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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.

The Nanowerk article mentions programs in Europe that have the affect of monitoring or preventing pollution, such as self-cleaning paints and "anti-fouling" coatings.  Further, there are at least four sites in the United States, and an at least two in Canada, using nanomaterials on an experimental basis to test groundwater remediation. 

These kinds of advances in environmental protection and remediation should not be lost in the discussion over the possible impacts of nanotechnology.  It is important to keep in mind that while there is potential for unintended impacts, nanotechnology can have many uses, including maintaining and supporting environmental health.

 Exposure studies lag being hazard studies. Evaluating nanomaterials is difficult because they are extremely diverse; a limitless capacity to create such materials leads to no overarching framework of potential hazards. So far analytical tools are poorly developed for understanding risk so beware of over generalizing nanomaterial behavior, either good or bad. Current barriers to understanding risk include (1) lack of strategic research, (2) lack of standards, (3) uncertain regulatory environment, (4) transparency and responsiveness of public concerns, and (5) lack of sufficient funding. However, the International Council on Nanotechnology is developing a database of technical material and is releasing a survey of how firms handle nanomaterials on Nov. 13 (will be available on their website). Predictions for 2007: increased pressure on regulatory agencies to understand how nanotechnology fits into existing statutes and regs, increased call for labeling of consumer products, development of the research framework for evaluating risk, new standards for workplace handling, and better evaluation of potential risks.

Balbus agreed with much of what Kulinowski's comments. Nanomaterials hold great promise as solutions to energy and health issues so the challenge is to achieve the benefits without repeating past mistakes re risk. For the discussion of potential risks, analogize to combustion particles, fine and ultra fine, because we know about their serious health effects. Particles can get through physiological barriers so enter the blood system and be taken up into cells by different mechanisms. They also can pick up unwanted other toxic materials and so deliver secondary particles. We are at early stages in understanding risk; the approach so far has been to analogize to larger particles, hypothesize using computer models, and conduct actual studies. Some studies have been reassuring but others had surprising results such as the evidence of direct stimulatory effect on cells and increased water solubility. We also have gaps in our understanding of bioaccumulation: do these materials accumulate in the body or are they secreted? Are they mobile in the environment or do they breakdown? How interact with critical cells and molecules? What are their structural activity relationships (i.e. how surface characteristics relate to toxicity? What about chronic toxicity? Difficult to make strong conclusions about toxicity of nanoparticles at this time. Reasons for a gaps in understanding: (1) infinite variation, (2) expensive to get enough material for long-term studies, (3) need instruments to detect and measure, and (4) materials tend to clump together so hard to recreate actual exposure situations. Need to develop a risk management framework. Existing regulatory coverage uncertain so companies are doing more to avoid liability than to meet existing regs; a document will be released in 2007 on Dupont's attempts to manage risk. Need more investment to research risk, need transparency in research, and need proactive stance by regulatory agencies.

Points made during question and answer. Concerns over lack of standards or guidelines for labeling consumer products. Concerns over the harmonization of international efforts over terminology and nomenclature, and standards for handling. Not sure how the REACH regime in Europe will apply to nanotechnology. Two efforts at voluntary standards: ASTM document out soon (protocol for minimizing exposure) and ISO document out later. Top research priorities: instrumentation and monitoring equipment, bioaccumulation and transport, and exposure to consumers and the environment.