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

California's Department of Toxic Substances Control (CDTSC) held a conference today during which they identified the next six nanoscale materials they intend to target in their second round of data call ins.  Regular readers may remember that CDTSC targeted 26 manufacturers/importers of carbon nanotubes with its first data call in in 2009. 

In addition to identifying the nanoscale materials which will be the subject of the data call in, CDTSC also provided a preliminary list of manufacturers/importers that will receive the data call in, as well as the proposed questions they will be asked.  We cover each material below.

CDTSC also indicated that carbon nanotube manufacturers/importers will receive a second round of data call in questions. 

CDTSC plans to issue all of these new data call ins sometime before the end of the year.  Stay tuned . . .

Nano Silver

Proposed Questions:  What is the chemical composition of your nanosilver material? What is particle size of your nanosilver material used? What is the concentration of nanosilver used in your material? What are the instrumental techniques used to characterize your nanosilver material?What are the analytical methods used in your nanosilver material? How do you measure and monitor fate and transport after useful life of your nanosilver material? How do you detect, measure and monitor releases during facility operations?

Preliminary Recipients:  Nano Composix, Cambrios Technologies, Seashell Technology, Sun Innovations, Stanford Materials, MTI Corporation.

Nano Zero Valent Iron

Proposed Questions:  What are the analytical methods for assessment of toxic effects and safe uses of nano zero valent iron across its lifecycle? How do you sample, measure, and monitor quality? Performance? How do you detect, measure, and monitor releases from facility operations? How do you measure and monitor fate and transport after useful life?

Preliminary Recipients:  American Elements, AMEC Geomatrix, hepure Technologies, OnMaterials, Quantum Sphere, Stanford Materials, Sun Innovations.

Nano Titanium Dioxide

Proposed Questions: What machines and methods do you use to analyze your materials? What are the properties of your materials? After modification? What types of monitoring program are you using in your work place? In air? In water? What is the toxicity when your material is directly contacted with human skin? What is the weathering, liberation rate of your material into the environment? Impacts? What is you actual production amount this year?

Preliminary Recipients:  DuPont, BASF, Evonik, Ishihara, Altair nano, Huntsman, Kronos, Kemira, Kon Corp., Tronox, Nanocompsix, Nano-oxide, Green millenium, MK nano, Advanced Nano, NanoCo, Pilkington.

Nano Zinc Oxide

Proposed Questions:  Describe .specifically the nanostructure, functionalities, and properties (physical, chemical, and biological) of nano zinc oxide material that is produced in the facility.  Describe the in-house instrument and analytical methods you use to determin the presence of nano zinc oxide in the workplace and environment. Describe the chemical information provided by external vendors relative to nano zinc oxide nanostructure, functionalities, and properties.  Describe the instrumentation and analytical methods used by external laboratories that provided the above chemical information.

Preliminary Recipients:  UC San Diego, UC Berkeley, USC, Ferity Zinc Oxide Inc., APF Laboratories, Atomate Corporation, Stanford Materials, Alpha Enivornmental, Nanophase technologies, Sokang nano, Antaria Corporation, Ocean Nano Tech, LaamScience, Advanced nanotechnology, NanoGate, Inframat Advanced Materials, Reade Advanced Materials, KIA, Nanjing Hi Tech Nano Material Co., ltd., Nanozinc Oxide South Africa, NanoMaterials Technology, UmiCore Group, Horsehead Corporation.

Nano Cerium Oxide

Proposed Questions:  What machines and methods do you use to analyze your materials?  What are the properties of your materials? After modification? What types of monitoring program are you using in your work place? In air? In water? Do you know reactions when your material is released into aquatic environment? Do you know reactions when your material is released into air? What is you actual production amount this year?

Preliminary Recipients:  Saint-Gobain, Evonik, Meliorum Tech., Inframat Advanced materials, Antaria, HEFA Rare Earth Canada, Nanocerox, Nyacol, Energenics, MTI Corporation.

Quantum Dots

Proposed Questions:  What are the chemical compositions (purity, concentration, and chemical make-up) of your product's core and shell structures (including organic and inorganic attachments)? Specify its size, hydrodynamic diameter (HD), and surface area.  What analytical detection methods do you use to determine its presence in the workplace and environment? What are the surface properties (surface reactivity, groups, charge) and solubility in water and other solvents? What is the stability of your product in different environments (variable pH, temp, pressure, O2, UV light, water, etc.)? Does it aggregate in aquatic media?

Preliminary Recipients:  Nanosys/QD Soleil, Bloo Solar, Life Technologies, Stio, Quantum Dot Corporation, Chemicon International, Zymera, Invisage Technologies, University of California schools, Intelligent Optical Systems, Kovlo, NanoGram, Philips Lumileds Lighting Co., Toshiba America Electronics Components, Samsung Semiconductor, SEMI, Ultratech, Shrink Nanotechnologies.

 

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Nanotechnology Law & Business just published its new edition.  For those who might be interested, Volume 6.2 contains an article I co-authored with several nano-friends entitled: "Nano Risk Governance: Current Developments and Future Perspectives."  You can find the article here.  An abstract follows.

As with many new technologies, developing a framework for making risk management decisions for nanotechnology is a challenge. Risk assessment has been proposed as the foundation for many regulatory frameworks for nanomaterials. Although the traditional risk assessment paradigm successfully used by the scientific community since the early 1980s may be generally applicable, its application to nanotechnology requires a significant information base. The authors’ experience supporting federal agencies in the United States, Canada, and the European Union—as well as state agencies in Massachusetts and New York and cities such as Berkeley and Cambridge—suggests that nanomaterial regulatory frameworks could be built upon existing regulatory approaches with the addition of a more rigorous and transparent method for integrating technical information and expert judgment. The authors argue that the current focus on studying the amount of risk acceptable for a specific technology or material should be shifted toward comparative assessment of available alternatives, and the use of science and policy to identify alternative nanotechnologies and opportunities for risk reduction and innovation. This approach involves the use of both quantitative and qualitative decision analysis tools, offering roadmaps for assessing different information sources and making policy decisions. Two representative methods presented are the Alternatives Assessment method and the Multi-Criteria Decision Analysis method.

Igor Linkov, U.S. Army
F. Kyle Satterstrom, Harvard University
John C. Monica Jr., Porter Wright Morris & Arthur LLP
Steffen Foss Hansen, Technical University of Denmark
Thomas A. Davis, University of Montreal

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"How have Canada and other jurisdictions reacted to the recent emergence of nanotechnology-based products in the marketplace (and what is the current state of affairs)?"

That was the question that the Carlton University Regulatory Governance Initiative posed. To answer it, Jennifer Pelley and Marc Saner produced "International Approaches to the Regulatory Governance of Nanotechnology", which examines how Canada, the United States, the United Kingdom, the EU, and Australia, arrived at their regulatory policies affecting nanotechnology, summarizing the policy papers that informed those decisions, and looking at the external pressures on those governments from industry, unions, consumers, etc.

The report makes for very dry reading, but its a good reference source and worth reading. Just make sure you have a large cup of strong coffee nearby.

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Nanotechnology Law Report -- Spring 2009

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Updating yesterday's information that Canada anticipates enacting national regulation concerning the reporting and tracking of nanomaterials, there is some additional confirmation.  CBC News is similarly reporting that Environment Canada anticipates enacting a national reporting regulation next month.  While Environment Canada is not commenting directly on the news, CBC states, "Department officials said the plan is to send out a notice that requires companies and institutions that used more than one kilogram of nanomaterials in 2008 to provide information to the government."  The release also indicates that Environment Canada has been "negotiating with private industry" for over year concerning nanotechnology regulation in Canada.

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The Project on Emerging Nanotechnologies, via Nanowerk, is reporting that Canada will announce, in February, that it will release a national regulation aimed at requiring the submission of the "use of engineered nanomaterials" by manufacturers and users.  "The information gathered under the requirement will be used to evaluate the risks of engineered nanomaterials and will help to develop appropriate safety measures to protect human health and the environment."  No further information is available concerning the nature of the regulation, the eventual scope, release date, and no statement is readily available directly from Environment Canada.

However, this announcement does follow on the heels of both US EPA's interim report on the Nanoscale Materials Stewardship Program, and the 2007 announcement by Environment Canada concerning nanomaterials' treatment under Canada's New Substance Program.

Should Canada release a national regulation concerning the tracking and reporting of nanomaterials for use by the government in developing additional health and safety regulations, that will be a significant step (perhaps more than a step?) towards the full regulation of nanomaterials.  To this point, only isolated state and local governments have made binding regulations with regard to nanotechnologies, while all national governments have remained aware, but mostly disengaged on the question of regulation.  Case in point, Canada, the United States, and the United Kingdom have all studied nanomaterials, or sought voluntary data submission, but none have regulated nanotechnology coast-to-coast.  This could be the first signal that national governments are becoming more comfortable with nanotechnology and believe they can begin putting reasonable requirements in place.  Or, this could signal that national governments are beginning to crack under increased calls for action and are putting requirements in place in order to answer the growing list of critics.  Without knowing the details of Canada's plan, we won't know for sure until its ultimate release and effective date.  February starts next week, so we should know soon enough.

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