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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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

This introduction to the special issue focuses on the economics of labeling genetically modified (GM) foods and implications of GM-labeling policies and the specific contributions of papers included. [ABSTRACT FROM AUTHOR]

Abstract: The unintended presence of traces of genetically modified (GM) crops in the harvests of non‐GM crops plays a prominent role in the debate over the coexistence of GM and non‐GM crops. One way to address the issue is the formation of GM‐free or GM‐only clubs. We model the decisions of individual farmers to cultivate either GM or non‐GM crops and combine this with a game theoretic model of club formation to investigate the feasibility of such clubs. We consider two liability regimes: GM farmers are liable or they are not. We consider two benchmarks: Nash equilibrium without negotiations and the efficient allocation and compare those with partial co‐operation through a Coasean club. We find that in both regimes a relatively large club can form but they are not always necessary to reach the efficient allocation. In fact, if farmers can freely decide under profit maximisation what to cultivate, they reach 95% of an efficient allocation. This holds independent of the property rights system and provides strong support for coexistence policies based on ex‐post liability such as in the US and Spain. [ABSTRACT FROM AUTHOR]

A number of new crops have been developed that address important traits of particular relevance for smallholder farmers in Africa. Scientists, policy makers, and other stakeholders have raised concerns that the approval process for these new crops causes delays that are often scientifically unjustified. This article develops a real option model for the optimal regulation of a risky technology that enhances economic welfare and reduces malnutrition. We consider gradual adoption of the technology and show that delaying approval reduces uncertainty about perceived risks of the technology. Optimal conditions for approval incorporate parameters of the stochastic processes governing the dynamics of risk. The model is applied to three cases of improved crops, which either are, or are expected to be, delayed by the regulatory process. The benefits and costs of the crops are presented in a partial equilibrium that considers changes in adoption over time and the foregone benefits caused by a delay in approval under irreversibility and uncertainty. We derive the equilibrium conditions where the net-benefits of the technology equal the costs that would justify a delay. The sooner information about the safety of the technology arrive, the lower the costs for justifying a delay need to be i.e. it pays more to delay. The costs of a delay can be substantial: e.g. a one year delay in approval of the pod-borer resistant cowpea in Nigeria will cost the country about 33 million USD to 46 million USD and between 100 and 3,000 lives. [ABSTRACT FROM AUTHOR]

EU member states require farmers growing transgenic maize to respect a minimum distance from fields with non-transgenic maize. Previous studies have theoretically argued that such minimum distance requirements may lead to a so-called ‘domino effect’ where farmers who want to grow transgenic maize are forced to grow the non-transgenic variety and in turn impose the same constraints on their neighbors. This article applies a spatially explicit farm model to a dairy region in the Southern Netherlands to assess how farmers growing non-transgenic maize limit other farmers'' potential to grow transgenic herbicide-resistant maize. The results indicate that the minimum distance requirements can severely limit the benefits from herbicide resistant maize. Having different land use options in one farm, however, enables dairy farmers to grow transgenic maize despite having one or more neighbors growing non-transgenic maize. We also find that the share of the domino effect in the overall impact of minimum distance requirements decreases with the density of farmers not growing transgenic maize. [Copyright &y& Elsevier]

Abstract: Genetically modified (GM) crops and food are still controversial. This paper analyzes consumers’ perceptions and institutional awareness and trust toward GM banana regulation in Uganda. Results are based on a study conducted among 421 banana-consuming households between July and August 2007. Results show a high willingness to purchase GM banana among consumers. An explanatory factor analysis is conducted to identify the perceptions toward genetic modification. The identified factors are used in a cluster analysis that grouped consumers into segments of GM skepticism, government trust, health safety concern, and food and environmental safety concern. Socioeconomic characteristics differed significantly across segments. Consumer characteristics and perception factors influence consumers’ willingness to purchase GM banana. The institutional awareness and trust varied significantly across segments as well. The findings would be essential to policy makers when designing risk-communication strategies targeting different consumer segments to ensure proper discussion and addressing potential concerns about GM technology. [Copyright &y& Elsevier]

Summary: The decision to release a new transgenic crop variety for planting in the European Union (EU) is a decision under irreversibility and uncertainty. We use a real option model to assess the ex-ante incremental benefits and costs of the decision to release Bt maize and HT maize in the EU-15 member states. The analysis uses Eurostat data for modelling the benefits and costs of non-transgenic maize using partial equilibrium models. The farm-level benefits and costs of Bt maize and HT maize are derived from field trials conducted within the EU-funded ECOGEN project in combination with secondary data sources. Adoption curves, hurdle rates and Maximum Incremental Social Tolerable Irreversible Costs (MISTICs) are calculated at country level for selected EU-15 member states. In general, the results show that the MISTICs on a per capita level are very small confirming previous results calculated in values for the year 1995. The MISTICs per farm are much larger. This indicates a problem for decision makers. [Copyright &y& Elsevier]

In Germany, products derived from livestock who were fed GMO are not required to be labeled as GMO. However, non-GMO labeling requires compliance with the national public non-GMO production standard, including a confirmation that no GM feed was used. In addition to the national standard, firms can adopt a private collaborative certification standard set by a multi-stakeholder organization. Using a survey of German dairies, we show that firms with more suppliers were more likely to adopt the multi-stakeholder standard or to stay conventional if their perceived risk of reputation loss and liability issues for non-GMO production were higher. Firms with lower perceived risks were more likely to comply only with the public standard for non-GMO labeling (i.e., not adopt the private standard). We discuss how potential incongruent interests of the various stakeholders that set the private production and certification standard may have incentivized firms to adopt the non-GMO standard in the initial phase after the introduction of the labeling option. [ABSTRACT FROM AUTHOR]

A food system transformation is needed to address food and nutrition security, minimise impacts on planetary health, reduce climate change emissions, and contribute to equity, diversity, and the Sustainable Development Goals. This paper summarizes findings of the European Commission's High Level Expert Group on Food Systems Science, which reviewed obstacles that prevent food systems policy from achieving society-wide impacts. These barriers include knowledge and translation gaps in food-related science-policy-interfaces (SPIs), insufficient attention to the priorities of diverse stakeholders, and a failure to adequately consider equity, diversity, political economy, and societal engagements. Three potential pathways can ensure science and policy support food systems transformation: (1) Adapt the current SPI landscape with extra resources and a wider mandate to ensure coordinated action across the full food system, (2) Enhance the current policy landscape with a range of multisectoral taskforces designed to fulfill specific functions such as creating an enhanced food systems data portal, and (3) Establish a "network of networks" to provide both global coordination as well as organize defined agendas at global through to regional scales. In embarking on these pathways, a revised science-policy- society landscape (SPSIs) should deliver the following core functions: (1) Engage and empower multi-stakeholder dialogue; (2) Build capacity at multiple scales to translate evidence into tangible real-world outcomes; (3) Ensure access to openly accessible data for the entire food system; (4) Use models, forecasts, and scenario building exercises to explore the potential future of food systems; (5) Produce assessment reports and policy publications; and (6) Establish fora for diplomacy that will be empowered to create standards set targets and establish policy. • Engage multi-stakeholder dialogue and build capacity at national and local levels. • Ensure open access to data from across the food system. • Explore the future of food systems through modelling, forecasting, and scenarios. • Deliver independent assessment reports and policy pathway documents; and. • Create a forum for diplomacy, standards and target-setting and policy making. [ABSTRACT FROM AUTHOR]

Genetically engineered ( GE) crops are subject to regulatory oversight to ensure their safety for humans and the environment. Their approval in the European Union ( EU) starts with an application in a given Member State followed by a scientific risk assessment, and ends with a political decision-making step (risk management). In the United States ( US) approval begins with a scientific (field trial) step and ends with a 'bureaucratic' decision-making step. We investigate trends for the time taken for these steps and the overall time taken for approving GE crops in the US and the EU. Our results show that from 1996-2015 the overall time trend for approval in the EU decreased and then flattened off, with an overall mean completion-time of 1,763 days. In the US in 1998 there was a break in the trend of the overall approval time. Initially, from 1988 until 1997 the trend decreased with a mean approval time of 1,321 days; from 1998-2015, the trend almost stagnated with a mean approval time of 2,467 days. [ABSTRACT FROM AUTHOR]

In 1998, Genetically Modified (GM) maize entered European Agriculture. After the publication of the European Commission's guidelines on coexistence in 2003, Portugal developed ex-ante regulatory and ex-post tort liability rules on the coexistence of GM and non-GM maize crops. There is an on-going debate on the extent to which the coexistence policies affect adoption. In this study we measure the costs and benefits of planting GM maize as a member of a cooperative. All group members achieved a higher gross margin by planting GM maize rather than non-GM maize on their farms. Group members did not face any ex-post liability costs and had zero ex-ante regulatory costs as they could easily internalize the ex-ante coexistence regulations. The results show that coexistence regulations such as informing neighbors or keeping minimum distances do not necessarily lead to increased production costs provided they are flexible enough. [Copyright &y& Elsevier]

Abstract: We examined ways of improving the incentive structure of a safari company, the state, and the local communities within a wildlife co-management framework in Northern Cameroon. To this end, we built an integer linear programming model with state-allocated quotas and a profit maximisation objective function for a typical hunting concession. The model was evaluated under three scenarios representing varying taxation schemes and apportionment of trophy fees and company''s profits. Further, we set forth three principles that should underlie a good incentive structure, namely (i) a close link to the resource base, (ii) economic sustainability, and (iii) a transfer of land property rights from the state to the communities neighbouring the hunting areas. Our results indicate that the safari company would improve its profits if the concession term is extended to 15 years and a single business tax is substituted to the current myriad of levies. The local communities should be apportioned 25% of the trophy fees and a negotiated percentage of the company''s profit, in return for resource custodianship. Finally, the state could expect an increased efficiency of its conservation policy through an improved regulatory framework and a more equitable distribution of wildlife revenues. [Copyright &y& Elsevier]

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. Sustainable food systems will require profound changes in people's consumption patterns and lifestyles, which is true regardless of the farming methods used and does not change the fact that organic farming often requires more land than conventional farming for the same quantity of food output. Some features of organic farming in the EU contribute to the Sustainable Development Goals (SDGs); other features may jeopardize the achievement of SDGs 2, 13, and 15. The negative indirect effects of additional land-use change may outweigh the positive direct effects on global climate and biodiversity, so that a large-scale switch to organic farming in the EU could possibly turn out to be a disservice to global sustainability. Achieving the SDGs would benefit from the inclusion of biotech innovations in organic farming. The implementation of required changes in the EU law is unlikely under current political realities but is nevertheless recommended from a scientific perspective. [ABSTRACT FROM AUTHOR]

We discuss a diversity measure combining information of relative abundances and taxonomic distinctiveness suggested by Ricotta (2004). We show that Ricotta's measure violates weak species monotonicity, a condition that requires that the addition of a species should always increase a diversity index if abundances change only marginally. We suggest an alternative index satisfying weak species monotonicity and apply it to the ‘Zeesserveld’ forest reserve in the Netherlands. [ABSTRACT FROM AUTHOR]

Food self-sufficiency is an important contributor to food security, and one of the potential solutions to this problem is increased food production productivity through agricultural biotechnology. In this paper, we study the relationship between a country's genetically modified (GM) food policy and the food self-sufficiency rate (SSR) under conflicting interests, with the example of GM crop regulation and GM maize production in South Africa. We develop a theoretical model of a small open economy and investigate the GM food policy as the outcome of a GM and a non-GM food groups' lobbying game that follows the model of Grossman and Helpman. The government maximises its payoff by considering the weighted sum of social welfare and contributions from interest groups. Our findings suggest that a lower GM food regulation supports domestic agricultural production, and we offer potential reasons why a country that has a low SSR still has a strict GM food policy regulation. We also find that the food SSR is a biased measure of food availability when both production and consumption change simultaneously. [ABSTRACT FROM AUTHOR]

• An historical explanation for success and failure in crop technology uptake. • Emphasis on how regulations can block uptake. • Emphasis on necessary social and political factors to avoid blockage. • A projection for future uptake of CRISPR crops. Applications of new crop science often spread widely to reach farm fields, but sometimes they do not. The Green Revolution seeds first released in the 1960s and 1970s were taken up widely and quickly, but the transgenic GMO seeds first released in the 1990s, which also performed well, have remained highly restricted. After more than two decades, 84 percent of all GMO crop acres around the world are still in just four Western Hemisphere countries, and 97.2 percent of total acres are still planted to just four crops. The presence or absence of six "success factors" can explain these divergent uptake trajectories. The success factors are 1) a broad social agreement on the urgent need to boost food production, 2) an immediate and obvious benefit for farmers when they plant the new seeds 3) social trust in the institutions producing and delivering the new technology, 4) an absence of new consumer food safety concerns, 5) an absence of organized opposition from environmental advocacy groups, and 6) the absence of a simple means to detect the altered genetics of the new seeds. The Green Revolution seeds enjoyed all six of these success factors, while GMO seeds enjoyed only one of the six. This same approach can be used to predict the future uptake of genome-edited crops, which show three of the six success factors, predicting a rate of uptake slower than for the Green Revolution but wider and faster than for GMOs. A preliminary scan of national regulatory decisions being made toward genome-edited seeds strengthens this prediction. [ABSTRACT FROM AUTHOR]

Summary: 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. [ABSTRACT FROM AUTHOR]

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. [ABSTRACT FROM AUTHOR]

Summary: 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. [ABSTRACT FROM AUTHOR]

In the last two decades, voluntary standards have played an increasing role in reshaping the non-GMO labeling schemes in the EU and the US. This work compares the mandatory and voluntary labeling schemes for food produced from or with GMO in these two markets. After reviewing the EU and US regulatory frameworks, we introduce the incentives for the implementation of private and public voluntary standards. We describe the experiences of voluntary standards adoption by highlighting the development of non-GMO labeled products markets in EU and US. We emphasize the similarities between EU and US frameworks, the convergence between public and private standards, and identify the potential for future development of the non-GMO market. We conclude by describing the policy and economic implications of the development of the non-GMO labeled products markets and consequences of the regulation that will apply to crops derived by new genetic modification techniques. [ABSTRACT FROM AUTHOR]

Innovative biological pest control of the western corn rootworm (WCR) Diabrotica virgifera virgifera and wireworms Agriotes spp. in maize and potato cultivation in Europe is driven by (1) the economic damages caused and (2) the restrictions on chemical pesticides. We analyze the efficacy of biological control agents for WCR and wireworms based on European field trails. A partial equilibrium displacement model is used to estimate the changes in producer and consumer surplus for France, Italy, Spain, Germany, Austria and Romania given different adoption ceiling and adoption speed. Furthermore, the benefit of a potential reduction in pesticide use due to biological control application is evaluated. The results suggest a total annual welfare gain of ca. €190 million from biocontrol of WCR in maize production for the countries under consideration at an adoption ceiling and adoption speed of 30% and 2.41, respectively. In potato production, an annual welfare gain of over €2 million may be recorded in ecological and/or organic cultivation. Overall, the biological control methods provide an economical alternative in maize and can contribute to increase the competitiveness of European Union (EU) agriculture, while they look promising for certified organic potato production at the current level of control efficiency. [ABSTRACT FROM AUTHOR]

The policy debates on plant protection products (PPPs) in the European Union (EU) are dominated by the environmental implications of crop protection (in particular, the use of herbicides) and the concentration of the herbicide industry. This article aims at presenting an overview of the patterns herbicide usage over time between and within European countries, and an overview of the industry structure. Potential determinants driving some of these differences are discussed, such as the recent PPP policies adopted by the EU. Results show that herbicides are the most important input used in crop protection, but regional differences are substantial. The concentration of the industry is high, but below levels that would raise concerns by EU regulators. The sector is also highly regulated, which contributes to a high concentration and a consequent decline in innovations. This finding raises the possibility of substituting bans of active ingredients in herbicides with alternative solutions. [ABSTRACT FROM AUTHOR]

We estimate the perceived costs of legal requirements ('coexistence measures') for growing genetically modified (GM) Bt maize in Germany using a choice experiment. The costs of the evaluated ex-ante and ex-post coexistence measures range from zero to more than €300 per measure and most are greater than the extra revenue the farmers in our survey expect from growing Bt maize or than estimates in the literature. The cost estimates for temporal separation, the highest in our evaluation, imply that the exclusion of this measure in Germany is justified. The costliest measures of the ones that are currently applied in Germany are joint and strict liability for all damages. Our results further show that neighbours do not cause a problem and opportunities for reducing costs through agreements with them exist. Finally, we find that farmers' attitudes towards GM crops affect the probability of adoption of Bt maize. Our results imply that strict liability will deter the cultivation of Bt maize in Germany unless liability issues can be addressed through other means, for example, through neighbours agreements. [ABSTRACT FROM AUTHOR]

Abstract: Biofuel substitution for fossil fuels has been recommended in the literature and promoted in many countries; however, there are concerns about its economic viability. In this paper we focus on the cost-effectiveness of fuels, i.e., we compare the social costs of biofuels and fossil fuels for a functional unit defined as 1 km of vehicle transportation. We base our empirical results on a case study in Vietnam and compare two biofuels and their alternative fossil fuels: ethanol and gasoline, and biodiesel and diesel with a focus on the blends of E5 and E10 for ethanol, and B5 and B10 for biodiesel. At the discount rate of 4%, ethanol substitution for gasoline in form of E5 or E10 saves 33% of the social cost of gasoline if the fuel consumption of E5 and E10 is the same as gasoline. The ethanol substitution will be cost-effective if the fuel consumption of E5 and E10, in terms of L km−1, is not exceeding the consumption of gasoline by more than 1.7% and 3.5% for E5 and E10 respectively. The biodiesel substitution would be cost-effective if the fuel consumption of B5 and B10, in terms of L km−1 compared to diesel, would decrease by more than 1.4% and 2.8% for B5 and B10 respectively at the discount rate of 4%. [Copyright &y& Elsevier]

Abstract: Biofuel production has been promoted to save fossil fuels and reduce greenhouse gas (GHG) emissions. However, there have been concerns about the potential of biofuel to improve energy efficiency and mitigate climate change. This paper investigates energy efficiency and GHG emission saving of cassava-based ethanol as energy for transportation. Energy and GHG balances are calculated for a functional unit of 1 km of road transportation using life-cycle assessment and considering effects of land use change (LUC). Based on a case study in Vietnam, the results show that the energy input for and GHG emissions from ethanol production are 0.93 MJ and 34.95 g carbon dioxide equivalent per megajoule of ethanol respectively. The use of E5 and E10 as a substitute for gasoline results in energy savings, provided that their fuel consumption in terms of liter per kilometer of transportation is not exceeding the consumption of gasoline per kilometer by more than 2.4% and 4.5% respectively. It will reduce GHG emissions, provided that the fuel consumption of E5 and E10 is not exceeding the consumption of gasoline per kilometer by more than 3.8% and 7.8% respectively. The quantitative effects depend on the efficiency in production and on the fuel efficiency of E5 and E10. The variations in results of energy input and GHG emissions in the ethanol production among studies are due to differences in coverage of effects of LUC, CO2 photosynthesis of cassava, yields of cassava, energy efficiency in farming, and by-product analyses. [Copyright &y& Elsevier]

Corrections are presented to the articles regarding the use of herbicides by the plant protection products (PPP) industry in the Europe Union and active ingredients in herbicides.