Category Archives: regulation

Corporate influence, nanotechnology regulation, and Friends of the Earth (FoE) Australia

The latest issue of the newsletter, Chain Reaction # 121, July 2014, published by Friends of the Earth (FoE) Australia features an article by Louise Sales ‘Corporate influence over nanotechnology regulation‘ that has given me pause. From the Sales article,

I recently attended an Organisation for Economic Co-operation and Development (OECD) seminar on the risk assessment and risk management of nanomaterials. This was an eye-opening experience that graphically illustrated the extent of corporate influence over nanotechnology regulation globally. Representatives of the chemical companies DuPont and Evonik; the Nanotechnology Industries Association; and the Business and Industry Advisory Committee to the OECD (BIAC) sat alongside representatives of countries such as Australia, the US and Canada and were given equal speaking time.

BIAC gave a presentation on their work with the Canadian and United States Governments to harmonise nanotechnology regulation between the two countries. [US-Canada Regulatory Cooperative Council] [emphasis mine] Repeated reference to the involvement of ‘stakeholders’ prompted me to ask if any NGOs [nongovernmental organizations] were involved in the process. Only in the earlier stages apparently − ‘stakeholders’ basically meant industry.

A representative of the Nanotechnology Industries Association told us about the European NANoREG project they are leading in collaboration with regulators, industry and scientists. This is intended to ‘develop … new testing strategies adapted to innovation requirements’ and to ‘establish a close collaboration among authorities, industry and science leading to efficient and practically applicable risk management approaches’. In other words industry will be helping write the rules.

Interestingly, when I raised concerns about this profound intertwining of government and industry with one of the other NGO representatives they seemed almost dismissive of my concerns. I got the impression that most of the parties concerned thought that this was just the ‘way things were’. As under-resourced regulators struggle with the regulatory challenges posed by nanotechnology − the offer of industry assistance is probably very appealing. And from the rhetoric at the meeting one could be forgiven for thinking that their objectives are very similar − to ensure that their products are safe. Right? Wrong.

I just published an update about the US-Canada Regulatory Cooperation Council (RCC; in  my July 14, 2014 posting) where I noted the RCC has completed its work and final reports are due later this summer. Nowhere in any of the notices is there mention of BIAC’s contribution (whatever it might have been) to this endeavour.

Interestingly. BIAC is not an OECD committee but a separate organization as per its About us page,

BIAC is an independent international business association devoted to advising government policymakers at OECD and related fora on the many diversified issues of globalisation and the world economy.

Officially recognised since its founding in 1962 as being representative of the OECD business community, BIAC promotes the interests of business by engaging, understanding and advising policy makers on a broad range of issues with the overarching objectives of:

  • Positively influencing the direction of OECD policy initiatives;

  • Ensuring business and industry needs are adequately addressed in OECD policy decision instruments (policy advocacy), which influence national legislation;

  • Providing members with timely information on OECD policies and their implications for business and industry.

Through its 38 policy groups, which cover the major aspects of OECD work most relevant to business, BIAC members participate in meetings, global forums and consultations with OECD leadership, government delegates, committees and working groups.

I don’t see any mention of safety either in the excerpt or elsewhere on their About us page.

As Sales notes in her article,

Ultimately corporations have one primary driver and that’s increasing their bottom line.

I do wonder why there doesn’t seem to have been any transparency regarding BIAC’s involvement with the RCC and why no NGOs (according to Sales) were included as stakeholders.

While I sometimes find FoE and its fellow civil society groups a bit shrill and over-vehement at times, It never does to get too complacent. For example, who would have thought that General Motors would ignore safety issues (there were car crashes and fatalities as a consequence) over the apparently miniscule cost of changing an ignition switch. From What is the timeline of the GM recall scandal? on Vox.com,

March 2005: A GM project engineering manager closed the investigation into the faulty switches, noting that they were too costly to fix. In his words: “lead time for all solutions is too long” and “the tooling cost and piece price are too high.” Later emails unearthed by Reuters suggested that the fix would have cost GM 90 cents per car. [emphasis mine]

March 2007: Safety regulators inform GM of the death of Amber Rose, who crashed her Chevrolet Cobalt in 2005 after the ignition switch shut down the car’s electrical system and air bags failed to deploy. Neither the company nor regulators open an investigation.

End of 2013: GM determines that the faulty ignition switch is to blame for at least 31 crashes and 13 deaths.

According to a July 17, 2014 news item on CBC (Canadian Broadcasting Corporation) news online, Mary Barra, CEO of General Motors, has testified on the mater before the US Senate for a 2nd time, this year,

A U.S. Senate panel posed questions to a new set of key players Thursday [July 17, 2014] as it delves deeper into General Motors’ delayed recall of millions of small cars.

An internal report found GM attorneys signed settlements with the families of crash victims but didn’t tell engineers or top executives about mounting problems with ignition switches. It also found that GM’s legal staff acted without urgency.

GM says faulty ignition switches were responsible for at least 13 deaths. It took the company 11 years to recall the cars.

Barra will certainly be asked about how she’s changing a corporate culture that allowed a defect with ignition switches to remain hidden from the car-buying public for 11 years. It will be Barra’s second time testifying before the panel.

H/T ICON (International Council on Nanotechnology) July 16, 2014 news item. Following on the topic of transparency, ICON based at Rice University in Texas (US) has a Sponsors webpage.

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.

Canada-US joint Regulatory Cooperation Council nanotechnology initiative completed and Canada endorses OECD nanomaterials recommendation

Thanks to Lynn Bergeson’s July 9, 2014 posting on Nanotechnology Now, I learned the Canada-US joint Regulatory Cooperation Council (RCC) nanotechnology initiative has completed its work and will be filing final reports later this summer (2014).

I have featured the RCC here in at least three postings, a Dec. 3, 2012 posting, a June 26, 2013 posting, and a January 21, 2014 posting. Briefly, the RCC was first announced in 2011 and is intended to harmonize Canadian and US regulatory frameworks in a number of areas including, agriculture and food, transportation, personal care products and pharmaceuticals and more. Significantly, nanotechnology was also part of their portfolio.

The latest information about RCC doings was obtained from the Canadian government’s 2014 summer issue of the Chemicals Management Plan (CMP) Progress Report (a second thank you for Bergeson for information about this publication),

The Canada-U.S. Regulatory Cooperation Council Nanotechnology Initiative is now complete. Canada and the U.S. are implementing the new approaches and lessons learned in risk assessments of nanomaterials. An important outcome of the initiative is the development of consistent policy principles on the regulatory oversight of nanomaterials, which have now been endorsed by the Government of Canada. Watch for the publication of the final reports from the Canada-U.S. Regulatory Cooperation Council Nanotechnology Initiative this summer. The reports will include recommendations about ways in which Canada and the U.S. can align their nanomaterial regulatory work, including the application of consistent risk assessment approaches and methodologies and identifying categories of nanomaterials.

The 2014 CMP summer issue offers a second tidbit of information. This time it’s about Canada and the OECD,

Canada has endorsed a recommendation from the Organisation for Economic Co-operation and Development’s Council on the Safety Testing and Assessment of Manufactured Nanomaterials. The recommendation states that countries “apply the existing international and national chemical regulatory frameworks or other management systems, adapted to take into account the specific properties of manufactured nanomaterials.” The recommendation was based on the work of the Organisation for Economic Co-operation and Development’s Working Party on Manufactured Nanomaterials, which is a harmonization effort to inform regulatory programs regarding the environmental and health and safety implications of manufactured nanomaterials.

For enthusiasts, Canada’s Chemicals Management Plan progress report is expected to be published twice/year. There are now two issues available, the first with a Dec. 30, 2013 publication date. Here’s more about the CMP progress reports,

The Chemicals Management Plan Progress Report has been created to keep stakeholders and other interested parties up to date on the activities and programs related to Canada’s Chemicals Management Plan (CMP). The report is produced jointly by Environment Canada and Health Canada and will be published twice a year. It will report on advances in major initiatives and highlight key activities related to the Government of Canada’s recent work under the CMP. It will also inform you about coming events, dates of interest and how to get involved.

We encourage you to share the reports with anyone who may be interested. We also welcome your feedback or suggestions. We can be reached at [email protected]

Anyone interested in more information about the RCC (Regulatory Cooperation Council) and its nanotechnology efforts can find it here.

Nanotechnology Policy and Regulation in Canada, Australia, the European Union, the UK, and the US: a timeline for us all

The Timeline: Nanotechnology Policy and Regulation in Canada, Australia, the European Union, the United Kingdom, and the United States (PDF; h/t July 10, 2014 news item on Nanowerk) issued by the University of Ottawa’s Institute for Science, Society and Policy (ISSP) takes as its starting point the invention of the field emission microscope in 1936 by Erwin Wilhelm Müller.

This fascinating 40 pp document seems comprehensive to me. While the title suggests otherwise, there are a few mentions of events involving Asian countries and they also include the Berkeley bylaw governing nanotechnology manufacture in the city. From the Timeline, p. 16 (Note: The formatting has been changed significantly),

The City of Berkeley (US)
December 2006

The Berkeley Municipal Code is amended to introduce new measures regarding manufactured nanomaterial health and safety

These amendments require facilities that manufacture or use nanomaterials to disclose in writing which nanomaterials are being used as well as the current toxicology of the materials reported (to the extent known) and to further describe how the facility will safely handle, monitor, contain, dispose, track inventory, prevent releases and mitigate such materials.

Berkeley is currently the only municipal government in the United States to regulate nanotechnology

While searching a month ago (June 2014), I was having difficulty finding information online about the Berkeley bylaw, so this was a delightful surprise.

There is (arguably) an omission and that is the Yale Law School Cultural Cognition Project. The Yale researchers have done some influential work about emerging technologies, including a special nanotechnology project devised in the aftermath of the Berkeley bylaw. Their focus then and now has been on public perceptions and attitudes as they affect policy.

Given how many public perception projects there have been and the timeline’s specific focus on regulation and policy, it’s understandable that not many have been included in the timeline.

Still, I was curious to see if the 2012 nanosunscreen debacle in Australia would be included in the timeline. It was not and, given that this incident didn’t directly involve policy or regulation, it’s understandable. Still, I would like to suggest its inclusion in future iterations. (For the curious, my Feb. 9, 2012 posting titled: Unintended consequences: Australians not using sunscreens to avoid nanoparticles? offers a summary and links to this story about an Australian government survey and some unexpected and dismaying results.)

The timeline appears to have a publication date of April 2014 and was compiled by Alin Charrière and Beth Dunning. It is a ‘living’ document so it will be updated in the future. If you have any comments, [email protected] (I will be sending mine soon.)

It is one of a series which includes two other technologies, Synthetic biology and Bioenergy, at this point (July 10, 2014). You can go here for more about the ISSP.

Finally, bravo and bravo to Charrière and Dunning for a job well done.

Aug. 5, 2014 deadline for European Union public consultation on measures to increase transparency on nanomaterials on the market

A May 14, 2014 news item on Nanowerk announces a new ‘nanomaterials’ consultation (Public Consultation  on Impact Assessment on Possible Measures to Increase Transparency on Nanomaterials on the Market) in Europe,

As part of the Communication on the Second Regulatory Review on Nanomaterials, the European Commission has announced to launch an impact assessment to identify and develop the most adequate means to increase transparency and ensure regulatory oversight on nanomaterials.

The text of the May 14, 2014 news item can be found on this announcement page, which explains the background leading up to this consultation and the role of the companies  engaged to hold the study and the consultation, on the Risk Policy Analysts website,

More information on the background, methodology and planned timing of this impact assessment can be found in the working document – CASG(Nano)/02/14 (an updated version including a final version of the problem definition, objectives and policy options will be published in the second half of May). This document also contains a draft problem definition, policy objectives and a more detailed description of the following policy options that are under consideration:

     0.  Baseline scenario

  1. Recommendation on how to implement a “best practice model” for Member States wishing to establish a national system (soft law approach)
  2. Structured approach to collect information (“Nanomaterials Observatory”)
  3. Regulation creating an EU nanomaterial registry with one annual registration per substance for each manufacturer/importer/downstream user/distributor
  4. Regulation creating an EU nanomaterial registry with one annual registration per use (including substances, mixtures and articles with intended release)

The European Commission (DG Enterprise and Industry) has commissioned Risk & Policy Analysts Ltd. (RPA) and BiPRO GmbH to undertake a study to support the Commission on the preparation of this impact assessment. The terms of reference and the resulting reports are available here.

The description of the terms for the public consultation follows,

This public consultation is an integral part of this study. The objective of the public consultation is to obtain stakeholder views on the currently available information on nanomaterials on the market (as defined here), the problem definition that forms the basis of the impact assessment, as well as the potential positive and/or negative impacts of the aforementioned policy options.

Please be aware that within the European Union, France has already established a mandatory reporting scheme for manufactured nanomaterials produced, imported or distributed in its territory.  The Interministerial decree No. 2012-232 entered into force in January 2013. Moreover, at European level, when cosmetic products containing nanomaterials are put on the EU market, Article 16 of Regulation (EC) No 1223/2009 requires the responsible persons to submit information on the nanomaterial(s) contained through the Cosmetic Products Notification Portal.   Further information on these and other proposed schemes is available here.

Complete the questionnaire for non-industry stakeholders

(preview in pdf or in Word)

Complete the questionnaire for industry stakeholders

(preview in pdf or in Word)

Please note that, if your company/organisation is registered in the Transparency Register, you will be requested to indicate your Register ID number.  Your contribution will then be considered as representing the views of your organisation.  If your organisation is not registered, you have the opportunity to learn more and/or register now.

Please note that if your company has to notify to the French Notification System and/or to the Cosmetic Products Notification Portal but did not participate in the consultation undertaken by RPA/BiPRO for the European Commission in early 2014, please take the time to fill in the questionnaire on the administrative burden of the notification schemes which is available here.

I wonder what it means when the Cosmetic Products Notification Portal does not participate. This nonparticipation adds a level of intrigue I hadn’t anticipated when I caught sight of this announcement. Are the ‘cosmetics portal’ people boycotting the consultation for some reason?

* Upper case ‘M” changed to lower case ‘m’ in head on May 16, 2014 at 9:47 am PDT.

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

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.

NANoReg invites you to April 11, 2014 workshop in Athens, Greece

For anyone interested in nanomaterials and/or attending an EHS-themed (environment, health, and safety) event in Athens, Greece, NANoREG is holding an April 2014 workshop at the Industrial Technologies 2014 conference (April 9 – 11, 2014). From a March 14, 2014 news item on Nanowerk (Some links have been removed),

NANoREG will identify EHS [environment, health, and safety] aspects that are most relevant from a regulatory point of view. It will provide tools for testing the EHS aspects and the assessment and management of the risks to the regulators and other stakeholders.

To assure that the final results of the project can be implemented in an efficient and effective way, Industry and Regulators are strongly involved in the project.
We kindly invite you to attend the NANoREG workshop and to give your opinion on the regulatory testing of nanomaterials, as a valuable contribution to future economic success of nanotechnology!

The workshop will take place on Friday, April 11, 2014 from 11:15 a.m. to 1:30 p.m. in Athens, Greece, as part of the Industrial Technologies 2014 event. For registration please use the offi cial registration portal: www.naturalway.gr/industrial_technologies

Here’s more about the workshop from the NANoREG workshop page on the Industrial Technologies 2014 website,

1. The NANoREG approach: Answers from Science to the questions/needs of Industry and the Regulation Authorities.
2. First entrypoints, the regulatory questions and needs, an overview, matching of needs
3. NANoREG results: Materials, SOPs and the advancement of Regulatory Risk Assessment and Testing.
4.Overview of the NANoREG projects.
5. Whe window for industry participation, keeping pace with innovation.
6. Modes of collaboartion [sic] for industry.
7. Outlook

A joint workshops of EU FP7 Projects SANOWORK, nanoMICEX and Scaffold funded under the topic NMP.2011.1.3-2 “Worker Protection and exposure risk management strategies for nanomaterials production, use and disposal”, will focus on the main achievements of the three Projects in the related area. All three projects are committed to support the needs of companies and aim to provide a practical overview of the results of current research in the field of management of exposure to nanomaterials.

Here are links to the other three projects collaborating on the NANoREG workshop  SANOWORKnanoMICEX, and Scaffold.

Ecotoxicology and environmental fate of manufactured nanomaterials—testing guidelines from Organization for Economic Cooperation and Development (OECD)

The Organization for Economic Cooperation and Development (OECD) has released guidelines for testing manufactured nanomaterials according to a March 11, 2014 news item on Nanowerk,

As part of its Programme on the Safety of Manufactured Nanomaterials, and in particular work on the testing and assessment of manufactured nanomaterials, OECD initiated a series of expert meetings to improve the applicability of the OECD Test Guidelines to nanomaterials. With this in mind, the Working Party on Manufactured Nanomaterials agreed to address the ecotoxicology and environmental fate of manufactured nanomaterials.

The OECD Expert Meeting on Ecotoxicology and Environmental Fate took place on 29th-31st January 2013 in Berlin, Federal Press Office. The event was hosted by the German delegation and funded by the German Federal Ministry of the Environment, Nature Conservation and Nuclear Safety (BMU) as well as the United States Environment Protection Agency (US EPA).

Three documents were published one of which being a preview,

The OECD expert meeting on ecotoxicology and environmental fate — Towards the development of improved OECD guidelines for the testing of nanomaterials by Dana Kühnel and Carmen Nickel. Science of The Total Environment Volume 472, 15 February 2014, Pages 347–353 http://dx.doi.org/10.1016/j.scitotenv.2013.11.055

This document is open access.

The report itself,

OECD. ENVIRONMENT DIRECTORATE.
JOINT MEETING OF THE CHEMICALS COMMITTEE AND
THE WORKING PARTY ON CHEMICALS, PESTICIDES AND BIOTECHNOLOGY. Environment, Health and Safety Publications
Series on the Safety of Manufactured Nanomaterials. ENV/JM/MONO(2014)1

ECOTOXICOLOGY AND ENVIRONMENTAL FATE OF MANUFACTURED NANOMATERIALS:
TEST GUIDELINES Expert Meeting Report
Series on the Safety of Manufactured Nanomaterials No. 40

Ecotoxicology and Environmental Fate of Manufactured Nanomaterials: Test Guidelines

There’s an addendum which includes the presentations made at the meeting (you can find both the report, proper, and the addendum on this page scroll to report no. 40),

OECD. ENVIRONMENT DIRECTORATE JOINT MEETING OF THE CHEMICALS COMMITTEE AND
THE WORKING PARTY ON CHEMICALS, PESTICIDES AND BIOTECHNOLOGY. Environment, Health and Safety Publications. ENV/JM/MONO(2014)1/ADD

ADDENDUM TO EXOTOXICOLOGY AND ENVIRONMENTAL FATE OF MANUFACTURED
NANOMATERIALS: TEST GUIDELINES

Series on the Safety of Manufactured Nanomaterials No. 40
Ecotoxicology and Environmental Fate of Manufactured Nanomaterials:
Test Guidelines.

As it can get a little tricky accessing OECD documents, I’ve tried to give a couple different links and as much identifying information as possible. Good luck!

Organization for Economic Cooperation and Development’s (OECD) report on responsible development of nanotechnology plus news about upcoming survey on nanotechnology commercialization

I stumbled onto this OECD (Organization for Economic Cooperation for Development) information in the context of research on another, unrelated, story about the current state of nanotechnology standards and regulations (Dec. 23, 2013 news item on Nanotechnology Now) which is not likely to be written up here.  Getting back to this posting, I found a report from the OECD’s Working Party on Nanotechnology dated Nov. 29, 2013 and titled: RESPONSIBLE DEVELOPMENT OF NANOTECHNOLOGY
Summary Results from a Survey Activity (report no. DSTI/STP/NANO(2013)9/FINAL). This 34 pp. report includes the latest information for 25 countries that agreed to take part in the survey. Here’s the information supplied by Canada,

Canada
While Canada does not have a distinct policy for nanotechnology, the Government of Canada is engaged in a number of activities which specifically address the responsible development of
nanotechnology:
Policy principles for regulation and oversight: Federal departments are working together under the Canada-United States Regulatory Cooperation Council Nanotechnology Initiative to strengthen current policy principles to guide government decision-making concerning the responsible development of nanotechnology. These principles address the need to protect human health, safety, and the environment, while not unnecessarily hampering innovation and the exploitation of potential benefits from nanotechnology use.
Research and international collaboration: In collaboration with domestic and international partners, the Government of Canada is actively involved in research and other activities to assess the environmental, health, and safety aspects of nanomaterials and to develop appropriate and internationally compatible approaches for their responsible development and application (e.g. through safety assessment work at the OECD, ISO/IEC nanotechnology standards development, bilateral regulatory co-ordination, and government research and government-funded extramuralresearch).
Development of new policy tools: In October 2011, Health Canada introduced a Working Definition of Nanomaterials to provide a tool to assist the Government to gather safety information about nanomaterials in support of Health Canada’s mandate. The Working Definition is not an additional source of authority, but applies within existing regulatory frameworks that allow for obtaining information (www.hc-sc.gc.ca/sr-sr/pubs/nano/pol-eng.php).
Federal science and technology (S&T) strategies: Federal strategies for S&T research recognise the interconnection between responsible innovation, regulation, and socioeconomic development. Through its 2007 strategy, Mobilising Science and Technology to Canada’s Advantage, for example, the Government of Canada is committed to ensuring the responsible development of nanotechnology. Federal strategies set out the general priority areas for government S&T research support (www.science.gc.ca/S&T_Reports-WS5F25C99B-1_En.htm). [Ed. Note: I would describe the information as statistical data rather than strategy and,in fact, the webpage you're being directed to is titled: Science and Technology Data.)
• Interdepartmental collaboration and coordination: Federal science-based departments and agencies (SBDAs) are engaged in an initiative to foster interdepartmental collaboration and coordination of activities for the responsible governance of nanotechnology. The results of this initiative will inform SBDA work and activities concerning innovation, regulation, public engagement and research.
External collaboration and coordination: Federal departments and agencies collaborate with external partners, such as provincial nanotechnology associations, on issues related to the responsible development of nanotechnology. (p. 9)

I mentioned the Canada-United States Regulatory Cooperation Council Nanotechnology Initiative in a June 26, 2013 posting.

As for this OECD report, there's always the question, What constitutes 'responsible' development? The OECD report provides an answer,

For the purpose of this activity the responsible development of nanotechnology was described as actions to stimulate the growth of nanotechnology applications in diverse sectors of the economy, while addressing the potential risks and the ethical and societal challenges the technology might raise. Policy and initiatives for the responsible development of nanotechnology aim both at supporting research (and/or business activities) and implementing effective legal and regulatory frameworks in order to assure that risk and safety standards are met. They also aim at supporting and stimulating the debate on the place of science and technology in society by engaging with the public on social and ethical issues. As nanotechnology develops, countries and regions have begun to develop, refine and/or articulate regulatory approaches to support the responsible development of nanotechnology. (p. 7)

The question as to which countries have a specific policy for the responsible development of nanotechnology is answered at length (from the OECD report),

All participating delegations responded to the questions on whether a dedicated policy for the responsible development of nanotechnology was in place or if nanotechnology was addressed as part of other policies; and whether a dedicated research programme for nanotechnology was in place or if nanotechnology formed a part of other research programmes.

Many delegations reported a specific policy for the responsible development of nanotechnology, with 11 delegations, out of the 25 participating, indicating the development of a policy brief, a regulatory framework, a legislative framework and/or an overall strategy for the responsible development of nanotechnology. All of these delegations reported that the policy had already been implemented. Some of the delegations that indicated a dedicated policy for the responsible development of nanotechnology also indicated that nanotechnology was included within other policies.

Where there was a dedicated policy for nanotechnology, the policy operated at the national level in all cases with the exception of Spain, which indicated that there was a nanotechnology policy in some of its regions, in parallel with the national dedicated nanotechnology policy for R&D and innovation.

Nine delegations [Canada was one of the nine delegations] indicated there was no dedicated policy for the responsible development of nanotechnology, but those delegations indicated that nanotechnology was included as part of other policies.

Two delegations indicated there was neither a dedicated policy for the responsible development of nanotechnology nor a policy of which nanotechnology was a part. However, these delegations either reported a dedicated research programme on nanotechnology, or that nanotechnology had been recognised as a strategic research area.

Finally, three delegations, out of the 25 participating, indicated that a policy for the responsible development of nanotechnology was under development (Sweden, Turkey, and the United Kingdom) with publication planned for 2013-2014. For those countries, nanotechnology is currently included under the general umbrella of science and technology policy.

The majority of delegations highlighted the importance of collaboration and co-operation across- ministries, departments and agencies to ensure responsible and efficient development of the technology. Indeed, nanotechnology was expected to impact on a variety of industrial and economic sectors; this cross- sectoral nature appears to be a challenge for policy makers who require the involvement of all governmental stakeholders likely to be impacted by nanotechnology development. The majority of delegations involved a number of relevant ministries and departments in the development of their strategies for the responsible development of nanotechnology. This broad involvement was noted as a clear requirement in order to succeed in the development of nanotechnology.

… (pp. 7-8)

Finally, there is an OECD survey currently underway regarding nanotechnology commercialization according to a Dec. 20, 2013 notice on the Nanotechnology Industries Association (NIA) website (Note: A link has been removed),

NIA Members Consultation: OECD WPN Survey on Nanotechnology Commercialisation Policy – Deadline: 3 January 2014
Posted on 20 Dec 2013

The Working Party on Nanotechnology (WPN) of the Organisation for Economic Cooperation and Development (OECD) is undertaking a project examining policies that support the commercialisation of nanotechnology research. It aims to identify:

Which existing government policies help companies efforts in commercialisation;
How significant this support is; and
What else governments could do/do more of, that would most significantly increase the commercialisation of nanotechnology research.

As part of its role within the Business and Industry Advisory Committee (BIAC), NIA is asking its members to provide their views to the project via a short questionnaire.

Participating members have the option to remain anonymous, with their identity and other information kept confidential by the project.

The findings from the questionnaire responses will be presented in a final OECD WPN Report and will be made available to all participants in the new year.

Only NIA members have access to the questionnaire and I cannot find any mention of it on the OECD website although I did stumble on this delightful page titled: OECD Working Party on Nanotechnology: Second meeting of the Working Party on Nanotechnology, which contains a number of documents including one which outlines a 2007 Canadian project: Nanotechnology Pilot Survey by Statistics Canada.

I hope to hear about this commercialization survey in a more timely fashion than I’ve been managing lately. In any event, it’s nice to get caught up on the Canadian nanotechnology scene.

On a related front: In March 2013 the OECD and the US National Nanotechnology Initiative (NNI) held a joint symposium about assessing nanotechnology’s economic impacts. My Sept. 19, 2013 posting features the final report on the symposium. There’s also my July 23, 2012 interview with Vanessa Clive, Industry Canada’s Nanotechnology Policy Advisor and one of the symposium organizers. Finally, there’s the OECD’s 2010 report, The Impacts of Nanotechnology on Companies: Policy Insights from Case Studies. This report was co-designed and co-led by Vanessa, one of her Canadian colleagues and a Swiss colleague. The report itself was written by OECD staff as per Vanessa’s comments in my March 29, 2012 posting.