Category: Government standards

nano 3The National Nanotechnology Initiative (NNI) recently held a Stakeholder Workshop for the purpose of assessing and strategizing in anticipation of the next version of the NNI Strategic Plan, a draft of which is due in late 2013 or early 2014.  Stakeholders from industry, government, and academia attended the workshop.  Participants considered questions related to technical challenges; commercial nanotechnology; environmental, health, and safety considerations; infrastructure needs; and ethical, legal, and societal implications of nanotechnology.

On the subject of environmental, health, and safety considerations, one report from the workshop indicated that NIOSH officials have recommended folding these matters into the other goals, rather than maintaining a separate approach.  The officials noted that of the $1.65 billion in federal funding allocated in FY2013 for nanotechnology research and development, environmental, health, and safety initiatives constituted only 7.6% of those funds.

Some of the other issues addressed, according to the report were:

1.  Improving communication among researchers.

2.  Balancing availability of research with confidentiality of proprietary information.

3.  Developing a common dose metric for research.

This news report may be found by subscription at:

Robert Iafolla, Include Safety, Environmental Concerns in Strategic Plan, Nano Researcher Say, 115 BNA Daily Env’t Rep. A-8 (June 14, 2013), available at

http://www.bloomberglaw.com/document/XE9G8OHO000000?campaign=bnaemaillink&issue=20130614&jcsearch=bna%2520a0d9h7q4n9&js=0&sitename=bna&subscriptiontype=bnaden#jcite

 

Whatever steps may be necessary to ensure that environmental, health, and safety concerns are at the forefront of the discussion about nanotechnology should be made a priority.

 

A detailed presentation of the Questions for Stakeholders for discussion at the 2013 NNI Strategic Planning Stakeholder Workshop, with further links, may be found at:

http://nano.gov/sites/default/files/questions_for_stakeholders_final_numbered.pdf

Many of the posts on this blog have addressed the regulation dilemma of whether to incorporate nanomaterials into the existing regulatory framework or develop separate regulations to manage their potential hazards.  This same dilemma is playing out in a slightly different way through a public-private partnership on exposures to carbon nanotubes in consumer products.

The NanoRelease project is engaged in this effort, with the support of numerous organizations, including U.S. EPA, Environment Canada, HealthCanada, and the American Chemistry Council.  Undertaken by the Government of Canada, the project has selected multi-walled carbon nanotubes in polymer to begin its study of the nature of exposures to nanomaterials.  The study includes determining likely release scenarios, evaluating release measurements, and considering needs for laboratory testing.  The research foundation has stated:  “The NanoRelease project will foster the safe development of nanomaterials by supporting development of methods to understand the release of nanomaterials used in products.”  Among other things, the group pledges to develop a “state of the science” report.

A summary of the project is available at

www.ilsi.org/ResearchFoundation/Documents/NR%20Orientation%20Powerpoint%20Presentation.pdf

Both the National Institute of Occupational Safety and Health (NIOSH) and the Consumer Product Safety Commission (CPSC) are very interested in the ongoing process.  But will the ultimate result be “consensus standards” for nanomaterials that are efficient and effective?  Will consensus standards be followed by industry without a direct mandate?

Bloomberg BNA’s Daily Environment Reporter quoted John Howard, the director of NIOSH, as saying:  “We want to make sure that if we are developing consensus standards . . . that people are reading them and that people are adhering to them.  Otherwise heavy-handed government regulation – that industry always objects to – will come into fore and then we’ll have a less effective control system, a less efficient risk management system.”  (quoted in Pat Rizzuto, Regulators, Industry Sorting Through Potential Exposures to Carbon Nanotubes, 122 Daily Env’t Rep. (BNA) A-9 (June 26, 2012) (by subscription))

Will industry and governments agree on standards?  If so, some measure of regulation will be necessary, but probably not the “heavy-handed” sort that concerned Dr. Howard.  Consensus standards can be incorporated into existing regulatory regimes, perhaps rendering unnecessary separate extensive regulation for nanomaterials.  But essentially we are circling the same issue over and over again:  Is it possible to avoid separate, independent, and perhaps “heavy-handed” regulation of nanomaterials in the interest of public health and safety?  No question that it is an important issue.  And it remains unanswered.

imagesThe National Institute of Standards and Technology (NIST) has issued what is being touted as the world’s first reference material for single-wall carbon nanotube soot.  In its statement, NIST calls single-wall carbon nanotubes (SWCNT) “perhaps the archetype of all nanoscale materials.”  The promise of SWCNT in industrial use is great (NIST chemical engineer Jeffrey Fagan stated that “full development of these materials should enable lighter, stronger materials, as well as improve many technologies from sensors to electronics and batteries”).  But as with most things, there’s a catch.

Production of SWCNT involves a complex process that is known for inconsistent quality, variability from batch to batch, and significant resulting impurities.  NIST has sought to provide the first standardized guidelines – both chemical and metric – to the production of nanotubes, through the publication of its Standard Reference Material SRM 2483 – Single-Wall Carbon Nanotubes (Raw Soot) on December 20, 2011.  The purpose of the SRM is to provide industrial developers and producers with a means to evaluate chemical and instrumental methods of analysis of carbon nanotubes with the goal of improving quality and consistency across the board.

Of special interest to me is the Material Safety Data Sheet (MSDS) for SWCNT raw soot, which was simultaneously issued by NIST.  The MSDS reveals that little is known about the potential hazards of this substance in the workplace setting.  The MSDS contains the following statement regarding single-wall carbon nanotubes raw soot:

“According to NIOSH, currently there are no studies reported in the literature of adverse health effects in workers producing or using carbon nanotubes or carbon nanofibers.  The concern about worker exposure to these materials arises from results of animal studies.  Several studies in rodents have shown an equal or greater potency of carbon nanotubes compared to other inhaled particles known to be hazardous to exposed workers (ultrafine carbon black, crystalline silica, and asbestos) in causing adverse lung effects including pulmonary inflammation and fibrosis.”

Did the word “asbestos” jump off the page?  And just because this substance is not listed as a potential carcinogen in the National Toxicology Program (NTP) Report on Carcinogens, the International Agency for Research on Cancer (IARC) Monographs, or by OSHA does not mean that it doesn’t pose a significant health risk to workers.  Pulmonary fibrosis, in the form of asbestosis and silicosis, has been a major public health problem for decades and a legal problem of immeasurable proportions.

Furthermore, the MSDS states, under Toxicology Information, that “[a]nimal in vitro cell studies have shown that SWCNT can cause genotoxicity and abnormal chromosome number due to interference with mitosis.”  But the research has not yet demonstrated any effects in the animals other than the observed impact, perhaps because the technology is so new and the research in its infancy.

Under Ecotoxicity Data, the MSDS states, “No data available.”

Clearly, there is an urgent need for more study of the potential health hazards of SWCNT, both acute and chronic.  So while the Standard Reference Material is a giant step toward consistency of standards, the MSDS reveals that it is only a baby step in the larger scheme of things.  Much research needs to be done on the impact of these new technologies on workers and ultimately on consumers and the environment.

The NIST statement, with image, is available at

http://www.nist.gov/mml/polymers/cnt-122011.cfm

The Standard Reference Material is available at

https://www-s.nist.gov/srmors/view_detail.cfm?srm=2483

The MSDS, with sources, is available through a link from the Standard Reference Material page immediately above.