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

Here is the Summer 2010 edition of NanoLawReport.  Heading out to the beach for a few days to top off the summer.  :)

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This article originally appeared on the National Nanomanufacturing Network's InterNano website on August 25, 2010.  It is licensed under Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Unported.

Massachusetts’ Office of Technical Assistance and Technology (OTA) recently released its “OTA Technology Guidance Document: Nanotechnology - Considerations for Safe Development” which has been in development for the past couple of years. The document begins by noting the tremendous positive influence nanotechnology is predicted to have in the fields of biomedical devices, electronics, clean energy, and materials engineering, while at the same time acknowledging that “there are indications of potential harm from certain exposures and release of engineered nanoparticles.” OTA also believes that there “is little uncertainty” regarding available means to prevent potential workplace exposure to nanoscale materials. Simply put, despite unknown EHS risks, there is more than adequate knowledge to control potential exposure in OTA’s view.

The end of the report contains a bibliography of existing resources covering state-of-the-art workplace good practices for nanoscale materials. The bibliography includes the “usual suspect” documents and websites published by NIOSH, ICON, German government, British Standards Institute, ED/DuPont, NanoSafe, and ASTM. From these primary sources, OTA distills a basic set of good practices for entities working with nanoscale materials in Massachusetts.

First, establish a risk reduction plan for facilities working with nanoscale materials. Such a plan should have two levels. First, it should attempt to protect against direct and immediate worker exposure. Second, it should also attempt to protect against possible releases during transport, use, and disposal after the nanoscale materials leave the manufacturing facility.

Second, evaluate potential worker exposure to nanoscale materials during the manufacturing process and then implement a hierarchy of exposure controls, including: substituting source materials with non-nano substances where appropriate, implementing engineering controls, using administrative controls, and requiring the use of personal protective equipment. This is all standard NIOSH-fare drawn from NIOSH’s excellent “Approaches to Safe Nanotechnology: Managing the Risks and Safety Concerns Associated with Engineered Nanoparticles.” OTA’s guidance document, however, does a good job of drawing out the most important “nuggets” of information from the NIOSH document in a few short pages.

Third, analyze whether unintentional release of nanoscale materials may occur with consumer use or disposal of the product. Along these lines, OTA recommends companies consider: labeling products as already suggested by BSI and the EU, warning potentially affected downstream users and others regarding potential EHS risks through the use of the Material Safety Data Sheets and other written warnings, complying with existing environmental laws such as the Toxic Substances Control Act, conducting an open and transparent risk and hazard testing regime for the product throughout its complete lifecycle, and recognizing that proactive prevention of EHS concerns is required for successful commercialization of nanotechnology.

In the end, OTA’s document is a helpful quick reference guide, but it does not cover any new ground or delve deeply into its existing source material. Businesses involved in nanomanufacturing should still consult the underlying source material cited in the document, as well as EHS and legal experts as necessary. Massachusetts should be commended, however, for putting out this basic guidance document and attempting to proactively address these issues.
 

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The EPA recently released a draft of its "Nanomaterial Case Study: Nanoscale Silver in Disinfectant Spray" which you can download here.  The document is 323 pages long and has 6 chapters: (i) Introduction; (ii) Introduction to Silver and Nanoscale Silver; (iii) Life-Cycle Stages; (iv) Fate and Transport in Environmental Media; (v) Exposure, Uptake, and Dose; and (vi) Characterization of Effects.

In two chapters most pertinent to our readers, the document discusses the possible EHS ramifications of the manufacturing and use of nanoscale silver disinfectants over a wide-range of issues.  Regarding Life-Cycle Stages, the document covers five primary product stages: feedstocks; manufacturing; distribution and storage; use; and disposal.  Similarly, regarding fate and transport in the environment, the document discusses air, terrestrial, and aquatic systems and factors that effect transport and fate in each media.

Overall , the document appears to mirror the approach used in EPA's prior draft case study on nanoscale titanium dioxide used in drinking water systems and in sunscreens which was published in 2009. 

Written comments on the draft are due to EPA by September 27, 2010.

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Following California's lead, Wisconsin's legislature recently formed a special committee to study the potential regulation of nanomaterials from an environmental, health, and safety perspective.   Our readers will be interested in the committee's membership and focus:

Special Committee on Nanotechnology
Chair: Rep. Chuck Benedict
Vice Chair: Sen. Mark Miller
Legislative Council Staff: Mary Matthias, Pam Shannon, and Larry Konopacki
Member List

The Special Committee is directed to examine the human health and environmental concerns related to the manufacture, use, and disposal of nanomaterials and develop legislation to address these concerns. In particular, the Special Committee shall consider the establishment of methods to monitor nanomaterials by use of a nanotechnology registry system or the imposition of other disclosure requirements. The Special Committee shall also develop strategies to facilitate the development of nanotechnology to create and retain jobs in Wisconsin, including ways in which government can help nanotechnology researchers, small firms, and start-ups address potential risks and meet regulatory requirements.
 

You can find prior articles about Wisconsin's prior efforts here and here.  The committee's first meeting appears to be scheduled for September 2010.

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Here is a bit of shameless self-promotion.  The 2010 edition of my book -- "Nanotechnology Law" -- has just been published by West/Thomson/Reuters.  You can find it here.  Please pass the word.

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On July 20, 2010, David Hwang of Lux Research gave a webinar entitled: "Lux Research Nanomaterials: The Rise of MWNTs: Oversupply Hides Real Opportunities."

Mr. Hwang’s presentation identified the top global producers of multi-walled carbon nanotubes (MWCNTs), explained why commercialization over the past 25 years has been relatively "anemic," and made some predictions for where the market is heading in the next decade. He explained that while total sales of MWCNTs were under $100 million for 2008, the market is predicted to grow to approximately 2389 tons by 2020.

Two major forces slowing past commercialization included (i) a "you first" mentality by which companies wanted to see others take the first successful steps towards commercialization before they joined the trend, and (ii) regulatory risks inherent in the development of any new technology -- a commercialization bottleneck related to the potential environmental, health, and safety (EHS) impacts of certain carbon nanotubes.  (Regular readers will note that this is a recurring theme in our articles).

Mr. Hwang further explained that he believes the market for MWCNTs is currently in a transition phase, and that an oversupply will exist until 2017.  He commented that total sales in 2009 equaled $75 million and would increase to $513 million by 2020.   Mr. Hwang then covered four specific markets that are leading the commercialization for MWCNTs and provided 2009 versus 2020 material usage estimates:

Mr. Hwang closed with some further trends he saw forthcoming in the next decade which included market consolidation and a shakeout of smaller manufacturers, as well as a "crackdown" through EHS regulation of MWCNTs over the next two years.  Regarding the later point, he indicated that companies which proactively addressed EHS issues would have a competitive advantage over the long run.

You can find a link to the webinar here. 

http://bit.ly/dcrrHD.

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Public comments regarding California's Green Chemistry Draft Regulation for Safer Consumer Products were due last week.  My comment /letter on the nanotechnology provisions contained in the draft regulation is set forth below.  Additionally, you can find a copy of the draft regulation here.

July 15, 2010

Heather Jones, MS 22A
California Department of Toxic Substances Control
Office of Legislation & Regulatory Policy
P.O Box 806
Sacramento, CA 95812
Re: Comments regarding draft regulation: Safer Consumer Product Alternatives, Chapter 53 of Division 4.5 of Title 22, California Code of Regulations

Dear Ms. Jones:

Please accept this letter as my personal comments regarding the nanotechnology-related provisions of the above-referenced draft regulation. Many thanks in advance for your consideration of my brief thoughts.

As a general matter, I believe chemical regulations should be drafted to provide the State with all of the power it needs to effectively do its job without unfairly maligning any chemical substance, either directly or by implication. It is a delicate balance that this draft regulation obviously attempts to achieve. I hope that my specific comments further assist in this regard.

Definition of “Chemical:” I do not believe that Part 3 of the definition of “Chemical” on Page 5 of the draft regulation is necessary. As you know, that provision provides an alternative definition of “Chemical” as: “Materials or substances manufactured or engineered at the nanoscale, which contains nanostructures, or is considered to be a nanomaterial.” Simply put, the first two parts of the definition of “Chemical” in their current form are more than broad enough to capture all nanoscale chemical substances. There is no need to single them out in a separate provision. Doing so implies some type of special skepticism or worry which is not necessary to accomplish the purpose or objectives of the draft regulation.

Definition of “Importer:” The definition of “Importer” on Page 7 of the draft regulation should contain a phrase acknowledging that “Importers” are entities physically located or operating in California. Businesses located outside of the State which ship products into the State are covered by the definition of “Make available for use in California” on Page 8. This distinction is important because some out-of-state manufacturers/distributors of carbon nanotubes were considered “importers” under the CDTSC’s January 2009 carbon nanotube data call-in. This issue should be remedied in the proposed regulation.

Definitions of “Nanomaterial,” “Nanoscale,” and “Nanostructure”: The definitions of these three terms on Page 8 of the draft regulation are only necessary if Part 3 of the definition of “Chemical” on Page 5 is retained. Consistent with my above recommendation, I respectfully suggest that they be eliminated along with Part 3 of the definition of “Chemical” which incorporates them by reference. However, in the event these terms are retained, the State should strongly consider changing the definition of “Nanoscale” to follow commonly accepted definitions used throughout the world which rely on a size range of 1 to 100 nanometers. Any deviation from this traditional definition should be thoroughly explained and justified by the State.

If the State is concerned that some companies might claim they are exempt from the regulation because the materials they manufacture are larger than 100 nm and thus are not truly “nanoscale,” the definitions of “Chemical” provided in Parts 1 and 2 on Page 5 are still broad enough to capture these companies’ materials. Additionally, the term “approximately” could be inserted in the definition of “Nanoscale” which would provide CDTSC the latitude it needs to review companies seeking to invoke any arbitrary size limitation. Further, the definitions of “Nanomaterial” and “Nanostructure” on Page 8 of the draft regulation could be amended to include materials made or sold by any company representing that it or its products are “nano,” or nanoenabled, etc. This would further prevent undue reliance on a technical size limitation.

Finally, the terms “nanomaterial,” “nanoscale,” and “nanostructure” are currently the subject of draft technical specifications being prepared by the International Organization for Standardization (ISO) which has 163 country participants. If technical definitions are included in California’s regulation, I believe ISO’s definitions are the best place to start. I am sure that ISO would be happy to provide the State with current drafts of the relevant technical specifications upon request.
Thank you again for taking the time to consider my thoughts. I would be happy to discuss the draft regulation with you or anyone else at any time.

Very truly yours,

John C. Monica, Jr.
JCM:alm
 

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This article originally appeared on the National Nanomanufacturing Network's InterNano website on July 20, 2010.  It is licensed under Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Unported.

On July 9, 2010, the U.S. Technical Advisory Group (TAG) to the International Organization for Standardization’s (ISO) Technical Committee 229 on Nanotechnologies presented a webinar requesting general public input regarding ISO’s draft technical specification (TS) entitled “Labeling of Manufactured Nano-Objects and Products Containing Manufactured Nano-Objects.” The U.S. TAG is accredited by the American National Standards Institute, the leading standards organization in the U.S. ISO has 163 members countries and its standards often become the de facto standard of care for certain industries.

The document discussed during the webinar is a draft technical specification developed jointly by ISO and the European Committee for Standardization. In general, a TS can be thought of as a guidance document which is one step down in authority from an actual standard. However, it may ultimately become a full-fledged standard in a few years if ISO and its members are so inclined. This particular draft TS will be voted on by ISO in late 2010, and any comments will be resolved in early-to-mid 2010. If passed, the draft TS will most likely take effect in late 2011.

The draft TS has four basic purposes: (i) encourage a standardized approach to nano-product labeling; (ii) ensure that companies in the nano supply chain can adequately identify manufactured nano-objects in products in order to make informed decisions regarding purchasing, distribution, handling, use, and disposal; (iii) standardize labeling use of the “nano” prefix and suffix where appropriate; and (iv) “provide guidance on the use of other specific terms in” nano-labeling.

The draft TS is limited to manufactured nano-objects and products containing such objects. Incidental and natural nano-objects are excluded from coverage, as are products containing manufactured nano-objects bound in a matrix which are not subject to release under reasonably foreseeable use or disposal scenarios.

Getting to the heart of the draft TS, the document recommends the use of the prefix or suffix “nano” when products either contain manufactured nano-objects or display nanoscale phenomena. Additionally, the draft TS suggests that products not containing nano-objects but displaying unique characteristics commonly associated with nanoscale materials should bear a negative label: “This product does not contain manufactured nano-objects.”

The draft TS also provides five suggested forms of nano-disclosure for use in the existing ingredient section of product labels:

• “a manufactured nanoscale form of X;”
• “0.1 g of nanoscale X;”
• “X, approximately size range P nm - Q nm, specific surface area R m2 g-1;”
• “a dispersion of manufactured nanoscale X in Y;” and/or
• “[nanoscale shape of] X, with an aspect ratio of 1:20.”

In addition to these suggested ingredient statements, the draft TS also asks manufacturers to consider including the following information in their nanoproduct labels: (i) whether the nano-objects are in free or unbound form; (ii) any special disposal needs; (iii) the source from which the nano-objects were derived; (iv) the intended function or purpose of the nano-objects in the product; (v) instructions for the safe opening of the nanoproduct package; and (vi) any necessary warnings regarding potential product instability.

Finally, the draft TS recommends that business-to-business nanoproduct labels contain sufficient information for the purposes of (i) unambiguous product identification; (ii) “employee training, batch control, and [explaining] contract conditions of purchase;” and (iii) assigning purchasers “responsibility for identification, safety, [and] production control systems.”

Unfortunately, the entire draft TS is not currently publicly available in written form. However, there is a 2007 document published by the British Standards Institute upon which the draft appears to be based. Although it is difficult to fully analyze the draft TS without having a copy in hand, anyone with comments regarding its general approach should e-mail the U.S. ISO Liaison Representative at: marrapese@khlaw.com
 

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On Friday, the United States Government Accountability Office issued its Report to the Chairman (Barbara Boxer) of the Committee on Environment and Public Works, US Senate, GAO-10-549:

Nanotechnology: Nanomaterials Are Widely used in Commerce, but EPA Faces Challenges in Regulating Risk.

Highlights from the report follow.  The report confirms speculation that EPA intends to issue certain new rules pertaining to select nanomaterials by the end of 2010.

Background

"EPA has taken a mulitpronged approach to understanding and regulating the risks of nanomaterials, including conducting further research and implementing a voluntary data collection program. Furthermore, under its existing statutory framework, EPA has regulated some nanomaterials but not others. Although the EPA is planning to issue additional regulations later this year, these changes have not yet gone into effect and products may be entering into the market without EPA review of all available information on their potential risk. Moreover, EPA faces challenges in effectively regulating nanomaterials that may be released in air, water, and waste because it lacks the technology to monitor and characterize these materials or the statutes include volume based regulatory thresholds that may be too high for effectively regulating the production and disposal of nanomaterials."

TSCA

"In the fall of 2009, EPA announced it would reconsider the policy described in its January 2008 document, TSCA Inventory Status of Nanoscale Substances -- General Approach, and subsequently announced it planned to develop a SNUR to regulate nanoscale versions of conventional scaled chemicals that are already on the TSCA inventory as a significant new use of that chemical. The agency intends to propose this rule in December 2010."

"TSCA also gives EPA authority to issue rules requiring companies to submit certain information about chemicals. EPA plans to issue one such rule for nanomaterials that would require manufacturers to provide information on production volume, methods of manufacture and processing, and exposure and release, as well as available health and safety studies. Evaluation of this information will provide EPA with an opportunity to consider appropriate action under TSCA to reduce unreasonable risks to human health or the environment, according to EPA. This rule may also help them collect information on nanomaterials not covered by the SNUR discussed above. EPA intends to propose this rule in December 2010."

"EPA officials told us they intend to propose a rule in December 2010 that would require companies to generate test data on the health effects of 15 to 20 different nanomaterials, including carbon nanotubes, nanoclays, and nano aluminum, and also on nanomaterials used in aerosol-applied products. This information will help EPA correlate the properties of these materials with specific health effects, manage or minimize risk and exposure, and help EPA determine the need for additional testing of these materials, according to EPA. EPA officials told us they will be working with the National Institute for Safety and Health Administration, and the Consumer Product Safety Commission on this effort."

FIFRA

"EPA officials told us that if a company replaces a conventionally sized active ingredient in a pesticide with a nanoscale version of that ingredient, it is mandatory for the company to amend its registration. Officials also noted, however, that the agency's position on this point needs to be made explicit to the regulated community and such a clarification could be made in EPA guidance. According to stakeholders, manufacturers of nanopesticides are required to obtain an amended registration in such a circumstance even without new EPA guidance explicitly requiring it since the registration requirement is based not only on questions of chemical identity, but also on claims made about the pesticide; its composition; and its chemistry, toxicology, and other information."

GAO's Recommendations

"We recommend that the Administrator of EPA, take the following three actions:

• Complete its plan to issue a Significant New Use rule for nanomaterials.
• Modify FIFRA pesticide registration guidelines to require applicants to identify nanomaterial ingredients in pesticides.
• Complete its plan to clarify that nanoscale ingredients in already registered pesticides, as well as in those products for which registration is being sought, are to be reported to EPA and that EPA will consider nanoscale ingredients to be new.

In addition, the Administrator of EPA should make greater use of the agency's authorities to gather information under existing environmental statutes. Specifically, EPA should

• complete its plan to use data gathering and testing authorities under TSCA to gather information on nanomaterials, including production volumes, methods of manufacture and processing, exposure and release, as well as available health and safety studies; and
• use information-gathering provisions of the Clean Water Act to collect information about potential discharges containing nanomaterials.

Finally, the Administrator of EPA should consider revising the Inventory Update under TSCA so that it will capture information on the production and use of nanomaterials and so that the agency will receive periodic updates on this material."

EPA's May 4, 2010 Response to GAO

Finally, attached as an exhibit to the report was a written response from EPA in which the agency largely agreed with all of GAO's recommendations. Regarding GAO's Clean Water Act recommendation, EPA stated that its Office of Research and Development is currently developing methods to detect nanomaterials in water and predict levels of concern. Once able to detect and measure nanomaterials in water, EPA will then consider whether reporting requirements should be amended.

We will continue to monitor these issues and provide timely updates to our readers.

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The NanoSafety Consortium for Carbon has recently posted a bibliography of in vivo tox studies on its website.  The bibliography is (obviously) a work in progress.  We would greatly appreciate it if our readers would bring to our attention any pertinent articles that are not already on the bibliography.  The articles will be used to inform and guide our attempt in crafting a representative toxicity testing regime with US EPA.  Many thanks in advance for your input.

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The Nano-Network and Wright State University are holding a joint conference on Multifunctional Nanomaterials: Cross-cutting Growth Opportunities in Energy, Environment and Aerospace Applications on May 24, 2010 at Wright State University in Dayton, Ohio.  

"The aim of this one-day networking event is to bring together leaders and sponsors from Ohio industry, AFRL, AFOSR and university faculty to discuss possible growth options and collaborative opportunities."

For more info. contact:

Ken Vaughan, Executive Director
Nano-Network
PolymerOhio Inc.
155 Commerce Park Drive, Suite 8
Westerville, Ohio 43082
Phone: (614) 776-5720
Email: kvaughan44@aol.com
URL: http://www.polymerohio.org/  
 

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Inside EPA reports today that a "senior policy adviser for EPA's Office of Pesticide Programs, said EPA would issue in June a long-awaited response to a 2008 activist petition asking the agency to regulate nanoscale silver under FIFRA."  The article also mentions that EPA intends to define nanoscale ingredients for FIFRA purposes as "an ingredient that contains particles that have been intentionally produced to have at least one dimension that measures between approximately 1 and 100 nanometers."

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This article originally appeared on the National Nanomanufacturing Network's InterNano website on April 30, 2010.  It is licensed under Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Unported.

The Program on Reproductive Health and the Environment (PRHE) at the University of California, San Francisco (UCSF) is part of the Department of Obstetrics, Gynecology & Reproductive Services located in UCSF’s School of Medicine. PRHE recently published its draft “A Nanotechnology Policy Framework: Policy Recommendations for Addressing Potential Health Risks from Nanomaterials in California.1” The draft nanotechnology policy framework will be presented to Cal/EPA’s Office of Environmental Health Hazard Assessment once finalized to “better inform . . . risk assessment recommendations for decision makers and risk managers.” It was designed to provide the State “with an overview of nanotechnology materials and their potential exposures and human health risks, and proposes a selection of policy options for addressing potential hazards and risks from nanotechnology.”

For those who might wonder about PRHE’s focus, its “mission is to create a healthier environment for human reproduction and development through advancing scientific inquiry, clinical care and health policies that prevent exposures to harmful chemicals in our environment.” While its draft nanotechnology policy framework briefly touches upon reproductive issues, it provides a more general approach to what its authors see as difficulties presented by the potential regulation of nanotechnology (or lack thereof) in California.

The draft nanotechnology policy framework was written by three PRHE staff members with the assistance of an eleven member scientific advisory panel. Only one business – DuPont – had a representative on the scientific advisory panel, and there were no representatives from the federal government (FDA, EPA, NIOSH or otherwise). In fact, federal efforts to deal with nano-related environmental, health, and safety issues are summarily dismissed: “In light of the NRC’s analysis that the federal government is inadequately prepared to deal with strategic nanotechnology risk research, and given the current changing field of chemicals policy in California, it is an appropriate time to consider new ways of regulation in the area of nanotechnology.”

The first three chapters of PRHE’s draft nanotechnology policy framework provide a general introduction to nanotechnology including an overview of some of the science regarding nano-material toxicology; potential for exposure and assessing the alleged risks of nanotechnology; and fate, transport, and transformation of nanoscale materials in the environment and biological systems. It also contains several “case studies” covering previous chemical substances which PRHE believes may have been mishandled, and thus could provide some insight to California regulators regarding how to address some of the uncertainties presented by certain nanoscale materials. The overview provided by these chapters is unbalanced and somewhat skewed, but the general themes have been covered in depth by several other organizations. At the very least, these chapters of the draft nanotechnology policy framework show that PRHE is truly attempting to understand these complex issues.

Fifteen Policy Recommendations

For our readers, the most interesting part of the draft nanotechnology policy framework will likely be its fifteen specific policy recommendations appearing in Chapter 4:

1. Develop a description of nanomaterials that can be used to identify them.
2. Identify and define priority properties which could be used in risk characterization and collect these properties for each nanomaterial, including: "traditional" risk assessment or hazard identification properties, such as molecular formula, density, solubility, vapor pressure, melting point, etc. as applicable; "unique” nanomaterial-specific properties, such as size, shape, surface functionality, charge, stability, and reactivity.
3. Develop characteristics by which to define, describe, and group nanomaterials according to conventional or unique properties.
4. Gather information regarding what types of nanomaterials are being manufactured and in what products they are being used.
5. Support a publicly accessible clearing house and inventory of products and sources of nanomaterials. Require disclosure of where nanomaterials are manufactured, in what quantities and for what new or existing products such as through product labeling.
6. Collect information on fate and transport of nanomaterials, including monitoring in environmental and biological media. Require centralized reporting mechanisms, and maintain them in a systematic manner (could be incorporated into clearinghouse in recommendation 5 above).
7. Develop a framework for making policy and regulatory decisions based on nanomaterials’ use, exposure potential, and exposure to susceptible subpopulations, while weighing public health or societal benefit.
8. Require testing of release and exposure potential for nanomaterials in consumer products that have widespread use, such as titanium dioxide, silver nanoparticles and carbon nanotubes. Testing must be completed for products to remain on the market.
9. Integrate nanomaterial safe handling practices into standard lab safety training for academic, industrial and other laboratory workers and students.
10. Use existing hazard traits from other chemicals and toxicological and environmental health-related endpoints to assess potential adverse health outcomes from nanomaterial exposure.
11. Risk assessment guidelines should be evaluated to determine whether they sufficiently cover nanomaterials and if found to be lacking, adjust or incorporate accordingly to include them in decisions. Use existing data to evaluate and consider applying an adjustment factor to address enhanced risk for those nanomaterials that exhibit certain properties such as charge, certain size and certain surface functionalities.
12. Targeted research in the area of biological transport and distribution of nanomaterials including sources, routes of contact, and internal distributions. Integrate this with the information gathered on exposure potential.
13. Develop and maintain relationship with other governments (i.e. EU, Canada) and researchers (i.e. California NanoSystems Institute at University of California, Los Angeles) who conduct the research, to share relevant data and information.
14. Require sufficient toxicological testing information to assess safety of risks to consumers, including susceptible subpopulations such as infants preferable premarket, and post-market as necessary.
15. Implement a labeling system that requires labeling products that contain nanomaterials. Evaluate nanomaterials to determine if any should be placed on Prop 65 list.

Should California Reinvent the Wheel?

Several of these recommendations have been voiced by other groups including the federal government, ISO, OECD, etc. PRHE’s draft nanotechnology policy framework could benefit from a detailed analysis of the effectiveness of existing programs already in place in the US and globally to achieve many of the recommendations urged by the authors. It is difficult to imagine that California has the desire (or funds) to replicate the same research being undertaken by hundreds of top researchers already in the field.

For example, should California develop its own definition of “nanomaterials,” or is it better and more effective to rely upon definitions promulgated by standard setting bodies such as ASTM, ANSI, and ISO? Similarly, these bodies are already developing methods to determine the “characteristics by which to define, describe, and group nanomaterials according to conventional or unique properties.” Should California join their efforts, or pursue its own independent path?

As another example, should California come up with its own policy and guidelines to “integrate nanomaterial safe handling practices into standard lab safety training for academic, industrial and other laboratory workers and students,” or should it defer to NIOSH’s excellent existing guidelines on this issue?2 - or even the Department of Energy’s?3

As a third example, there is already a large amount of research ongoing regarding the “biological transport and distribution of nanomaterials including sources, routes of contact, and internal distributions.” One need only search the International Council on Nanotechnology’s Virtual Journal of Nanotechnology Environment, Health and Safety4 to see what has already been published on these issues. OECD also has a nice online database covering these areas.5 Should California reinvent the wheel in this regard?

Perhaps the answer to all of the above-questions is “Yes.” Maybe California should undertake all of these efforts because they are not being effectively addressed by others. However, before making such recommendations the authors should at least evaluate and critique ongoing efforts in these areas so California’s policy makers can better prioritize their efforts.

Disconnect Between Science, Existing Regulation, and Policy Recommendations

Another major issue with PRHE’s draft nanotechnology policy framework is the disconnect between the science overview set forth in its first three chapters and the 15 policy recommendations appearing in its fourth chapter. It would be interesting for PRHE to develop the linkage, if any, between what it sees as the main gaps or deficiencies in the existing science and regulation surrounding nanoscale materials and PRHE’s specific policy recommendations. Simply put, how do PRHE’s 15 specific policy recommendations works towards solving the problems it identifies? Of course, the document is only a draft and perhaps PRHE will address these issues in its final version.

Two Most Controversial Recommendations

Perhaps the two most controversial recommendations in PRHE’s draft nanotechnology policy framework are its proposals to require pre-market testing for consumer products containing nanoscale materials and the mandatory labeling of such products. Both approaches have been considered and rejected (for the time being) by the federal government. Unfortunately, little effort is taken to develop the factual, logical, scientific, or legal support for these recommendations. This is particularly frustrating because the two major groups of effected stakeholders -- consumers and consumer product manufacturers/distributors -- appear to have had little, if any, input into the draft nanotechnology policy framework. However, quite a bit has already been written on these subjects, and authors have plenty of source material to assist in their analysis before the draft is finalized.

Public Comments and Meeting

PRHE has invited public comments regarding the draft nanotechnology policy framework and is holding a conference on May 5, 2010 which will include presentations from the science advisory panel who worked on the document, as well as time for public comment.6 Given the scope of the report, it will be interesting to see what comments and analysis can be pulled together by interested stakeholders in the relatively short time allotted by PRHE for review.

References

1. A Nanotechnology Policy Framework: Policy Recommendations for Addressing Potential Health Risks from Nanomaterials in California, http://prhe.ucsf.edu/prhe/nanoreportDRAFT.pdf (last visited Apr. 29, 2010).
2. Approaches to Safe Nanotechnology: Managing the Health and Safety Concerns Associated with Engineered Nanomaterials, http://www.cdc.gov/niosh/docs/2009-125/pdfs/2009-125.pdf (last visited Apr. 29, 2010).
3. Department of Energy, Nanoscale Science Research Centers, Approach to Nanomaterial ES&H, http://orise.orau.gov/ihos/nanotechnology/files/NSRCMay12.pdf (last visited Apr. 29, 2010).
4. The International Council on Nanotechnology, Virtual Journal of Nanotechnology Environment, Health and Safety, http://icon.rice.edu/virtualjournal.cfm (last visited Apr. 29, 2010).
5. OECD Database on Research into Safety of Manufactured Nanomaterials, http://webnet.oecd.org/NanoMaterials/Pagelet/Front/Default.aspx? (last visited Apr. 29, 2010).
6. PRHE Announcement, http://prhe.ucsf.edu/prhe/nanoannouncement.pdf (last visited Apr. 29, 2010).

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Just a quick plug for our new NanoSafety Consortium for Carbon which was recently launched to address potential EHS issues concerning its members' products.  You can learn more about the consortium at: www.nanosafetyconsortium.com.

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To our knowledge, this press release announces the first nano-specific liability insurance coverage available in the United States. Many nano-related businesses have been waiting a long time for a product like this. It will be interesting to see industry reaction.

Lexington Insurance Company Introduces LexNanoShieldSM
March 30, 2010 10:15 AM Eastern Daylight Time

NEW YORK--(EON: Enhanced Online News)--Lexington Insurance Company, a Chartis company, today introduced LexNanoShield, an integrated insurance product and array of risk management services designed for firms whose principal business is manufacturing nanoparticles or nanomaterials, or using them in their processes.

“LexNanoShield can help insureds assess and manage these new nanotechnology exposures.”
For the exposures faced by these pioneering companies, LexNanoShield includes liability coverage that provides protection for general liability, product liability, product pollution legal liability and product recall liability exposures. In addition, first party product recall coverage is available to reimburse expenses incurred if a product containing nanoparticles or nanomaterials is recalled from the market for safety reasons. LexNanoShield also provides insureds with legal, technical and loss control consulting services to help develop, implement and assess nanotechnology-specific risk management programs.

“The enhanced reactivity of materials on the nanoscale has led to sunscreens you can’t see, clothes that don’t wrinkle, and paint coatings that don’t scratch. Because many of these products and others like them are relatively new, they require unique coverage and service,” said Tom McLaughlin, Lexington’s Senior Vice President of Specialty Casualty. “LexNanoShield can help insureds assess and manage these new nanotechnology exposures.”
 

For more information regarding LexNanoShield, contact Bob Nevin, Product Line Manager, at 617-772-4546 or robert.nevin@chartisinsurance.com, or Tom McLaughlin, Senior Vice President of Lexington’s Specialty Casualty unit, at 617-330-8555 or thomas.mclaughlin@chartisinsurance.com. You can also visit www.lexingtoninsurance.com.
 

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This article originally appeared on the National Nanomanufacturing Network's InterNano website earlier today. It is licensed under Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Unported.

Maxine Savitz[1] and Ed Penhoe[2] provided a recent presentation summarizing the highlights of the President’s Council of Advisors on Science and Technology (PCAST)[3] report on the status of the US National Nanotechnology Initiative (NNI) at a public meeting held at the National Academics on March 12, 2010.

Ms. Savitz provided a brief review at the beginning of the presentation regarding how, when, and why NNI was formed; its history from 2000 - 2010; and some of the participants in the PCAST review process. Participants included representatives from DuPont, IBM, A123 Systems, Nanocomp Technologies, Rice, Harvard, Caltech, Sandia National Labs, and the Woodrow Wilson Institute. Ms Savitz also explained that the group held two prior working meetings to solicit input from government agencies, the legislative and executive branches, as well as outside stakeholders. Finally, she explained that PCAST’s report has three major thematic areas: NNI program management; NNI output and work product; and NNI environmental, health, and safety programs and strategies.

Ed Penhoet then provided an update regarding NNI’s continued successes. He noted that the US is currently the world leader in nanotechnology and commercialization, but that other nations are gaining fast -- particularly in Asia and Europe. He further noted that NNI has had a substantial impact on the US nanotechnology industry over the past ten years, which can be seen in the larger number of nanotechnology patents filed, nano-related publications, and nano-related products hitting the commercial market during that period.

Mr. Penhoet further explained that while NNI is being effectively managed, there is still room for some improvement and greater coordination.

For an example, Mr. Penhoet pointed out that there is a lack of basic underlying data from which to analyze the economics of nano-related research, development, and commercialization in the US. Thus, it is difficult to precisely quantify the economic effectiveness of the NNI in measurable terms.

As another example, Mr. Penhoet also mentioned the need to identify and understand potential nano-related risks -- both for purposes of fundamental science, and also to provide a clear regulatory environment and path for commercialization. While undoubtedly a significant portion of PCAST’s written report touches on these issues, the topic was only briefly mentioned in passing during the presentation.

Mr. Penhoet then spent the majority of his presentation explaining the five major recommendations embodied in PCAST’s written report:

• Increase NNI funding for manufacturing research while maintaining support for basic research.
• Strengthen the NNCO, the NNI coordinating entity, with additional funds and a broader mandate.
• Require that metrics be developed to track benefits of nanotechnology such as job creation.
• Develop a cross agency strategy that links EHS research and knowledge gaps and decision making needs.
• Expedite the citizenship review process for those receiving advanced degrees in science and engineering.

The presentation closed with comments by several PCAST members regarding (i) potential methods for developing the underlying economic data needed to properly evaluate nano-related job creation and return on investment; and (ii) potential methods for increasing retention rates of foreign students obtaining advanced nano-related degrees in the US by reducing and/or streamlining citizenship restrictions.

PCAST voted to accept and approve the report after it is amended to reflect the comments discussed during the presentation.

References
[1] Director of the Washington Advisory Group, an LECG Company. Ms. Savitz is the former Deputy Assistant Secretary for Conservation, US Department of Energy. Prior to her DOE service, she was program manager for Research Applied to National Needs at the National Science Foundation. Following her government service, she served in executive positions in the private sector, including: President of Lighting Research Institute, assistant to the vice president for engineering at The Garrett Corporation, and General Manager of Allied Signal Ceramic Components. She recently retired from the position of General Manager for Technology Partnerships at Honeywell.

[2]President of the Gordon and Betty Moore Foundation. Mr. Penhoet is the former dean of the School of Public Health at the University of California, Berkeley, prior to which he cofounded and managed the Chiron Corporation. Prior that he was a faculty member of the Biochemistry Department of U.C. Berkeley. Mr. Penhot currently serves as the vice chairman of the Independent Citizen’s Oversight Committee which oversees the California Institute for Regenerative Medicine created by the passage of Proposition 71, the stem cell initiative.

[3] http://www.whitehouse.gov/administration/eop/ostp/pcast.

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Our friends at Nanodialog.eu will now be publishing summaries of select nanolawreport blogs in Polish.  Here's an example:

NOWOSCI The Nanotechnology Education Act  Pełny artykuł zamieszczony  1 lutego, 2010, w Nanotechnology Law Report przez Robert Oszakiewski : http://www.nanolawreport.com/2010/02/articles/the-nanotechnology-education-act/ 06.03.2010. Streszczenie i tłumaczenie: Ewa Lockard Końcem stycznia 2010, dwóch kongresmanów amerykańskich: David Wu i Daniel Lipinski, zaproponowali wprowadzenie ustawy (The Nanotechnology Education Act), której celem byłoby stworzenie pogramu dotacji wspomagających wprowadzenie i ulepszenie programów i infrastruktur związanych z nauczaniem nanotechnologii. Dotacje obejmowałyby zarówno szkoły średnie, college, uczelnie jak i nieformalne centra technologiczne. Fundusze byłyby przeznaczone na: zakup sprzętu i oprogramowania, zatrudnienie nauczycieli włącznie ze szkoleniami dla nauczycieli nanotechnologii. Zmieniony ( 06.03.2010. ) Czytaj całość…

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Readers may be interested in learning that my 2009 book "Nanotechnology Law" is now online. You can find it on Westlaw as Nanotechnology Law (NANOTECH). 

The Westlaw version is very helpful because you can now electronically search for any nano-related legal topic and let your computer do all the work -- it even provides links to the footnotes.

As another shameless plug, "Nanotechnology Law" is the only comprehensive legal text on nanotechnology currently on the market and weighs in at 1006 pages.  (All the better reason to use the Westlaw search function).

Finally, I am in the process of updating the book for the 2010 edition.  Thus, if there is anything important from 2009 that you would like to see analyzed in the 2010 edition -- please let me know and I will see what I can do.

JCM

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Last September we predicted that sometime in 2010 EPA would reverse its "distinct molecular identity" approach to determining when and whether nanoscale materials are considered New Chemical Substances requiring premanufacturing notice and approval under the Toxic Substances Control Act (TSCA).   We have been advising clients accordingly. 

Inside EPA is now reporting that "EPA toxics chief Steve Owens" . . . "is expected to announce the shift Feb. 5."

Thus, tomorrow should be an interesting day in nano-regulatory-land.  We will provide our readers with a detailed analysis should EPA in fact reverse itself on this important issue.  Stay tuned . . .

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This article originally appeared on the National Nanomanufacturing Network's InterNano website earlier today.  It is licensed under Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Unported. 

In late December 2009, California’s Department of Toxic Substances Control (DTSC) received the first response¹ to its January 22, 2009 information request regarding carbon nanotubes². The original request targeted 26 purported California manufacturers and/or importers of carbon nanotubes³.

It asked for information regarding analytical test methods, environmental fate and transport, and other relevant environmental, health, and safety information. The request was issued by DTSC under authority granted by California's Health and Safety Code 699, Sections 57018-57020. Stanford University was the first entity to respond to the six specific questions contained in DTSC’s request:

1.  What is the value chain for your company? For example, in what products are your carbon nanotubes used by others? In what quantities? Who are your major customers?

2.  What sampling, detection and measurement methods are you using to monitor (detect and measure) the presence of your chemical in the workplace and the environment? Provide a full description of all required sampling, detection, measurement and verification methodologies. Provide full QA/QC protocol.

3.  What is your knowledge about the current and projected presence of your chemical in the environment that results from manufacturing, distribution, use, and end-of-life disposal?

4.  What is your knowledge about the safety of your chemical in terms of occupational safety, public health and the environment?

5.  What methods are you using to protect workers in the research, development and manufacturing environment

6.  When released, does your material constitute a hazardous waste under California Health & Safety Code provisions? Are discarded off-spec materials a hazardous waste? Once discarded are the carbon nanotubes you produce a hazardous waste? What are your waste handling practices for carbon nanotubes?

Stanford’s response was thoughtful, yet very basic. The University confirmed that it follows standard laboratory safety procedures, has implemented most of the nanosafety guidelines issued by the National Institute for Occupational Safety and Health (NIOSH), and that it treats nano-waste as “hazardous waste” for disposal purposes. A summary of Stanford’s answers follows.

In response to DTSC’s first “value chain” question, Stanford responded that it has identified 16 of its laboratories that are working with carbon nanotubes. Research topics include medical applications, electronics, energy storage, fuel production, fundamental physics, and material science research. To support its “value chain” answer, Stanford attached five research papers resulting from its laboratories’ activities.

Regarding DTSC’s second “monitoring” question, Stanford answered that because there are only minimal risks of exposure and release of carbon nanotubes in its laboratories, it has not yet developed or implemented any quantitative sampling or detection methods. The University also advised that it was working with NIOSH to conduct a possible site visit of its facilities in 2010 to potentially address these issues.

Responding to DTSC’s third question concerning the “projected presence” of carbon nanotubes in the environment which may result from Stanford’s activities, the University answered that there could conceivably be (i) accidental releases and spills, (ii) routine releases from laboratory handling, and (iii) the presence of carbon nanotubes in its laboratory waste stream. Importantly, Stanford indicated that the combined use of carbon nanotubes in all of its laboratories only amounts to approximately 16 grams per year and that its nano-waste stream is treated as “hazardous waste.”

Regarding DTSC’s fourth question concerning Stanford’s knowledge of the possible environmental, health, and safety effects of its carbon nanotubes, the University responded that it takes “a precautionary, but reasonable approach” and uses good laboratory safety practices when working with nanoscale materials. Additionally, Stanford maintained that one the articles attached to its submission supports the position that carbon nanotubes are cleared from the body without adverse health effects. Finally, Stanford indicated that it closely follows the nano-EHS literature posted on NIOSH’s website, as well as the comprehensive nano-EHS website of the International Council on Nanotechnology at Rice University.

In response to DTSC’s fifth question concerning the nano-specific workplace safety measures implemented by Stanford, the University responded that (i) it follows a standard chemical hygiene plan created and implemented under existing California law, (ii) has implemented its “General Principles and Practices for Working Safely with Engineered Nanomaterials,” and (iii) has created a standard operation procedure template for use by its nano-laboratories “to assist in determining the [appropriate] levels and types of controls” which should be used in each laboratory working with nanoscale materials. Stanford’s “General Principles” document⁴ can be found on its website and basically summarizes the key points from NIOSH’s “Approaches to Safe Nanotechnology” document⁵ in a condensed bullet point format.

Finally, regarding DTSC’s sixth “hazardous waste” question, Stanford largely mooted the question by explaining that it treats its carbon nanotube waste stream as “hazardous waste,” whether or not such material actually constitutes “hazardous waste” from a scientific and/or regulatory perspective.

On the whole, Stanford put considerable effort into its response to DTSC’s information request, but it contained no “earth shattering” revelations. The University appears to be following state of the art procedures for working safely with carbon nanotubes. More importantly, there was little information in Stanford’s response that the State did not already know or could have learned with a simple telephone call. Of course, all of this begs the question of whether a formal data call in was even necessary in the first place and/or whether California is squandering its rapidly diminishing capital on this project. At the very least, the data call in should have contained a minimum threshold requirement in order to weed out minimal users and to prevent them from having to engage in the time consuming process which Stanford went through.

References:

1. Stanford University CNT Submittal Letter
2. DTSC January 22, 2009, Information Request Regarding Carbon Nanotubes
3. DTSC Carbon Nanotube Contact List
4. Stanford's General Principles Document
5. NIOSH's Approaches to Safe Nanotechnology

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Our readers might be interested in seeing an article published by BNA's Toxics Law Report which was published on December 3, 2009 -- "Nanotechnology: The Next Battleground for Mass Torts?"  The article by a prominent California attorney and one of his Chicago-based associates is primarily a summary of our prior October 2008 article: "A Nano-Mesothelioma False Alarm" with a few added procedural suggestions for defense attorneys.  Glad to see someone out there is reading.  :)

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Earlier today, an IEEE blogger commented on a nanosilver article we previously re-published on this cite.   The original article was written by the Silver Nanotechnology Working Group and was first published on the University of Massachusetts, Amherst's InterNano website (where I am Contibuting Editor for Environmental, Health and Safety and Regulation). 

Dexter Johnson comments on the Nanoclast blog of IEEE's Spectrum website:

"In what must come as a blow to NGOs around the world it turns out that the material that has fueled much of their indignation about nanotechnology, nanosilver, has not only been 'rationally manufactured, regulated, and used commercially for over a century with no significant adverse environmental, health, and safety effects', but also the EPA has specifically been looking at nanosilver as far back as the 1950s."

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This article was written by John C. Monica, Jr. and Dr. Diana Bowman and originally appeared on the National Nanomanufacturing Network's InterNano website earlier today.  It is licensed under Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Unported.

Dr. Bowman is a Senior Research Fellow in the School for Population Health at the University of Melbourne and a Visiting Research Fellow in the Department of International and European Law, KU Leuven. Dr. Bowman is also a co-editor, along with Matthew Hull, of the book “Nanotechnology Environmental Health and Safety: Risks, Regulation and Management,” (Elsevier, 2010).

In November 2009, the Australian Government’s Department of Health and Aging (DHA) published a public discussion paper —“Proposal for Regulatory Reform of Industrial Nanomaterials”—in relation to the National Industrial Chemicals Notification and Assessment Scheme (NICNAS), which provides a national system of notification and assessment of industrial chemicals. For the purpose of the scheme, “industrial chemicals” include chemical entities found in, for example, many plastics and paints. And, unlike many jurisdictions, those chemicals found in cosmetic products. The paper provides concrete recommendations for the regulation of both “new” nanoscale chemical substances and “existing” chemical substances in nanoscale formulations, while thoughtfully considering legitimate business needs.

Regarding “new” nanoscale chemical substances, the paper notes that—by legal definition—these substances are those which are not already listed on the Australian Inventory of Chemical Substances and as such are subject to existing regulatory requirements. The paper also notes that several permitting exemptions currently exist for certain uses of chemicals already on the Inventory. As an initial nano-regulatory step, the paper recommends excluding “new” nanoscale materials not already on the Inventory from regulatory low volume exemptions, “thereby shifting a post-market audit activity to a pre-market assessment (i.e. new nanomaterials to be assessed under permit or certification categories prior to commercialization).” The suggestion is not unduly punitive, and a similar approach is already in use by the US EPA.

Additionally, the paper recommends modifying the Research and Development exemption for “new” chemical substances to require annual reporting of nanoscale materials produced in quantities exceeding 100 grams per year. While the paper could benefit from some explanation of why this specific threshold was selected, the idea of providing basic information on nanoscale materials used in sufficient quantities for research and development is not onerous.

The main rationale for these modifications is that the “uncertainty surrounding the hazards, exposure, and risk assessment methodologies . . . means that the determination of ‘no unreasonable risk’ or ‘non-hazardous’, both of which are prerequisites to a range of exemptions, is not expected to be straightforward,” and the accompanying need for a case-by-case approach to the responsible development of nanoscale chemical substances.

Regarding “existing” nanoscale chemical substances, the paper recommends that the Australian Government consider following up on their somewhat disappointing voluntary data call-ins under the NICNAS scheme (held in 2006 and 2008) with a study on “the feasibility of a mandatory notification and assessment program.” Such a program would be designed to establish a database of “existing” nanoscale chemicals in use in Australia and increase public confidence in regulatory oversight efforts. U.S. EPA is also considering a mandatory data call-in for nanoscale materials, while California has already issued a mandatory data call-in for carbon nanotubes and is targeting several additional nanoscale materials.

Australia’s DHA’s recommendations are well-balanced. Business and commercialization needs are recognized even though human and environmental, health, and safety regulatory needs are given priority. However, the paper largely ignores the most difficult topic in this space—whether nanoscale versions of “existing” chemicals already on the Australian Inventory of Chemical Substances should be considered “new” chemical substances for regulatory purposes, as suggested by Ludlow, Bowman, and Hodge in their review of Australia’s regulatory framework for nanotechnology, thus triggering pre-market approval requirements prior to commercialization. This issue has been argued back and forth in the US, the EU and other jurisdictions for quite some time, and it is unlikely that Australia will be able to avoid similar strong debate. It is perhaps the biggest issue facing regulators seeking to modify Australia’s industrial chemical legislative framework to fully cover both “new” and “existing” nanoscale materials.

Beyond the substantive regulatory changes noted above, the paper does an excellent job of explaining what “industrial nanomaterials” are, their current regulatory status in Australia, and national and international regulatory activities for nanoscale materials. Moreover, the paper is written in sharp, clear language. It provides lots of key questions for stakeholders to consider when thinking about these issues, as well as surveys and questionnaires encouraging feedback and input. The Australian Government is also sponsoring public consultation activities in most of the country’s larger metropolitan areas to explains the paper to stakeholders first-hand and to solicit additional input.

References

National Industrial Chemical Notification and Assessment Scheme (Department of Health and Aging, Australian Government). Proposal for Regulatory Reform of Industrial Nanomaterials. Public Discussion Paper. November 2009. Available from NICNAS. http://www.nicnas.gov.au/Current_Issues/Nanotechnology/Stakeholder_Consultation.asp

Ludlow K, Bowman DM, and Hodge GA. 2007. A Reveiw of Possible Impacts of Nanotechnology on Australia'a Regulatory Framework. Monash Centre for Regulatory Studies, Monash University, Melbourn.
 

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New Edition of Nanotechnology Law Report

Inside you will find:

• EPA Considering New Approach to Nanoscale Materials Under TSCA
• EPA May Issue Mandatory Data Collection Rule for Nanoscale Materials Under TSCA
• EPA Takes Aim at Antimicrobial Products Under FIFRA
• EPA Unveils New Principles for Chemical Management Reform
• EPA Report on the Use of Nanoscale TiO2 in Water and Sunscreens
• EPA Withdraws Carbon Nanotube SNURs
• Press Release: New Contributing Editor for InterNano
• Virginia CLE presentation: “Insurance, Nanotechnology, and Risk”
• Nanoparticles and Deaths in the People’s Republic
• Sweating the Small Stuff
• Soil Association Cites China Deaths in Renewed Call for Moratorium on Nanotechnology Commercialization
• Nanotechnology Legislation in the 111th Congress
• Mapping Nano
• Flight of the Nanobees

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The National Nanomanufacuring Network (NNN) at the University of Massachusetts, Amherst just published its October newsletter which you can find here.  There is a nice article by Barbara Beck and Chris Long from Gradient regarding the recent Song nanoparticle study from China which was my first contributing editor piece for NNN's InterNano.  Please read the newsletter and follow NNN's valuable work.

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This article was originally published by the National Nanomanufacturing Network's "InterNano" project (www.internano.com).  It is licensed under a Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Unported.

A recent study published in the well-known medical journal, the European Respiratory Journal, has been receiving significant publicity as the authors have claimed their findings support an apparent linkage between workplace exposures to nanoparticles and severe respiratory disease. Specifically, in this study, investigators at China's Capital University of Medical Science related unusual and progressive lung disease in seven Chinese workers, two of whom died, to nanoparticle exposures in a print plant where a polyacrylic ester paste containing nanoparticles was used. This linkage was made by the study investigators despite a general lack of exposure data for the workers. 
 

The complete review is after the jump . . .

Reviewed by Christopher M. Long, Sc.D., and Barbara D. Beck, Ph.D., DABT, FATS, Gradient

• Song Y, Li X, Du X. 2009. Exposure to nanoparticles is related to pleural effusion, pulmonary fibrosis and granuloma. Eur Respir J. 34(3):559-67.  DOI:10.1183/09031936.00178308.

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We have previously reported on a study by Arizona State researchers looking into the potential release of nanosilver particles from odor-killing socks during theoretical wash cycles.  A new study from Switzerland examines the issue in further detail.

L. Geranio, et al., "The Behavior of Silver Nanotextiles during Washing," Environ. Sci. Technol. (Sept. 2009).

Three authors from the Swiss Federal Laboratories for Materials Testing and Research conducted the study with the aim of determining "the amount and the form of Ag released during washing from nine fabrics with different ways of silver incorporation into or onto the fibers."  The study generally found that when washed at low pH levels, there was little dissolution of nanoparticles from the textiles being tested.  However, the researchers theorized that the use of bleach "can greatly accelerate the dissolution of Ag."  The percentage of total silver emitted during one wash cycle for the fabrics varied between 1% and 45%.  Almost 75% of the silver released was greater than 450 nm in diameter. 

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Nanotechnology Law & Business just published our new article on the EPA's recent treatment of nanoscale materials under the Toxic Substances Control Act.  An abstract for the article is below and you can find a copy of the article itself here.

Abstract: This article provides a summary of recent (2008-2009) regulatory efforts by the U.S. Environmental Protection Agency under the Toxic Substances Control Act concerning nanoscale materials. These efforts include entering into two consent orders with a manufacturer of carbon nanotubes; issuing four significant new use rules for two siloxane-based nanoparticles and two carbon nanotubes (and then withdrawing the latter two); intimating that new testing and data collection rules will be implemented for certain nanoscale materials; and proposing and/or requiring acute toxicity rat inhalation testing regimes in certain instances. The authors explain these developments in detail and then provide some initial strategic and legal considerations for businesses attempting to navigate this emerging regulatory thicket.

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Our friends at AZoNano (www.AZoNano.com) recently sent us this full page, color, sunscreen advertisement from the September 16, 2009 Weekend Australian Magazine.  The sunscreen in question, called "Invisible Zinc," claims to use an invisible film of zinc oxide to provide UVA and UVB skin protection to its users.  Our readers will quickly note the prominent disclaimer appearing in the upper right hand corner of the page -- "*Micronised (Not Nano)."  It's the first I've seen.  If you know of others, please forward them to me if you get a chance.

It appears that the anti-nano sunscreen publicity occurring over the past few years is now taking root in demonstrable ways.

Author's note:  Technology is truly decreasing the size of our world.  AZoNano's CEO -- Dr. Ian Birkby -- found this "Invisible Zinc" advertisement in Australia where he lives, and then wrote about it on Twitter.  I picked up his tweet and asked for a copy, which he kindly emailed to me.  Now nanolawreport readers from various countries can also read about the advertisement.  Dr. Birkby is @Birkers on Twitter, while I am @nanolaw.  Hope to hear from you soon.

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There are often developments in the nano legal world that do not fit into our traditional Nanotechnology Law Report format, yet might be of interest to some of our readers. You can now find these short postings and other musings on twitter.com/nanolaw  .

Additionally, you can find me on linkedin under "John Monica," as well as on our new "Nano EHS Forum".  Please feel free to link in or to join our new discussion group.

Happy networking!

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A much valued contributor from CyberRegs provided us with the following information from the Federal Register that may be of interest to readers:

There will be a 4-day consultation meeting of the Federal Insecticide, Fungicide, and Rodenticide Act Scientific Advisory Panel (FIFRA SAP) to consider and review a set of scientific issues related to the assessment of hazard and exposure associated with nanosilver and other nanometal pesticide products.

DATES: The consultation meeting will be held on November 3 - 6, 2009, from approximately 8:30 a.m. to 5:00 p.m. The consultation meeting will be held at the Environmental Protection Agency, Conference Center, Lobby Level, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA 22202.

Comments. The Agency encourages that written comments be submitted by October 20, 2009 and requests for oral comments be submitted by October 27, 2009. Mail: Office of Pesticide Programs (OPP) Regulatory Public Docket (7502P), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001.

FOR FURTHER INFORMATION CONTACT: Joseph E. Bailey, DFO, Office of Science Coordination and Policy (7201M), Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: (202) 564-2045; fax number: (202) 564-8382; e-mail address:
bailey.joseph@epa.gov.

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For anyone interested, I am presenting my recently approved Virginia CLE presentation "Insurance, Nanotechnology, and Risk" in mid-September to a national intellectual property law firm based here in D.C.  The presentation covers issues related to the alleged environmental, health, and safety (EHS) risks accompanying certain nanoscale materials from the perspective of both the insured and insurer. Particular emphasis is placed on (i) insurer approaches to EHS risk and uncertainty, (ii) the first commercial insurance exclusion for nanotechnology in the US, (iii) industry reaction to certain recent adverse EHS studies concerning carbon nanotubes, and (iv) three initial steps nano-related businesses should consider when dealing with these issues. The PowerPoint was originally presented at the Nanotechnology Health and Safety Forum in Seattle in June 2009, and the National Nanotechnology Initiative also asked for it to be presented at the opening plenary for its October 2009 workshop on "Nanomaterials and the Environment & Instrumentation."  I anticipate additional presentations of the CLE in D.C. and Virginia over the upcoming months.  Please let me know if you have any interest in attending one of the future sessions and I will try to hook you up for some free CLE credit.

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Earlier today, the Guardian printed a letter from the Soil Association criticizing the paper's nanotechnology supplement appearing last Thursday.  The letter cites the Song study from China as more evidence supporting its call for a moratorium on nanoscale materials along with "nano-free" standards, which we have previously covered.  Key statements from the letter follow:

"Seven women working in a factory [in China] where nanoparticles were used in paint fell ill with serious lung disease and two died. Researchers . . . found nanoparticles deep in the lungs of the women . . . A chemical in the paint, the patients' lung tissue and the liquid surrounding the lungs were all found to contain nanoparticles."

"There should be an immediate freeze on the commercial release of nanomaterials until there is a sound body of scientific research into all the health impacts."

The letter does not attempt to explain any of the severe criticism the Song article has received by most main stream scientists, and is a good example of bad science put to a questionable use.

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For anyone who might be interested, I will be speaking on nano-related insurance issues at the opening plenary of the National Nanotechnology Initiative's upcoming Oct. 6 -7 conference and workshop on Nanomaterials and the Environment & Instrumentation.  The draft agenda for the conference can be found here, and the plenary is also supposed to be broadcast on the web.  I will post the information for the simulcast as we get closer to the conference date.  Cost, location, and registration info. is here.

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For anyone interested, here is the index to my new book "Nanotechnology Law."  You can find the book on Amazon.

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Eight months after EPA's interim report on industry participation (or lack thereof) in its Nanoscale Materials Stewardship Program, EPA's Toxic Substances Control Act's ("TSCA") Interagency Testing Committee ("ITC") published a report in today's Federal Register mentioning that EPA intends to issue a new mandatory data collection rule for nanoscale materials under TSCA Section 8(a):

"EPA intends to develop a proposed TSCA section 8(a) rule to obtain information on the production, uses, and exposures of existing nanoscale materials.  EPA has indicated that it will ensure that the chemicals where there is ITC interest as described in this unit are either included in that action or are otherwise new chemical substances subject to premanufacture notifications (PMN) reporting under TSCA.  EPA also intends to develop a proposed TSCA section 4 rule to develop needed environmental, health, and safety data."

Among other things, TSCA section 8(a) allows EPA to issue a rule requiring the mandatory submission of data regarding:

(A) The common or trade name, the chemical identity, and the
molecular structure of each chemical substance or mixture for which
such a report is required.

(B) The categories or proposed categories of use of each such
substance or mixture.

(C) The total amount of each such substance and mixture
manufactured or processed, reasonable estimates of the total amount
to be manufactured or processed, the amount manufactured or
processed for each of its categories of use, and reasonable
estimates of the amount to be manufactured or processed for each of
its categories of use or proposed categories of use.

(D) A description of the byproducts resulting from the
manufacture, processing, use, or disposal of each such substance or
mixture.

(E) All existing data concerning the environmental and health
effects of such substance or mixture.

(F) The number of individuals exposed, and reasonable estimates
of the number who will be exposed, to such substance or mixture in
their places of employment and the duration of such exposure.

(G) . . . the manner or method of its disposal, and in any
subsequent report on such substance or mixture, any change in such
manner or method.
 

Some of the nanoscale materials prompting ITC's interest appear to be: fullerenes; titanium oxide nanowires; titanium oxide nanoparticles; nano zinc oxide; nanosilver; silica; quartz; cerium oxide; indium tin oxide; dendrimers; single-walled carbon nanotubes; multi-walled carbon nanotubes; carbon nanofibers; Se and Cd quantum dots; nanoceramic particles; and nanoclays.

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Last Friday, EPA's Office of Research and Development announced in the Federal Register a 45 day comment period for its new draft case study on the use of nanoscale TiO2 in water and sunscreens:

"Nanomaterial Case Studies: Nanoscale Titanium Dioxide in Water Treatment and in Topical Sunscreen"

FR 74,146 at 38188 (July 31, 2009).  The report focuses on two specific applications of nanoscale titanium dioxide (nano-TiO2): (i) as an agent for removing arsenic from drinking water, and (ii) as an active ingredient in topical sunscreen. The draft report is divided into five chapters:

1. Introduction
2. Life Cycle Stages
3. Fate and Transport
4. Exposure - Dose Characterization
5. Characterization of Effects

The report is formidable in length, scope, and detail.  For those looking for some quick highlights, the report provides a great series of summaries of the existing TiO2 environmental, health, and safety literature.  For example:

• Table 4-4 presents an overview of approximately 25 existing TiO2 skin absorption/penetration studies dating back to 1997;

• Table 5-3 provides a summary of nano-TiO2 ecological effects; and

• Tables 5-4 through 5-6 provide a summary of health effects of nano-TiO2 particles in mammalian animal models via dermal, oral, and respiratory exposure routes.

EPA notes that the "document is not intended to serve as a basis for risk management decision in the near term on these specific uses of nano-TiO2."  Rather, its focus is on developing necessary data for "future assessment efforts." Specifically, the "document is a starting point to determine what is known and what needs to be known about selected nanomaterials as part of a process to identify and prioritize research to inform future assessments of the potential ecological and health implications of these materials."

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Readers may interested in learning that EPA issued a clarification today regarding its single-walled and multi-walled carbon nanotube SNURs previously issued in June 2009. EPA's announcement follows.  Stay tuned . . .

Good afternoon.  On June 24, 2009, the U.S. EPA issued final Significant New Use Rules (SNURs) under the Toxic Substances Control Act (TSCA) for 23 new chemicals, including two carbon nanotubes (nanoscale materials) (http://www.epa.gov/fedrgstr/EPA-TOX/2009/June/Day-24/t14780.pdf).  The SNURs will allow the commercialization of these specific carbon nanotubes under limited conditions to protect against unreasonable risks to human health and the environment.  

The SNURs require companies to notify EPA at least 90 days before manufacture, import, or processing of the specific carbon nanotubes for any activity not meeting the conditions specified in the rules at 40 C.F.R. 721.10155  and 40 C.F.R. 721.10156.

Upon reviewing the rules some stakeholders have asked EPA whether these SNURs apply to all variants of carbon nanotubes. This is not the case. These SNURs only apply to the specific carbon nanotubes that were the subject of the premanufacture notices (PMNs) submitted under Section 5 of TSCA and not to any other carbon nanotubes.  Other carbon nanotubes must be notified through EPA's New Chemicals Program.   The U.S. EPA strongly encourages all manufacturers and importers of nanoscale materials that are intended for commercial use to consult with the Agency in advance of production or importation.

If you have any questions, please contact:

Zofia Kosim (202-564-8733) or kosim.zofia@epa.gov
Jim Alwood (202-564-8974) or alwood.jim@epa.gov
--------------------------------------------------------------------
David E. Giamporcaro
Industry and Small Business Liaison
Environmental Assistance Division
Office of Pollution Prevention and Toxics
U.S. Environmental Protection Agency
East Building
1200 Pennsylvania Avenue, N.W. (MC7408M)
Washington, D.C. 20460
Phone: (202)564-8107
Fax: (202)564-8813

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Zurich North America recently published the June 2009 edition of its Industry Insight online magazine which focuses exclusively on nanotechnology issues. The magazine contains four informative articles which are well worth reading:

• "At the leading edge: Zurich's thought leadership on nanotechnology;"
• "No small thing: The enormous potential of nano;"
• "The kings of small things: The regulatory environment for nanotechnology development;" and
• "Large risks from small things? Myth and reality of nano-risks."

Our readers may be particularly interested in the "leading edge" article in which Zurich describes its nanotechnology emerging risk activities dating back to 2006. The article discusses Zurich's involvement in ANSI's TAG to ISO/TC 229 Nanotechnologies standards and nomenclature group; its ongoing efforts to make sure its voice is heard in the ongoing regulatory debate surrounding certain nanoscale materials; and the formation of a new Zurich Nanotechnology Exposure Protocol™ (ZNEP™).

As Zurich explains, its new ZNEP™ is a risk assessment protocol designed to understand potential nano-related insurance risks:

"By working closely with corporate customers, collecting data on the specific nano-particles they were using, learning about the specific applications where they're employed, and then combining this information, Zurich could form a global overview of nanotechnology and its various facets of risk. Such an activity would not only be a very good way to protect is business, but it could form a basis for providing risk management advice to its customers going forward."

Zurich is working with Seattle-based Intertox to implement its ZNEP™, which it also hopes will dramatically shorten the lag time between discovery of new nanotechnology-based inventions and their insurability.  Readers may also recall that Zurich's Director of Emerging Issues recently spoke on insurance issues at the very well-attended Nanotechnology Health and Safety Forum in Seattle, Washington.

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Here is the Summer 2009 edition of Nanotechnology Law Report.  The newsletter contains the below-listed articles (and more):

• EPA Issues Significant New Use Rules for Carbon Nanotubes
• Are Nanoparticles Released by Cutting or Compounding Nano-Composites?
• Annual Nano TiO2 Production Estimated at 44,000 Metric Tons
• Are Nano Consumer Products Headed Underground?
• Oversight of Next Generation Nanotechnology
• Regulating Nanotechnologies
• More Interesting Nano-Regulatory Developments
• Nano Tug of War
• Pumpkins & Nanoparticles
• Green Nano
• NanoBiotech 2009
• Take two silver nanoparticles and call me in the morning
• International Approaches to the Regulatory Governance of Nanotechnology
• ETUC Resolution on Nanotechnologies and Nanomaterials
• Private Spending on Nano Exceeds Government Spending
• EMERGNANO Released

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Chubb Insurance is hosting a one-day nanotechnology insurance conference on October 13, 2009 in North Branch, New Jersey:

"Nanotechnology: What is the Best Safety and Risk Management Approach?" 

From the conference website:

"This conference brings together prominent nanotechnology speakers who will review nanotechnology background, health and safety, and potential insurance and liability issues. Current risk assessment and 'best practice' controls will be shared, helping attendees better recognize and manage potential nanotechnology risks. A nanotechnology toolkit will be provided to help attendees stay abreast of critical developments in this dynamic field."

Speakers include: Charles Geraci (NIOSH), Charles Kingdollar (General Reinsurance Corp.); John Monica (Porter Wright); Susan Berry (DRS Technologies); Ganesh Skandan (NEI Corp.); William Barr (Chubb); Erik Olsen (Chubb); and Louise Vallee (Chubb).

More from the conference website:

Emerging risks require new risk management practices. Nanotechnology applications have outpaced safety and health research. The big challenge is trying to figure out a risk management roadmap when there is a scientific and regulatory abyss with the potential for future litigation looming in the distance. Companies that delay nanotechnology innovation awaiting safety consensus or regulations risk falling behind the competition. While these tiny materials and processes are big business, many risk managers and insurance buyers haven’t fully considered potential risks to employees, consumers and the environment, resulting in workers compensation, product liability and environmental liability exposures. Company risk managers and insurance buyers would value and benefit from knowledgeable broker and agent guidance. Application and control strategies considered now may have far-reaching future implications.

Nano insurance issues have received a lot of renewed interest lately.  This should be a great conference on the topic and is open to the public.  Hope to see you there.

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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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 "Nanotechnology Law" by John Monica was just published this week by West/Thomson/Reuters, the world's leading legal publisher. The book is the first comprehensive legal text on nanotechnology and weighs in at a healthy 900 pages. The table of contents is here. The book is divided into ten informative chapters:

• Nanotechnology Introduction
• National Nanotechnology Initiative and Federal Development Efforts
• Potential Nano-Related Environmental, Health, and Safety Concerns
• Nanotechnology Environmental Regulatory Issues
• Nano-Related Food and Drug Regulatory Issues
• Nanoscale Materials in the Workplace
• Nano-Consumer Products and Insurance Issues
• Municipal, Regional, and State Development and Regulation of Nanotechnology
• Nanotechnology Standards and Nomenclature
• Nano-Intellectual Property Landscape

More information can be found here.

 

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In the June 24, 2009 federal register, the U.S. Environmental Protection Agency (EPA) issued two proposed Significant New Use Rules (SNUR) under Section 5(a) of the Toxic Substances Control Act (TSCA) for multi-walled and single walled carbon nanotubes.  The SNURs followed up on the EPA's prior September 2008 consent orders entered into with Thomas Swan & Co. Ltd. (Swan) for two of its Elicarb carbon nanotube products.

Under TSCA, the prior September 2008 consent orders were only binding on Swan.  "Consequently, after signing a Section 5(e) Consent Order, EPA generally promulgates a Significant New Use Rule (SNUR) that mimics the Consent Order to bind all other manufacturers and processors to the terms and conditions contained in the Consent Order.  The SNUR requires that manufacturers, importers and processors of certain substances notify EPA at least 90 days before beginning any activity that EPA has designated as a "significant new use. These new use designations are typically those activities prohibited by the Section 5(e) Consent Order."

Under the terms of the Septmeber 2008 consent orders which are incorporated into the new proposed SNURs, significant new uses of multi-walled and singled-walled carbon nanotubes are deemed to occur when employees do not “use gloves impervious to nanoscale particles and chemical protective clothing;” and/or fail to “use a NIOSH-approved full-face respirator with an N-100 cartridge while exposed by inhalation in the work area.”

Thus, the new proposed SNURs require these same conditions.

Manufacturers should also be aware that the EPA considers carbon nanotubes new chemical substances requiring full PMN notice, registration, and approval under Section 5 of TSCA, and has initiated at least one recent enforcement action against a carbon nanotube manufacturer who has failed to properly register its products.

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Perhaps the most overlooked issue when examining potential nano-related environmental, health, and safety concerns is whether there is any true likelihood of exposure in reasonably foreseeable use scenarios.  While there should continue to be extensive toxicity testing for certain nanoscale materials, the most interesting research (from my perspective) relates to potential workplace and/or condumer exposure in realistic settings.  We examine two studies along these lines below.

C. Su-Jung et al., "Control of Airborne Nanoparticles Releases During Compounding of Polymer Nanocomposites," 3 Nano: Brief Reports and Reviews 4, 301 - 309 (2008).

This study was conducted by researchers at the National Science Foundation-funded Center for High-Rate Nanomanufacturing at the University of Massachusetts at Lowell.  The scientists examined potential nanoparticle release related to the twin-screw extruder compounding of polymer nanocomposites.  The test was conducted because "commercial compounding (mixing) of nanocomposites is typically achieved by feeding the nanoparticles and polymer into a twin-screw extruder, the airborne particles associated with nanoparticles reinforcing agents are of particular concern, as they can readily enter the body through inhalation."

The nanoparticles in question were nano aluminum oxide particles acquired from Nanophase Technologies in commercially available form.  The particles were spherical in shape and ranged from 27 to 53 nm in diameter.  They were also specifically "engineered to form agglomerates with a nominal size of 200 nm."

Regarding the test itself, the scientists fed 2.3kg of polymer pellets and 0.16 kg of nano-alumina particles into a twin-screw extruder for processing and then measured potential nanoparticle release through two measurement techniques: (i) TSI Fast Mobility Particle Spectrometer for real time measurement; and (ii) personal air sampling using a special filter media designed to catch nanoparticles. 

The study concluded that "[t]he twin-screw extrusion process for compounding polymer nanocomposites tends to break up nanoparticle aggregates and mechanically disperse particles thoroughly during the extrusion process."  The study also found that "[nano]particle diffusion was enhanced by . . . poorly-performing local and general exhaust systems."

Interestingly, for part of the test the scientists applied a nominal engineering control by covering the open top of the extruder feeding tube throat with aluminum foil which they found "dramatically reduced" nanoparticle measurements.  They also found that consistently cleaning the lab after each use "reduced laboratory background nanoparticle concentration."

D. Bello et al., "Exposure to nanoscale particles and fibres during machining of hybrid advanced composite containing carbon nanotubes," 11 J. Nanopart Res 231 - 249 (2009).

The researchers in this study investigated whether and to what extent airborne nanoparticles were generated by wet and dry cutting of two hybrid carbon nanotube composites.  The dry cutting method employed a diamond coated band saw.  The wet cutting was performed using a diamond grit rotary cutting wheel with water lubricating the cutting surfaces during the process.  Because the scientists were interested in potential "worst case" scenarios, no vacuum or emission controls were used in tests.

The researchers found that wet cutting did not produce airborne nanoparticle emissions above background levels, but that dry cutting "generated statistically significant quantities of nanoscale and fine particles as compared to background (p<0.05), regardless of the composite type, . . . as expected."

Interestingly, the study also found that "CNTs, either individual or in bundles, were not observed in extensive microscopy of collected samples" for either wet or dry tests.

We will continue to track down and summarize these types of potential exposure studies.  Right now, they are few and far between.

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The Investor Environmental Health Network (IEHN) claims to represents 20 investment organizations with $22 billion under management that are seeking to ensure that the companies they invest in are taking appropriate steps to reduce risks associated with the toxic chemicals used in their products.  IEHN's ultimate objective is to use "public policy work regarding investor rights and disclosure, as well as dialog and shareholder resolutions, [to address] the risks and opportunities associated with toxic chemicals and safer alternatives in products." IEHN previously issued a report on the use of nanotechnology in cosmetics in February 2007. 

IEHN's new report -- "Bridging the Credibility Gap: Eight Corporate Liability Accounting Loopholes that Regulators Must Close," Investor Environmental Health Network, 2009 -- focuses on corporate disclosure issues surrounding the commercialization of nanoscale materials. IEHN identifies eight "loopholes" that it believes companies and regulators must close to protect shareholder value.

IEHN's eight purported "loopholes" are:

1. Shortsightedness: Failing to make a full accounting of potential risks and liability be focusing solely on short term issues.

2. Concealed Science: "Concealing emergency science that forewarns of potential liabilities in the future."

3. The Known Minimum: Basing business decisions on low end risk assessments rather than true case "worst case" scenarios.

4. Privileging Secrecy: Using the attorney client privilege to shield against public disclosure of potential liability.

5. Inconsistent Estimates: Providing different risk estimates to insurers on the one hand, and investors on the other.

6. Hidden Assumptions: "Using hidden assumptions to minimize estimates of liability.

7. Missing Benchmarks: Failing to benchmark a company's potential liability against its competitors in the same business facing similar liability issues.

8. Risk-Free Proxies: Failing to allow shareholders to place EHS questions on annual proxy ballots.

These purported  "loopholes" are not exclusive to nanotechnology.  IEHN hypothetically compares the potential corporate liability of companies using nanoscale materials to the ruin faced by companies involved in asbestos manufacturing from the 1930s forward. Basically, IEHN argues that failing to close these eight identified "loopholes" destroyed the asbestos industry and the same thing might happen to the nanomaterials industry if it does not act differently.

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Inside U.S. Trade reports three interesting nano-regulatory developments: (i) the "EPA has signaled that it may soon decide to regulate nano-silver as a pesticide under " FIFRA; (ii) the "EPA may rule favorably on some points" raised in the 2008 citizen's petition filed by 14 advocacy groups seeking more restrictive regulation of nanoscale silver; and (iii) Congresswoman Kathy DahlKemper (D-Pa) on the House Science and Technology Committee "is pursuing a Cosmetics Safety Bill that would require registration of cosmetics containing nanomaterials."

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EurActiv.com (EU News, Policy Positions, and EU Actions on line) published an article on June 15, 2009 entitled "Nanotech claims 'dropped' for fear of consumer recoil." 

The article reported on a nanotechnology conference which took place in Brussels during the week of June 10 at which a scientist from the Woodrow Wilson International Center for Scholars' Project on Emerging Nanotechnologies maintained that some of the current environmental, health, and safety controversy accompanying certain nanoscale materials is not grounded in scientific fact, but has nonetheless led some manufacturers to remove "nano" from their product labels and advertising. He further stated that "we have seen some companies drop the 'nano' claim while continuing to use nanotechnology. This suggests nanotechnology is going underground."

Providing a counterpoint, the Director of the European Nanotechnology Industries Association said that "[v]arying definitions [of nanotechnology] leads to claims that the industry is not open to information. But nobody is lying and nobody is misleading the public or authorities. Let's agree on what we're talking about and work together to inform consumers."

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Mark your calendar for the one-day conference “NanoBiotech 2009” set for October 19, 2009 which is being co-sponsored by Rensselaer Polytechnic Institute (Troy, NY) and Bawa Biotechnology Consulting LLC (Ashburn, VA). This is the sixth in a series of international conferences they have conducted dating back to 2003 on the converging areas of nanotechnology and biotechnology.

From the conference's website: "The conference will feature 20+ speakers, including 2 keynotes and a networking luncheon. All presentations (20-30 minute Power Points) will be fast-paced, focused and will rely upon extensive color graphics and animations to reach the diverse audience. Raffle drawings will be held throughout the day."

You can find the agenda from last year's highly recommended conference here.
 

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The Nanotechnology Health and Safety Forum which is being sponsored by Battelle, Porter Wright, University of Washington, University of Oregon, Oregon State University, and several others is taking place on June 8 - 9, 2009 at the Edgewater Hotel in Seattle, Washington.

Keynote speakers include: Dr. Leroy Hood, Co-Founder of the Institute for Systems Biology; Dr. Kenneth Dawson, Director of the Centre for BioNano Interactions; Dr. Justin Teeguarden Senior Research Scientist at Pacific Northwest National Laboratory and recent co-author of the NRC's assessment of the NNI's EHS research strategy; Dr. Vladimir Murashov from NIOSH; Dr. Saber Hussain from the Air Force Research Laboratory; former U.S. Congressman George Nethercutt; and Dr. Robert Tanguay from Oregon State University.

The program has 4 units:  Framing the Unknown; nanoEHS Perspective; Insurance, Nanotechnology, and Risk; and Nanotechnology: The Next Ten Years.

I will be speaking on the Insurance, Nanotechnology, and Risk panel on the second day of the conference along with Steve Knutson from Zurich North America; Walter Andrews from Hunton & Williams; and William E. Barr from Chubb Insurance.

You can sign up for the conference here.  Hope to see you there.

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Nanotechnology Law Report -- Spring 2009

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A high-profile occupational health and safety attorney was interviewed yesterday on ABC Local Radio in Australia regarding potential workplace safety risks accompanying exposure to certain nanoscale materials in some circumstances.

The reporter conducting the interview evidently led off the radio report by stating that "[t]o one of the nation's leading work safety lawyers, the nanotechnology industry represents a ticking time bomb." 

Not good . . .

The attorney apparently then advised that "employers at the moment may be unaware of the extent of the potential liability sometime down the track.   . . . We could be facing another epidemic in our industrial history of people, large groups of people, displaying latent symptoms from current exposures that are taking place at the moment. . . . We just don't have a clue as to what the long-term impact of the use of that technology will have.  . . . . You can see the dilemma here.  It's not necessarily that the zinc product using nanotechnology is necessarily harmful, we just simply don't know."

Personally, I would not jump from "we don't know" to "ticking time bomb" and/or "epidemic."  Readers can find the transcript from the radio program here.

We recently posted about concerns voiced by Australian labor unions regarding potential workplace exposure to nanoscale materials.  The ABC Radio Australia interview will no doubt add more fuel to this fire.

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Steffen Foss Hansen is a Ph.D. candidate at the Technical University of Denmark's Department of Environmental Engineering.    Here is a link to his well-written Ph.D. thesis -- "Regulation and Risk Assessment of Nanomaterials -- Too Little, Too Late?" 

Dr. Hansen's thesis investigates whether existing environmental, health, and safety regulations and risk assessment techniques are adequate for nanotechnology and provides "some recommendations on how to govern nanotechnologies."   While I don't always agree with Dr. Hansen on nano-related EHS issues, there is no doubt that his work is detailed, thorough, and thought provoking.  Read it.  :)

As an aside, I also had the pleasure of contributing with Dr. Hansen and others on a nanogovernance book chapter this past year which might be of interest to Nanolawreport readers:

Considerations for Implementation of Manufactured Nanomaterial Policy and Governance, NANOMATERIALS RISKS AND BENEFITS, NATO Science for Peace and Security Series C: Environmental Security, (Igor Linkov and Jeffery Steevens eds., Springer 2008).

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SPEECH OF
HON. MICHAEL M. HONDA
OF CALIFORNIA
IN THE HOUSE OF REPRESENTATIVES
TUESDAY, FEBRUARY 3, 2009

Mr. HONDA. Madam Speaker, I rise today to discuss the introduction of the Nanotechnology Advancement and New Opportunities (NANO) Act.

The NANO Act is a comprehensive bill to promote the development and responsible stewardship of nanotechnology in the United States. The legislation draws upon the work of the Blue Ribbon Task Force on Nanotechnology, a panel of California nanotechnology experts with backgrounds in established industry, startup companies, consulting groups, non-profits, academia, government, medical research, and venture capital that I convened with during 2005.

Nanotechnology has the potential to create entirely new industries and radically transform the basis of competition in other fields, and I am proud of my work with former Science Committee Chairman Sherry Boehlert on the Nanotechnology Research and Development Act of 2003 to foster research in this area.

But one of the things I have heard from experts in the field is that while the United States is a leader in nanotechnology research, our foreign competitors are focusing more resources and effort on the commercialization of those research results than we are.

In its report Thinking Big About Thinking Small, which can be found on my website, the Blue Ribbon Task Force on Nanotechnology made a series of recommendations for ways that the nation can promote the development and commercialization of nanotechnology. The NANO Act includes a number of these recommendations.

In addition, the bill addresses concerns that have been raised about whether the federal government is doing enough to address potential health and safety risks associated With nanotechnology. The NANO Act requires the development of a nanotechnology research strategy that establishes research priorities for the federal government and industry that will ensure the development and responsible stewardship of nanotechnology. This strategy will help to resolve the uncertainty that is one of the major obstacles to the commercialization of nanotechnology--uncertainty about what the risks might be and uncertainty about how the Federal government might regulate nanotechnology in the future.

The NANO Act also includes a number of provisions to create partnerships, raise awareness, and implement strategic policies to resolve obstacles and promote nanotechnology. It will: create a public-private investment partnership to address the nanotechnology commercialization gap; establish a tax credit for investment in nanotechnology firms; authorize a grant program to support the establishment and development of nanotechnology incubators; establish a Nanoscale Science and Engineering Center for ``nano-CAD'' tools; establish grant programs for nanotechnology research to address specific challenges in the areas of energy, environment, homeland security, and health; establish a tax credit for nanotechnology education and training program expenses; establish a grant program to support the development of curriculum materials for interdisciplinary nanotechnology courses at higher education institutions; direct NSF to establish a program to encourage manufacturing companies to enter into partnerships with occupational training centers for the development of training to support nanotechnology manufacturing; and call for the development of a strategy for increasing interaction on nanotechnology interests between DOE national labs and the informal science education community.

I look forward to working with Science and Technology Committee Chairman Gordon to incorporate these provisions as his committee works to reauthorize the Nation's nanotechnology research and development program.
 

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By Laurie N. Jacques:

Counterfeiting is widespread because it is lucrative and often difficult to detect. Nanowerk highlights the use of nanotechnology in the battle against counterfeit goods. Nanoencryption provides a new option for distinguishing between genuine and counterfeit goods, particularly pharmaceuticals.

Drug counterfeiting is particularly problematic because it compromises patient safety in addition to causing monetary losses and erosion of brand value. The Center for Medicine in the Public Interest estimates that counterfeit drug sales are growing at an annual rate of about 13% – nearly the twice the growth rate of genuine pharmaceutical products – and could reach $75 billion by 2010.

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Researchers at the Georgia Institute of Technology (Georgia Tech) have discovered that multi walled carbon nanotubes will remain suspended in water for a month or longer when combined with other organic materials.  The January issue of the journal Environmental Science & Technology , will fully report the findings by Assistant Professor Jaehong Kim, Professor Joseph Hughes, researcher John Fortner, and graduate student Hoon Hyung.  However, the initial conclusion from the experiments is that multi walled carbon nanotubes are easily dispersed throughout the environment due to their extended suspension in river water.  The nanotubes interacted with the organic material found in water from the Suwannee River, and as a result, remained suspended in the water.  As reported by Georgia Tech,  "Carbon nanotubes, which can be single- or multiwalled, are cylindrical carbon structures with novel properties that make them potentially useful in a wide variety of applications including electronics, composites, optics and pharmaceuticals."

This, of course, adds to the body of science regulators are looking to as the try to develop sound policy for governing nanotechnology.  Check back for updates as the full report on the experiment is released.

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Ed. note: every Friday (more or less) Nanotechnology Law Report's David Fischer will look back at the week’s news and analysis of nano related issues.  If you have something you’d like to bring to our attention, email him.

• The big event this week was the International Conference on Nanotechnology Occupational and Environmental Health & Safety in Cincinnati, Ohio.  Nanotechnology Law Report's John Monica filed two reports (one, two) and Nanotechbuzz's George Elvin filed one too.
• Nanopublic on why red milk is one nano product that will not work.
• Nanodot previews a new book by German physicist Jürgen Altmann of Dortmund University on military nanotechnology; it sounds very interesting (Responsible Nanotechnology also posts about this book).
• Nanotechbuzz on nanotechnology and toothpaste and nanotechnology and molecular computers.
• Nanotechnology Law Report's Patrick Lewis examines consumer attitudes towards nanotechnology and Michael Heintz on the Berkley City Council's consideration of code amendments to require additional reporting by companies which produce or use nanotechnology.
• The ASTM International Committee on Nanotechnology approved its first standard: Terminology of Nanotechnology.

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