Revisions to USDA biotechnology regulations: The SECURE rule.

In keeping with the directive in Executive Order 13874 (Modernizing the Regulatory Framework for Agricultural Biotechnology Products) to adopt regulatory approaches that are proportionate to risk and avoid arbitrary distinctions across like products, the US Department of Agriculture (USDA) revised its biotechnology regulations by promulgating the Sustainable, Ecological, Consistent, Uniform, Responsible, and Efficient (SECURE) rule. Specifically, the SECURE rule 1) establishes exemptions for plants modified by genetic engineering where the modification could otherwise have been made through conventional breeding, 2) uses risk posed by the introduced trait to determine whether an organism is regulated, rather than relying on whether the organism was developed using a plant pest, and 3) provides a mechanism for a rapid initial review to efficiently distinguish plants developed using genetic engineering that do not pose plausible pathways to increased plant pest risk from those that do. As a result of the focused oversight on potentially riskier crops developed using genetic engineering, USDA is expected to improve the efficiency and effectiveness of its oversight program. The reduced regulatory burden is expected to promote innovation by expanding the number and diversity of developers to include smaller businesses and academics and to increase the number and variety of traits being developed through biotechnology.

Regulatory approaches for genome edited agricultural plants in select countries and jurisdictions around the world.

Genome editing in agriculture and food is leading to new, improved crops and other products. Depending on the regulatory approach taken in each country or region, commercialization of these crops and products may or may not require approval from the respective regulatory authorities. This paper describes the regulatory landscape governing genome edited agriculture and food products in a selection of countries and regions.

Precision Regulation Approach: A COVID-19 Triggered Regulatory Drive in South Korea.

COVID-19 has triggered various changes in our everyday lives and how we conceptualize the functions of governments. Some areas require stricter forms of regulation while others call for deregulation. The challenge for the regulatory authorities is to manage these potentially conflicting demands in regulation and define coherently their overall regulatory rationale. The precision regulation approach can be a helpful approach. It is defined here as a streamlined approach to regulation to deliver the right methods of regulation for the right group of people at the right time. This problem-solving innovation in regulation triggered by the recent epidemiologic crisis in South Korea demonstrates the emergence of the precision regulation approach. South Korea has implemented streamlined fast-track services for the biotechnology industry to produce test kits swiftly. This article expands the definition of precision regulation from AI regulation literature, and positions the term as a new regulatory rationale, not as a regulatory tool, using the case study from South Korea.

Production of Bulk Chemicals with Biocatalysis: Drivers and Challenges Reflected in Recent Industrial Granted Patents (2015-2020).

The application of biocatalysis and White Biotechnology tools in chemical areas concerning the production of bulk compounds and other related low-added value products (with high volumes) has been gaining importance in recent years. The expected drivers of biocatalysis for these sectors are energy savings, regioselectivity (leading to cleaner products), the possibility of using thermolabile substrates, as well as the generation of less by-products and manageable wastes. This paper explores some recent industrial granted patents related to biocatalysis and bulk chemicals. Several patents have been identified in fields such as biodiesel and esterification reactions, and sugar or furan chemistry. Overall, innovative strategies involve the identification of novel enzymes, the set-up of improved immobilization methods, as well as novel reactor designs that can offer improved performances and economics. The reported examples indicate that biocatalysis can certainly offer opportunities for these areas as well, far from the typical pharmaceutical and fine chemical applications often reported in the literature.

Legal and practical challenges to authorization of gene edited plants in the EU.

According to a predominant interpretation of the C-528/16 judgment of the Court of Justice of the European Union, mutants resulting from gene editing, even those featuring only single nucleotide variants, should be subject to the authorization procedures designed for organisms developed through genetic modification (i.e. insertion of large DNA fragments). In this article, we illustrate practical problems with the authorization of products of gene editing in the EU. On the basis of these problems, we analyze the influence of the current interpretation of EU legislation and judgment on the practical ability to authorize and detect such products on the EU market. We show that the predominant interpretation of the judgment leads to legally unacceptable consequences, in particular to the violation of the principle of proportionality with regard to individuals who wish to develop and market products of gene editing. As a result of our considerations, we show that the C-528/16 judgment did not need to be interpreted in the dominant way.

Biodegradable Plastics: Standards, Policies, and Impacts.

Plastics are ubiquitous in our society. They are in our phones, clothes, bottles, and cars. Yet having improved our lives considerably, they now threaten our environment and our health. The associated carbon emissions and persistency of plastics challenge the fragile balance of many ecosystems. One solution is using biodegradable plastics. Ideally, such plastics are easily assimilated by microorganisms and disappear from our environment. This can help reduce the problems of climate change, microplastics, and littering. However, biodegradable plastics are still only a tiny portion of the global plastics market and require further efforts in research and commercialization. Here, a critical overview of the state of the art of biodegradable plastics is given. Using a material flow analysis, the challenges of the plastic market are highlighted, and with it the large market potential of biodegradable plastics. The environmental and socio-economic impact of plastics, government policies, standards and certifications, physico-chemical properties, and analytical techniques are covered. The Review concludes with a personal outlook on the future of bioplastics, based on our own experience with their development and commercialization.

Why the Synthetic Cell Needs Democratic Governance.

Engineering synthetic cells from the bottom up is expected to revolutionize biotechnology. How can synthetic cells support societal transitions necessary to tackle our current global challenges in a socially equitable and sustainable manner? To answer this question, we need to assess socioeconomic considerations and engage in early constructive public dialogue.

[The crispr / cas9 techniques applied to human genetic enhancement: a biotechnological, anthropological-philosophical and legal dialogue]. / Las técnicas crispr/cas9 aplicadas al mejoramiento genético humano: un diálogo biotecnológico, antropológico-filosófico y jurídico.

The CRISPR editing method is revolutionary. This technique opens the possibility of countless operations in the genome of living beings. However, the risks are high and, in some cases, unpredictable. Therefore, based on an anthropology that recognizes the human person with an inherent dignity that includes the body, this article intends to propose bases for a regulation capable of facing the challenge of CRISPR, especially, given the possibility of confusing its therapeutic resource with the eugenics, also before the imminent risk of unleashing unforeseen consequences such as mutations, malformations and side effects that could be devastating for human life.

Synergy effect of science and technology policies on innovation: Evidence from China.

This paper explores the synergy effect of the government subsidies, tax incentives, and government procurement on innovation based on synergy theory, and further analyzes its path and mechanism in the process of innovation. We find that government subsidies, tax incentives, and government procurement exert positive synergy effect on innovation. Furthermore, in the process of innovation, government subsidies are shown to play strongest roles in the stages of innovation input and technological development, while government procurement is the most crucial in the transformation stage of technological innovation, and tax incentives play balanced roles. We also find that innovation resource input, innovation technology spillover, and innovation cooperation all play partial mediating roles in the synergy effect of science and technology policies on innovation. This paper applies the synergy theory to the field of innovation policies, which enriches and expands relevant researches, and provides micro-evidence for in-depth understanding of the effect of science and technology policies on innovation.

[Status quo of global bioindustry and its policy implications].

The advent of the bioeconomy era is triggers a new wave of technology and industrial revolution. Bioeconomy has become the commanding heights that major developed countries and emerging economies try to seize. This paper analyzes the spatiotemporal characteristics of global bioindustry development from four perspectives: biomedical industry, genetically modified crop planting industry, bioenergy industry, and bio-based chemical industry. Then it summarizes the main characteristics of the development of the global bioindustry, and further put forward policy recommendations for the bottleneck problems in the development of China's bioindustry, which can guide the future development of China's bioeconomy.

Options to Reform the European Union Legislation on GMOs: Post-authorization and Beyond.

We discuss options to reform the EU genetically modified organism (GMO) regulatory framework, make risk assessment and decision-making more consistent with scientific principles, and lay the groundwork for international coherence. In this third of three articles, we focus on labeling and coexistence as well as discuss the political reality and potential ways forward.

An open-source GIS-enabled lookup service for Nagoya Protocol party information.

The Nagoya Protocol on Access and Benefit Sharing is a transparent legal framework, which governs the access to genetic resources and the fair and equitable sharing of benefits arising from their utilization. Complying with the Nagoya regulations ensures legal use and re-use of data from genetic resources. Providing detailed provenance information and clear re-usage conditions plays a key role in ensuring the re-usability of research data according to the FAIR (findable, accessible, interoperable and re-usable) Guiding Principles for scientific data management and stewardship. Even with the framework provided by the ABS (access and benefit sharing) Clearing House and the support of the National Focal Points, establishing a direct link between the research data from genetic resources and the relevant Nagoya information remains a challenge. This is particularly true for re-using publicly available data. The Nagoya Lookup Service was developed for stakeholders in biological sciences with the aim at facilitating the legal and FAIR data management, specifically for data publication and re-use. The service provides up-to-date information on the Nagoya party status for a geolocation provided by GPS coordinates, directing the user to the relevant local authorities for further information. It integrates open data from the ABS Clearing House, Marine Regions, GeoNames and Wikidata. The service is accessible through a REST API and a user-friendly web form. Stakeholders include data librarians, data brokers, scientists and data archivists who may use this service before, during and after data acquisition or publication to check whether legal documents need to be prepared, considered or verified. The service allows researchers to estimate whether genetic data they plan to produce or re-use might fall under Nagoya regulations or not, within the limits of the technology and without constituting legal advice. It is implemented using portable Docker containers and can easily be deployed locally or on a cloud infrastructure. The source code for building the service is available under an open-source license on GitHub, with a functional image on Docker Hub and can be used by anyone free of charge.

Comparing agronomic and phenotypic plant characteristics between single and stacked events in soybean, maize, and cotton.

Genetically modified (GM) crops are one of the most valuable tools of modern biotechnology that secure yield potential needed to sustain the global agricultural demands for food, feed, fiber, and energy. Crossing single GM events through conventional breeding has proven to be an effective way to pyramid GM traits from individual events and increase yield protection in the resulting combined products. Even though years of research and commercialization of GM crops show that these organisms are safe and raise no additional biosafety concerns, some regulatory agencies still require risk assessments for these products. We sought out to investigate whether stacking single GM events would have a significant impact on agronomic and phenotypic plant characteristics in soybean, maize, and cotton. Several replicated field trials designed as randomized complete blocks were conducted by Monsanto Regulatory Department from 2008 to 2017 in field sites representative of cultivation regions in Brazil. In total, twenty-one single and stacked GM materials currently approved for in-country commercial use were grown with the corresponding conventional counterparts and commercially available GM/non-GM references. The generated data were presented to the Brazilian regulatory agency CTNBio (National Biosafety Technical Committee) over the years to request regulatory approvals for the single and stacked products, in compliance with the existing normatives. Data was submitted to analysis of variance and differences between GM and control materials were assessed using t-test with a 5% significance level. Data indicated the predominance of similarities and neglectable differences between single and stacked GM crops when compared to conventional counterpart. Our results support the conclusion that combining GM events through conventional breeding does not alter agronomic or phenotypic plant characteristics in these stacked crops. This is compatible with a growing weight of evidence that indicates this long-adopted strategy does not increase the risks associated with GM materials. It also provides evidence to support the review and modernization of the existing regulatory normatives to no longer require additional risk assessments of GM stacks comprised of previously approved single events for biotechnology-derived crops. The data analyzed confirms that the risk assessment of the individual events is sufficient to demonstrate the safety of the stacked products, which deliver significant benefits to growers and to the environment.