Tag Archives: REACH

European Commission has issued evaluation of nanomaterial risk frameworks and tools

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Despite complaints that there should have been more, there has been some research into risks where nanomaterials are concerned. While additional research would be welcome, it’s perhaps more imperative that standardized testing and risk frameworks are developed so, for example, carbon nanotube safety research in Japan can be compared with the similar research in the Netherlands, the US, and elsewhere. This March 15, 2017 news item on Nanowerk features some research analyzing risk assessment frameworks and tools in Europe,

A recent study has evaluated frameworks and tools used in Europe to assess the potential health and environmental risks of manufactured nanomaterials. The study identifies a trend towards tools that provide protocols for conducting experiments, which enable more flexible and efficient hazard testing. Among its conclusions, however, it notes that no existing frameworks meet all the study’s evaluation criteria and calls for a new, more comprehensive framework.

A March 9, 2017 news alert in the European Commission’s Science for Environment Policy series, which originated the news item, provides more detail (Note: Links have been removed),

Nanotechnology is identified as a key emerging technology in the EU’s growth strategy, Europe 2020. It has great potential to contribute to innovation and economic growth and many of its applications have already received large investments. However,there are some uncertainties surrounding the environmental, health and safety risks of manufactured nanomaterials. For effective regulation, careful scientific analysis of their potential impacts is needed, as conducted through risk assessment exercises.

This study, conducted under the EU-funded MARINA project1, reviewed existing frameworks and tools for risk assessing manufactured nanomaterials. The researchers define a framework as a ‘conceptual paradigm’ of how a risk assessment should be conducted and understood, and give the REACH chemical safety assessment as an example. Tools are defined as implements used to carry out a specific task or function, such as experimental protocols, computer models or databases.

In all, 12 frameworks and 48 tools were evaluated. These were identified from other studies and projects. The frameworks were assessed against eight criteria which represent different strengths, such as whether they consider properties specific to nanomaterials, whether they consider the entire life cycle of a nanomaterial and whether they include careful planning and prioritise objectives before the risk assessment is conducted.

The tools were assessed against seven criteria, such as ease of use, whether they provide quantitative information and if they clearly communicate uncertainty in their results. The researchers defined the criteria for both frameworks and tools by reviewing other studies and by interviewing staff at organisations who develop tools.

The evaluation was thus able to produce a list of strengths and areas for improvement for the frameworks and tools, based on whether they meet each of the criteria. Among its many findings, the evaluation showed that most of the frameworks stress that ‘problem formulation’, which sets the goals and scope of an assessment during the planning process, is essential to avoid unnecessary testing. In addition, most frameworks consider routes of exposure in the initial stages of assessment, which is beneficial as it can exclude irrelevant exposure routes and avoid unnecessary tests.

However, none of the frameworks met all eight of the criteria. The study therefore recommends that a new, comprehensive framework is developed that meets all criteria. Such a framework is needed to inform regulation, the researchers say, and should integrate human health and environmental factors, and cover all stages of the life cycle of a product containing nanomaterials.

The evaluation of the tools suggested that many of them are designed to screen risks, and not necessarily to support regulatory risk assessment. However, their strengths include a growing trend in quantitative models, which can assess uncertainty; for example, one tool analysed can identify uncertainties in its results that are due to gaps in knowledge about a material’s origin, characteristics and use.

The researchers also identified a growing trend in tools that provide protocols for experiments, such as identifying materials and test hazards, which are reproducible across laboratories. These tools could lead to a shift from expensive case-by-case testing for risk assessment of manufactured nanomaterials towards a more efficient process based on groupings of nanomaterials; and ‘read-across’ methods, where the properties of one material can be inferred without testing, based on the known properties of a similar material. The researchers do note, however, that although read-across methods are well established for chemical substances, they are still being developed for nanomaterials. To improve nanomaterial read-across methods, they suggest that more data are needed on the links between nanomaterials’ specific properties and their biological effects.

That’s all, folks.

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

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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.

Introducing the LIFE project NanoMONITOR

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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.

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

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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.

Nanomaterials and safety: Europe’s non-governmental agencies make recommendations; (US) Arizona State University initiative; and Japan’s voluntary carbon nanotube management

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I have three news items which have one thing in common, they concern nanomaterials and safety. Two of these of items are fairly recent; the one about Japan has been sitting in my drafts folder for months and I’m including it here because if I don’t do it now, I never will.

First, there’s an April 7, 2014 news item on Nanowerk (h/t) about European non-governmental agencies (CIEL; the Center for International Environmental Law and its partners) and their recommendations regarding nanomaterials and safety. From the CIEL April 2014 news release,

CIEL and European partners* publish position paper on the regulation of nanomaterials at a meeting of EU competent authorities

*ClientEarth, The European Environmental Bureau, European citizen’s Organization for Standardisation, The European consumer voice in Standardisation –ANEC, and Health Care Without Harm, Bureau of European Consumers

… Current EU legislation does not guarantee that all nanomaterials on the market are safe by being assessed separately from the bulk form of the substance. Therefore, we ask the European Commission to come forward with concrete proposals for a comprehensive revision of the existing legal framework addressing the potential risks of nanomaterials.

1. Nanomaterials are different from other substances.

We are concerned that EU law does not take account of the fact that nano forms of a substance are different and have different intrinsic properties from their bulk counterpart. Therefore, we call for this principle to be explicitly established in the REACH, and Classification Labeling and Packaging (CLP) regulations, as well as in all other relevant legislation. To ensure adequate consideration, the submission of comprehensive substance identity and characterization data for all nanomaterials on the market, as defined by the Commission’s proposal for a nanomaterial definition, should be required.

Similarly, we call on the European Commission and EU Member States to ensure that nanomaterials do not benefit from the delays granted under REACH to phase-in substances, on the basis of information collected on their bulk form.

Further, nanomaterials, due to their properties, are generally much more reactive than their bulk counterpart, thereby increasing the risk of harmful impact of nanomaterials compared to an equivalent mass of bulk material. Therefore, the present REACH thresholds for the registration of nanomaterials should be lowered.

Before 2018, all nanomaterials on the market produced in amounts of over 10kg/year must be registered with ECHA on the basis of a full registration dossier specific to the nanoform.

2. Risk from nanomaterials must be assessed

Six years after the entry into force of the REACH registration requirements, only nine substances have been registered as nanomaterials despite the much wider number of substances already on the EU market, as demonstrated by existing inventories. Furthermore, the poor quality of those few nano registration dossiers does not enable their risks to be properly assessed. To confirm the conclusions of the Commission’s nano regulatory review assuming that not all nanomaterials are toxic, relevant EU legislation should be amended to ensure that all nanomaterials are adequately assessed for their hazardous properties.

Given the concerns about novel properties of nanomaterials, under REACH, all registration dossiers of nanomaterials must include a chemical safety assessment and must comply with the same information submission requirements currently required for substances classified as Carcinogenic, Mutagenic or Reprotoxic (CMRs).

3. Nanomaterials should be thoroughly evaluated

Pending the thorough risk assessment of nanomaterials demonstrated by comprehensive and up-to-date registration dossiers for all nanoforms on the market, we call on ECHA to systematically check compliance for all nanoforms, as well as check the compliance of all dossiers which, due to uncertainties in the description of their identity and characterization, are suspected of including substances in the nanoform. Further, the Community Roling Action Plan (CoRAP) list should include all identified substances in the nanoform and evaluation should be carried out without delay.

4. Information on nanomaterials must be collected and disseminated

All EU citizens have the right to know which products contain nanomaterials as well as the right to know about their risks to health and environment and overall level of exposure. Given the uncertainties surrounding nanomaterials, the Commission must guarantee that members of the public are in a position to exercise their right to know and to make informed choices pending thorough risk assessments of nanomaterials on the market.

Therefore, a publicly accessible inventory of nanomaterials and consumer products containing nanomaterials must be established at European level. Moreover, specific nano-labelling or declaration requirements must be established for all nano-containing products (detergents, aerosols, sprays, paints, medical devices, etc.) in addition to those applicable to food, cosmetics and biocides which are required under existing obligations.

5. REACH enforcement activities should tackle nanomaterials

REACH’s fundamental principle of “no data, no market” should be thoroughly implemented. Therefore, nanomaterials that are on the market without a meaningful minimum set of data to allow the assessment of their hazards and risks should be denied market access through enforcement activities. In the meantime, we ask the EU Member States and manufacturers to use a precautionary approach in the assessment, production, use and disposal of nanomaterials

This comes on the heels of CIEL’s March 2014 news release announcing a new three-year joint project concerning nanomaterials and safety and responsible development,

…

Supported by the VELUX foundations, CIEL and ECOS (the European Citizen’s Organization for Standardization) are launching a three-year project aiming to ensure that risk assessment methodologies and risk management tools help guide regulators towards the adoption of a precaution-based regulatory framework for the responsible development of nanomaterials in the EU and beyond.

Together with our project partner the German Öko-Institut, CIEL and ECOS will participate in the work of the standardization organizations Comité Européen de Normalisation and International Standards Organization, and this work of the OECD [Organization for Economic Cooperation and Development], especially related to health, environmental and safety aspects of nanomaterials and exposure and risk assessment. We will translate progress into understandable information and issue policy recommendations to guide regulators and support environmental NGOs in their campaigns for the safe and sustainable production and use of nanomaterials.

The VILLUM FOUNDATION and the VELUX FOUNDATION are non-profit foundations created by Villum Kann Rasmussen, the founder of the VELUX Group and other entities in the VKR Group, whose mission it is to bring daylight, fresh air and a better environment into people’s everyday lives.

Meanwhile in the US, an April 6, 2014 news item on Nanowerk announces a new research network, based at Arizona State University (ASU), devoted to studying health and environmental risks of nanomaterials,

Arizona State University researchers will lead a multi-university project to aid industry in understanding and predicting the potential health and environmental risks from nanomaterials.

Nanoparticles, which are approximately 1 to 100 nanometers in size, are used in an increasing number of consumer products to provide texture, resiliency and, in some cases, antibacterial protection.

The U.S. Environmental Protection Agency (EPA) has awarded a grant of $5 million over the next four years to support the LCnano Network as part of the Life Cycle of Nanomaterials project, which will focus on helping to ensure the safety of nanomaterials throughout their life cycles – from the manufacture to the use and disposal of the products that contain these engineered materials.

An April 1, 2014 ASU news release, which originated the news item, provides more details and includes information about project partners which I’m happy to note include nanoHUB and the Nanoscale Informal Science Education Network (NISENet) in addition to the other universities,

Paul Westerhoff is the LCnano Network director, as well as the associate dean of research for ASU’s Ira A. Fulton Schools of Engineering and a professor in the School of Sustainable Engineering and the Built Environment.

The project will team engineers, chemists, toxicologists and social scientists from ASU, Johns Hopkins, Duke, Carnegie Mellon, Purdue, Yale, Oregon’s state universities, the Colorado School of Mines and the University of Illinois-Chicago.

Engineered nanomaterials of silver, titanium, silica and carbon are among the most commonly used. They are dispersed in common liquids and food products, embedded in the polymers from which many products are made and attached to textiles, including clothing.

Nanomaterials provide clear benefits for many products, Westerhoff says, but there remains “a big knowledge gap” about how, or if, nanomaterials are released from consumer products into the environment as they move through their life cycles, eventually ending up in soils and water systems.

“We hope to help industry make sure that the kinds of products that engineered nanomaterials enable them to create are safe for the environment,” Westerhoff says.

“We will develop molecular-level fundamental theories to ensure the manufacturing processes for these products is safer,” he explains, “and provide databases of measurements of the properties and behavior of nanomaterials before, during and after their use in consumer products.”

Among the bigger questions the LCnano Network will investigate are whether nanomaterials can become toxic through exposure to other materials or the biological environs they come in contact with over the course of their life cycles, Westerhoff says.

The researchers will collaborate with industry – both large and small companies – and government laboratories to find ways of reducing such uncertainties.

Among the objectives is to provide a framework for product design and manufacturing that preserves the commercial value of the products using nanomaterials, but minimizes potentially adverse environmental and health hazards.

In pursuing that goal, the network team will also be developing technologies to better detect and predict potential nanomaterial impacts.

Beyond that, the LCnano Network also plans to increase awareness about efforts to protect public safety as engineered nanomaterials in products become more prevalent.

The grant will enable the project team to develop educational programs, including a museum exhibit about nanomaterials based on the LCnano Network project. The exhibit will be deployed through a partnership with the Arizona Science Center and researchers who have worked with the Nanoscale Informal Science Education Network.

The team also plans to make information about its research progress available on the nanotechnology industry website Nanohub.org.

“We hope to use Nanohub both as an internal virtual networking tool for the research team, and as a portal to post the outcomes and products of our research for public access,” Westerhoff says.

The grant will also support the participation of graduate students in the Science Outside the Lab program, which educates students on how science and engineering research can help shape public policy.

Other ASU faculty members involved in the LCnano Network project are:

• Pierre Herckes, associate professor, Department of Chemistry and Biochemistry, College of Liberal Arts and Sciences
• Kiril Hristovski, assistant professor, Department of Engineering, College of Technology and Innovation
• Thomas Seager, associate professor, School of Sustainable Engineering and the Built Environment
• David Guston, professor and director, Consortium for Science, Policy and Outcomes
• Ira Bennett, assistant research professor, Consortium for Science, Policy and Outcomes
• Jameson Wetmore, associate professor, Consortium for Science, Policy and Outcomes, and School of Human Evolution and Social Change

I hope to hear more about the LCnano Network as it progresses.

Finally, there was this Nov. 12, 2013 news item on Nanowerk about instituting  voluntary safety protocols for carbon nanotubes in Japan,

Technology Research Association for Single Wall Carbon Nanotubes (TASC)—a consortium of nine companies and the National Institute of Advanced Industrial Science and Technology (AIST) — is developing voluntary safety management techniques for carbon nanotubes (CNTs) under the project (no. P10024) “Innovative carbon nanotubes composite materials project toward achieving a low-carbon society,” which is sponsored by the New Energy and Industrial Technology Development Organization (NEDO).

Lynn Bergeson’s Nov. 15, 2013 posting on nanotech.lawbc.com provides a few more details abut the TASC/AIST carbon nanotube project (Note: A link has been removed),

Japan’s National Institute of Advanced Industrial Science and Technology (AIST) announced in October 2013 a voluntary guidance document on measuring airborne carbon nanotubes (CNT) in workplaces. … The guidance summarizes the available practical methods for measuring airborne CNTs:  (1) on-line aerosol measurement; (2) off-line quantitative analysis (e.g., thermal carbon analysis); and (3) sample collection for electron microscope observation. …

You can  download two protocol documents (Guide to measuring airborne carbon nanotubes in workplaces and/or The protocols of preparation, characterization and in vitro cell based assays for safety testing of carbon nanotubes), another has been published since Nov. 2013, from the AIST’s Developing voluntary safety management techniques for carbon nanotubes (CNTs): Protocol and Guide webpage., Both documents are also available in Japanese and you can link to the Japanese language version of the site from the webpage.

What do you do with a problem like regulating nanotechnology risks?

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You get points for recognizing the “Sound of Music’ reference. Of course, the points aren’t useful for anything, which leads me in a roundabout way to Michael Berger’s fascinating May 28, 2013 Nanowerk Spotlight article, Does the EU’s chemical regulation sufficiently address nanotechnology risks? It’s a digest of a discussion, published in Nature Nanotechnology’s May 2013 issue, about nanotechnology regulations in light of the European Commission’s (EC; a unit in the European Union structure) Second Regulatory Review on Nanomaterials.

Berger summarizes Steffen Foss Hansen’s The European Union’s chemical legislation needs revision (article is behind a paywall) and Antonio Tajani’s response to Hansen, Substance identification of nanomaterials not key to ensuring their safe use (article is behind a paywall; Note: Links have been removed from the following excerpt),

The European Union’s chemical legislation known as REACH needs revision argues Steffen Foss Hansen, Associate Professor at DTU Environment, Technical University of Denmark. In a correspondence to the Editor of Nature Nanotechnology (“The European Union’s chemical legislation needs revision”), Hansen argues that REACH needs to be revised in three major areas.

First of all, a distinction needs to be made in the legal text of REACH between the bulk and the nano form of a given material and Hansen argues that the European Commission should acknowledge that nanomaterials cannot be identified solely by chemical composition. Additional main identifiers (such as primary particle size distribution, shape – including aspect ratio – specific surface area and surface treatment) are needed as this is the only manner in which it can be made clear that the properties and behavior of nanomaterials differ fundamentally from each other and from the bulk material.

…

In a response to Hansen’s Correspondence, Antonio Tajani, Vice-President of the European Commission and Commissioner for Industry and Entrepreneurship, writes that substance identification of nanomaterials is not key to ensuring their safe use (“Substance identification of nanomaterials not key to ensuring their safe use”).

Tajani argues that substance identification is only one element and that trying to identify unambiguous rules for substance identification is probably elusive and might result in ever more complex rules on what is considered as the same substance as opposed to different substances, without necessarily resulting in more safety of nanomaterials. Instead, Tajani and the European Commission wish to focus on clarifying what is needed to demonstrate the safe use while also noting that the implementation of regulatory changes would take several years and hence is not desirable.

As per my Oct. 25, 2011 posting (Nanoparticle size doesn’t matter), my thinking on environmental, health, and safety issues regarding engineered nanomaterials has been in the process of change and I note that focusing on the size, shape, and other factors would make regulation next to impossible. So, I’m inclined to agree with Tajani’s arguments that trying to develop “unambiguous rules for substance identification” is not a worthwhile approach to dealing with any EHS issues that nanomaterials may present and will likely prove futile in the same way as gaining points for recognizing my attempted ‘Sound of Music’ reference.

I assume that Tajani and Hansen are referring to engineered nanomaterials as opposed to naturally occurring nanomaterials. (I too forget to specify but unless otherwise noted I’m usually referring to engineered nanomaterials.)

For me, two of the most compelling issues that Hansen presents revolve around a lack of data and standardized testing (from Hansen’s article in Nature),

… there are few measured exposure data and that few environmental fate and behaviour studies are available. …

… there are currently no standardized (eco)toxicity test guidelines in use …

I do wonder how many the word ‘few’ represents as I’m reminded of the plethora of studies on silver nanoparticles and on long, multi-walled carbon nanotubes. Certainly, they are attempting to address the situation regarding consistent testing protocols in the US as per my May 8, 2013 post about the NanoGo Consortium. Perhaps the EC folks could consider using these protocols as a model for a European version?  I assume that Hansen is commenting on a broader, European-inflected picture rather than the piecemeal, ‘globalish’ picture I have formed from my meanderings in the nanosphere.

Hansen also points this out in his Nature article (Note: Footnotes have been removed),

Another disturbing aspect of the Second Regulatory Review on Nanomaterials is that it focuses only on first-generation nanomaterials (that is, passive nanostructures such as nanoparticles). The Staff Working Paper acknowledges that second- and third-generation nanomaterials (for example, targeted drug-delivery systems and novel robotic devices) are entering early stages of market development, …

I’m beginning to find the discussion about definitions and resultant regulations wearing and am coming to the conclusion that the focus should be on bringing the information already gathered together, standardizing tests, determining what is  known and not known, and establishing some forward momentum.

Webinar featuring REACH and JRC perspectives on the European Union’s definition of nanomaterials

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NanoSight is once more hosting a webinar on the European Union’s definition of nanomaterials (the first nanomaterials definitiion webinar was mentioned in my March 6, 2012 posting).  Here’s more about their latest nanomaterials definition webinar,  from NanoSight’s webinar registration page,

Update on the EU Nanomaterials Definition: Impact of Recent EU and JRC [European Commission’s Joint Research Centre] Publications

Wednesday, 14th November 2012
Live at 15:00 GMT (16:00 CET, 07:00 PST, 10:00 EST)
Repeated Live at 17:00 GMT (18:00 CET, 09:00 PST, 12:00 EST)

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Dr Denis Koltsov is an international nanotechnology legislation and control expert. He is Director and Principal Consultant at BREC Solutions offering technology consulting services. He also holds a lectureship in the Department of Engineering at Lancaster University.
Dr Matteo Della Valle is from the REACH Centre, an organization that provides the highest quality advice on the many regulatory, technical and commercial aspects of REACh and other chemical regulations.

…

During the 30 minute interactive presentations, the speakers will

  • Review the JRC methods document and dicuss the key conclusions and the challenges presented
  • Outline the EU’s Second Regulatory Review and forthcoming legislation where it will have most impact with particular emphasis on the REACh [European Community’s (Registration, Evaluation, Authorisation and restriction of CHemicals] registration process
  • Report on the USA perspective concerning regulation of nanomaterials. This reporting will include matters tabled as SENN2012 – International Congress on Safety of Engineered Nanoparticles and Nanotechnologies, at the end of this month in Helsinki

As part of this fully interactive presentation you will be able to put your question to both myself and Denis, so please take advantage of this opportunity to clarify any queries you may have.

H/T to Azonano’s Nov. 2, 2012 news item.

Bureaucratic incomprehensibility: REACH Nanomaterials Implementation Projects

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This looks to be one of those announcements made by an organization that is simply going through the motions or perhaps they’ve forgotten that no one understands bureaucratese unless they’re intimately involved.

This first bit isn’t so bad, from the Oct.19, 2011 news item on Nanowerk,

Final reports have been published from two REACH Implementation Projects on Nanomaterials (RIP-oN 2&3). Commissioned by the JRC’s Institute for Health & Consumer Protection, the projects intended to develop specific advice on the implementation of REACH for nanomaterials. The outputs from the projects have been developed over a period of 12-16 months in consultation with a range of stakeholders. The reports have scoped the current state-of-the-science regarding assessment of nanomaterials in the context of REACH, and provide recommendations to the European Commission on how the REACH Guidance on Information Requirements and Chemical Safety Assessment could be further developed to better address nanomaterials.

So we have two final reports. Here’s the description of the reports,

The RIP-oN 2 project has addressed the REACH information requirements on intrinsic properties of nanomaterials, and the information needed for safety evaluation of nanomaterials. The RIP-oN 3 project has addressed exposure assessments and hazard and risk characterisation for nanomaterials within the REACH context.

Not the most informative description I’ve ever read. And as it turns out, there’s a third report,

Under a separate process, a third report from the RIPoN activity relating to Substance Identity (Rip-oN 1) has also been published. This report is also available online, however, according to the Commission it was not possible to reach consensus amongst the experts on the recommendations, therefore further work of the Commission, in collaboration with CARACAL, is required before recommendations can be forwarded to ECHA

Maybe a government bureaucrat understands some of this?