Tag Archives: Society for Risk Analysis (SRA)

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.

Deadline extension (travel grants and poster abstracts) for alternate testing strategies (ATS) of nanomaterials workshop

It seems there have been a couple of deadline extensions (to August 1, 2014) for the September 15-16, 2014 ‘Workshop to Explore How a Multiple Models Approach can Advance Risk Analysis of Nanoscale Materials’ in Washington, DC (first mentioned in my July 10, 2014 posting featuring a description of the workshop). You can go here to submit a poster abstract (from any country) and you can go here if you’re a student or young professional (from any country) in search of a $500 travel award.

I managed to speak to one of the organizers, Lorraine Sheremeta, (Assistant Director, Ingenuity Lab, University of Alberta and co-author a July 9, 2014 Nanowerk Spotlight article about the workshop). Lorraine (Lori) kindly spoke to me about the upcoming workshop, which she described as an academic conference,.

As I understand what she told me, the hosts for the September 15-16, 2014 Workshop to Explore How a Multiple Models Approach can Advance Risk Analysis of Nanoscale Materials in Washington, DC want to attract a multidisciplinary group of people to grapple with a few questions. First, they want to establish a framework for establishing which are the best test methods for nanomaterials. Second, they are trying to move away from animal testing and want to establish which methods are equal to or better than animal testing. Thirdly, they want to discuss what they are going to do with the toxicological data  that we have  been collecting on nanomaterials for years now.

Or, as she and her colleague from the Society of Risk Analysis (Jo Anne Shatkin) have put in it in their Nanowerk Spotlight article:

… develop a report on the State of the Science for ATS for nanomaterials, catalogue of existing and emerging ATS [alternate testing strategies] methods in a database; and develop a case study to inform workshop deliberations and expert recommendations

The collaborative team behind this event includes, the University of Alberta’s Ingenuity Lab, the Society for Risk Analysis, Environment Canada, Health Canada, and the Organization for Economic Co-operation and Development (OECD) Working Party on Manufactured Nanomaterials (WPMN) .

The speaker lineup isn’t settled at this time although they have confirmed Vicki Stone of Heriot-Watt University in Scotland (from her university bio page),

Vicki Stone, Professor of Toxicology, studies the effects of nanomaterials on humans and environmentally relevant species.  Current research projects investigate the mechanism of toxicity of a range of nanomaterials in cells of the immune system (macrophages and neutrophils), liver (hepatocytes) , gastrointestinal tract, blood vessels (endothelium) and lung.  She is interested in interactions between nanomaterials, proteins and lipids, and how this influences subsequent toxicity.  Current projects also develop in vitro alternatives using microfluidics as well as high resolution imaging of individual nanomaterials in 3D and over time.  In addition Vicki collaborates with ecotoxicologists to investigate the impacts of nanomaterials on aquatic organisms. Vicki coordinated a European project to identify the research priorities to develop an intelligent testing strategy for nanomaterials (www.its-nano.eu).

Vicki is Director of the Nano Safety Research Group at Heriot-Watt University, Edinburgh, and Director of Toxicology for SAFENANO (www.safenano.org). She has acted as the Editor-in-chief of the journal Nanotoxicology (http://informahealthcare.com/nan) for 6 years (2006-2011). Vicki has also published over 130 publications pertaining to particle toxicology over the last 16 years and has provided evidence for the government commissioned reports published by the Royal Society (2003) and the on Environmental Pollution (2008).  Vicki was previously a member of the UK Government Committee on the Medical Effects of Air Pollution (COMEAP) and an advisory board member for the Center for the Environmental Implications of NanoTechnology (CEINT; funded by the US Environmental Protection Agency)).

A representative from PETA (People for the Ethical Treatment of Animals) will also be speaking. I believe that will be Amy Clippinger (from the PETA website’s Regulatory Testing webpage; scroll down about 70% of the way),

Science adviser Amy Clippinger has a Ph.D. in cellular and molecular biology and genetics and several years of research experience at the University of Pennsylvania.

PETA representatives have been to at least one other conference on the topic of nano, toxicology, and animal testing as per my April 24, 2014 posting about NANOTOX 2014 in Turkey,

Writing about nanotechnology can lead you in many different directions such as the news about PETA (People for the Ethical Treatment of Animals) and its poster presentation at the NanoTox 2014 conference being held in Antalya, Turkey from April 23 – 26, 2014. From the April 22, 2014 PETA news release on EurekAlert,

PETA International Science Consortium Ltd.’s nanotechnology expert will present a poster titled “A tiered-testing strategy for nanomaterial hazard assessment” at the 7th International Nanotoxicology Congress [NanoTox 2014] to be held April 23-26, 2014, in Antalya, Turkey.

Dr. Monita Sharma will outline a strategy consistent with the 2007 report from the US National Academy of Sciences, “Toxicity Testing in the 21st Century: A Vision and a Strategy,” which recommends use of non-animal methods involving human cells and cell lines for mechanistic pathway–based toxicity studies.

There is a lot of interest internationally in improving how we test for toxicity of nanomaterials. As well, the drive to eliminate or minimize as much as possible the use of animals in testing seems to be gaining momentum.

Good luck to everyone submitting a poster abstract and/or an application for a travel grant!

In case you don’t want to scroll up, the SRA nano workshop website is here.

An upcoming alternate testing strategies (ATS) for nanomaterials workshop and the quest to reduce animal testing

It’s too late to announce a call for poster abstracts or travel awards but that still leaves the possibility of attending a September 15-16, 2014 Workshop to Explore How a Multiple Models Approach can Advance Risk Analysis of Nanoscale Materials in Washington, DC. In a July 9, 2014 Nanowerk Spotlight article,, Jo Anne Shatkin (President, Vireo Advisors) and Lorraine Sheremeta (Assistant Director, Ingenuity Lab, University of Alberta) tout the workshop in the context of describing new approaches to nanotoxicology research (Note: A link has been removed),

Engineered nanoscale materials (ENM or ‘nanomaterials’) offer the potential to create safer and more effective products through the use of smaller quantities of improved performance materials. Currently nanomaterials are used to improve the performance of life-saving drugs and medical technologies, to make renewable energy more efficient, to make value added products from industrial waste streams, to improve food, packaging, to lightweight materials used in transportation systems, and to improve many of the personal care products that we use every day. Nanomaterial manufacture and use is expected to increase over the coming years and despite the widespread use of nanomaterials in a variety of consumer products, we are only beginning to understand the impacts of these emerging materials on our health and the environment. To this end, the University of Alberta’s Ingenuity Lab is collaborating with the Society for Risk Analysis to evaluate the potential to use alternative test strategies (ATS) to improve our ability to assess nanomaterial toxicity and environmental impact.

Shatkin and Sheremeta describe toxicology tests and explain the importance of refining and improving these tests (from the article),

Standard in vivo toxicology test methods that depend heavily on the use of animals have long been used to assess chemical safety. [emphasis mine*] Existing and novel in vitro and in silico test methods provide important alternatives to in vivo animal testing for chemicals and potentially for ENM. Genotoxicity tests, for example, are used to assess the mutagenic potential of chemicals or nanomaterials in the replication of DNA in cells. Driven in part by increasing market and regulatory requirements for safer and more sustainable products, large international infrastructure has developed for creating, testing and validating in vitro test methods, and its use is expanding to chemical and nanomaterial assessment (NSF, 2007). The goals of reducing, refining and replacing animal testing (the commonly cited ‘three Rs’) – resonate with key and diverse stakeholders including animal rights groups, the bioethics community, the pharmaceutical industry, regulatory agencies and the broader public. [emphasis mine*]

Despite nearly a decade of effort in the conduct toxicology and exposure research to inform the assessment of health and environmental risks of nanomaterials, major gaps remain in the ability to understand and quantify risks. While there is now a large body of published data on carbon nanotubes and metal oxide nanoparticles, concern has been raised that speculation about nanomaterial risk has hardened into an assumption that there are ‘as-yet-to-be-discovered risks’ that we must identify and manage (Maynard, 2014) that demands extensive testing.

The authors describe ATS (alternative test strategies) in greater detail,

ATS approaches are regarded by many to have the potential for rapid screening of large numbers and types of materials. They can include a breadth of techniques including high throughput screening methods (HTS), high content screening, computational approaches, toxicogenomics, cell-based methods, in vitro assays and non-mammalian whole animal models. The emergence of ATS raises questions about how the results of these methods may be used for assessing the potential risks of ENM. For instance, ATS could be used in combination in a multiple models approach to evaluate new ENM in a number of rapid assays and compare with well-studied substances using in vivo testing; thereby identifying ENM for additional testing in a more strategic fashion than is possible through conventional testing approaches.

They also describe the current state of affairs with ATS,

In the United States, the U.S. ToxCast program has, as part of their 21st century toxicity screening program (NRC, 2007), tested 29 NMs with 62 in vitro test methods (Wang et al. 2013). Many researchers, including several from the University of Alberta, have proposed and developed ATS to include a variety of methods, some which are standardized for chemicals, and others which take advantage of developments including advanced biological mechanistic understanding, genomics, metabolomics, automation and informatics. However, these existing as well as emerging ATS have a short history with nanomaterials, and have not yet proven to be reliable for quantitative estimation of ENM risk. Still, several international efforts have developed ATS that have potential to be used for screening purposes, and to guide further testing priorities for regulatory decision making. The goal of the September [2014] workshop by the Society for Risk Analysis is to explore ways in which distinct ATS may be used for screening and prioritizing the need for more extensive testing of novel ENM.

The parties (including the authors of the article) involved in developing this risk workshop are listed, also mentioned are members of the international testing scene,

Lori Sheremeta, the Assistant Director of Ingenuity Lab in Edmonton Alberta and past Chair of the Society for Risk Analysis (SRA) Emerging Nanoscale Materials Specialty Group (ENMSG), is collaborating with U.S.-based nanomaterials risk expert Jo Anne Shatkin (an SRA Councilor and co-founder of the SRA ENMSG), Environment Canada, Health Canada, the SRA ENMSG and others on a Pilot Project with the Organization for Economic Co-operation and Development (OECD) Working Party on Manufactured Nanomaterials (WPMN) to develop a report on the State of the Science for ATS for nanomaterials, catalogue of existing and emerging ATS methods in a database; and develop a case study to inform workshop deliberations and expert recommendations.

There are many international efforts to develop, as well as to validate and standardize, these methods for chemicals, including organizations such as the US National Toxicology Program Interagency Center for the Evaluation of Alternative Toxicological Methods (ICCVAM), the European Union Reference Laboratory European Centre for the Validation of Alternative Methods (EURL ECVAM), the Japanese Center for the Validation of Alternative Methods (JacVAM), the Korean Centre for the Validation of Alternative Methods (KoCVAM) and the OECD. There is wide recognition that the diversity of NMs renders it impractical to use traditional animal testing to evaluate safety, hence there is significant interest in assessing the performance of both existing and emerging alternative testing strategies for NMs. Further, the EU directive REACH (Directive 2006/121/EC) requires replacing in vivo testing, and there is widespread popular agreement about the desire to limit animal testing. Finally, there is a need for more biologically informative toxicology methods (Hartung, 2010; Silbergeld et al, 2011; Landsiedel et al, 2009).

A list of the workshop objectives is offered  in the article,

The main objectives of the workshop are to:

assess the state of the science on HTS and ATS from a ‘multiple models’ perspective to identify areas of common findings from differing approaches, areas of greatest uncertainty, and priorities for follow up in applied research toward risk assessment of ENM;
evaluate the ability to use data from ATS/HTS methods for screening purposes – combining suites of assays and comparing well-studied substances to novel ones;

assess the ability to use a suite of ATS methods to amplify the Weight of Evidence;

characterize uncertainty associated with predictive relationships and propose strategies to address uncertainties;

elicit the perspectives of diverse stakeholders about the use of HTS/ATS for screening purposes in risk analysis of ENM; and

develop a set of recommendations for these alternative approaches to become more widely adopted for environmental, health and safety decision making about ENM across the product life cycle. The output of the workshop holds potential for transformation through risk screening approaches that promote safer and more sustainable material and technology development.

You can find more about the September 15-16, 2014 Workshop to Explore How a Multiple Models Approach can Advance Risk Analysis of Nanoscale Materials in Washington, DC here.

The text in the article is a bit rough. Some of the ideas and topics don’t follow each other logically. So, be prepared to spend a little time reading, Happily, there are references included with the article.

I last mentioned Jo Anne Shatkin here in the context of a 2013 paper on alternative test strategies (ATS) in an Aug. 22, 2013 posting. I think the most recent mention of Lorraine Sheremeta here is in a Jan. 11, 2010 posting about Canada, nanotechnology, and food.

Final note, I am hoping to get some more information about the workshop and ATS scene from Lorraine Sheremeta to be published in a subsequent posting.

* I added the emphases at 0830 hours PDT July 10, 2014.