Bill targeting Chinese firms worries U.S. researchers.

Biosecure Act could hinder science collaborations, limit sequencer purchases.

Biotechnological sovereignty is not a mere nationalist concept, it is a necessity for Colombia and Latin America.

During the pandemic, Latin American countries suffered the collapse of their health systems. This was caused by the high demand for care of patients infected with SARS-CoV-2, which was added to the care of patients with other diseases. The significant increase in demand for health services caused medical and laboratory supplies to decline rapidly. The COVID-19 pandemic exacerbated a health crisis in several developing countries, mainly caused by insufficient systematic policies for integrating scientific knowledge. The current Colombian government must formulate a Biotechnological or Biosecurity Sovereignty Law that guarantees scientific autonomy, ensuring that Colombia is self-sufficient in Science, Technology, and Innovation. Colombian government should also focus on establishing and developing pharmaceutical chemical production by acquiring active chemical ingredients from other countries. This strategy could reduce the production costs and final prices of medicines, as well as generate high-level employment and wealth for the country. In this way, the Colombian government could prevent shortage of essential medicines and excessive price increases by commercial intermediation. In conclusion, the manuscript focuses on the lack of biotechnological sovereignty in Colombia. We propose a model of a Latin American Science and Technology ecosystem to achieve biotechnological sovereignty via state funding of research, strengthening universities, and fostering participation among private companies and Ministries of Science, Education, Trade, and Health. Scientific autonomy based on innovative processes that strengthen biotechnological independence can contribute to the economy by generating gross added value, creating high-quality employment, and facilitating the appropriation and social dissemination of knowledge, and cost reduction.

Regulatory framework for genetically modified organisms in the Kingdom of Eswatini.

The Kingdom of Eswatini is a Party to the Convention on Biological Diversity and to the Cartagena Protocol on Biosafety. As Party, Eswatini has domesticated these agreements by passing the Biosafety Act, of 2012 to provide for the safe handling, transfer, and use of living modified organisms (LMOs) in the country. The Act regulates living modified organisms to be used for confined field trials, commercial release, import, export, and transit, and for food, feed, and processing. Guidance is provided for prospective applicants before any application is made to the Competent Authority. This framework also provides for the regulation of emerging technologies such as synthetic biology and genome editing. The regulatory framework for living modified organisms aims to provide an enabling environment for the precautionary use of modern biotechnology and its products in the country in order to safeguard biological diversity and human health.

Biotechnology executive order opens door for regulatory reform and social acceptance of genetically engineered microbes in agriculture.

In the United States, regulatory review of genetically engineered microbes for agriculture falls under the Coordinated Framework for the Regulation of Biotechnology (CFRB). However, the lack of a centralized regulatory pathway and multiple oversight authorities can lead to uncertainty in regulatory review. Using three microbial-based technologies for agriculture as illustrative examples, this commentary identifies the weaknesses and challenges associated with the CFRB by assessing the current system and proposed changes to the system under a multi criteria decision analysis framework. In addition, it discusses opportunities for regulatory reform to improve clarity, efficiency, and public acceptance of genetically engineered microbes in agriculture under the CHIPS and Science Act and the 2022 Executive Order on the Bioeconomy.

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.

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.

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.

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.

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.