Legal aspects of nanotechnology vs. COVID 19 / Aspectos jurídicos de la nanotecnología frente a COVID 19

Despite the lack of specific regulatory guidelines, many nanomedicines are on the market and their number is growing steadily. These are mainly used in cancer therapy because they require persistent toxic compounds and the tumor landscape is very difficult, which hinders effective drug treatment. The lack of formal regulation of nanomedicines and the manufacture of nanomaterials for health-related applications is a worldwide problem. Inconsistency among differentgovernment agencies results in some nanomedicines being classified as medicaldevices and others as drugs. Therefore, a global consortium for nanomaterialsregulation should be formed to advance these agendas and issue formal guidance to the research communities. Currently, in the context of nanomaterials in the European Union, we are dealing with both binding legal acts and non-binding legal acts, such as recommendations on the fair conduct of scientific research or on the application of a uniform definition of nanomaterials.

A pesar de la falta de directrices regulatorias específicas, encontramos en el mercado un número creciente de nanomedicinas. Se utilizan, sobre todo, en la terapia del cáncer, ya que requieren compuestos tóxicos persistentes y el paisaje tumoral es muy difícil, lo que dificulta un tratamiento farmacológico eficaz. La falta de regulación oficial de los nanomedicamentos y la fabricación de nanomateriales para aplicaciones relacionadas con la salud es un problema mundial. La incoherencia entre las distintas agencias gubernamentales hace que algunas nanomedicinas se clasifiquen como dispositivos médicos y otras como fármacos. Por lo tanto, debería formarse un consorcio mundial para la regulación de los nanomateriales con el fin de avanzar en esta agenda y emitir orientaciones formales para las comunidades investigadoras. En la actualidad, en el contexto de los nanomateriales en la Unión Europea, encontramos tanto herramientas jurídicas vinculantes, como no vinculantes; tal es el caso de las recomendaciones sobre la adecuada realización de investigación científica o sobre la aplicación de una definición uniforme de los nanomateriales. (AU)

Nanomaterials in the Environment: Research Hotspots and Trends.

Research on the field of nanomaterials in environment has continued to be a major area of interest in recent years. To present the up-to-date progress in this field, a bibliometric study is conducted to analyze 7087 related publications in the Science Citation Index (SCI) core collection of Web of Science based on the expanded SCI. These publications are identified through using representative keywords in the research directions environment of the Web of Science. This study finds that China and the United States dominate the field; one difference between them is that China issued more independent publications and the United States issued more cooperative publications. In addition, the number of the related publications in Asian countries has exceeded that of European and American ones. A Chinese institution, the Chinese Academy of Sciences, has an absolute dominance in this field. Traditional high-impact environmental journals have ruled this field. The number of publications in the Energy and Environmental Science field has gradually decreased. In addition, a co-citation analysis shows that previous studies in this field can be divided into four major branches, and that graphene oxide and nano-inorganic particles are increasingly becoming research hotspots.

From fundamental supramolecular chemistry to self-assembled nanomaterials and medicines and back again - how Sam inspired SAMul.

This feature article provides a personal insight into the research from my group over the past 10 years. In particular, the article explains how, inspired in 2005 by meeting my now-husband, Sam, who had cystic fibrosis, and who in 2011 went on to have a double lung transplant, I took an active decision to follow a more applied approach to some of our research, attempting to use fundamental supramolecular chemistry to address problems of medical interest. In particular, our strategy uses self-assembly to fabricate biologically-active nanosystems from simple low-molecular-weight building blocks. These systems can bind biological polyanions in highly competitive conditions, allowing us to approach applications in gene delivery and coagulation control. In the process, however, we have also developed new fundamental principles such as self-assembled multivalency (SAMul), temporary 'on-off' multivalency, and adaptive/shape-persistent multivalent binding. By targeting materials with applications in drug formulation and tissue engineering, we have discovered novel self-assembling low-molecular-weight hydrogelators based on the industrially-relevant dibenzylidenesorbitol framework and developed innovative approaches to spatially-resolved gels and functional multicomponent hybrid hydrogels. In this way, taking an application-led approach to research has also delivered significant academic value and conceptual advances. Furthermore, beginning to translate fundamental supramolecular chemistry into real-world applications, starts to demonstrate the power of this approach, and its potential to transform the world around us for the better.

Review of achievements of the OECD Working Party on Manufactured Nanomaterials' Testing and Assessment Programme. From exploratory testing to test guidelines.

This paper charts the almost ten years of history of OECD's work on nanosafety, during which the programme of the OECD on the Testing and Assessment of Manufactured Nanomaterials covered the testing of eleven nanomaterials for about 59 end-points addressing physical-chemical properties, mammalian and environmental toxicity, environmental fate and material safety. An overview of the materials tested, the test methods applied and the discussions regarding the applicability of the OECD test guidelines, which are recognised methods for regulatory testing of chemicals, are given. The results indicate that many existing OECD test guidelines are suitable for nanomaterials and consequently, hazard data collected using such guidelines will fall under OECD's system of Mutual Acceptance of Data (MAD) which is a legally binding instrument to facilitate the international acceptance of information for the regulatory safety assessment of chemicals. At the same time, some OECD test guidelines and guidance documents need to be adapted to address nanomaterials while new test guidelines and guidance documents may be needed to address endpoints that are more relevant to nanomaterials. This paper presents examples of areas where test guidelines or guidance for nanomaterials are under development.

Nanomaterial toxicity testing in the 21st century: use of a predictive toxicological approach and high-throughput screening.

The production of engineered nanomaterials (ENMs) is a scientific breakthrough in material design and the development of new consumer products. While the successful implementation of nanotechnology is important for the growth of the global economy, we also need to consider the possible environmental health and safety (EHS) impact as a result of the novel physicochemical properties that could generate hazardous biological outcomes. In order to assess ENM hazard, reliable and reproducible screening approaches are needed to test the basic materials as well as nanoenabled products. A platform is required to investigate the potentially endless number of biophysicochemical interactions at the nano/bio interface, in response to which we have developed a predictive toxicological approach. We define a predictive toxicological approach as the use of mechanisms-based high-throughput screening in vitro to make predictions about the physicochemical properties of ENMs that may lead to the generation of pathology or disease outcomes in vivo. The in vivo results are used to validate and improve the in vitro high-throughput screening (HTS) and to establish structure-activity relationships (SARs) that allow hazard ranking and modeling by an appropriate combination of in vitro and in vivo testing. This notion is in agreement with the landmark 2007 report from the US National Academy of Sciences, "Toxicity Testing in the 21st Century: A Vision and a Strategy" (http://www.nap.edu/catalog.php?record_id=11970), which advocates increased efficiency of toxicity testing by transitioning from qualitative, descriptive animal testing to quantitative, mechanistic, and pathway-based toxicity testing in human cells or cell lines using high-throughput approaches. Accordingly, we have implemented HTS approaches to screen compositional and combinatorial ENM libraries to develop hazard ranking and structure-activity relationships that can be used for predicting in vivo injury outcomes. This predictive approach allows the bulk of the screening analysis and high-volume data generation to be carried out in vitro, following which limited, but critical, validation studies are carried out in animals or whole organisms. Risk reduction in the exposed human or environmental populations can then focus on limiting or avoiding exposures that trigger these toxicological responses as well as implementing safer design of potentially hazardous ENMs. In this Account, we review the tools required for establishing predictive toxicology paradigms to assess inhalation and environmental toxicological scenarios through the use of compositional and combinatorial ENM libraries, mechanism-based HTS assays, hazard ranking, and development of nano-SARs. We will discuss the major injury paradigms that have emerged based on specific ENM properties, as well as describing the safer design of ZnO nanoparticles based on characterization of dissolution chemistry as a major predictor of toxicity.

Nanomaterials: a challenge for toxicological risk assessment?

Nanotechnology has emerged as one of the central technologies in the twenty-first century. This judgment becomes apparent by considering the increasing numbers of people employed in this area; the numbers of patents, of scientific publications, of products on the market; and the amounts of money invested in R&D. Prospects originating from different fields of nanoapplication seem unlimited. However, nanotechnology certainly will not be able to meet all of the ambitious expectations communicated, yet has high potential to heavily affect our daily life in the years to come. This might occur in particular in the field of consumer products, for example, by introducing nanomaterials in cosmetics, textiles, or food contact materials. Another promising area is the application of nanotechnology in medicine fueling hopes to significantly improve diagnosis and treatment of all kinds of diseases. In addition, novel technologies applying nanomaterials are expected to be instrumental in waste remediation and in the production of efficient energy storage devices and thus may help to overcome world's energy problems or to revolutionize computer and data storage technologies. In this chapter, we will focus on nanomaterials. After a brief historic and general overview, current proposals of how to define nanomaterials will be summarized. Due to general limitations, there is still no single, internationally accepted definition of the term "nanomaterial." After elaborating on the status quo and the scope of nanoanalytics and its shortcomings, the current thinking about possible hazards resulting from nanoparticulate exposures, there will be an emphasis on the requirements to be fulfilled for appropriate health risk assessment and regulation of nanomaterials. With regard to reliable risk assessments, until now there is still the remaining issue to be resolved of whether or not specific challenges and unique features exist on the nanoscale that have to be tackled and distinctively addressed, given that they substantially differ from those encountered with microsized materials or regular chemicals. Based on the current knowledge, we finally provide a proposal on how risk assessment in the nanofield could be achieved and how it might look like in the near future.

Historical overview of nanotechnology and nanotoxicology.

Although scientists have been studying nanoscience phenomena for many decades, technological developments in the second half of the twentieth century provided valuable tools that permitted researchers to study and develop materials in the nanoscale size range and helped formalize nanotechnology as a scientific field. This chapter provides a brief history of the field of nanotechnology, with an emphasis on the development of nanotoxicology as a scientific field. A brief overview of the worldwide regulatory activities for nanomaterials is also presented. The future development and safe use of nanomaterials in a diverse range of consumer products will be interesting, intellectually challenging, exciting, and hopefully very beneficial for the society.

120 years of nanosilver history: implications for policy makers.

Nanosilver is one nanomaterial that is currently under a lot of scrutiny. Much of the discussion is based on the assumption that nanosilver is something new that has not been seen until recently and that the advances in nanotechnology opened completely new application areas for silver. However, we show in this analysis that nanosilver in the form of colloidal silver has been used for more than 100 years and has been registered as a biocidal material in the United States since 1954. Fifty-three percent of the EPA-registered biocidal silver products likely contain nanosilver. Most of these nanosilver applications are silver-impregnated water filters, algicides, and antimicrobial additives that do not claim to contain nanoparticles. Many human health standards for silver are based on an analysis of argyria occurrence (discoloration of the skin, a cosmetic condition) from the 1930s and include studies that considered nanosilver materials. The environmental standards on the other hand are based on ionic silver and may need to be re-evaluated based on recent findings that most silver in the environment, regardless of the original silver form, is present in the form of small clusters or nanoparticles. The implications of this analysis for policy of nanosilver is that it would be a mistake for regulators to ignore the accumulated knowledge of our scientific and regulatory heritage in a bid to declare nanosilver materials as new chemicals, with unknown properties and automatically harmful simply on the basis of a change in nomenclature to the term "nano".

25 years of C60.

The discovery of buckminsterfullerene has had a widespread impact throughout science.

Elegance and empiricism.

C60 was discovered in 1985 but it took five years to confirm that this famous molecule was spherical. Chris Toumey revisits a debate that highlighted different approaches to science.

Health effects of nanomaterials.

With the rapid growth of nanotechnology and future bulk manufacture of nanomaterials comes the need to determine, understand and counteract any adverse health effects of these materials that may occur during manufacture, during use, or accidentally. Nanotechnology is expanding rapidly and will affect many aspects of everyday life; there are already hundreds of products that utilize nanoparticles. Paradoxically, the unique properties that are being exploited (e.g. high surface reactivity and ability to cross cell membranes) might have negative health impacts. The rapid progress in development and use of nanomaterials is not yet matched by toxicological investigations. Epidemiological studies implicate the ultrafine (nano-sized) fraction of particulate air pollution in the exacerbation of cardiorespiratory disease and increased morbidity. Experimental animal studies suggest that the increased concentration of nanoparticles and higher reactive surface area per unit mass, alongside unique chemistry and functionality, is important in the acute inflammatory and chronic response. Some animal models have shown that nanoparticles which are deposited in one organ (e.g. lung and gut) may access the vasculature and target other organs (e.g. brain and liver). The exact relationship between the physicochemistry of a nanoparticle, its cellular reactivity, and its biological and systemic consequences cannot be predicted. It is important to understand such relationships to enjoy the benefits of nanotechnology without being exposed to the hazards.