Strategic environmental assessment: assessing the environmental impact of biotechnology

Poverty reduction, Agricultural research, Environmental protection, Genetically modified organisms, Crops, Agricultural biotechnology Research, Investments, Strategic Environmental Assessment,

Requirements for market entry of gene drive-modified mosquitoes for control of vector-borne diseases: analogies to other biologic and biotechnology products

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

Cantaloupe line CZW-30 containing coat protein genes of cucumber mosaic virus, zucchini yellow mosaic virus, and watermelon mosaic virus-2 is resistant to these three viruses in the field

Cantaloupe line CZW-30 containing coat protein gene constructs of cucumber mosaic cucumovirus (CMV), zucchini yellow mosaic potyvirus (ZYMV), and watermelon mosaic virus 2 potyvirus (WMV-2) was investigated in the field over two consecutive years for resistance to infections by CMV, ZYMV, and/or WMV-2. Resistance was evaluated under high disease pressure achieved by mechanical inoculations and/or natural challenge inoculations by indigenous aphid vectors. Across five different trials, homozygous plants were highly resistant in that they never developed systemic symptoms as did the nontransformed plants but showed few symptomatic leaves confined close to the vine tips. Hemizygous plants exhibited a significant delay (2-3 weeks) in the onset of disease compared to control plants but had systemic symptoms 9-10 weeks after transplanting to the field. Importantly, ELISA data revealed that transgenic plants reduced the incidence of mixed infections. Only 8% of the homozygous and 33% of the hemizygous plants were infected by two or three viruses while 99% of the nontransformed plants were mixed infected. This performance is of epidemiological significance. In addition, control plants were severely stunted (44% reduction in shoot length) and had poor fruit yield (62% loss) compared to transgenic plants, and most of their fruits (60%) were unmarketable. Remarkably, hemizygous plants yielded 7.4 times more marketable fruits than control plants, thus suggesting a potential commercial performance. This is the first report on extensive field trials designed to assess the resistance to mixed infection by CMV, ZYMV, and WMV-2, and to evaluate the yield of commercial quality cantaloupes that are genetically engineere

To reach the poor: results from the ISNAR-IFPRI Next Harvest study on genetically modified crops, public research, and policy implications

"Local farming communities throughout the world face productivity constraints, environmental concerns, and diverse nutritional needs. Developing countries address these challenges in a number of ways. One way is public research that produces genetically modified (GM) crops and recognize biotechnology as a part of the solution. To reach these communities, GM crops, after receiving biosafety agreement, must be approved for evaluation under local conditions. However, gaps between approvals in the developed and developing world grow larger, as the process of advancing GM crops in developing countries becomes increasingly difficult. In several countries, only insect resistant cotton has successfully moved from small, confined experimental trials to larger, open trials and to farms. By far, most GM crop approvals have been for commercial products that perform well under tropical conditions. However, complete information on public GM crop research in developing countries has not been assessed. “Will policies and research institutions in the developing world stimulate the safe use of publicly funded GM food crops?” The relatively few GM crops approved from public research, coupled with growing regulatory, biosafety capacity, trade, and political concerns, argue to the contrary. To tackle this issue, we identified and analyzed public research pipelines for GM crops among 16 developing countries and transition economies. Respondents reported 209 genetic transformation events for 46 different crops at the time when the survey was conducted. The pipelines demonstrate scientific progress among publicly funded crop research institutes in participating countries. Information and findings are presented for GM crops nearing final stages of selection. Additional details are provided for the types of genes and traits used, the breadth of genetic resources documented, implications for regulation, and the type of research partnerships employed. Regulations, GM crop approvals, choice of transgene, and policy implications are discussed as they affect this research. Based on these findings, recommendations are presented that would help sustain and increase efficiency of publicly supported research while meeting biosafety requirements. To do so, the study examines results concerning investments and choices made in research, capacity, and policy development for biotechnology. These indicate the risk and potential for GM technologies in developing countries. Policy makers, those funding biotechnology, and other stakeholders can use this information to prioritize investments, consider product advancement, and assess relative magnitude of potential risks, and benefits." Authors' Abstract

Results from the workshop “problem formulation for the use of gene drive in mosquitoes”.

CAPRISA, 2017.Abstract available in pdf

Assessment of risk of insect-resistant transgenic crops to nontarget arthropods

An international initiative is developing a scientifically rigorous approach to evaluate the potential risks to nontarget arthropods (NTAs) posed by insect-resistant, genetically modified (IRGM) crops. It adapts the tiered approach to risk assessment that is used internationally within regulatory toxicology and environmental sciences. The approach focuses on the formulation and testing of clearly stated risk hypotheses, making maximum use of available data and using formal decision guidelines to progress between testing stages (or tiers). It is intended to provide guidance to regulatory agencies that are currently developing their own NTA risk assessment guidelines for IRGM crops and to help harmonize regulatory requirements between different countries and different regions of the world

Guidance framework for testing of genetically modified mosquitoes

Reproduced in accordance with the publishers guidelines "The use of content from this health information product for all non-commercial education, training and information purposes is encouraged".Commissioned by TDR and the Foundation for the National Institutes of Health (FNIH), this framework was drafted by four different working groups (efficacy; safety; ethical, legal and social; and regulation), each of which received comments about their draft from experts in the field and the public. Genetically modified mosquitoes (GMM) engineered to be incapable of transmitting certain pathogens or able to reduce populations of similar native mosquito vectors have emerged as a promising new tool to combat vector-borne diseases like malaria and dengue in the more than 100 countries where they’re endemic. The guidance framework aims to foster quality and consistency among processes for testing and regulating new genetic technologies by proposing standards of efficacy and safety testing comparable to those used for trials of other new public health tools. The framework does not represent the views of the World Health Organization (WHO) or FNIH or provide recommendations on what to do. Rather, it is a document that brings together what is known, based on current research evidence, about how best to evaluate GMM