|Hideo Shindo has been chief representative of the Washington, D.C., office of the New Energy and Industrial Technology Development Organization (NEDO) since July 2004. The NEDO is a quasi-governmental, non-profit, R&D facilitating organization. Before his transfer to NEDO headquarters in 2003, he worked for the Japanese government’s Ministry of Economy, Trade and Industry, dealing with policies pertaining to R&D, trade, and standards and conformity assessment. Currently Shindo also serves as the Washington representative of the Japanese Industrial Standards Committee.
||Nanotechnology Standardization in Japan
As science and technology advance, observation and manipulation techniques on the nanometre level have become possible, and moreover necessary, in a variety of technologies such as semiconductor production, biotechnology and the development of new materials. One nanometre is one billionth of a metre, which corresponds to ultra-micro worlds such as the width of a semiconductor line, the size of a virus (10-100 nm), a protein molecule, a hydrogen atom, or the diameter of a DNA double helix (1-10 nm). The exploration of this world requires not only proportional miniaturizing of conventional technologies, but also the development of a totally different technology nanotechnology, which relates across various technology sectors.
Nanotechnology has been counted as one of the four priority technology areas in Japan’s Second Science and Technology Basic Plan (2001-2005). Several specific nanomaterials, such as carbon nanotubes and fullerenes, have been developed with unique characteristics in strength and conductivity, etc., and various applications are expected. In total, the nanotechnology market in 2010 is expected to be worth 20-30 trillion Japanese yen (about US $200-300 billion) including nanoelectronics in the information technology sector and nanobiotechnologies. Based on such expectations, Japanese industries established a forum called the Nanotechnology Business Creation Initiative in July 2003, in which about 300 companies now participate.
Why Is Standardization Necessary?
Because nanotechnology is a brand new technology across many sectors, various research institutes, universities and company laboratories use the distinct terminologies, research approaches and evaluation methods of their own technology sectors.
This has led to two major concerns: the first is the lack of a common language for trade. Though it is necessary for a company that wants to develop, produce, or sell nanotechnology products to utilize various vendors’ materials and parts, it would be impossible for the buyer to know to what extent it could believe the vendors’ reports if they used different terminologies for product performance and different evaluation methods. This problem is especially significant in nanotechnology because of its relevance among very disparate technology sectors.
The second concern is the lack of a basis on which to scientifically discuss and resolve the public’s fears about nanotechnology. The mass media raise such fears as sensational topics every several months. The academic community and regulatory agencies also must seriously consider whether, when and/or how nanoparticles, which are almost comparable in size to protein molecules and genes, might penetrate into, accumulate in and do imperceptible harm to a human body or the environment.
When genetically modified organisms were developed in the past, an initial GMO boom was soon overwhelmed by strong concerns and fears raised by the public, regardless of a scientific debate. Industries related to nanotechnology seriously consider it necessary to have scientifically reasonable discussions in the early stages of development on whether nanotechnology and/or nanoparticles are really safe, or how they can be made safely, since the potential nanotechnology market in the future is inestimable.
However, it is actually impossible to designate a nanoparticle as dangerous or not; the answer would be totally different in each case, depending on a particle’s composition, structure and/or surface situation. Moreover, there has been no consensus, even in academia, on how to accurately express such characteristics of a nanoparticle, nor on how to debate its safety based on what type of evaluation methodologies are used.
Global Trend Toward Nanotechnology Standardization
Based on this background, discussions with regard to nanotechnology standardization have increased in the last year in the United States, Europe and Japan.
• In August 2004, the American National Standards Institute established the ANSI Nanotechnology Standards Panel in response to a request by the U.S. Office of Science and Technology Policy.
• In early 2004, ASTM International began the process of establishing what would evolve into Committee E56 on Nanotechnology. The committee was officially organized in January 2005 and held its first full meeting May 16-19 in Reno, Nev.
• The Institute of Electrical and Electronics Engineers has dealt with several nanotechnology standards such as its standard on the use of chemical vapor deposition in nanoscale devices.
• In March 2004, the European Commission for Standardization, or CEN, created a study group called CEN Technical Board Working Group 166 on Nanotechnology to analyze the need for nanotechnology standardization and to draft a business plan for a new CEN technical committee.
• In January, the British Standards Institution submitted a proposal to the International Organization for Standardization (ISO) to create a technical committee for nanotechnology standardization; the proposal was approved by the ISO Technical Management Board in May.
• The International Electrotechnical Commission began a discussion in April on how to address nanotechnology standardization issues. When asked by the IEC Standardization Management Board whether the IEC should create a new technical committee on nanotechnology, Japan, the United Kingdom and the United States proposed the setup of an advisory committee to cooperate with related technical committees and subcommittees within IEC and to establish a liaison with ISO.
The immediate challenges regarding the activities above, in the framework of international standardization, are how to align various nanotechnology standardization activities in such forums as ASTM International, ISO, IEC, etc., and how to facilitate coordination among new and existing standardization activities.
On the other hand, in terms of substance, Japanese stakeholders see ASTM Committee E56 as the first and most comprehensive standardization initiative. Six subcommittees have been established on terminology and nomenclature, characterization, environmental and occupational health and safety, international law and intellectual property, liaison and international cooperation, and risk management/product stewardship; substantial activities have begun within these subcommittees. The vice chair of E56 is Akira Ono, coordinator of Japan’s National Institute of Advanced Industrial Science and Technology. The AIST is the core R&D organization among many research institutes in Japan that conduct research and development projects on metrology and test methods for nanotechnology funded by the other independent administrative agency, the New Energy and Industrial Technology Development Organization. These R&D projects include the Nanoscopic Measurement Technological Infrastructure Project (2001-2007) and the R&D of Nanoscale Certified Reference Material Project (2002-2006).
Committee for Nanotechnology Standardization Research and Study
The Japanese Industrial Standards Committee is the national standards body representing the nation to ISO and IEC. In November 2004, the Ministry of Economy, Trade and Industry, or METI (which is the JISC secretariat), established a study group, the Committee for Nanotechnology Standardization Research and Study, in cooperation with the Japanese Standards Association. This committee consists of experts from industry, academia and public institutions, and it is regarded as a driver of necessary research for Japan’s international standardization strategies in nanotechnology. According to METI, the committee’s objective is to survey industry priorities for the standardization of nanotechnology-related issues such as terminology and metrology, and to recommend appropriate future strategies for domestic standardization as well as proposals to ISO and IEC.
The committee’s survey was circulated among 612 organizations, including companies in the Nanotechnology Business Creation Initiative; 27 organizations returned their answers.
The survey’s key questions and answers included:
Q: What size of nanoparticles does your institution focus on?
A: Seventy percent said less than 50 nm.
Q: What type (inorganic, organic, etc.) of nanomaterials does your institution have great interest in?
A: Fifty percent said inorganic materials.
Q: What factors (structure, composition, status, etc.) should be measured when investigating observed performances further at the material level?
A: Fifty percent answered formation. Also, more than half also focused on the utilization of composite materials.
Q: What standardization goals among the six subcommittee activities in Committee E56 does your institution have interest in?
A: Six votes for terminology and nomenclature, and seven votes for characterization as well as environmental and occupational health and safety.
The Committee for Nanotechnology Standardization Research and Study has been active in international information exchange. For example, it invited Dr. Vicki Colvin, a professor of Rice University, who later became a representative to ASTM International Committee E56, to its second meeting in Tokyo in November 2004.
Further rigorous discussions about a variety of nanotechnology standardization activities are expected in the Japanese committee; particularly on terminology and nomenclature, which is the most urgent issue. Other discussions will take place on measurement and testing methodologies, in which Japanese experts have considerable technical expertise, and on the safety and risk of nanoparticles, as well as how to deal with nanoparticles in research laboratories and/or workplaces.
Japan expressed its intent to submit a proposal to ISO to create a subcommittee on metrology and test methods for nanocharacterization in ISO’s pending technical committee on nanotechnology. This subcommittee would address the standardization of metrology, including reference materials and test methods used to characterize the physical, chemical, and biological properties of nanomaterials and nanostructures. Japanese experts look forward to contributing to progress in the international standardization of nanotechnology by sharing their experiences in metrology and test methods. Toward this end, this topic was presented and discussed at the May 18 meeting of ASTM International Subcommittee E56.05 on Liaison and International Cooperation. The meeting attendees agreed on the need for strong liaison and communication in this area, and cited the existing relationship between AIST and ASTM as a significant and necessary step in the right direction.
In April 2005, the METI announced the launch of a three-year project to address R&D for the standardization of evaluation methods on the safety of nanoparticles under its R&D for International Standardization Program. The budget for the first year of this project is about 30 million Japanese yen (about US $300,000). The solicitation for participating research institutions is now in progress. This project is also expected to contribute to international nanotechnology standardization.
Domestic Organizations Led by the AIST
A domestic organizational structure for international standardization in nanotechnology will soon be established in Japan, corresponding to ISO’s decision to create a technical committee on nanotechnology standardization. The AIST will take a lead, and companies and universities will provide various inputs to standardization activities on terminology and nomenclature, metrology and test methods, and safety and risk issues (including toxicity and the impact on the environment).
The AIST is expected to become a secretariat of a mirror committee for international standardization on nanotechnology. The AIST will also serve a secretariat role for the Committee for Nanotechnology Standardization Research and Study, which the JSA has so far served. In the mirror committee, the AIST will provide the chair, vice chair, and all of the heads of three working groups. Akira Ono, vice chair of ASTM Committee E56 on nanotechnology, will chair the mirror committee. Junko Nakanishi, head of the AIST Research Center for Chemical Risk Management, will serve as vice chair.
The AIST has also reached an agreement with ASTM to cooperate on a nanotechnology terminology document prepared in ASTM Committee E56.
Nanotechnology standardization will require extremely broad discussions and coordination on many topics across various technology sectors and various stakeholders as well as many countries and regions in the world. Japan will continuously make its best effort, through extensive information exchange with the United States, Europe, Asia and other countries and regions, to facilitate speedy and meaningful nanotechnology standardization. //