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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.

New ISO report: characterizing nanomaterials before studying possible toxicological effects

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It makes sense to characterize materials before testing them for possible toxicological effects since you want to ensure scientists around the world know they can compare their results with some confidence.  According to the International Standardization Organization (ISO) website, May 8, 2012 is the publication date for a technical report, which establishes standards for nanomaterials (specifically, nano-objects) testing: ISO/TR 13014:2012; Nanotechnologies – Guidance on physico-chemical characterization of engineered nanoscale materials for toxicologic assessment.

The May 30, 2012 news item on Nanowerk provides more details about this new report,

ISO TR 13014:2012, Nanotechnologies – Guidance on physicochemical characterization of engineered nanoscale materials for toxicologic assessment, is intended to assist health scientists and experts to understand, plan, identify, and address relevant physicochemical characteristics of nano-objects before conducting toxicological tests on them.

ISO TR 13014:2012 was prepared by ISO TC 229, Nanotechnologies, Working Group (WG) 3, Health, Safety and Environment, under the project leadership of Dr. Richard Pleus of the United States. This group is U.S.-led, operating under the leadership of Dr. Laurie Locascio of the National Institute of Standards and Technology (NIST). Dr. Vladimir Murashov of the National Institutes of Occupational Safety and Health (NIOSH) serves as the WG 3 chair for the U.S. Technical Advisory Group (TAG) to ISO TC 229, which is accredited and administered by the American National Standards Institute (ANSI).

“By understanding the chemical and physical characteristics of nano-objects, we are working to decrease toxicity of materials and promote the development of safer alternatives,” said Dr. Pleus. “The work done in this document has a fundamental importance in toxicology, as it tells scientists the material being tested needs to be understood: What does it look like? What is it made of? How does it interact with the surrounding environment?”

You can find out more about ANSI and its nanotechnology efforts here.  From ANSI’s Technology Advisory Group webpage for nanotechnologies,

Specific tasks include developing standards for: terminology and nomenclature; metrology and instrumentation, including specifications for reference materials; test methodologies; modelling and simulations; and science-based health, safety, and environmental practices.

ANSI administers the U.S. Technical Advisory Group (TAG) for ISO/TC 229 Nanotechnologies. The Scope of the U.S. TAG mirrors the above scope of ISO/TC 229.

…

Membership on the ANSI-Accredited U.S. TAG is open to all materially affected U.S. parties interested in the coordination and development of International Standards related to nanotechnology

Environmental Nanoscience Initiative goes transatlantic (UK/US) in phase 2 and related ISO news

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Launched in 2006, the Environmental Nanoscience Initiative (ENI) will see scientists from the US and UK collaborate on three projects in phase 2. From the Jan. 26, 2011 news item on Nanowerk,

One of the ENI consortia will carry out a risk assessment for manufactured nanoparticles used in consumer products. Earlier research has focused on the toxicities – the degrees to which the nanoparticles can affect organisms – at the source. It has also shown that nanomaterials can affect marine organisms and change the properties of chemicals they come into contact with. For this project the researchers intend to evaluate the effect of the nanoparticles on people and aquatic animals at the point of exposure.

A second research team will investigate how the nanoparticles and nanotubes are transported into sewage treatment systems, into soil, surface waters and sediments, as well as their toxicity and absorption into a range of organisms such as bacteria, algae, invertebrates and fish.

The third group will examine the rate and behaviour of nanomaterials carried into soils used for agriculture and absorbed into plants, bacteria and invertebrates such as worms. They will also be generating new knowledge for use in risk assessment models using a unique pilot-scale waste water treatment facility.

Overall this research will provide key information about whether wildlife and humans are exposed to manufactured nanomaterials, and if so in what form.

…

The three Phase 2 consortium projects and the institutes involved are:

Risk assessment for manufactured nanoparticles used in consumer products (RAMNUC):
UK – Imperial College, London; Health Protection Agency, Oxfordshire.
USA – University of Medicine and Dentistry of New Jersey; Rutgers University, Piscataway NJ; Duke University, Durham, NC.

Consortium for manufactured nanomaterial bioavailability & environmental exposure (nanoBEE):
UK – University of Birmingham; Napier University, Edinburgh; Natural History Museum, London.
USA – Rice University, Houston, TX; Clemson University, SC; University of California, Davis, CA. [emphasis mine]

Transatlantic initiative for nanotechnology and the environment (TINE):
UK – Rothamsted Research, Hertfordshire; Cranfield University, Cranfield, Bedfordshire; Centre for Ecology & Hydrology, Wallingford, Oxfordshire; Lancaster University, Lancashire.
USA – University of Kentucky, Lexington, KY; Duke University, Durham, NC; Carnegie Mellon University, Pittsburgh, PA.

I first came across the news in a Jan. 26, 2011 article in the Houston (Texas) Business Journal which provides more details about the research team that includes professor Vicki Colvin from Rice University,

Colvin, a professor of chemistry and director of the Center for Biological and Environmental Nanotechnology at Rice, is heading up a team of three researchers in the U.S., which is collaborating with three U.K. researchers on the project.

Known as the Nanomaterial Bioavailability and Environmental Exposure Consortia, it will focus on creating a “plug and play” tool for regulators to input information about the size and type of the nanomaterial, local water chemistry, soil types and other factors. Once this data is in the system, regulators will be shown how much of the material could be safely released into a given area.

Coincidentally or not, the ENI announcement was made the same day as the International Standards Organization (ISO) announced a new standard for establishing nanoparticle inhalation toxicity testing. From the Jan. 26, 2011 ISO news release,

Dr. Peter Hatto, Chair of the committee that developed the standard explains, “With the rapid expansion of nanotechnology applications comes a growing risk of exposure to potentially toxic substances, especially for workers in nanotechnology-based industries. Moreover, if airborne nanoparticles were liberated from products, the general public could also be affected. Ensuring the safety of these particles is therefore paramount for the well-being of workers and consumers.”

Carefully monitored tests are used to establish the inhalation toxicity of airborne nanoparticles. The new standard, ISO 10808:2010, Nanotechnologies – Characterization of nanoparticles in inhalation exposure chambers for inhalation toxicity testing, helps ensure that the results of such tests are reliable and harmonized worldwide.

While these projects are distantly related (with the ENI focused on establishing possible risks associated with nanomaterials released  into soil and water and the ISO standard focused on developing parameters for standards for testing toxicity when nanoparticles are inhaled), this all suggests that we are learning to assess the impact of nanotechnology-enabled products and processes.