Tag Archives: European Commission

US Environmental Protection Agency finalizes its one-time reporting requirements for nanomaterials

The US Environmental Protection Agency (EPA) has announced its one-time reporting requirement for  nanomaterials. From a Jan. 12, 2017 news item on Nanowerk,

The U.S. Environmental Protection Agency (EPA) is requiring one-time reporting and recordkeeping requirements on nanoscale chemical substances in the marketplace. These substances are nano-sized versions of chemicals that are already in the marketplace.
EPA seeks to facilitate innovation while ensuring safety of the substances. EPA currently reviews new chemical substances manufactured or processed as nanomaterials prior to introduction into the marketplace to ensure that they are safe.

For the first time, EPA is using [the] TSCA [Toxic Substances Control Act] to collect existing exposure and health and safety information on chemicals currently in the marketplace when manufactured or processed as nanoscale materials.

The companies will notify EPA of certain information:
– specific chemical identity;
– production volume;
– methods of manufacture; processing, use, exposure, and release information; and,available health and safety data.

Reactions

David Stegon writes about the requirement in a Jan. 12, 2017 posting on Chemical Watch,

The US EPA has finalised its nanoscale materials reporting rule, completing a process that began more than 11 years ago.

The US position contrasts with that of the European Commission, which has rejected the idea of a specific mandatory reporting obligation for nanomaterials. Instead it insists such data can be collected under REACH’s registration rules for substances in general. It has told Echa [ECHA {European Chemicals Agency}] to develop ‘nano observatory’ pages on its website with existing nanomaterial information. Meanwhile, Canada set its reporting requirements in 2015.

The US rule, which comes under section 8(a) of TSCA, will take effect 120 days after publication in the Federal Register.

It defines nanomaterials as chemical substances that are:

  • solids at 25 degrees Celsius at standard atmospheric pressure;
  • manufactured or processed in a form where any particles, including aggregates and agglomerates, are between 1 and 100 nanometers (nm) in at least one dimension; and
  • manufactured or processed to exhibit one or more unique and novel property.

The rule does not apply to chemical substances manufactured or processed in forms that contain less than 1% by weight of any particles between 1 and 100nm.

Taking account of comments received on the rulemaking, the EPA made three changes to the proposed definition:

  • it added the definition of unique and novel properties to help identify substances that act differently at nano sizes;
  • it clarified that a substance is not a nanomaterial if it fits the specified size range, but does not have a size-dependent property that differs from the same chemical at sizes greater than 100nm; and
  • it eliminated part of the nanomaterial definition that had said a reportable chemical may not include a substance that only has trace amounts of primary particles, aggregates, or agglomerates in the size range of 1 to 100nm.

The EPA has added the new information gathering rule (scroll down about 50% of the way) on its Control of Nanoscale Materials under the Toxic Substances Control Act webpage.

There’s also this Jan. 17, 2017 article by Meagan Parrish for the ChemInfo which provides an alternative perspective and includes what appears to be some misinformation (Note: A link has been removed),

It was several years in the making, but in the final stages of its rule-making process for nanomaterial reporting, the Environmental Protection Agency declined to consider feedback from the industry.

Now, with the final language published and the rule set to go into effect in May, some in the industry are concerned that the agency is requiring an unnecessary amount of costly reporting that isn’t likely to reveal potential hazards. The heightened regulations could also hamper the pace of innovation underway in the industry.

“The poster child for nanotechnology is carbon nanotubes,” says James Votaw, a partner with Manatt, Phelps & Phillips, of the form of carbon that is 10,000 smaller than human hair but stronger than steel. “It can be used to make very strong materials and as an additive in plastics to make them electrically conductive or stiffer.”

The EPA has been attempting to define nanomaterials since 2004 and assess the potential for environmental or human health risks associated with their use. In 2008, the EPA launched an effort to collect voluntarily submitted information from key players in the industry, but after a few years, the agency wasn’t happy with amount of responses. The effort to create a mandatory reporting requirement was launched in 2010.

Yet, according to Votaw, after a 2015 proposal of the rule was extensively criticized by the industry for being overly ambiguous and overly inclusive of its coverage, the industry asked the EPA to reopen a dialogue on the rule. The EPA declined.

The new reporting requirement is expected to cost companies about $27.79 million during the first year and $3.09 million in subsequent years. [emphasis mine]

As far as I’m aware, this is a one-time reporting requirement. Although I’m sure many would like to see that change.

As for the Canadian situation, I mentioned the nanomaterials mandatory survey noted in Stegon’s piece in a July 29, 2015 posting. It was one of a series of mandatory surveys (currently, a survey on asbestos is underway) issued as part of Canada’s Chemicals Management Plan. You can find more information about the nanomaterials notice and approach to the survey although there doesn’t appear to have been a report made public but perhaps it’s too soon. From the Nanomaterials Mandatory Survey page,

The Government of Canada is undertaking a stepwise approach to address nanoscale forms of substances on the DSL. The proposed approach consists of three phases:

  • Establishment of a list of existing nanomaterials in Canada (this includes the section 71 Notice);
  • Prioritization of existing nanomaterials for action; and
  • Action on substances identified for further work.

The overall approach was first described in a consultation document entitled Proposed Approach to Address Nanoscale Forms of Substances on the Domestic Substances List, published on March 18, 2015. This consultation document was open for a 60-day public comment period to solicit feedback from stakeholders, particularly on the first phase of the approach.

A second consultation document entitled Proposed Prioritization Approach for Nanoscale Forms of Substances on the Domestic Substances List was published on July 27, 2016. In this document, the approach proposed for prioritization of existing nanomaterials on the DSL is described, taking into consideration the results of the section 71 Notice.  Comments on this consultation document may be submitted prior to September 25, 2016 …

I look forward to discovering a report on the Canadian nanomaterials survey should one be made public.

The Center for Nanotechnology in Society at the University of California at Santa Barbara offers a ‘swan song’ in three parts

I gather the University of California at Santa Barbara’s (UCSB) Center for Nanotechnology in Society is ‘sunsetting’ as its funding runs out. A Nov. 9, 2016 UCSB news release by Brandon Fastman describes the center’s ‘swan song’,

After more than a decade, the UCSB Center for Nanotechnology in Society research has provided new and deep knowledge of how technological innovation and social change impact one another. Now, as the national center reaches the end of its term, its three primary research groups have published synthesis reports that bring together important findings from their 11 years of activity.

The reports, which include policy recommendations, are available for free download at the CNS web site at

http://www.cns.ucsb.edu/irg-synthesis-reports.

The ever-increasing ability of scientists to manipulate matter on the molecular level brings with it the potential for science fiction-like technologies such as nanoelectronic sensors that would entail “merging tissue with electronics in a way that it becomes difficult to determine where the tissue ends and the electronics begin,” according to a Harvard chemist in a recent CQ Researcher report. While the life-altering ramifications of such technologies are clear, it is less clear how they might impact the larger society to which they are introduced.

CNS research, as detailed the reports, addresses such gaps in knowledge. For instance, when anthropologist Barbara Herr Harthorn and her collaborators at the UCSB Center for Nanotechnology in Society (CNS-UCSB), convened public deliberations to discuss the promises and perils of health and human enhancement nanotechnologies, they thought that participants might be concerned about medical risks. However, that is not exactly what they found.

Participants were less worried about medical or technological mishaps than about the equitable distribution of the risks and benefits of new technologies and fair procedures for addressing potential problems. That is, they were unconvinced that citizens across the socioeconomic spectrum would share equal access to the benefits of therapies or equal exposure to their pitfalls.

In describing her work, Harthorn explained, “Intuitive assumptions of experts and practitioners about public perceptions and concerns are insufficient to understanding the societal contexts of technologies. Relying on intuition often leads to misunderstandings of social and institutional realities. CNS-UCSB has attempted to fill in the knowledge gaps through methodologically sophisticated empirical and theoretical research.”

In her role as Director of CNS-UCSB, Harthorn has overseen a larger effort to promote the responsible development of sophisticated materials and technologies seen as central to the nation’s economic future. By pursuing this goal, researchers at CNS-UCSB, which closed its doors at the end of the summer, have advanced the role for the social, economic, and behavioral sciences in understanding technological innovation.

Harthorn has spent the past 11 years trying to understand public expectations, values, beliefs, and perceptions regarding nanotechnologies. Along with conducting deliberations, she has worked with toxicologists and engineers to examine the environmental and occupational risks of nanotechnologies, determine gaps in the U.S. regulatory system, and survey nanotechnology experts. Work has also expanded to comparative studies of other emerging technologies such as shale oil and gas extraction (fracking).

Along with Harthorn’s research group on risk perception and social response, CNS-UCSB housed two other main research groups. One, led by sociologist Richard Appelbaum, studied the impacts of nanotechnology on the global economy. The other, led by historian Patrick McCray, studied the technologies, communities, and individuals that have shaped the direction of nanotechnology research.

Appelbaum’s research program included studying how state policies regarding nanotechnology – especially in China and Latin America – has impacted commercialization. Research trips to China elicited a great understanding of that nation’s research culture and its capacity to produce original intellectual property. He also studied the role of international collaboration in spurring technological innovation. As part of this research, his collaborators surveyed and interviewed international STEM graduate students in the United States in order to understand the factors that influence their choice whether to remain abroad or return home.

In examining the history of nanotechnology, McCray’s group explained how the microelectronics industry provided a template for what became known as nanotechnology, examined educational policies aimed at training a nano-workforce, and produced a history of the scanning tunneling microscope. They also penned award-winning monographs including McCray’s book, The Visioneers: How a Group of Elite Scientists Pursued Space Colonies, Nanotechnologies, and Limitless Future.

Reaching the Real World

Funded as a National Center by the US National Science Foundation in 2005, CNS-UCSB was explicitly intended to enhance the understanding of the relationship between new technologies and their societal context. After more than a decade of funding, CNS-UCSB research has provided a deep understanding of the relationship between technological innovation and social change.

New developments in nanotechnology, an area of research that has garnered $24 billion in funding from the U.S. federal government since 2001, impact sectors as far ranging as agriculture, medicine, energy, defense, and construction, posing great challenges for policymakers and regulators who must consider questions of equity, sustainability, occupational and environmental health and safety, economic and educational policy, disruptions to privacy, security and even what it means to be human. (A nanometer is roughly 10,000 times smaller than the diameter of a human hair.)  Nanoscale materials are already integrated into food packaging, electronics, solar cells, cosmetics, and pharmaceuticals. They are far in development for drugs that can target specific cells, microscopic spying devices, and quantum computers.

Given such real-world applications, it was important to CNS researchers that the results of their work not remain confined within the halls of academia. Therefore, they have delivered testimony to Congress, federal and state agencies (including the National Academies of Science, the Centers for Disease Control and Prevention, the Presidential Council of Advisors on Science and Technology, the U.S. Presidential Bioethics Commission and the National Nanotechnology Initiative), policy outfits (including the Washington Center for Equitable Growth), and international agencies (including the World Bank, European Commission, and World Economic Forum). They’ve collaborated with nongovernmental organizations. They’ve composed policy briefs and op eds, and their work has been covered by numerous news organizations including, recently, NPR, The New Yorker, and Forbes. They have also given many hundreds of lectures to audiences in community groups, schools, and museums.

Policy Options

Most notably, in their final act before the center closed, each of the three primary research groups published synthesis reports that bring together important findings from their 11 years of activity. Their titles are:

Exploring Nanotechnology’s Origins, Institutions, and Communities: A Ten Year Experiment in Large Scale Collaborative STS Research

Globalization and Nanotechnology: The Role of State Policy and International Collaboration

Understanding Nanotechnologies’ Risks and Benefits: Emergence, Expertise and Upstream Participation.

A sampling of key policy recommendations follows:

1.     Public acceptability of nanotechnologies is driven by: benefit perception, the type of application, and the risk messages transmitted from trusted sources and their stability over time; therefore transparent and responsible risk communication is a critical aspect of acceptability.

2.     Social risks, particularly issues of equity and politics, are primary, not secondary, drivers of perception and need to be fully addressed in any new technology development. We have devoted particular attention to studying how gender and race/ethnicity affect both public and expert risk judgments.

3.     State policies aimed at fostering science and technology development should clearly continue to emphasize basic research, but not to the exclusion of supporting promising innovative payoffs. The National Nanotechnology Initiative, with its overwhelming emphasis on basic research, would likely achieve greater success in spawning thriving businesses and commercialization by investing more in capital programs such as the Small Business Innovation Research (SBIR) and Small Business Technology Transfer (STTR) programs, self-described as “America’s seed fund.”

4.     While nearly half of all international STEM graduate students would like to stay in the U.S. upon graduation, fully 40 percent are undecided — and a main barrier is current U.S. immigration policy.

5.     Although representatives from the nanomaterials industry demonstrate relatively high perceived risk regarding engineered nanomaterials, they likewise demonstrate low sensitivity to variance in risks across type of engineered nanomaterials, and a strong disinclination to regulation. This situation puts workers at significant risk and probably requires regulatory action now (beyond the currently favored voluntary or ‘soft law’ approaches).

6.     The complex nature of technological ecosystems translates into a variety of actors essential for successful innovation. One species is the Visioneer, a person who blends engineering experience with a transformative vision of the technological future and a willingness to promote this vision to the public and policy makers.

Leaving a Legacy

Along with successful outreach efforts, CNS-UCSB also flourished when measured by typical academic metrics, including nearly 400 publications and 1,200 talks.

In addition to producing groundbreaking interdisciplinary research, CNS-UCSB also produced innovative educational programs, reaching 200 professionals-in-training from the undergraduate to postdoctoral levels. The Center’s educational centerpiece was a graduate fellowship program, referred to as “magical” by an NSF reviewer, that integrated doctoral students from disciplines across the UCSB campus into ongoing social science research projects.

For social scientists, working side-by-side with science and engineering students gave them an appreciation for the methods, culture, and ethics of their colleagues in different disciplines. It also led to methodological innovation. For their part, scientists and engineers were able to understand the larger context of their work at the bench.

UCSB graduates who participated in CNS’s educational programs have gone on to work as postdocs and professors at universities (including MIT, Stanford, U Penn), policy experts (at organizations like the Science Technology and Policy Institute and the Canadian Institute for Advanced Research), researchers at government agencies (like the National Institute for Standards and Technology), nonprofits (like the Kauffman Foundation), and NGOs. Others work in industry, and some have become entrepreneurs, starting their own businesses.

CNS has spawned lines of research that will continue at UCSB and the institutions of collaborators around the world, but its most enduring legacy will be the students it trained. They bring a true understanding of the complex interconnections between technology and society — along with an intellectual toolkit for examining them — to every sector of the economy, and they will continue to pursue a world that is as just as it technologically advanced.

I found the policy recommendations interesting especially this one:

5.     Although representatives from the nanomaterials industry demonstrate relatively high perceived risk regarding engineered nanomaterials, they likewise demonstrate low sensitivity to variance in risks across type of engineered nanomaterials, and a strong disinclination to regulation. This situation puts workers at significant risk and probably requires regulatory action now (beyond the currently favored voluntary or ‘soft law’ approaches).

Without having read the documents, I’m not sure how to respond but I do have a question.  Just how much regulation are they suggesting?

I offer all of the people associated with the center my thanks for all their hard work and my gratitude for the support I received from the center when I presented at the Society for the Study of Nanotechnologies and Other Emerging Technology (S.Net) in 2012. I’m glad to see they’re going out with a bang.

A European nanotechnology ‘dating’ event for researchers and innovators

A Dec. 13, 2016 Cambridge Network press release announces a networking (dating) event for nanotechnology researchers and industry partners,

The Enterprise Europe Network, in partnership with Innovate UK, the Dutch Ministry of Economic Affairs, the Netherlands Enterprise Agency, Knowledge Transfer Network and the UK Department of Business Energy & Industrial Strategy invite you to participate in an international partnering event and information day for the Nanotechnologies and Advanced Materials themes of the NMBP [Nannotechnologies, Advanced Materials, Biotechnology and Production] Work Programme within Horizon 2020.

This one-day event on 4th April 2017 will introduce the forthcoming calls for proposals, present insights and expectations from the European Commission, and offer a unique international networking experience to forge the winning partnerships of the future

The programme will include presentations from the European Commission and its evaluators and an opportunity to build prospective project partnerships with leading research organisations and cutting-edge innovators from across industry.

A dedicated brokerage session will allow you to expand your international network and create strong consortia through scheduled one-to-one meetings. Participants will also have the opportunity to meet with National Contact Points (UK and Netherlands confirmed) and representatives of the Enterprise Europe Network and the UK’s Knowledge Transfer Network.

The day will also include an optional proposal writing workshop in which delegates will be given valuable tips and insight into the preparation of a winning proposal including a review of the key evaluation criteria.

This event is dedicated to Key Enabling Technologies and will target upcoming calls in the following thematic fields: Nanotechnologies; Advanced materials

Participation for the day is free of charge, but early registration is recommended as the number of participants is limited.  Please note that participation may be limited to a maximum of two delegates per organization.  To register, please do so via the b2match website using this link: https://www.b2match.eu/h2020nmp2017

How does it work? Once you have registered, your profile will be screened by our event management team and once completed you will receive a validation email confirming your participation. You can browse the participant list and book meetings with organisations you are interested in, and a week before the event you will receive your personal meeting schedule.

Why attend? Improve your chances of success by understanding the main issues and expectations for upcoming H2020 calls based on feedback from previous rounds. It’s a great opportunity to raise your profile with future project partners from industry and research through pre-arranged one-to-one meetings. There is also the chance to hear from an experienced H2020 evaluator to gain tips and insight for the preparation of a strong proposal.

Good luck on getting registered for the event. By the way, the Enterprise Europe Network webpage for this event describes it as an Horizon 2020 Brokerage Event.

Sustainable Nanotechnologies (SUN) project draws to a close in March 2017

Two Oct. 31, 2016 news item on Nanowerk signal the impending sunset date for the European Union’s Sustainable Nanotechnologies (SUN) project. The first Oct. 31, 2016 news item on Nanowerk describes the projects latest achievements,

The results from the 3rd SUN annual meeting showed great advancement of the project. The meeting was held in Edinburgh, Scotland, UK on 4-5 October 2016 where the project partners presented the results obtained during the second reporting period of the project.

SUN is a three and a half year EU project, running from 2013 to 2017, with a budget of about €14 million. Its main goal is to evaluate the risks along the supply chain of engineered nanomaterials and incorporate the results into tools and guidelines for sustainable manufacturing.

The ultimate goal of the SUN Project is the development of an online software Decision Support System – SUNDS – aimed at estimating and managing occupational, consumer, environmental and public health risks from nanomaterials in real industrial products along their lifecycles. The SUNDS beta prototype has been released last October, 2015, and since then the main focus has been on refining the methodologies and testing them on selected case studies i.e. nano-copper oxide based wood preserving paint and nano- sized colourants for plastic car part: organic pigment and carbon black. Obtained results and open issues were discussed during the third annual meeting in order collect feedbacks from the consortium that will inform, in the next months, the implementation of the final version of the SUNDS software system, due by March 2017.

An Oct. 27, 2016 SUN project press release, which originated the news item, adds more information,

Significant interest has been payed towards the results obtained in WP2 (Lifecycle Thinking) which main objectives are to assess the environmental impacts arising from each life cycle stage of the SUN case studies (i.e. Nano-WC-Cobalt (Tungsten Carbide-cobalt) sintered ceramics, Nanocopper wood preservatives, Carbon Nano Tube (CNT) in plastics, Silicon Dioxide (SiO2) as food additive, Nano-Titanium Dioxide (TiO2) air filter system, Organic pigment in plastics and Nanosilver (Ag) in textiles), and compare them to conventional products with similar uses and functionality, in order to develop and validate criteria and guiding principles for green nano-manufacturing. Specifically, the consortium partner COLOROBBIA CONSULTING S.r.l. expressed its willingness to exploit the results obtained from the life cycle assessment analysis related to nanoTiO2 in their industrial applications.

On 6th October [2016], the discussions about the SUNDS advancement continued during a Stakeholder Workshop, where representatives from industry, regulatory and insurance sectors shared their feedback on the use of the decision support system. The recommendations collected during the workshop will be used for the further refinement and implemented in the final version of the software which will be released by March 2017.

The second Oct. 31, 2016 news item on Nanowerk led me to this Oct. 27, 2016 SUN project press release about the activities in the upcoming final months,

The project has designed its final events to serve as an effective platform to communicate the main results achieved in its course within the Nanosafety community and bridge them to a wider audience addressing the emerging risks of Key Enabling Technologies (KETs).

The series of events include the New Tools and Approaches for Nanomaterial Safety Assessment: A joint conference organized by NANOSOLUTIONS, SUN, NanoMILE, GUIDEnano and eNanoMapper to be held on 7 – 9 February 2017 in Malaga, Spain, the SUN-CaLIBRAte Stakeholders workshop to be held on 28 February – 1 March 2017 in Venice, Italy and the SRA Policy Forum: Risk Governance for Key Enabling Technologies to be held on 1- 3 March in Venice, Italy.

Jointly organized by the Society for Risk Analysis (SRA) and the SUN Project, the SRA Policy Forum will address current efforts put towards refining the risk governance of emerging technologies through the integration of traditional risk analytic tools alongside considerations of social and economic concerns. The parallel sessions will be organized in 4 tracks:  Risk analysis of engineered nanomaterials along product lifecycle, Risks and benefits of emerging technologies used in medical applications, Challenges of governing SynBio and Biotech, and Methods and tools for risk governance.

The SRA Policy Forum has announced its speakers and preliminary Programme. Confirmed speakers include:

  • Keld Alstrup Jensen (National Research Centre for the Working Environment, Denmark)
  • Elke Anklam (European Commission, Belgium)
  • Adam Arkin (University of California, Berkeley, USA)
  • Phil Demokritou (Harvard University, USA)
  • Gerard Escher (École polytechnique fédérale de Lausanne, Switzerland)
  • Lisa Friedersdor (National Nanotechnology Initiative, USA)
  • James Lambert (President, Society for Risk Analysis, USA)
  • Andre Nel (The University of California, Los Angeles, USA)
  • Bernd Nowack (EMPA, Switzerland)
  • Ortwin Renn (University of Stuttgart, Germany)
  • Vicki Stone (Heriot-Watt University, UK)
  • Theo Vermeire (National Institute for Public Health and the Environment (RIVM), Netherlands)
  • Tom van Teunenbroek (Ministry of Infrastructure and Environment, The Netherlands)
  • Wendel Wohlleben (BASF, Germany)

The New Tools and Approaches for Nanomaterial Safety Assessment (NMSA) conference aims at presenting the main results achieved in the course of the organizing projects fostering a discussion about their impact in the nanosafety field and possibilities for future research programmes.  The conference welcomes consortium partners, as well as representatives from other EU projects, industry, government, civil society and media. Accordingly, the conference topics include: Hazard assessment along the life cycle of nano-enabled products, Exposure assessment along the life cycle of nano-enabled products, Risk assessment & management, Systems biology approaches in nanosafety, Categorization & grouping of nanomaterials, Nanosafety infrastructure, Safe by design. The NMSA conference key note speakers include:

  • Harri Alenius (University of Helsinki, Finland,)
  • Antonio Marcomini (Ca’ Foscari University of Venice, Italy)
  • Wendel Wohlleben (BASF, Germany)
  • Danail Hristozov (Ca’ Foscari University of Venice, Italy)
  • Eva Valsami-Jones (University of Birmingham, UK)
  • Socorro Vázquez-Campos (LEITAT Technolоgical Center, Spain)
  • Barry Hardy (Douglas Connect GmbH, Switzerland)
  • Egon Willighagen (Maastricht University, Netherlands)
  • Nina Jeliazkova (IDEAconsult Ltd., Bulgaria)
  • Haralambos Sarimveis (The National Technical University of Athens, Greece)

During the SUN-caLIBRAte Stakeholder workshop the final version of the SUN user-friendly, software-based Decision Support System (SUNDS) for managing the environmental, economic and social impacts of nanotechnologies will be presented and discussed with its end users: industries, regulators and insurance sector representatives. The results from the discussion will be used as a foundation of the development of the caLIBRAte’s Risk Governance framework for assessment and management of human and environmental risks of MN and MN-enabled products.

The SRA Policy Forum: Risk Governance for Key Enabling Technologies and the New Tools and Approaches for Nanomaterial Safety Assessment conference are now open for registration. Abstracts for the SRA Policy Forum can be submitted till 15th November 2016.
For further information go to:
www.sra.org/riskgovernanceforum2017
http://www.nmsaconference.eu/

There you have it.

Radical copyright reform proposal in the European Union

It seems the impulse to maximize copyright control has overtaken European Union officials. A Sept. 14, 2016 news item on phys.org lays out a few details,

The EU will overhaul copyright law to shake up how online news and entertainment is paid for in Europe, under proposals announced by European Commission chief Jean-Claude Juncker Wednesday [Sept. 14, 2016].

Pop stars such as Coldplay and Lady Gaga will hail part of the plan as a new weapon to bring a fair fight to YouTube, the Google-owned video service that they say is sapping the music business.

But the reform plans have attracted the fury of filmmakers and start-up investors who see it as a threat to European innovation and a wrong-headed favour to powerful media groups.

A Sept. 14, 2016 European Commission press release provides the European Union’s version of why more stringent copyright is needed,

“I want journalists, publishers and authors to be paid fairly for their work, whether it is made in studios or living rooms, whether it is disseminated offline or online, whether it is published via a copying machine or commercially hyperlinked on the web.”–President Juncker, State of the Union 2016

On the occasion of President Juncker’s 2016 State of the Union address, the Commission today set out proposals on the modernisation of copyright to increase cultural diversity in Europe and content available online, while bringing clearer rules for all online players. The proposals will also bring tools for innovation to education, research and cultural heritage institutions.

Digital technologies are changing the way music, films, TV, radio, books and the press are produced, distributed and accessed. New online services such as music streaming, video-on-demand platforms and news aggregators have become very popular, while consumers increasingly expect to access cultural content on the move and across borders. The new digital landscape will create opportunities for European creators as long as the rules offer legal certainty and clarity to all players. As a key part of its Digital Single Market strategy, the Commission has adopted proposals today to allow:

  • Better choice and access to content online and across borders
  • Improved copyright rules on education, research, cultural heritage and inclusion of disabled people
  • A fairer and sustainable marketplace for creators, the creative industries and the press

Andrus Ansip, Vice-President for the Digital Single Market, said: “Europeans want cross-border access to our rich and diverse culture. Our proposal will ensure that more content will be available, transforming Europe’s copyright rules in light of a new digital reality. Europe’s creative content should not be locked-up, but it should also be highly protected, in particular to improve the remuneration possibilities for our creators. We said we would deliver all our initiatives to create a Digital Single Market by the end of the year and we keep our promises. Without a properly functioning Digital Single Market we will miss out on creativity, growth and jobs.

Günther H. Oettinger, Commissioner for the Digital Economy and Society, said: “Our creative industries [emphasis mine] will benefit from these reforms which tackle the challenges of the digital age successfully while offering European consumers a wider choice of content to enjoy. We are proposing a copyright environment that is stimulating, fair and rewards investment.”

Today, almost half of EU internet users listen to music, watch TV series and films or play games online; however broadcasters and other operators find it hard to clear rights for their online or digital services when they want to offer them in other EU countries. Similarly, the socio-economically important sectors of education, research and cultural heritage too often face restrictions or legal uncertainty which holds back their digital innovation when using copyright protected content, including across borders. Finally, creators, other right holders and press publishers are often unable to negotiate the conditions and also payment for the online use of their works and performances.

Altogether, today’s copyright proposals have three main priorities:

1. Better choice and access to content online and across borders

With our proposal on the portability of online content presented in December 2015, we gave consumers the right to use their online subscriptions to films, music, ebooks when they are away from their home country, for example on holidays or business trips. Today, we propose a legal mechanism for broadcasters to obtain more easily the authorisations they need from right holders to transmit programmes online in other EU Member States. This is about programmes that broadcasters transmit online at the same time as their broadcast as well as their catch-up services that they wish to make available online in other Member States, such as MyTF1 in France, ZDF Mediathek in Germany, TV3 Play in Denmark, Sweden and the Baltic States and AtresPlayer in Spain. Empowering broadcasters to make the vast majority of their content, such as news, cultural, political, documentary or entertainment programmes, shown also in other Member States will give more choice to consumers.

Today’s rules also make it easier for operators who offer packages of channels (such as Proximus TV in Belgium, Movistar+ in Spain, Deutsche Telekom’s IPTV Entertain in Germany), to get the authorisations they need: instead of having to negotiate individually with every right holder in order to offer such packages of channels originating in other EU Member States, they will be able to get the licenses from collective management organisations representing right holders. This will also increase the choice of content for their customers.

To help development of Video-on-Demand (VoD) offerings in Europe, we ask Member States to set up negotiation bodies to help reach licensing deals, including those for cross-border services, between audiovisual rightholders and VoD platforms. A dialogue with the audiovisual industry on licensing issues and the use of innovative tools like licensing hubs will complement this mechanism.

To enhance access to Europe’s rich cultural heritage, the new Copyright Directive will help museums, archives and other institutions to digitise and make available across borders out-of commerce works, such as books or films that are protected by copyright, but no longer available to the public.

In parallel the Commission will use its €1.46 billion Creative Europe MEDIA programme to further support the circulation of creative content across borders . This includes more funding for subtitling and dubbing; a new catalogue of European audiovisual works for VoD providers that they can directly use for programming; and online tools to improve the digital distribution of European audiovisual works and make them easier to find and view online.

These combined actions will encourage people to discover TV and radio programmes from other European countries, keep in touch with their home countries when living in another Member State and enhance the availability of European films, including across borders, hence highlighting Europe’s rich cultural diversity.

2. Improving copyright rules on research, education and inclusion of disable [sic] people

Students and teachers are eager to use digital materials and technologies for learning, but today almost 1 in 4 educators encounter copyright-related restrictions in their digital teaching activities every week. The Commission has proposed today a new exception to allow educational establishments to use materials to illustrate teaching through digital tools and in online courses across borders.

The proposed Directive will also make it easier for researchers across the EU to use text and data mining (TDM) technologies to analyse large sets of data. This will provide a much needed boost to innovative research considering that today nearly all scientific publications are digital and their overall volume is increasing by 8-9% every year worldwide.

The Commission also proposes a new mandatory EU exception which will allow cultural heritage institutions to preserve works digitally, crucial for the survival of cultural heritage and for citizens’ access in the long term.

Finally, the Commission is proposing legislation to implement the Marrakesh Treaty to facilitate access to published works for persons who are blind, have other visual impairments or are otherwise print disabled. These measures are important to ensure that copyright does not constitute a barrier to the full participation in society of all citizens and will allow for the exchange of accessible format copies within the EU and with third countries that are parties to the Treaty, avoiding duplication of work and waste of resources.

3. A fairer and sustainable marketplace for creators and press

The Copyright Directive aims to reinforce the position of right holders to negotiate and be remunerated for the online exploitation of their content on video-sharing platforms such as YouTube or Dailymotion. Such platforms will have an obligation to deploy effective means such as technology to automatically detect songs or audiovisual works which right holders have identified and agreed with the platforms either to authorise or remove.

Newspapers, magazines and other press publications have benefited from the shift from print to digital and online services like social media and news aggregators. It has led to broader audiences, but it has also impacted advertising revenue and made the licensing and enforcement of the rights in these publications increasingly difficult.The Commission proposes to introduce a new related right for publishers, similar to the right that already exists under EU law for film producers, record (phonogram) producers and other players in the creative industries like broadcasters.

The new right recognises the important role press publishers play in investing in and creating quality journalistic content, which is essential for citizens’ access to knowledge in our democratic societies. As they will be legally recognised as right holders for the very first time they will be in a better position when they negotiate the use of their content with online services using or enabling access to it, and better able to fight piracy. This approach will give all players a clear legal framework when licensing content for digital uses, and help the development of innovative business models for the benefit of consumers.

The draft Directive also obliges publishers and producers to be transparent and inform authors or performers about profits they made with their works. It also puts in place a mechanism to help authors and performers to obtain a fair share when negotiating remuneration with producers and publishers. This should lead to higher level of trust among all players in the digital value chain.

Towards a Digital Single Market

As part of the Digital Single Market strategy presented in May 2015, today’s proposals complement the proposed regulation on portability of legal content (December 2015), the revised Audiovisual Media and Services Directive, the Communication on online platforms (May 2016). Later this autumn the Commission will propose to improve enforcement of all types of intellectual property rights, including copyright.

Today’s EU copyright rules, presented along with initiatives to boost internet connectivity in the EU (press releasepress conference at 15.15 CET), are part of the EU strategy to create a Digital Single Market (DSM). The Commission set out 16 initiatives (press release) and is on the right track to deliver all of them the end of this year.

While Juncker mixes industry (publishers) with content creators (journalists, authors), Günther H. Oettinger, Commissioner for the Digital Economy and Society clearly states that ‘creative industries’ are to be the beneficiaries. Business interests have tended to benefit disproportionately under current copyright regimes. The disruption posed by digital content has caused these businesses some agony and they have responded by lobbying vigorously to maximize copyright. For the most part, individual musicians, authors, visual artists and other content creators are highly unlikely to benefit from this latest reform.

I’m not a big fan of Google or its ‘stepchild’, YouTube but it should be noted that at least one career would not have existed without free and easy access to videos, Justin Bieber’s. He may not have made a penny from his YouTube videos but that hasn’t hurt his financial picture. Without YouTube, he would have been unlikely to get the exposure and recognition which have in turn led him to some serious financial opportunities.

I am somewhat less interested in the show business aspect than I am in the impact this could have on science as per section (2. Improving copyright rules on research, education and inclusion of disable [sic] people) of the European Commission press release. A Sept. 14, 2016 posting about a previous ruling on copyright in Europe by Mike Masnick for Techdirt provides some insight into the possible future impacts on science research,

Last week [Sept. 8, 2016 posting], we wrote about a terrible copyright ruling from the Court of Justice of the EU, which basically says that any for-profit entity that links to infringing material can be held liable for direct infringement, as the “for-profit” nature of the work is seen as evidence that they knew or should have known the work was infringing. We discussed the problems with this standard in our post, and there’s been a lot of commentary on what this will mean for Europe — with a variety of viewpoints being expressed. One really interesting set of concerns comes from Egon Willighagen, from Maastricht University, noting what a total and complete mess this is going to be for scientists, who rarely consider the copyright status of various data as databases they rely on are built up …

This is, of course, not the first time we’ve noted the problems of intellectual property in the science world. From various journals locking up research to the rise of patents scaring off researchers from sharing data, intellectual property keeps getting in the way of science, rather than supporting it. And that’s extremely unfortunate. I mean, after all, in the US specifically, the Constitution specifically says that copyrights and patents are supposed to be about “promoting the progress of science and the useful arts.”

Over and over again, though, we see that the law has been twisted and distorted and extended and expanded in such a way that is designed to protect a very narrow set of interests, at the expense of many others, including the public who would benefit from greater sharing and collaboration and open flow of data among scientific researchers. …

Masnick has also written up a Sept. 14, 2016 posting devoted to the EU copyright proposal itself,

This is not a surprise given the earlier leaks of what the EU Commission was cooking up for a copyright reform package, but the end result is here and it’s a complete disaster for everyone. And I do mean everyone. Some will argue that it’s a gift to Hollywood and legacy copyright interests — and there’s an argument that that’s the case. But the reality is that this proposal is so bad that it will end up doing massive harm to everyone. It will clearly harm independent creators and the innovative platforms that they rely on. And, because those platforms have become so important to even the legacy entertainment industry, it will harm them too. And, worst of all, it will harm the public greatly. It’s difficult to see how this proposal will benefit anyone, other than maybe some lawyers.

So the EU Commission has taken the exact wrong approach. It’s one that’s almost entirely about looking backwards and “protecting” old ways of doing business, rather than looking forward, and looking at what benefits the public, creators and innovators the most. If this proposal actually gets traction, it will be a complete disaster for the EU innovative community. Hopefully, Europeans speak out, vocally, about what a complete disaster this would be.

So, according to Masnick not even business interests will benefit.

Promethean Particles claims to be world’s largest nanomaterial production plant

It’s a bit puzzling initially as both the SHYMAN (Sustainable Hydrothermal Manufacturing of Nanomaterials) project and Promethean Particles are claiming to be the world’s biggest nanomaterials production facility. In a battle of press release titles (one from CORDIS and one from the University of Nottingham) it becomes clear after reading both that the SHYMAN project is the name for a European Commission 7th Framework Programme funded project and Promethean Particles, located at the University of Nottingham (UK), is a spinoff from that project. So, both claims are true, although confusing at first glance.

An Aug. 1, 2016 news item on Nanowerk breaks the news about the ‘SHYMAN project’s’ production facility (Note: A link has been removed),

The European SHYMAN project aims to establish continuous hydrothermal synthesis as the most flexible and sustainable process to create nanomaterials at industrial scale. After demonstrating this potential in the lab, the project has now announced the opening of its first facility in Nottingham.

An (Aug. 1, 2016?) CORDIS press release, which originated the news item,

‘This new facility opens up a significant amount of new opportunities for us,’ says Professor Ed Lester, Technical Coordinator of Promethean Particles. This spin-out of the University of Nottingham is in charge of operating the new plant, which is expected to produce over 1 000 tonnes of nanomaterials every year. The production cost is lower than that of other facilities and the chosen production method – continuous hydrothermal synthesis – is expected to impact even markets for which sale prices had so far been an obstacle.

‘We have already had a lot of interest from companies in a diverse range of sectors. From healthcare, where nano-particles can be used in coatings on medical devices, to enhanced fabrics, where nano-materials can add strength and flexibility to textiles, and in printed electronics, as we are able to print materials such as copper,’ Prof. Lester continues. Solvay, Fiat, PPG and Repsol are among the major companies already set to benefit from the plant’s products.

To reach these impressive levels of production, the plant notably relies on high pressure triplex plunger pumps manufactured by Cat Pumps. These pumps have helped the 18-strong consortium to overcome engineering issues related to the mixing of the heated fluid and the aqueous metal salt flow, by creating the continuous pressure and fluid flow necessary to achieve continuous production.

Another enabling technology is the Nozzle Reactor, a customised design that uses buoyancy-induced eddies to produce an ‘ideal’ mixing scenario in a pipe-in-pip concentric configuration in which the internal pipe has an open-ended nozzle. This technology allows Promethean Particles to dramatically improve reproducibility and reliability whilst controlling particles properties such as size, composition and shape.

Betting on hydrothermal synthesis

Started in 2012, SHYMAN built upon the observation that hydrothermal synthesis had numerous advantages compared to alternatives: it doesn’t resort to noxious chemicals, uses relatively simple chemistry relying on cheap precursors, allows straightforward downstream processing, can avoid agglomeration and allows for narrow and well-controlled size and shape distribution.

The optimisation of hydrothermal synthesis has been a key objective of the University of Nottingham for the past 14 years, and SHYMAN is the pinnacle: the project began with the development of bench scale reactors, followed by a 30-times-larger pilot scale reactor. The reactor at the heart of the new production plant is 80 times larger than the latter and features four Cat Pumps Model 3801 high pressure triplex plunger pumps.

‘These are very exciting times for Promethean Particles,’ said Dr Susan Huxtable, Director of Intellectual Property and Commercialisation at the University of Nottingham. ‘The new facility opens up a myriad of opportunities for them to sell their services into new markets right across the world. It is a great example of how many of the technologies developed by academics here at the University of Nottingham have the potential to benefit both industry and society.’

The July 12, 2016 University of Nottingham press release, while covering much of the same ground, offers some additional detail,

The plant [Promethean Particles] was developed as part of a pan-European nano-materials research programme, known as SHYMAN (Sustainable Hydrothermal Manufacturing of Nanomaterials). The project, which had a total value of €9.7 million Euros, included partner universities and businesses from 12 European countries.

The outcome of the project was the creation of the largest multi-material nano-particle plant in the world, based in Nottingham. The plant is now operated by Promethean, and it is able to operate at supercritical conditions, producing up to 200 kg of nano-particles per hour.

You can find out more about the SHYMAN project here and Promethean Particles here.

Replicating brain’s neural networks with 3D nanoprinting

An announcement about European Union funding for a project to reproduce neural networks by 3D nanoprinting can be found in a June 10, 2016 news item on Nanowerk,

The MESO-BRAIN consortium has received a prestigious award of €3.3million in funding from the European Commission as part of its Future and Emerging Technology (FET) scheme. The project aims to develop three-dimensional (3D) human neural networks with specific biological architecture, and the inherent ability to interrogate the network’s brain-like activity both electrophysiologically and optically. It is expected that the MESO-BRAIN will facilitate a better understanding of human disease progression, neuronal growth and enable the development of large-scale human cell-based assays to test the modulatory effects of pharmacological and toxicological compounds on neural network activity. The use of more physiologically relevant human models will increase drug screening efficiency and reduce the need for animal testing.

A June 9, 2016 Institute of Photonic Sciences (ICFO) press release (also on EurekAlert), which originated the news item, provides more detail,

About the MESO-BRAIN project

The MESO-BRAIN project’s cornerstone will use human induced pluripotent stem cells (iPSCs) that have been differentiated into neurons upon a defined and reproducible 3D scaffold to support the development of human neural networks that emulate brain activity. The structure will be based on a brain cortical module and will be unique in that it will be designed and produced using nanoscale 3D-laser-printed structures incorporating nano-electrodes to enable downstream electrophysiological analysis of neural network function. Optical analysis will be conducted using cutting-edge light sheet-based, fast volumetric imaging technology to enable cellular resolution throughout the 3D network. The MESO-BRAIN project will allow for a comprehensive and detailed investigation of neural network development in health and disease.

Prof Edik Rafailov, Head of the MESO-BRAIN project (Aston University) said: “What we’re proposing to achieve with this project has, until recently, been the stuff of science fiction. Being able to extract and replicate neural networks from the brain through 3D nanoprinting promises to change this. The MESO-BRAIN project has the potential to revolutionise the way we are able to understand the onset and development of disease and discover treatments for those with dementia or brain injuries. We cannot wait to get started!”

The MESO-BRAIN project will launch in September 2016 and research will be conducted over three years.

About the MESO-BRAIN consortium

Each of the consortium partners have been chosen for the highly specific skills & knowledge that they bring to this project. These include technologies and expertise in stem cells, photonics, physics, 3D nanoprinting, electrophysiology, molecular biology, imaging and commercialisation.

Aston University (UK) Aston Institute of Photonic Technologies (School of Engineering and Applied Science) is one of the largest photonic groups in UK and an internationally recognised research centre in the fields of lasers, fibre-optics, high-speed optical communications, nonlinear and biomedical photonics. The Cell & Tissue Biomedical Research Group (Aston Research Centre for Healthy Ageing) combines collective expertise in genetic manipulation, tissue engineering and neuronal modelling with the electrophysiological and optical analysis of human iPSC-derived neural networks. Axol Bioscience Ltd. (UK) was founded to fulfil the unmet demand for high quality, clinically relevant human iPSC-derived cells for use in biomedical research and drug discovery. The Laser Zentrum Hannover (Germany) is a leading research organisation in the fields of laser development, material processing, laser medicine, and laser-based nanotechnologies. The Neurophysics Group (Physics Department) at University of Barcelona (Spain) are experts in combing experiments with theoretical and computational modelling to infer functional connectivity in neuronal circuits. The Institute of Photonic Sciences (ICFO) (Spain) is a world-leading research centre in photonics with expertise in several microscopy techniques including light sheet imaging. KITE Innovation (UK) helps to bridge the gap between the academic and business sectors in supporting collaboration, enterprise, and knowledge-based business development.

For anyone curious about the FET funding scheme, there’s this from the press release,

Horizon 2020 aims to ensure Europe produces world-class science by removing barriers to innovation through funding programmes such as the FET. The FET (Open) funds forward-looking collaborations between advanced multidisciplinary science and cutting-edge engineering for radically new future technologies. The published success rate is below 1.4%, making it amongst the toughest in the Horizon 2020 suite of funding schemes. The MESO-BRAIN proposal scored a perfect 5/5.

You can find out more about the MESO-BRAIN project on its ICFO webpage.

They don’t say anything about it but I can’t help wondering if the scientists aren’t also considering the possibility of creating an artificial brain.

Lungs: EU SmartNanoTox and Pneumo NP

I have three news bits about lungs one concerning relatively new techniques for testing the impact nanomaterials may have on lungs and two concerning developments at PneumoNP; the first regarding a new technique for getting antibiotics to a lung infected with pneumonia and the second, a new antibiotic.

Predicting nanotoxicity in the lungs

From a June 13, 2016 news item on Nanowerk,

Scientists at the Helmholtz Zentrum München [German Research Centre for Environmental Health] have received more than one million euros in the framework of the European Horizon 2020 Initiative [a major European Commission science funding initiative successor to the Framework Programme 7 initiative]. Dr. Tobias Stöger and Dr. Otmar Schmid from the Institute of Lung Biology and Disease and the Comprehensive Pneumology Center (CPC) will be using the funds to develop new tests to assess risks posed by nanomaterials in the airways. This could contribute to reducing the need for complex toxicity tests.

A June 13, 2016 Helmholtz Zentrum München (German Research Centre for Environmental Health) press release, which originated the news item, expands on the theme,

Nanoparticles are extremely small particles that can penetrate into remote parts of the body. While researchers are investigating various strategies for harvesting the potential of nanoparticles for medical applications, they could also pose inherent health risks*. Currently the hazard assessment of nanomaterials necessitates a complex and laborious procedure. In addition to complete material characterization, controlled exposure studies are needed for each nanomaterial in order to guarantee the toxicological safety.

As a part of the EU SmartNanoTox project, which has now been funded with a total of eight million euros, eleven European research partners, including the Helmholtz Zentrum München, want to develop a new concept for the toxicological assessment of nanomaterials.

Reference database for hazardous substances

Biologist Tobias Stöger and physicist Otmar Schmid, both research group heads at the Institute of Lung Biology and Disease, hope that the use of modern methods will help to advance the assessment procedure. “We hope to make more reliable nanotoxicity predictions by using modern approaches involving systems biology, computer modelling, and appropriate statistical methods,” states Stöger.

The lung experts are concentrating primarily on the respiratory tract. The approach involves defining a representative selection of toxic nanomaterials and conducting an in-depth examination of their structure and the various molecular modes of action that lead to their toxicity. These data are then digitalized and transferred to a reference database for new nanomaterials. Economical tests that are easy to conduct should then make it possible to assess the toxicological potential of these new nanomaterials by comparing the test results s with what is already known from the database. “This should make it possible to predict whether or not a newly developed nanomaterial poses a health risk,” Otmar Schmid says.

* Review: Schmid, O. and Stoeger, T. (2016). Surface area is the biologically most effective dose metric for acute nanoparticle toxicity in the lung. Journal of Aerosol Science, DOI:10.1016/j.jaerosci.2015.12.006

The SmartNanoTox webpage is here on the European Commission’s Cordis website.

Carrying antibiotics into lungs (PneumoNP)

I received this news from the European Commission’s PneumoNP project (I wrote about PneumoNP in a June 26, 2014 posting when it was first announced). This latest development is from a March 21, 2016 email (the original can be found here on the How to pack antibiotics in nanocarriers webpage on the PneumoNP website),

PneumoNP researchers work on a complex task: attach or encapsulate antibiotics with nanocarriers that are stable enough to be included in an aerosol formulation, to pass through respiratory tracts and finally deliver antibiotics on areas of lungs affected by pneumonia infections. The good news is that they finally identify two promising methods to generate nanocarriers.

So far, compacting polymer coils into single-chain nanoparticles in water and mild conditions was an unsolved issue. But in Spain, IK4-CIDETEC scientists developed a covalent-based method that produces nanocarriers with remarkable stability under those particular conditions. Cherry on the cake, the preparation is scalable for more industrial production. IK4-CIDETEC patented the process.

Fig.: A polymer coil (step 1) compacts into a nanocarrier with cross-linkers (step 2). Then, antibiotics get attached to the nanocarrier (step 3).

Fig.: A polymer coil (step 1) compacts into a nanocarrier with cross-linkers (step 2). Then, antibiotics get attached to the nanocarrier (step 3).

At the same time, another route to produce lipidic nanocarriers have been developed by researchers from Utrecht University. In particular, they optimized the method consisting in assembling lipids directly around a drug. As a result, generated lipidic nanocarriers show encouraging stability properties and are able to carry sufficient quantity of antibiotics.

Fig.: On presence of antibiotics, the lipidic layer (step 1) aggregates the the drug (step 2) until the lipids forms a capsule around the antibiotics (step 3).

Fig.: On presence of antibiotics, a lipidic layer (step 1) aggregates the drug (step 2) until the lipids forms a capsule around antibiotics (step 3).

Assays of both polymeric and lipidic nanocarriers are currently performed by ITEM Fraunhofer Institute in Germany, Ingeniatrics Tecnologias in Spain and Erasmus Medical Centre in the Netherlands. Part of these tests allows to make sure that the nanocarriers are not toxic to cells. Other tests are also done to verify that the efficiency of antibiotics on Klebsiella Pneumoniae bacteria when they are attached to nanocarriers.

A new antibiotic for pneumonia (PneumoNP)

A June 14, 2016 PneumoNP press release (received via email) announces work on a promising new approach to an antibiotic for pneumonia,

The antimicrobial peptide M33 may be the long-sought substitute to treat difficult lung infections, like multi-drug resistant pneumonia.

In 2013, the European Respiratory Society predicted 3 millions cases of pneumonia in Europe every year [1]. The standard treatment for pneumonia is an intravenous administration of a combination of drugs. This leads to the development of antibiotic resistance in the population. Gradually, doctors are running out of solutions to cure patients. An Italian company suggests a new option: the M33 peptide.

Few years ago, the Italian company SetLance SRL decided to investigate the M33 peptide. The antimicrobial peptide is an optimized version of an artificial peptide sequence selected for its efficacy and stability. So far, it showed encouraging in-vitro results against multidrug-resistant Gram-negative bacteria, including Klebsiella Pneumoniae. With the support of EU funding to the PneumoNP project, SetLance SRL had the opportunity to develop a new formulation of M33 that enhances its antimicrobial activity.

The new formulation of M33 fights Gram-negative bacteria in three steps. First of all, the M33 binds with the lipopolysaccharides (LPS) on the outer membrane of bacteria. Then, the molecule forms a helix and finally disrupts the membrane provoking cytoplasm leaking. The peptide enabled up to 80% of mices to survive Pseudomonas Aeruginosa-based lung infections. Beyond these encouraging results, toxicity to the new M33 formulation seems to be much lower than antimicrobial peptides currently used in clinical practice like colistin [2].

Lately, SetLance scaled-up the synthesis route and is now able to produce several hundred milligrams per batch. The molecule is robust enough for industrial production. We may expect this drug to go on clinical development and validation at the beginning of 2018.

[1] http://www.erswhitebook.org/chapters/acute-lower-respiratory-infections/pneumonia/
[2] Ceccherini et al., Antimicrobial activity of levofloxacin-M33 peptide conjugation or combination, Chem Med Comm. 2016; Brunetti et al., In vitro and in vivo efficacy, toxicity, bio-distribution and resistance selection of a novel antibacterial drug candidate. Scientific Reports 2016

I believe all the references are open access.

Brief final comment

The only element linking these news bits together is that they concern the lungs.

Introducing the LIFE project NanoMONITOR

I believe LIFE in the project title refers to life cycle. Here’s more from a June 9, 2016 news item from Nanowerk (Note: A link has been removed),

The newly started European Commission LIFE project NanoMONITOR addresses the challenges of supporting the risk assessment of nanomaterials under REACH by development of a real-time information and monitoring system. At the project’s kickoff meeting held on the 19th January 2016 in Valencia (Spain) participants discussed how this goal could be achieved.

Despite the growing number of engineered nanomaterials (ENMs) already available on the market and in contract to their benefits the use, production, and disposal of ENMs raises concerns about their environmental impact.

A REACH Centre June 8, 2016 press release, which originated the news item, expands on the theme,

Within this context, the overall aim of LIFE NanoMONITOR is to improve the use of environmental monitoring data to support the implementation of REACH regulation and promote the protection of human health and the environment when dealing with ENMs. Within the EU REACH Regulation, a chemical safety assessment report, including risk characterisation ratio (RCR), must be provided for any registered ENMs. In order to address these objectives, the project partners have developed a rigorous methodology encompassing the following aims:

  • Develop a novel software application to support the acquisition, management and processing of data on the concentration of ENMs.
  • Develop an on-line environmental monitoring database (EMD) to support the sharing of information.
  • Design and develop a proven monitoring station prototype for continuous monitoring of particles below 100 nm in air (PM0.1).
  • Design and develop standardized sampling and data analysis procedures to ensure the quality, comparability and reliability of the monitoring data used for risk assessment.
  • Support the calculation of the predicted environmental concentration (PEC) of ENMs in the context of REACH.

Throughout the project’s kick off meeting, participants discussed the status of the research area, project goals, and expectations of the different stakeholders with respect to the project outcome.

The project has made this graphic available,

LIFE_NanoMONITOR

You can find the LIFE project NanoMONITOR website here.

Nanosafety Cluster newsletter—excerpts from the Spring 2016 issue

The European Commission’s NanoSafety Cluster Newsletter (no.7) Spring 2016 edition is some 50 pp. long and it provides a roundup of activities and forthcoming events. Here are a few excerpts,

“Closer to the Market” Roadmap (CTTM) now finalised

Hot off the press! the Cluster’s “Closer to the Market” Roadmap (CTTM)  is  a  multi-dimensional,  stepwise  plan  targeting  a framework to deliver safe nano-enabled products to the market. After some years of discussions, several consultations of a huge number of experts in the nanosafety-field, conferences at which the issue of market implementation of nanotechnologies was talked  about,  writing  hours/days,  and  finally  two public consultation rounds, the CTTM is now finalized.

As stated in the Executive Summary: “Nano-products and nano-enabled applications need a clear and easy-to-follow human and environmental safety framework for the development along the innovation chain from initial idea to market and beyond that facilitates  navigation  through  the  complex  regulatory and approval processes under which different product categories fall.

Download it here, and get involved in its implementation through the Cluster!
Authors: Andreas Falk* 1, Christa Schimpel1, Andrea Haase3, Benoît Hazebrouck4, Carlos Fito López5, Adriele Prina-Mello6, Kai Savolainen7, Adriënne Sips8, Jesús M. Lopez de Ipiña10, Iseult Lynch11, Costas Charitidis12, Visser Germ13

NanoDefine hosts Synergy Workshop with NSC projects

NanoDefine  organised  the  2nd Nanosafety  Cluster  (NSC)  Synergy Workshop  at  the  Netherlands  House  for Education  and  Research  in Brussels  on  2nd  February  2016. The  aim  was  to  identify  overlaps and synergies existing between different projects that could develop into
outstanding cooperation opportunities.

One central issue was the building of a common ontology and a European framework for data management and analysis, as planned within eNanoMapper, to facilitate a closer interdisciplinary collaboration between  NSC projects and to better address the need for proper data storage, analysis and sharing (Open Access).

Unexpectedly, there’s a Canadian connection,

Discovering protocols for nanoparticles: the soils case
NanoFASE WP7 & NanoSafety Cluster WG3 Exposure

In NanoFASE, of course, we focus on the exposure to nanomaterials. Having consistent and meaningful protocols to characterize the fate of nanomaterials in different environments is therefore of great interest to us. Soils and sediments are in this respect very cumbersome. Also in the case of conventional chemicals has the development of  protocols for fate description in terrestrial systems been a long route.

The special considerations of nanomaterials make this job even harder. For instance, how does one handle the fact that the interaction between soils and nanoparticles is always out of equilibrium? How does one distinguish between the nanoparticles that are still mobile and those that are attached to soil?

In the case of conventional chemicals, a single measurement of a filtered soil suspension often suffices to find the mobile fraction, as long one is sure that equilibrium has been attained. Equilibrium never occurs in the case of  nanoparticles, and the distinction between attached/suspended particles is analytically less clear to do.

Current activity in NanoFASE is focusing at finding protocols to characterize this interaction. Not only does the protocol have to provide meaningful parameters that can be used, e.g. in modelling, but also the method itself should be fast and cheap enough so that a lot of data can be collected in a reasonable amount of time. NanoFASE is  in a good position to do this, because of its focus on fate and because of the many international collaborators.

For  instance,  the Swedish  Agricultural  University (Uppsala)  is  collaborating  with  McGill  University (Montreal, Canada [emphasis mine]), an advisory partner to NanoFASE, in developing the OECD [Organization for Economic Cooperation and Development] protocol for column tests (OECD test nr 312:  “Leaching in soil columns”). The effort is led by Yasir Sultan from Environment Canada and by Karlheinz Weinfurtner from the Frauenhofer institute in Germany. Initial results show the transport of nanomaterials in soil columns to be very limited.

The OECD protocol therefore does not often lead to measurable breakthrough curves that can be modelled to provide information about  nanomaterial  mobility  in  soils  and  most  likely  requires adaptations  to  account  for  the  relatively  low mobility  of  typical pristine nanomaterials.

OECD 312 prescribes to use 40 cm columns, which is most likely too long to show a breakthrough in the case of nanoparticles. Testing in NanoFASE will therefore focus on working with shorter columns and also investigating the effect of the flow speed.

The progress and the results of this action will be reported on our website (www.nanofase.eu).

ENM [engineered nanomaterial] Transformation in and Release from Managed Waste Streams (WP5): The NanoFASE pilot Wastewater Treatment Plant is up and running and producing sludge – soon we’ll be dosing with nanoparticles to test “real world” aging.

Now, wastewater,

ENM [engineered nanomaterial] Transformation in and Release from Managed Waste Streams (WP5): The NanoFASE pilot Wastewater Treatment Plant is up and running and producing sludge – soon we’ll be dosing with nanoparticles to test “real world” aging.

WP5 led by Ralf Kaegi of EAWAG [Swiss Federal Institute of Aquatic Science and Technology] (Switzerland) will establish transformation and release rates of ENM during their passage through different reactors. We are focusing on wastewater treatment plants (WWTPs), solid waste and dedicated sewage sludge incinerators as well as landfills (see figure below). Additionally, lab-scale experiments using pristine and well characterized materials, representing the realistic fate relevant forms at each stage, will allow us to obtain a mechanistic understanding of the transformation processes in waste treatment reactors. Our experimental results will feed directly into the development of a mathematical model describing the transformation and transfer of ENMs through the investigated reactors.

I’m including this since I’ve been following the ‘silver nanoparticle story’ for some time,

NanoMILE publication update: NanoMILE on the air and on the cover

Dramatic  differences  in  behavior  of  nano-silver during  the  initial  wash  cycle  and  for  its  further dissolution/transformation potential over time depending on detergent composition and form.

In an effort to better relate nanomaterial aging procedures to those which they are most likely to undergo during the life cycle of nano-enhanced products, in this paper we describe the various transformations which are possible when exposing Ag engineered nanoparticles (ENPs) to a suite of commercially available washing detergents (Figure 1). While Ag ENP transformation and washing of textiles has received considerable attention in recent years, our study is novel in that we (1) used several commercially available detergents allowing us to estimate the various changes possible in individual homes and commercial washing settings; (2) we have continued  method  development  of  state  of  the  art nanometrology techniques, including single particle ICP-MS, for the detection and characterization of ENPs in complex media; and (3) we were able to provide novel additions to the knowledge base of the environmental nanotechnology research community both in terms of the analytical methods (e.g. the first time ENP aggregates have been definitively analyzed via single particle ICP-MS) and broadening the scope of “real world” conditions that should be considered when understanding AgENP through their life cycle.

Our findings, which were recently published in Environmental Science and Toxicology (2015, 49: 9665), indicate that the washing detergent chemistry causes dramatic differences in ENP behavior during the initial wash cycle and has ramifications for the dissolution/transformation potential of the Ag ENPs over time (see Figure 2). The use of silver as an  antimicrobial  treatment  in  textiles  continues  to garner  considerable  attention.  Last  year  we  published  a manuscript in ACS Nano that considered how various silver treatments to textiles (conventional and nano) both release  nano-sized  material  after  the  wash  cycle  with  similar chemical  characteristics.  That  study  essentially conveyed that multiple silver treatments would become more similar through the product life cycle. Our newest  work expands this by investigating one silver ENP under various washing conditions thereby creating more varied silver products as an end result.

Fascinating stuff if you’ve been following the issues around nanotechnology and safety.

Towards the end of the newsletter on pp. 46-48, they list opportunities for partnerships, collaboration, and research posts and they list websites where you can check out job opportunities. Good Luck!