Keywords: Regulation
Regulatory Provisions for Post-Release Monitoring of Genetically Modified Organisms in Africa
35497Julia Njagi, John Muriuki, Paul Mbugua, et al., Frontiers in Bioengineering and Biotechnology, 2026-03-10 09:22:44.
Genetically modified (GM) crops with improved traits such as resistance to biotic and abiotic stresses and enhanced nutritional profiles have been commercially cultivated for over three decades. Despite extensive safety data and long-term cultivation experience, concerns continue to be raised about the potential risks and benefits of genetically modified organisms (GMOs). This is particularly true for the African region, where only eight out of fifty-four countries have so far commercialized GMOs. Upon release into the environment, GM crops may interact with ecosystems in complex ways, possibly leading to unanticipated ecological effects. Consequently, post-release monitoring of GMOs is essential to identify early signs of adverse impacts, enabling timely responses such as adjustments in risk management strategies, mitigation measures, or re-evaluation of previous regulatory decisions. A supportive policy and regulatory environment are critical for facilitating the safe development, testing, and commercialization of GMOs. This study conducted a desktop review of post-release monitoring frameworks for GMOs in selected African countries, as well as interviews with key informants in countries that have commercialized at least one GMO product. The findings reveal that most sampled countries lack clearly defined environmental protection goals and specific provisions regarding the scope and duration of post-release monitoring of GMOs. Where the duration of monitoring is prescribed, it is a blanket cover for all GMOs regardless of their life cycles. Moreover, the responsibility for monitoring is often delegated entirely to the applicant, and where local institutions are involved, there is no clear coordination mechanism for data sharing. These findings underscore the need for case-by-case monitoring approaches, guided by clearly articulated national protection goals and clear roles and coordination among stakeholders to ensure the safe and responsible deployment of GMOs.
Biocontrol practitioners’ perspectives on emerging genetic-based technologies for weed management
35412Rafter, M.A., Kumaran, N., Brookes, D.R. et al., BioControl, 2026-01-31 16:43:25.
Weed biocontrol researchers have been at the forefront of developing management solutions for invasive weeds for over 100 years and have a unique perspective to offer on the emerging field of genetic-based technologies such as gene drive and RNAi. As part of the XVI International Symposium on Biological Control of Weeds in May 2023 we conducted a focus group discussion workshop to explore biocontrol practitioners’ perspectives related to: (1) Genetic-based control technologies, and the factors influencing support (or not) for their application to weed management, especially weed biocontrol, (2) perceived opportunities to apply genetic-based control tools to enhance or complement weed biocontrol, focusing on whether/how genetic tools can be applied to fundamentally change the practice of weed biocontrol, and (3) genetic-based control in weed management and how it can operate within the Access and Benefit Sharing regulatory landscape. We analyse the perspectives of biocontrol scientists from the workshop and discuss the prospects and challenges of integrating novel genetic-based control tools with weed biocontrol.
A target product profile for a rapid diagnostic test to monitor mosquito gene drive presence and frequency
35345Prateek Verma, Sebald Verkuijl, Calvin K. Yee, et al., bioRxiv, 2025-12-18 10:23:36.
Malaria remains a major global health challenge, with over 263 million cases and nearly 600,000 deaths reported in 2023, the majority in sub-Saharan Africa. While conventional interventions such as insecticide-treated nets, indoor residual spraying and antimalarial drugs have reduced transmission, progress has stalled due to the limitations of these interventions and the emergence of resistance. Gene drive-modified mosquitoes represent a promising, potentially transformative vector control strategy, capable of spreading malaria-refractory traits or suppressing mosquito populations. Successful field deployment will depend upon monitoring systems to track the presence and frequency of gene drive constructs as they spread and persist. Current molecular surveillance techniques, though effective, are resource-intensive and reliant on laboratory infrastructure and technical competencies. Here, we make the case for a near-universal and low-cost rapid diagnostic test (RDT) designed to detect gene drive mosquitoes in the field, to complement existing surveillance infrastructure. Two use cases are outlined: i) to detect the presence of the drive construct in a new population, and ii) to provide an estimate of drive frequency prior to more accurate laboratory-based measurements. We provide a target product profile for the RDT outlining minimally essential and ideal characteristics, including test procedures, sensitivity, specificity, usability by a range of stakeholders in field settings, and compatibility with pooled testing of mosquito samples. An RDT for gene drive construct detection would support community access and participation in monitoring, enhance regulatory oversight, and promote transparency in field trials, thereby facilitating responsible deployment of gene drive-based malaria interventions.
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.
Gene drives, species complexes, and the risks of collateral damage
35296C. Boëte, Proc. Natl. Acad. Sci., 122. 2025-11-09 18:26:26.
The development of engineered gene drive systems continues to garner significant interest. Theoretically, these systems could spread traits in a target species (an approach known as population replacement) or eliminate a population within a few generations (population suppression). Some researchers have promoted this disruptive technology for potential applications ranging from public health (e.g., malaria control) to conservation (e.g., protection of endangered species, elimination of invasive ones) to agriculture (e.g., pest control). But in the case of a gene drive intended to target a specific species, the risk of affecting non-target species must be taken into account, and researchers must strive to minimize collateral damage. Hybridization between a target and a non-target species could result in unintended gene flow, as could the horizontal transfer of the gene drive cassette (1). While some researchers have proposed the “Target Species Complex” (TSC) framework to account for off-target effects, the concept is unlikely to provide a safeguard. Rather, it risks reframing collateral impacts as intentional outcomes, narrowing, rather than broadening, the scope of ecological and regulatory considerations. Researchers must therefore make sure to incorporate risk assessments that take into account the effects on numerous species and make a concerted effort to understand the downstream effects.
Innovation under pressure: bold ideas for a changing malaria landscape
35253Epstein, A., Tangena, JA., BMC Glob. Public Health, 3. 2025-10-27 10:36:07.
Innovation has never been more urgent. Encouragingly, the malaria research community is responding. Next-generation insecticide-treated nets (ITNs) [1], new indoor residual sprays (IRS) [2], and spatial emanators are reaching communities [3]. Vaccines such as R21 and RTS,S are moving from trials into wider use [4, 5]. On the treatment front, the pipeline now includes long-lasting antimalarials [6], triple combination therapies (TACTs) [7], and single-dose drugs like tafenoquine [8]. Novel approaches such as ivermectin, recently shown to reduce malaria incidence when deployed in mass drug administration campaigns, are also gaining traction [9]. Looking further ahead, early breakthroughs in gene drive in mosquitoes to bias inheritance of a specific genetic trait (like sterility or resistance to malaria) is passed on to offspring, and monoclonal antibodies, which point to bold new frontiers [10, 11]. Together, these advances represent the most significant broadening of the malaria toolkit in decades. But innovation alone will not be enough. The momentum is colliding with deep structural challenges. Funding cuts threaten to derail the rollout of new tools. Resistance is mounting: mosquitoes have developed resistance to most insecticides used for vector control, and parasites are showing reduced sensitivity to artemisinin and even lumefantrine, a key partner drug to control artemisinin resistance, in East Africa [12]. Climate change is redrawing the risk map by shifting mosquito habitats. Health systems remain fragile, weakened by COVID-19, extreme weather, and political unrest. Even when technologies are available, their potential can be weakened by regulatory delays, fragmented governance, or inequities in access and limited community trust. The path forward requires more than breakthroughs in science. Sustained progress will depend equally on the strength of delivery systems, stable financing, and governance that can translate innovation into equitable impact.
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.
Exploring experts’ uncertainties about gene drive technology for agricultural pest control in the U.S.: a qualitative study to inform innovation and decision-making
35241Barry, N., Barnhill, S.K. & Johnson, B.B., Environment Systems and Decisions, 45. 2025-10-15 08:34:10.
As experts consider what it might look like for gene drives to manage agricultural pests, there remain several uncertainties across a broad range of issues, including technical, ecological, regulatory, and social implications. Drawing on 25 expert interviews, we parse out these uncertainties and the potential for Adaptive Management to help guide development, deployment, and governance of gene drives for invasive agricultural pest management. Adaptive Management emerged specifically to attend to uncertainties in complex social-ecological systems, prescribing collective learning and responsiveness to stakeholder feedback to effectively reach management goals. Thus, Adaptive Management provides clear direction on how to account for and make decisions in the face of considerable uncertainties surrounding these gene drive tools. We also give some attention to the ways in which the uncertainties that are specific to agricultural applications are somewhat distinct from or consistent with global discourse around gene drive development across sectors.
Biotechnology Is a Powerful Tool for Conservation
35205Emma Kovak, The Ecomodernist, 2025-09-30 15:40:23.
What do the American Chestnut tree, the black rat, and the northern white rhinoceros have in common? They are all prime targets for conservation through biotechnology. Genetic engineering could give American chestnut trees disease resistance and restore the keystone species to Eastern forests, gene drives could eliminate rats from islands and save seabirds from the invasive predators, and assisted reproduction technology could rescue the Northern white rhinoceros from the brink of extinction. The U.S. Department of Agriculture is poised to approve an American chestnut engineered to resist the blight that functionally eliminated the species from Eastern forests. Meanwhile, the International Union for Conservation of Nature (IUCN)—the world’s largest conservation network—is voting on whether to ban biotechnology outright or recommend thoughtful case-by-case evaluation. These decisions are important determinants of biotechnology’s role in the conservation toolkit. With extinction rates accelerating, conservation efforts should be able to use as many tools as possible.
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.
OPINION: Military Shuts Down Bill Gates Genetically Modified Mosquito Project in West Africa
35137Jon Fleetwood, Substack, 2025-09-12 15:41:16.
Last month, the military government of Burkina Faso has done what no Western regulator dared to do: it ordered the immediate termination of Bill Gates’ genetically modified mosquito project—‘Target Malaria’—and the destruction of all bioengineered insect samples inside the country. This wasn’t a health agency issuing a polite memo. It was a military crackdown on a Gates-funded scheme that released engineered mosquitoes into villages without real informed consent from the people forced to live with the consequences. The press release from Target Malaria itself admits the sequence of events. First came the release: “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.” Translation: genetically engineered insects were already unleashed in Burkinabè villages, exposing citizens to an irreversible genetic experiment without their consent. Then came the military order to shut it down: “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.” Finally, the junta (a government that has taken power by military force) made it permanent: “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.’” This wasn’t a pause. This was a military-ordered termination of Bill Gates’ mosquito project.
After ‘humiliating’ raid, Burkina Faso halts ‘gene drive’ project to fight malaria
35111Kai Kupferschmidt, Science, 2025-09-03 09:35:57.
On 11 August, the international nonprofit Target Malaria celebrated a milestone: In the village of Souroukoudingan, Burkina Faso, its researchers released about 16,000 male mosquitoes genetically modified to produce almost exclusively male offspring. The release, the first of its kind in Africa, was part of a project supported by the Gates Foundation that aims to rid the world of malaria using a so-called gene drive, a controversial technique to help desirable genes spread through a population fast. But a week later, that dream suffered a major setback. On 18 August, judicial police showed up at the Research Institute in Health Sciences (IRSS) in Bobo-Dioulasso, a key partner in Target Malaria, to stage what scientists described as a “brutal, humiliating” raid. According to minutes of a 26 August meeting between researchers and the country’s science minister, IRSS scientists were “treated like criminals, with their offices and laboratories sealed and marked as crime scenes.” The minutes noted that “everyone was searched, including their vehicles, on the grounds that researchers might be carrying mosquitoes in their pockets.” Four days later, the government suspended all of Target Malaria’s activities in Burkina Faso indefinitely. IRSS scientists killed the mosquitoes still living in their insectary, and the government sent a team to spray insecticides in Souroukoudingan to kill the mosquitoes released there.
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.
Governance Landscape of Gene Drive for Malaria
35069GeneConvene Global Collaborative, 2025-08-28 10:24:11.
This infographic presents a hypothetical example of how real governance mechanisms could work to make decisions about gene drive field trials.
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.
AUDA-NEPAD Delegation visits Target Malaria at the Uganda Virus Research Institute
35083Richard Linga and Christopher Maiso, Target Malaria, 2025-08-20 16:20:01.
Target Malaria Uganda was honored to host delegates from African member states at the Uganda Virus Research Institute. The delegates were taking part in a benchmarking visit during the East African Regional Engagement on Biosafety and Environmental Regulation for Malaria Elimination, organized by the African Union Development Agency – New Partnership for Africa’s Development (AUDA-NEPAD). The delegates were welcomed by Prof. Pontiano Kaleebu, Director of the Uganda Virus Research Institute (UVRI), who commended their interest in Uganda’s advancing research on genetically modified mosquitoes, and thanked AUDA-NEPAD for supporting regional dialogue on innovative malaria control strategies. In his speech, Dr. Johnson Wiltshire, Programme Coordinator at the AUDA-NEPAD and head of the delegation, emphasized the urgent need for Africa to adopt innovative health solutions to effectively address persistent public health challenges. He noted that for African member states to fully benefit from emerging technologies, such as gene drive, regulatory requirements must be harmonized across the region. He further highlighted the importance of ensuring quality, access, and sustainability in the implementation of such innovations.
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.
CRISPR Mosquitoes That Can’t Bite
35031Science Techniz, 2025-08-09 19:49:44.
Scientists have used CRISPR gene editing to alter female mosquitoes so that their proboscis — the needle-like mouthpart used to pierce skin — develops like a male’s. The consequence is simple and profound: modified females can no longer pierce skin and therefore cannot take a blood meal or transmit human diseases like malaria and dengue. Researchers identified a gene involved in the developmental pathway that produces the female proboscis morphology. Using CRISPR-based edits, they altered that gene’s function so that genetically female mosquitoes develop a male-like mouthpart. Because males naturally do not bite (they feed on nectar), the modification removes the biting behavior without fundamentally disrupting other survival traits in lab tests. It’s important to stress that this is a high-level description intended to explain the concept, not a protocol or “how-to.” The work is complex, tightly regulated, and performed under strict laboratory and ethical oversight.
Coproducing a Technology Readiness Level framework for non-persistent genetic biocontrol of aquatic invasive species
34984Julie Badger, Rex Alirigia, Isabel Ameli, et al, Journal of Environmental Management, 391. 2025-07-24 10:00:28.
Developing and implementing novel pest control technologies requires coordination and communication between technology developers, funding agencies, federal and state regulators, and early technology adopters. Efficient communication is particularly important for first-in-class technologies. Misunderstandings or lack of communication may hinder social engagement, jeopardize regulatory approval, decrease utility of the technology, deter public adoption, or compromise risk mitigation approaches. We, a team of diverse stakeholders in aquatic invasive species (AIS) control, here propose a shared language for discussing the development of non-persistent genetic biocontrol methods. Specifically, we adapted the existing Technology Readiness Level framework to apply to the development of non-persistent genetic biocontrol for invasive Cyprinus carpio (common carp) as a model case. The result of this effort is a tool for designing responsible technology development of a promising new class of pest management tools.
Importation of the non gene drive male bias mosquito to Uganda
34926Target Malaria, YouTube, 2025-06-23 14:55:08.
This video documents the importation of non gene drive male bias mosquitoes by Target Malaria’s team in Uganda. The video follows the journey from Entebbe Airport to the Arthropod Containment Level 2 (ACL2) insectary at the Uganda Virus Research Institute, highlighting key moments such as interviews with project staff and stakeholders—including regulatory officials and members of the community consultative group. It also captures the process of unpacking the eggs from the secure packaging and transferring them to the larval trays. Produced in both English and Luganda, this video is designed for project stakeholders, supporting presentations and other communication efforts to keep communities and partners informed about the project’s activities in Uganda.
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.”
Status of gene drive research in Africa; Ifakara Health Institute
34941African Genetic Biocontrol Consortium, YouTube, 2025-06-16 08:56:50.
The African Genetic Biocontrol Consortium is an agreement established by not-for-profit member organizations based in Africa with a vision to build an informed local leadership to support the requirements for development, decision-making and on the utility of genetic biocontrol technologies for animal, public health, and conservation in Africa. To fulfil this vision the Consortium has established a Forum for Institutional Committees in Africa (IBC - Africa Forum) to provide a platform for interaction among African experts and institutions to enhance opportunities for technical capacity strengthening, knowledge exchange and deliberation about the challenges and opportunities of genetic biocontrol technologies for the public good, which will amplify African influence on their development and provide critical input for decision-making by product developers, policy makers, and other stakeholders. An Institutional Biosafety Committee (IBC) is a committee created in an Institution in accordance with the Biosafety law or regulation in a Country. The IBC reviews, approves and oversees research involving the use of genetically modified organisms (GMOs), recombinant or synthetic DNA/RNA and other biohazards. The IBC assists the Principal Investigator, supervisors, funders, and the Biosafety Regulators with obtaining proper authorization for their studies. The Committee also approves procedures for procurement, use, storage, transportation, and disposal of bio-hazardous material.
Strengthening gene drive research in Africa through engagement, regulation, and regional cooperation
34909Dickson W. Lwetoijera, Outreach Network for Gene Drive Research, 2025-06-15 18:59:18.
On the sidelines of this year’s World Health Assembly, I had the opportunity to speak on a panel exploring the role of genomics in public health. The event, supported by the Science Summit, brought together researchers, regulators, and policymakers to examine how genomic tools can support stronger, more equitable health systems. I spoke alongside Prof. Georges Christophides of Imperial College London and Dr. Brian B. Tarimo of the Ifakara Health Institute (IHI). Together, we reflected on how gene drive technologies could strengthen the fight against malaria in Tanzania and the broader East African region, exploring progress made in gene drive research, and reflecting on what it will take to move forward. Prof. Christophides opened with a stark reminder of challenges faced in the fight against malaria: in 2023, Tanzania recorded over 8,000,000 cases and just under 25,000 malaria deaths, with 95% of the population at risk. With challenges such as insecticide resistance weakening the impact of current tools like treated nets and indoor residual spraying, the need for new interventions is necessary and unavoidable. Gene drive technologies offer one such possibility, but only if the right systems are in place to support their development and implementation. Prof. Christophides stressed the importance of strengthening frameworks that enable progress while maintaining safety and transparency. He also highlighted the need for long-term institutional partnerships, where African agencies are not just consulted, but lead the way. Dr. Tarimo focused on the importance of community engagement, a key aspect of the research. At Transmission Zero, we are working with district-level teams in areas that may host future field trials of gene drive technologies to ensure that communities are informed, involved, and heard. Engaging with local communities means recognizing that their values and concerns must shape the direction of our work from the outset. Without that trust, no technology, no matter how promising, can succeed.
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.
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.”
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.
GeneConvene Global Collaborative | Considerations for the First Field Trials of Gene Drive for Malaria
33388GeneConvene Global Collaborative, YouTube, 2024-11-04 17:19:36.
A webinar organized by the GeneConvene Global Collaborative discussed the potential first field trials of gene drive technology for malaria control. This genetic modification approach aims to alter mosquito populations to reduce their ability to transmit malaria. While laboratory results are promising, no field trials have been conducted yet. Experts convened to explore key considerations for trial design, including efficacy, safety, and stakeholder perceptions. The challenges of indefinite spread associated with low-threshold gene drives complicate trial logistics, necessitating a phased testing approach recommended by the WHO. Key factors for site selection include regulatory structures, existing health data, and the need for isolated mosquito populations. The session aimed to share insights and foster discussion on the future of gene drive applications in malaria control.
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.
Operationalizing stakeholder engagement for gene drive research in malaria elimination in Africa – translating guidance into practice
32212Pare Toe L, Dicko B, Linga R, Barry N, et al., Malar J, 21:225. 2024-10-03 13:14:18.
Gene drive mosquitoes are increasingly considered a potential transformational tool for vector control of malaria mosquitoes. As part of efforts to promote responsible research in this field, a number of guidance documents have been published by the World Health Organization, National Academies and expert groups. While virtually all recent guidance documents on gene drive research stress the importance of stakeholder engagement activities, no specific guidelines on implementing them have been established. Target Malaria, a not-for-profit research consortium developing a vector-control gene drive approach to eliminate malaria, has reflected on how its stakeholder engagement strategy translates engagement guidance documents into practice. The project analysed and addressed the tension between the context specificities and the international recommendations. The engagement strategy combines published recommendations for responsible gene drive research, information collected from the local context where the project operates and a set of principles guiding the choices made. This strategy was first developed during the early phases of the project’s research, years ahead of any activities with gene drive mosquitoes in those countries of operations. These earlier activities, and their related engagement, allow the project to develop and adapt an engagement strategy appropriate for potential gene drive research in its field site countries. This paper offers a description of a stakeholder engagement strategy operationalization based on (1) adaptation to stakeholder preferences, (2) inclusiveness and (3) empowerment and accountability. The authors hope to offer concrete examples to support other projects with the development and implementation of their engagement strategies with particular attention to the co-development principle.
EPA, USDA, and FDA to Clarify Overlapping Biotechnology Regulatory Frameworks
30347Alan J. Sachs, Jack B. Zietman, The National Law Review, 2024-05-21 18:51:44.
On May 8, 2024, the U.S. Environmental Protection Agency (EPA), U.S. Department of Agriculture (USDA), and U.S. Food and Drug Administration (FDA) released a joint plan to identify areas of ambiguity, gaps, or uncertainty in their coordinated regulation of biotechnology products. Consistent with a directive issued by President Biden in September 2022, the agencies’ plan identifies specific issues that each has either recently addressed or will work to address to promote such products’ safe use. President Biden’s executive order defined “biotechnology” as “technology that applies to or is enabled by life sciences innovation or product development.” Biotechnology products thus may include organisms (plants, animals, fungi, or microbes) developed through genetic engineering or manipulation, products derived from such organisms, and products produced via cell-free synthesis. These products may, in turn, be regulated under the overlapping statutory frameworks of the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA), Federal Food, Drugs and Cosmetics Act (FFDCA), Plant Pest Act (PPA), Federal Meat Inspection Act, Poultry Products Inspection Act, and more. Therefore, close coordination between EPA, USDA, and FDA is essential to ensure effective and efficient regulation of biotechnology products.
Transformative Novel Technologies and Global Environmental Governance
28377F. Rabitz, Cambridge University Press, 2023-11-13 09:55:21.
Transformative Novel Technologies are potential gamechangers for confronting climate change, biodiversity loss, and many other elements of the global environmental crisis, allowing us to achieve a more sustainable future. The contemporary and future international governance of these technologies has crucial implications for managing the global transition towards sustainability. This book is the first to present a comprehensive assessment of the impact of these technologies on international politics. The author examines the responses of international institutions to the emergence of these technologies, focusing on three broad domains: biotechnology, climate engineering, and mineral extraction in areas beyond national jurisdiction (the ocean floor or near-Earth asteroids). This book is aimed at a non-specialist, academic audience with interest in the international and environmental politics of sustainability and technology. This title is part of the Flip it Open Programme and may also be available Open Access. Check our website - Cambridge Core - for details.
Conceptual risk assessment of mosquito population modification gene-drive systems to control malaria transmission: preliminary hazards list workshops
28220A. Kormos, G. Dimopoulos, E. Bier, G. C. Lanzaro, J. M. Marshall and A. A. James, Frontiers in Bioengineering and Biotechnology, 11. 2023-10-26 14:54:57.
The field-testing and eventual adoption of genetically-engineered mosquitoes (GEMs) to control vector-borne pathogen transmission will require them meeting safety criteria specified by regulatory authorities in regions where the technology is being considered for use and other locales that might be impacted. Preliminary risk considerations by researchers and developers may be useful for planning the baseline data collection and field research used to address the anticipated safety concerns. Part of this process is to identify potential hazards (defined as the inherent ability of an entity to cause harm) and their harms, and then chart the pathways to harm and evaluate their probability as part of a risk assessment. The University of California Malaria Initiative (UCMI) participated in a series of workshops held to identify potential hazards specific to mosquito population modification strains carrying gene-drive systems coupled to anti-parasite effector genes and their use in a hypothetical island field trial. The hazards identified were placed within the broader context of previous efforts discussed in the scientific literature. Five risk areas were considered i) pathogens, infections and diseases, and the impacts of GEMs on human and animal health, ii) invasiveness and persistence of GEMs, and interactions of GEMs with target organisms, iii) interactions of GEMs with non-target organisms including horizontal gene transfer, iv) impacts of techniques used for the management of GEMs and v) evolutionary and stability considerations. A preliminary hazards list (PHL) was developed and is made available here. This PHL is useful for internal project risk evaluation and is available to regulators at prospective field sites. UCMI project scientists affirm that the subsequent processes associated with the comprehensive risk assessment for the application of this technology should be driven by the stakeholders at the proposed field site and areas that could be affected by this intervention strategy.
Benefits and risks of gene drives for invasive plant management – the case for common tansy
28162L. Croghan, A. G. Smith, M. A. Tancos, N. O. Anderson and R. L. Becker, Frontiers in Agronomy, 5. 2023-10-20 12:05:59.
Invasive plants cause significant environmental and economic damage, but land managers have few control options. Common tansy (Tanacetum vulgare) is prevalent in many US states and is one of the most reported invasive plants in Minnesota. Controlling common tansy poses a challenge due to its extensive distribution and association with diverse plant communities. A gene drive is being explored as a genetic biocontrol method for the management of several non-native invasives, including common tansy in North America. Gene drives have emerged as a novel biotechnology application with potential to improve public health, promote conservation, and increase agricultural productivity. In common tansy, gene drives could be developed to target genes that would reduce or eliminate female fertility and consequently inhibit common tansy seed production. Using common tansy as an example, we outline risks associated with the use of gene drive technology for invasive plant control and explain how risks may be mitigated. Understanding potential benefits and risks associated with gene drives in the early stages of development is crucial. Mitigating risks, receiving stakeholder input, and navigating the regulatory environment will play an important role in gene drive development and deployment.
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.
World malaria report 2023
34046Geneva: World Health Organization, Licence: CC BY-NC-SA 3.0 IGO. 2023-06-15 00:00:00.
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.
Regulation of gene drive technologies for malaria control & elimination
33083Ifakara Health Institute, 2023-05-16 13:15:08.
The video talks about the importance of ensuring effective and thoughtful community and stakeholder engagement throughout research, development and deployment of gene drives for malaria control.
Guidelines and Standard Operating Procedures for Research on Genetically Engineer Insects, 2023
26270Government of India, Government of India, 2023-04-17 09:55:34.
Department of Biotechnology, Government of India is delighted to release "Guidelines and Standard Operating Procedures for Research on Genetically Engineered Insects, 2023". This document is pertinent for enabling potential of genetic engineering in insect research to revolutionize the field of entomology, understanding of role of insects in ecosystems as well as their interactions with humans. These guidelines and standard operating procedures are intended to provide guidance on regulatory requirement and data requirement of genetic engineering research on insects under containment conditions.
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.
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.
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.
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.
Genes drive organisms and slippery slopes
24322D. B. Resnik, R. F. Medina, F. Gould, G. Church and J. Kuzma, Pathog Glob Health, 2022-12-22 08:58:12.
The bioethical debate about using gene drives to alter or eradicate wild populations has focused mostly on issues concerning short-term risk assessment and management, governance and oversight, and public and community engagement, but has not examined big-picture- 'where is this going?'-questions in great depth. In other areas of bioethical controversy, big-picture questions often enter the public forum via slippery slope arguments. Given the incredible potential of gene drive organisms to alter the Earth's biota, it is somewhat surprising that slippery slope arguments have not played a more prominent role in ethical and policy debates about these emerging technologies. In this article, we examine a type of slippery slope argument against using gene drives to alter or suppress wild pest populations and consider whether it has a role to play in ethical and policy debates. Although we conclude that this argument does not provide compelling reasons for banning the use of gene drives in wild pest populations, we believe that it still has value as a morally instructive cautionary narrative that can motivate scientists, ethicists, and members of the public to think more clearly about appropriate vs. inappropriate uses of gene drive technologies, the long-term and cumulative and emergent risks of using gene drives in wild populations, and steps that can be taken to manage these risks, such as protecting wilderness areas where people can enjoy life forms that have not been genetically engineered.
Gene editing and agrifood systems
24291FAO, FAO, 2022-12-20 09:22:56.
Gene-editing technologies represent a promising new tool for plant and animal breeding in low- and middle-income countries. They enhance precision and efficiency over current breeding methods and could lead to rapid development of improved plant varieties and animal breeds. However, as for any new technology, they have their merits and demerits. There is, as yet, no international consensus regarding if and how gene-edited organisms should be regulated, and whether their release would fall under the regulatory framework of the Cartagena Protocol on Biosafety to the Convention on Biological Diversity. This science- and evidence-based Issue Paper on gene editing and agrifood systems presents a balanced discussion of the most pertinent aspects of gene editing, including the consequences for human hunger, human health, food safety, effects on the environment, animal welfare, socioeconomic impact and distribution of benefits. Intrinsic ethical concerns and issues of governance and regulation are addressed, and the roles of the public and private sectors, alone and in partnership, are summarized. Various scenarios are also presented for how gene editing might be used in the future to help transform agrifood systems.
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.
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.
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.
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
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 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
Importation of the non gene drive genetically modified male bias mosquito strain into Burkina Faso
22496A. Diabate, Target Malaria, 2022-05-11 07:37:11.
On March 16 and 21, the team at the Institut de Recherche en Sciences de la Santé (IRSS), Target Malaria’s partner institution in Burkina Faso, received packages containing live genetically modified mosquito eggs from Italy. The National Biosafety Agency (ANB) officers were at the airport to inspect the packages. The eggs are of non gene drive genetically modified male bias mosquitoes. It is another strain of genetically modified mosquitoes, compared to the sterile male strain imported in 2016 and released in 2019. This male bias strain does not carry the gene drive technology. The mosquito is fertile and it is genetically modified to produce mainly male offspring (up to 95% in the laboratory). The male bias strain is not a vector control tool. The purpose of this phase is to understand this new fertile strain, develop capacity, train Target Malaria teams and engage with regulatory authorities and stakeholders.
Genetically modified mosquitoes for controlling vector-borne diseases? Successful trial gives hope
21821T. Deol, Down To Earth, 2022-04-21 06:07:50.
Preliminary results of an open-air study of genetically engineered mosquitoes — with an aim to suppress a wild population of virus-carrying mosquitoes — in the United States have shown promising results. The aim of the experiment by Oxitec, a United Kingdom-based biotechnology firm, is to reduce the population of wild Aedes aegypti mosquitoes that is a vector for viruses such as chikungunya, dengue, zika and yellow fever. The scientists engineered a gene that will kill the female offspring. The results, achieved after a decade-long fight for public acceptance and regulatory approvals, are not enough. Larger studies are needed to understand whether the goal can be achieved or not. Their findings, yet to be published, were released during a webinar on 6 April. The experiment began in April 2021 in the Florida Keys but not without resistance from the residents. Their concerns ranged from the modified mosquitoes harming people, its impact on mosquito-eating species and other unintended consequences such as the emergence of a deadly virus.
Release of genetically modified mosquitoes created to fight disease a success: Biotech firm
21818C. Greenberg, National Post, 2022-04-20 06:03:19.
The release of genetically modified mosquitoes in the United States created to fight disease has gone according to plan, biotechnology firm Oxitec says.The first phase of the pilot study consisted of releasing almost 5 million modified Aedes aegypti male mosquitoes in the Florida Keys, a group of islands off the southern tip of Florida, in April 2021. The results indicated that the method may eventually succeed in eradicating or downsizing the number of Aedes aegypti mosquitoes. Aedes aegypti only make up 4 per cent of the mosquito population in the Keys, but are responsible for spreading yellow fever, dengue, chikungunya and Zika virus, Oxitec said during an online seminar revealing their findings on April 6. “The mosquito is very difficult to control. It likes to live around people, in houses, under houses,” said Andrea Leal, executive director of the Florida Keys Mosquito Control District. “We’re also seeing an increase in resistance to a number of our adulticide products that we use for mosquito control, so at the end of it, we’re looking for new tools to put in our toolbox to help us control this particular mosquito.”
Tests of Genetically Modified Mosquitoes Prove Positive
21816R. Ellis, WebMD, 2022-04-20 05:59:18.
The first open-air study of genetically modified mosquitoes in the United States has yielded positive results, says Oxitec, the UK-based company that ran the study. However, Oxitec says larger tests are needed to determine whether the insects can suppress the disease-spreading mosquito population in the wild, according to Nature. Dengue, Zika, and yellow fever are some of the diseases the experiments hope to reduce. Scientists at Oxitec mass produced and genetically modified male Aedes aegypti mosquito eggs in a lab. The males were released into the wild to mate with females and pass along a gene designed to kill the female offspring, which are the only ones that bite and spread the diseases. The male offspring live on.
Genetically Modified Mosquitoes Work as Intended
21814M. L. Ford, NEWSER, 2022-04-19 05:54:33.
Results are in from a pilot study in Florida, where millions of genetically engineered mosquitoes were released into the wild. Some referred to it as the “Jurassic Park” experiment when it was announced last year, but—so far—everything is going to plan, according to UK biotech firm Oxitec. Per Nature, the experiment is part of a long-term plan to develop new tools in the fight against the invasive Aedes aegypti mosquito, which can carry dengue, Zika, and other gnarly viruses. Genetically modified male mosquitoes were released into the wild to mate with the local females; as hoped, affected female offspring died before reaching adulthood, and male offspring carried the engineered gene. By the way, the engineered males and their offspring do not bite humans. Ultimately, the hope is to suppress if not eradicate A. aegypti; however, this phase was focused on ensuring that the method works. In addition to preventing reproduction, the gene was successfully passed to succeeding generations of males for three months, and then it disappeared from the local population. Oxitec’s work is EPA-approved, and it works closely with state wildlife agencies. Similar experiments will soon begin in California. “I like the way they’re going about it,” Thomas Scott, an entomologist at UC-Davis, told Nature. “They’re doing it in a systematic, thoughtful way. So I’m encouraged.”
The plan to release genetically engineered mosquitoes in California
21703M. Petersen, Phys Org, 2022-04-12 08:50:04.
In the mosquito breeding rooms of British biotech company Oxitec, scientists line up fresh eggs, each the size of a grain of salt. Using microscopic needles, the white-coated researchers inject each egg with a dab of a proprietary synthetic DNA. For four days, Oxitec technicians care for the eggs, watching for those that hatch into wriggling brown larvae. Those "injection survivors," as the company calls them, face a battery of tests to ensure their genetic modification is successful. Soon, millions of these engineered mosquitoes could be set loose in California in an experiment recently approved by the federal government. Oxitec, a private company, says its genetically modified bugs could help save half the world's population from the invasive Aedes aegypti mosquito, which can spread diseases such as yellow fever, chikungunya and dengue to humans. Female offspring produced by these modified insects will die, according to Oxitec's plan, causing the population to collapse. "Precise. Environmentally sustainable. Non-toxic," the company says on its website of its product trademarked as the "Friendly" mosquito.
Genetically-Modified Mosquitos Could Soon Be Released in California
21693A. Madrigal, KQED, 2022-04-12 08:31:27.
Millions of genetically-modified, non-biting mosquitoes may soon be set loose in California after federal regulators gave the green light to a study aimed at preventing transmission of diseases like Zika and dengue. British biotech firm Oxitech says its technology alters male mosquitos to only produce viable male offspring, leading to population declines as females die off. While it may sound like the plot of a horror movie, the company says the new process is safe and necessary to address the growing global threat of mosquito-borne diseases. But some scientists and other critics say it could create even more virulent mosquitos, among other health and environmental risks. We’ll discuss the plan, which still requires state approval.
Will genetic modification of mosquitoes take a bite out of insects’ population?
21708N. Patel, KCRW, 2022-04-11 08:58:40.
An invasive species of aggressive “ankle biters” called the Aedes aegypti mosquito is now in LA, and it’s spreading quickly. These tiny vampires can lay eggs in a space as small as a water-filled bottle cap, and they carry diseases like yellow fever and dengue. A British company called Oxitec is now trying to eradicate them through genetic modification. Oxitec will release millions of modified mosquitoes that can only produce female offspring that will die. Without an ability to reproduce, the mosquito population will collapse. The Environmental Protection Agency (EPA) granted the company a permit to release their modified mosquitoes in San Bernardino, Fresno, Stanislaus, and Tulare Counties.
An army of genetically engineered mosquitoes is about to be released
21705M. Menard, KNX NEWS, 2022-04-11 08:53:53.
A British biotech company has been altering the DNA of mosquitoes with the goal of killing off a more dangerous breed capable of spreading deadly diseases. And now they’re preparing to release their “friendly mosquitoes” into the wild. In California. Aedes aegypti is an invasive breed of mosquito that has been rapidly spreading throughout the state since their first detection about 10 years ago. It is a known carrier of such diseases as yellow fever, chikungunya and dengue.
California’s first genetically modified mosquitoes may soon be released
21698A. M. Asperin, FOX11 Los Angeles, 2022-04-10 08:41:01.
How would you feel about a few genetically engineered mosquitoes flying into your neighborhood? It's a possibility after the US Environmental Protection Agency on Friday approved pilot projects of Oxitec's mosquitoes in specific districts in California and Florida. The next step is for applications to be submitted to state regulators, who must approve the project for it to move forward.
In California, an army of genetically engineered mosquitoes awaits release. Will it backfire?
21652M. Petersen, Los Angeles Times, 2022-04-08 15:00:55.
In the mosquito breeding rooms of British biotech company Oxitec, scientists line up fresh eggs, each the size of a grain of salt. Using microscopic needles, the white-coated researchers inject each egg with a dab of a proprietary synthetic DNA. For four days, Oxitec technicians care for the eggs, watching for those that hatch into wriggling brown larvae. Those “injection survivors,” as the company calls them, face a battery of tests to ensure their genetic modification is successful. Soon, millions of these engineered mosquitoes could be set loose in California in an experiment recently approved by the federal government. Oxitec, a private company, says its genetically modified bugs could help save half the world’s population from the invasive Aedes aegypti mosquito, which can spread diseases such as yellow fever, chikungunya and dengue to humans. Female offspring produced by these modified insects will die, according to Oxitec’s plan, causing the population to collapse.
Federal Government Approves Release of Millions of Genetically Engineered Mosquitoes in California
21681A. Jose, The Western Journal, 2022-04-08 08:10:32.
Genetically modified Aedes aegypti mosquitoes could soon buzz around in California and Florida after the federal government greenlighted a plan to release the insects in the states. The project is spearheaded by biotechnology firm Oxitec, which, among other things, specializes in biological pest control solutions. “Oxitec’s Friendly™ safe, non-biting male mosquitoes are designed to suppress local wild populations of disease-spreading mosquitoes,” Oxitec’s website states. According to the company, the genetically modified mosquitoes have a “self-limiting gene,” which ensures that when the “Friendly™ mosquito males mate with wild females, their offspring inherit a copy of this gene.” The gene stops female offspring from maturing into adulthood, culling their reproducibility. However, male offspring carrying the gene will survive and pass those on to their offspring, the company said.
Billions of Genetically Modified Mosquitoes Are Set to Descend on California and Florida This Summer
21658J. Rossen, MENTAL FLOSS, 2022-04-06 15:11:44.
Californians may not know it on sight, but there’s going to be something different about their mosquitoes this summer. An invasive species of the bite-prone insects has been genetically modified in an attempt at controlling disease spread. According to Smithsonian, the Environmental Protection Agency (EPA) has approved plans by biotech firm Oxitec to release 2.4 billion male Aedes aegypti mosquitos in both California and Florida that have been altered so their genes can only participate in producing surviving male offspring. (Females will die before reaching adulthood.) The insects will be introduced as eggs, which will then hatch when exposed to water. Because male mosquitoes do not bite, the theory is that a declining female mosquito population will reduce transmission of Zika, yellow fever, dengue, and other infectious diseases that can be passed on to humans from the bites. The goal is halting outbreaks before they begin. In 2021, Oxitec released 144,000 genetically modified mosquitoes in the Florida Keys. The insects have also been introduced in Brazil, the Cayman Islands, Panama, and India. While there is no spread of such diseases in California, the firm says a growing mosquito population could eventually pose a problem and that such pilot programs are necessary to assess effectiveness
Genetically modified mosquitoes, a potential antidote to deadly diseases
21634TRTWorld, TRTWorld, 2022-04-01 08:08:35.
The US approved the release of billions of genetically modified mosquitoes to reduce the transmission of diseases but critics point to possible unintended consequences. Can genetically modified animals combat the spread of deadly diseases? The United States Environmental Protection Agency (EFA) thinks so. The agency has approved the release of over 2 billion mosquitoes that were genetically altered specifically to reduce the transmission of deadly transmissible diseases such as Zika, chikungunya, dengue, and yellow fever.The program in Florida and California will be put into action by the British biotechnology company Oxitec that genetically modify the mosquitos, mainly male Aedes aegypti eggs, in a lab. The mosquitos then will mate with females, only to pass the modified gene that would kill the female offspring. As a result, only the male offspring will stay alive as only the female ones spread the disease. The project also needs the approval of both states’ regulators and will be carried out in partnership with the Delta Mosquito and Vector Control district in Tulare county.
Why a U.S. Company Plans to Release 2.4 Billion Genetically Modified Mosquitoes
21569M. Osborne, Smithosonian Magazine, 2022-03-30 12:35:35.
The Environmental Protection Agency has cleared the release of 2.4 billion genetically-modified mosquitoes in California and Florida. The mosquitoes, created by biotech firm Oxitec, will be non-biting Aedes aegypti males engineered to only produce viable male offspring, per the company. Oxitec says the plan will reduce numbers of the invasive Aedes aegypti, which can carry diseases like Zika, yellow fever and dengue. Female mosquitoes will die, while males will reproduce and spread the self-limiting gene to the next generation, eventually leading to population declines. While these diseases aren’t yet spreading in California, the invasive insect has been flagged as a growing risk as their numbers increase across the state, reports the Guardian’s Gabrielle Canon. “Given the growing health threat this mosquito poses across the U.S., we’re working to make this technology available and accessible,” Oxitec CEO Grey Frandsen says in a statement. “These pilot programs, wherein we can demonstrate the technology’s effectiveness in different climate settings, will play an important role in doing so.”
US poised to release 2.4bn genetically modified male mosquitoes to battle deadly diseases
21571G. Canon, The Guardian, 2022-03-26 12:38:38.
Genetically modified male mosquitoes may soon be buzzing across areas of California, in an experiment to stop the spread of invasive species in a warming climate. Earlier this month, the EPA cleared the UK-based biotech company Oxitec to release a maximum of roughly 2.4bn of its genetically modified mosquitoes through 2024, expand its existing trial in Florida and start a new pilot project in California’s Central Valley, where mosquito numbers are on the rise. Oxitec’s modified mosquitoes are male, and therefore don’t bite. They were developed with a special protein so that when they pair with a female mosquito the only viable offspring they produce are also non-biting males. The project specifically targets the Aedes aegypti mosquito, one of more than 3,500 mosquito species and a dangerous invasive insect that has spread diseases like dengue, Zika, Chikungunya, and yellow fever in other countries.
Millions of genetically engineered mosquitoes are here to protect us
21551M. Kaufman, MASHABLE, 2022-03-26 12:06:29.
Aedes aegypti almost certainly traveled to California in cargo, like many invasive species do. The species, which flourishes in warmer climes, has colonized places like Los Angeles County, and is expected to multiply and spread in these temperate regions as the climate continuously warms. The invasive species has already thrived in the Gulf states for centuries. Crucially, Aedes aegypti aren't simply an itchy annoyance (the females voraciously bite for blood meals): The mosquitoes spread viral diseases like dengue fever, yellow fever, Zika, among others. Future outbreaks in new and old parts of the U.S. have a realistic, unsettling potential. To prepare, the U.S. Environmental Protection Agency recently allowed for the carefully regulated, experimental release of over 2.4 million genetically-modified mosquitoes in California and Florida over the next couple of years. It's a pilot project intended to prove that Aedes aegypti populations can be repressed by genetically-altered mosquitoes. The modified mosquitoes are non-biting males carrying a manipulated gene that, after mating, kills the insects' offspring. The biotechnology company Oxitec devised this mosquito-control strategy, and will run the tests.
A scourge of genetically modified mosquitoes could be unleashed in California
21236J. Bote, SFGATE, 2022-03-21 05:16:37.
A genetically modified scourge of mosquitoes could be unleashed throughout California as municipalities across the state grapple with increasing bouts of an invasive mosquito species. The mosquitoes, developed by the British biotech firm Oxitec, are known as OX5034 — a modified male version of Aedes aegypti, the species that first emerged in Los Angeles County about a decade ago before spreading to at least 22 different counties across the state. They are an invasive species known to carry dengue, Zika and a host of other diseases, and naturally spread in contained, urban spaces with standing water, such as flowerpots and open water bottles. Up to 2 million OX5034 mosquitoes could be released in the coming years throughout the state, pending state approval by the California Department of Pesticide Regulation. The male species, which naturally do not bite humans, carry a gene that will ensure that female offspring do not grow into childhood. Male offspring, however, will survive — and continue to pass down the gene to further generations, hopefully eradicating the invasive species for good.
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
Billions of GE Mosquitoes May Soon Be Released in California and Florida
21009A. N. Mitra, Earth Island Journal, 2022-03-16 06:18:31.
he US Environmental Protection Agency’s decision last week to allow the release of billions of genetically engineered mosquitoes in California and Florida has several environmental and public health groups worried about the potential impacts of the experimental releases on public health and the environment. The EPA move follows last year’s pilot field trial in the Florida Keys where, starting April 2021, the British biotechnology company Oxitec and the Florida Keys Mosquito Control released half a billion of these transgenic mosquitoes. The purpose was to test if they could help reduce populations of Aedes aegypti, a mosquito species that can carry viruses that cause deadly diseases like yellow fever, dengue, chikungunya, and Zika — none of which are major concerns in the United States.
California’s first lab-grown mosquitoes may take flight—stirring controversy
21022L. M. Krieger, Phys Org, 2022-03-15 06:51:22.
A biotech firm is seeking permission to release genetically modified mosquitoes into the open air of California for the first time later this year, aiming to reduce the expanding populations of invasive mosquitoes and prevent deadly disease. The controversial research project—planned for the Tulare County community of Visalia, with potential expansion into Fresno, San Bernadino and Stanislaus counties—will over time introduce 2 million male mosquitoes with a "kill switch" built into their DNA. When they mate with wild insects, their offspring die, causing an eventual collapse of the population. Their target: Swarms of the mosquito, first detected in Los Angeles County in 2011, which have since spread northward into 20 California counties. While California's native mosquito emerges at dusk, these black-and-white-striped invaders hunt for blood during the day, when people are outside. Elsewhere, they transmit potentially fatal Zika, dengue, yellow fever, chikungunya and other viruses.
Genetically modified mosquitoes kill their own offspring
21024C. Ward, SYFY, 2022-03-14 06:55:40.
Oxitec, a biotech company, has developed a strain of A. aegypti which they call Friendly. Their modified mosquitos are all males and carry a gene which prevents the birth of females in subsequent generations. In short, they’re reducing disease-carrying mosquitos by killing their babies before they hatch. The Environmental Protection Agency has granted permission for the release of the experimentally modified mosquitos in Florida, and those same mosquitos may soon be released in California. While the federal government has agreed to the program, permission must also be obtained from the states where the releases will occur before they can proceed. Should California grant permission, populations of modified mosquitos could be released in Stanislaus, Fresno, Tulare, and San Bernadino counties soon. Once released, modified male mosquitos breed with wild females, delivering the desired gene sequence to the next generation. Any females in the next generation are terminated before being born and all males which are produced carry the same gene, allowing them to continue the cycle through several generations. Oxitec considers the modification inherently self-limiting and estimates that it will vanish from the overall population after a few generations, at which point mosquito populations will return to normal reproduction.
Millions Of Genetically Modified Mosquitoes To Be Set Loose In US
20638H. Wilmerding, Daily Caller, 2022-03-11 08:11:40.
Millions of genetically modified mosquitoes will be released in the United States as part of an initiative to replace the insects carrying deadly diseases, the company behind the plan announced Tuesday. The program, led by biotechnology company Oxitec, will release roughly 2 million genetically altered mosquitoes in California and Florida to fend off other mosquitoes carrying deadly diseases like Zika, yellow fever, dengue and chikungunya, the company said in a press release. The Environmental Protection Agency (EPA) approved Oxitec’s plan on March 8. “Given the growing health threat this mosquito poses across the U.S., we’re working to make this technology available and accessible,” Oxitec chief executive officer Grey Frandsen said in the press release.
Florida Begins Release of Genetically Altered Mosquitoes to Prevent Spread of Zika
20632Entrepreneur staff, Entrepreneur, 2022-03-11 08:01:36.
Since 2016, Zika , a disease transmitted by a virus that spreads an invasive species of mosquito, has plagued various regions of the world, including areas of Florida and Texas in the United States. In May 2020, the Environmental Protection Agency (EPA) approved a program to release millions of genetically altered mosquitoes that, in theory, will help reduce the population of female Aedes aegypti specimens, the species that carries the virus. n 2016, the disease became a public health issue throughout the world and caused multiple cases of a condition called microcephaly, in babies of women who were infected during pregnancy. Infected babies were born with smaller heads than expected due to partial collapse of the skull and limited movement in some of their joints. The Zika virus has spread to more than 30 countries, including Bolivia, Brazil, Guatemala, Honduras, Venezuela, El Salvador, Mexico, and parts of the United States.This week the first step was taken in a program that, if successful, could culminate in the release of up to 750 million genetically altered flies that would help control the spread of the disease. The first phase will last 12 weeks and will consist of introducing up to 12,000 genetically modified eggs in small areas. In theory, the specimens that hatch from these eggs are capable of transmitting a gene that only kills the females (they are the ones that bite and infect people) before they reach adulthood and start biting.
2 Billion Genetically Modified Mosquitoes Have Been Approved For Release In Florida And California
20609J. U. Nisa, Wonder Engineering, 2022-03-10 12:21:31.
The US Environmental Protection Agency (EPA) has sanctioned the release of 2 billion genetically modified mosquitos in Florida and California, Oxitec, the company that created the genetically modified mosquitoes, said. Oxitec’s experimental program intends to reduce the spread of hazardous diseases like dengue, Zika, and yellow fever by destroying the offspring of a common type of mosquito, Aedes aegypti, which transmits diseases through its sting. Scientists at Oxitec, located in the United Kingdom, mass generate and genetically engineer male Aedes aegypti eggs in a lab. These male mosquitos will be released into the wild to mate with females and pass on a gene that kills the female offspring, which are the only ones that sting and carry disease. The male offspring survive.
Billions of genetically modified male mosquitos will be released in California and Florida as a ‘natural pest control’ to stop the spread of diseases like Zika, yellow fever and Dengue
20599R. Morrison, Daily Mail, 2022-03-10 12:07:54.
Billions of genetically engineered male mosquitos will be released in California and Florida over the next two years, as part of a mission to kill off biting females. Oxitec, based in Oxford UK, is a biological pest control development firm, that has produced the edited version of the flying insects to combat mosquito-borne diseases like Dengue, yellow fever and Zika. Male Aedes aegypti mosquitos don't bite humans, but females do, and so the genetic modification causes females to die off soon after being born. The project has been cleared by the Environmental Protection Agency (EPA), and the first wave is due to be released this year, although it isn't clear exactly when this will happen, as it requires state regulatory approval in Florida and California. It isn't likely to be a problem in Florida, as the state played host to a trial last year that saw millions of the same type of Oxitec mosquitos released in the Florida Keys.
2 billion genetically modified mosquitos are about to be released in the US
20635J. Hawkins, yahoo, 2022-03-10 08:06:35.
Scientists have been playing god with mosquitos for a couple of years now. Back in 2021, British company Oxitec released 750 million lab-modified mosquitos in Florida. Now, the company is gearing up to release another 2 billion genetically modified mosquitos across more of Florida and in California as well.The new species, codenames OX5034, is made up entirely of male mosquitos. The new species is derived from the Aedes aegypti family of mosquitos. Just like others the company has released, this new 2 billion should produce larvae that die off before they reach adulthood. This is thanks to the self-limiting gene that Oxitec has created. The new gene essentially disrupts the generation of essential proteins the larvae need to develop. Without the needed proteins, it is unable to complete its development process.
2 Billion Genetically Altered Mosquitoes Will Be Released in Fla. and Calif. to Fight Disease
20628A. Adams, People, 2022-03-10 07:50:39.
Billions of genetically modified mosquitoes are expected to be released within the next two years as part of an expanded version of an Environmental Protection Agency (EPA) study — but the project is receiving criticism from advocacy groups that believe it could be dangerous.The EPA said in an announcement on Monday that it will extend its current study into reducing the population of the Aedes aegypti, a mosquito commonly found in the United States, through April 2024. The EPA looking to broaden its work to Monroe County in Florida and four counties in California: Stanislaus, Fresno, Tulare and San Bernardino. Under the project's revised Experimental Use Permit (EUP), the EPA is permitted to release nearly 2.5 billion Aedes aegypti mosquitoes containing a protein called Tetracycline Trans-Activator Variant (tTAV-OX5034) into the wild.
Genetically modified mosquitoes could be tested in California soon
20605S. Milius, Science News, 2022-03-09 12:15:25.
Genetically modified mosquitoes might soon be whining on both U.S. coasts. The U.S. Environmental Protection Agency has approved two more years of testing Oxitec’s genetically modified mosquitoes as living pest controls, continuing a pilot program started in 2021 in the Florida Keys and expanding it to up to four counties in California. Now the Florida and California state governments will consider whether to grant permission. The male mosquitoes, OX5034 Aedes aegypti engineered by the biotech company Oxitec, carry daughter-killing genes that get passed generation to generation. When these males mate with local females outside a lab, only the sons should survive. Those inheriting the sabotage gene will grow up to mate with normal females, dooming their daughters too.
Why millions of genetically modified mosquitoes could be released across US
20601J. Rogers, New York Post, 2022-03-09 12:11:08.
The US could soon be swarming with genetically altered mosquitoes after the Environmental Protection Agency approved a plan to test the insects. It is hoped the new altered mosquitoes will ward off their natural, disease-causing counterparts. Biotechnology company Oxitec has developed altered Aedes aegypti mosquitoes which have been genetically modified so that males, which do not bite, are released into the wild and mate with females, which do bite. Their offspring, either male or female, never survive to reach maturity, according to the company.
Genetically Modified Mosquitoes May Be Released in Fla and Calif
20597R. Ellis, WebMD, 2022-03-09 12:04:50.
The U.S. Environmental Protection Agency has approved the release of 2 billion genetically altered mosquitoes in Florida and California, the company that created the genetically modified mosquitoes said. The experimental program created by Oxitec is designed to reduce the transmission of harmful diseases such as dengue, Zika, and yellow fever. The program is an extension of one in which millions of mosquitoes were released last year in the Florida Keys, USA Today reported. State agencies in Florida and California will have to approve the programs before the releases occur. The aim of the program is to reduce cases of diseases like yellow fever by killing off the offspring of a common kind of mosquito, Aedes aegypti, which spreads diseases through its bite.
2 Billion Genetically Modified Mosquitoes Cleared for Release in California and Florida
20595E. Cara, gizmodo, 2022-03-09 11:59:00.
British biotech firm Oxitec announced this week that it has received approval from the U.S. Environmental Protection Agency for its genetically modified mosquitoes to be released in parts of Florida and in California, following the completion of a pilot program last year. The modified male insects are designed to produce infertile offspring, ideally reducing local populations and rates of mosquito-borne illness. The male mosquitoes developed by Oxitec—codenamed species OX5034—are derived from Aedes aegypti, a notorious carrier of many diseases, including Zika, dengue, and yellow fever. When these mosquitoes mate with the native females in an area, they’re said to produce female larvae that simply die off before reaching adulthood, thus dooming the population as a whole. And because only female mosquitoes bite and suck blood from humans, the modified insects are thought to pose no danger to people.
Genetically Modified Mosquitoes Set to Be Released in California and Florida
20591K. Roberts, The Epoch Times, 2022-03-09 11:33:43.
Millions of genetically modified mosquitoes are set to be released in California and Florida in an effort to reduce the number of real, disease-carrying invasive mosquitoes. The U.S. Environmental Protection Agency on Monday approved use of the genetically engineered insects in pilot projects in specific districts across both states. The mosquitoes were made by UK-based biotechnology firm Oxitec, which is funded by the Bill and Melinda Gates Foundation, in an effort to combat insect-borne diseases such as dengue fever, yellow fever, and the Zika virus. According to Oxitec, its “sustainable and targeted biological pest control technology does not harm beneficial insects like bees and butterflies and is proven to control the disease-transmitting Aedes aegypti mosquito, which has invaded communities in Florida, California, and other U.S. states.” Since it was first detected in California in 2013, the Aedes aegypti mosquito has spread rapidly to more than 20 counties throughout the state, increasing the risk of mosquito-borne diseases being transmitted to humans.
Proposed moquito release for Tulare County draws concern
20584E. Smith, The Business Journal, 2022-03-08 11:20:42.
News of the approval to release genetically-modified mosquitoes in Tulare County and Monroe County, Florida has drawn the ire of activists who say the company behind the project has not provided data demonstrating the insects are safe. At the same time, the company says it has the studies to demonstrate the safety of the program it calls “another tool in the integrated approach to pest control.” The U.S. Environmental Protection Agency has granted U.K.-based Oxitec an experimental-use permit giving the company the first green light to release male, non-biting mosquitoes in Tulare County and Monroe County in Florida, according to Rajeev Vaidyanathan, director of operations for Oxitec. The test is to see whether the engineered mosquitoes can reduce the number of Aedes aegypti mosquitoes that have spread throughout the country with the potential to carry tropical diseases such as dengue, yellow fever, Zika and chikungunya. Before they can begin the program, the California Department of Pesticide Regulations has to approve the proposal.
Millions of genetically modified mosquitoes may soon be buzzing in Florida and California. Here’s why.
20582R. W. Miller, USA Today, 2022-03-08 11:13:28.
Millions of genetically altered mosquitoes that seek to ward off their natural, disease-causing counterparts may soon be released in Florida and California after the Environmental Protection Agency approved a plan to further test the modified insects. Developed by the biotechnology company Oxitec, the Aedes aegypti mosquitoes are genetically modified so that males, which do not bite, are released into the wild and mate with females, which do bite. Their offspring are either male or females that never survive to reach maturity, the company says. Millions of the mosquitoes were released in the Florida Keys in a pilot project last year, and the EPA has authorized the extension of the project in Florida as well as the expansion into four counties in California, pending approval from the states' regulators.
‘Halt this nightmare immediately’: EPA approves release of genetically-engineered mosquitoes
20579J. Corbett, AlterNet, 2022-03-08 11:05:13.
Environmental and public health advocates responded with alarm after the Biden administration on Monday gave a British biotechnology company a green light to unleash billions of genetically engineered mosquitoes in the United States. The Environmental Protection Agency (EPA) granted Oxitec an experimental use permit that could lead to the release of genetically engineered (GE) mosquitoes in four California counties and extend a widely criticized program in Florida's Monroe County. While the release is intended to investigate whether the GE mosquito can reduce the population of Aedes aegypti mosquitoes—which carry various viruses—the species is not common in California and there are no reported cases of the targeted diseases. "This experiment is unnecessary and even dangerous, as there are no locally acquired cases of dengue, yellow fever, chikungunya, or Zika in California," declared Jaydee Hanson, policy director for the International Center for Technology Assessment and Center for Food Safety. Oxitec's altered male mosquitoes are supposed to pass on a gene that causes their offspring to die before reaching maturity. However, a peer-reviewed study published in September 2019 by Yale University researchers showed that releasing the GE mosquitoes in Brazil not only failed to reduce populations of Aedes aegypti but also resulted in hybrid mosquitoes.
Genetically Engineered Mosquito Imminent Mass Release Ignores Science, Public Health and Environmental Risks
20577H. Bourque, Friends of the Earth, 2022-03-07 11:00:22.
In defiance of science and public health concerns, today the Environmental Protection Agency (EPA) approved the mass release of billions of experimental genetically engineered (GE) mosquitoes into the United States’ most populous and agriculturally significant states. The biotechnology company Oxitec was granted an Experimental Use Permit for the release of a genetically engineered version of the species Aedes aegypti across Fresno, Tulare, San Bernadino and Stanislaus Counties in California and in Monroe County in Florida. This will be the biggest release of GE insects in the world. EPA’s approval came despite growing concerns raised by scientists, public health experts and environmental groups about potential impacts of the experimental releases to public health, the environment and endangered species. No publicly available data supports Oxitec’s claims that GE mosquitoes will reduce incidence of mosquito borne diseases. An independent peer-reviewed study from Yale University scientists revealed that over two years of continual releases of the GE mosquitoes at a test site in Brazil failed to reduce populations of Aedes aegypti. The Yale study also found that the GE mosquitoes bred with local Aedes aegypti, resulting in hybrid mosquitoes in the wild that may be more aggressive, more difficult to eradicate and may increase the spread of mosquito-borne disease.
Should we kill every mosquito on Earth?
20519J. Phelan, LiveScience, 2022-02-28 08:05:44.
Before you grab that can of bug spray, know this: While some mosquitoes are dangerous to us, not all are. Even those that are sometimes harmful tend not to feed on humans, preferring honeydew, plant sap and nectar, according to Mosquito Joe, a mosquito control company. There are around 3,500 mosquito species, but "only around 100 will potentially bite and spread disease to humans," Steven Sinkins, a professor in microbiology and tropical medicine at the Centre for Virus Research at the University of Glasgow in Scotland, told Live Science in an email. For instance, Culiseta mosquitoes often bite humans, but are not known to carry any debilitating diseases, while Toxorhynchites, which are common the world over and tend to live in forests, prefer nectar sugars to blood, according to Entomology Today. Therefore, it probably wouldn't be necessary to get rid of every mosquito species. Instead, we could target the more problematic ones, such as Aedes aegypti, which carry diseases such as yellow fever and Zika. A. aegypti is now ubiquitous, but it wasn't always this way. The species first spread out of Africa during the slave trade between the 15th and 19th centuries, through trade with Asia in the 18th and 19th centuries, and via troop movements during World War II, according to the World Mosquito Program, a nonprofit based in Australia.
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.
An Ethical Overview of the CRISPR-Based Elimination of Anopheles gambiae to Combat Malaria
20442I. J. Wise and P. Borry, Journal of Bioethical Inquiry, 2022-02-17 09:30:10.
Approximately a quarter of a billion people around the world suffer from malaria each year. Most cases are located in sub-Saharan Africa where Anopheles gambiae mosquitoes are the principal vectors of this public health problem. With the use of CRISPR-based gene drives, the population of mosquitoes can be modified, eventually causing their extinction. First, we discuss the moral status of the organism and argue that using genetically modified mosquitoes to combat malaria should not be abandoned based on some moral value of A. gambiae. Secondly, we argue that environmental impact studies should be performed to obtain an accurate account of the possible effects of a potential eradication of the organism. However, the risks from the purposeful extinction of A. gambiae should not overtake the benefits of eradicating malaria and risk assessments should be used to determine acceptable risks. Thirdly, we argue that the eventual release of the genetically modified mosquitoes will depend on transparency, community involvement, and cooperation between different nations.
A Closing Window of Opportunity for Gene Drive Governance in the United States
20445K. L. Warmbrod, M. Montague and G. K. Gronvall, Health Security, 20:3-5. 2022-02-15 09:35:05.
The COVID-19 pandemic has brought forth a number of biotechnological advances to enhance the public's health: new diagnostic tests, mRNA vaccines, and new antiviral medications. Biotechnology is also being used to address global challenges like climate change, food insecurity, and building the bioeconomy, which directly or indirectly improve public health. Gene drives are one such biotechnology. They are genetically engineered systems that can alter the inheritance patterns in a host species, such as a mosquito, so that a greater percentage of its progeny inherit a specific desired trait. Research and investments in biotechnology have been used to reduce arthropod-borne infectious diseases, such as malaria and Zika, and to manage or eliminate invasive species.2 Funding thus far has been adequate. For example, Target Malaria, a global consortium of researchers developing a gene drive to decrease the burden of malaria, has an average of US$11.5 million per year in funding.3 Although no gene drive has been released into the environment yet, technologies with similar attributes have been released in field trials, notably by Oxitec in Florida
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).
iGEM and Gene Drives: A Case Study for Governance
20040P. Millett, T. Alexanian, M. J. Palmer, S. W. Evans, T. Kuiken and K. Oye, Health Security, 2022-01-11 09:49:06.
Gene drives have already challenged governance systems. In this case study, we explore the International Genetically Engineered Machine (iGEM) competition's experiences in gene drive-related research and lessons in developing, revising, and implementing a governance system. iGEM's experiences and lessons are distilled into 6 key insights for future gene drive policy development in the United States: (1) gene drives deserve special attention because of their potential for widescale impact and remaining uncertainty about how to evaluate intergenerational and transboundary risks; (2) an adaptive risk management approach is logical for gene drives because of the rapidly changing technical environment; (3) review by individual technical experts is limited and may fail to incorporate other forms of expertise and, therefore, must be complemented with a range of alternative governance methods; (4) current laboratory biosafety and biosecurity review processes may not capture gene drive research or its components in practice even if they are covered theoretically; (5) risk management for research and development must incorporate discussions of values and broader implications of the work; and (6) a regular technology horizon scanning capacity is needed for the early identification of advances that could pose governance system challenges.
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).
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.
Deficits of Public Deliberation in U.S. Oversight for Gene Edited Organisms
19650J. Kuzma, Hastings Center Report, 51 Suppl 2:S25-s33. 2021-12-14 18:49:23.
Environmental releases of gene edited (GEdOs) and gene drive organisms (GDOs) will likely occur under conditions of high uncertainty and in complex socioecological systems. Therefore, public deliberation is especially important to account for diverse interpretations of safety, risks, and benefits; to draw on experiential and public wisdom in areas of proposed release; to ameliorate dangers of technological optimism; and to increase the public legitimacy of decisions. Yet there is a "democratic deficit" in the United States' oversight system for GEdOs and GDOs, as unconflicted experts, publics, and skeptical stakeholders are most often excluded from decision-making and unavailable to critically examine potential risks and benefits or raise broader concerns about socioeconomic or cultural impacts. This article argues for the need to open up decision-making for GEdOs and GDOs, discusses the challenges for doing so within the current oversight framework, and finally, proposes institutional, policy, and attitudinal changes that are likely important for overcoming barriers to public deliberation.
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.
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.
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.
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.
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.
New report demands moratorium on gene drives
18792GM Watch, GM Watch, 2021-09-21 13:49:44.
To help the public understand what's at stake, the Germany-based NGO Save Our Seeds (SOS) has published a report, "Gene Drives: The New Dimension of Genetic Engineering", which can be downloaded as a pdf document. The report provides a scientifically founded overview of how gene drive systems work, their possible areas of application, and the scientific discussion about their risks. It summarises the status of legislation and regulation at the German, European and global levels and recommends urgent political measures. The report explains how gene drives could be used in agriculture – research is focused on controlling pests and weeds and reversing the herbicide resistance in weeds that was caused and exacerbated by the spread of GM herbicide-tolerant crops. Not coincidentally, the report also notes that gene drives could be employed as bioweapons – for example, to eradicate beneficial insects in a region. The report points out, "The US military‘s Defense Advanced Research Projects Agency (DARPA) is one of the largest funders of gene drive research and is financially involved in almost every gene drive research project."
Gene Drive Organisms: A new dimension of genetic engineering
18790V. Henn and M. Imken, Save Our Seeds, 2021-09-21 13:42:53.
Enabled by new genetic engineering techniques such as CRISPR/Cas9, so-called gene drives have been developed in recent years that enable humans to spread new genes throughout the genome of wild animal populations. Gene drives force the inheritance of newly introduced genes to be inherited by all offspring, even if this lowers the survival chances of the affected species. In the most extreme case, gene drive technology could drive an entire species to extinction or replace wild populations with genetically modified organisms.
Gene Drive-Modified Organisms: Developing Practical Risk Assessment Guidance
34039Devos, Yann et al. Trends in Biotechnology, Volume 39, Issue 9:853 – 856. 2021-09-15 00:00:00.
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.
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.
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.
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
US Gene Drive Governance: A Special Feature in Health Security
16685L. Warmbrod, A. Kobokovich, R. West, G. K. Gronvall and M. Montague, Health Security, 19:131-132. 2021-04-08 14:51:20.
The novel potential of gene drives and related genetic pest control measures highlights a gap in the oversight of products using such technologies in the United States. The US Coordinated Framework for Regulation of Biotechnology, as applied by US Environmental Protection Agency, the US Food and Drug Administration, and US Department of Agriculture, may not fully encompass modern synthetic biology techniques that have significantly expanded the scope of genetic modification technology applications.
Systematic identification of plausible pathways to potential harm via problem formulation for investigational releases of a population suppression gene drive to control the human malaria vector Anopheles gambiae in West Africa
16668J. B. Connolly, J. D. Mumford, S. Fuchs, G. Turner, C. Beech, A. R. North and A. Burt, Malaria Journal, 20:170. 2021-03-29 18:49:26.
Population suppression gene drive has been proposed as a strategy for malaria vector control. A CRISPR-Cas9-based transgene homing at the doublesex locus (dsxFCRISPRh) has recently been shown to increase rapidly in frequency in, and suppress, caged laboratory populations of the malaria mosquito vector Anopheles gambiae. Here, problem formulation, an initial step in environmental risk assessment (ERA), was performed for simulated field releases of the dsxFCRISPRh transgene in West Africa.
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.
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.
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.
Quantifying the risk of vector-borne disease transmission attributable to genetically modified vectors
16530G. R. Hosack, A. Ickowicz and K. R. Hayes, Royal Society Open Science, 8:201525. 2021-03-03 18:28:51.
The relative risk of disease transmission caused by the potential release of transgenic vectors, such as through sterile insect technique or gene drive systems, is assessed with comparison with wild-type vectors. The probabilistic risk framework is demonstrated with an assessment of the relative risk of lymphatic filariasis, malaria and o'nyong'nyong arbovirus transmission by mosquito vectors to human hosts given a released transgenic strain of Anopheles coluzzii carrying a dominant sterile male gene construct. Harm is quantified by a logarithmic loss function that depends on the causal risk ratio, which is a quotient of basic reproduction numbers derived from mathematical models of disease transmission. The basic reproduction numbers are predicted to depend on the number of generations in an insectary colony and the number of backcrosses between the transgenic and wild-type lineages. Analogous causal risk ratios for short-term exposure to a single cohort release are also derived. These causal risk ratios were parametrized by probabilistic elicitations, and updated with experimental data for adult vector mortality. For the wild-type, high numbers of insectary generations were predicted to reduce the number of infectious human cases compared with uncolonized wild-type. Transgenic strains were predicted to produce fewer infectious cases compared with the uncolonized wild-type.
GeneConvene Global Collaborative Webinar Series | Ecological Modeling in Risk Assessment of Gene Drives
16445Hector Quemada and David O'Brochta, 2021-02-23 18:20:53.
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.
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.
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.
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
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?
Laboratory biosafety manual, fourth edition
34044Geneva: World Health Organization; 2020 (Laboratory biosafety manual, fourth edition and associated monographs), Licence: CC BY-NC-SA 3.0 IGO, 2020-12-21 00:00:00.
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.
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.
A Gene Drive Could Wipe Out Mosquitoes. But What If We Want To Turn It Off?
15424A. Winkler, freethink, 2020-12-05 15:48:03.
Gene drives are powerful tools: they allow scientists to hack how animals pass down genes to their offspring. They could allow us to wipe out malaria-carrying mosquitoes, preserve endangered species, or fight off crop-eating pests. But once it's out in the wild, a gene drive can't be stopped from spreading — and that makes people nervous. If there are unintended consequences, we want to be able to pull the brakes. Now, UC San Diego researchers have developed a new genetic system that would let scientists halt or neutralize gene drives, even after they are released into the wild. The implications could be huge.
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.
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.
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.
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.
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
34032EFSA, 2020-10-15 00:00:00.
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.
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
Embracing Dynamic Models for Gene Drive Management
14596A. J. Golnar, E. Ruell, A. L. Lloyd and K. M. Pepin, Trends in Biotechnology, 2020-09-30 13:54:04.
We describe how quantitative tools can reduce risk uncertainty, streamline empirical research, guide risk management, and promote cross-sector collaboration throughout the process of gene drive technology development and implementation.
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.
Why the UK could end up deploying risky gene drives while ignoring natural biological control
14385J. Mathews, GM Watch, 2020-09-14 15:10:57.
First they cloned Dolly the sheep. Now they’re targeting grey squirrels
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.
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.
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.
Release of genetically modified mosquitoes in the Florida Keys put on hold
13355D. Goodhue, Miami Herald, 2020-07-21 19:27:08.
Opponents of a plan to release millions of genetically modified mosquitoes in the Florida Keys landed a temporary win on Tuesday.
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.
EPA approves field trials of genetically modified mosquito
13449A. Wernick, WBFO npr, 2020-07-17 16:18:01.
The Environmental Protection Agency has given biotech company Oxitec the go-ahead to test the effectiveness of genetically modified mosquitoes in parts of Florida and Texas. Oxitec has been developing genetically modified mosquitoes in hopes of reducing local populations of mosquitoes that carry dengue fever, yellow fever and the Zika virus. About 750,000 people die each year from mosquito-borne illnesses, making the insect indirectly responsible for more human deaths than any other animal in the world.
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.
Who is afraid of genetically modified mosquitoes?
12738G. Odogwu, The PUNCH, 2020-06-25 13:27:54.
Genetically Modified Organisms have raised concerns in our clime, the same way they have in other countries of the world – where a clear line is drawn between the pro and the anti-GMO citizens. Nonetheless, this modern biotechnological technique is still at its infancy here. As of the moment, we can only boast of the development of the PBR cowpea as the only genetically modified food crop to be approved by the Nigerian government.
Mosquito district workshop focuses on Keys trials
12732S. Matthis, KEYSWEEKLY, 2020-06-25 13:21:52.
Now that the Oxitec “Friendly Mosquito” trials have been approved by the federal and state governments, it’s up to the Florida Keys Mosquito Control District to decide if, when and where to embrace the technology said to decrease the chances of mosquito-borne diseases such as dengue fever (there are two new cases in the Keys; see sidebar) and zika.
Genetically modified mosquitoes to be released in Florida and Texas
12735O. Ron, The Jerusalem Post, 2020-06-24 13:24:12.
A plan to release 750 million genetically modified mosquitoes in Florida and Texas has been approved, The Guardian reported. According to the plan, the Aedes aegypti mosquitoes will be released into the wild, as they contain a special protein that would kill female offspring, which are the ones who bite, and thus preventing the spread of such illnesses as dengue fever and Zika.
Before genetically modified mosquitoes are released, we need a better EPA
12720N. Kofler and J. Kuzma, The Boston Globe, 2020-06-22 13:07:55.
While the attention of the American public has rightfully been focused on the COVID-19 pandemic, its associated racial disparities, and broader issues of structural racism, the US government made a serious public health decision — one that could affect our health and our environment for generations to come. Last month, the US Environmental Protection Agency approved the release of genetically modified mosquitoes. Under a 2-year Experimental Use Permit, a company called Oxitec has been granted permission to release over 1 billion genetically modified mosquitoes across 6,600 acres in Florida and Texas.
Are Genetically Modified Mosquitoes Coming To Florida?
12726M. Taylor, Y100, 2020-06-19 13:13:35.
I'm not even going to lie, mosquitoes should be classified under domestic terrorism. The flying, biting bugs you can barely see wreak havoc on my life every single summer. I'm not sure if I'm allergic to them, but whenever I'm bit by them, that area of my skin swells up. It's the most annoying feeling in the world.
The Florida Keys are one step closer to getting genetically modified mosquitoes
12723D. Goodhue, Miami Herald, 2020-06-19 13:10:57.
An international biotech company is one step closer to being able to release genetically modified mosquitoes in the Florida Keys. The Florida Department of Agriculture and Consumer Services this week granted Oxitec an experimental use permit to release potentially millions of lab-made male Aedes aegypti mosquitoes throughout Monroe County. The goal is to wipe out the Keys population of the invasive bugs, which carry diseases like dengue fever, Zika and yellow fever. The Florida Department of Health reported a case of dengue fever in the Keys in March.
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?
The value of existing regulatory frameworks for the environmental risk assessment of agricultural pest control using gene drives
34040Jörg Romeis, Jana Collatz, Debora C.M. Glandorf, Michael B. Bonsall, Environmental Science & Policy, Volume 108:Pages 19-36. 2020-06-15 00:00:00.
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 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.
EPA Approves Genetically Modified Mosquito Trial For Florida Keys
11450Nancy Klingener, WLRN, 2020-05-07 18:22:34.
A plan to test genetically modified mosquitoes in the Florida Keys has received approval from the federal government.
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.
Beyond limits – the pitfalls of global gene drives for environmental risk assessment in the European Union
11458M. Dolezel, C. Lüthi and H. Gaugitsch, BioRisk, 15:1-29. 2020-05-04 14:58:37.
We evaluate the novel features of GDOs and outline the resulting challenges for the environmental risk assessment.
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 Touching Tipping Points
11251Brodee Breckling, Arnim von Gleich,, Gene Drives at Tipping Points, 2020-04-28 18:24:58.
Tipping points and tipping elements, phase transitions and similar critical phenomena are widely discussed in scientific as well as socio-economic contexts as components to understand unforeseen far reaching changes and critical transitions from one stage into another in complex systems caused by small perturbations or gradual changes. For the risk assessment of self-propagating artificial genetic elements in self-sustaining population wild populationsof animals or plants, it is crucial to understand, where tipping elements could become relevant, how they could be anticipated and to what extent surprises and unexpected effects might occur.
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.
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
34033EFSA, 2020-04-24 00:00:00.
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).
Engineering multiple species-like genetic incompatibilities in insects
12543M. Maselko, N. Feltman, A. Upadhyay, A. Hayward, S. Das, N. Myslicki, A. J. Peterson, M. B. O’Connor and M. J. Smanski, bioRxiv, 2020-04-05 17:32:23.
Speciation constrains the flow of genetic information between populations of sexually reproducing organisms. Gaining control over mechanisms of speciation would enable new strategies to manage wild populations of disease vectors, agricultural pests, and invasive species. Additionally, such control would provide safe biocontainment of transgenes and gene drives. Natural speciation can be driven by pre-zygotic barriers that prevent fertilization or by post-zygotic genetic incompatibilities that render the hybrid progeny inviable or sterile. Here we demonstrate a general approach to create engineered genetic incompatibilities (EGIs) in the model insect Drosophila melanogaster. Our system couples a dominant lethal transgene with a recessive resistance allele. EGI strains that are homozygous for both elements are fertile and fecund when they mate with similarly engineered strains, but incompatible with wild-type strains that lack resistant alleles. We show that EGI genotypes can be tuned to cause hybrid lethality at different developmental life-stages. Further, we demonstrate that multiple orthogonal EGI strains of D. melanogaster can be engineered to be mutually incompatible with wild-type and with each other. Our approach to create EGI organisms is simple, robust, and functional in multiple sexually reproducing organisms.
The value of existing regulatory frameworks for the environmental risk assessment of agricultural pest control using gene drive
8194J. Romeis, J. Collatz, D. C. M. Glandorf and M. B. Bonsall, Environmental Science & Policy, 108:19-36. 2020-03-27 20:20:04.
The application of (synthetic) gene drives is a powerful tool to control populations of insects that are agricultural pests, vectors of diseases, or a threat to biodiversity potentially leading to the local or global eradication of a species. The potential use of gene drive organisms has triggered a heated discussion regarding their environmental impacts and regulatory oversight. However, experience exists in assessing the environmental impacts of a number of established agricultural pest control methods that require the release of living organisms, that provide high levels of area-wide control and that might be irreversible. This includes classical biological control, the sterile insect technique, the incompatible insect technique that is based on the cytoplasmic incompatibility caused by Wolbachia endosymbionts, and genetically modified insects containing self-limiting traits. The different technologies are described, the regulatory practice and experience is summarized and pathways through which these control technologies could harm valued ecosystem services are presented. With a focus on the application of gene drives in agriculture, using the invasive Drosophila suzukii (Diptera: Drosophilidae) as a case study we then discuss to what extent the existing frameworks could assist the risk assessment of insects carrying gene drives. We suggest that drawing on existing practices, experiences and legislative frameworks will provide a pragmatic and proportionate approach to evaluate the environmental risks of novel solutions based on gene drive technologies.
Stakeholder workshop: Problem formulation for the environmental risk assessment of gene drive modified insects (15 May 2019, Brussels)
34038European Food Safety Authority (EFSA): Yann Devos, Barbara Gallani, Leslie G Firbank., EFSA Supporting Publications, Vol 17 (3). 2020-03-16 00:00:00.
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.
Phased Conditional Approach for Mosquito Management Using Sterile Insect Technique
7351J. Bouyer, H. Yamada, R. Pereira, K. Bourtzis and M. J. B. Vreysen, Trends in Parasitology, 2020-02-05 21:36:11.
Mosquito-borne diseases represent a major threat to humankind. Recently, the incidence of malaria has stopped decreasing while that of dengue is increasing exponentially. Alternative mosquito-control methods are urgently needed. The sterile insect technique (SIT) has seen significant developments recently and may play an important role. However, testing and implementing SIT for vector control is challenging, and a phased conditional approach (PCA) is recommended, that is, advancement to the next phase depends on completion of activities in the previous one. We herewith present a PCA to test the SIT against mosquitoes within an area-wide-integrated pest-management programme, taking into account the experience gained with plant and livestock pests and the recent developments of the technique against mosquitoes.
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.
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 cross-sectional survey of biosafety professionals regarding genetically modified insects
5650O’Brochta, D. A., W. K. Tonui, B. Dass and S. James, Applied Biosafety, 2019:1-9. 2019-12-17 17:57:33.
Background:Genetic technologies such as gene editing and gene drive create challenges for existing frameworks used to assess risk and make regulatory determinations by governments and institutions. Insect genetic technologies including transgenics, gene editing, and gene drive may be particularly challenging because of the large and increasing number of insect species being genetically modified and the degree of familiarity with these organisms and technologies by biosafety officials charged with making containment decisions.Methods:An anonymous online survey of biosafety professionals was distributed to the membership of ABSA International, a global society of biosafety professionals, to investigate their perspectives on their preparedness to meet these new challenges.Results:Existing guidance used to make containment decisions for nongenetically modified insects was widely seen as adequate, and most respondents thought the available guidance for making containment decisions for genetically modified insects with and without gene drives was inadequate. Most respondents reported having less confidence in their decisions concerning containment of genetically modified insects compared to decisions involving genetically modified microbes, (noninsect) animals, and plants.Conclusions:These results reveal a need for additional support for biosafety professionals to improve the quality of and confidence in containment decisions regarding genetically modified insects with and without gene drive. These needs might be addressed by increasing training, updating existing guidance, creating new guidance, and creating a third-party accreditation entity to support institutions. Sixty percent of the respondents said they either would or might use a voluntary third-party accreditation service to support insect containment decisions.
Plasmodium falciparum (Haemosporodia: Plasmodiidae) and O’nyong-nyong virus development in a transgenic Anopheles gambiae (Diptera: Culicidae) strain
5634Mumford, J. D., C. A. Long, S. C. Weaver, K. Miura, E. Wang, R. Rotenberry, E. M. Dotson and M. Q. Benedict, " Journal of Medical Entomology, 56:936-941. 2019-12-17 16:55:10.
ransgenic Anopheles gambiae Giles (Diptera: Culicidae) mosquitoes have been developed that confer sexual sterility on males that carry a transgene encoding a protein which cuts ribosomal DNA. A relevant risk concern with transgenic mosquitoes is that their capacity to transmit known pathogens could be greater than the unmodified form. In this study, the ability to develop two human pathogens in these transgenic mosquitoes carrying a homing endonuclease which is expressed in the testes was compared with its nontransgenic siblings. Infections were performed with Plasmodium falciparum (Welch) and o’nyong-nyong virus (ONNV) and the results between the transgenic and nontransgenic sibling females were compared. There was no difference observed with ONNV isolate SG650 in intrathoracic infections or the 50% oral infectious dose measured at 14 d postinfection or in mean body titers. Some significant differences were observed for leg titers at the medium and highest doses for those individuals in which virus titer could be detected. No consistent difference was observed between the transgenic and nontransgenic comparator females in their ability to develop P. falciparum NF54 strain parasites. This particular transgene caused no significant effect in the ability of mosquitoes to become infected by these two pathogens in this genetic background. These results are discussed in the context of risk to human health if these transgenic individuals were present in the environment.
What risk assessments of genetically modified organisms can learn from institutional analyses of public health risks
5628Rajan, S. R. and D. K. Letourneau, Journal of Biomedicine and Biotechnology, 2012:8. 2019-12-17 16:46:43.
The risks of genetically modified organisms (GMOs) are evaluated traditionally by combining hazard identification and exposure estimates to provide decision support for regulatory agencies. We question the utility of the classical risk paradigm and discuss its evolution in GMO risk assessment. First, we consider the problem ofuncertainty, by comparing risk assessment for environmental toxins in the public health domain with genetically modified organisms in the environment; we use the specific comparison of an insecticide to a transgenic, insecticidal food crop. Next, we examine normal accident theory (NAT) as a heuristic to consider runaway effects ofGMOs, such as negative community level consequences of gene flow from transgenic, insecticidal crops. These examples illustrate how risk assessments are made more complex and contentious by both their inherent uncertainty and the inevitability of failure beyond expectation in complex systems. We emphasize the value of conducting decision-support research, embracing uncertainty, increasing transparency, and building interdisciplinary institutions that can address the complex interactions between ecosystems and society. In particular, we argue against black boxing risk analysis, and for a program to educate policy makers about uncertainty and complexity, so that eventually, decision making is not the burden that falls upon scientists but is assumed by the public at large
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).
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 Mosquitoes: Ethics, Environment and Efficacy
18233L. Wilburn, ScienceInnovationUnion, 2019-09-20 17:06:38.
The Bill and Melinda Gates foundation has recently donated over $75 million to fund gene drive mosquito research by Target Malaria , a consortium that aims to develop technology for malaria control. The first planned release of gene drive mosquitoes is set to happen over the next two years in Burkina Faso, West Africa. But what exactly is gene drive, why do we need it and what are the wider implications of the technology? Malaria is a parasitic disease spread by the bite of the female Anopheles mosquito. Malaria can present as a range of symptoms including, mild fever, muscle pains (which can progress to severe malaria where the patient can experience severe anaemia and bleeding), renal failure, neurological disorders and death. In 2017, there were an estimated 219 million cases and 435,000 deaths attributed to malaria (1). Over 91% of these cases occurred in the Africa region, and children under the age of 5 were at the highest risk of contracting severe malaria. Fortunately, due to interventions such as insecticide-treated bed nets, indoor spraying of insecticides and improved medical infrastructure, from 2010-2017 malaria deaths were reduced by an estimated 28% (1). However, these control efforts may be severely jeopardised due to the rapid emergence of resistance to all insecticide classes and the most effective anti-malarial drugs (2, 3). Currently, there are only five classes of insecticides approved for public health use. In areas such as West Africa, there are multi-resistant mosquitoes which show resistance to all insecticide classes (4). Therefore, if the World Health Organisation (WHO) is to meet its goal of reducing global malaria by 90% by 2030, novel and effective strategies for malaria control must be identified (5). One such proposed strategy is gene drive mosquitoes.
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.
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).
Arthropod Containment Guidelines, Version 3.2
34042American Committee of Medical Entomology; American Society of Tropical Medicine and Hygiene, VECTOR-BORNE AND ZOONOTIC DISEASES, Volume 19, Number 3. 2019-06-15 00:00:00.
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.
Identification of fk-1;, a Meiotic Driver Undergoing RNA Editing in Neurospora
15131N. A. Rhoades, A. M. Harvey, D. A. Samarajeewa, J. Svedberg, A. Yusifov, A. Abusharekh, P. Manitchotpisit, D. W. Brown, K. J. Sharp, D. G. Rehard, J. Peters, X. Ostolaza-Maldonado, J. Stephenson, P. K. T. Shiu, H. Johannesson and T. M. Hammond, Genetics, 212:93. 2019-05-03 16:12:34.
These findings indicate that unedited and edited rfk-1 transcripts exist and that these transcripts could have different roles with respect to the mechanism of meiotic drive by spore killing. Regardless of RNA editing, spore killing only succeeds if rfk-1 transcripts avoid silencing caused by a genome defense process called meiotic silencing by unpaired DNA (MSUD). We show that rfk-1’s MSUD avoidance mechanism is linked to the genomic landscape surrounding the rfk-1 gene, which is located near the Sk-2 border on the right arm of chromosome III. In addition to demonstrating that the location of rfk-1 is critical to spore-killing success, our results add to accumulating evidence that MSUD helps protect Neurospora genomes from complex meiotic drive elements.
Using problem formulation for fit-for-purpose pre-market environmental risk assessments of regulated stressors
34034Yann Devos, Wendy Craig, Robert H Devlin, Alessio Ippolito, Rosalind A Leggatt, Jorg Romeis, Richard Shaw, Claus Svendsen and Christopher J Topping, EFSA Journal, 2019;17(S1):e170708. 2019-04-01 00:00:00.
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.
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.
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.
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.
An introduction to the proceedings of the environmental release of engineered pests: Building an international governance framewor
5646Brown, Z. S., L. Carter and F. Gould, BMC Proceedings, 12:10. 2018-12-17 17:44:54.
In October 2016, a two-day meeting of 65 academic, government and industry professionals was held at North Carolina State University for early-stage discussions about the international governance of gene drives: potentially powerful new technologies that can be used for the control of pests, invasive species and disease vectors. Presenters at the meeting prepared seven manuscripts elaborating on the ideas raised. This BMC Proceedings issue presents the collection of these peer-reviewed manuscripts.
Towards inclusive social appraisal: risk, participation and democracy in governance of synthetic biology
5642Stirling, A., K. R. Hayes and J. Delborne, BMC Proceedings, 12:15. 2018-12-17 17:05:25.
Frameworks that govern the development and application of novel products, such as the products of synthetic biology, should involve all those who are interested or potentially affected by the products. The governance arrangements for novel products should also provide a democratic mechanism that allows affected parties to express their opinions on the direction that innovation does or does not take. In this paper we examine rationales, obstacles and opportunities for public participation in governance of novel synthetic biology products. Our analysis addresses issues such as uncertainties, the considering of alternative innovations, and broader social and environmental implications. The crucial issues in play go beyond safety alone, to include contending social values around diverse notions of benefit and harm. The paper highlights the need for more inclusive social appraisal mechanisms to inform governance of Synthetic Biology and alternative products, and discusses a few practical methods to help achieve this goal.
Public engagement pathways for emerging GM insect technologies
5640Burgess, M. M., J. D. Mumford and J. V. Lavery, BMC Proceedings, 12(Suppl 8):12. 2018-12-17 17:02:52.
Policy and management related to the release of organisms generated by emerging biotechnologies for pest management should be informed through public engagement. Regulatory decisions can be conceptually distinguished into the development of frameworks, the assessment of the release of a specific modified organism, and implementation decisions such as location and timing. Although these decisions are often intertwined in practice, the negotiation takes place at different stages of technology development and suggests different roles for public engagement. Some approaches to public engagement are more appropriate for different purposes and situations, and it is not always obvious how to go about matching the approach to the purpose. In addition to the diverse technologies involved in generating modified organisms, there are diverse publics with particular interests and different kinds of knowledge. Institutional interests range from commercial development to public regulation and future uptake. Contextual features, such as agency mandates, may limit or structure the extent and approach to public engagement. Different convening groups (government agencies, public interest groups, academics, businesses) and the kind of decision that is being considered determine what kind of input is needed and how the engaging groups will be constituted. This paper considers how the context of the release of genetically modified insects for pest control requires expanding approaches to the design of the public engagement.
GM insect pests under the Brazilian regulatory framework: development and perspectives
5638Andrade, P. P., M. A. da Silva Ferreira, M. S. Muniz and A. de Casto Lira-Neto, BMC Proceedings, 12:15. 2018-12-17 17:00:23.
The emergence of new technologies for genetic modification has broadened the range of possible new products. The regulations of many countries that could benefit from these new products may not be prepared to assess risks and enable science-based decision-making. This is especially acute in the case of genetically modified insects with potential use in public health and agriculture. Modifications of the regulatory framework, sometimes necessary to allow a proper risk assessment of products from new technologies, are strongly influenced by political decisions derived from the balance of power and interest among stakeholders. This article discusses the genesis of the Brazilian regulatory framework, its applicability for the risk assessment of genetically modified insects and the scenarios that have shaped the two biosafety laws that established the basis for the use of modern biotechnology in the country. It is concluded that, for the adoption of the new technologies, it is important to carefully navigate the political tensions by seeking the engagement and empowerment of stakeholders supporting science-based decision-making in order to gather the necessary support for adoption of risk assessment as the basis for final decisions, allowing the use of new technologies.
Regulation of emerging gene technologies in India
5636Ahuja, V., BMC Proceedings, 12:14. 2018-12-17 16:57:35.
In India, genetically modified organisms (GMOs) and the products thereof are regulated under the “Rules for the manufacture, use, import, export & storage of hazardous microorganisms, genetically engineered organisms or cells, 1989” (referred to as Rules, 1989) notified under the Environment (Protection) Act, 1986. These Rules are implemented by the Ministry of Environment, Forest and Climate Change, Department of Biotechnology and State Governments though six competent authorities. The Rules, 1989 are supported by series of guidelines on contained research, biologics, confined field trials, food safety assessment, environmental risk assessment etc.
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.
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
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.
Gene drives promise great gains and great dangers
4552The Economist, The Economist, 2018-11-08 00:00:00.
Extinctions are seldom cause for celebration. Humans are wiping out species at a frightening rate, whether hunting them into history or, far more threateningly, damaging the habitats on which they depend. But occasionally, the destruction is warranted. Smallpox was officially eradicated in 1980, and no one laments the fate of the virus that caused it; campaigns to save the virus that causes polio are thin on the ground. How, then, to think about a new technology that will make driving a species to extinction far easier?
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 – 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.
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.
Developing standard operating procedures for gene drive research in disease vector mosquitoes
15680Z. N. Adelman, D. Pledger and K. M. Myles, Pathogens and Global Health, 111:436-447. 2018-01-18 14:41:42.
Here we discuss information to be considered by principal investigators, biosafety officers, and institutional biosafety committees as they work together to develop SOPs for experiments involving gene drive in arthropods, and describe various courses of action that can be used to maintain the effectiveness of SOPs through evaluation and revision. The information provided herein will be especially useful to investigators and regulatory personnel who may lack extensive experience working with arthropods under containment conditions.
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.
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
Guidance on the use of the weight of evidence approach in scientific assessments
34041EFSA Scientific Committee, Anthony Hardy, Diane Benford, Thorhallur Halldorsson, Michael John Jeger, Helle Katrine Knutsen, Simon More, Hanspeter Naegeli, Hubert Noteborn et al., EFSA Journal, 15 (8): 4971. 2017-08-03 00:00:00.
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.
Ethical issues associated with vector-borne diseases. Report of a WHO scoping meeting, Geneva, 23–24 February 2017
34043Geneva: World Health Organization, Licence: CC BY-NC-SA 3.0 IGO, WHO Reference Number: WHO/HTM/NTD/VEM/2017. 2017-02-24 00:00:00.
Unintended consequences of 21st century technology for agricultural pest management
4075Young, SL, EMBO reports, 18:1478-1478. 2017-01-13 00:00:00.
Comment on Agricultural pest control with CRISPR-based gene drive: time for public debate by Courtier-Orgogozo et al.
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.
CRISPR-based gene drive in agriculture will face technical and governance challenges
4045Gutzmann, NE, Johanna E.; Barnes, Jessica Cavin; Baltzegar, Jennifer; Jones, Michael S.; Sudweeks, Jayce, EMBO reports, 18:1479-1480. 2017-01-03 00:00:00.
Comment on "Agricultural pest control with CRISPR-based gene drive: time for public debate" by Courtier-Orgogozo et al.
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.
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.
Engineering the wild: Gene drives and intergenerational equity
6948J. Kuzma and L. Rawls, Jurimetrics, 56:279-296. 2016-03-01 16:08:02.
New genetic engineering methods are allowing scientists to insert genes into organisms that have the potential to spread themselves throughout natural populations upon the release of individuals carrying those genes. Gene drive technology is being researched and developed for purposes of reducing or eliminating human, ecological or agricultural pest populations, or immunizing other desirable or endangered species against pests and disease. The ability of humans to alter populations within ecosystems through genetic engineering raises issues associated with biodiversity and conservation that, in turn, may affect the abilities of current and future generations to use and enjoy the benefits of the natural world. Yet, children and future generations are not typically given voice in legal, policy, or ethical debates. This article examines several of the intergenerational equity issues posed by gene drive technologies. A typology of gene drive purposes and their potential ecological impacts is developed, followed by an examination of how they may intersect with concerns about intergenerational equity. To our knowledge, this analysis is the first to explore human intervention through genetically engineering populations in the wild and the impacts on future generations
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.
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.
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.
Scientific opinion addressing the safety assessment of plants developed through cisgenesis and intragenesis
34036EFSA Panel on Genetically Modified Organisms (GMO) European Food Safety Authority (EFSA), Parma, Italy, EFSA Journal, 0 (2): 2561. 2012-06-15 00:00:00.
Scientific opinion addressing the safety assessment of plants developed using Zinc Finger Nuclease 3 and other Site-Directed Nucleases with similar function
34035EFSA Panel on Genetically Modified Organisms (GMO). European Food Safety Authority (EFSA), Parma, Italy., EFSA Journal, 2012; 10 (10): 2943. 2012-06-15 00:00:00.
Biosafety for human health and the environment in the context of the potential use of genetically modified mosquitoes. Training Manual. A Tool for biosafety training (internet version) based on courses in Africa, Asia and Latin America, 2008-2011
34045World Health Organization, p. 242, 2011-06-15 00:00:00.
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.
Ethical, legal and social aspects of the approach in Sudan
25823B. B. El Sayed, C. A. Malcolm, A. Babiker, E. M. Malik, M. A. H. El Tayeb, N. S. Saeed, A. H. D. Nugud and B. G. J. Knols, Malaria Journal, 8:S3. 2009-11-16 10:10:31.
The global malaria situation, especially in Africa, and the problems frequently encountered in chemical control of vectors such as insecticide resistance, emphasize the urgency of research, development and implementation of new vector control technologies that are applicable at regional and local levels. The successful application of the sterile insect technique (SIT) for the control of the New World screwworm Cochliomyia hominivorax and several species of fruit flies has given impetus to the use of this method for suppression or elimination of malaria vectors in some areas of Africa including Northern State of Sudan. The research and development phase of the Northern State feasibility study has been started. Sudanese stakeholders are working side-by-side with the International Atomic Energy Agency in the activities of this important phase. Several ethical, legal and social issues associated with this approach arose during this phase of the project. They need to be seriously considered and handled with care. In this paper, these issues are described, and the current and proposed activities to overcome potential hurdles to ensure success of the project are listed.
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.
DIRECTIVE 2001/18/EC OF THE EUROPEAN PARLIAMENT AND OF THE COUNCIL of 12 March 2001 on the deliberate release into the environment of genetically modified organisms and repealing Council Directive 90/220/EEC
34037THE EUROPEAN PARLIAMENT AND OF THE COUNCIL, 2001-03-12 00:00:00.
