Standards for Nanotechnology Material Specifications

Posted on September 29, 2008 by John C. Monica, Jr.

This fifth and final article in a series on standards for the nanotechnology community contributed by ANSI explains the development of specifications that will look at raw nanomaterials in terms of their use in a variety of applications.

By 2007, the development of international guidelines for nanotechnology was well underway within the International Organization for Standardization (ISO). Each of the projects of ISO Technical Committee (TC) 229, Nanotechnologies, had been categorized into one of the TC’s working groups: WG 1, Terminology and Nomenclature, WG 2, Measurement and Characterization, or WG 3, Health, Safety, and Environment.

But when the Standardization Administration of China (SAC), China’s national standards body, submitted two new work item proposals in October 2007, TC 229 members recognized that the proposed areas of technical activity – addressing specifications for nanomaterials in terms of possible applications – did not fit easily into any of the existing WGs.

Material specifications had already been identified as a priority area in the TC 229 business plan, which was based on the results of a 2006 survey, “ISO TC 229 Nanotechnologies Survey of Standardization Needs.” Some aspects of the SAC-proposed work items, however, fell under the scope of each of the WGs and yet other parts of the proposals didn’t fit into any of the groups.

In response to these newly identified needs, a new working group on Material Specifications (WG 4) was formed in early 2008.

Leadership and Work Items for WG 4

Given their important role in the creation of WG 4, China holds the convenorship of the group through SAC and Professor Limin Wang. The scope of the group is still being drafted with the help of several international stakeholders, including many from the United States. This scope, once established, will serve as a roadmap for how to further the efforts of the WG.

TC 229/WG 4 currently has three work items in development to examine raw materials in terms of their purpose in a variety of uses. The first two of these are the original SAC-submitted work items that sparked the formation of WG 4, and are currently being led by SAC:

• Nano TiO2 (Titanium Dioxide) specifies the characteristics and measurement methods for engineered nanoscale titanium dioxide (powder form). The material has numerous industrial applications, including use in sunblock, certain fibers and plastics, paints, printing ink, coatings, ceramics, and catalysts and catalyst carriers.

• Nano CaCO3 (Calcium Carbonate) specifies the characteristics and measurement methods for engineered nanoscale calcium carbonate (powder form). Industrial applications for this material include fillers in rubbers, plastics, coatings, paint, and printing ink.

Each of these work items will be divided into two parts: characterization of measurement and methods; and use of the nanoscale material in applications.

The third work item under WG 4 is being led by BSI British Standards, the national standards body for the United Kingdom:

• Guide to specifying nanomaterials will provide guidance on the preparation of comprehensive technical specifications for manufactured nanomaterials in order to ensure the delivery of a product that behaves in a reproducible manner.

Impact on Industry

As the standards developed under WG 4 can be used in industrial applications and consumer products from paint and coatings to textiles and sunblock, they will have a tremendous impact on manufacturers in a wide variety of industries, both in the U.S. and abroad. Interested stakeholders are encouraged to provide input that can help to formulate the strategy for WG 4.

U.S. involvement in ISO/TC 229 and its Working Groups begins with the U.S. Technical Advisory Group (TAG) to ISO/TC 229, administered by the American National Standards Institute (ANSI). Led by Clayton Teague, director of the National Nanotechnology Coordination Office, the TAG is organized into Working Groups that mirror their efforts on the scope of each TC 229 WG.

The mirror group for WG 4 is led by Dr. David S. Ensor, of RTI International.

“American industry has a rare opportunity to shape the content of these very early stage working draft standards and influence the strategic direction of WG 4,” said Dr. Ensor.

How to Participate

Participation in the U.S. TAG to ISO/TC 229 WG 4 is open to all nationally interested stakeholders. The TAG actively seeks participants who have expert knowledge in all aspects of nanotechnology material specifications.

“I encourage interested organizations to participate in the U.S. TAG and help develop U.S. positions to guide the deliberations of our experts to WG 4,” Dr. Ensor added. “We expect WG 4 will likely become an important ISO/TC 229 activity with time because it will eventually build on the standards developed by the other working groups.”

To join the ANSI-accredited U.S. TAG for ISO/TC 229 or any of its WGs, contact Heather Benko (hbenko@ansi.org; 212.642.4912).

For more information on the U.S. TAG for ISO/TC 229, visit http://www.ansi.org/isotc229tag.
 

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For Good Measure: Standards for Nanotechnology Measurement and Characterization

Posted on September 22, 2008 by John C. Monica, Jr.

This fourth article in a series contibuted by ANSI on standards for the nanotechnology community addresses the development of specifications for measurement, characterization, and test methods that will provide a common reference point for material manufacturers and their customers.

Measurement and characterization standards fly under the radar, affecting our lives in innumerable ways – from the number of miles driven to work to the paper loaded in the office printer. To imagine daily activities without these concepts would be nearly impossible, but that is exactly the challenge faced by scientists and manufacturers in the nanotechnology community.

For the growing number of industries that work with or are affected by nano-materials, consistent and globally accepted methods for testing, measurement, and characterization will provide a common reference point. By establishing a baseline to determine the starting properties of materials, these standards can facilitate meaningful comparisons of manufacturing and research results from different organizations and labs, and help to form a basis for the measurement of additional material properties.

When the American National Standards Institute (ANSI) Nanotechnology Standards Panel (NSP) first convened in September of 2004 to discuss priority recommendations for nanotechnology standardization, participants earmarked metrology, methods of analysis, and test methods as areas needing urgent attention. In particular, guidelines for particle size and shape, as well as particle number and distribution, were considered critical.

These needs are being addressed by the International Organization for Standardization (ISO) through its Technical Committee (TC) 229, Nanotechnologies, Working Group (WG) 2, Measurement and Characterization. Convened by Japan under the Japanese Industrial Standards Committee (JISC), WG 2 focuses on the development of standards for consistent descriptions, assessment, and test methods for nanotechnologies, taking into consideration the need for metrology and reference materials.

U.S. participation in ISO/TC 229 WG 2

U.S. participation in ISO/TC 229 and its Working Groups is centered in the U.S. Technical Advisory Group (TAG) to ISO/TC 229, chaired by Clayton Teague, director of the National Nanotechnology Coordination Office. The TAG, which is administered by ANSI, is organized into Working Groups that mirror their efforts on the scope of each TC 229 WG.

The U.S. mirror group for WG 2 is led by Dr. Ray Tsui of Motorola. The TAG WG plays an important role in establishing ANSI’s positions on the issues addressed in the group with the help of experts from the industry, government, and academia.

Several other U.S. organizations actively participate in the both the international and domestic WG 2 work efforts, including the National Institute of Standards and Technology (NIST) and the National Aeronautics and Space Administration (NASA), as well as Honeywell, Hyperion Catalysis, and others.

Guidance Documents in Progress

Representative of its efforts over the past three years, WG 2 is currently developing 10 work items; most involve single-walled or multi-walled carbon nanotubes, and how to characterize them using specific instrumentation methods. Four of these work items are led or co-led by the United States:

• ISO/Approved Work Item (AWI) Technical Specification (TS) 10797, Nanotubes – Use of transmission electron microscopy in walled carbon nanotubes (co-led by the U.S. and Japan)

• ISO/AWI TS 10798, Nanotubes – Scanning electron microscopy and energy dispersive X-ray analysis in the characterization of single walled carbon nanotubes (led by the U.S.)

• ISO/New Work Item Proposal (NP) TS 10812, Nanotechnologies – Use of Raman spectroscopy in the characterization of single-walled carbon nanotubes (led by the U.S.)

• ISO/AWI TS 11308, Nanotechnologies – Use of thermo gravimetric analysis in the purity evaluation of single-walled nanotubes (co-led by the U.S. and Korea)

“The activities in WG 2 are strongly coupled to the other efforts within ISO/TC 229,” said Dr. Tsui. “The work of WG 1, Terminology and Nomenclature, defines the materials being measured, while the output from WG2 provides important information regarding intrinsic material properties and measurement methods that can be used by WG 3, Health, Safety, and Environment, and WG 4, Material Specifications.”

This overlap is apparent in one work item that is currently in the domain of WG 3: Guidance on physico-chemical characterization of engineered nano-objects for toxicologic assessment. This document, being developed under U.S. leadership, will serve as a reference for characterizing nano-objects to be used in toxicology testing. WG 3 is presently creating toxicology guidelines as they relate to health and safety; WG 2 may join the effort to assist in the development of methods used to characterize toxicity.

Getting Involved in ISO/TC 229 WG 2

Participation in the U.S. TAG ISO/TC 229 Working Group is open to all nationally interested stakeholders. The TAG actively seeks participants who have expert knowledge in all aspects of nanotechnology measurement and characterization. To join the ANSI-accredited U.S. TAG for ISO/TC 229 or any of its WGs, contact Heather Benko (hbenko@ansi.org; 212.642.4912).

For more information on the U.S. TAG for ISO/TC 229, visit http://www.ansi.org/isotc229tag.

Stay Tuned: The next article in this series will introduce ISO/TC 229/WG 4, Material Specifications.

 

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Nanotechnology Law Report -- July 2008

Posted on July 30, 2008 by John C. Monica, Jr.
Nanotechnology Law Report -- July 2008
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Nanotechnology Standards for Health, Safety, and Environmental Factors

Posted on July 21, 2008 by John C. Monica, Jr.

This Article Was Authored and Contributed by the American National Standards Intititute

This second article in a series on nanotechnology standardization introduces the international working group that, under US leadership, is creating the standards needed to support the health, safety, and environmental aspects of nanotechnology.


In the post-war era of the late 1940s, global leaders of government and industry formed a central body to “facilitate the international coordination and unification of industrial standards.” Twenty-six member nations came together in 1947 to form the International Organization for Standardization (ISO). 

 

ISO and its national member bodies – including the American National Standards Institute (ANSI) – are constantly evolving to meet changing demands. Today, ISO is addressing issues such as industrialization, the advancement of information technologies, quality, the environment, and the health and safety of workers and consumers. Today, roughly one of every twenty ISO standards addresses issues pertaining to health, safety or the environment.

In June 2005, ISO formed a new Technical Committee to help focus the world’s attention on standards that would support the growth of nano-related industries. The scope of that committee, ISO/TC 229 – Nanotechnologies, includes standardization in the areas of terminology and nomenclature; measurement and instrumentation; material specifications; and health, safety and the environment. The standards that are being created by this Committee can be utilized by national bodies to support regulatory activity within nanotechnology development, which in turn supports workers that encounter nanotechnologies on the job.

As new materials, structures, devices and systems are developed that derive their properties and function due to their nanoscale dimensions, standards act to enhance the development of these technologies by encouraging cooperation and collaboration in the industry. Bringing experts together for the purpose of standardization promotes the best uses and highest functioning of nanotechnology across the wide range of industries that it affects.

“Standards are important for supporting research aimed to safely develop and apply nanotechnology for societal benefit and economic growth,” said Clayton Teague, director of the National Nanotechnology Coordination Office, Executive Office to the President of the United States. “Standards are equally important for research aimed to better protect public health and the environment, and for facilitating the review and regulation of nanotechnology-based materials and products. They are therefore one of the foundational components that enable effective assessment of products created with nanomaterials, as well as development of associated policies and best practices to protect the people who manufacture, work with, and use those materials.”

Work in Progress for Health and Safety Standards

ISO TC 229’s standard-setting activities are assigned to four Working Groups (WGs). Responsibility for the development of science-based standards for the safe development and use of nanotechnologies falls to WG 3, Health, Safety and Environment. Operating under the leadership of Steven Brown of Intel Corporation (USA), the group has become a focal point for nanotechnology safety experts.

Representatives from seventeen of TC 229’s thirty participating national bodies are active in the work of the WG. Several other internationally-recognized bodies participate as liaisons to the committee, including: the European Committee for Standardization (CEN) TC 352, Nanotechnologies; the European Commission Joint Research Centre (EC-JRC); and the Organisation for Economic Co-Operation and Development Working Party on Manufactured Nanomaterials (OECD WPMN).

Its workload is heavy, with five active projects and a proposed sixth work item now under consideration.

As announced in last month’s article, the WG’s most mature document, a guidance document that provides critical information on occupational safety for those involved in the manufacture and use of nanomaterials in the workplace, was recently finalized.

Publication of the report, entitled Health and safety practices in occupational settings relevant to nanotechnologies, is anticipated by year-end 2008.

“This technical report will serve as a foundation for responsible national nanotechnology occupational safety and health programs worldwide,” said Vladimir Murashov, special assistant on nanotechnology to the director of the National Institute for Occupational Safety and Health (NIOSH), and the project leader for this initiative.

The report builds on guidance originally provided by NIOSH, the federal agency responsible for conducting research and making recommendations for the prevention of work-related injury and illness.

Japan and South Korea have also stepped forward in leadership roles, serving as project leaders for three of the WG’s other active projects:

Endotoxin test on nanomaterial samples for in vitro systems;
Generation of nanoparticles for inhalation toxicity texting; and
Monitoring nanoparticles in inhalation exposure chambers for inhalation toxicity testing.
The fifth – and newest – WG 3 work item, Guidance on physico-chemical characterization of engineered nano-objects for toxicologic assessment, will serve as a reference for characterizing nano-objects for toxicology testing. The United States, under the leadership of Dr. Richard C. Pleus (Intertox) is spearheading this effort.

How to Participate

For each ISO Technical Committee or Subcommittee where the U.S. is a participating member, ANSI accredits a Technical Advisory Group (TAG) to develop and transmit our national positions on standards proposals and related activities. In the case of nanotechnology activities within ISO, one U.S. TAG, supported by multiple working groups, determines U.S. positions and advocates those positions at ISO

Dr. Laurie Locascio of the National Institute of Standards and Technology (NIST) chairs the U.S. ISO/TC 229 TAG Working Group on Health, Safety and Environment. Members of the TAG WG include representatives of academia, government, standards developing organizations, and industry. With this expert input, the TAG WG prepares the U.S. position for WG 3 issues, recommends future work items, and considers proposals from other national bodies.

“With Steve Brown’s leadership of the WG, and the active participation of our TAG members, the U.S. has the ability to help set the pace of nanotechnology standardization for health, safety, and the environment,” said Dr. Locascio. “Developing standards in this area will have a powerful impact on our ability to move this technology platform forward in a responsible manner.”

Participation in the U.S. ISO/TC 229 TAG Working Group is open to all nationally interested stakeholders, and the TAG actively seeks participants who have expert knowledge in all aspects of nanotechnology as it relates to health, safety, and the environment. To join the U.S. TAG for ISO/TC 229 or any of its WGs, contact Heather Benko (hbenko@ansi.org; 212.642.4912).

For more information on the U.S. TAG for ISO/TC 229, visit www.ansi.org/iscotc229tag.

Stay Tuned: The next article in this series will introduce ISO/TC 229/WG 1, Terminology and nomenclature.

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Nanotechnology Law Report -- June 2008

Posted on July 3, 2008 by John C. Monica, Jr.
Nanotechnology Law Report -- June 2008
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Setting Global Standards for Nanotechnology

Posted on June 23, 2008 by John C. Monica, Jr.

This Article Was Authored and Contributed by the American National Standards Intititute

As the nanotechnology industry evolves, the need for globally relevant standards – from particle properties and terminology to health, safety, and the environment – is becoming increasingly apparent. This article, the first in a series, introduces how the U.S. is influencing nano-related standards on the international scene.

The burgeoning nanotechnology industry has created a critical need for standards to support the cross-border trade of nano-related goods and services while also protecting the environment and the health and safety of consumers. These standards can only be set if there is active engagement by the same individuals and organizations that are working to advance the technology. Stakeholder insights and knowledge help to identify the priorities for standard-setting that will impact the widespread commercialization of nanotechnology and its influence in areas ranging from medicine to energy conservation.

The Building Blocks: Cross-Sector Coordination

In 2004, the American National Standards Institute (ANSI) formed its Nanotechnology Standards Panel (ANSI-NSP) in direct response to a request from the Office of Science and Technology Policy in the Executive Office of the President of the United States. This group serves as a cross-sector coordinating body that facilitates the development of standards in the area of nanotechnology. The Panel does not itself develop standards; rather, ANSI-NSP works with other national, regional, and international standards bodies, as well as industry, academic, and government stakeholders, to establish work plans, harmonize efforts, and mitigate duplication or overlap.

By soliciting participation from nanotechnology-related sectors and academia that have not traditionally participated in the voluntary standards system, the Panel provides opportunities for experts to identify and shape the specific needs to be addressed.

The next advancements came in 2005 and 2006, respectively, when the International Organization for Standardization (ISO) and the International Electrotechnical Commission (IEC) each formed Technical Committees (TCs) to create and promote the implementation of nanotechnology standards. As the official U.S. national body to ISO and, via the U.S. National Committee, the IEC, ANSI offers U.S. stakeholders a voice on the global stage.

IEC’s TC 113, Nanotechnology standardization for electrical and electronic products and systems, focuses on relevant nanotechnological aspects in developing generic standards for electrical and electronic products and systems. This includes electronics, optics, magnetics and electromagnetics, electroacoustics, multimedia, telecommunication, and energy production. Dr. Thomas Chapin of Underwriters Laboratories represents the U.S. as chairman of TC 113, and the USNC-approved U.S. Technical Advisory Group (TAG) to TC 113 is administered by the National Electrical Manufacturers Association (NEMA).

A TAG develops national input on technical issues, submitting contributions on behalf of its constituents and responding to the contributions of other nations. Accordingly, delegations comprised of TAG members present these positions to ISO, where consensus agreements are reached.

Every member of a TAG has an equal voice, from industry giants to smaller organizations and institutions that focus specifically on the development of nanoscale materials.

Working with a broader perspective, ISO’s TC 229, Nanotechnologies, develops standards that support the nanotechnology industry, specifically in the areas of terminology, nomenclature, measurement, and instrumentation. The Committee’s scope of work also includes specifications for reference materials, test terminologies, modeling and simulation, and science-based health, safety, and environmental practices. Nearly thirty nations participate actively in the TC; nine additional countries monitor the work of the TC as observers.

The TC’s technical activities are divided among four Working Groups* (WGs):

WG 1, Terminology and nomenclature;

WG 2, Measurement and characterization;

WG 3, Health, Safety and Environment; and

WG 4, Material specifications.

TC 229/WG 3, which deals with the development of science-based standards in the areas of health, safety, and environmental aspects of nanotechnologies, is convened by Steven Brown of Intel Corporation.

Across the board, the United States participates actively in the work of ISO/TC 229 and its subsidiary bodies.

National input is developed by U.S. TAG to ISO/TC 229, a group that is accredited and administered by ANSI. Working primarily via correspondence or meeting in-person as needed, the TAG reviews documents and position statements from other countries and formulates U.S. positions for consideration at meetings of ISO/TC 229 and its WGs. The TAG also provides information about ISO’s standards development activities to the U.S. nanotechnology community, including stakeholders from the industry, government, academic, and standards and conformity assessment communities.

Call for Participation

Through the work of ANSI-NSP, participation in IEC TC 113 and ISO/TC 229 – via the respective U.S. TAGs – and leadership of the TC 229 WG on health, safety, and environmental aspects of nanotechnology, the U.S. is influencing how nanotechnology standards will shape the future of multiple industries across the world.

Interested parties are encouraged to join these efforts and participate actively in the groups of interest:

-- For more information on ANSI-NSP, visit www.ansi.org/nsp.
-- For more information on the U.S. TAG for ISO/TC 229, visit www.ansi.org/iscotc229tag.
-- To participate in ANSI-NSP or join the U.S. TAG for ISO/TC 229, please contact Heather Benko 212.642.4912, hbenko@ansi.org).


*The work of ISO/TC 229 and its WGs will be explained in more detail during this series.

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ANSI to Publish New Series in NanoLawReport

Posted on June 16, 2008 by John C. Monica, Jr.
The American National Standards Institute (ANSI) is at the cutting edge of nanotechnology standardization and nomenclature development.  ANSI has graciously agreed to publish a 4-5 part series on their efforts in this regard -- as well as their work with/through the International Organization for Standardization (ISO) -- in Nanotechnology Law Report starting in our upcoming June edition.  We are pleased to have ANSI's participation which should be an effective way to increase our readers' awareness and participation in the standardization process.   We encourage readers to check back regularly for ANSI updates.
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Unraveling Nanotechnology Standards

Posted on May 19, 2008 by Michael E. Heintz
One of my "go to" nano news sources, Nanowerk, posted an interesting story last week concerning the competing standards that are emerging with regards to the technical side of nanotechnology.  The article outlines the various scientific standards that are developing, and the lack of any one overarching, or governing, standard.

The author, Michael Berger, lists the following five problems with regards to a lack of consistent nanotechnology standardization:

  • "no internationally agreed terminology/definitions for nanotechnology
  • no internationally agreed protocols for toxicity testing of nanoparticles
  • no standardized protocols for evaluating environmental impact of nanoparticles
  • no standardized measurement techniques and instruments
  • no standardized calibration procedures and certified references materials"

In addition, there are no fewer than seven organizations with competing nanotechnology standards statements, including ASTM, ANSI, IEEE, and ISO--all well respected organizations.  In addition, the nanotechnology standards debate has been going since at least December of 2003.

Well, this got me to thinking.  In an instance of life imitating life, the competing technical standards for nanotechnology closely resembles the diverging regulatory standards that are developing (oh, c'mon, you knew where I was going with this didn't you?).

For example, take a look at the three state statutes concerning the definition of "nanotechnology."  Each of Michigan, Arkansas, and Oklahoma have enacted binding, statewide laws concerning what defines nanotechnology:

  • Arkansas, A.C.A. §15-4-2103(5): “Materials and systems whose structures and components exhibit novel and significantly improved physical, chemical, and biological properties, phenomena, and processes due to their nanoscale size;"
  • Oklahoma, 74 Okl St. Ann. §5060.4(12): “‘Technology developed at the molecular range (1 nm to 100 nm) to create and use structures, devices, and systems that have novel properties because of their small size;"
  • Michigan, M.C.L.A. 206.30 -125.2088a: “Materials, devices, or systems at the atomic, molecular, or macromolecular level with a scale measured in nanometers;"

Now, take a look at the bold sections.  All three of these statements concerning the size of nanotechnology have slightly different meanings.  In fact, only one, Oklahoma, actually defines nanotechnology as existing between 1-100 nanometers.  While this may not seem to be an overly important consideration now, imagine what these further regulations in these states will look like with diverging bases.  Add to these emerging state statutes the previously discussed Berkeley standards, and the forthcoming Cambridge standards, and a very murky picture begins to develop indeed. 

While I am not suggesting that there should be one, all-inclusive set of regulatory standards for nanotechnology, I am suggesting that we need to be mindful of these diverging paths and strive to reduce uncertainty and confusion by the regulated community as these standards develop.  Just like consistent technical standards will provide certainty to the scientific community, developing regulatory standards with an eye towards consistency will provide certainty for the regulated community.
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