Donor-acceptor Stenhouse adduct functionalised polymer microspheres.

Polymers that carry donor-acceptor Stenhouse adducts (DASAs) are a very relevant class of light-responsive materials. Capable of undergoing reversible, photoinduced isomerisations under irradiation with visible light, DASAs allow for on-demand property changes to be performed in a non-invasive fashion. Applications include photothermal actuation, wavelength-selective biocatalysis, molecular capture and lithography. Typically, such functional materials incorporate DASAs either as dopants or as pendent functional groups on linear polymer chains. By contrast, the covalent incorporation of DASAs into crosslinked polymer networks is under-explored. Herein, we report DASA-functionalised crosslinked styrene-divinylbenzene-based polymer microspheres and investigate their light-induced property changes. This presents the opportunity to expand DASA-material applications into microflow assays, polymer-supported reactions and separation science. Poly(divinylbenzene-co-4-vinylbenzyl chloride-co-styrene) microspheres were prepared by precipitation polymerisation and functionalised via post-polymerisation chemical modification reactions with 3rd generation trifluoromethyl-pyrazolone DASAs to varying extents. The DASA content was verified via 19F solid-state NMR (ssNMR), and DASA switching timescales were probed by integrated sphere UV-Vis spectroscopy. Irradiation of DASA functionalised microspheres led to significant changes in their properties, notably improving their swelling in organic and aqueous environments, dispersibility in water and increasing mean particle size. This work sets the stage for future developments of light-responsive polymer supports in solid-phase extraction or phase transfer catalysis.

Polymersome-based protein drug delivery - quo vadis?

Protein-based therapeutics are an attractive alternative to established therapeutic approaches and represent one of the fastest growing families of drugs. While many of these proteins can be delivered using established formulations, the intrinsic sensitivity of proteins to denaturation sometimes calls for a protective carrier to allow administration. Historically, lipid-based self-assembled structures, notably liposomes, have performed this function. After the discovery of polymersome-based targeted drug-delivery systems, which offer manifold advantages over lipid-based structures, the scientific community expected that such systems would take the therapeutic world by storm. However, no polymersome formulations have been commercialised. In this review article, we discuss key obstacles for the sluggish translation of polymersome-based protein nanocarriers into approved pharmaceuticals, which include limitations imparted by the use of non-degradable polymers, the intricacies of polymersome production methods, and the complexity of the in vivo journey of polymersomes across various biological barriers. Considering this complex subject from a polymer chemist's point of view, we highlight key areas that are worthy to explore in order to advance polymersomes to a level at which clinical trials become worthwhile and translation into pharmaceutical and nanomedical applications is realistic.

Corrigendum: Sustainable production of the cyanophycin biopolymer in tobacco in the greenhouse and field.

[This corrects the article DOI: 10.3389/fbioe.2022.896863.].

Sustainable Production of the Cyanophycin Biopolymer in Tobacco in the Greenhouse and Field.

The production of biodegradable polymers as coproducts of other commercially relevant plant components can be a sustainable strategy to decrease the carbon footprint and increase the commercial value of a plant. The biodegradable polymer cyanophycin granular polypeptide (CGP) was expressed in the leaves of a commercial tobacco variety, whose seeds can serve as a source for biofuel and feed. In T0 generation in the greenhouse, up to 11% of the leaf dry weight corresponded to the CGP. In T1 generation, the maximum content decreased to approximately 4% dw, both in the greenhouse and first field trial. In the field, a maximum harvest of 4 g CGP/plant could be obtained. Independent of the CGP content, most transgenic plants exhibited a slight yield penalty in the leaf biomass, especially under stress conditions in greenhouse and field trials. After the harvest, the leaves were either Sun dried or ensiled. The resulting material was used to evaluate the extraction of CGP compared to that in the laboratory protocol. The farm-level analysis indicates that the extraction of CGP from tobacco plants can provide alternative income opportunities for tobacco farmers. The CGP yield/ha indicates that the CGP production in plants can be economically feasible depending on the cultivation and extraction costs. Moreover, we analyzed the consumer acceptance of potential applications associated with GM tobacco in four European countries (Germany, Finland, Italy and the Netherlands) and found unexpectedly high acceptance.

Does China have a public debate on genetically modified organisms? A discourse network analysis of public debate on Weibo.

We examine stakeholder participation in the online debate on genetically modified organisms in China and assess how the debate has changed over time. Therefore, we compare messages posted between 2013 and 2020 on the Chinese microblog website Weibo by using discourse network analysis. Our findings reveal strong opposition to genetically modified crops, along with the existence of two competing coalitions of supporters and opponents. We further observe an increasing number of posts supporting genetically modified organisms by the public in recent years. Consequently, there is an indication that the positions of stakeholders have changed over time. We discuss the policy implications for China and draw conclusions for other countries.

The future of genome editing innovations in the EU.

The European Commission (EC) recommends that policy within the EU should consider how to make the regulation of new genomic techniques 'more resilient, future-proof and uniformly applied' than is presently the case. In this article, we explore what this might mean for the EU and what solutions might exist.

Europe's Farm to Fork Strategy and Its Commitment to Biotechnology and Organic Farming: Conflicting or Complementary Goals?

The European Commission's Farm to Fork (F2F) strategy, under the European Green Deal, acknowledges that innovative techniques, including biotechnology, may play a role in increasing sustainability. At the same time, organic farming will be promoted, and at least 25% of the EU's agricultural land shall be under organic farming by 2030. How can both biotechnology and organic farming be developed and promoted simultaneously to contribute to achieving the Sustainable Development Goals (SDGs)? We illustrate that achieving the SDGs benefits from the inclusion of recent innovations in biotechnology in organic farming. This requires a change in the law. Otherwise, the planned increase of organic production in the F2F strategy may result in less sustainable, not more sustainable, food systems.

The Cost of Postponement of Bt Rice Commercialization in China.

To maintain self-sufficiency in rice production and national food security, the Chinese government strongly supports research that aims at increasing the productivity of rice cultivation. Rice with genetic material from Bacillus thuringiensis (Bt rice) is transgenic rice that can reduce lepidopteran pest damage and the use of insecticides. It was developed in the 1990s and earned biosafety certificates in 2009. However, because of political reasons, its commercialization in China has been postponed, and, to date, Bt rice is not grown in China. We assess the opportunity cost of postponement of Bt rice commercialization in China between the years 2009 and 2019 and consider the external costs of pesticide use and potential technology spill-overs of Bt rice. We estimate the cost of postponement of Bt rice over the analyzed period to be 12 billion United States (US) dollars per year.

Getting an Imported GM Crop Approved in China.

What are the procedures and trends for obtaining approval for imported genetically modified (GM) crops in China, and how do approval dates and length of approval in China compare with those in other countries? The answers are crucial for current food security in China and the future of crops derived by gene editing.

Investing in antibiotics to alleviate future catastrophic outcomes: What is the value of having an effective antibiotic to mitigate pandemic influenza?

Over 95% of post-mortem samples from the 1918 pandemic, which caused 50 to 100 million deaths, showed bacterial infection complications. The introduction of antibiotics in the 1940s has since reduced the risk of bacterial infections, but growing resistance to antibiotics could increase the toll from future influenza pandemics if secondary bacterial infections are as serious as in 1918, or even if they are less severe. We develop a valuation model of the option to withhold wide use of an antibiotic until significant outbreaks such as pandemic influenza or foodborne diseases are identified. Using real options theory, we derive conditions under which withholding wide use is beneficial, and calculate the option value for influenza pandemic scenarios that lead to secondary infections with a resistant Staphylococcus aureus strain. We find that the value of withholding an effective novel oral antibiotic can be positive and significant unless the pandemic is mild and causes few secondary infections with the resistant strain or if most patients can be treated intravenously. Although the option value is sensitive to parameter uncertainty, our results suggest that further analysis on a case-by-case basis could guide investment in novel agents as well as strategies on how to use them.

Maximum vs minimum harmonization: what to expect from the institutional and legal battles in the EU on gene editing technologies.

New plant-breeding technologies (NPBTs), including gene editing, are widely used and drive the development of new crops. However, these new technologies are disputed, creating uncertainty in how their application for agricultural and food uses will be regulated. While in North America regulatory systems respond with a differentiated approach to NPBTs, the Court of Justice of the European Union (EU) has in effect made most if not all NPBT subject to the same regulatory regime as genetically modified organisms (GMOs). This paper discusses from a law and economics point of view different options that are available for the EU's multi-level legal order. Using an ex-ante regulation versus ex-post liability framework allows the economic implications of different options to be addressed. The results show that under current conditions, some options are more expensive than others. The least costly option encompasses regulating new crops derived from NPBTs similar to those used in 'conventional' breeding. The current regulatory situation in the EU, namely making the use of NPBTs subject to the same conditions as GMOs, is the most costly option. © 2019 The Authors. Pest Management Science published by John Wiley & Sons Ltd on behalf of Society of Chemical Industry.

The Economics of Regulating New Plant Breeding Technologies - Implications for the Bioeconomy Illustrated by a Survey Among Dutch Plant Breeders.

New plant breeding technologies (NPBTs) are increasingly used for developing new plants with novel traits. The science tells us that those plants in general are as safe as than those once developed using "conventional" plant breeding methods. The knowledge about the induced changes and properties of the new plants by using NPBTs is more precise. This should lead to the conclusion that plants developed using NPBTs should not be regulated differently than those developed using "conventional" plant breeding methods. This contribution discusses the economics of regulating new plant breeding technologies. We first develop the theoretical model and elaborate on the different regulatory approaches being used and compare their advantages and disadvantages. Then we provide a perspectives on EU regulation around mutagenesis-based New Plant Breeding Techniques (NPBT), formed by new insights from a survey among Dutch plant breeding companies. The survey measures the attitude of breeding companies towards the ruling of the EU Court of Justice that subjected the use of CRISPR-Cas in the development of new plant varieties under the general EU regulations around GMOs. The results show that plant breeders experience a financial barrier because of the ruling, with perceived negative impact on competitiveness and investments in CRISPR-Cas as a result. The degree of negative impact differs however significantly among seed-sectors and company sizes. One of the most striking results was the relative optimism of companies in the sector about more lenient legislation in the next five years, despite the stated negative effects.

Perspective: regulation of pest and disease control strategies and why (many) economists are concerned.

Pests and diseases are a continuous challenge in agriculture production. A wide range of control strategies have been and will continue to be developed. New control strategies are in almost all countries around the world assessed prior to approval for use in farmers' fields. This is rightly so to avoid and even reduce negative effects for human health and the environment. Over the past decades the approval processes have become increasingly politicized resulting in an increase in the direct approval costs and the length in approval time without increasing the safety of the final product. This reduces the development of control strategies and often has negative human health and environmental effects. Possibilities exist for improvements. They include reducing approval costs and approval time by streamlining the approval process and substituting approval requirements by strengthening ex-post liability. © 2018 Society of Chemical Industry.

A comparison of the EU and US regulatory frameworks for the active substance registration of microbial biological control agents.

BACKGROUND: Microbial biological control agents (MBCA) are biopesticides based on living microbes. They have huge potential for the control of pests and diseases, but have trouble reaching the European Union (EU) market. According to several authors, this is caused by the regulatory regime, which is less supportive compared with that in the USA. The main objective of this paper is to present regulatory differences between the USA and the EU, and the resulting effects and developments of registration in both regions. RESULTS: Results show that EU registration is more complex due to differences between EU- and Member State (MS)-level processes, large actor heterogeneity and low flexibility. As a result, EU registration takes, on average, ∼ 1.6 years longer than US registration. Regulatory amendments have improved EU-level processes and led to a significant contraction of procedural time spans, but processes at the MS level have not improved and have become a larger procedural obstacle. CONCLUSION: The results correspond with the idea that EU registration is complex and lengthy compared with that in the USA. To improve regulation, national-level processes should be targeted for amendment. To that end, the authors suggest various ways of expanding the registration capacity of MS. © 2018 The Authors. Pest Management Science published by John Wiley & Sons Ltd on behalf of Society of Chemical Industry.

A comparison of the EU regulatory approach to directed mutagenesis with that of other jurisdictions, consequences for international trade and potential steps forward.

A special regulatory regime applies to products of recombinant nucleic acid modifications. A ruling from the European Court of Justice has interpreted this regulatory regime in a way that it also applies to emerging mutagenesis techniques. Elsewhere regulatory progress is also ongoing. In 2015, Argentina launched a regulatory framework, followed by Chile in 2017 and recently Brazil and Colombia. In March 2018, the USDA announced that it will not regulate genome-edited plants differently if they could have also been developed through traditional breeding. Canada has an altogether different approach with their Plants with Novel Traits regulations. Australia is currently reviewing its Gene Technology Act. This article illustrates the deviation of the European Union's (EU's) approach from the one of most of the other countries studied here. Whereas the EU does not implement a case-by-case approach, this approach is taken by several other jurisdictions. Also, the EU court ruling adheres to a process-based approach while most other countries have a stronger emphasis on the regulation of the resulting product. It is concluded that, unless a functioning identity preservation system for products of directed mutagenesis can be established, the deviation results in a risk of asynchronous approvals and disruptions in international trade.

New Plant Breeding Techniques Under Food Security Pressure and Lobbying.

Different countries have different regulations for the approval and cultivation of crops developed by using new plant breeding technologies (NPBTs) such as gene editing. In this paper, we investigate the relationship between global food security and the level of NPBT regulation assuming a World Nation Official (WNO) proposes advice on global NPBT food policies. We show that a stricter NPBT food regulation reduces food security as measured by food availability, access, and utilization. We also find that political rivalry among interest groups worsens the food security status, given the NPBT food technology is more productive and the regulatory policy is influenced by lobbying. When the WNO aims to improve food security and weighs the NPBT food lobby contribution more than the non-NPBT food lobby's in the lobbying game, the total lobbying contributions will be the same for the WNO, and the NPBT food lobby will be more successful in the political process. The NPBT food lobby, however, under food security loses its advantage in the political competition, and this may result in a strict NPBT food policy. Under food security problems implementing stricter NPBT food regulations results in welfare losses. JEL Code: D04, D43, D72, P16.