Journal of Tropical Medicine and Hygiene, tpmd211148. 2021-11-30 14:49:53.
Gene drive technologies have not yet been field tested, however, there are no data on the possible environmental or health effects of releasing gene drive–modified organisms. For this reason, there have been widespread calls for additional guidance on risk assessment and management, and some have even proposed a moratorium on gene drive research until such guidance is in place. One immediate need has been for guidance on appropriate containment measures that researchers should follow when investigating gene drive–modified organisms, given that these are meant to spread their transgenes by inter breeding with compatible local species. For example, a 2020 survey of biosafety professionals revealed that the majority felt existing guidance was inadequate for making risk assessments and containment decisions regarding gene drive–modified arthropods. Lack of standard guidance can lead to uneven application of containment measures among institutions and decreased public confidence in the research. The American Committee of Medical Entomology (ACME)of the American Society of Tropical Medicine and Hygiene has responded to this need with the recent publication of an addendum to its widely influential Arthropod ContainmentGuidelines. The new addendum6provides specific recommendations on containment practices for arthropods modified with engineered transgenes capable of gene drive.
New molecular genetic techniques: regulatory and societal considerations
19403Nielsen, K. M., AREA-WIDE INTEGRATED PEST MANAGEMENT: Development and Field Application, 2021-11-29 18:07:46.
A rapidly expanding toolbox of techniques available for genome editing provides the basis for a new continuum in types of modifications that can be introduced into a genome and blur the bimodal GMO vs. non-GMO (genetically modified organism) divide. Site-directed nucleases (SDN) are now used to modify existing nucleotides within genomes instead of adding recombined DNA as transgenes. Moreover, new gene drive approaches are in development based on SDNs. A number of potential drive applications have been reported, but uncertainties in trait stability and limitations in knowledge of the affected system at various temporal and spatial levels slow down their current uses. Adoption of new genome targeted technology takes place in a social context. The context will vary between countries and cultures, expressed in values, ethics, politics and priorities - that are translated into different regulatory approaches. Some developed products using new genome editing techniques clearly fall under internationally negotiated regulations of GMOs. However, other product outcomes of editing techniques challenge our current understanding and definition of GMOs. There is an urgent need for further research, for building international consensus and harmonizing regulatory approaches to facilitate categorization, predictability, transparency, trust and trade.
Genome editing and its applications for insect pest control: Curse or blessing?
19401Hacker, I. , and Schetelig, M. F, AREA-WIDE INTEGRATED PEST MANAGEMENT: Development and Field Application, 2021-11-29 18:00:39.
Gene and genome editing are described as cutting-edge research tools with the potential to tackle urgent global challenges in the management of agricultural pests and human disease vectors such as mosquitoes. The field is defined by the chances and challenges to interlink the disciplines of insect genomics, molecular biology, and pest control together with the need for clear risk assessment, policy development and public approval of the application of such novel technologies. The goal is to generate innovative and sustainable pest control solutions applied in the best interest for the environment and human society. Here, starting from available genome editing technologies, the current strategies and applications for insect pest control are discussed, including approaches to overcome the evolution of resistance alleles and other potential pitfalls to be expected from selective pressures resulting from gene drive applications. They are supplemented by views on regulatory, policy and ethical considerations that in our opinion will be necessary to define how the different tools can be used in the future in a safe and responsible way.
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.
CRISPR-based gene drives for combatting malaria: Need for an early stage technology assessment.
19374Liebert, W., AREA-WIDE INTEGRATED PEST MANAGEMENT: Development and Field Application, 2021-11-29 17:09:24.
The potential power of CRISPR-based gene drives makes it necessary to engage in science and technology assessment already in early stages of research and development. In order to argue for efforts to address this urgent need, gene drives to combat malaria-transmitting mosquitoes are discussed using the concept of prospective technology assessment. First, development risks are described, followed by considerations about anticipatable risks and irreversible consequences, as well as unforeseeable effects and uncertainties. Afterwards, fundamental problems in connection with the development of gene drives against malaria mosquitoes are raised. Opportunities for shaping technology are briefly discussed, before alternatives, in particular the World Health Organization's elimination strategy, are considered. Finally, several normative questions are put forward.
Barriers and facilitators of area-wide management including sterile insect technique application: The example of Queensland fruit fly
19365Mankad, A., Loechel, B., and Measham, P. F., AREA-WIDE INTEGRATED PEST MANAGEMENT: Development and Field Application, 2021-11-29 16:44:16.
The area-wide management (AWM) of highly mobile insect pests such as tephritid fruit flies requires an integrated understanding of technical, social and institutional processes that drive a coordinated approach within a defined area. Furthermore, the success of an AWM programme is dependent upon the coordinated efforts of key stakeholders within the designated area (e.g. growers, community members). Yet, public views regarding AWM may not reflect those views held by scientists or stakeholders. Public considerations for acceptance are likely varied and multidimensional. A series of qualitative (phases 1-2) and quantitative (phase 3) studies examined stakeholder and community attitudes towards AWM to manage Queensland fruit fly Bactrocera tryoni (Froggatt) (Tephritidae) and the novel use of the Sterile Insect Technique (SIT) as a possible component of AWM. Research was conducted over three regions of varying pest prevalence, ranging from zero to endemic; participants included growers, extension officers, industry and government representatives, and members of the general public. Participants in this research were asked to consider potential barriers and facilitators to the widespread uptake of AWM integrating the SIT, including any relevant institutional-level factors. Combined data revealed potential social barriers to AWM and SIT uptake. Most notably, there were perceptions of low efficacy in successfully coordinating key social groups for the purposes of an AW-IPM approach, and a concern for the possibility of 'free-riders' within an areawide system. On the other hand, innovation complexity and observability of outcomes were important factors contributing to acceptance of AWM. Importantly, all participants were influenced by the attitudes and behaviours of important others. Participants also identified key facilitators that could assist in the uptake of AWM using the SIT. These facilitators include the importance of trustworthy information sources and harnessing the persuasive influence of community champions and central packing houses on commercial growers. Overall, there was high stated acceptance for the SIT, both on-farm and in towns, as long as SIT application was found to be economically feasible at individual farm or household level and the community was adequately consulted.
Podcast: Malaria Gene Drive
19474S. Hartley, S. Neema and C. Opesen, University of Exeter Business School, 2021-11-25 15:15:30.
Professor Sarah Hartley and her two colleagues in Uganda, Stella Neema and Chris Opesen discuss gene drive research for malaria control. Funded by British Academy and Wellcome trust, their work is to understand the social science challenges around the development of this kind of technology and to consider how governance and ethics should be managed when dealing with a scientific breakthrough such as this.
A Household-Based Survey to Understand Factors Influencing Awareness, Attitudes and Knowledge towards Wolbachia-Aedes Technology
19435L. T. Soh, Z. Ong, K. Vasquez, I. Chen, X. Li, W. Niah, C. Panchapakesan, A. Sheldenkar, S. Sim, L. C. Ng and M. O. Lwin, International Journal of Environmental Research and Public Health, 18. 2021-11-15 20:37:00.
In 2016, Singapore introduced the release of male Wolbachia-Aedes mosquitoes to complement vector control efforts and suppress Aedes aegypti mosquitoes in selected study sites. With ongoing expansion of Project Wolbachia-Singapore to cover larger areas, a household-based survey was conducted between July 2019 to February 2020 in two Project Wolbachia study sites using a structured questionnaire, to evaluate current sentiments and assess the need for enhanced public messaging and engagement. The association of factors that influence awareness, attitudes, and knowledge towards the use of Wolbachia-Aedes technology was analysed using Pearson's Chi-square test and binary logistic regression. Of 500 respondents, 74.8% were aware of Project Wolbachia-Singapore. Comparatively, the level of knowledge on Wolbachia-Aedes technology was lower, suggesting knowledge gaps that require enhanced communication and messaging to address misinformation. Longer exposure to the project predicted greater awareness, whereas higher education levels predicted higher knowledge levels. Younger age groups and higher education levels were associated with high acceptance towards the project. High levels of trust and acceptance towards the project were also observed across the population. The public's positive perception of the project is a testament to the effective public communication undertaken to date and will facilitate programme expansion.
Gene drives in malaria control: what we need to know
19289R. Mudziwapasi, M. C. Changara, A. Ndudzo, T. Kaseke, F. Godobo, F. L. Mtemeli, R. Shoko, F. Songwe, S. Ndlovu and S. Sandra Mlambo, Biotechnology and Biotechnological Equipment, 35:1623-1631. 2021-11-15 13:42:40.
Gene drives are being used to enhance a DNA sequence?s likelihood of passing between generations via sexual reproduction. Gene drives can be deployed to manipulate natural populations. They can be used to suppress populations by reducing the number of individuals in a population or to modify populations. There are more than 3000 mosquito species in the world, some of which are vectors of diseases. Malaria is a typical disease whose vectors are mosquitoes. It affects mostly tropical countries. It kills many people annually, many of whom are children. Interventions currently in use, such as indoor residual spraying and mosquito nets, are proving insufficient to eradicate malaria. Gene drives can be used in different ways to control mosquito populations or to eliminate mosquito species, thereby reducing malaria cases and deaths. This can occur through population replacement or suppression. However, before the elimination of any mosquito species for malaria control, it is necessary to consider the effects of such an action. Additionally, there is a need to review the options available for the control of mosquitoes and to create awareness of the benefits and risks of such an action. This paper, therefore, looks at the role of mosquitoes in the environment, the methods of controlling mosquitoes and malaria and necessary considerations when using gene drives inter alia.
Containment Practices for Arthropods Modified with Engineered Transgenes Capable of Gene Drive Addendum 1 to the Arthropod Containment Guidelines, Version 3.2
19069American Committee of Medical Entomology, Vector-Borne and Zoonotic Diseases, 2021-10-28 20:19:33.
Responsible conduct of research is a cornerstone of rigorous scientific discovery. Institutional committees, independent advisory panels, and expert steering groups are among the frameworks in academia meant to provide guidance and assurances that research activities do not result in harm to the environment, research staff, or public safety. For research involving arthropods of public health importance, several documents currently exist to guide investigators in methodologies to consider for reducing risks from arthropod escape. However, to date, there has been no standardized set of recommendations on containment practices for arthropods modified with engineered transgenes capable of gene drive. This document is meant to serve as a practical reference to fill that gap. Recommendations outlined here address containment considerations when a risk assessment indicates a possibility of establishment of a new arthropod vector species or genetically modified arthropods in the local environment.
European Parliament adopts text on biodiversity, calls for no releases of gene drive organisms
19071Third World Network, TWN Biosafety Briefing, 2021-10-27 20:24:55.
Gene drive technologies, such as GM mosquitoes for the control of vector-borne diseases, pose serious and novel threats for the environment and nature, including irreversible changes to food chains and ecosystems, and losses of biodiversity, on which the world’s poorest depend for their livelihoods; therefore reiterates concern about the new legal, environmental, biosafety and governance challenges that might arise from the release of genetically engineered gene drive organisms into the environment, including for nature conservation purposes; reiterates that the free, prior and informed consent of IPLCs must be sought and obtained prior to the release of any technologies which may impact on their traditional knowledge, innovation, practices, livelihoods and use of land, resources and water; stresses that this must be done in a participatory manner involving all potentially affected communities prior to any deployment. Given that gene drive technologies raise concerns about the difficulties of predicting their behaviour, and that gene drive organisms could become invasive species; therefore considers that no releases of genetically engineered gene drive organisms should be permitted, including for nature conservation purposes, in line with the precautionary principle.
Genome Editing Tools and Gene Drives: A Brief Overview (1st ed.).
19295R. Mudziwapasi, R. Chekera, C. Z. Ncube, I. Shoko, B. Ncube, T. Moyo, J. G. Chimbo, J. Dube, F. F. Mashiri, M. A. Mubani, D. Maruta, C. Chimbo, M. Masuku, R. Shoko, R. P. Nyamusamba and F. N. Jomane, CRC Press, 2021-10-21 14:20:34.
Genome-editing methods are becoming routine tools for molecular and cell biologists. Such tools include ZFNs, CRISPR, megaTALs and TALENs. These tools are revolutionizing the creation of precisely manipulated genomes to modify the characteristics of organisms or cells. Additionally, gene drives have altered the way we understand inheritance laws. They give us the ability to have total control of the inheritance of traits of choice and importance. This succinct volume summarizes the history, principles and applications – as well as the advantages and disadvantages – of each of these tools and various kinds of gene drives. The book is part of a program to produce books helpful to students and faculties of science at colleges and universities. This volume in the Pocket Guides to Biomedical Sciences series will help demystify these technologies. The book fills the gap between established conventional methods and the novel and exciting newly introduced tools of genome editing and gene drives. It will help young scientists understand the emerging genome-editing tools and gene drives, thereby promoting related research and adoption.
Gene drive and RNAi technologies: a bio-cultural review of next-generation tools for pest wasp management in New Zealand
19000S. Palmer, P. K. Dearden, O. R. Mercier, A. King-Hunt and P. J. Lester, Journal of the Royal Society of New Zealand, 1-18. 2021-10-14 15:09:43.
There is a global need for novel, next-generation technologies and techniques to manage pest species. We review work on potential step-changing technologies for large landscape (>1000 hectares) pest management of social Vespula wasps. We also review M?ori perspectives on these controls to gauge social and cultural acceptability to research, test and use of novel controls. Approaches discussed are the use of gene silencing (RNAi) and gene drives (CRISPR-Cas 9) involving genetic modification, which has potential for pest control but vary in feasibility, cost, benefits and off-target risks. RNAi may be better suited for wasp control in high-value cropping systems due to scaling inefficiencies. Gene drives offer potential for large-scale control but would require legislative and wide social deliberation due to their status as genetic modification. Both RNAi and gene drives will require consultation with tangata whenua. M?ori interest groups agreed that exotic wasps must be controlled and expressed aversion to non-targeted traditional control methods. We present a diversity of opinions in parallel with scientific research underscoring the need for continued dialogue with M?ori. Novel biotechnological controls must satisfy a broad range of social and cultural criteria, receive regulatory approval, along with being demonstrated as safe, selective, and cost-effective.
Small-scale release of non-gene drive mosquitoes in Burkina Faso: from engagement implementation to assessment, a learning journey
18910L. Pare Toe, N. Barry, A. D. Ky, S. Kekele, W. Meda, K. Bayala, M. Drabo, D. Thizy and A. Diabate, Malaria Journal, 20:395. 2021-10-11 14:50:37.
This study provides a review of engagement activities relevant to field trials on non-gene drive genetically-modified mosquitoes as well as an assessment framework-using both qualitative and quantitative studies as well as an audit procedure. The latter was implemented to evaluate whether the release activities could proceed with the appropriate level of agreement from the community. RESULTS: This paper shows the importance of this first phase of work to innovate and learn about engagement processes for responsible research in the field of genetic approaches for malaria vector control. The function of these assessments is crucial for the learning agenda. The assessments demonstrated ways to increase understanding and ensure effective progress with field studies and, therefore, the pathway for responsible research.
Weltnaturschutzunion sucht Position
18803Anonymous, Informationsdienst Gentechnik, 2021-09-22 19:07:43.
Die Weltnaturschutzunion IUCN will in den nächsten drei Jahren eine breite interne Diskussion führen, ob Gentechnik und Gene Drives im Naturschutz eingesetzt werden sollen. Mit diesem Beschluss ist der Versuch gentechnikfreundlicher Organisationen, mit Artenschutz-Argumenten neuen gentechnischen Verfahren die Tür zu öffnen, vorerst abgewehrt. Der 1948 gegründeten International Union for Conservation of Nature gehören über 1300 staatliche und nichtstaatliche Naturschutzorganisationn aus aller Welt an. Sie trafen sich Mitte September in Marseille zu ihrem Weltnaturschutzkongress und verabschiedeten dabei mit der Resolution Nummer 75 auch einen Fahrplan, um zu einer „IUCN-Politik zur synthetischen Biologie in Bezug auf den Naturschutz“ zu gelangen. Der Begriff synthetische Biologie umfasst dabei alle gentechnischen Verfahren, mit denen biologische Systeme künstlich konstruiert oder umgestaltet werden.
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.
To exterminate, or not to: Scientists debate tweaking wild genomes
18529French Press Agency, Daily Sabah, 2021-09-12 16:11:31.
veryone remembers Jeff Goldblum's famous speech in 1993 classic Jurassic Park: “Your scientists were so preoccupied with whether they could, they didn't stop to think if they should.” Well, these scientists are debating whether one should. In the movie, reconstructing and tweaking genetic material had made it possible to bring dinosaurs back to life. Today, a technology that manipulates animal genomes, called gene drive, has become a reality. The goal, however, is not to revive long-gone species, but to eliminate invasive ones. Steven Spielberg's film was set on an imaginary island off the coast of Costa Rica, and it is also on an island that the first open-air experiments in programmed extinction could take place, according to experts gathered at the International Union for the Conservation of Nature (IUCN) Congress in Marseille. It could happen within a decade, they told Agence France-Presse (AFP). That's because fragile island ecosystems are in crisis. Dozens of vertebrate species have vanished in the last century, and dozens more are on a glide path to extinction. The culprits are non-native rats, snakes and mosquitoes – all introduced by humans, for the most part by accident – that eat bird eggs, infect birds with disease, or outcompete indigenous amphibians and mammals. For more than 20 years, Island Conservation has been working to eradicate rodents and other invasive alien species, which are a major threat to biodiversity globally, the organization's Royden Saah told AFP. The conservation NGO has been successful on two Galapagos islands – Seymour North and Mosquera – using traps and poison-delivering drones. But species eradication using these tools is costly and has no guarantee of success. Rat poison is effective, but poses risks to other species.
The viral era
18352B. Giese, EMBO reports, 22:e53229. 2021-09-06 13:54:36.
New biotechnologies such as gene drives and engineered viruses herald a viral era that would give humans exceptional power over any organism at the level of the genotype. In synthetic biology, orthogonality—in the sense of lack of interference—between different systems or system components is sought for new creations. Current approaches to controlling gene drives also aim for orthogonality, but at a higher level of organisms, populations and species. To keep information under control, orthogonality and reversibility have to be guaranteed before any releases. As with chemical substances, where persistence and bioaccumulation are reasons for concern, the same should apply to genetic information released into nature
The international governance of gene drive organisms
18320F. Rabitz, Environmental Politics, 2021-08-29 13:07:16.
Gene Drive Organisms (GDOs) are a proposed biotechnological intervention that might generate significant benefits for the conservation and sustainable use of biological diversity while also raising critical biosafety issues. Despite their inevitable transboundary effects, their implications for international institutions remain undertheorized. This text develops a theoretical analysis of international GDO governance. First, it elaborates the problem-structural characteristics of GDOs that turn them into a novel and distinct governance challenge, focusing on leverage, cost-benefit distributions, irreversibility, as well as uncertainty and unpredictability. Second, it derives the implications of problem structure for institutional design by focusing on pre-release risk assessment and authorization, as well as post-release monitoring and liability. Third, it uses these institutional implications for benchmarking the Cartagena Protocol on Biosafety, the focal point in international biotechnology regulation, for effective GDO governance. The text concludes that institutional reforms are required for folding GDOs into international biodiversity policy.
Knowing and Controlling: Engineering Ideals and Gene Drive for Invasive Species Control in Aotearoa New Zealand
18025C. H. Ross, Nature Remade: Engineering Life, Envisioning Worlds, 2021-08-10 17:51:46.
On the islands of Aotearoa, also called New Zealand, invasive species have been a prominent and persistent concern for local ecosystems. Traditional methods of biological control, though, can be difficult to implement and often have harmful side- effects for the environment and human health. Recent developments in genetic engineering have led to the creation of a new technology called gene drive, which some have suggested may pro-vide a safer, easier alternative way to “restore damaged ecosystems and save endangered wildlife by genetically removing invasive species.” 1 While the promises of gene drive for invasive species control have attracted the attention of many in Aotearoa New Zealand interested in preserving or restoring the islands’ native environment, at the same time it has prompted calls for caution regarding their controllability and possible unintended consequences of their use. 2 However, the consideration of gene drive for the control of invasive species in Aotearoa New Zealand is more than just an issue of a controversial use of emerging biotechnology. At stake also are critical questions about what it means to know and control life. What are the kinds of knowledge that enable and underwrite the notions of controlling of life? If gene drive confers the power to control inva-sive species, who decides whether and how that control is exercised and with what responsibilities? And, crucially, what visions of the world are embedded in the aspirations of scientifically knowing and technologically controlling life?Controlling life has long been a central aspiration of the biological sciences. In the early twentieth century, aspirations to greater control over life manifested in rigorous laboratory experimentation, attempts to engineer organisms to be more amenable to human purposes, and explanatory commitments to a mechanistic conception of life. 3 Mechanistic approaches have been ubiquitous in biological practice aimed at bringing living things and their functions into the purview of human intention and volition by isolating, manipulating, and better understanding the function of more fundamental parts. 4 The widespread mechanistic approaches in biology
2021 WHO guidelines on genetically modified mosquitoes
18084M. Makoni, The Lancet Microbe, 2:e353. 2021-08-01 17:27:59.
On May 19, 2021, WHO updated its guidelines for research and development on genetically modified mosquitoes, which define the standards for decision-making about how and when testing should proceed and describe best practices to ensure that research done in a public health context is safe, ethical, and rigorous. TDR, WHO's Special Programme for Research and Training in Tropical Diseases, and the GeneConvene Global Collaborative, an initiative of the Foundation for the National Institutes of Health, developed the updated guidelines building on the 2014 recommendations, integrating the latest advancements in mosquito genetic modification. “Vector-borne diseases are a major global public health issue. Over 100 countries are endemic for diseases such as dengue, malaria, and Zika. Dengue alone puts 2·5 billion people at risk”, says John Reeder (TDR and Department of Research for Health, WHO). Attacking the mosquitoes is an effective way of controlling the transmission of these diseases, but it is a massive task. “We are badly in need of new technologies that will change the game and allow effective, widespread control”, Reeder told The Lancet Microbe.
Oxitec and MosquitoMate in the United States: lessons for the future of gene drive mosquito control
17890C. E. Schairer, J. Najera, A. A. James, O. S. Akbari and C. S. Bloss, Pathogens and Global Health, 2021-07-27 12:51:01.
ABSTRACTIn response to growing concerns regarding mosquito-borne diseases, scientists are developing novel systems of vector control. Early examples include Oxitec?s OX513A genetically-engineered mosquito and MosquitoMate?s Wolbachia-infected mosquito, and systems using ?gene-drive? are in development. Systems based on genetic engineering are controversial and institutions around the world are grappling with the question of who should have a say in how such technologies are field-tested and used. Based on media coverage and public records, we created comparative timelines of the efforts of Oxitec and MosquitoMate to navigate federal and local governance and bring their products to market in the United States. We analyze these timelines with particular attention to the role of public input in technology governance. These cases illustrate how governance of technology in the US is diverse, complex, and opaque. Further, the public response to proposed field trials of the Oxitec product highlights inconsistencies between public expectations for governance and actual practice. As gene-drive mosquito control products develop, both federal and local agencies will find their legitimacy tested without a better procedure for transparently integrating public input.
Risk management recommendations for environmental releases of gene drive modified insects
17829Y. Devos, J. D. Mumford, M. B. Bonsall, D. C. M. Glandorf and H. D. Quemada, Biotechnology Advances, 2021-07-25 13:02:06.
The ability to engineer gene drives (genetic elements that bias their own inheritance) has sparked enthusiasm and concerns. Engineered gene drives could potentially be used to address long-standing challenges in the control of insect disease vectors, agricultural pests and invasive species, or help to rescue endangered species. However, risk concerns and uncertainty associated with potential environmental release of gene drive modified insects (GDMIs) have led some stakeholders to call for a global moratorium on such releases or the application of other strict precautionary measures to mitigate perceived risk assessment and risk management challenges. Instead, we provide recommendations that may help to improve the relevance of risk assessment and risk management frameworks for environmental releases of GDMIs. These recommendations include: (1) developing additional and more practical risk assessment guidance to ensure appropriate levels of safety; (2) making policy goals and regulatory decision-making criteria operational for use in risk assessment so that what constitutes harm is clearly defined; (3) ensuring a more dynamic interplay between risk assessment and risk management to manage uncertainty through closely interlinked pre-release modelling and post-release monitoring; (4) considering potential risks against potential benefits, and comparing them with those of alternative actions to account for a wider (management) context; and (5) implementing a modular, phased approach to authorisations for incremental acceptance and management of risks and uncertainty. Along with providing stakeholder engagement opportunities in the risk analysis process, the recommendations proposed may enable risk managers to make choices that are more proportionate and adaptive to potential risks, uncertainty and benefits of GDMI applications, and socially robust.
Gene Drives – Engineering the Wild
17825L. Sharratt, Sentinel, 2021-07-13 14:52:05.
So far, genetically engineered organisms have been mostly limited to agricultural use, with partial success. Around the world, a few major crops (mostly corn, soy, and cotton) are genetically engineered, predominantly for herbicide tolerance and insect resistance. However, the newer techniques of genome editing (also called gene editing) mean that a much wider variety of organisms can now be genetically engineered, including for many purposes outside of food and farming. This increased power is most dramatically illustrated in the development of gene drive technology. Unlike genetically engineered plants and animals intended for confined use in agricultural production, gene drive organisms are expressly designed for intentional, long-lived release into the wild. Gene drives are a technology through which a few individual genetically engineered organisms would be deployed to intentionally push new genes through an entire population of a species in the wild or in a farm ecosystem. Through the gene drive mechanism, new genes would be inherited by all offspring in subsequent generations, not just the expected half in normal inheritance. When gene drive organisms reproduce, specific traits as well as the gene drive mechanism itself would be passed on. Making such spreading genetic changes to an organism, or eliminating it in the wild, could disrupt whole ecosystems in ways that are difficult or impossible to predict or reverse.
Earth system interventions as technologies of the Anthropocene
17730J. L. Reynolds, Environmental Innovation and Societal Transitions, 40:132-146. 2021-07-10 15:16:46.
Earth system interventions (ESIs)—intentional large-scale interventions in Earth systems—are not entirely new. However, in response to threats to sustainability, particularly from climate change and biodiversity loss, some scientists and others are researching, developing, and using new, largely technological ESIs. These include carbon dioxide removal, solar geoengineering, in situ genetically modified organisms, gene drive organisms, de-extinction, and high-tech ecosystem restoration. Some emerging ESIs appear to be effective and feasible, both technically and economically, and may be necessary to achieve important sustainability and human welfare objectives. They also pose serious environmental risks. This paper identifies more than a dozen social, political, and ethical challenges that are common across many of the emerging technological ESIs. Governance could mitigate and manage these issues, and it would be made more effective and robust by understanding and treating new ESIs as such and as a potentially transformative set of innovations in human-Earth system relations.
Africa Turning to Gene Drive Technology for Malaria Elimination
17669M. Hearty, Science Africa, 2021-07-09 20:02:22.
With Africa accounting for nine out of ten malaria cases globally, the continent is turning to gene drive technology to control the disease. This is according to a decision made by African leaders at the 29th Summit of Heads of States and Governments of the African Union held in Addis Ababa. There are 3500 to 4000 mosquito species worldwide and 837 of the species are in Africa, with only 3 species transmitting malaria in sub-Saharan Africa. Speaking during a virtual conference by the African Union Development Agency (AUDA-NEPAD) , Dr Abdoulaye Diabate, Head of Medical Entomology and Parasitology at the Research Institute in health Sciences in Burkina Faso who presented on Gene Drive for Malaria Control and Elimination in Africa said that two options for genetic control of mosquito-borne infectious diseases identified were population suppression and population replacement. “Population suppression involves releasing of modified mosquitoes into the population, and this can cause transient or permanent suppression. With the population replacement method, modified mosquitoes released into the population can lead to the spread of a gene that blocks malaria transmission,” the Medical Entomologist stated.
West African countries working together to develop framework to regulate genetically engineered mosquitos: Target Malaria
17663Anonymous, Global News, 2021-07-08 19:50:08.
Abdoulaye Diabaté, principal investigator for Target Malaria, says West African countries like Burkina Faso, Mali and Benin are working with the New Partnership for Africa’s Development (NEPAD) to develop a pan-West African framework to regulate gene drive mosquitos.
Potential use of gene drive modified insects against disease vectors, agricultural pests and invasive species poses new challenges for risk assessment
17551Y. Devos, J. D. Mumford, M. B. Bonsall, A. M. Camargo, L. G. Firbank, D. C. M. Glandorf, F. Nogué, K. Paraskevopoulos and E. A. Wimmer, Critical Reviews in Biotechnology, 2021-06-24 13:49:18.
Potential future application of engineered gene drives (GDs), which bias their own inheritance and can spread genetic modifications in wild target populations, has sparked both enthusiasm and concern. Engineered GDs in insects could potentially be used to address long-standing challenges in control of disease vectors, agricultural pests and invasive species, or help to rescue endangered species, and thus provide important public benefits. However, there are concerns that the deliberate environmental release of GD modified insects may pose different or new harms to animal and human health and the wider environment, and raise novel challenges for risk assessment. Risk assessors, risk managers, developers, potential applicants and other stakeholders at many levels are currently discussing whether there is a need to develop new or additional risk assessment guidance for the environmental release of GD modified organisms, including insects. Developing new or additional guidance that is useful and practical is a challenge, especially at an international level, as risk assessors, risk managers and many other stakeholders have different, often contrasting, opinions and perspectives toward the environmental release of GD modified organisms, and on the adequacy of current risk assessment frameworks for such organisms. Here, we offer recommendations to overcome some of the challenges associated with the potential future development of new or additional risk assessment guidance for GD modified insects and provide considerations on areas where further risk assessment guidance may be required.
‘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.
European Parliament calls for ban on gene drive technology
17296Save Our Seeds, Save Our Seeds, 2021-06-09 10:56:17.
The European Parliament yesterday confirmedi it‘s precautionary stance towards the use of a new genetic engineering technology called gene drive. In its report on the EU’s Biodiversity Strategy for 2030, adopted at the European Parliament’s plenary on 08.06.2021, Parliamentarians demand that „no releases of genetically engineered gene drive organisms should be allowed, including for nature conservation purposes, in line with the precautionary principle.“ Mareike Imken, coordinator of the European Stop Gene Drive Campaign welcomes this decision and comments: „With its position today, the European Parliament recognizes that this technology raises a series of scientific, regulatory, societal and ethical questions and concerns. As its use could severely harm biodiversity, the European Parliament calls to postpone any environmental releases until these questions have been addressed and settled. This is an important message that should feed into the ongoing discussions about global regulations at the next meeting of the International Union for Conservation of Nature (IUCN) in September in Marseille and those of the Convention on Biological Diversity in October in Kunming, China.“ 27 civil society and science organisations from across the EU had sent a letter to Parliamentarians in support of the amendment ahead of the vote. It „provides reasonable suggestions on how to implement the European Parliament’s previous position in its resolution on the 15th meeting of the Conference of Parties (COP15) to the Convention on Biological Diversity (2019/2824(RSP)“. In that previous position, adopted in January 2020, the European Parliament had called “on the Commission and the Member States to call for a global moratorium at the COP15 on releases of gene drive organisms into nature, including field trials, in order to prevent these new technologies from being released prematurely and to uphold the precautionary principle, which is enshrined in the Treaty on the Functioning of the European Union as well as the CBD“.
Living With the Limits of Our New Clerisy’s Knowledge
17306R. Fernandez, PJ Media, 2021-06-08 11:22:01.
We are living in a strange time when reason has fallen short of human expectations and there is, once again, pressure to place our trust in faith. Leighton Woodhouse hit the nail on the head when he argued that we have appointed a New Clerisy to rule over us, not because they are infallible but to save ourselves from the tide of uncertainty that seems to have engulfed our once seemingly confident global world. Unfortunately, the new clergy seem too fallible to take on trust. They flip-flop on expert advice and one scientist denounces the other on YouTube. Once things seemed more cut and dried. Once we were at the End of History. Science could predict the future more or less and the public hoped with increasing accuracy. Ever since the 17th century, the expectation was that the scientific revolution would supply the answers. As the frontier moved from the simple, computable problems of the early 20th century to complex systems — of which biotechnology, artificial intelligence, social networks, and eco-engineering are prime examples — they began to involve the management of uncertainty because it was difficult to control all the variables involved. The care with which some scientists have approached the subject of gene drives, a biological technology as powerful as “gain of function,” illustrates the challenges of dealing with uncertainties.
African Experts Welcome WHO Guidance on Ethics, Standards, and Governance of Genetically Modified Mosquito Research
17200E. Nakkazi, Health Policy Watch, 2021-06-01 15:24:31.
Researchers engaged in mosquito gene drive technologies are optimistic that new World Health Organization (WHO) guidance on best research practices will ensure that their work is safe and ethical. Such guidance also helps research results advance from laboratories to be used in the field, the researchers told Health Policy Watch. Due to limiting regulatory frameworks, most African countries doing research on genetically modified mosquitoes have been accused of carrying out unethical research. Some confine their work to laboratories because regulations mostly focus on handling plant-based genetically modified organisms. The WHO recently released essential standards for the study and evaluation of genetically modified mosquitoes so use of this public health tool can be ethical, effective, and affordable. Malaria kills more than 400,000 people a year worldwide. “Genetically modified mosquitoes are one of a number of promising new tools that could help speed the pace of progress against malaria and other vector-borne diseases,” WHO Global Malaria Programme Director Dr Pedro Alonso said.
What is wrong in extinguishing a species? Charting the Ethical Challenges of using Gene-Drive Technologies to eradicate A. gambiae vector populations
17161M. Annoni and T. Pievani, Biolaw Journal-Rivista Di Biodiritto, 2021-05-31 19:04:09.
This article analyses three ethical arguments against the use of gene-drive technologies to control for, and possibly extinguish, a particular species of vector mosquitoes (Anopheles gambiae) causing the malaria infection. We conclude that none of these arguments is truly persuasive in the specific case and, therefore, that using gene-drive technologies to suppress or eradicate the population of Anopheles gambiae could be ethically justifiable provided certain cautions referring to ecological consequences, evolutionary effects and social engagement of local communities.
WHO releases new guidance for deployment of genetically modified mosquitoes
17130E. Henderson, News Medical Life Sciences, 2021-05-28 19:13:57.
The World Health Organization (WHO) has released new guidance for the deployment of genetically modified (GM) mosquitoes to combat vector-borne diseases like malaria and dengue. GM mosquitoes may carry a gene that kills female progeny and the technology can be used against the Aedes aegypti mosquito that carries dengue, chikungunya and Zika viruses. For malaria, genetic modification has focused on reducing the ability of the female Anopheles mosquito to carry the parasite that causes the disease. The WHO guidance, released this month, relates to research and development of GM mosquitoes as well as issues around effectiveness, safety, affordability and ethics. Presently, measures against mosquito vectors include the use of insecticides and elimination of the breeding spots of mosquito larva, said the guidance, developed in partnership with WHO collaborators such as the Special Programme for Research and Training in Tropical Diseases and the GeneConvene Global Collaborative.
Q&A: WHO updates guidance on testing genetically modified mosquitoes
17135E. N. Dreisbach, Healio, 2021-05-24 13:04:56.
Researchers have been exploring the use of genetically modified mosquitos as a potential control method for vector-borne diseases. Just last month, Oxitec began releasing its genetically modified (GM), self-limiting male Aedes aegypti mosquitoes in the Florida Keys in the hope of reducing the mosquito population.This month, WHO released the second edition of its guidance for testing GM mosquitos (GMMs), updating guidelines that were originally released in 2014. We spoke with Jan Kolaczinski, PhD, MSc, head of the vector control and insecticide resistance unit in WHO’s Global Malaria Program, about the new guidance and what it means for researchers.
Why the EU should back research into gene drive – even if Europe never uses it
17132R. Müller, The Brussels Times, 2021-05-23 12:00:13.
As the EU’s Biodiversity Strategy reaches the European Parliament, it has reopened a worrying debate about research into gene drive technology, a tool which could pave the way for biasing the inheritance of desired genetic traits through targeted species. Advances in this kind of genetic technology could allow scientists to create a blueprint for stopping diseases spread by mosquitoes and protecting endangered species, both significant reasons for supporting this emerging field. Yet even if EU decision makers see no need for gene drive technology in Europe at present, there are compelling reasons for supporting ongoing research, and rejecting irresponsible and short-sighted calls for a moratorium. Firstly, the threat of malaria and other mosquito-borne diseases may be minimal today but it existed on the continent within living memory, with Europe first becoming malaria-free in 1975, and then again only as recently as 2015.
Genetically modified mosquitoes; WHO issues new guidance for research
17084DTE Staff, Down To Earth, 2021-05-20 15:10:16.
Genetically-modified mosquitoes or GMMs have been used across the world to control mosquitoes. GMMs have been able to bring down the population of the Aedes aegypti by 90 per cent in countries like Brazil, the Cayman Islands, Panama and Malaysia. But there have never been any global protocols or standards on the breeding of GMMs. The World Health Organization has addressed this by setting essential standards for the research and development of GMMs. These standards are mainly about ethics, safety, affordability and effectiveness of GMMS. GMMs are male mosquitoes modified to carry a lethal gene. When they mate, the genes get passed on to their offspring. The gene prevents female offspring from building an essential protein and causes them to die before reaching maturity. GMMs could become a cost-effective and powerful tool to control mosquitoes. Over 40,000 people die from malaria and 100-400 million people get infected with dengue each year. They can reach mosquito populations and mosquito larval breeding sites that are currently expensive and difficult to reach. It can target specific mosquito species and thus avoid the ecological and environmental hazards of usual insecticides.
WHO issues new guidance for research on genetically modified mosquitoes to fight malaria and other vector-borne diseases
17076WHO, reliefweb, 2021-05-19 14:55:10.
New guidance from the World Health Organization (WHO) sets essential standards to inform future research and development on genetically modified mosquitoes, particularly in addressing issues relating to ethics, safety, affordability and effectiveness. Malaria and other vector-borne diseases, including dengue and Zika, affect millions globally. More than 400 000 people a year die from malaria alone. If proven safe, effective and affordable, genetically modified vector mosquitoes could be a valuable new tool to fight these diseases and eliminate their enormous health, social and economic burden. The guidance framework for testing genetically modified mosquitoes, developed in partnership with TDR, the Special Programme for Research and Training in Tropical Diseases, and the GeneConvene Global Collaborative, an initiative of the Foundation for the National Institutes of Health, describes best practices to ensure that the study and evaluation of genetically modified mosquitoes as public health tools is safe, ethical and rigorous. Current strategies for limiting transmission of mosquito-borne diseases are only partially effective. New, complementary approaches are needed to close the gaps in current vector control interventions, such as effective control of outdoor biting, and to provide alternatives to manage the increasing threat of insecticide resistance. Research suggests genetically modified mosquitoes could be a powerful and cost-effective tool to supplement existing interventions.
Guidance framework for testing of genetically modified mosquitoes, second edition
17049WHO, WHO-TDR, 2021-05-19 10:41:03.
For more than 2 decades, scientists have been working to harness the promise of molecular biology to develop genetically modified mosquitoes (GMMs) for use as public health tools to prevent the transmission of vector-borne diseases. Responding to a need for additional standards and guidance, the WHO Special Programme for Research and Training in Tropical Diseases (WHO-TDR) and the Foundation for the National Institutes of Health (FNIH) published in 2014 the first WHO Guidance framework for testing genetically modified mosquitoes. This revised version takes into account the technical progress made and lessons learned in this rapidly advancing field of research. Like the original guidance framework, it is intended to provide standards that foster quality and consistency in the processes for developing, testing and regulating these new genetic technologies. Best practices recommended in the 2021 guidance framework will further contribute to the comparability of results and credibility of conclusions in order to facilitate decision-making by countries interested in the potential use of GMMs as public health tools for the control of vector-borne diseases.
The legal regulation of gene drive technologies
16914C. Elves, Univeristy of Oxford, 2021-05-01 13:32:03.
Gene drive technologies purport to provide a panacea and yet in doing so present unprecedented risks that threaten to change, potentially irreversibly, the way in which we live in the world. Gene drive technologies raise questions about what ends societies ought to seek for their citizens, how they are constituted and how those ends might be attained. Despite this, current discussions surrounding gene drive technologies and their regulation focus almost exclusively on the technical implications. Drawing on the work of sociologists and STS scholars, this thesis argues that lawyers ought to think critically about the ways in which they go about developing their understandings of new technologies as regulatory objects. Lawyers need to evaluate and scrutinize the knowledge claims with which they are presented, and work to identify those extending beyond the required technical expertise, if the regulatory frames they build are to bear fidelity to the realities of the technology. This thesis draws out the regulatory disconnection generated by the current regulation of gene drive technologies through the existing European Union GMO regime. It then goes on to describe the ways in which regulatory reconnection might be achieved by constructing broader frames through which we describe gene drive technologies as a regulatory object. In thinking about how lawyers might go about broadening the frames that they build, this thesis takes examples from Public Health Law scholarship and legislation. In response to both the normative and epistemic lacunae highlighted above, this thesis develops an account of why and how ethical enquiry ought to play a significant role in informing our descriptions of gene drive technologies as regulatory objects. Furthermore, this thesis argues that ethical enquiry is capable of articulating questions to which technical experts must provide answers if we are to develop fuller understandings of the technologies we regulate. In this way, ethical enquiry can help lawyers bridge both the normative and epistemic gaps that they are so often faced with in the regulation of emerging technologies.
Driving genetic destruction
16899Anonymous, Alliance for Natural Health, 2021-04-29 17:41:37.
Genetically-engineered (GE) mosquitoes have been released in a number of countries, including the US. We’ve known for some time that these experiments have not gone to plan, but a new paper provides a better understanding of how they’ve went awry, and provides a harrowing warning for what could go wrong with a new era of gene editing known as “gene drives” in which the genetics of entire species can be tampered with. This could create a nightmare scenario where, instead of a disease-carrying mosquito population being controlled or eliminated, unpredicted changes occur that make them even more virulent and dangerous. Current GE experiments involve altering the genetics of mosquitoes to be “self-limiting,” meaning that offspring inherit a gene that prevents them from surviving to adulthood, thus driving the population down. The goal is to limit the spread of diseases like dengue and yellow fever. But what has happened is that a certain percentage of the offspring of the GE mosquitoes are surviving and integrating into the gene pool of the local population. Scientists note this will have unpredictable consequences and could lead to more pathogenic disease strains—the very opposite of what these experiments were supposed to accomplish.
Selection of Sites for Field Trials of Genetically Engineered Mosquitoes with Gene Drive
16932G. C. Lanzaro, M. Campos, M. Crepeau, A. Cornel, A. Estrada, H. Gripkey, Z. Haddad, A. Kormos, S. Palomares and W. Sharpee, bioRxiv, 2021.04.28.441877. 2021-04-28 15:53:05.
Novel malaria control strategies using genetically engineered mosquitoes (GEMs) are on the horizon. Population modification is one approach wherein mosquitoes are engineered with genes rendering them refractory to the malaria parasite coupled with a low-threshold, Cas9-based gene drive. When released into a wild vector population, GEMs preferentially transmit these beneficial genes to their offspring, ultimately modifying a vector population into a non-vector one. Deploying this technology awaits evaluation including ecologically contained field trials. Here, we consider a process for site selection, the first critical step in designing a trial. Our goal is to identify a site that maximizes prospects for success, minimizes risk, and serves as a fair, valid, and convincing test of efficacy and impacts of a GEM product intended for large-scale deployment in Africa. We base site selection on geographical, geological, and biological, rather than social or legal, criteria. We recognize the latter as critically important but not preeminent. We propose physical islands as being the best candidates for a GEM field trial and present an evaluation of 22 African islands. We consider geographic and genetic isolation, biological complexity, island size, topography, and identify two island groups that satisfy key criteria for ideal GEM field trial sites.Competing Interest StatementThe authors have declared no competing interest.
Fighting mosquitoes with mosquitoes
16825W. Feng, The Daily Targum, 2021-04-21 16:38:39.
When you think about the animal that has killed the greatest number of humans in the world, you generally tend to think of large predators. Is it perhaps the great white shark or maybe the cute but deadly hippopotamus? While these animals are certainly deadly, the number of annual fatalities caused by them are eclipsed by the number of individuals killed by the tiny blood-sucking mosquito. According to the World Health Organization, approximately 725,000 people are killed every year by mosquito-borne diseases. The mosquito has been the center of numerous pathogenic outbreaks over the last couple decades, such as the West Nile virus, malaria and the Zika virus. While conventional control strategies have been employed, these have all failed to stop the spread of these viruses. To combat this issue, one solution that has been proposed is gene drives. While further testing and research is still required to ensure the safety and efficacy of gene drives, the benefits of this technology far outweigh any potential consequences, lending them to be extremely helpful in the battle against insect-borne diseases.
CRISPR-Cas and Its Wide-Ranging Applications: From Human Genome Editing to Environmental Implications, Technical Limitations, Hazards and Bioethical Issues
17324R. Piergentili, A. Del Rio, F. Signore, F. U. Ronchi, E. Marinelli and S. Zaami, Cells, 10:24. 2021-04-21 12:06:42.
The CRISPR-Cas system is a powerful tool for in vivo editing the genome of most organisms, including man. During the years this technique has been applied in several fields, such as agriculture for crop upgrade and breeding including the creation of allergy-free foods, for eradicating pests, for the improvement of animal breeds, in the industry of bio-fuels and it can even be used as a basis for a cell-based recording apparatus. Possible applications in human health include the making of new medicines through the creation of genetically modified organisms, the treatment of viral infections, the control of pathogens, applications in clinical diagnostics and the cure of human genetic diseases, either caused by somatic (e.g., cancer) or inherited (mendelian disorders) mutations. One of the most divisive, possible uses of this system is the modification of human embryos, for the purpose of preventing or curing a human being before birth. However, the technology in this field is evolving faster than regulations and several concerns are raised by its enormous yet controversial potential. In this scenario, appropriate laws need to be issued and ethical guidelines must be developed, in order to properly assess advantages as well as risks of this approach. In this review, we summarize the potential of these genome editing techniques and their applications in human embryo treatment. We will analyze CRISPR-Cas limitations and the possible genome damage caused in the treated embryo. Finally, we will discuss how all this impacts the law, ethics and common sense.
Oxitec Receives Landmark Biosafety Approval for New Fall Armyworm Control Solution
16810Oxitec, Oxitec, 2021-04-15 16:03:00.
Approval of Oxitec’s Friendly™ fall armyworm technology by the Brazilian government’s regulatory agency CTNBio confirms that it is safe for people, animals and the environment. Oxitec’s Friendly™ fall armyworm is a new, safe, and sustainable solution to one of the world’s most devastating crop pests. CTNBio’s decision is a significant step towards deployment on commercial corn fields in Brazil. This is the world’s first commercial biosafety approval of an agricultural Friendly™ insect solution, following the regulatory approval in Brazil for Oxitec’s Friendly™ Aedes aegypti mosquito in 2020
Experimenting with co-development: a qualitative study of gene drive research for malaria control in Mali
16639S. Hartley, K. Ledingham, R. Owen, S. Leonelli, S. Diarra and S. Diop, Social Science and Medicine, 2021-03-21 14:37:21.
Our findings suggest co-development is opening up previously expert-dominated spaces as researchers attempt to take responsibility for the societal implications of their work. However, its main function is as a project management tool to enable and instrumentally support technological development, field trials and eventual deployment. This function extends into areas which are traditionally the responsibility of the state, such as regulatory development, facilitated by Mali’s fragile political and economic situation. Paradoxically, co-development simultaneously depoliticises gene drive, masking power relations and closing down substantive debate and agency. Characterised by extreme poverty, conflict and weak institutions, Mali may become a site for technological experimentation where there is little interrogation of gene drive or its governance.
Commercial Release of Genetically Modified Crops in Africa: Interface Between Biosafety Regulatory Systems and Varietal Release Systems
27487O. Akinbo, S. Obukosia, J. Ouedraogo, W. Sinebo, M. Savadogo, S. Timpo, R. Mbabazi, K. Maredia, D. Makinde and A. Ambali, Frontier in Plant Sciences, 12. 2021-03-21 13:38:05.
African countries face key challenges in the deployment of GM crops due to incongruities in the processes for effective and efficient commercial release while simultaneously ensuring food and environmental safety. Against the backdrop of the preceding scenario, and for the effective and efficient commercial release of GM crops for cultivation by farmers, while simultaneously ensuring food and environmental safety, there is a need for the close collaboration of and the interplay between the biosafety competent authorities and the variety release authorities. The commercial release of genetically modified (GM) crops for cultivation requires the approval of biosafety regulatory packages. The evaluation and approval of lead events fall under the jurisdiction of competent national authorities for biosafety (which may be ministries, autonomous authorities, or agencies). The evaluation of lead events fundamentally comprises a review of environmental, food, and feed safety data as provided for in the Biosafety Acts, implementing regulations, and, in some cases, the involvement of other relevant legal instruments. Although the lead GM event may be commercially released for farmers to cultivate, it is often introgressed into locally adapted and farmer preferred non-GM cultivars that are already released and grown by the farmers. The introduction of new biotechnology products to farmers is a process that includes comprehensive testing in the laboratory, greenhouse, and field over some time. The process provides answers to questions about the safety of the products before being introduced into the environment and marketplace. This is the first step in regulatory approvals. The output of the research and development phase of the product development cycle is the identification of a safe and best performing event for advancement to regulatory testing, likely commercialization, and general release. The process of the commercial release of new crop varieties in countries with established formal seed systems is guided by well-defined procedures and approval systems and regulated by the Seed Acts and implemented regulations. In countries with seed laws, no crop varieties are approved for commercial cultivation prior to the fulfillment of the national performance trials and the distinctness, uniformity, and stability tests, as well as prior to the approval by the National Variety Release Committee. This review outlines key challenges faced by African countries in the deployment of GM crops and cites lessons learned as well as best practices from countries that have successfully commercialized genetically engineered crops.
Ethics of Genome Editing
16622European Group on Ethics, European Group on Ethics in Science and New Technologies, 2021-03-19 18:16:09.
This Opinion addresses the profound ethical questions raised and revived by them. It analyses various domains of application, from human health to animal experimentation, from livestock breeding to crop variety and to gene drives. With its wide view across areas, it identifies underlying and overarching issues that deserve our concerted attention, among them, the different meanings that ought to be attributed to humanness, naturalness or diversity. This enables conclusions that provide panoramic perspectives complementing narrower, area-specific analyses. In the same vein, the Opinion is concerned with the global dimension of genome editing and its regulation and formulates recommendations with a particular focus on the international level.
The ethical scientist in a time of uncertainty
16620L. Zoloth, Cell, 184:1430-1439. 2021-03-18 17:59:56.
Using the example of gene drives for malaria control to explore the problem of deep uncertainty in biomedical research, I argue that profound uncertainty is an essential feature. Applying the language and presumptions of the discipline of philosophical ethics, I describe three types of uncertainty that raise ethical challenges in scientific research. Rather than mitigate these challenges with excessive precautions and limits on progress, I suggest that researchers can cultivate classic values of veracity, courage, humility, and fidelity in their research allowing science to proceed ethically under conditions of deep uncertainty.
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.
Experts’ moral views on gene drive technologies: a qualitative interview study
16565N. de Graeff, K. R. Jongsma and A. L. Bredenoord, BMC Medical Ethics, 22:25. 2021-03-08 13:56:59.
Gene drive technologies (GDTs) promote the rapid spread of a particular genetic element within a population of non-human organisms. Potential applications of GDTs include the control of insect vectors, invasive species and agricultural pests. Whether, and if so, under what conditions, GDTs should be deployed is hotly debated. Although broad stances in this debate have been described, the convictions that inform the moral views of the experts shaping these technologies and related policies have not been examined in depth in the academic literature.
Renew Europe | The science & ethics of gene drive technology from a conservation & development perspective
16584Renew Europe, Renew Europe, 2021-03-05 15:18:26.
This hearing intends to examine gene-drive technology and its possible impacts, including unintended ones and reveal the complexity of an unknown technology with inherent uncertainties. Scientists from different backgrounds in the field of gene-drive research will present most recent scientific findings and allow us to exchange on a technical, but also ethical debate. Hosted by MEPs Soraya Rodríguez & Charles Goerens with a keynote speech by Commissioner for Envinronment Virginijus Sinkevičius.
Demographic and psychographic drivers of public acceptance of novel invasive pest control technologies
17086F. Eppink, P. J. Walsh and E. MacDonald, Ecology and Society, 26. 2021-03-01 15:15:26.
Invasive mammals are a primary threat to New Zealand's endemic species. In remote areas, aerial delivery of poison is the preferred method of pest management, although it faces some public backlash. Novel pest control technologies are currently being investigated as alternatives but may face similar concerns. To investigate potential social and demographic determinants of public perceptions of new methods for pest control, we conducted a national choice experiment, focused on several novel technologies: gene drives, Trojan females, and species-specific poisons. We found that preferences strongly depend on the type of technology, with Trojan female technology strictly preferred to the other two. Although several characteristics affected preferences in predictable ways education, trust in science, and liberal political leaning increased acceptance ;the same did not hold with preferences for aerial delivery. Our results are useful for targeting future engagement campaigns and leveraging existing efforts.
GeneConvene Webinar Series on: Ecological Modeling in Risk Assessment of Gene Drives
16435Hector Quemada and David O'Brochta, 2021-02-23 16:59:25.
Unlike non-gene drive organisms, which can be limited in time and space and therefore provide data in small scale tests that can be relevant to large scale releases, the potential for large-scale spread from a limited release, even in well-isolated trials, means that reliance on models will be a more important tool for risk assessors. To date, this work has only started to receive attention. This series of four presentations deals with the development and use of models in ecology generally. Some of these presentations will also deal with the use of models specifically to assess the ecological impacts of gene drive organisms.
Emergent challenges for CRISPR: biosafety, biosecurity, patenting, and regulatory issues
19398Braddick, D. , and Ramarohetra, R. F., Genome Engineering Via Crispr-Cas9 System, 2021-02-18 17:46:33.
The recent advancements of CRISPR-Cas technologies have transformed this simple and efficient gene editing technique into an extraordinarily powerful tool. The most anticipated applications could create novel therapeutics against mankind's most serious afflictions and help eradicate vector-based diseases. However, with these desired benefits come new ethical questions and potential threats. CRISPR technologies are not yet fully developed toward delivering all of their promises, and suffer from biosafety problems in human products and biosecurity threats arising from its potential dual use and errant gene drives. Furthermore, the future innovations of CRISPR technologies may encounter non-scientific challenges in patentability and unclear legal regulations at the national and international levels. This chapter will discuss these issues, and where possible, will highlight the currently proposed solutions that could mitigate the threats, and could address the problems that hold back CRISPR's full potential.
Scientifically framed gene drive communication perceived as credible but riskier
16406E. A. MacDonald, E. D. Edwards, J. Balanovic and F. Medvecky, People and Nature, 2021-02-17 18:23:29.
Framing is a communication technique in which certain beliefs or values are emphasized that resonate with the target audience. Framing may increase how much people objectively think about new information and update their opinions; framing may mitigate emo
A Code of Ethics for Gene Drive Research
16379G. J. Annas, C. L. Beisel, K. Clement, A. Crisanti, S. Francis, M. Galardini, R. Galizi, J. Grünewald, G. Immobile, A. S. Khalil, R. Müller, V. Pattanayak, K. Petri, L. Paul, L. Pinello, A. Simoni, C. Taxiarchi and J. K. Joung, The CRISPR Journal, 4:19:1-8. 2021-02-10 14:57:13.
A code of ethics can be a useful tool for all parties involved in the development and regulation of gene drives and can be used to help ensure that a balanced analysis of risks, benefits, and values is taken into consideration for the interest of society and humanity. We have developed a code of ethics for gene drive research with the hope that this code will encourage the development of an international framework that includes ethical guidance of gene drive research and is incorporated into scientific practice by gaining broad agreement and adherence.
Public attitudes towards synthetic biology
16363CSIRO, Synthetic Biology Future Science Platform, 2021-02-08 20:06:39.
A national survey has been conducted by CSIRO’s Synthetic Biology Future Science Platform as an important first step in measuring public attitudes towards synthetic biology. The survey draws on the views of more than 8,000 Australians, and researchers are examining the data to determine current attitudes to these emerging technologies
How to engage communities on a large scale? Lessons from World Mosquito Program in Rio de Janeiro, Brazil [version 2; peer review: 1 approved, 2 approved with reservations]
16361G. B. Costa, R. Smithyman, S. L. O'Neill and L. A. Moreira, Gates Open Research, 2021-02-04 19:26:09.
Here we discuss and analyse the framework for community engagement implemented by the WMP in Brazil, during the large-scale deployment of the method in the municipalities of Niterói and Rio de Janeiro, Brazil. Our experience indicates that the community engagement work for arboviruses control should be understood as an opportunity for local development. It is necessary, based on an integrated analysis of the territory, to understand that the actions for arboviruses control could be a catalyst for the necessary socioenvironmental, cultural and public health changes. Furthermore, it is essential to understand that community engagement goes beyond informing or asking for population consent, but it constitutes a possibility for dialogue and exchange between the various stakeholders present in the territories, to build on cooperation for mosquito-borne disease control.
Les Européens très critiques vis-à-vis du forçage génétique
16231L. Duboua-Lorsch, EURACTIV, 2021-01-29 16:38:41.
Cette technique, qui vise à éradiquer ou modifier certaines espèces dites nuisibles, sera au cœur des négociations cette année, alors que se profile la COP15 sur la biodiversité. maginez un monde débarrassé d’insectes porteurs de maladies, de parasites agricoles, d’espèces envahissantes… Les possibilités semblent infinies avec la nouvelle technique du « gene drive », en français forçage génétique. Née au début des années 2000, cette technique de modification génétique permet à un gène d’être transmis de manière quasi-systématique à ses descendants. En quelques générations seulement, l’ensemble d’une espèce sauvage peut être remplacée par ces nouveaux individus génétiquement forcés.
GENE DRIVE ACCEPTANCE SURVEY
16233YouGov, Pollinis, 2021-01-27 16:47:37.
This representative survey was conducted by the international market research institute YouGov and polled 8.826 citizens from 8 EU countries in December 2020. It was commissioned by WeMove Europe, Save Our Seeds (Germany), Skiftet (Sweden), France Nature Environnement (FNE) (France), POLLINIS (France), OGM Dangers (France), Bund für Umwelt und Naturschutz (BUND) (Germany), Deutscher Naturschutzring (DNR) (Germany), Umweltinstitut München (Germany), Za Zemiata (Bulgaria). Deviations from 100% are due to rounding.
Playing God and tampering with nature: popular labels for real concerns in synthetic biology
16201L. Carter, A. Mankad, E. V. Hobman and N. B. Porter, Transgenic Research, 2021-01-27 15:26:41.
We present the findings from a large Australian study (N = 4593) which suggests ‘playing God’ objections and their variants can be multilayered and, at times, accompanied by meaningful information about risk perceptions. We use qualitative analysis of ope
RNAi-based products: A sustainable alternative to hazardous pesticides
16211Ghent University, Phys Org, 2021-01-27 13:59:48.
RNAi-based biocontrol is a great alternative to hazardous pesticides and can contribute towards reversing the alarming decline in farmland birds and beneficial insects (especially pollinating ones). RNAi is a well-known natural biological process in most
The Promises and Realities of Integration in Synthetic Biology: A View From Social Science
16287L. Carter and A. Mankad, Frontiers in Bioengineering and Biotechnology, 8. 2021-01-21 17:25:32.
We take stock of thepromises and realities of science integration by sharing our experiences of embarking onthis very challenge in Australia. We conclude by offering suggestions for bringing aboutthe enabling conditions for improved integration across the natural and social sciences.Four key actions are articulated to help pivot synthetic biology toward a more integratedscientific endeavor: (a) formalizing inclusivity from inception to project conclusion; (b)valuing differing philosophical positions as a strength rather than a barrier; (c) acceptingthat integration takes persistence and communication but is immensely rewarding; and(d) promoting meaningful interactions, such as pursuing joint opportunities, co-designingand co-publishing research. We argue that these actions arekey enablers for realizingscience integration in synthetic biology.
Exploring Gene Drive Technologies in Agriculture, Biodiversity and Human Disease
15963The GBIRd Partnership and The GeneConvene Global Collaborative, Gene Drive Research Forum, 2021-01-14 21:37:12.
The GBIRd Partnership and The GeneConvene Global Collaborative recently collaborated through The Gene Drive Research Forum, to create and produce an engaging conversation between Drs. Fred Gould and Charles Godfray about gene drive technologies – the potential benefits and complicating factors for agriculture, biodiversity, and human disease.
Demystifying the Risk Assessment Process for Laboratory-Based Experiments Utilizing Invasive Genetic Elements: It Is More Than Gene Drive
18156Z. N. Adelman, Applied Biosafety, 2021-01-07 18:05:08.
Advances in recombinant DNA approaches have resulted in the development of transgene architectures that severely bias their own inheritance, a process commonly referred to as ?gene drive.? The rapid pace of development, combined with the complexity of many gene drive approaches, threatens to overwhelm those responsible for ensuring its safe use in the laboratory, as even identifying that a specific transgene is capable of gene drive may not be intuitive. Although currently gene drive experiments have been limited to just a few species (mosquitoes, flies, mice, and yeast), the range of organisms used in gene drive research is expected to increase substantially in the coming years. Here the defining features of different gene drive approaches are discussed. Although this will start with a focus on identifying when gene drive could or could not occur, the emphasis will also be on establishing risk profiles based on anticipated level of invasiveness and persistence of transgenes in the surrounding environment. Attention is also called to the fact that transgenes can be considered invasive without being considered gene drive (and vice versa). This further supports the notion that adequate risk assessment requires information regarding the specific circumstances a given transgene or set of transgenes is capable of invading a corresponding population. Finally, challenges in the review and evaluation of work involving gene drive organisms are discussed.
Next-generation tools to control biting midge populations and reduce pathogen transmission
15940P. Shults, L. W. Cohnstaedt, Z. N. Adelman and C. Brelsfoard, Parasites and Vectors, 14:31. 2021-01-07 14:52:23.
Biting midges of the genus Culicoides transmit disease-causing agents resulting in a significant economic impact on livestock industries in many parts of the world. Localized control efforts, such as removal of larval habitat or pesticide application, can be logistically difficult, expensive and ineffective if not instituted and maintained properly. With these limitations, a population-level approach to the management of Culicoides midges should be investigated as a means to replace or supplement existing control strategies. Next-generation control methods such as Wolbachia- and genetic-based population suppression and replacement are being investigated in several vector species. Here we assess the feasibility and applicability of these approaches for use against biting midges. We also discuss the technical and logistical hurdles needing to be addressed for each method to be successful, as well as emphasize the importance of addressing community engagement and involving stakeholders in the investigation and development of these approaches.
Conservation pest control with new technologies: public perceptions
15913E. A. MacDonald, M. B. Neff, E. Edwards, F. Medvecky and J. Balanovic, Journal of the Royal Society of New Zealand, 2021-01-04 13:45:38.
We conducted eleven focus groups in New Zealand to explore three questions about novel technologies (gene drive and two others for comparison of pest control tools): (1) what are the risks/benefits? (2) how do they compare to current methods? and (3) who should be represented on a panel that evaluates the tools and what factors should they consider?
Application of the Relationship-Based Model to Engagement for Field Trials of Genetically Engineered Malaria Vectors
15898A. Kormos, G. C. Lanzaro, E. Bier, G. Dimopoulos, J. M. Marshall, J. Pinto, A. Aguiar dos Santos, A. Bacar, H. Sousa Pontes Sacramento Rompão and A. A. James, The American Journal of Tropical Medicine and Hygiene, 2020-12-21 14:17:29.
Although guidelines and recommendations for engagement for gene drives have recently been described, we argue here that communities and stakeholders should lead the planning, development, and implementation phases of engagement. The RBM provides a new approach to the development of ethical, transparent, and effective engagement strategies for malaria control programs.
New GE unintentionally leaves traces in cells
15620C. Then, Testbiotech, 2020-12-18 16:22:58.
A new scientific publication shows that CRISPR/Cas gene scissor applications in animals unintentionally leave traces. The findings are not related to unintended changes in the DNA, which have often been described, but to gene regulation, i.e. epigenetics. The effects are heritable and may, for example, result in disruption of embryonic development. The new scientific publication describes CRISPR/Cas experiments with mice in which their DNA is cut and additional genetic information inserted. Besides intended changes in DNA in the target region, the findings also showed unintended changes in so-called epigenetic markers that control gene regulation. The effects were heritable and could still be identified after ten generations. According to the authors, the effects can also be used to identify CRISPR/Cas gene scissor applications.
Core commitments for field trials of gene drive organisms
15161K. C. Long, L. Alphey, G. J. Annas, C. S. Bloss, K. J. Campbell, J. Champer, C.-H. Chen, A. Choudhary, G. M. Church, J. P. Collins, K. L. Cooper, J. A. Delborne, O. R. Edwards, C. I. Emerson, K. Esvelt, S. W. Evans, R. M. Friedman, V. M. Gantz, F. Gould,, Science, 370:1417-1419. 2020-12-17 20:01:12.
While field trials of gene drive organisms (GDOs) ultimately will depend on public policy decisions, those engaged in GDO work can play critical roles in support of these decisions by generating evidence and developing evaluation strategies in fair and effective partnerships with relevant authorities and other stakeholders. The authorship of this statement reflects the current reality that GDO development is occurring primarily in high-income countries. However, fair partnership with counterparts and communities in low- and middle-income countries where many GDOs have the highest potential for positive impact, as well as recognition of the need for capacity-building and global cooperation, underlies each of our commitments.
Scientists paved the way for field trials of gene-driven organisms
15559K. Winslet, FLORIDA News Times, 2020-12-17 15:01:59.
The recent rise of gene drive research, accelerated by CRISPR-Cas9 gene editing technology, has brought about a wave of transformation throughout science.Developed with selected traits that have been genetically engineered to spread throughout the population, Gene Drive Organisms (GDOs) provide solutions to a variety of difficult health and environmental challenges, from control to protection of dengue and malaria. A crop against plant pests that has the power to dramatically change the way it develops.But before these gene-drive organisms move from laboratory to field testing, scientists are proposing courses for responsible testing of this powerful technology. These issues are addressed in the new Policy Forum article on Biotechnology Governance, “Core Commitment for Field Trials of Gene Drive Organisms,” published December 18, 2020. Science By more than 40 researchers, including several scientists at the University of California, San Diego.“Gene drives have led to rapid research, so we need to take a step back and think about its application and its impact on humankind,” said Akbari, the lead author of the article. Associate Professor, Faculty of Biological Sciences, University of California, San Diego. “A new initiative to tackle field testing is to ensure that testing is conducted safely, transparent, publicly accountable, and scientifically, politically and socially robust.”
Technical Support to Burkina Faso on Gene Drive Stage 2 Dossier Review
15557AUDA-NEPAD, AUDA-NEPAD, 2020-12-17 14:58:32.
AUDA-NEPAD in partnership with the National Biosafety Agency (ANB) in Burkina Faso organised a training workshop to support to the National Biosafety Committee (NBC) on stage 2 dossier review, on December 3 – 5, 2020, in Bobo-Dioulasso, Burkina Faso. In addition to the NBC members, and based on recommendations from previous in-country consultations, the meeting audience was extended to include researchers, faculty members and PhD students. The meeting brought together 25 participants. Amongst the countries piloting the gene drive research in the continent, Burkina Faso has successfully completed the activities in stage 1 of the process nd is now contemplating to commence stage 2. An application has been prepared and submitted to the national regulatory agency, following a successful pre-review by the Institutional Biosafety Committee (IBC).
Gene Drive-Modified Organisms: Developing Practical Risk Assessment Guidance
15554Y. Devos, M. B. Bonsall, L. G. Firbank, J. Mumford, F. Nogué and E. A. Wimmer, Trends in Biotechnology, 2020-12-17 14:48:35.
Risk assessors, risk managers, developers, potential applicants, and other stakeholders at many levels discuss the need for new or further risk assessment guidance for deliberate environmental releases of gene drive-modified organisms. However, preparing useful and practical guidance entails challenges, to which we offer recommendations based on our experience drafting guidance.
Scientists Set a Path for Field Trials of Gene Drive Organisms
15551M. Aguilera, UC San Diego News Center, 2020-12-17 14:41:55.
The modern rise of gene drive research, accelerated by CRISPR-Cas9 gene editing technology, has led to transformational waves rippling across science. Gene drive organisms (GDOs), developed with select traits that are genetically engineered to spread through a population, have the power to dramatically alter the way society develops solutions to a range of daunting health and environmental challenges, from controlling dengue fever and malaria to protecting crops against plant pests. But before these gene drive organisms move from the laboratory to testing in the field, scientists are proposing a course for responsible testing of this powerful technology. These issues are addressed in a new Policy Forum article on biotechnology governance, “Core commitments for field trials of gene drive organisms,” published Dec. 18, 2020 in Science by more than 40 researchers, including several University of California San Diego scientists.
Interdisciplinary development of a standardized introduction to gene drives for lay audiences
15381C. E. Schairer, C. Triplett, A. Buchman, O. S. Akbari and C. S. Bloss, BMC Medical Research Methodology, 20:15. 2020-12-10 15:09:37.
While there is wide consensus that the public should be consulted about emerging technology early in development, it is difficult to elicit public opinion about innovations unfamiliar to lay audiences. We sought public input on a program of research on genetic engineering to control mosquito vectors of disease that is led by scientists at the University of California and funded by the U.S. Defense Advanced Research Projects Agency (DARPA). In preparation for this effort, we developed a series of narrated slideshows to prompt responses to the development of gene drive mosquito control strategies among lay people. We describe the development and content of these slideshows and evaluate their ability to elicit discussions among focus group participants.
Burkina Faso Stakeholders consultations on Gene Drive Technology for integrated vector management towards malaria elimination
15384AUDA-NEPAD, AUDA-NEPAD, 2020-12-08 15:09:47.
Under its flagship Integrated Vector Management (IVM) Programme, African Union Development Agency (AUDA-NEPAD) in partnership with the National biosafety agency (ANB) of Burkina Faso organized an information sharing workshop on the applications of "Gene Drive" technology and facilitated discussions for the establishment of a consultative group on integrated vector management in Burkina Faso. The meeting was held from November 30th to December 1st, in Ouagadougou and brought together healthcare, environmental and biosafety regulators and other decision makers from different relevant institutions in the country.
Evaluating Gene Drive Approaches for Public Benefit
15296M. R. Santos, GMOs: Implications for Biodiversity Conservation and Ecological Processes, 2020-12-02 17:14:49.
Gene drive approaches—those which bias inheritance of a genetic element in a population of sexually reproducing organisms—have the potential to provide important public benefits. The spread of selected genetic elements in wild populations of organisms may help address certain challenges, such as transmission of vector-borne human and animal diseases and biodiversity loss due to invasive animals. Adapting various naturally occurring gene drive mechanisms to these aims is a long-standing research area, and recent advances in genetics have made engineering gene drive systems significantly more technically feasible. Gene drive approaches would act through changes in natural environments, thus robust methods to evaluate potential research and use are important.
Engineered Gene Drives and their Value in the Control of Vector-Borne Diseases, Weeds, Pests, and Invasive Species
15294K. Hefferon and R. Herring, GMOs: Implications for Biodiversity Conservation and Ecological Processes, 2020-12-02 17:10:55.
Genetic engineering has created potential for moving medical and agricultural research and application frontiers forward in unprecedented ways. Despite its accepted use as a powerful tool in medical research, genetic modification and genome editing technologies remain controversial in large-scale ecological intervention and open-field agriculture. Gene drive is a technology based on genome editing that enables a trait to be pushed through a given population at a greater than expected rate. While gene drives show enormous promise as a way to address a number of challenges, such as the reduction of populations of disease-spreading pests and invasive species, they also incite great social unease because of unknown risks. The following chapter describes the mechanics of gene drives and how they could be utilized to control vector-borne diseases, weeds, and crop pests and even protect populations of endangered species. Limitations and risks associated with gene drive technologies, such as containment strategies and potential resistance, are discussed. Finally, the social impacts of gene drives with respect to international governance and public acceptance are considered.
Engineered Gene Drives: Ecological, Environmental, and Societal Concerns
15292J. Kuzma, GMOs: Implications for Biodiversity Conservation and Ecological Processes, 2020-12-02 17:07:26.
This chapter overviews the types, purposes, and potential impacts of gene drive organisms (GDOs) and discusses challenges with foreseeing and assessing these impacts prior to their environmental release. It concludes with a few examples of risk analysis methods and governance systems that scholars have proposed to cope with the novelty of GDOs and uncertainties associated with their use. With GDOs poised for release in the near future, it is urgent that technologists, ecologists, social scientists, ethicists, stakeholders, and publics work together to grapple with the immense challenges associated with assessments of GDOs and the design of governance systems to ensure their responsible development and potential use.
Genetically Engineered Fish: Potential Impacts on Aquaculture, Biodiversity, and the Environment
15290R. A. Dunham and B. Su, GMOs: Implications for Biodiversity Conservation and Ecological Processes, 2020-12-02 17:03:48.
Studies on transgenic fish for the aquaculture industry have focused on improving growth rates, enhancing disease resistance, altering body composition, acting as biological factories for medical proteins, and even altering temperature tolerance and coloration. The future impact of transgenesis will likely be quite large. Growth hormone-transgenic salmon has been approved for human consumption and has been introduced to the market in Canada and soon to the USA. This is the first human consumption of approved transgenic meat. Transgene insertion has many pleiotropic effects. Several studies have projected the fitness of transgenic fish to be low, in general, compared to non-transgenic and wild fish; thus, their environmental risk is likely low and they would have minimal, if any, long-term impact on ecosystems or biodiversity. However, there have been no actual escapements; thus, only projections of risk are available based on small-scale experiments and the characteristics of transgenic fish compared to controls. An active area of research is repressible transgenic sterilization and sterilization using gene editing, both of which would allow application of transgenic fish with only short-term consequences for ecosystems in the worst-case scenario. Transgenic technology could also be potentially used to reduce or eliminate populations of nuisance species.
Invasive Species Control and Resolution of Wildlife Damage Conflicts: A Framework for Chemical and Genetically Based Management Methods
15286L. Clark, J. Eisemann, J. Godwin, K. E. Horak, K. Oh, J. O’Hare, A. Piaggio, K. Pepin and E. Ruell, GMOs: Implications for Biodiversity Conservation and Ecological Processes, 2020-12-02 16:52:40.
Vertebrate wildlife damage management relates to developing and employing methods to mitigate against damage caused by wildlife in the areas of food production, property damage, and animal or human health and safety. Of the many management tools available
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.
Transformation and slippage in co-production ambitions for global technology development: The case of gene drive
16634K. Ledingham and S. Hartley, Environmental Science & Policy, 116:78-85. 2020-11-24 17:41:43.
Co-production is an increasingly popular framework for knowledge generation, evaluation and decision making. Despite its potential to open up decisions and practices to the input of others, co-production regularly falls short of its transformative ambitions. Through documentary analysis, we investigate the meaning and dynamics of co-production as it stretches beyond the local into global research and technology spaces. We find that in the case of global gene drive, the meaning of co-production is extended in novel ways and underpinned by new possibilities for meaningful transformation. At the same time, we also identify a simultaneous resurfacing of reductive framings of collaboration. In the paper we present ‘slippage’ as a useful heuristic in helping to understand why co-production fails. We argue that if co-production in these new spaces is to achieve its transformative ambitions, there is a need to engage with new and entrenched knowledge hierarchies that contribute to this slippage.
FNIH Panel on Gene Drive Regulation Emphasizes Need for Local Community Engagement
15222C. Rizk, GenomeWeb, 2020-11-19 21:16:21.
Genetically modified organisms are another topic of deep debate, with some activists agitating for and getting governments to implement deep restrictions on modified crops. More recently, GMO crops have started to regain public favor, particularly in countries where boosting the levels of nutrients in staple crops could provide a benefit for children, or where certain genome modifications could increase crop yields. But reversing public biases and, more importantly, governmental regulations against GMOs won't be a simple matter, even if scientists can show a benefit to the modifications. So, when it comes to the development of the gene drive — another gene modification technology meant to promote the spread of certain genes in organisms such as mosquitoes in order to control or eradicate their populations in a controlled manner — many researchers are determined to foster debate that focuses on the science, includes local communities in the discussion, and leads to governance and regulations that will benefit both the environment and human health.
Engineering biological diversity: the international governance of synthetic biology, gene drives, and de-extinction for conservation
15251J. L. Reynolds, Current Opinion in Environmental Sustainability, 49:1-6. 2020-11-17 18:23:24.
In the face of insufficient progress in conserving and restoring biodiversity, the in situ use of advanced genetic modification, gene drives, and other biotechnologies for conservation purposes are being considered, researched, and developed. This paper introduces the methods, applications, environmental risks, and social challenges of ‘conservationist synthetic biology’; reviews existing governance, with an emphasis on international instruments, institutions, and processes; and offers observations of the politics of developing further governance. The most important multilateral environmental agreement is the Convention on Biological Diversity. Governance of such conservationist synthetic biology is vital but gaps remain. The further development of governance is a political process, and conservationist synthetic biology has a political landscape that is atypical for emerging technologies.
Further guidance required for assessment of gene drive technology, says EFSA
15137Euractiv, The World News Monitor, 2020-11-16 16:25:26.
Existing guidelines are adequate for evaluating risks associated with gene-drive modified insects, but further guidance is needed for some areas, most notably for environmental risk assessments. The evaluation was requested to explore the issue ahead of the consideration of any possible applications of the technology and is also designed to support the EU in discussions on the biosafety of GMOs in international fora such as the United Nations. It found that while existing guidelines are sufficient for evaluating risks associated with technology, further guidance is needed for some areas, such as molecular characterisation, environmental risk assessment and post-market environmental monitoring.
Mutagenic chain reaction cannot be sufficiently controlled
15135Christoph Then, Testbiotech, 2020-11-16 16:21:27.
The European Food Safety Authority (EFSA) has published the results of its public consultation on the risks of so-called gene drive organisms. Testbiotech accuses the authority of disguising the real dimension of the risks. Gene drives are designed to spread artificial genetic constructs throughout populations of wild species much faster than would be expected naturally. Currently, gene drives are being developed with the aid of tools such as the CRISPR/Cas gene scissors. There are plans, e.g. to apply gene drives in insects (flies and mosquitoes) or rodents (rats or mice). The aim is to replace or eradicate natural populations. Once started the process cannot be controlled effectively or reliably. The damage to humans, the environment and nature could be severe.
Adequacy and sufficiency evaluation of existing EFSA guidelines for the molecular characterisation, environmental risk assessment and post-market environmental monitoring of genetically modified insects containing engineered gene drives
15043E. Panel o. G. M. Organisms, H. Naegeli, J.-L. Bresson, T. Dalmay, I. C. Dewhurst, M. M. Epstein, P. Guerche, J. Hejatko, F. J. Moreno, E. Mullins, F. Nogué, N. Rostoks, J. J. Sánchez Serrano, G. Savoini, E. Veromann, F. Veronesi, M. B. Bonsall, J. Mumfor, EFSA Journal, 18:e06297. 2020-11-12 19:24:46.
As a proactive measure, the European Food Safety Authority (EFSA) has been requested by the European Commission to review whether its previously published guidelines for the risk assessment of genetically modified animals (EFSA, 2012 and 2013), including insects (GMIs), are adequate and sufficient for GDMIs, primarily disease vectors, agricultural pests and invasive species, for deliberate release into the environment. Under this mandate, EFSA was not requested to develop risk assessment guidelines for GDMIs. In this Scientific Opinion, the Panel on Genetically Modified Organisms (GMO) concludes that EFSA's guidelines are adequate, but insufficient for the molecular characterisation (MC), environmental risk assessment (ERA) and post-market environmental monitoring (PMEM) of GDMIs. While the MC,ERA and PMEM of GDMIs can build on the existing risk assessment framework for GMIs that do not contain engineered gene drives, there are specific areas where further guidance is needed for GDMIs.
Outcome of a public consultation on the draft adequacy and sufficiency evaluation of existing EFSA guidelines for the molecular characterisation, environmental risk assessment and post-market environmental monitoring of genetically modified insects containing engineered gene drives
15040European Food Safety Authority, Y. Devos, M. B. Bonsall, F. Nogué, K. Paraskevopoulos, E. A. Wimmer and L. G. Firbank, EFSA Supporting Publications, 17:1939E. 2020-11-12 19:10:10.
The European Food Safety Authority (EFSA) carried out an online public consultation to receive input from interested parties/persons on the draftscientific opinion on the adequacy and sufficiencyevaluation of existing guidelines for the molecular characterisation (MC), environmental risk assessment (ERA) and post-market environmental monitoring (PMEM) of genetically modified insects containing engineered gene drives. This draft scientific opinion was endorsed by the EFSA Panel on Genetically Modified Organisms (GMOs) for public consultation on 29 January 2020, and prepared by EFSA'sGene Drive expert Working Group and scientific officers. The public consultation was open from 17 February 2020 until 24 April 2020.
EFSA advises on risk assessment of engineered gene drives
15069EFSA, European Food and Safety Authority, 2020-11-12 18:15:34.
EFSA’s existing guidelines for the risk assessment of genetically modified animals are adequate for evaluating risks associated with gene drive modified insects. However, further guidance is needed for some areas, such as molecular characterisation, environmental risk assessment and post-market environmental monitoring, say EFSA’s experts on Genetically Modified Organisms.
Gene drives, species, and compassion for individuals in conservation biology
15072Y. Rohwer, Ethics, Policy and Environment, 2020-11-10 18:20:29.
In this paper I argue that these compassionate conservationists have a moral obligation to support the investigation and development of genetic modification technologies because of their potential to minimize suffering and eliminate killing in conservation. Furthermore, I will end the paper by suggesting that these genetic technologies can help avoid actions that could be damaging to one's moral character.
NIH NExTRAC (Novel and Exceptional Technology and Research Advisory Committee) | Workshop
15015NIH Office of Science Policy, National Institutes of Health (NIH), 2020-11-09 19:56:25.
NExTRAC provides advice to the Director of the National Institutes of Health (NIH) on matters related to the conduct and oversight of research involving emerging technologies in biomedical science. NExTRAC also makes recommendations on research involving the use of, and developments in, emerging biotechnologies and will address scientific, safety, ethical, and social issues associated with areas of emerging biotechnology research for which the NIH requests advice or guidance. One of the technologies this committee is considering is gene drive. The November 2020 meeting was a workshop: GENE DRIVES: BIOSAFETY GUIDANCE AND CONDITIONS FOR FIELD RELEASE RESEARCH
When Extinction is Warranted: Invasive Species, Suppression-Drives, and the Worst-Case Scenario
15050A. C. Thresher, Ethics, Policy and Environment, 2020-11-09 19:31:52.
The focus of this paper is on one such risk ? the danger of a suppression-drive escaping containment and wiping out the target species globally. Here, I argue that in most cases this risk is significant enough to warrant holding off on the technology. In some cases, however, we can bypass the precautionary principle by using a dominance approach that hinges on what I term the ?Worst-Case Clause?. This clause, in turn, provides us with a litmus test that can be fruitfully used to determine what species are viable targets for suppression-drives in the wild. Using this metric in concert with other considerations, I suggest that only three species are currently possible viable targets ? the European rabbit, ship rat, and Caribbean Tree Frog.
Brave New Planet: Reshaping Nature Through Gene Drives
15047E. Lander, Brave New Planet, 2020-11-09 19:26:24.
A new technology, called gene drives, has the power to spread any genetic instructions you wish across an entire animal or plant species in the wild. It might let us restore ecosystems ravaged by invasive species, or help species adapt to climate change. And, it might save millions of children from dying of malaria. But could altering nature in this way, and on this scale, have unintended consequences? And, when it comes reshaping ecosystems, who needs to say yes?
The ethical way to alter organisms
15033K. Esvelt, Boston Globe, 2020-11-09 15:42:31.
As my colleagues and I first described in 2014, we can use CRISPR genome editing to duplicate the most powerful form of “gene drive,” a ubiquitous natural phenomenon that happens when a genetic change is inherited more frequently than usual. Encode the CRISPR machinery next to a useful edit we’ve made in the genome, and genome editing will reoccur in every generation, replacing the original with the edited version without limit. In principle, releasing such organisms would gradually alter entire wild populations and associated ecosystems.
Gene Drives: A Controversial Tool to Fight Malaria
15008H. Albert, LABIOTECH.eu, 2020-11-09 15:41:52.
The possibility of creating gene drives was introduced into the scientific community in 2003 by Austin Burt, a professor at Imperial College London. Burt was studying ‘selfish genes’ that can copy themselves into a specific target DNA sequence. He suggested that these genes, called homing endonucleases, could be used to make the majority of an organism’s offspring inherit a specific gene, instead of only half of it. This technology has a lot of potential. For example, it could be used to decimate populations of malaria-carrying mosquitoes by making the majority of their offspring male. However, there are concerns about the permanent nature of these genetic modifications and whether it could cause irreparable damage to the ecosystem it is used in.
Advances in genetic engineering test democracy’s capacity for good decision-making
15027N. Kofler and R. Taitingfong, Boston Globe, 2020-11-09 15:31:50.
New advances in genetic engineering and their application for environmental conservation and public health are further testing our democracy’s capacity for good decision-making. With minimal public input, the Environmental Protection Agency recently approved the release of genetically modified mosquitoes in Florida and Texas. An application for the planting of GM American Chestnut trees, engineered to reproduce and spread in the wild, is currently under review by the US Department of Agriculture. And even more complex and powerful genetic technologies intended for environmental release are in the research pipeline.
GeneConvene Global Collaborative | Research and Innovation for biodiversity: what role for gene drive research?
14968EP Intergroup CCBSD, European Bureau of Conservation and Development, 2020-11-06 19:06:04.
This webinar will provide an overview of how gene drive works and the problems it seeks to solve, introduce the most advanced research projects on gene drive in the sector of public health and conservation and present the work that international and European bodies such as WHO, IUCN and EFSA are carrying out on gene drive. It will also be an opportunity to address any questions participants may have with regards to gene drive and stimulate an open debate on the safe and responsible development of the research in this field.
Inauguration and first meeting of WA-IVM Technical Working Groups
14872AUDA-NEPAD, AUDA-NEPAD News, 2020-10-27 19:37:33.
African Union Development Agency – NEPAD (AUDA-NEPAD) in collaboration with the West Africa Health Organization (WAHO), the Ministry of Health and the Ministry of Environment in Cote d’Ivoire, organized the inaugural meeting of WA-IVM Technical Working Groups (TWGs) from 24 – 26 April, 2019, in Abidjan, Cote d’Ivoire. Dr. ABLE, Inspector General of the Ministry of Health and Public Hygiene, representing the Minister, co-chaired the opening ceremony with Mr LAVRY, Technical Advisor of the Ministry of Environment and Sustainable Development.
GeneConvene Global Collaborative Webinar Series | Engineered Gene Drives: Policy and Regulatory Considerations Webinar Series October-December 2020
14808Hector Quemada and David O'Brochta, GeneConvene Global Collaborative, 2020-10-22 19:38:17.
In this series of webinars the regulatory and policy challenges of moving new innovative genetic biocontrol products such as gene drive technologies to the field will be featured. Each seminar is ~60 minutes in length followed by questions and answers.
WHO Refers to GM Mosquitoes as Beneficial Technology
14820ISAAA, Crop Biotech Update, 2020-10-21 17:27:43.
The World Health Organization (WHO) released its official statement to clarify its stance on the evaluation and use of genetically modified (GM) mosquitoes and its use to control vector-borne diseases (VBD). WHO says it supports the investigation of all potentially beneficial technologies, and these include GM mosquitoes.
Position of ARRIGE Scientific Committee on Gene Drive
14801ARRIGE Scientific Committee on Gene Drive, ARRIGE Newsletter, 2020-10-21 15:16:40.
We are facing a change of paradigm that must lead us to be responsible for altered inheritance and the hybridization between artefacts, considered as natural or artificial, at the very moment when this division itself is blurred by the engineering capacity to act on mutations, without knowing in advance the possibly adverse, short or long term, side effects, on the manipulated and other connected species.
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.
Ethics and vector-borne diseases
14904Geneva: World Health Organization, WHO Guidance, 2020-10-14 18:57:10.
The guidance was developed by an international group of experts in vector control, infectious disease ethics, maternal and child health, ecology and climate change, research and vaccine development, and public health communication. It examines a broad range of ethical considerations related to VBD prevention and control, including the social and environmental determinants of health; vector control methods, including emerging technologies; screening, surveillance and research; vaccine campaigns; and mass drug administration.
GeneConvene Global Collaborative Webinar Series | Gene Drive Policy and Regulatory Considerations 2020
14677Hector Quemada and David O'Brochta, GeneConvene Global Collaborative, 2020-10-13 17:50:24.
This is series of webinars the regulatory and policy challenges of moving new innovative genetic biocontrol products such as gene drive technologies to the field will be featured.
ESA Position Statement on the Importance of Continued Innovation in Gene Drive Technology
14700Entomological Society of America, Annals of the Entomological Society of America, 2020-10-13 17:39:58.
The risks and benefits of GDTs should be considered with the risks and benefits of continuing current pest control interventions, which may be comparatively less effective or pose exposure risks to human health and the environment.
GeneConvene Global Collaborative Webinar Series | Gene Drive Policy and Regulatory Consideration
14670Hector Quemada and David O'Brochta, GeneConvene Global Collaborative, 2020-10-13 17:34:35.
This is series of webinars the regulatory and policy challenges of moving new innovative genetic biocontrol products such as gene drive technologies to the field will be featured.
Evaluation of genetically modified mosquitoes for the control of vector-borne diseases
14661Global Malaria Programme, WHO - Position Statement, 2020-10-13 15:58:38.
In the spirit of fostering innovation, WHO takes the position that all potentially beneficial new technologies, including GMMs, should be investigated to determine whether they could be useful in the continued fight against diseases of public health concern. Such research should be conducted in steps and be supported by clear governance mechanisms to evaluate the health, environmental and ecological implications
Do Africans Want Genetically Modified Mosquitoes?
14591U. Effiong, The Pursuit, 2020-09-30 13:38:38.
The recent publication by fellow Nigerian scientists—Patricia Okorie and colleagues—originally drew my attention to the issue of GMMs.
Gene Drive: Modern Miracle or Environmental Disaster
14491K. Brooks, Journal of Law, Technology and Policy, 2020-09-25 19:57:31.
This Note will show how gene drive technology fits imperfectly into the old regulatory framework through case studies. The Analysis will also describe how the different regulatory agencies handle similar gene drive-like organisms inconsistently, and the inherent danger of this approach considering upcoming developments in the field.
Global citizen deliberation on genome editing
14607J. S. Dryzek, D. Nicol, S. Niemeyer, S. Pemberton, N. Curato, A. Bächtiger, P. Batterham, B. Bedsted, S. Burall, M. Burgess, G. Burgio, Y. Castelfranchi, H. Chneiweiss, G. Church, M. Crossley, J. de Vries, M. Farooque, M. Hammond, B. He, R. Mendonça, J., Science, 369:1435. 2020-09-18 18:32:40.
Here we show how, as the global governance vacuum is filled, deliberation by a global citizens' assembly should play a role, for legitimate and effective governance.
Risks of releasing gene drives mosquitoes – a possible future scenario
15143Testbiotech, 2020-09-17 17:01:45.
Genetically engineering the genome of an organism with gene drive means that it will be replicated in every following generation. This allows the altered gene to spread rapidly throughout natural populations, which may be decimated or even eradicated. The video contains both factual and fictional content (the latter marked as „possible future scenario“). The fictional content shows the possible future consequences of using gene drive technology - and is intended to stimulate broad public debate. Civil society needs to engage intensively with issues around new developments in the field of biotechnology and genetic engineering.
Scientists Evaluate Environmental Impacts of Gene Drive Organisms
14334Staff, American Laboratory, 2020-09-04 18:06:56.
Researcher Marion Dolezel, from the Environment Agency Austria, and a team of international scientists published in the open-access journal BioRisk, discuss the potential risks and impacts on the environment.
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.
Governing New Biotechnologies for Biodiversity Conservation: Gene Drives, International Law, and Emerging Politics
14258J. L. Reynolds, Global Environmental Politics, 20:28-48. 2020-08-31 14:28:38.
This article describes and analyzes the international law and politics of gene drives’ research, development, and possible use, with an emphasis on their potential biodiversity applications.
Viewpoint: Is there a scientific basis to ban gene drive technology that can rid us of virus-carrying rodents and mosquitoes?
13845K. Vavitas, Genetic Literacy Project, 2020-08-18 13:51:23.
Gene drives may be invaluable tools to control the spread of parasites, invasive species, and disease carriers. But the technology has faced strong opposition from activist groups and some mainstream scientists based on environmental and food safety. Are these concerns valid?
Bednets or Biotechnology: To Rescue Current Persons or Research for the Future?
14236D. E. Callies, Fudan Journal of the Humanities and Social Sciences, 14. 2020-08-13 13:44:08.
After an exploration of the duty to rescue and cost-effectiveness analysis, I suggest we look towards the literature on intergenerational justice for a justifiable answer to the question of how we ought to allocate our malaria resources.
Incorporating Characteristics of Gene Drive Engineered Ae. aegypti as Methods to Reduce Dengue and Zika Virus into the Bayesian Network – Relative Risk Model, Using Ponce, Puerto Rico as a Case Study
16097S. R. Eikenbary, WWU Graduate School Collection, 2020-08-10 19:24:02.
The Bayesian network relative risk model can perform the risk assessment of gene drive engineered Ae. aegypti for vector control and as part of an adaptive management strategy to reduce dengue and Zika transmission. This study illustrates how the BN-RRM can integrate gene drive related information within a risk assessment framework suitable for adaptive management of these novel stressors.
Global Governing Bodies: A Pathway for Gene Drive Governance for Vector Mosquito Control
13605A. Kelsey, D. Stillinger, T. B. Pham, J. Murphy, S. Firth and R. Carballar-Lejarazú, American Journal of Tropical Medicine and Hygiene, 2020-08-05 12:34:11.
We examined the current institutions and governing bodies among various continents that could have an impact on gene drive governance or the potential to adapt to its future use. Possible governance strategies also are proposed that seek to bridge gaps and promote an ethically sound policy framework. Ideally, governance strategies should be developed before or at the same pace as gene drive research to anticipate field releases and maximize their impact as a public health tool.
Exploring gene drive’s role in fight against malaria
13536J. Conrow, Genetic Literacy Project, 2020-08-02 17:02:28.
J. Conrow (2020) Genetic Literacy Project. An international initiative has formed to ensure that gene drive technology gets a chance to prove its mettle in the quest to control malaria.
Biotechnologies in pest wasp control: taking the sting out of pest management for Māori businesses?
14710S. Palmer and O. R. Mercier, New Genetics and Society, 2020-07-31 19:13:18.
A Maori-centered mixed-method study gauged the perceptions of eight Maori businesses about the potential use of five specific new biotechnological controls in pest management.
Après les OGM, la nouvelle technique du forçage génétique inquiète écologistes et scientifiques
13595H. Leussier, Reporterre, 2020-07-28 13:04:33.
Les organismes issus du forçage génétique peuvent transmettre, sans autre intervention humaine, des gènes modifiés à tous leurs descendants. Cette technique permettrait d’éradiquer des espèces nuisibles, comme certains moustiques vecteurs de la malaria. Mais des associations, des scientifiques et des responsables politiques, inquiets de potentiels effets dévastateurs, réclament un moratoire international.
Lettre ouverte a Monsieur le Premier Ministre demandant l’interdiction de la production, de l’utilisation et de la dissémination de tout OGM issu du forçage génétique
13447A. Bossu, N. Laarman, D. Houdebine, H. Le Meur, F. Jacquemart and F. Warlop, Open Letter, 2020-07-22 15:04:01.
A. Bossu, N. Laarman, D. Houdebine, H. Le Meur, F. Jacquemart and F. Warlop (2020). Open Letter. An open letter from French civil society organizations urging the French Parliament to support a resolution at the upcoming Convention on Biodiversity that would call for a moratorium on the release of organisms containing engineered gene drive technologies.
Providing a policy framework for responsible gene drive research: an analysis of the existing governance landscape and priority areas for further research
13231D. Thizy, I. Coche and J. de Vries, Wellcome Open Research, 2020-07-20 12:19:36.
D. Thizy, I. Coche and J. de Vries (2020). Wellcome Open Research. doi: 10.12688/wellcomeopenres.16023.1 In this manuscript, we review the existing regulatory landscape around gene drive research and map areas of convergence and divergence, as well as gaps in relation to guidelines for community engagement in gene drive research.
Genome Editing in Food and Farming: Risks and unexpected consequences
13186J. Cotter and D. Perls, Canadian Biotechnology Action Network, 2020-07-14 17:53:41.
J. Cotter and D. Perls (2020). Canadian Biotechnology Action Network. In this report, we provide an overview of genome editing techniques being explored in agriculture, and the range of potential unexpected effects that can arise from them. The report draws on recent scientific publications, in a rapidly evolving field of research including gene drive and genetic biocontrol.
Genome Editing 2020: Ethics and Human Rights in Germline Editing in Humans and Gene Drives in Mosquitoes
13198G. J. Annas, American Journal of Law and Medicine, 46:143-165. 2020-07-12 18:17:19.
G. J. Annas (2020). American Journal of Law and Medicine. doi: 10.1177/0098858820933492. I begin with a discussion of so far disastrously unsuccessful attempts to regulate germline editing in humans, including a summary of the first application of germline genome editing in humans and its aftermath. I then turn to a discussion of setting ethical standards for a genomic technology that has not yet been deployed in nature—gene drives. Finally, I end by suggesting that human rights can and should be directly applicable to defining the ethics of genomic research.
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.”
NGOs call for moratorium on controversial ‘gene drive organisms’
13170N. Foote, EURACTIV, 2020-07-03 14:50:12.
https://borgenproject.org/3-innovative-technologies-stopping-malaria/
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,”.
Soon we’ll be able to engineer the wild, can the policies keep up with the science?
13158M. Montague and A. Kobokovich, The Hill, 2020-06-29 14:32:02.
Humans have been able to genetically alter the world around them for thousands of years. With the domestication of dogs at least 14,000 years ago, genetically modified organisms (GMOs) have been a constant feature of human society; only recently have we gained the ability to perform these modifications at the molecular level. Even more recently, gene drive technology has fundamentally added the ability of humans to modify wild organisms, not only domesticated organisms. With the ability to make rapid, permanent changes to wild species on the near horizon, we must act now to implement policies that will carefully regulate their use while allowing for vital scientific research to continue.
ENSSER | Gene Drive Webinar Series
12568European Network of Scientists for Social and Environmental Responsibility, 2020-06-16 20:50:52.
This series of five Webinars by some of the authors of the interdisciplinary Gene Drive Report (2019) and were organised by four organisations of independent scientists: the European Network of Scientists for Social and Environmental Responsibility (ENSSER), Critical Scientists Switzerland (CSS), Vereinigung Deutscher Wissenschaftler (VDW), Sciences Citoyennes (SC). The series was aimed at a lay audience and were intended to address these questions. Does it really work? Is it being applied? What problems do gene drives address? What side effects can they have? Who has an interest in this? Should we do it? Are gene drives regulated by law? Are they a wise solution to these problems? Who decides?
Species Extinction & the Case for a Global Moratorium on Gene Drives
12454M. Imken, ARC, 2020-06-14 20:33:30.
One million species are currently threatened with extinction, and humanity faces the challenge of stopping the sixth mass extinction in the history of our planet. Yet a new technology called Gene Drive enables human beings to reprogram wild species by genetic engineering and to drive these species to self-destruction and extinction.
Gene Drive: Can this be the Future of Agricultural Pest Management?
13156P. Mondal, U. Mohapatra and M. Ganguly, International Journal of Current Microbiology and Applied Sciences, 9. 2020-06-10 14:25:16.
A world free of hunger may be possible when the agricultural production exceeds the global demand for the food. In the era of increasing population, the need for increased food production can be attainable by managing the destructive pests of the agricultural and horticultural crops. The detrimental effects of the pesticides and the attitudes of society towards transgenic crops indicate the researchers to catch out Gene Drive as the substitute method for former methods of crop pest management. In this context, the present narration describes how the self-sustaining CRISPR-based gene drive technology will be the leading technique in the near future for agriculture pest management.
Gene drives: benefits, risks, and possible applications
12414A. Deplazes-Zemp, U. Grossniklaus, F. Lefort, P. Müller, J. Romeis, A. Rüegsegger, N. Schoenenberger and E. Spehn, Swiss Academies Factsheets, 15. 2020-06-05 19:48:13.
Gene drives are genetic elements that skew the pattern of inheritance of a given characteristic in sexually reproducing organisms. They can be used to spread a characteristic that can alter or even reduce the numbers of individuals in wild populations of a certain species. As they spread by being inherited from one generation to the next, they could persist in populations long-term. The spreading property of gene drives could be a source of great potential in areas as diverse as the control of disease vectors, invasive species, agricultural pests and predators of endangered species. However, the same property may make containment challenging and therefore may also pose novel environmental risks. The evaluation, distribution of risks and benefits and the fact that gene drives may be seen as a particularly profound interference with nature raises further novel ethical considerations.
Genetically modified mosquitoes could be released in Florida and Texas beginning this summer – silver bullet or jumping the gun?
12409B. Allan, C. Stone, H. Tuten, J. Kuzma and N. Kofler, The Conversation, 2020-06-03 18:53:50.
On May 1, 2020, the company Oxitec received an experimental use permit from the U.S. Environmental Protection Agency to release millions of GM mosquitoes (labeled by Oxitec as OX5034) every week over the next two years in Florida and Texas. Females of this mosquito species, Aedes aegypti, transmit dengue, chikungunya, yellow fever and Zika viruses. When these lab-bred GM males are released and mate with wild females, their female offspring die. Continual, large-scale releases of these OX5034 GM males should eventually cause the temporary collapse of a wild population. However, as vector biologists, geneticists, policy experts and bioethicists, we are concerned that current government oversight and scientific evaluation of GM mosquitoes do not ensure their responsible deployment.
Position Paper on Integrated Vector Management: Strengthening AU Members’ Regulatory Capacities for Responsible Research Towards Elimination of Malaria in Africa
12743African Union Development Agency - NEPAD, AUDA-NEPAD, 2020-06-01 13:48:16.
Africa continues to bear a heavy brunt of the malaria which is a disease transmitted by the female Anopheles mosquito. Thousands of lives, mostly of young children, are lost every year; which undermines efforts deployed at various levels for increased life expectancy and improved wellbeing for the socio-economic transformation of the continent. Accelerated changes and complementary tools are urgently needed to ensure effective elimination of malaria on the continent. Genetic engineering has been identified as one of such promising tools when applied to mosquito populations to reduce the transmission of the malaria parasite. The African Union Development Agency – NEPAD (AUDA-NEPAD), based on recommendations from the African Union High-Level Panel on Emerging Technologies (APET), continues to provide African Union Members States with the necessary support to ensure that research on and development of new genetically-based vector control tools are conducted in a responsible manner and in full compliance with safety requirements for human health and the environment for the benefit of African communities.
Gene Drives: Pursuing opportunities, minimizing risk
11966K. L. Warmbrod, A. Kobokovich, R. West, G. Ray, M. Trotochaud and M. Montague, Center for Health Security, 2020-05-18 18:14:50.
This study analyzed the current state of gene drive technologies, the ways in which they might be deployed in the field, and the state of regulatory policy governing their development.
The EU not ready for the release of Gene drive organisms into the environment.
11602Pensoft Publishers, ScienceDaily, 2020-05-07 15:59:25.
In their study, published in the open-access journal BioRisk, an international group of scientists led by Marion Dolezel from the Environment Agency Austria, discuss the potential risks and impacts on the environment.
The development of complex and controversial innovations. Genetically modified mosquitoes for malaria eradication
11431V. Cisnetto and J. Barlow, Research Policy, 49:103917. 2020-05-04 13:32:20.
e use a longitudinal process approach and qualitative system dynamics modelling to study the development of genetically modified (GM) mosquitoes for malaria eradication in an African country.
EPA Grants First Permit to Test Genetically Modified Mosquitoes
11436Adam Allington, Bloomberg Law, 2020-05-01 14:05:51.
British biotech company Oxitec Ltd was granted an experimental use permit to release a genetically engineered type of the mosquito species Aedes aegypti, which is a known vector of Zika virus and viruses that cause yellow fever and dengue fever, the Environmental Protection Agency office of Chemical Safety and Pollution announced.
EPA Approves Experimental Use Permit to Test Innovative Biopesticide Tool to Better Protect Public Health
11434EPA, EPA, 2020-05-01 14:02:09.
Today, after extensive evaluation of the best available science and public input, the U.S. Environmental Protection Agency (EPA) has granted an experimental use permit (EUP) to Oxitec Ltd. to field test the use of genetically engineered Aedes aegypti mosquitoes as a way to reduce mosquito populations to protect public health from mosquito-borne illnesses.
EFSA discusses risk assessment of gene drives
11606C. Then, Testbiotech, 2020-04-30 16:03:36.
The European Food Safety Authority (EFSA) carried out a public consultation on guidance for the risk assessment of so-called gene drives at the request of the EU Commission. At the same time, a new Testbiotech scientific paper was accepted after peer review. The paper shows that the EFSA concept is insufficient. To control the risks of gene drives, ‘cut-off criteria’ need to be defined to prevent the uncontrolled spread of genetically engineered organisms.
Alternative Techniques and Options for Risk Reduction of Gene Drives
11265Bernd Giese, Arnim von Gleich and Johannes L. Frieß, Gene Drives at Tipping Points, 2020-04-28 18:59:49.
In this chapter, we analyse and compare different types of gene drives as well as promising alternative approaches that may provide a reduced risk.
Vulnerability Analysis of Ecological Systems
11253Carina R. Lalyer, Arnim von gleich, Bernd Giese, Gene Drives at Tipping Points, 2020-04-28 18:28:04.
Vulnerability analysis can be seen as the counterpart to technology characterization. Technology characterisation scrutinises the intervening technology. Vulnerability analyses potentially affected systems. That may be socio-ecological, socio-technical, socio-economic or other systems. In this chapter ecological systems are in focus.
Gene Drives at Tipping Points
11247Amin von Gleich and Winfried Schroder, Gene Drives at Tipping Points, 2020-04-28 18:14:49.
This open access book reports on a pilot project aiming at collecting information on the socio-ecological risks that could arise in the event of an uncontrolled spread of genetically engineered organisms into the environment. The researchers will, for instance, be taking a closer look at genetically engineered oilseed rape, genetically engineered olive flies as well as plants and animals with so-called gene drives. The book mainly adresses researchers.
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.
GENE DRIVE ORGANISMS: Implications for the environment and nature conservation
16092M. Dolezel, S. Simon, M. Otto, M. Engelhard and W. Zughart, Umweltbundesamt, 2020-04-09 15:46:47.
Recent advances in biotechnology aim at the genetic modification of wild living populations. Some potential applications consider self-propagating genetic elements to generate gene drive organisms (GDOs), also for nature conservation. Due to the potential of GDOs to spread spatially and temporally unlimited, impacts on the environment and ecosystems may be irreversible and are difficult to predict. This technical report summarizes the status of gene drive applications currently discussed in the scientific literature. It outlines their potential implications for the environment and nature conservation and highlights challenges with respect to the environmental risk assessment and post-release monitoring of GDOs, in particular in a context of high complexity and uncertainty.
Spatio-temporal controllability and environmental risk assessment of genetically engineered gene drive organisms from the perspective of EU GMO Regulation
11208C. Then, K. Kawall and N. Valenzuela, Integrated Environmental Assessment and Management, 2020-04-06 14:38:52.
Gene drive organisms are a recent development created by using methods of genetic engineering; they inherit genetic constructs that are passed on to future generations with a higher probability than with Mendelian inheritance. There are some specific challenges inherent to the environmental risk assessment (ERA) of genetically engineered (GE) gene drive organisms, since subsequent generations of these GE organisms might show effects that were not observed or intended in the former generations. Unintended effects can emerge from interaction of the gene drive construct with the heterogeneous genetic background of natural populations and/or be triggered by changing environmental conditions. This is especially relevant in case of gene drives with invasive characteristics and typically takes dozens of generations to render the desired effect. Under these circumstances, ‘next generation effects’ can substantially increase the spatial and temporal complexity associated with a high level of uncertainty in ERA. To deal with these problems, we suggest the introduction of a new additional step in the ERA of GE gene drive organisms that takes three criteria into account: the biology of the target organisms, their naturally occurring interactions with the environment (biotic and abiotic) and their intended biological characteristics introduced by genetic engineering. These three criteria are merged to form an additional step in ERA, combining specific ‘knowns’ and integrating areas of 'known unknowns' and uncertainties, with the aim of assessing the spatio‐temporal controllability of GE gene drive organisms. The establishment of assessing spatio‐temporal controllability can be used to define so‐called ‘cut‐off’ criteria in the risk analysis of GE gene drive organisms: if it is likely that GE gene drive organisms escape spatio‐temporal controllability, the risk assessment cannot be sufficiently reliable because it is not conclusive. Under such circumstances, the environmental release of the GE gene drive organisms would not be compatible with the precautionary principle (PP).
Stakeholder workshop “Problem formulation for the environmental risk assessment of gene drive modified insects” (15 May 2019, Brussels)
8192European Food Safety, A., Devos, Y., Gallani, B. & Firbank, L. G, A. European Food Safety, Y. Devos, B. Gallani and L. G. Firbank, 17:1819E. 2020-03-09 20:12:26.
Recent advances in molecular and synthetic biology are enabling the engineering of gene drives that spread genes of interest through interbreeding populations at a frequency greater than the rate expected by simple Mendelian inheritance. At present, insects represent the most likely cases of gene drive modified organisms for deliberate release into the environment. Through an open workshop, the European Food Safety Authority (EFSA) aimed to engage with stakeholders to discuss potential environmental risks associated with the deliberate release into the environment of gene drive modified insects. Workshop participants were invited to contribute to an example problem formulation to: (1) identify relevant broad protection goals and make them operational for use in environmental risk assessment; (2) formally devise examples of plausible pathways to harm that describe how the deployment of gene drive modified insects could be harmful; (3) formulate example risk hypotheses about the likelihood and severity of such events; (4) identify possible information that would be useful to test these risk hypotheses; and (5) identify how to acquire new data for hypothesis testing when existing information is deemed insufficient for regulatory decision-making. The problem formulation exercise was run for two hypothetical case studies (i.e. self-sustaining low threshold gene drives to control disease-spreading mosquitoes (Aedes albopictus, the Asian tiger mosquito) and agricultural pests (Drosophila suzukii, the spotted-wing Drosophila)). Points raised by the workshop participants reveal different often contrasting opinions/perspectives toward gene drive and their risk assessment. Overall, there was agreement that the problem formulation process is fit-for-purpose for the environmental risk assessment of gene drive modified insects, but it was acknowledged that practical challenges may be encountered. Points raised by the workshop participants, on defining protection goals, formulating specific pathways to harm and on structuring risks, have been considered by EFSA's Panel on genetically modified organisms during its deliberations.
Toward the definition of efficacy and safety criteria for advancing gene drive-modified mosquitoes to field testing
7971S. L. James, J. M. Marshall, G. K. Christophides, F. O. Okumu and T. Nolan, Vector Borne and Zoonotic Diseases, 20:237. 2020-03-09 14:54:00.
Mosquitoes containing gene drive systems are being developed as complementary tools to prevent transmission of malaria and other mosquito-borne diseases. As with any new tool, decision makers and other stakeholders will need to balance risks (safety) and benefits (efficacy) when considering the rationale for testing and deploying gene drive-modified mosquito products. Developers will benefit from standards for judging whether an investigational gene drive product meets acceptability criteria for advancing to field trials. Such standards may be formalized as preferred product characteristics and target product profiles, which describe the desired attributes of the product category and of a particular product, respectively. This report summarizes discussions from two scientific workshops aimed at identifying efficacy and safety characteristics that must be minimally met for an investigational gene drive-modified mosquito product to be deemed viable to move from contained testing to field release and the data that will be needed to support an application for first field release.
Risk assessment challenges of synthetic gene drive organisms
12529E. Sirinathsinghji, TWN Biosafety Briefing, 2020-03-01 15:12:11.
Gene Drives: New and Improved
7945R. M. Friedman, J. M. Marshall and O. S. Akbari, Issues in Science and Technology, 36:1-7. 2020-02-18 20:39:12.
Our goal here is to describe the various options under development in nontechnical terms for a policy-making audience, review how far along each is, and examine the broader context of how this new suite of technologies compares with other available alternatives. Early engagement by the policy and regulatory communities will be of great help to product developers, and thus ultimately to society through better and more appropriate products. Our hope is that this improved understanding of what is in the development pipeline will enhance the dialogue between the policy community and developers.
Public Opinion Towards Gene Drive as a Pest Control Approach for Biodiversity Conservation and the Association of Underlying Worldviews
7348E. A. MacDonald, J. Balanovic, E. D. Edwards, W. Abrahamse, B. Frame, A. Greenaway, R. Kannemeyer, N. Kirk, F. Medvecky, T. L. Milfont, J. C. Russell and D. M. Tompkins, Environmental Communication-a Journal of Nature and Culture, 15:1-16. 2020-01-27 21:27:11.
Synthetic gene drive approaches are nascent technologies with potential applicability for pest control for conservation purposes. Responsible science mandates that society be engaged in a dialogue over new technology, particularly where there exist global ramifications as with gene drive. We hypothesize that public attitudes towards gene drive are not formed on scientific knowledge or demographics alone, but are heavily influenced by underlying worldviews, which encapsulate a broad and interactive system of attitudes, beliefs, and values. To test this, we conducted a national survey in New Zealand (n = 8199) and found that respondents clustered into four distinct segments with underlying worldviews, better able to explain attitudes toward gene drive than either the participants' scientific knowledge or other explanatory factors such demographics, political ideology or religiosity. We found that the use of gene drive for biodiversity conservation currently has moderate (32%) levels of support in New Zealand but that varied substantially across the four segments. Should gene drive become a technically viable approach for pest control, understanding the worldviews that shape public decision-making can guide a more empathetic engagement process and empower society to participate in informed decision-making about if and how gene drive should be used for conservation purposes.
Regulation of GM Organisms for Invasive Species Control
6701H. J. Mitchell and D. Bartsch, Frontiers in Bioengineering and Biotechnology, 7:1-11. 2020-01-21 18:17:37.
Invasive species can cause significant harm to the environment, agriculture, and human health, but there are often very limited tools available to control their populations. Gene drives (GD) have been proposed as a new tool which could be used to control or eliminate such species. Here, GD describes a variety of molecular biology applications which all enable the introduction of genetic elements at a higher than expected frequency. These elements can change the genotypes in target populations rapidly with consequences either for (intrinsic) fitness or host-parasite interaction, or both. Beneficial applications are foreseen for human and animal health, agriculture, or nature conservation. This rapidly developing technology is likely to have major impacts in the fight against various diseases, pests, and invasive species. The majority of GD applications involve genetic engineering and novel traits. Therefore, applicants and GMO regulators need to interact to achieve the benefits in innovation while cautiously avoiding unacceptable risks. The release into the environment may include transboundary movement and replacement of target populations, with potential impact on human/animal health and the environment. This article summarizes knowledge-based discussions to identify information gaps and analyzes scenarios for responsible introduction of GD organisms into the environment. It aims to connect the latest scientific developments with regulatory approaches and decision-making.
Irreversible ecosystem engineering with Gene Drive Organisms
8178Save Our Seeds, Save Our Seeds, 2020-01-18 19:56:07.
Gene drive technology is a particular application of the new genetic engineering tool CRISPR/Cas9. It is designed to genetically modify, replace or eradicate wild populations or entire species. So far it works in mosquitos, mice, flies, yeast and nematodes. But in principle it could be used to genetically modify any sexually reproducing organism. Gene drive organisms (GDOs) are meant to mate with their wild relatives and spread their engineered genes to ALL of their offspring. This forced inheritance pattern circumvents natures normal rules of inheritance. It triggers a genetic chain reaction in which the genetic engineering tool CRISPR/Cas9 and sometimes an additional new gene are passed on from generation to generation. Genetic changes induced by a gene drive can lead to sterility or the change of sex ratio of their descendants, leading to a crash in their population. First field trials in nature are foreseen for the near future.
Gene Drive Film
6665Save Our Seeds, 2020-01-16 16:39:24.
This is a video based on the findings in GENE DRIVES: A report on their science, applications, social aspects, ethics and regulations which you can find here. There was a Symposium on May 24, 2019 that covers the topics in the report and the presentations at that symposium can be found here.
The gene drive dilemma: We can alter entire species but should we?
6302J. Kahn, New York Times Magazine, 2020-01-08 20:03:00.
One early summer evening in 2018, the biologist Anthony James drove from his office at the University of California, Irvine, to the headquarters of the Creative Artists Agency, a sleek glass-and-steel high-rise in Los Angeles. There, roughly 200 writers, directors and producers — many of them involved in the making of science-and-technology thrillers — were gathered for an event called Science Speed Dating, where James and other scientists would explain their work. The sessions were organized, James told me, “in hopes of getting the facts at least somewhat straight.”
Metaphor, Trust and Support for Non-native Species Control
13833P. A. Kohl, S. J. Collins and M. Eichholz, Environmental Communication, 14:672-685. 2020-01-07 15:29:47.
This experimental study used a representative sample of U.S. residents (N = 1,042) to test whether the use of the term "invasive" increases support for non-native species control efforts. The term invasive had a small influence on support for two out of three non-native species control methods. We also found stronger support for control methods using gene editing technologies than control methods using poison.
Scenario analysis on the use of rodenticides and sex-biasing gene drives for the removal of invasive house mice on islands
6221M. E. Serr, R. X. Valdez, K. S. Barnhill-Dilling, J. Godwin, T. Kuiken and M. Booker, Biological Invasions, 2020-01-06 21:34:59.
Since the 1960s conservation efforts have focused on recovering island biodiversity by eradicating invasive rodents. These eradication campaigns have led to considerable conservation gains, particularly for nesting seabirds. However, eradications are complex and lengthy endeavors and are even more challenging when humans are co-inhabitants of the targeted island. Furthermore, the method of eradication matters and recent proposals to consider genetic technologies for rodent eradication require specific scrutiny. One such technology is the potential use of a gene drive for biasing offspring sex ratios in invasive house mice, Mus musculus, that would spread and prevent the production of one sex, allowing die-off from lack of reproduction and natural attrition. Practitioners can gain insight into the potential for adoption of this technology from examining stakeholder engagement. This paper uses scenario analysis to address the eradication of rodents on inhabited and uninhabited islands, by specifically comparing the traditional approach of using rodenticides with sex-biasing gene drives. Concurrently the International Union for Conservation of Nature is assessing the risks and value of gene drives in general for conservation. Hence, we make the case that the ethical challenges with the use of gene drive sex-biasing techniques and the effectiveness of this tool will rely as much on its public acceptance and its democratic use as the actual science used to construct the technology.
Beyond Mendelian genetics: Anticipatory biomedical ethics and policy implications for the use of CRISPR together with gene drive in humans.
6227M. W. Nestor and R. L. Wilson, Journal of Bioethical Inquiry, 2020:1-12. 2020-01-03 21:43:18.
Clustered regularly interspaced short palindromic repeats (CRISPR) genome editing has already reinvented the direction of genetic and stem cell research. For more complex diseases it allows scientists to simultaneously create multiple genetic changes to a single cell. Technologies for correcting multiple mutations in an in vivo system are already in development. On the surface, the advent and use of gene editing technologies is a powerful tool to reduce human suffering by eradicating complex disease that has a genetic etiology. Gene drives are CRISPR mediated alterations to genes that allow them to be passed on to subsequent populations at rates that approach one hundred per cent transmission. Therefore, from an anticipatory biomedical ethics perspective, it is possible to conceive gene drive being used with CRISPR to permanently ameliorate aberrant genes from wild-type populations containing mutations. However, there are also a number of possible side effects that could develop as the result of combining gene editing and gene drive technologies in an effort to eradicate complex diseases. In this paper, we critically analyse the hypothesis that the combination of CRISPR and gene drive will have a deleterious effect on human populations from an ethical perspective by developing an anticipatory ethical analysis of the implications for the use of CRISPR together with gene drive in humans.
Technology Factsheet: Gene Drives
7265J. Lunshof, C. Shachar, R. Edison, A. Jayanti, Belfer Center for Science and International Affairs, 2020-01-01 17:03:29.
Gene drives can be defined as genetic elements that pass from parents to unusually high numbers of their offspring due to biased inheritance (sometimes referred to as the possession of “selfish” genetic elements).1,2 There are different ways of achieving this biased inheritance needed for a drive, but the shared outcome is one where the offspring of a parent carrying a certain genetic variant has over a 50% likelihood of inheriting it. With regular inheritance, in the absence of a gene drive, each of the two alleles carried by a parent are equally likely to be inherited by offspring. By implementing modern gene editing technology, such as CRISPR, gene drives can be manufactured by humans to intentionally suppress a target population or spread a trait through a population. For example, gene drives could be used to target weeds, spreading a trait that would reverse their evolved resistance to non-toxic herbicides. Gene drives could also be used for human health purposes, in particular for the control of vector-borne diseases, such as malaria through populations of mosquitos. There are many outstanding governance questions with regards to the specific research, development, testing, and deployment of gene drives—including who should be taking ownership of drafting regulations and policy. At this stage, few countries currently have regulations that are defined specifically for gene drive, and in most countries the closest relevant regulations are those written for a broader swath of gene editing technologies. As there becomes more momentum around the potentially unique opportunities of gene drives though, it is important for U.S. legislators and policymakers to remain engaged in the technology’s technical, ethical, and practical progress and consider technology-specific governance.
A typology of community and stakeholder engagement based on documented examples in the field of novel vector control
6032C. E. Schairer, R. Taitingfong, O. S. Akbari and C. S. Bloss, PLoS Neglected Tropical Diseases, 13:e0007863. 2019-12-30 20:46:44.
Background Despite broad consensus on the importance of community and stakeholder engagement (CSE) for guiding the development, regulation, field testing, and deployment of emerging vector control technologies (such as genetically engineered insects), the types of activities pursued have varied widely, as have the outcomes. We looked to previous CSE efforts for clarity about appropriate methods and goals. Our analysis yielded a typology of CSE, and related vocabulary, that describes distinctions that funders, organizers, and scholars should make when proposing or evaluating CSE. Methods We compiled available formal documentation of CSE projects, starting with projects mentioned in interviews with 17 key informants. Major features of these examples, including the initiators, target groups, timing, goals, and methods were identified using qualitative coding. Based on these examples, subcategories were developed for a subset of features and applied to the identified cases of CSE in the documents. Co-occurrence of subcategorized features was examined for patterns. Results We identified 14 documented examples CSE projects, which were comprised of 28 distinct CSE activities. We found no clear patterns with respect to timing. However, we found that grouping examples according to whether initiators or targets could enact the immediate desired outcome could help to clarify relationships between goals, methods, and targets.
Articulating ‘free, prior and informed consent’ (FPIC) for engineered gene drives
5800George, D. R., T. Kuiken and J. A. Delborne, Proceedings of the Royal Society B: Biological Sciences, 286:20191484.. 2019-12-19 14:30:32.
Recent statements by United Nations bodies point to free, prior and informed consent (FPIC) as a potential requirement in the development of engineered gene drive applications. As a concept developed in the context of protecting Indigenous rights to self-determination in land development scenarios, FPIC would need to be extended to apply to the context of ecological editing. Without an explicit framework of application, FPIC could be interpreted as a narrowly framed process of community consultation focused on the social implications of technology, and award little formal or advisory power in decision-making to Indigenous peoples and local communities. In this paper, we argue for an articulation of FPIC that attends to issues of transparency, iterative community-scale consent, and shared power through co-development among Indigenous peoples, local communities, researchers and technology developers. In realizing a comprehensive FPIC process, researchers and developers have an opportunity to incorporate enhanced participation and social guidance mechanisms into the design, development and implementation of engineered gene drive applications.
Exterminator genes: The right to say no to ethics dumping
5654Bassey-Orovwuje, M., J. Thomas and T. Wakeford, Development, 62:121-127. 2019-12-17 18:09:38.
The scientific-industrial complex is promoting a new wave of genetically modified organisms, in particular gene drive organisms, using the same hype with which they tried to persuade society that GMOs would be a magic bullet to solve world hunger. The Gates Foundation claims that GDOs could help wipe out diseases such as malaria. Powerful conservation lobby groups claim GDOs will protect engendered species. Not only are the benefits from GDOs based, like their predecessors, on flawed ecological thinking, but they are backed by the same agri-business interests that have devastated agroecological farming systems. The rights of communities to say ‘no’ to new genetic technologies is being eroded, despite United Nations agreements, such as the Convention on Biological Diversity, which call for the free, prior and informed consent of affected communities to be respected. By exporting their field trials to countries with weak regulatory regimes and lowering of the standards of consent the Gates Foundation’s Target Malaria project has already been guilty of ethics dumping. These developments demonstrate the urgent need to democratize the development of new technologies.
Gene drives in Africa – A Podcast
5592Wakeford, T., etc Group, 2019-12-16 19:57:27.
In Episode #1 ETC's Tom Wakeford speaks with Ugandan lawyer and advocate Barbara Ntambirweki about gene drives, a powerful new genetic technology that can change species in the wild and make species go extinct.
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
An Initial Framework for the Environmental Risk Assessment of Synthetic Biology-Derived Organisms with a Focus on Gene Drives.
16281W. G. Landis, E. A. Brown and S. Eikenbary, Synthetic Biology 2020: Frontiers in Risk Analysis and Governance. Risk, Systems and Decisions., 2019-11-29 17:16:37.
We apply the structure of source-stressor-habitat-effect-impact pathway derived from the relative risk model (Landis and Wiegers 2005) and as was demonstrated to be applicable in the National Academy of Sciences, Engineering and Medicine (NASEM) 2016 report Gene Drives on the Horizon. This relative risk model is now calculated employing Bayesian networks and has been applied to forestry management (Ayre and Landis 2012), infectious disease (Ayre et al. 2014), invasive species (Herring et al. 2015), contaminated sites (Landis et al. 2017a; Johns et al. 2017), and watershed management (Hines and Landis 2014; Graham et al. 2019).
Peri-Urban Community Attitudes towards Codling Moth Trapping and Suppression Using the Sterile Insect Technique in New Zealand
17774G. Paterson, G. L. W. Perry, J. T. S. Walker and D. M. Suckling, Insects, 10. 2019-10-09 15:21:37.
New, more socially-acceptable technologies are being developed to suppress horticultural pests, because suppression is technically difficult with current technologies, especially in urban areas. One technique involves the release of sterile insects to prevent offspring in the next generation. This technology involves aerial or ground release systems, but this could also create issues for the public. This study investigated community perceptions of a recently-introduced response to codling moth control in New Zealand—Sterile Insect Technique (SIT). Community attitudes to SIT were examined in Hastings, New Zealand, in April, 2018. Eighty-six detailed interviews were undertaken with a random sample of households. This community was very willing (98% agreement) to host a sex pheromone trap in their gardens, and condoned regular visits to monitor traps. Attitudes to SIT were very positive (98% in favor). Once explained, the concept of using unmanned aerial vehicles to deliver sterile insects was also acceptable (98%) to the community. Use of unmanned aerial vehicles to release sterile insects during a hypothetical incursion response of an exotic fruit fly was also supported at 98% by respondent householders. Investigation of community attitudes can be valuable to guide practitioners in determining suitable technologies before an area-wide programme is launched.
Efforts to enhance safety measures for CRISPR/Cas-based gene drive technology in Japan
6035T. Tanaka, N. Tanaka, Y. Nagano, H. Kanuka, D. S. Yamamoto, N. Yamamoto, E. Nanba and T. Nishiuch, Journal of Environment and Safety, 2019-10-07 20:47:13.
Gene drive is a powerful system that can spread a desirable genetic trait into an entire species and/or population of a certain region, bypassing Mendelian rules of inheritance. Recently, one of the genome editing technologies, CRISPR/Cas, has been developed, making it easier to use gene drive in many different organisms. However, gene drive has potential risks that impact genetic diversity when organisms produced by CRISPR/Cas-based Gene Drive Technology (CCGDT) are accidentally released; therefore, a high degree of prudence is required when CCGDT is used. In Japan, a Working Group on Gene Drive has been established in the Academic Association for Promotion of Genetic Studies (AAPGS), and a Statement on the Handling of Gene Drive was issued to the public including research institute across Japan, after comprehensive and extensive discussions by the working group in order to reduce risks posed by CCGDT. A national-wide survey on CCGDT was implemented. The survey revealed that those in managerial positions including members and secretariats of institutional review boards on recombinant DNA, and biosafety officers are conscious of CCGDT, and efforts to grasp experimental plans involving CCGDT are made by utilizing an application form for recombinant DNA experiment. In contrast, potential risks of CCGDT are not understood by many researchers. All stakeholders need to disseminate potential risks and preventive measures regarding CCGDT to all researchers who may wish to use this technology. Researchers should use CCGDT upon understanding its potential risks and taking necessary measures. This report refers to how safety measures for CRISPR/Cas-based gene drive technology which has potential risks to ecological system has been discussed and results of national-wide questionnaire survey on gene drive in Japan based on the poster presentation at the Asian Conference on Safety & Education in Laboratory 2018.
Gene Drives: Dynamics and Regulatory Matters-A Report from the Workshop “Evaluation of Spatial and Temporal Control of Gene Drives,” April 4-5, 2019, Vienna
12396B. Giese, J. L. Friess, N. H. Barton, P. W. Messer, F. Debarre, M. F. Schetelig, N. Windbichler, H. Meimberg and C. Boete, Bioessays, 41:3. 2019-10-07 18:26:19.
Gene Drives are regarded as future tools with a high potential for population control. Due to their inherent ability to overcome the rules of Mendelian inheritance, gene drives (GD) may spread genes rapidly through populations of sexually reproducing organisms. A release of organisms carrying a GD would constitute a paradigm shift in the handling of genetically modified organisms because gene drive organisms (GDO) are designed to drive their transgenes into wild populations and thereby increase the number of GDOs. The rapid development in this field and its focus on wild populations demand a prospective risk assessment with a focus on exposure related aspects. Presently, it is unclear how adequate risk management could be guaranteed to limit the spread of GDs in time and space, in order to avoid potential adverse effects in socio‐ecological systems. The recent workshop on the “Evaluation of Spatial and Temporal Control of Gene Drives” hosted by the Institute of Safety/Security and Risk Sciences (ISR) in Vienna aimed at gaining some insight into the potential population dynamic behavior of GDs and appropriate measures of control. Scientists from France, Germany, England, and the USA discussed both topics in this meeting on April 4–5, 2019. This article summarizes results of the workshop.
Gene Drive Technologies: Powerful and destructive
5510SWISSAID, 2019-09-16 19:05:21.
Gene drive organisms can put our environment, food and health in danger: this is made clear by the video from SWISSAID, the Alliance for GMO-free Switzerland and the ETC Group.
Gene Drives: Experience with gene drive systems that may inform an environmental risk assessment
4583Rüdelsheim, PKJS, G., COGEM, 2019-09-05 00:00:00.
Gene drives are genetic mechanisms that allow for a trait to be propagated throughout a population; beyond Mendelian inheritance. Active in sexually-reproducing species, they are powerful tools to “drive”; a gene, i.e. increase its frequency, independent of external selection pressure. They have been proposed; as offering solutions for many challenges in public health, agriculture, conservation and others. They have; inspired researchers to use gene drives to combat diseases transmitted by insects such as malaria,; dengue and Zika.; For decennia attempts have been made to use or modify naturally occurring gene drive mechanisms. Yet,; natural gene drives have their limitations. Transposable element-based drives turned out to be not efficient; enough. Moreover, they cannot be directed. Translocation drives are hard to establish and suffer from a; high fitness cost. Others are only active in specific species (e.g. meiotic drive, MEDEA).
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.
Autonomy of Nations and Indigenous Peoples and the Environmental Release of Genetically Engineered Animals with Gene Drives
12398Z. Meghani, Global Policy, 10:554-568. 2019-08-05 18:30:26.
This article contends that the environmental release of genetically engineered (GE) animals with heritable traits that are patented will present a challenge to the efforts of nations and indigenous peoples to engage in self-determination. The environmental release of such animals has been proposed on the grounds that they could function as public health tools or as solutions to the problem of agricultural insect pests. This article brings into focus two political-economic-legal problems that would arise with the environmental release of such organisms. To address those challenges, it is proposed that nations considering the environmental release of GE animals must take into account the underlying circumstances and policy failures that motivate arguments for the use of the modified animals. Moreover, countries must recognize that the UN International Covenant on Civil and Political Rights and the UN International Covenant on Economic, Social and Cultural Rights place on them an obligation to ensure that GE animals with patented heritable traits are not released without the substantive consent of the nations or indigenous peoples that could be affected.
Synthetic Biology: Research Needs for Assessing Environmental Impacts
17467C. M. Warner, S. R. Carter, R. F. Lance, F. H. Crocker, H. N. Meeks, B. L. Adams, M. L. Magnuson, T. Rycroft, K. Pokrzywinski and E. J. Perkins, Synthetic Biology 2020: Frontiers in Risk Analysis and Governance, 2019-08-01 18:23:43.
Synthetic biology and its applications have the potential to greatly improve economic development, public health, environmental stewardship, technological advancement, and many other areas. In May 2017, sixty individuals gathered in Lexington, Massachusetts for a workshop sponsored by the U.S. Army Engineer Research and Development Center (ERDC) to discuss applications of synthetic biology with likely or intended interaction with the environment. Representatives from academia, government agencies, industry, and non-governmental organizations convened to identify knowledge gaps and research needs to assess potential environmental impacts from these technologies. The group discussed challenges in environmental risk assessment, regulation, and community engagement for emerging synthetic biology technologies. The workshop was structured around four hypothetical case studies, including the use of gene drive engineered organisms to control infectious disease vectors, engineered microbes for bioremediation, cell-free applications for advanced chemical production, and engineered viruses for water treatment. Meeting these research needs will facilitate appropriate environmental risk assessment and informed decision making for the development and potential deployment of synthetic biology organisms and components in the environment.
Gene Drives in Africa: Civil Society Speaks Out
13132African Centre for Biodiversity, 2019-07-26 13:51:13.
On Monday 1st July 2019, Target Malaria announced the release of genetically modified (GM) sterile male mosquitoes in Bana, a village in Burkina Faso – the first GM insect to be released in Africa. This is Phase I – by Phase III, Target Malaria aims to release gene drive mosquitoes. This release occurred despite strong opposition from civil society, in Burkina Faso, and across the continent. In this video, key CSO figures discuss their concerns regarding gene drive technology and explain how their governments, and the Africa Union’s, position on gene drives, has been captured.
Synthetic Biology and the United Nations
7967H.-E. Lai, C. Canavan, L. Cameron, S. Moore, M. Danchenko, T. Kuiken, Z. Sekeyová and P. S. Freemont, Trends in Biotechnology, 37:1146-1151. 2019-06-27 14:42:54.
Synthetic biology is a rapidly emerging interdisciplinary field of science and engineering that aims to redesign living systems through reprogramming genetic information. The field has catalysed global debate among policymakers and publics. Here we describe how synthetic biology relates to these international deliberations, particularly the Convention on Biological Diversity (CBD).
Biological control of pests and a social model of animal welfare
16284A. Mankad, U. Kennedy and L. Carter, Journal of Environmental Management, 247:313-322. 2019-06-25 17:21:12.
We consider the role of perceived humaneness or, more accurately, animal welfare as it relates to managing invasive species from a scientific and social perspective. In order to highlight and articulate particular nuances and standards across different pest control contexts, we use three case examples (feral cats, wild rabbits, and invasive cane toads) and explore where biological pest control and animal welfare interests intersect.
Vereinigung Deutscher Wissenschaftler e.V. | Gene Drive Symposium-Critical Science Switzerland
6674Critical Scientists Switzerland; European Network of Scientists for Social and Environmental Responsibility; Vereinigung Deutscher Wissenschaftler, 2019-05-24 18:26:07.
Gene Drives: A report on their science, applications, social aspects, ethics and regulations
6670H. Dressel, Critical Scientists Switzerland; European Network of Scientists for Social and Environmental Responsibility; Vereinigung Deutscher Wissenschaftler, 2019-05-17 18:00:50.
Engineered Gene Drives are a new form of genetic modification that provides the tools for permanently modifying or potentially even eradicating species or populations in the wild. Unlike the previous genetically modified organisms (GMOs), gene drive organisms (GDOs) are not meant to stay where they are released, but instead are designed and purpose-built to spread and to drive their modified genes far and wide into wild populations.
Gene drives and the international biodiversity regime
18784F. Rabitz, Review of European, Comparative & International Environmental Law, 2019-05-17 17:30:54.
Gene drives are genetic modifications designed for rapidly diffusing traits throughout a target population. They are currently being proposed as biological control agents to combat, for instance, invasive alien species and disease vectors. They also raise concerns regarding their potential adverse effects on biological diversity. This text assesses gene drive governance under the Convention on Biological Diversity (CBD) and its Cartagena Protocol on Biosafety. While gene drives are directly relevant for the objectives of both agreements, their regulatory frameworks have not kept up with the pace of technological change. The focus of this article is on the analysis of gaps and inconsistencies within both agreements. It highlights numerous elements of the CBD and the Cartagena Protocol that raise challenges for gene drive governance, such as matters related to regulatory scope, transboundary movements, precaution and invasive alien species.
Gene drive organisms: What Africa should know about actors, motives and threats to biodiversity and food systems
5923Sirinathsinghji, E., African Centre for Biodiversity., 2019-05-13 16:51:45.
In this briefing paper, we set out the key issues that our governments should have addressed with African civil society before endorsing positions and setting the benchmark for Africa-wide policy. In this regard, we point out that, while the impetus for the AU position might well have been gene drive technologies proposed by the Gates-funded Target Malaria consortium, as a tool to reduce the transmission of malaria on the continent, the debate about gene drive organisms goes well beyond gene drive mosquitoes. Plans by gene drive developers target pests, pollinators, weeds and the speeding up of plant breeding programmes. The logic of using these technologies in agriculture relies on the continued deception that exceedingly complex problems in the food system in Africa can be resolved simply by new high-tech innovations, while downplaying their potential risks to biodiversity and livelihoods.
When Policy Meets Practice: The Dilemma for Guidance on Risk Assessment Under the Cartagena Protocol on Biosafety
34344Karen E Hokanson, Frontiers in Bioengineering and Biotechnology, 7. 2019-04-30 14:52:07.
RISCOS BIOTECNOLÓGICOS AMBIENTAIS E PARTICIPAÇÃO SOCIAL: POR UMA GESTÃO DEMOCRÁTICA DA BIOTECNOLOGIA GENE DRIVE NA ATUAÇÃO DA CTNBIO
23872L. C. Rodrigues, Revista Jurídica (FURB), 22. 2019-03-15 09:15:24.
This research aims to study the way in which the environmental risks of Gene Drive biotechnology challenge forms of effective social participation, inserted in the management of biotechnological risks, whose responsibility lies with the organs linked to the State (CTNBio performance). The method of hypothetical-deductive approach, the method of topical and systematic juridical interpretation and the technique of bibliographic research were used. The conclusion reached was that the need to strengthen the objective sharing of information in an advisory manner to the general public in the face of Gene Drive's biotechnology risks within the framework of the CTNBio from the modification of the current Public Hearings legal model, which gives indications of omissions and lags before the complexity of the theme..
An overview of OECD activities related to modern techniques of biotechnology and genome editing
3923Kearns, P, Transgenic Research, 28:41-44. 2019-01-21 00:00:00.
Since commercial use of genetically-engineered (genetically- modified) plants started in 1996, many agricultural products have been developed to improve crop traits. The foods and feeds derived from these commodities have drastically increased worldwide. However, answering health and environmental safety concerns associated with the agricultural use of biotechnology is essential in countries producing the products, as well as in countries using them. To address these concerns, the OECD conducts programmes of work for sharing information, developing tools to facilitate a harmonised approach of risk assessment, and contributing to building consensus between national authorities. This report provides background information on some OECD activities related to safety considerations associated with the use of biotechnology in agriculture (covering applications to crop plants, trees, animals, micro-organisms), including the recent emergence of genome editing techniques.
Does the U.S. public support using gene drives in agriculture? And what do they want to know?
3922Jones, MSD, Jason A.; Elsensohn, Johanna; Mitchell, Paul D.; Brown, Zachary S., Science Advances, 5:eaau8462. 2019-01-20 00:00:00.
Gene drive development is progressing more rapidly than our understanding of public values toward these technologies. We analyze a statistically representative survey (n = 1018) of U.S. adult attitudes toward agricultural gene drives. When informed about potential risks, benefits, and two previously researched applications, respondents’ support/opposition depends heavily (+22%/?19%) on whether spread of drives can be limited, non-native versus native species are targeted (+12%/?9%), or the drive replaces versus suppresses target species (±2%). The one-fifth of respondents seeking out non–GMO–labeled food are more likely to oppose drives, although their support exceeds opposition for limited applications. Over 62% trust U.S. universities and the Department of Agriculture to research gene drives, with the private sector and Department of Defense viewed as more untrustworthy. Uncertain human health and ecological effects are the public’s most important concerns to resolve. These findings can inform responsible innovation in gene drive development and risk assessment.
Gene drive gone wild: exploring deliberative possibilities by developing One Health ethics
3898Capps, B, Law, Innovation and Technology, 11:231-256. 2019-01-16 00:00:00.
Gene editing may be used to engineer organisms that are better or worse adapted to survival. Coupled with gene drives ? molecular genetic strategies that perpetuate specific phenotypes in a target species ? it would now be possible to edit wild animal populations that impact on public health. It is generally agreed that community engagement should guide prospective gene drive field trials. However, the analysis in this article reveals that there is a tension between publics and the public interest: it is contentious to allow communities to decide policy when doing so will have consequences beyond their own interests, as surely gene drives will; conversely, it goes against ideal deliberation for the state to impose policy without this democratic condition. The gene drive controversy creates further dichotomies illustrative of this tension: giving effect to weighted decisions that discriminate between culture and nature, local and global, private and public, and present and future interests. In this article, an emerging concept of One Health ethics (OH) is employed to strengthen ethical engagement on the policy roadmap used to navigate the gene drive controversy. OH in practice has been shown to provide insightful solutions at the interface between animal and human health; and, in this article, that advantage is extended to the public good and public interest. In so doing, OH ethics ? as spelled out here ? is coextensive with public health ethics.
Safe CRISPR: Challenges and Possible Solutions
3937Pineda, ML, A.; Collins, J. P.; Kiani, S., Trends in Biotechnology, 37:389-401. 2019-01-15 00:00:00.
Applications of CRISPR in human health and in gene drives are at the forefront of biological research as tools. This technology will affect humankind and our environment, so as this technology pushes forward, the design and implementation of safety measures is imperative. Novel technologies and forethought in various applications of CRISPR are essential for using this technology safely. Here, we review environmental and health-related safety concerns associated with using CRISPR and ways proposed to minimize risk.
The ethical landscape of gene drive research
3897Callies, DE, Bioethics, 33:1091-1097. 2019-01-15 00:00:00.
Gene drive technology has immense potential. The ability to bypass the laws of Mendelian inheritance and almost ensure the transmission of specific genetic material to future generations creates boundless possibilities. But alongside these boundless possibilities are major social and ethical issues. This article aims to introduce gene drive technology, some of its potential applications, and some of the social and ethical issues that arise during research into the technology. For example, is investigation into gene drives hubristic? Would applications of gene drives count as technological fixes? Or does research into such a technology sit on a slippery slope or lock us in to its full-scale use? Are there perverse effects of engaging in research, and, most importantly, who ought to be included in the decision-making process regarding research and field trials? Understanding the basic ethical landscape of this technology will prove invaluable to the public, scientists, and policy-makers as research moves forward.
CRISPR in sub-Saharan Africa: Applications and education
3935Ogaugwu, CEA, S. O.; Adekoya, M. A., Trends in Biotechnology, 37:234-237. 2019-01-13 00:00:00.
Clustered regularly interspaced shortpalindromicrepeats (CRISPR) technology has enabled genetic engineering feats previously considered impracticable, offering great hopes for solutions to problems facing society. We consider it timely to highlight how CRISPR can benefit public health, medicine, and agriculture in sub-Saharan Africa (SSA) and offer recommendations for successful implementation.
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.
Promises and perils of gene drives: Navigating the communication of complex, post-normal science
3892Brossard, DB, Pam; Gould, Fred; Wirz, Christopher D., Proceedings of the National Academy of Sciences of the United States of America, 116:7692-7697. 2019-01-10 00:00:00.
In November of 2017, an interdisciplinary panel discussed the complexities of gene drive applications as part of the third Sackler Colloquium on “The Science of Science Communication.” The panel brought together a social scientist, life scientist, and journalist to discuss the issue from each of their unique perspectives. This paper builds on the ideas and conversations from the session to provide a more nuanced discussion about the context surrounding responsible communication and decision-making for cases of post-normal science. Deciding to use gene drives to control and suppress pests will involve more than a technical assessment of the risks involved, and responsible decision-making regarding their use will require concerted efforts from multiple actors. We provide a review of gene drives and their potential applications, as well as the role of journalists in communicating the extent of uncertainties around specific projects. We also discuss the roles of public opinion and online environments in public engagement with scientific processes. We conclude with specific recommendations about how to address current challenges and foster more effective communication and decisionmaking for complex, post-normal issues, such as gene drives.
Gene drives as a new quality in GMO releases-a comparative technology characterization
3911Friess, JLvG, A.; Giese, B., Peerj, 7:e6793. 2019-01-09 00:00:00.
Compared to previous releases of genetically modified organisms (GMOs) which were primarily plants, gene drives represent a paradigm shift in the handling of GMOs: Current regulation of the release of GMOs assumes that for specific periods of time a certain amount of GMOs will be released in a particular region. However, now a type of genetic technology arises whose innermost principle lies in exceeding these limits-the transformation or even eradication of wild populations. The invasive character of gene drives demands a thorough analysis of their functionalities, reliability and potential impact. But such investigations are hindered by the fact that an experimental field test would hardly be reversible. Therefore, an appropriate prospective assessment is of utmost importance for an estimation of the risk potential associated with the application of gene drives. This work is meant to support the inevitable characterization of gene drives by a comparative approach of prospective technology assessment with a focus on potential sources of risk. Therein, the hazard and exposure potential as well as uncertainties with regard to the performance of synthetic gene drives are addressed. Moreover, a quantitative analysis of their invasiveness should enable a differentiated evaluation of their power to transform wild populations.
A Question of Consent: Exterminator Mosquitoes in Burkina Faso
5538ETC group, 2019-01-08 20:10:07.
Target Malaria’s planned release of GMO mosquitos is step toward release of gene drive mosquitoes, a high-risk technology aimed at the elimination of entire species. Hundreds of organizations have demanded a moratorium on the use of this technology outside of strictly-controlled laboratories.
Problem formulation for gene drive mosquitoes designed to reduce malaria transmission in Africa: results from four regional consultations 2016–2018
3950Teem, JLA, Aggrey; Glover, Barbara; Ouedraogo, Jeremy; Makinde, Diran; Roberts, Andrew, Malaria Journal, 18:347. 2019-01-08 00:00:00.
Gene drive mosquitoes have been proposed as a possible means to reduce the transmission of malaria in Africa. Because this technology has no prior use-history at this time, environmental risk assessments for gene drive mosquitoes will benefit from problem formulation—an organized and ordered process to identify protection goals and potential pathways to harm to the environment, or animal or human health. Recognizing this need, the New Partnership for Africa’s Development (NEPAD), with support from African and international partners, organized four regional consultative workshops in Africa to initiate this process.
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.
Governing extinction in the era of gene editing
3928Monast, JJ, North Carolina Law Review, 97:1329-1358. 2019-01-06 00:00:00.
CRISPR-Cas9 genome-editing technology (“CRISPR”) offers a potential solution for some of the world’s critical conservation challenges. Scientists are harnessing CRISPR to expand genetic diversity of endangered species, control invasive species, or enhance species’ resiliency to a changing climate. Recreating extinct species is now realistic, as is engineering entirely new species. CRISPR also creates opportunities to address vector-borne infectious diseases such as malaria, dengue fever, and Zika using gene drive techniques that can spread genetic alterations through populations. ; While CRISPR is a powerful tool to address public health and conservation goals, it could allow scientists to bypass longstanding value choices underlying national and international conservation efforts and foster permanent ecosystem impacts before public policy can react. This Article argues that, while current conservation laws do not directly address many of the specific questions that arise with CRISPR, the Endangered Species Act (“ESA”) establishes a framework that can, and should, guide the use of gene editing. The proposal calls for: (1) a presumption against the release of genetically modified organisms that could cause species extinction, (2) exemptions for specific public health and environmental goals, and (3) updates to the ESA to clarify oversight of gene editing.
Using problem formulation for fit-for-purpose pre-market environmental risk assessments of regulated stressors
3908Devos, YC, W.; Devlin, R. H.; Ippolito, A.; Leggatt, R. A.; Romeis, J.; Shaw, R.; Svendsen, C.; Topping, C. J., EFSA Journal, 17:e170708. 2019-01-06 00:00:00.
Pre-market/prospective environmental risk assessments (ERAs) contribute to risk analyses performed to facilitate decisions about the market introduction of regulated stressors. Robust ERAs begin with an explicit problem formulation, which involves among other steps: (1) formally devising plausible pathways to harm that describe how the deployment of a regulated stressor could be harmful; (2) formulating risk hypotheses about the likelihood and severity of such events; (3) identifying the information that will be useful to test the risk hypotheses; and (4) developing a plan to acquire new data for hypothesis testing should tests with existing information be insufficient for decision-making. Here, we apply problem formulation to the assessment of possible adverse effects of RNA interference-based insecticidal genetically modified (GM) plants, GM growth hormone coho salmon, gene drive-modified mosquitoes and classical biological weed control agents on non-target organisms in a prospective manner, and of neonicotinoid insecticides on bees in a retrospective manner. In addition, specific considerations for the problem formulation for the ERA of nanomaterials and for landscape-scale population-level ERAs are given. We argue that applying problem formulation to ERA maximises the usefulness of ERA studies for decision-making, through an iterative process, because: (1) harm is defined explicitly from the start; (2) the construction of risk hypotheses is guided by policy rather than an exhaustive attempt to address any possible differences; (3) existing information is used effectively; (4) new data are collected with a clear purpose; (5) risk is characterised against well-defined criteria of hypothesis corroboration or falsification; and (6) risk assessment conclusions can be communicated clearly. However, problem formulation is still often hindered by the absence of clear policy goals and decision-making criteria (e.g. definition of protection goals and what constitutes harm) that are needed to guide the interpretation of scientific information. We therefore advocate further dialogue between risk assessors and risk managers to clarify how ERAs can address policy goals and decision-making criteria. Ideally, this dialogue should take place for all classes of regulated stressors, as this can promote alignment and consistency on the desired level of protection and maximum tolerable impacts across regulated stressors. (C) 2019 European Food Safety Authority. EFSA Journal published by John Wiley and Sons Ltd on behalf of European Food Safety Authority.
Informed consent and community engagement in open field research: lessons for gene drive science
3945Singh, JA, BMC Medical Ethics, 20:54. 2019-01-03 00:00:00.
The development of the CRISPR/Cas9 gene editing system has generated new possibilities for the use of gene drive constructs to reduce or suppress mosquito populations to levels that do not support disease transmission. Despite this prospect, social resistance to genetically modified organisms remains high. Gene drive open field research thus raises important questions regarding what is owed to those who may not consent to such research, or those could be affected by the proposed research, but whose consent is not solicited. The precise circumstances under which informed consent must be obtained, and from whom, requires careful consideration. Furthermore, appropriate engagement processes should be central to any introduction of genetically modified mosquitos in proposed target settings.
Two minutes to midnight-what international law can do about genome editing
3925Lee, TL, Asian Journal of Wto & International Health Law and Policy, 14:227-265. 2019-01-03 00:00:00.
With its ability to transform the ecosystem, gene drives, a powerful genome-editing technology, poses nuanced regulatory challenges. In particular, as gene drives can override the normal rule of inheritance, where the impacts of gene-drive modified organisms on the environment could be irreversible, leading to a permanent population change. Moreover, as these gene-drive modified organisms are designed to spread to large populations, they can also penetrate national and geographic borders, with global implications. Insofar as gene drive applications could be both potentially beneficial as well as hazardous to the world, this article seeks to explore ways in which international law could provide a useful platform to engage the relevant stakeholders in general, and encourage responsible science in specific.
Africa kicks against proposed gene drive moratorium at UN Biodiversity Conference
4560Gakpo, JO, Cornell Alliance for Science, 2018-11-20 00:00:00.
Africa has kicked against a proposed moratorium on the environmental release of organisms containing gene drives now under debate at the United Nation’s biodiversity conference in Egypt.
Burkina Faso’s mosquito controversy: Consent, awareness and risk assessment in Target Malaria’s gene drive project
4559Fuhr, L, Klima der Gerechtigkeit, 2018-11-20 00:00:00.
The 14th Conference of the Parties (COP 14) to the Convention on Biological Diversity is taking place in Sharm El-Sheikh, Egypt, from the 17th to the 29th of November, 2018. Amongst other things, delegates are discussing a moratorium on the release of gene drives, a powerful genetic extinction technology.
Genetic extinction technology challenged at UN Convention on biodiversity
4582reporter, A, Ekklesia, 2018-11-20 00:00:00.
From November 17-29 2018, international conservation and environmental leaders are meeting to call on governments to protect biodiversity and Indigenous Peoples’ and local communities’ rights from controversial new biotechnologies. Friends of the Earth says gene drives have the capacity to wipe out or alter species forever, and to significantly disrupt or modify the ecosystems on which humanity strongly depends for its survival. Gene drives pose serious and potentially irreversible threats to biodiversity and ecosystems, human health, as well as national sovereignty, peace and food sovereignty.
Viewpoint: UN should reject a proposed ban on gene drives
4544Bailey, R, Genetic Literacy Project, 2018-11-20 00:00:00.
A draft resolution would revise the U.N. Convention on Biological Diversity to call on governments to “refrain from” releasing organisms containing engineered gene drives, according to the MIT Technology Review. A gene drive is a technology that can rapidly propagate a particular set of genes throughout a population, including genes that cause sterility in a species.
Global body to consider moratorium on release of organisms with engineered ‘gene drives’
4549Channel, D, Development Channel, 2018-11-19 00:00:00.
Governments from across the globe will consider imposing a temporary ban on the release of organisms carrying altered genes that can propagate through a population, as the consequence of deployment of the technology, which has the potential to eradicate disease, control pests and alter entire ecosystems is thought to be unpredictable.
Zambian citizens call on leaders to raise concerns on GMOs at upcoming meeting in Egypt
4546Biodiversity, ZAfAa, Lusakatimes, 2018-11-17 00:00:00.
Zambia supports the global call for a moratorium on Gene Drive releases, including applied research such as open field trials
From geoengineering to gene drives: move over, moratoria
4592Woods, E, In Verba, 2018-11-16 00:00:00.
Around this time six years ago I was in Hyderabad in India getting to grips with moratoria. Back then conversations revolved around geoengineering – techniques to reduce global warming by intervening in the Earth’s climate system – and whether a ban on geoengineering research should be adopted by the UN Convention on Biological Diversity (UN CBD).
From terminator to exterminator
4556etc group, etc group, 2018-11-15 00:00:00.
20 years after suicide seeds, civil society mobilizes in Egypt this week to stop the sequel – Gene Drive Organisms
Let’s say we can force the mosquito into extinction — should we do it?
4579Porterfield, A, Genetic Literacy Project, 2018-11-15 00:00:00.
Not many people like mosquitoes. So why not eliminate them?; Newer techniques like CRISPR/Cas9 gene editing may make this possible. A new study by researchers at Imperial College London showed how CRISPR/Cas9 can generate a mutant gene that renders female mosquitos infertile, while males can spread the same mutation to offspring. Using a genetic tweak called gene drive, the scientists found they could extend the mutation in subsequent offspring at high enough rates to offset the effects of normal versions of the gene. This essentially wiped out the test population of Anopheles gambiae, a species of mosquito responsible for spreading malaria.
Proposed U.N. test ban on gene drives is idiotic
4543Bailey, R, Reason, 2018-11-15 00:00:00.
A draft resolution would revise the U.N. Convention on Biological Diversity to call on governments to "refrain from" releasing organisms containing engineered gene drives, according to the MIT Technology Review. A gene drive is a technology that can rapidly propagate a particular set of genes throughout a population, including genes that cause sterility in a species.
Research on gene drive technology can benefit conservation and public health.
4576Outreach Network for Gene Drive Research, Outreach Network for Gene Drive Research, 2018-11-14 00:00:00.
As a global community, we are facing life-threatening challenges that undermine our future, from catastrophic loss of biodiversity to acute public health threats.
A Call to Protect Food Systems from Genetic Extinction Technology
12040Global Food and Agriculture Movement, etc Group, 2018-10-16 20:31:12.
Gene drives threaten natural systems. If released experimentally into the environment they may spread engineered genes uncontrollably through wild and domesticated species. This could alter ecological systems and food webs, harm biodiversity and eradicate beneficial organisms such as pollinators. Gene drives could disrupt lands, waters, food and fiber economies and harm Indigenous and peasant agroecological practices and cultures.
Gene Drives
6636SciLine, SciLine, 2018-04-25 20:09:28.
For many years now, scientists have been able to alter genes inside microbial, plant, and animal cells to change organisms’ traits, creating, for example, plants that produce their own protective insecticides and fish that grow to maturity almost twice as fast as normal. But while it has become practically routine for scientists to genetically alter individual organisms, a new set of advances promises something much more ambitious: the ability to propagate new genetic traits* into entire populations over just a few generations. Rapid, population-wide dissemination of new traits is challenging because in most sexually reproducing species, only half of an individual’s offspring will inherit any given version of a gene.
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
Gene Drives – Wundermittel? Biowaffe?
12380Swiss Academy of Sciences, 2018-02-19 21:02:40.
Gene drives are genetic elements that skew the pattern of inheritance of a given characteristic in sexually reproduc- ing organisms. They can be used to spread a characteristic that can alter or even reduce the numbers of individuals in wild populations of a certain species.
The Convention on Biological Diversity as a legal framework for safeguarding ecosystem services
34337Christian Prip, Ecosystem Services, 29:199-204. 2018-02-01 14:46:40.
Summary
13808Committee on Gene Drive Research in Non-Human Organisms: Recommendations for Responsible, Journal of Responsible Innovation, 5:S243-S254. 2018-01-24 15:58:19.
Scientists have studied gene drives for more than 50 years. The development of a powerful genome editing tool in 2012, CRISPR/Cas9,1 led to recent breakthroughs in gene drive research that built on that half century’s worth of knowledge, and stimulated new discussion of the potential applications and implications of gene drive technologies.
Anomaly handling and the politics of gene drives
13806S. W. Evans and M. J. Palmer, Journal of Responsible Innovation, 5:S223-S242. 2018-01-24 15:56:09.
Decisions about the development and use of gene drives are framing broader debates about the need for fundamental changes to biotechnology regulatory systems. We summarize this debate and describe how gene drives are being constructed as potential anomalies within the regulatory landscape.
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.
A roadmap for gene drives: using institutional analysis and development to frame research needs and governance in a systems context
13790J. Kuzma, F. Gould, Z. Brown, J. Collins, J. Delborne, E. Frow, K. Esvelt, D. Guston, C. Leitschuh, K. Oye and S. Stauffer, Journal of Responsible Innovation, 5:S13-S39. 2018-01-24 15:34:37.
This paper reports on a workshop held in February 2016 to explore the complex intersection of political, economic, ethical, and ecological risk issues associated with gene drives. Workshop participants were encouraged to use systems thinking and mapping to describe the connections among social, policy, economic, and ecological variables as they intersect within governance systems. In this paper, we analyze the workshop transcripts and maps using the Institutional Analysis and Development (IAD) framework to categorize variables associated with gene drive governance and account for the complexities of socio-ecological systems.
Mapping research and governance needs for gene drives
13788J. Delborne, J. Kuzma, F. Gould, E. Frow, C. Leitschuh and J. Sudweeks, Journal of Responsible Innovation, 5:S4-S12. 2018-01-24 15:28:09.
This special issue represents both deep and broad thinking about gene drives. The papers were first drafted nearly two years ago, and since then have been reviewed and revised to flesh out key arguments and take account of ongoing developments in the field. This field has moved very fast indeed! Technical research publications have increased in number; NASEM released a major report in June 2016; and workshops have proliferated.
Gene drives and the expanding horizon of governance
13786E. Fisher, Journal of Responsible Innovation, 5:S1-S3. 2018-01-24 15:23:59.
Like other areas of emerging science and technology that trigger prolonged public debate over their transformative prospects, gene drives simultaneously generate prospects for new knowledge, hoped-for benefits, and formidable concerns. Their ability to bias inheritance of and in theory spread a genetic trait throughout an entire population of organisms—even to the point of extinction—is driving home the need for their responsible governance. Significantly, it is also driving home the need to develop capacities for such governance.
Means and ends of effective global risk assessments for genetic pest management
4022Turner, GB, Camilla; Roda, Lucia, BMC Proceedings, 12:13. 2018-01-20 00:00:00.
The development and use of genetic technologies is regulated by countries according to their national laws and governance structures. Legal frameworks require comprehensive technical evidence to be submitted by an applicant on the biology of the organism, its safety to human, animal health and the environment in which it will be released. Some countries also require information on socio-economic and trade impacts. One of the key elements that assists decision-making under those legal frameworks is the use of risk assessments. The risk assessment paradigm of problem formulation based on risk hypothesis, and the assessment of plausible scientific pathways leading to potential environmental and human harms being realised, has been used widely to assess potential risks of genetic technologies to human health and the environment, from crops to mosquitoes. This paper uses the case study of a genetically modified self-limiting olive fly (Bactrocera oleae) for a first deliberate release in Spain to examine the regulatory processes and stakeholders involved in the assessment of risk. It is anticipated that existing risk assessment frameworks are equally applicable to gene drive technologies that may spread and persist in the environment and cross-national borders, but it is the governance structures surrounding the involvement of civil society in regulatory processes that must be administered in a more transparent and defined manner.
Development of community of practice to support quantitative risk assessment for synthetic biology products: contaminant bioremediation and invasive carp control as cases
4021Trump, BF, C.; Rycroft, T.; Wood, M. D.; Bandolin, N.; Cains, M.; Cary, T.; Crocker, F.; Friedenberg, N. A.; Gurian, P.; Hamilton, K.; Hoover, J.J.; Meyer, C.; Pokrzywinski, K.; Ritterson, R.; Schulte, P.; Warner, C. ; Perkins, E.; Linkov, I., Environmental Systems and Decisions, 38:517-527. 2018-01-19 00:00:00.
Synthetic biology has the potential for a broad array of applications. However, realization of this potential is challenged by the paucity of relevant data for conventional risk assessment protocols, a limitation due to to the relative nascence of the field, as well as the poorly characterized and prioritized hazard, exposure, and dose–response considerations associated with the development and use of synthetic biology-derived organisms. Where quantitative risk assessment approaches are necessarily to fulfill regulatory requirements for review of products containing genetically modified organisms, this paper reviews one potential avenue for early-stage quantitative risk assessment for biosafety considerations of synthetic biology organism deployment into the environment. Building from discussion from a March 2018 US Army Engineer Research and Development Center workshop on developing such quantitative risk assessment for synthetic biology, this paper reviews the findings and discussion of workshop participants. This paper concludes that, while synthetic biology risk assessment and governance will continue to refine and develop in the coming years, a quantitative framework that builds from existing practice is one potentially beneficial option for risk assessors that must contend with the technology’s limited hazard characterization or exposure assessment considerations in the near term.
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;
Harnessing gene drive
3996Min, JS, Andrea L.; Najjar, Devora; Esvelt, Kevin M., Journal of Responsible Innovation, 5:S40-S65. 2018-01-14 00:00:00.
When scientists alter the genome of an organism, we typically reduce its ability to reproduce in the wild. This limitation has prevented researchers from rendering wild insects unable to spread disease, programing pests to ignore our crops, using genetics to precisely remove environmentally damaging invasive species, and much more. Gene drive occurs when a vertically transmitted genetic element reliably spreads through a population over generations despite providing no reproductive advantage to each host organism. Until recently, scientific efforts to take advantage of this natural phenomenon achieved only limited success. The advent of CRISPR genome editing has dramatically accelerated efforts to harness gene drive. Small groups of scientists may now be capable of unilaterally altering entire wild populations, and through them, the shared environment. Determining whether, when, and how to develop gene drive interventions responsibly will be a defining challenge of our time. Here we describe capabilities, safeguards, applications, and opportunities relevant to gene drive technologies.
Making policies about emerging technologies
5909Kaebnick, G. E. and M. K. Gusmano, Hastings Center Report, 48:S2-S11. 2018-01-01 16:23:19.
Can we make wise policy decisions about still-emerging technologies?decisions that are grounded in facts yet anticipate unknowns and promote the public's preferences and values? There is a widespread feeling that we should try. There also seems to be widespread agreement that the central element in wise decisions is the assessment of benefits and costs, understood as a process that consists, at least in part, in measuring, tallying, and comparing how different outcomes would affect the public interest. But how benefits and costs are best weighed when making decisions about whether to move forward with an emerging technology is not clear. Many commentators feel that the weighing is often inadequate or inappropriate. Those who argue for a ?precautionary? approach to the weighing do so precisely because they feel the need for a restraint on the dominant decision-making tools and processes for assessing outcomes. This Hastings Center special report examines those tools and processes, taking the method known as cost-benefit analysis as a starting point. In U.S. governance, CBA, sometimes informed by risk assessment, is the most widely used and extensively studied method, and authoritative reports on genetic and reproductive technologies often use language suggestive of cost-benefit analysis. There is also a long-running debate about the role of values in CBA and other formal impact assessment mechanisms?and about how those mechanisms compare to the precautionary principle. The guiding idea in the report is to engage in a close examination of the strengths and limits of CBA for ensuring that emerging technologies are used in ways that square with the public's values, drawing on applications of synthetic biology to illustrate and sharpen the analysis and then considering corrections to CBA and some alternative methodologies that handle values differently.
Open, Local, and Obligated
5467Yale University, 2017-12-13 17:04:29.
Kevin Esvelt, PhD, assistant professor at the MIT Media Lab and leader of the Sculpting Evolution Group talks about the need for new scientific structures based on transparency and open. This lecture was given at the 2017 Editing Nature Summit.
Informed consent in field trials of gene-drive mosquitoes
15682P. A. Kolopack and J. V. Lavery, Gates Open Research, 2017-12-11 14:46:00.
We argue that informed consent from individual research participants in gene drive trials may be required: (1) when blood and other forms of clinical data are collected from them, as will likely be the case in some studies involving epidemiological endpoints, such as the incidence of new infections with dengue and malaria; (2) when they participate in social science and/or behavioral research involving the completion of surveys and questionnaires; or (3) when their home or property is accessed and the location recorded as a spatial variable for the release or collection of mosquitoes because the precise location of the household is important for entomological reasons and these data constitute identifiable private information at the household level. Importantly, most regulations and guidelines allow these requirements to be waived or modified, to various degrees, according to the judgment of Institutional Review Boards.
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.
Conservation demands safe gene drive
13629K. M. Esvelt and N. J. Gemmell, PLOS Biology, 15:e2003850. 2017-11-16 14:03:39.
Here, we explore the risk of accidental spread posed by self-propagating gene drive technologies, highlight new gene drive designs that might achieve better outcomes, and explain why we need open and international discussions concerning a technology that could have global ramifications.
The potential for the use of gene drives for pest control in New Zealand: a perspective
14253P. K. Dearden, N. J. Gemmell, O. R. Mercier, P. J. Lester, M. J. Scott, R. D. Newcomb, T. R. Buckley, J. M. E. Jacobs, S. G. Goldson and D. R. Penman, Journal of the Royal Society of New Zealand, 48:225-244. 2017-10-25 14:20:45.
Here we describe the current state of gene drive technologies and present a series of examples to examine the potential benefits and problems arising from gene drive approaches for pest control in New Zealand.
Using CRISPR-based gene drive for agriculture pest control
13621V. Courtier-Orgogozo, B. Morizot and C. Boëte, EMBO Reports, 18:1481. 2017-09-01 13:15:07.
The authors respond to comments to their publication 10.15252/embr.201744205
ASSEMBLY OF THE UNION Twenty-Ninth Ordinary Session: DECISIONS, DECLARATIONS AND RESOLUTION
16078African Union, African Union, 2017-07-04 14:45:50.
Assembly/AU/Dec.649(XXIX): COMMITS to sustain the gains made in the fight against Malaria and monitor antimalarial drug resistance and insecticide resistance; COMMITS ALSO to invest in the development and regulation of the gene-drive technology as well as other new innovations including next generation insecticides for Indoor Residual Spraying and Long Lasting Insecticidal Nets, Rapid Diagnostic Tests and Artemisinin-based Combination Therapy for the elimination of malaria and REQUESTS the Commission, WHO and NEPAD Agency to support these initiatives;
The use of gene editing to create gene drives for pest control in New Zealand
16070Royal Society Te Apārangi Gene Editing Panel, Royal Society of New Zealand, 2017-06-06 13:54:28.
to explore the implications of gene editing technology for New Zealand, the Royal Society Te Apārangi has convened a multidisciplinary panel of some of New Zealand’s leading experts to consider the social, cultural, legal and economic implications of revolutionary gene-editing technologies for New Zealand to: • Raise awareness of the scientific possibilities and associated public issues of new gene editing technologies to inform debate • Provide information and guidance for policy makers to address current and new issues needing to be clarified or resolved • Show where gene-editing applications are covered by established policies and regulations and where changes are needed • Provide a New Zealand perspective to the global discussion on this technology and identify where global consensus is important T
Agricultural pest control with CRISPR-based gene drive: time for public debate
13636V. Courtier-Orgogozo, B. Morizot and C. Boëte, EMBO Reports, 18:878-880. 2017-06-01 14:19:16.
Gene drive technology to control disease vectors or pests has great potential for addressing humanitarian and public health problems. Its application for pest control in agriculture, however, raises important environmental, social and ethical issues.
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).
Genome editing: scientific opportunities, public interests and policy options in the European Union
16075EASAC, European Academies Science Advisory Council, 2017-03-01 14:41:21.
In many of the areas in which EASAC, the European Academies’ Science Advisory Council, works, where a large and solid body of knowledge is needed to inform the action of our societies, it is important to recognise that there is an intimate mix of science and values involved in discussion. Such discussions are most fruitful when both knowledge and values are well identified. This report presents a broad synthesis of genome editing, one of the newer aspects of the biosciences. It is our hope that presenting clearly the science involved – the duty of academies – will serve the ongoing discussions within society that the report recommends be vigorously pursued.
Adaptive risk management of gene drive experiments: Biosafety, biosecurity, and ethics
4054Lunshof, JEB, A., Applied Biosafety, 22:97-103. 2017-01-12 00:00:00.
Emerging technologies in the life sciences call for new models of biosafety risk management. We examine the question of how to; address new developments in the life sciences and biosciences in a bottom-up manner—that is, from the concrete level of; biosafety practice with a focus on the risk management and risk assessment of emerging technologies in the biology laboratory.; We use research on “gene drives” as an example of challenging work with new constructs that have major biosafety implications; for the work in the laboratory and beyond. Gene drives are intended for use in ecosystems and require, at an early stage, the; consideration of potential future biosafety, biosecurity, and societal impact. We argue for an integrative approach, a truly collaborative; model that involves scientists, biosafety officers, institutional leadership, and ethics consultants, with the aim of; maximizing safety as well as scientific progress.
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.
Guidance on risk assessment of living modified organisms and monitoring in the context of risk assessment
16062Ad Hoc Technical Expert Group (AHTEG) on Risk Assessment and Risk Management,, Convention on Biological Diversity, 2016-09-14 21:27:35.
This document was developed by the Ad Hoc Technical Expert Group (AHTEG) on Risk Assessment and Risk Management, with input from the Open-ended Online Expert Forum, in accordance with terms of reference set out by the Conference of the Parties serving as the meeting of the Parties to the Cartagena Protocol on Biosafety (COP-MOP) in its decisions BS-IV/11 and BSV/12 in response to an identified need for further guidance on risk assessment of LMOs. 4 It is intended to be a “living document” that may be updated and improved as appropriate and when mandated by the Parties to the Cartagena Protocol on Biosafety.
Biodiversity, GMOs, Gene Drives and the Militarised Mind
4605Shiva, V, Inter Press Service, 2016-07-18 00:00:00.
A recent report from the National Academy of Science of The United States, titled Gene Drives on the Horizon : Advancing Science, Navigating Uncertainty, and Aligning Research with Public Values”, warns:; “One possible goal of release of a gene-drive modified organism is to cause the extinction of the target species or a drastic reduction in its abundance.”; Gene Drives have been called “mutagenic chain reactions”, and are to the biological world what chain reactions are to the nuclear world. The Guardian describes Gene Drives as the “gene bomb”.
Gene Drives on the Horizon: Advancing Science, Navigating Uncertainty, and Aligning Research with Public Values
6356U. S. National Academies of Sciences, Engineering, and Medicine, The National Academies Press, 2016-07-08 20:32:51.
Scientists have studied gene drives for more than 50 years. The development of a powerful genome editing tool in 2012, CRISPR/Cas9,1 led to recent breakthroughs in gene drive research that built on that half century’s worth of knowledge, and stimulated new discussion of the potential applications and implications of gene drive technologies. Just prior to the beginning of this study and since the committee was first convened, scientists published four proofs of concept— one in yeast, one in fruit flies, and two in different species of mosquitoes—that demonstrate the successful development of gene drives in the laboratory, at least in these organisms. Proposed applications for gene-drive modified organisms for basic research, conservation, agriculture, public health and other purposes will likely continue to expand as gene editing tools become more refined. Gene-drive modified organisms are on the horizon. The fast moving nature of this field is both encouraging and concerning. While gene-drive modified organisms hold promise for addressing difficult to solve, persistent challenges, such as the eradication of vector-borne diseases and the conservation of threatened and endangered species, these proposed applications are based on limited proof-of-concept studies. The presumed efficiency of gene-drive modified organisms may lead to calls for their release in perceived crisis situations, before there is adequate knowledge of their ecological effects, and before mitigation plans for unintended harmful consequences are in place. Responding to this fast moving field, the National Institutes of Health (NIH) and the Foundation for the National Institutes of Health (FNIH)2 asked the National Academies of Sciences, Engineering, and Medicine to convene a committee with a broad range of expertise to summarize the scientific discoveries related to gene drives and considerations for their responsible use. Proof-of-concept in a few laboratory studies is not sufficient in and of itself to support a decision to release gene-drive modified organisms into the environment. Laboratory and field research is needed to refine CRISPR/Cas9-based gene drives and other gene drive mechanisms, and to understand how gene drives might work under different environmental conditions and in a wide variety of organisms. The considerable gaps in knowledge about potential off-target (within the organism) and non-target (in other species or the environment) effects necessitate a collaborative, multidisciplinary approach to research, ecological risk assessment, development of public policy, and decision making for each proposed application of a gene drive technology. General principles to guide responsible practices for gene drives from the laboratory setting through to field release and monitoring are embedded as recommendations throughout the report.
Gene Drive Technology: Where is the Future?
6904National Academy of Sciences Engineering Medicine, BioScience Talks, 2016-06-29 14:38:31.
Gene drives have the potential to revolutionize approaches to major public health, conservation, and agricultural problems. For instance, gene drives might one day prevent mosquitoes from spreading a variety of deadly diseases, including Zika virus, malaria, and others. A form of genetic modification, the technology works by causing a particular genetic element to spread through populations, thereby making it possible to change species in the wild. Despite the significant promise, caution is warranted, says a new report from the National Academies of Sciences, Engineering, and Medicine's Committee on Gene Drive Research. According to the committee, gene drives raise a variety of ecological and regulatory questions that have yet to be answered. For this episode of BioScience Talks, we're joined by committee co-chair Dr. James P. Collins of Arizona State University and committee member Dr. Joseph Travis of Florida State University. They fill us in on the specifics of the report and on the future of gene drives.
Openly Engineering Our Ecosystems
5479TEDxCambridge, 2016-06-22 18:00:37.
Which technologies should we develop and how? Kevin Esvelt, leader of the Sculpting Evolution group and a professor at the MIT Media Lab, describes how CRISPR 'gene drives' can single-handedly alter entire wild populations and the critical importance of requiring powerful technologies to be developed in the open light of day.
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.
National Academies of Science | Workshop: Science, Ethics, and Governance Considerations for Gene Drive Research – 2015
5544National Academy of Sciences Engineering Medicine, National Academy of Sciences, 2015-10-28 21:53:14.
Can systematic reviews inform GMO risk assessment and risk management?
4121Kohl, CF, G.; Sweet, J.; Spok, A.; Haddaway, N.R.; Wilhelm, R.; Unger, S.; Schiemann, J., Frontiers in Bioengineering and Biotechnology, 3:113. 2015-01-19 00:00:00.
Systematic reviews represent powerful tools to identify, collect, synthesize, and evaluate primary research data on specific research questions in a highly standardized and reproducible manner. They enable the defensible synthesis of outcomes by increasing precision and minimizing bias whilst ensuring transparency of the methods used. This makes them especially valuable to inform evidence-based risk analysis and decision making in various topics and research disciplines. Although seen as a “gold standard” for synthesizing primary research data, systematic reviews are not without limitations as they are often cost, labor and time intensive and the utility of synthesis outcomes depends upon the availability of sufficient and robust primary research data. In this paper, we (1) consider the added value systematic reviews could provide when synthesizing primary research data on genetically modified organisms (GMO) and (2) critically assess the adequacy and feasibility of systematic review for collating and analyzing data on potential impacts of GMOs in order to better inform specific steps within GMO risk assessment and risk management. The regulatory framework of the EU is used as an example, although the issues we discuss are likely to be more widely applicable.
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 framework for testing of genetically modified mosquitoes
15162WHO, WHO-TDR, 2014-06-01 18:49:50.
As the research progresses, a need has been expressed both within the scientific community and by the public for additional standards and guidance. WHO-TDR and the Foundation for the National Institutes of Health (FNIH) co-sponsored a technical consultation meeting in 2009 to assess current progress and future development of genetically modified mosquito technologies. The meeting was attended by participants from around the world with expertise in molecular biology, medical entomology, ecology, regulatory requirements, ethical, social and cultural issues, as well as staff from WHO, FNIH and other research funders WHO-TDR, 2010). Participants recommended the establishment by WHO and FNIH of a working group to develop a comprehensive guidance framework to provide quality standards for assessing the safety and efficacy of genetically modified xv mosquitoes and addressing legal, ethical, social and cultural issues that arise during their development and deployment. A multidisciplinary effort was subsequently commissioned and over 40 experts recruited to contribute at various stages of development. In accordance with the recommendations, the group included many members who possessed a broad knowledge in their topic areas but were not involved directly in research on GMMs. A draft guidance framework was produced and opened for public comment in late 2012. Responses to public comment have been incorporated into this current version.
Perceptions and recommendations by scientists for a potential release of genetically modified mosquitoes in Nigeria
12394P. N. Okorie, J. M. Marshall, O. M. Akpa and O. G. Ademowo, Malaria Journal, 13:154. 2014-04-23 18:22:17.
The use of genetically modified mosquitoes (GMMs) for the control of malaria and other mosquito-borne diseases has been proposed in malaria-endemic countries, such as Nigeria, which has the largest burden in Africa. Scientists are major stakeholders whose opinions and perceptions can adversely affect the success of the trials of GMMs if they are not involved early. Unfortunately, information on the awareness of Nigerians scientists and their overall perception of the GMMs is practically non-existent in the literature. Therefore, this study aimed at understanding how receptive Nigerian scientists are to a potential release of GMMs for the control of malaria.
Concerning RNA-guided gene drives for the alteration of wild populations
4139Esvelt, KMS, Andrea L.; Catteruccia, Flaminia; Church, George M., eLife, 3:e03401. 2014-01-17 00:00:00.
Gene drives may be capable of addressing ecological problems by altering entire; populations of wild organisms, but their use has remained largely theoretical due to technical; constraints. Here we consider the potential for RNA-guided gene drives based on the CRISPR; nuclease Cas9 to serve as a general method for spreading altered traits through wild populations; over many generations. We detail likely capabilities, discuss limitations, and provide novel; precautionary strategies to control the spread of gene drives and reverse genomic changes. The; ability to edit populations of sexual species would offer substantial benefits to humanity and the; environment. For example, RNA-guided gene drives could potentially prevent the spread of; disease, support agriculture by reversing pesticide and herbicide resistance in insects and weeds,; and control damaging invasive species. However, the possibility of unwanted ecological effects and; near-certainty of spread across political borders demand careful assessment of each potential; application. We call for thoughtful, inclusive, and well-informed public discussions to explore the; responsible use of this currently theoretical technology.
Regulatory experience and challenges for the release of GM insects
4135Beech, C, Journal Fur Verbraucherschutz Und Lebensmittelsicherheit-Journal of Consumer Protection and Food Safety, 9:S71-S76. 2014-01-13 00:00:00.
Genetically modified (GM) insects are a potentially valuable new tool for the biological control of insect pests of humans, animals and plants. Considerable progress has been made recently in transfer of GM insects from the laboratory to release and evaluation in the environment. As with other new genetic technologies, regulatory agencies have often found it challenging to determine the regulatory regime under which they should be evaluated, and have either adapted existing regulatory frameworks or adopted new ones. No country has legislation specifically for GM insects. However, irrespective of the regulatory regime under which they are evaluated, the purpose of their regulation remains the same; to protect human health and the environment. Consequently there are evaluation themes common to their regulatory scrutiny, which are elucidated here. There have also been some challenges and issues encountered during the risk evaluation for field release of GM insects, and this paper will highlight some of these to assist others when considering policy, regulation and assessment of GM insects. Useful regulatory and policy precedents also exist from the regulation of biological control agents and the global protection of plants from pests under the International Standards for Phytosanitary Measures (ISPM) framework. Where countries do not have existing regulations, these evaluation instruments could have the potential to be adapted to form a suitable framework for the assessment of risk for GM insects. Finally, some considerations for future policy and regulation in this area are discussed.
Regulating gene drives
4151Oye, KAE, K.; Appleton, E.; Catteruccia, F.; Church, G.; Kuiken, T.; Lightfoot, S. B. Y.; McNamara, J.; Smidler, A.; Collins, J. P., Science, 345:626-628. 2014-01-09 00:00:00.
Regulatory gaps must be filled before gene drives could be used in the wild
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.
Guidance on the environmental risk assessment of genetically modified animals.
4171EFSA GMO Panel (EFSA Panel on Genetically Modified Organisms), EFSA Journal, 11:3200. 2013-01-09 00:00:00.
This document provides guidance for the environmental risk assessment (ERA) of living genetically modified (GM) animals, namely fish, insects and mammals and birds, to be placed on the European Union (EU) market in accordance with Regulation (EC) No 1829/2003 or Directive 2001/18/EC. It provides guidance for assessing potential effects of GM animals on animal and human health and the environment and the rationales for data requirements for a comprehensive ERA. The ERA should be carried out on a case-by-case basis, following a step-by-step assessment approach. 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. Each specific area of risk is considered in a structured and systematic way following the aforementioned six steps. In addition, this Guidance Document describes several generic cross-cutting considerations (e.g. choice of comparators, use of non-GM surrogates, experimental design and statistics, long-term effects, uncertainty analysis) that need to be accounted for throughout the whole ERA.
Ethical issues in field trials of genetically modified disease-resistant mosquitoes
13538D. B. Resnik, Developing World Bioethics, 14:37-46. 2012-07-29 19:12:07.
Mosquito-borne diseases take a tremendous toll on human populations, especially in developing nations. In the last decade, scientists have developed mosquitoes that have been genetically modified to prevent transmission of mosquito-borne diseases, and field trials have been conducted. Some mosquitoes have been rendered infertile, some have been equipped with a vaccine they transmit to humans, and some have been designed to resist diseases.
The Nagoya – Kuala Lumpur Supplementary Protocol on Liability and Redress to the Cartagena Protocol on Biosafety
5660Secretariat of the Convention on Biological Diversity, Convention on Biodiversity, 2011:1-16. 2011-12-17 18:41:08.
Adopted as a supplementary agreement to the Cartagena Protocol on Biosafety, the Supplementary Protocol aims to contribute to the conservation and sustainable use of biodiversity by providing international rules and procedures in the field of liability and redress relating to living modified organisms, as stated in its Article 1. The Protocol applies to damage resulting from living modified organism which find their origin in a transboundary movement (Article 3). The Supplementary Protocol provides a definition of ‘damage’, referring to an adverse effect on the conservation and sustainable use of biological diversity that is measurable or otherwise observable and significant, taking also into account risks to human health. It provides for an indicative list of factors that should be used to determine the significance of an adverse effect. The Supplementary Protocol requires in Article 4 that a causal link between the damage and the living modified organism be established. States must require the appropriate operator or operators to take response measures in the event of damage resulting from living modified organisms which find their origin in a transboundary movement, as set out in Article 5. The ‘operator’ is defined as any person in direct or indirect control of the living modified organism. The operator must also take response measures where there is a sufficient likelihood that damage will result if timely response measures are not taken. Response measures may also be taken by the competent authority, for example when the operator has failed to do so. In such cases, the competent authority may recover the expenses and costs of such measures from the operator. In addition to the obligation to provide for response measures, Parties may develop civil liability rules and procedures to address damage. The Supplementary Protocol defines ‘response measures’ as reasonable actions to prevent, minimize, contain, mitigate or otherwise avoid damage, as appropriate, or reasonable actions to restore biological diversity. In addition to imposing a requirement for response measures, the Supplementary Protocol obliges Parties to continue to apply existing legislation on civil liability or to develop specific legislation concerning liability and redress for material or personal damage associated with damage to the conservation and sustainable use of biological diversity, as defined in the Supplementary Protocol. As response measures can be imposed by the competent administrative authority, rather than by a judicial body, the Supplementary Protocol is known as having introduced an ‘administrative approach’ to liability and redress.
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.
Problem formulation in the environmental risk assessment for genetically modified plants
4219Wolt, JDK, Paul; Raybould, Alan; Fitzpatrick, Julie W.; Burachik, Moisés; Gray, Alan; Olin, Stephen S.; Schiemann, Joachim; Sears, Mark; Wu, Felicia, Transgenic Research, 19:425-436. 2010-01-17 00:00:00.
Problem formulation is the first step in environmental risk assessment (ERA) where policy goals, scope, assessment endpoints, and methodology are distilled to an explicitly stated problem and approach for analysis. The consistency and utility of ERAs for genetically modified (GM) plants can be improved through rigorous problem formulation (PF), producing an analysis plan that describes relevant exposure scenarios and the potential consequences of these scenarios. A properly executed PF assures the relevance of ERA outcomes for decision-making. Adopting a harmonized approach to problem formulation should bring about greater uniformity in the ERA process for GM plants among regulatory regimes globally. This paper is the product of an international expert group convened by the International Life Sciences Institute (ILSI) Research Foundation.
Deployment of innovative genetic vector control strategies: progress on regulatory and biosafety aspects, capacity building and development of best-practice guidance
4220Beech, CV, S.S.; Quinlan, M.M.; Capurro, Margareth L.; Alphey, L.; Bayard, V.; Bouare, M.; McLeod, M.C.; Kittayapong, P.; Lavery, J.; Lim, L.H.; Marrelli, M.T.; Nagaraju, J.; Ombongi, K.; Othman, R.Y.; Pillai, V.; Ramsey, J.; Reuben, R.; Rose, R.I.; Tyagi, B.K.; Mumford, J., AsPac J. Mol. Biol. Biotechnol., 17:75-85. 2009-01-18 00:00:00.
In the ongoing fight against vectors of human diseases, disease endemic countries (DECs) may soon benefit from innovative control strategies involving modified insect vectors. For instance, three promising methods (viz. RIDL® [Release of Insects with a Dominant Lethal], Wolbachia infection, and refractory mosquito technology) are being developed by researchers around the world to combat Aedes aegypti, the primary mosquito vector of viral fevers such as dengue (serotypes 1–4), chikungunya and yellow fever. Some of these techniques are already being extended to other vectors such as Aedes albopictus (the secondary vector of these diseases) and Anopheles mosquito species that transmit malaria. To enable DECs to take advantage of these promising methods, initiatives are underway that relate to biosafety, risk assessment and management, and ethical–social–cultural (ESC) aspects to consider prior to and during the possible deployment of these technologies as part of an integrated vector control programme. This is a brief overview of the objectives and timelines of some of the initiatives being championed by international institutions, including the United Nations Development Programme (UNDP), the World Health Organization (WHO) and the Grand Challenges in Global Health (GCGH) initiative co-sponsored by the Bill & Melinda Gates Foundation.
Use of Genetically Engineered Fruit Fly and Pink Bollworm in APHIS Plant Pest Control Programs: Final Environmental Impact Statement—October 2008
16049USDA/APHIS, USDA/APHIS, 2008-10-01 20:18:57.
The U.S. Department of Agriculture (USDA), Animal and Plant Health Inspection Service (APHIS), in cooperation with several States and foreign countries, is proposing further development of genetically engineered fruit fly species and pink bollworm for use in various applications of the sterile insect technique (SIT) applied to agency invasive plant pest control programs. There have been laboratory and confined field studies to test the efficacy of certain genetic engineering applications that could provide benefits to these programs, but these techniques have not been applied in agency eradication actions or preventive release program (PRP) strategies.
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.
Guidelines for the export, shipment, import and release of biological control agents and other beneficial organisms
16037International Plant Protection Convention, Food and Agriculture Organization, 2005-04-01 19:55:50.
This standard provides guidelines for risk management related to the export, shipment, import and release of biological control agents and other beneficial organisms. It lists the related responsibilities of contracting parties to the IPPC, national plant protection organizations (NPPOs) or other responsible authorities, importers and exporters (as described in the standard). The standard addresses biological control agents capable of self-replication (including parasitoids, predators, parasites, nematodes, phytophagous organisms, and pathogens such as fungi, bacteria and viruses), as well as sterile insects and other beneficial organisms (such as mycorrhizae and pollinators), and includes those packaged or formulated as commercial products.
General principles for risk assessment of living modified organisms: Lessons from chemical risk assessment
4310Hill, RAS, C., Environ. Biosafety Res, 2:81-88. 2003-01-08 00:00:00.
Modern biotechnology has led to the development and use of Living Modified Organisms (LMOs) for agriculture and other purposes. Regulators at the national level are increasingly depending on risk assessment as a tool for assessing potential adverse effects of LMOs on the environment and human health. In addition, the Cartagena Protocol on Biosafety, an international agreement expected to enter into force in the near future, requires risk assessment as the basis for decision-making regarding import of some LMOs. While LMO risk assessment is relatively new, there are other risk assessment disciplines which have developed over longer time periods. The field of assessment of the environmental and human health risks of chemicals is particularly well developed, and is similar in application to LMO risk assessment. This paper aims to draw lessons for LMO risk assessment from the vast experience with chemical risk assessment. Seven general principles are outlined which should serve as a useful checklist to guide assessments of risks posed by LMOs.
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.
Cartagena Protocol on Biosafety to the Convention on Biological Diversity
5665Secretariat of the Convention on Biological Diversity, Convention on Biodiversity, 2000:1-19. 2000-12-17 18:48:56.
The Cartagena Protocol on Biosafety to the Convention on Biological Diversity is an international agreement which aims to ensure the safe handling, transport and use of living modified organisms (LMOs) resulting from modern biotechnology that may have adverse effects on biological diversity, taking also into account risks to human health. It was adopted on 29 January 2000 and entered into force on 11 September 2003.
A Guide to the Convention on Biological Diversity
34339Glowka, L, et al., IUCN, 1994-06-15 14:49:18.
