China\'s newly issued genome-edited crop safety assessment guidelines do not entirely deviate from the existing genetically modified regulatory regimes. However, there is an urgent need to reform the genome-edited regulatory framework based on scientific values and a novel regulatory philosophy that balances diverse values to enhance public trust.

CONCLUSIONS: Genome editing offers revolutionized solutions for plant breeding to sustain food production to feed the world by 2050. Therefore, genome-edited products are increasingly recognized via more relaxed legislation and community adoption. The world population and food production are disproportionally growing in a manner that would have never matched each other under the current agricultural practices. The emerging crisis is more evident with the subtle changes in climate and the running-off of natural genetic resources that could be easily used in breeding in conventional ways. Under these circumstances, affordable CRISPR-Cas-based gene-editing technologies have brought hope and charged the old plant breeding machine with the most energetic and powerful fuel to address the challenges involved in feeding the world. What makes CRISPR-Cas the most powerful gene-editing technology? What are the differences between it and the other genetic engineering/breeding techniques? Would its products be labeled as \"conventional\" or \"GMO\"? There are so many questions to be answered, or that cannot be answered within the limitations of our current understanding. Therefore, we would like to discuss and answer some of the mentioned questions regarding recent progress in technology development. We hope this review will offer another view on the role of CRISPR-Cas technology in future of plant breeding for food production and beyond.

At its current rate, the rise of antimicrobial-resistant (AMR) infections is predicted to paralyze our industries and healthcare facilities while becoming the leading global cause of loss of human life. With limited new antibiotics on the horizon, we need to invest in alternative solutions. Bacteriophages (phages)-viruses targeting bacteria-offer a powerful alternative approach to tackle bacterial infections. Despite recent advances in using phages to treat recalcitrant AMR infections, the field lacks systematic development of phage therapies scalable to different applications. We propose a Phage Foundry framework to establish metrics for phage characterization and to fill the knowledge and technological gaps in phage therapeutics. Coordinated investment in AMR surveillance, sampling, characterization, and data sharing procedures will enable rational exploitation of phages for treatments. A fully realized Phage Foundry will enhance the sharing of knowledge, technology, and viral reagents in an equitable manner and will accelerate the biobased economy.

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Argentina was the first country that enacted regulatory criteria to assess if organisms resulting from new breeding techniques (NBTs) are to be regarded as genetically modified organisms (GMOs) or not. The country has now accumulated 4 year of experience applying such criteria, reaching a considerable number of cases, composed mostly of gene-edited plants, animals, and microorganisms of agricultural use. This article explores the effects on economic innovation of such regulatory experience. This is done by comparing the cases of products derived from gene editing and other NBTs that have been presented to the regulatory system, against the cases of GMOs that have been deregulated in the country. Albeit preliminary, this analysis suggests that products from gene editing will have different profiles and market release rates compared with the first wave of products from the so called \"modern biotechnology.\" Gene editing products seems to follow a much faster development rate from bench to market. Such development is driven by a more diverse group of developers, and led mostly by small and medium enterprises (SMEs) and public research institutions. In addition, product profiles are also more diversified in terms of traits and organisms. The inferences of these findings for the agricultural and biotechnology sectors, particularly in developing countries, are discussed.

The primary international forum deliberating the regulation of \"synthetic biology\" is the Convention on Biological Diversity (CBD), along with its subsidiary agreements concerned with the biosafety of living modified organisms (LMOs; Cartagena Protocol on Biosafety to the CBD), and access and benefit sharing in relation to genetic resources (Nagoya Protocol to the CBD). This discussion has been underway for almost 10 years under the CBD agenda items of \"synthetic biology\" and \"new and emerging issues relating to the conservation and sustainable use of biological diversity,\" and more recently within the scope of Cartagena Protocol topics including risk assessment and risk management, and \"digital sequence information\" jointly with the Nagoya Protocol. There is no internationally accepted definition of \"synthetic biology,\" with it used as an umbrella term in this forum to capture \"new\" biotechnologies and \"new\" applications of established biotechnologies, whether actual or conceptual. The CBD debates are characterized by polarized views on the adequacy of existing regulatory mechanisms for \"new\" types of LMOs, including the scope of the current regulatory frameworks, and procedures and tools for risk assessment and risk mitigation and/or management. This paper provides an overview of international developments in biotechnology regulation, including the application of the Cartagena Protocol and relevant policy developments, and reviews the development of the synthetic biology debate under the CBD and its Protocols, including the major issues expected in the lead up to and during the 2020 Biodiversity Conference.

The policy of the United States government is to seek regulatory approaches, consistent with applicable laws, that protect health and the environment while reducing unnecessary regulatory burdens and avoiding unjustifiably inhibiting innovation, stigmatizing new technologies, or creating unnecessary trade barriers [Adapted from the National Strategy for Modernizing the Regulatory System for Biotechnology Products, Product of the Emerging Technologies Interagency Policy Coordination Committee\'s Biotechnology Working Group (OSTP 2016)]. U.S. agencies are focused on delivering health and environmental protection based on the best available science; establishing transparent, coordinated, predictable, and efficient regulatory practices across agencies; and promoting public confidence in the oversight of the products of biotechnology through clear and transparent public engagement [Adapted from the Task Force on Agriculture and Rural Prosperity Report (USDA 2017)]. U.S. agencies that regulate the products of agricultural biotechnology discuss regulatory approaches presented during the June 2018 OECD Conference on Genome Editing Applications in Agriculture, focusing on plants developed using genome editing.

The Conference of the Parties serving as the meeting of the Parties (COP-MOP) to the Cartagena Protocol on Biosafety to the Convention on Biological Diversity decided years ago to undertake the development of guidance on risk assessment of living modified organisms (LMOs) resulting from modern biotechnology, in order to assist the Parties to the protocol to conduct risk assessments in line with the principles and methodology described therein. After many years of working through ad hoc technical expert groups (AHTEG) and open-ended online forum discussions, including an extensive process to test and revise the guidance document, the COP-MOP did not decide to endorse the last version of the document when it was finally presented to them. A failure to achieve consensus that the guidance, as it had evolved, is relevant and useful is seen as a potential setback for many Parties to the protocol with little to no experience with risk assessment. There are a number of reasons for the lack of success in this attempt to develop useful guidance on risk assessment, including a poorly defined and shifting purpose, misplaced expertise, and a misguided testing process, mostly perpetuated by the constraints of using processes of the Convention. These problems with the development of the Guidance on Risk Assessment of LMOs are explored here in an effort to elucidate the missteps that should be avoided and the lessons that can be learned. Most prominent is a need to rely upon the expanding past and present experiences with actual cases of risk assessments of LMOs, if there is to be any further attempt to develop guidance on risk assessment under the Convention and its protocol.

The EU regulation of agricultural biotechnology is botched and convoluted: the pseudo-concept of \"Genetically Modified Organisms\" has no coherent semantic or scientific content. The reasons of the paradox by which the cultivation of \"GMOs\" is substantially banned in Europe, while enormous quantities of recombinant-DNA cereals and legumes are imported to be used as feedstuff, are explained. The Directive 2015/412, giving Member states the choice to refuse the cultivation of genetically engineered crops at a national or local level, paves the way for a mosaic-like, Harlequinesque form of protectionism: nothing resembling a well-regulated free market. In the meantime, importation of \"GMO\" feed goes on at full speed all over Europe. A proposal by the Commission to adjust the rules on importation according to those for cultivation has been rejected by the Parliament.This dynamics may be seen as an ongoing \"Schumpeterian\" chain of public choices: the calculus of consent drives politicians more than a science-based approach to law-making.  The EU should restart from scratch with the right concept, i.e. the careful examination of the pros and cons, the costs and benefits of each new agricultural product (\"GMO\" or otherwise), freely cultivated and/or imported, assessed case by case, at last acknowledging that the biotech processes used to create new varieties are of no practical or legal relevance. In doing so, the EU would pursue its stated \"better regulation\" approach, cancelling any sectoral and sectarian regulation.