Nanotechnology Lawyer & Attorney : Porter Wright Morris & Arthur : Nanotechnology Law Report - Germanium nanobead image provided by UT-Battelle, which manages Oak Ridge National Laboratory for the Department of Energy

A couple of news items to catch up on following the holidays that may be of interest to people.

First, the Occupational Safety & Health Administration (OSHA), has launched a dedicated website containing information such as: OSHA's definition of nanotechnology, the applicable OSHA standards, and workplace health effects related to nanotechnology.  Worth adding to your "bookmarks."

Second, the International Standards Organization (ISO) released ISO/TR 12885:2008, "Health and safety practices in occupational settings relevant to nanotechnologies."  The report addresses, "health and safety practices in occupational settings relevant to nanotechnologies."  The abstract further describes the report as follows: "ISO/TR 12885:2008 focuses on the occupational manufacture and use of engineered nanomaterials. It does not address health and safety issues or practices associated with nanomaterials generated by natural processes, hot processes and other standard operations which unintentionally generate nanomaterials, or potential consumer exposures or uses, though some of the information in ISO/TR 12885:2008 might be relevant to those areas.

Use of the information in ISO/TR 12885:2008 could help companies, researchers, workers and other people to prevent adverse health and safety consequences during the production, handling, use and disposal of manufactured nanomaterials. This advice is broadly applicable across a range of nanomaterials and applications."

Now that we are through the winter holidays and New Year (and a happy new year to you!), we expect the nano-related news and events to begin picking up soon.  Here's to whatever 2009 may hold!

• Email This
• Print
• Comments
• Trackbacks

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.
 

• Email This
• Print
• Comments
• Trackbacks

Nanowerk is reporting that the International Standards Organization (ISO) completed its first step in developing standards for nanotechnology regulation.  The definitions are revealed in ISO/TS 27687:2008, Nanotechnologies – Terminology.  

The three main materials covered by this first set of definitions and terminology are: 

• Email This
• Print
• Comments
• Trackbacks

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.

• Email This
• Print
• Comments
• Trackbacks

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.

• Email This
• Print
• Comments
• Trackbacks