Tag Archives: Lynn Bergeson

US Dept. of Agriculture wants to commercialize cellulose nanomaterials

Lynn Bergeson in an April 7, 2014 posting on the Nanotechnology Now website announced an upcoming ‘nano commercialization’ workshop (Note: A link has been removed),

The U.S. Department of Agriculture (USDA) and National Nanotechnology Initiative (NNI) will hold a May 20-21, 2014, workshop entitled “Cellulose Nanomaterial — A Path Towards Commercialization.” See http://www.nano.gov/ncworkshop The workshop is intended to bring together high level executives from government and multiple industrial sectors to identify pathways for the commercialization of cellulose nanomaterials and facilitate communication across industry sectors to determine common challenges.

You can find out more about the Cellulose Nanomaterial — A Path Towards Commercialization workshop here where you can also register and find an agenda, (Note: Links have been removed),

The primary goal of the workshop is to identify the critical information gaps and technical barriers in the commercialization of cellulose nanomaterials with expert input from user communities. The workshop also supports the announcement last December by USDA Secretary Thomas Vilsack regarding the formation of a public-private partnership between the USDA Forest Service and the U.S. Endowment for Forestry and Communities to rapidly advance the commercialization of cellulose nanomaterials. In addition, the workshop supports the goals of the NNI Sustainable Nanomanufacturing Signature Initiative/

The workshop is open to the public, after registration, on a first-come, first-served basis.

There is an invitation letter dated Feb. 7, 2014, which provides some additional detail,

The primary goals of the workshop are to identify critical information gaps and technical barriers in the commercialization of cellulose nanomaterials with expert input from user communities. We plan to use the outcome of the workshop to guide research planning in P3Nano and in the Federal Government.

The Cellulose Nanomaterial — A Path Towards Commercialization workshop agenda lists some interesting names. The names I’ve chosen from the list are the speakers from the corporate sectors, all eight of them with two being tentatively scheduled; there are 22 speakers listed in total at this time,

Tom Connelly – DuPont (Tentative)
Travis Earles, Technology Manager, Lockheed Martin
Beth Cormier, Vice President for R&D and Technology, SAPPI Paper
Ed Socci, Director of Beverage Packaging, PepsiCo Advanced Research
Mark Harmon, DuPont (tentative)
Kim Nelson, Vice President for Government Affairs, API
Jean Moreau, CEO, CelluForce
Yoram Shkedi, Melodea

For the most part the speakers will be academics or government bureaucrats and while the title is ‘cellulose nanomaterials’ the speaker list suggests the topic will be heavily weighted to CNC/NCC (cellulose nanocrystals, aka, nanocrystalline cellulose). Of course, I recognize the Canadian, Jean Moreau of CelluForce, a Canadian CNC production facility. I wonder if he will be discussing the stockpile, which was first mentioned here in my Oct. 3, 2013 posting,

I stumbled across an interesting little article on the Celluforce website about the current state of NCC (nanocrystalline cellulose aka CNC [cellulose nanocrystals]) production, Canada’s claim to fame in the nanocellulose world. From an August 2013 Natural Resources Canada, Canadian Forest Service, Spotlight series article,

The pilot plant, located at the Domtar pulp and paper mill in Windsor, Quebec, is a joint venture between Domtar and FPInnnovations called CelluForce. The plant, which began operations in January 2012, has since successfully demonstrated its capacity to produce NCC on a continuous basis, thus enabling a sufficient inventory of NCC to be collected for product development and testing. Operations at the pilot plant are temporarily on hold while CelluForce evaluates the potential markets for various NCC applications with its stockpiled material. [emphasis mine]

I also recognized Melodea which I mentioned here in an Oct. 31, 2013 posting titled: Israeli start-up Melodea and its nanocrystalline cellulose (NCC) projects.

A couple of final notes here, NCC (nanocrystalline cellulose) is also known as cellulose nanocrystals (CNC) and I believe the second term is becoming the more popular one to use. As for the final of these two notes, I had an illuminating conversation earlier this year (2014) about CNC and its accessibility. According to my source, there’s been a decision that only large industry players will get access to CNC for commercialization purposes. I can’t verify the veracity of the statement but over the last few years I’ve had a few individual entrepreneurs contact me with hopes that i could help them access the materials. All of them of them had tried the sources I was to suggest and not one had been successful. As well, I note the speaker list includes someone from PepsiCo, someone from Dupont, and someone from Lockheed Martin, all of which could be described as large industry players. (I’m not familiar with either API or SAPPI Paper so cannot offer any opinions as to their size or importance.) Melodea’s access is government-mandated due to research grants from the European Union’s Seventh Framework Program (FP7).

I’m not sure one can encourage innovation by restricting access to raw materials to large industry players or government-funded projects as one might be suspected from my back channel experience, the conversation as reported to me, and the speaker list for this workshop.

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.

Final report on joint OECD/NNI report on assessing nanotechnology’s economic impact

In March 2012, the Organization for Economic Cooperation and Development (OECD) and the US National Nanotechnology Initiative (NNI) held a symposium on assessing the economic impacts of nanotechnology, which was hosted by American Association for the Advancement of Science (AAAS) in Washington, DC.  Lynn Bergeson announced the release of the symposium’s final report in her Sept. 16, 2013 posting on the Nanotechnology Now website.

The title of the final report published by the OECD is Symposium on Assessing the Economic  Impact of Nanotechnology: Synthesis Report. I have excerpted some information including this introductory paragraph from the executive summary of this 81 pp report,

Governments have a fiscal and social responsibility to ensure that limited research and development resources are used wisely and cost-effectively in support of social, economic, and scientific aspirations. As a result of significant public and private investments in nanotechnology during the past decade and an expanding array of commercial applications, the field of nanotechnology has matured to the point of showing significant potential to help societies achieve the shared goal of improving efficiencies and accelerating progress in a range of economic sectors, including medicine, manufacturing, and energy. Countries that wish to promote the continued responsible development of nanotechnology will, however, need quantitative data on the economic impact of nanotechnology to guide further investment and policy decisions. Few widely accepted economic impact assessments have been conducted, however, and there are many questions regarding the best methodologies to be used. (p. 4)

The attendees considered the challenges associated with evaluating the impact of nanotechnology, some of which are common to emerging technologies in general and some or which are specific to nanotechnology (from the report),

The attendees also considered the question of a definition for nanotechnology. While operational definitions are developed at national or regional levels, e.g. for statistical or regulatory purposes, there are relatively few internationally agreed upon definitions or classifications for nanotechnology or its products and processes. Such definitions are essential for developing a methodology for an economic impact assessment and/or to facilitate data collection. Participants mentioned that definitions should be flexible so that they facilitate the development and valuation of the technology; they also noted that definitions might vary in different contexts or sectors.

Additional issues were raised:

 Its multipurpose, enabling nature makes measuring the impact of nanotechnology difficult. It can be fundamental to a product’s key functionality (e.g. battery charge time or capacity) but ancillary to the value chain (E.g. represent a small portion of the final product or process). Nanotechnology is also likely to have a range of incremental impacts on goods and services as well as existing manufacturing techniques. This requires understanding the value added at different stages of the production chain.

 Nanotechnology’s impact is often intermingled with that of many other interventions and technologies so that determining its precise role can be difficult.

 The large and varied amount of data linked to nanotechnology development may lead to difficulties in cleaning and manipulating the data meaningfully.

 Confidential business information and the proprietary nature of products and services may make it difficult to obtain information from industry. Moreover, it is not clear how a nanotechnology company or a company using nanotechnology is defined or defines itself or to what extent companies, universities and associate institutions are involved in exploiting and developing nanotechnology.

 For now, data are mainly collected through surveys. It is important to weigh the benefits against the additional workload that surveys place on administrations, research institutes and industries. Information should be obtained efficiently, focusing on the data of greatest interest for assessing the value of the technology.

 The nanotechnology policy landscape is evolving. It is important to consider non-specific, rather than nanotechnology-specific, funding strategies and policies when assessing economic impacts such as return on investment.

While certain issues may be resolved through improvements and over time, some restrict the ability to conduct valid nanotechnology impact assessments, such as the complex relationship between science, innovation and the economy; the interaction between public and private actors; the role of other factors in technology development and innovation; and the time lag between investments and their returns. (p. 8)

Of course the main issue being addressed was the development of tools/instruments to assess nanotechnology’s economic impact (from the report),

Some steps have been taken towards assessing the impact of nanotechnology. Examples mentioned during the symposium include the U.S. STAR METRICS database, which uses an input/output approach to determine the outputs of federal funding of science and technology, and Brazil’s Lattes system, in which researchers, students and institutions share information about their interests and backgrounds to facilitate information sharing and collaboration. The Lattes system is also intended to aid in the design of science, technology and innovation policies and to help understand the social and economic impacts of previous investments. DEFRA (Department for Environment, Food and Rural Affairs, United Kingdom) values a given nanotechnology product in monetary terms against an incumbent and thus calculates additional value added over current technology.

Other valuation methods mentioned included the “traditional” cost/ benefit analysis (often accompanied by scenario development for immature technologies such as nanotechnology) and life cycle assessment (LCA). LCA addresses the impact of nanotechnology along the entire product value chain. It is important to conduct LCAs as early as possible in product development to define the full value of a product using nanotechnology. Value chain assessments can also help address the challenge of determining the role of nanotechnology in a final product, where economic value is most commonly assessed. (p. 9)

Participants recognised the difficulty of developing a “one size fits all” methodology. The data collected and the indicators and the methodologies chosen need to fit the situation. Precisely defining the objectives of the impact assessment is critical: “What do we want to measure?” (e.g. the impact of a specific nanotechnology investment or the impact of a nano-enabled replacement product on environmental performance). “What outcomes do we want from the analysis?” (e.g. monetary value and GDP growth or qualitative measures of environmental and social benefits).

Input indicators (e.g. R&D investment, infrastructure) are the easiest to collect; they provide information on the development of a technology in a given region, country or globally. Output indicators, such as patents and publications, provide information on the trajectories of a technology and on key areas of innovation. The most useful for policy makers are indicators of impact, but high-quality data, especially quantitative data, are difficult to collect. Indicators of impact provide a basis for assessing direct (market share, growth of companies, new products, wealth creation) and indirect impacts (welfare gains, consumer surplus). The economic and social impact of nanotechnology goes beyond what can be measured with existing statistics and traditional surveys. A pilot survey by the Russian Federation plans to examine nanotechnology issues that are not necessarily covered by traditional statistical surveys, such as technology transfer and linkages between different segments of the national innovation system. The OECD Working Party of National Experts on Science and Technology Indicators is also working on the development of a statistical framework for the measurement of emerging, enabling and general purpose technologies, which includes the notion of impact.
While quantitative measures may be preferable, impact assessments based on qualitative indicators using methods such as technology assessment scenarios and mapping of value chains can also provide valuable information.

I haven’t read the entire report yet but the material after the executive summary bears a similarity to field notes. Generally in reports like this everything is stated in an impersonal third person with the speaker being mentioned only in the header for the section  so the contents have an  authority associated with holy books. While I haven’t seen any quotes, the speakers here are noted as having said such and such, e.g., “Mr. Tassey suggested a “technology-element” model as an alternative means of driving policy and managing the R&D cycle.” (p. 15) It’s not unheard of, just unusual.

For anyone interested in the earlier reports and/or in the Canadian participation in this 2012 symposium, there’s an interview with Vanessa Clive, Industry Canada, Nanotechnology Policy Advisor in my July 23, 2012 posting where she discusses the symposium and offers links to documents used as background material for the symposium.

Nanomaterials, toxicology, and alternatives to animal testing

It seems that alternatives to animal testing may offer some additional capabilities for nanotoxicology studies according to an Aug. 21, 2013 news item on Nanowerk,

A group of international experts from government, industry and academia have concluded that alternative testing strategies (ATSs) that don’t rely on animals will be needed to cope with the wave of new nanomaterials emerging from the boom in nanoscience and nanotechnology. …

… Tests on laboratory mice, rats and other animals have been the standard way of checking new materials for health and environmental effects. Since those tests are costly, labor-intensive and time-consuming, workshop participants considered whether ATSs could have a larger role in checking the safety of ENMs [engineered nanomaterials].

They concluded that rapid cellular screening, computer modeling and other ATSs could serve as quick, cost-effective and reliable approaches for gathering certain types of information about the health and environmental effects of ENMs. “After lively discussions, a short list of generally shared viewpoints on this topic was generated, including a general view that ATS approaches for ENMs can significantly benefit chemical safety analysis,” they say.

The experts have had their consensus statement from the workshop published and before offering a citation for and a link to the statement, here’s the Abstract,

There has been a conceptual shift in toxicological studies from describing what happens to explaining how the adverse outcome occurs, thereby enabling a deeper and improved understanding of how biomolecular and mechanistic profiling can inform hazard identification and improve risk assessment. Compared to traditional toxicology methods, which have a heavy reliance on animals, new approaches to generate toxicological data are becoming available for the safety assessment of chemicals, including high-throughput and high-content screening (HTS, HCS). With the emergence of nanotechnology, the exponential increase in the total number of engineered nanomaterials (ENMs) in research, development, and commercialization requires a robust scientific approach to screen ENM safety in humans and the environment rapidly and efficiently. Spurred by the developments in chemical testing, a promising new toxicological paradigm for ENMs is to use alternative test strategies (ATS), which reduce reliance on animal testing through the use of in vitro and in silico methods such as HTS, HCS, and computational modeling. Furthermore, this allows for the comparative analysis of large numbers of ENMs simultaneously and for hazard assessment at various stages of the product development process and overall life cycle. [emphasis mine] Using carbon nanotubes as a case study, a workshop bringing together national and international leaders from government, industry, and academia was convened at the University of California, Los Angeles, to discuss the utility of ATS for decision-making analyses of ENMs. …

It seems that ATS has opened the door to more comprehensive testing (as per life cycles) than has previously been possible.

For the curious, here’s the citation for and the link to the published paper,

A Multi-Stakeholder Perspective on the Use of Alternative Test Strategies for Nanomaterial Safety Assessment by Andre E. Nel, Elina Nasser, Hilary Godwin, David Avery, Tina Bahadori, Lynn Bergeson #, Elizabeth Beryt, James C. Bonner, Darrell Boverhof, Janet Carter, Vince Castranova, J. R. DeShazo, Saber M. Hussain ●, Agnes B. Kane, Frederick Klaessig, Eileen Kuempel, Mark Lafranconi, Robert Landsiedel, Timothy Malloy, Mary Beth Miller, Jeffery Morris, Kenneth Moss, Gunter Oberdorster, Kent Pinkerton, Richard C. Pleus, Jo Anne Shatkin, Russell Thomas, Thabet Tolaymat, Amy Wang, and Jeffrey Wong. ACS Nano, Article ASAP DOI: 10.1021/nn4037927 Publication Date (Web): August 7, 2013

Copyright © 2013 American Chemical Society

This article is behind a paywall.

Canada-US Regulatory Cooperation Council’s Nanotechnology Work Plan

Thanks for Lynn L. Bergeson for her Dec. 1, 2012 posting on the Nanotechnology Now website for the information about a Nov. 28, 2012 webinar that was held to discuss a Nanotechnology Work Plan developed by the joint Canada-US Regulatory Cooperation Council (or sometimes it’s called the US-Canada Regulatory Cooperation Council),

The RCC requested that industry provide more information on the commercial distribution of nanomaterials, as well as more transparency by claiming confidentiality of only that information absolutely critical to market advantage.

To compare risk assessment and risk management practices to highlight and identify best practices, data gaps, and differences between the two jurisdictions, the RCC sought nominations of a nanomaterial substance for a case study. Four nanomaterial substances were nominated: multiwall carbon nanotubes, nanocrystalline cellulose, nano silver, and titanium dioxide. The RCC has selected multiwall carbon nanotubes for the case study. The RCC intends to hold in March 2013 a workshop in Washington, D.C., to discuss information collected to date and approaches moving forward. In spring 2013, the RCC will hold one or two conference calls or webinars to discuss information gathered between countries and the path forward. Finally, in fall 2013, the RCC expects to hold a stakeholder consultation/workshop on results to date.

Here’s some background on the RCC. First announced in February 2011, the RCC had its first ‘stakeholder’ session (attended by approximately 240)  in January 2012 in Washington, DC. where a series of initiatives, including nanotechnology, were discussed (from the US International Trade Administration RCC Stakeholder Outreach webpage),

Agriculture and Food, Session A

  • Perimeter approach to plant protection

Agriculture and Food, Session B

  • Crop protection products

Agriculture and Food, Session C

  • Meat/poultry – equivalency
  • Meat/poultry – certification requirements
  • Meat cut nomenclature

Agriculture and Food, Session D

  • Veterinary drugs
  • Zoning for foreign animal disease

Agriculture and Food, Session E

  • Financial protection to produce sellers

Agriculture and Food, Session F

  • Food safety – common approach
  • Food safety – testing

Road Transport – Motor Vehicles

  • Existing motor vehicle safety standards
  • New motor vehicle safety standards

Air Transport

  • Unmanned aircraft

Transportation

  • Intelligent Transportation Systems

Transportation

  • Dangerous goods means of transportation

Marine Transport

  • Safety and security framework & arrangement for the St. Lawrence Seaway & Great Lakes System
  • Marine transportation security regulations
  • Recreational boat manufacturing standards
  • Standard for lifejackets

Rail Transport

  • Locomotive Emissions
  • Rail Safety Standards

Environment

  • Emission standards for light-duty vehicles

Personal Care Products & Pharmaceuticals

  • Electronic submission gateway
  • Over-the-counter products – common monographs
  • Good manufacturing practices

Occupational Safety Issues

  • Classification & labelling of workplace hazardous chemicals

Nanotechnology

  • Nanotechnology

Led jointly by senior officials from Canada and the United States, the purpose of the various technical review sessions was to seek expert advice and technical input from the approximately 240 stakeholders in attendance.

Since the Jan. 2012 meeting, a Nanotechnology Work Plan has been developed and that’s what was recently discussed at the Nov. 28, 2012 webinar. I did find more on a Canadian government website, Canada’s Economic Action Plan Nanotechnology Work Plan webpage,

Nanotechnology Work Plan

 Canada Leads: Karen Dodds, Assistant Deputy Minister, Science and Technology Branch, Environment Canada (EC)

Hilary Geller, Assistant Deputy Minister, Healthy Environments and Consumer Safety Branch, Health Canada (HC)

U.S. Lead: Margaret Malanoski, Office of Information and Regulatory Affairs, Office of Management and Budget

Deliverable Outcome: Share information and develop common approaches, to the extent possible, on foundational regulatory elements, including criteria for determining characteristics of concern/no concern, information gathering, approaches to risk assessment and management, etc. Develop joint initiatives to align regulatory approaches in specific areas such that consistency exists for consumers and industry in Canada and the US.

Principles: Identification of common principles for the regulation of nanomaterials to help ensure consistency for industry and consumers in both countries

3-6 months:

Canada provides initial feedback on US “Policy Principles for the US Decision-Making Concerning Regulation and Oversight of Applications of Nanotechnology and Nanomaterials”.

6-12 months:

Countries complete an initial draft of shared principles for the regulation of nanomaterials.

12-18 months:

Update of draft principles informed from on-going stakeholder and expert consultations.

18th month:

Stakeholder consultation / workshop on results to date and future ongoing engagement.

Beyond 18 months:

Countries complete final draft of shared principles for the regulation of nanomaterials.

Workplan for Industrial Nanomaterials

Priority-Setting: Identify common criteria for determining characteristics of industrial nanomaterials of concern/no-concern

1-3 months:

  1. Define and finalize workplan (1st month)
  2. Develop mechanisms for stakeholder outreach and engagement (1st month)
  3. Conference call with relevant stakeholders to share and discuss workplan and call for Industry to volunteer nanomaterials for joint CAN/US review

3-6 months:

Share available scientific evidence regarding characteristics of industrial nanomaterials including that obtained from existing international fora (e.g. OECD Working Party on Manufactured Nanomaterials [Canada is a lead in the OECD Working Party on Manufactured Nanomaterials]).

8th month:

Stakeholder workshop to discuss information collected to date and approaches moving forward.

6-12 months:

Initiate an analysis of characteristics of select nanomaterials: similarities, differences, reasons for them.

Initiate discussions on approaches to consider for common definitions and terminology.

12th month:

Second conference call with relevant stakeholders to discuss non-CBI information gathered between the Countries and to discuss path forward in terms of development of reports and analyses.

12-18 months:

Develop draft criteria for determining characteristics of industrial nanomaterials of concern/no-concern.

15th month:

Third conference call with relevant stakeholders to discuss progress and to prepare for the upcoming stakeholder consultation/workshop.

Here’s information for the leads should you feel compelled to make contact,

Canada

(Lead) Karen Dodds, Assistant Deputy Minister, Science and Technology, Environment Canada ([email protected]; ph. 613- 819-934-6851)

Hilary Geller, Assistant Deputy Minister, Healthy Environments and Consumer Safety Branch ([email protected]; ph. 613-946-6701)

United States

(Lead) Margaret Malanoski, Office of Management and Budget ([email protected])

I gather that the ‘stakeholders’ are business people, researchers, and policy analysts/makers as there doesn’t seem to be any mechanism for public consultation or education, for that matter.

US chemists talk nano in a June 27, 2012 Washington, DC briefing

The American Chemical Society (ACS) has a Science & the Congress Project where they provide information about various science and technology issues to policymakers. Their latest briefing will be on nanomaterials and the Toxic Substances Control Act.  From the June 21, 2012 news release on EurekAlert,

The American Chemical Society (ACS) Science & the Congress Project invites news media to attend a luncheon briefing on “Nanomaterial Safety: Do We Have the Right Tools?” It will be held Wednesday, June 27, 12-1:30 p.m., in the Russell Senate Office Building Room 325. To attend, register at http://tinyurl.com/ACSSciCongr-nanoEHS.

This briefing is hosted by the ACS Science & the Congress Project with honorary co-host the Congressional Nanotechnology Caucus.

With nanotechnology, scientists engineer materials on a molecular level; that is, they work with such basic factors as the size, shape and surface properties of substances, in addition to altering the chemical composition, to create materials that exhibit novel properties. While the science to engineer nanomaterials has been developed largely since the 1980s, public laws to regulate the safety of materials and chemicals, such as the Toxic Substances Control Act (TSCA), were crafted in the 1970s. Important questions for our times: Does our understanding of and information about nanotechnology adequately inform the policies designed to ensure safe product development? Likewise, do the current policies address both the possible problems and benefits associated with nanotechnology? This panel will discuss whether policymakers currently have the necessary tools, both scientific and policy mechanisms, to reap the potentials of nanotechnology.

The briefing will feature the following panelists and an open discussion:

Moderator: Kristen Kulinowski, Ph.D., Science and Technology Policy Institute, Institute for Defense Analyses

Panelists:

  • Lynn Bergeson, Bergeson & Campbell P.C.
  • Richard Denison, Ph.D., Environmental Defense Fund
  • Arturo Keller, Ph.D., University of California, Santa Barbara

For those of us who can’t attend, it is possible to find more information the Science &the Congress Project, from the About page (and if you keep reading you’ll find that you may still be able to access the briefing even if you can’t attend the real-time event),

Since 1995, the American Chemical Society (ACS) has operated the Science & the Congress Project to educate and inform Members of Congress and their staffs on the importance of science and technology to solving national challenges. The Science & the Congress Project has conducted well over 100 congressional briefings on important and timely policy topics, relying on panels of knowledgeable and diverse experts to provide comprehensive, balanced presentations about chosen topics, and to increase the level of scientific and technological literacy on Capitol Hill. The goals of the project include:

  • Highlighting the role of S&T in public policy.
  • Helping Members of Congress and their staffs gain a deeper knowledge of the science involved in policy issues.
  • Serving as a neutral and credible source of scientific information.
  • Promoting the responsible use of science in national policymaking.

Serving ACS and Its Members

The ACS Science & the Congress Project provides significant benefits for ACS and its members:

  • Balanced, nonpartisan briefings lend credibility to ACS policy efforts.
  • Initiation of briefings enhances ACS’s leadership role among peer organizations.
  • Collaborations with cosponsors enhance ACS’s ties and foster cooperation within the scientific community.
  • Online availability of briefing materials increases ACS members’ exposure to science policy topics.

Enhancing Relationships

During more than a decade of existence, the ACS Science & the Congress Project has conducted well over 100 briefings and built relationships with:

  • Congressional offices, committees, caucuses and staffers.
  • Experts in academia, non-governmental organizations and all levels of government.
  • Professional organizations with overlapping interests.

They also make their materials available after the briefing,

Serving as an Ongoing Source of Science Policy Information

Individual web pages for each Science & the Congress Project briefing provide a breadth of resources on the briefing’s topic, including:

  • The speakers’ presentations.
  • Speaker biographical and contact information.
  • Supplemental links, documents, and articles.

I checked and it is possible to access the briefings and other information without a subscription. I hope the nanomaterials briefing will be available soon on the website soon. Here’s the page you should check.

US National Nanotechnology Initiative holding EHS webinar

There’s an Oct. 15, 2011 news item on Nanowerk announcing the US National Nanotechnology Initiative’s Environmental, Health, and Safety webinar on research strategies.

Federal Agencies participating in the National Nanotechnology Initiative (NNI) are hosting a webinar to announce the release of the 2011 NNI Environmental, Health, and Safety (EHS) Research Strategy and to the discuss the development of this document and its key focus areas. The webinar will be held October 20, 2011 from 12 noon until 12:45p.m [EDT].

The event will consist of an overview of the strategy’s development followed by comments from industrial, regulatory, and public health perspectives. Dr. John Howard, Nanotechnology Environmental and Health Implications (NEHI) Working Group Co-Chair, will serve as the moderator. Panelists include:

  • Dr. Treye Thomas, NEHI Working Group Co-Chair
  • Dr. Shaun Clancy, Evonik DeGussa Corporation
  • Dr. Janet Carter, Occupational Safety and Health Administration (OSHA)
  • Ms. Lynn Bergeson, Bergeson & Campbell

The webinar will also feature a 20-minute question-and-answer segment following the presentations. Questions may be submitted prior to the webinar to [email protected] beginning at noon (EDT) Wednesday, October 19, 2011 and will be accepted until the close of the webinar at 12:45 p.m. Thursday, October 20, 2011. [???]

I’m pretty sure that last bit is an error. I can’t imagine a webinar that lasts for 25 hours, at least not on this topic.

As registration is necessary to watch the webinar, I tried to do so and failed each time. I think the problem is that I don’t have a zip code. Usually I can fill in a Canadian postal code instead but this system rejected every attempt. If you do have a US zip code, you can register here.

In preparation for this webinar about EHS research strategies to be undertaken by US federal agencies, Dr. Andrew Maynard has summarized some of the public comments about the  key recommendations in the draft version, which was published in December 2010. Excerpted from Andrew’s Oct. 15, 2011 posting,

Bill Kojola

An integrated and linked research effort to assess, via epidemiological studies, the impact of exposure to engineered nanomaterials on human health and any necessary resultant risk assessment/management responses seems to be missing from the strategy.

Andrew Maynard

…what would it take to craft a federal strategy that enabled agencies to work together more effectively in ensuring the safe use of nanomaterials?  I’m not sure that this is entirely possible – an internal strategy will always be constrained by the system in ways that an externally-crafted strategy isn’t.  But I do think that there are three areas in particular that could be built on here:

  1. Principles. The idea of establishing principles to which agencies sign up to is a powerful one, and could be extended further.  For instance, they could include a commitment to working closely and cooperatively with other agencies, to working toward a common set of aims, and to critically reviewing progress towards these aims on a regular basis.
  2. Accountability. The implementation and coordination framework set out in chapter 8 of the draft strategy contains a number of items that, with a bit of work, some group within the federal government could be held accountable to.  Formally, the NNCO would seem to be the most appropriate organization to be held responsible for progress here.  With accountability for actions that support the implementation and coordination of the strategy, a basis could be built for an actionable strategy, rather than wishful thinking.
  3. Innovation. So often in documents like this, there is a sense of defeatism – “this is the system, and there’s nothing we can do to change it”.  Yet there are always innovative ways to circumvent institutional barriers in order to achieve specific ends.  I would strongly encourage the NEHI to start from the question “where to we want to go, and how are we going to get there”, rather than “what are we allowed to do”, and from this starting point explore innovative ways of making substantive and measurable progress towards the stated mission of the strategy.  Just one possibility here is to use the model of the Signature Initiatives being developed elsewhere within the NNI – which overcome institutional barriers to encourage agencies to focus on a common challenge.  Something similar to a Signature Initiative focused on predictive modeling, or personal exposure measurement, or nanomaterial characterization, could enable highly coordinated and integrated cross-agency programs that accelerate progress toward specific goals.  But this is just one possibility – there are surely many more ways of getting round the system!

John DiLoreto, The Nanotechnology Coalition

A core mission of the NNI is to foster “technological advancements that benefit society” (Draft NNI 2011 Environmental, Health, and Safety Strategy, page 1). The NNI strategy provides valuable help in identifying key research areas and, in some cases, providing the necessary funding to conduct the research itself. The Coalition believes that to fulfill its mission in this regard, the NNI could and should direct its considerable influence and resources to educating regulatory and other officials in positions of influence about nanotechnology so they can better fulfill their responsibilities to protect the safety of consumers. The EHS research strategy should also examine ways that science-based safety information can be shared with regulatory officials and others in leadership positions and provide scientific resources to assist these officials in understanding what a ‘nanomaterial’ is and help create a better understanding of properties that may impact safety.

David Berube

Section 6, p. 56, line 23/25/26/30 – 23 conflates translation with risk communication (they are different). 25 “approaches” is unclear and should reference levels of acceptable caution. 26 high uncertainty may demand whole new algorithms – your assumption whether risk communication and risk management can be integrated is incorrect. 30 is a good point to discuss the conflation of translation which occurs between parties within similar ranges of understanding and public perception (NGOs) as well as perception of public perception (legislators). Each of these subset publics have different needs and interests and standardization of terminology is hardly sufficient to the task at hand.

p. 57 line 4 – see above and consider we might need to develop algorithms appropriate to different levels of certainty. The assumption the answer to uncertainty is more certainty is not necessarily valid for all publics. The simplified version in the document seems more attuned to strategic communication involving response strategies for different risks and certainty values involving variables like plausibility, phenomenon specificity, exigence, salience, etc.

p. 63 lines 34/37 34 (see above). 37 one model does not fit all. 38 link to trust is very complex and complicated by new/digital media sources as well as new credibility (social media) and reliability.

p. 58 lines 1/5/11/27 (see above) and this demands information sharing and transparency as well as answering how data is defined, who decides what is relevant data, how it is generated, how data is compiled and concatenated. how data is vetted and debunked, and how data is revised. 5 two ways is overly simplistic, try interactional. 11 this is a model issue and we do not have a model for high uncertainty. 27 assumes risk communication is a function of data, esp. scientific data and for many publics that is not true.

p. 76 – Explanation SP objective 4.2 re: needs of the stakeholders – it might be prudent to ask them what their needs are.

Samantha Dozier, PETA

A complete, step-wise method for rigorous characterization is imperative so that measurement is not questioned and studies are not repeated. A clear requirement for nanomaterial characterization will help eliminate redundancy and imprecise data-gathering and will aid in reducing animal use for the field.

For human health effects assessment, the NNI should promote the development of a tiered, weight-of-evidence approach that is based on the most relevant methods available and encourages the NNI to support the incorporation of appropriate in vitro human-relevant cell and tissue assays for all endpoints, instead of relying on inadequately modified, non-validated animal assays. This tiered approach should start with an initial characterization of the nanomaterial, followed by in vitro basal cell and portal-of-entry toxicity assessments according to human exposure potential and a full characterization of the toxicokinetic potential.

There’s a lot more in Andrew’s posting. It saddens me even more now that I see Andrew’s posting that Health Canada did not make the submissions to its public consultation on “Policy Statement on Health Canada’s Working Definition for Nanomaterials” available for viewing (my Oct. 11, 2011 posting).