The National Institute for Occupational Safety and Health (NIOSH) announced in its September 5, 2014, eNews that an international committee unanimously selected Dr. Vladimir Murashov, special assistant for nanotechnology to the NIOSH Director, “to lead an international working group on the health, safety, and environmental aspects of nanotechnologies.” NIOSH states that the working group is part of a larger initiative by the International Organization for Standardization (ISO) to develop standardization in the nanotechnologies field. According to NIOSH, “[a]s convener, Dr. Murashov will guide the working group as they develop science-based standards to improve worker, consumer, and environmental protections by promoting good practice in the production, use, and disposal of nanomaterials and nanotechnology products.”
Australian Pesticides and Veterinary Medicines Authority Will Hold Nanotechnology Regulation Symposium
The Australian Pesticides and Veterinary Medicines Authority (APVMA) will host a nanotechnology regulation symposium on October 28, 2014. APVMA states that it “has worked over many years to progressively develop a regulatory framework for nanoscale agvet chemicals and chemical products.” APVMA intends the symposium to provide industry and regulators with an opportunity for dialogue on the future regulation of nanopesticides and veterinary nanomedicines. Key topics covered will include the benefits and potential risks; definitions, metrology, properties, and manufacturing; and human health and environmental considerations. APVMA intends to publish a draft nanotechnology report in late September 2014, which will provide a basis for discussion at the symposium. According to APVMA, it will encourage participants to comment on the report, “thereby contributing to a better regulatory framework for nanomaterials.” Registration for the symposium is now open.
Fifteen European industry associations, including the Nanotechnology Industries Association (NIA) and the European Chemical Industry Council (CEFIC), have endorsed a brochure entitled “Europe needs safe and innovative nanotechnologies and nanomaterials.” According to the brochure, the associations “support the European Commission conclusion that the current European regulatory framework adequately covers nanomaterials, is science-based and proportionate.” The brochure highlights seven key points:
- Nanotechnologies provide solutions;
- Europe needs nanotechnologies to achieve the goals of the EU 2020 strategy;
- Safety is paramount;
- Openness and transparency are vital;
- The comprehensive European regulatory framework in place has the capacity to govern the production and use of nanomaterials;
- A common workable definition system for defining nanomaterials is welcome; and
- Europe cannot afford to miss out on the opportunities provided by nanotechnologies and the benefits they bring.
The National Nanotechnology Coordination Office, on behalf of the Nanoscale Science, Engineering, and Technology Subcommittee of the Committee on Technology, National Science and Technology Council, will hold a workshop entitled “Sensor Fabrication, Integration, and Commercialization” on September 11-12, 2014. According to the August 7, 2014, Federal Register notice announcing the workshop, it will bring together experts from a wide-range of application areas, stages of product development, and manufacturing. The workshop is intended to identify key challenges faced by sensor developers and determine the critical needs of the community, especially with respect to necessary standards, testing facilities, and advances in manufacturing. The notice states that the workshop will include case study examples of commercialization success, a small business panel focused on challenges faced in the commercialization of sensors, and breakout sessions to address explicitly the 2013 request for information questions regarding standards, testing, manufacturing, and commercialization.
On July 29, 2014, the House Energy and Commerce Subcommittee on Commerce, Manufacturing, and Trade held a hearing on “Nanotechnology: Understanding How Small Solutions Drive Big Innovation.” Witnesses included:
- James M. Tour, Ph.D., T.T. and W.F. Chao Professor of Chemistry, Professor of Computer Science, Materials Science and Nanoengineering, Smalley Institute for Nanoscale Science and Technology, Rice University;
- Christian Binek, Ph.D., Associate Professor Physics and Astronomy, University of Nebraska - Lincoln;
- Milan Mrksich, Ph.D., Henry Wade Rogers Professor of Biomedical Engineering, Chemistry and Cell and Molecular Biology, Northwestern University; and
- Jim Phillips, Chairman and Chief Executive Officer, NanoMech, Incorporated.
Subcommittee Chair Lee Terry stated that “nanotechnology is poised to drive the next surge of economic growth across all sectors.” According to Dr. Binek, nanotechnology has the potential to transform a range of industries, in fields such as information technology, medical applications, energy, water supply with strong correlation to the energy problem, smart materials, and manufacturing. Dr. Tour encouraged steps to help the U.S better compete with markets abroad, and suggested Congress work with industry, tax experts, and universities to design an effective incentive structure to increase industry support for research and development. Professor Mrksich discussed the economic opportunities of nanotechnology, and obstacles to realizing these benefits. According to Mrksich, current challenges “include the development of strategies to ensure the continued investment in fundamental research, to increase the fraction of these discoveries that are translated to technology companies, to have effective regulations on nanomaterials, to efficiently process and protect intellectual property to ensure that within the global landscape, the United States remains the leader in realizing the economic benefits of the nanotechnology industry.” Mr. Phillips testified: “It’s time for America to lead. . . . We must capitalize immediately on our great University system, our National Labs, and tremendous agencies like the National Science Foundation, to be sure this unique and best in class innovation ecosystem, is organized in a way that promotes nanotechnology, tech transfer and commercialization in dramatic and laser focused ways so that we capture the best ideas into patents quickly, that are easily transferred into our capitalistic economy so that our nation’s best ideas and inventions are never left stranded, but instead accelerated to market at the speed of innovation so that we build good jobs and improve the quality of life and security for our citizens faster and better than any other country on our planet.” An archived webcast of the hearing and witness testimony are available online.
On July 29, 2014, the Office of Science and Technology Policy (OSTP) and the National Economic Council (NEC) published a Federal Register notice requesting public comments to provide input for an upcoming update of the Strategy for American Innovation. According to the notice, the Strategy “helps to guide the Administration’s efforts to promote lasting economic growth and competitiveness through policies that support transformative American innovation in products, processes, and services and spur new fundamental discoveries that in the long run lead to growing economic prosperity and rising living standards.” The national priority areas outlined in the 2011 Strategy include nanotechnology. The 2011 Strategy states:
The President is committed to investments in innovation that promise to drive better health, future economic growth, and quality jobs in America. . . . The National Nanotechnology Initiative (NNI) is investing in areas such as nanoelectronics, which will foster a revolution in computing comparable to the transition from the vacuum tube to the transistor. And the FY 2012 Budget is making substantial investments to accelerate breakthroughs in advanced manufacturing technologies that can provide foundations for private sector investment and growth.
The July 29, 2014, Federal Register notice includes a number of questions, grouped into the following categories of innovation policy topics:
- Overarching questions;
- Innovation trends;
- Science, technology, and research and development priorities;
- Skilled workforce development;
- Manufacturing and entrepreneurship;
- Regional innovation ecosystems;
- Intellectual property/antitrust;
- Novel government tools for promoting innovation; and
- National priorities.
Comments are due September 23, 2014.
On July 24, 2014, the Organization for Economic Cooperation and Development (OECD) posted a report entitled Nanotechnology and Tyres: Greening Industry and Transport, which provides a risk management framework to enable site-specific or company-specific risk assessments or risk management strategies for using nanomaterials as additives in tires. OECD states that the report emphasizes the importance of:
- The policies to support research in the environmental, health, and safety risks, as well as those to support the commercialization of nanotechnology research results, for fostering responsible innovation in the tire sector;
- Using available tools to gain better insight into the socio-economic and environmental impacts of nanotechnology applications; and
- Collaboration between governments and industry to address the specific challenges raised by the introduction of new nanomaterials in different industry sectors.
The report summarizes the conclusions of a two-year project, which was originally proposed and supported by the Business and Industry Advisor Committee to the OECD through the Tyre Industry Project of the World Business Council for Sustainable Development.
On July 31, 2014, the National Nanotechnology Coordination Office (NNCO) will hold a public webinar to provide a forum to answer questions related to the federal government’s “Progress Review on the Coordinated Implementation of the National Nanotechnology Initiative 2011 Environmental, Health, and Safety Research Strategy.” According to the July 22, 2014, Federal Register notice, discussion will focus on the research activities undertaken by the National Nanotechnology Initiative (NNI) agencies to advance the current state of the science as highlighted in the Progress Review. Representative research activities as provided in the Progress Review will be discussed in the context of the 2011 NNI Environmental, Health, and Safety (EHS) Research Strategy’s six core research areas: nanomaterial measurement infrastructure; human exposure assessment; human health; the environment; risk assessment and risk management methods; and informatics and modeling. Questions on the Progress Review document may be submitted beginning July 24, 2014, through the close of the webinar. During the question-and-answer segment of the webinar, submitted questions will be considered in the order received.
EC and SCENIHR Begin Public Consultation on Preliminary Opinion on Guidance on the Determination of Potential Health Effects of Nanomaterials Used in Medical Devices
The European Commission (EC) and the Scientific Committee on Emerging Newly Identified Health Risks (SCENIHR) have begun a public consultation on the preliminary opinion concerning “Guidance on the Determination of Potential Health Effects of Nanomaterials Used in Medical Devices.” The aim of the opinion is to address the use of nanomaterials in medical devices and to provide information for risk assessors regarding specific aspects that need to be considered in the safety evaluation of nanomaterials. Guidance is provided on physico-chemical characterization of nanomaterials, the determination of hazards associated with the use of nanomaterials, and risk assessment for the use of nanomaterials in medical devices. The safety evaluation of nanomaterials used in medical devices is discussed in the context of the general framework for biological evaluation of medical devices as described in the International Organization for Standardization (ISO) 10993-30 1:2009 standard. Therefore, the risk assessment is performed taking into consideration type of device, type of tissue contact, and the duration of contact, thus identifying the specific exposure scenario. The Guidance is intended to provide information to help with safety evaluation and risk assessment of the use of nanomaterials in medical devices that should be considered in conjunction with the ISO 10993-1:2009 standard. The Guidance highlights the need for special considerations in relation to the safety evaluation of nanomaterials in view of the possible distinct properties, interactions, and/or effects that may differ from conventional forms of the same materials. For the risk evaluation of the use of nanomaterials in medical devices, a phased approach is recommended based on potential release and characteristics of the nanomaterials. SCENIHR is seeking comments on the risk assessment related to the Guidance. Comments are due October 3, 2014.
Registration is now open for Nano Risk Analysis (II), a workshop to explore how a multiple models approach can advance risk analysis of nanoscale materials. The workshop, which is being organized by the Emerging Nanoscale Materials Specialty Group (ENMSG) of the Society for Risk Analysis (SRA) and co-sponsored by Bergeson & Campbell, P.C., will be held September 15-16, 2014, in Washington, D.C. The workshop will bring together experts from diverse disciplines to explore ways that Alternative Testing Strategies (ATS) may be combined to create a Weight of Evidence (WOE) or “multiple models” approach to inform context -- specific decisions about risk from exposure to novel nanoscale materials. The goal is to advance a common understanding of the state of the science, early lessons, current opportunities, and next steps for developing ATS for use in decision making for nanoscale materials. The output of the workshop will be a set of recommendations reported to the Organization for Economic Cooperation and Development (OECD) Working Party on Manufactured Nanomaterials (WPMN) and via peer reviewed publications and web-based portals about ways in which these approaches may be practically applied in the near term to improve environmental decision making by governmental and industrial organizations. Abstracts for posters to be presented at the workshop are due August 1, 2014.