Agricultural genetic technologies typically achieve their agronomic aims by introducing laboratorygenerated modifications into target species' chromosomes. However, the speed and flexibility of this approach are limited, because modified chromosomes must be vertically inherited from one generation to the next. In an effort to remove this limitation, an ongoing research program funded by the U.S. Defense Advanced Research Projects Agency (DARPA) aims to disperse infectious genetically modified viruses that have been engineered to edit crop chromosomes directly in fields. This is genetic engineering through horizontal transfer, as opposed to vertical inheritance. The regulatory, biological, economic, and societal implications of dispersing such horizontal environmental genetic alteration agents (HEGAAs) into ecosystems are profound. Further, this program stipulates that the means of delivery of these viral HEGAAs into the environment should be insect-based dispersion (1). In the context of the stated aims of the DARPA program, it is our opinion that the knowledge to be gained from this program appears very limited in its capacity to enhance U.S. agriculture or respond to national emergencies (in either the short or long term). Furthermore, there has been an absence of adequate discussion regarding the major practical and regulatory impediments toward realizing the projected agricultural benefits. As a result, the program may be widely perceived as an effort to develop biological agents for hostile purposes and their means of delivery, which-if true-would constitute a breach of the Biological Weapons Convention (BWC). Announced by DARPA in November 2016 (1), the Insect Allies program is reportedly backed by more than $27 million in awarded research contracts (2-4). In July 2017, first of three consortia announced that they had been awarded a contract from DARPA to develop systems for insect dispersion of genetically modified viruses (2-4). These are contracts for completion of a 4-year work plan (1) that will culminate in large-scale greenhouse demonstrations of the fully functional insect-dispersed HEGAA approach. Maize and tomato plants are reportedly being used in current experiments (2-4), while dispersal insect species mentioned include leafhoppers, whiteflies, and aphids (3, 5). Since its public inception, the Insect Allies program has almost exclusively been presented as a means for farmers to address routine agricultural concerns (e.g., drought, frost, flooding, salinity, herbicides, and disease) (2-4, 6). Despite a 2-year time frame for the generation of a functional proof-of-principle system in greenhouses (1), there has been little public explanation of how developments arising from conducting the work plan of the Insect Allies program might be applied to achieve the agricultural benefits highlighted by the funder or the researchers involved. HEGAA Regulatory Pathways? Although the program work plan does not fully prescribe the nature of the horizontal environmental "genetic alteration agent," it does sti...
The increasing availability of brain data within and outside the biomedical field, combined with the application of artificial intelligence (AI) to brain data analysis, poses a challenge for ethics and governance. We identify distinctive ethical implications of brain data acquisition and processing, and outline a multi-level governance framework. This framework is aimed at maximizing the benefits of facilitated brain data collection and further processing for science and medicine whilst minimizing risks and preventing harmful use. The framework consists of four primary areas of regulatory intervention: binding regulation, ethics and soft law, responsible innovation, and human rights.
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