The new 2011 edition of Nanotechnology Law published by West/Thomson/Reuters is now out. I update the book every year and the new edition has lots of new stuff. They make excellent Christmas and Birthday gifts, and are a general cure for insomnia. All proceeds go to my underprivileged daughters’ college fund. Everyone should have one (or two). …
Readers may be interested in learning about a new subscription website devoted to nanoscale carbon — CNT Report.
CNT Report is dedicated to bringing its readers the most recent news concerning important issues affecting nanoscale carbon research, development, and commercialization. CNT Report closely covers all forms of nanoscale carbon in development on the global stage, including CNTs, graphene, fullerenes, specialty fibers, and all else in-between. CNT Report’s primary focus is on new scientific research developments, practical applications, finance, legal and regulatory issues, and general commercialization. CNT Report publishes news in several broad categories including: Business, Commercialization, Finance & Deals, Insurance, Intellectual Property, International Laws & Regulations, Policy, Standards, States, Science, Applications, Current Research, and Environmental, Health and Safety.
CNT Report also accepts press releases, research results, financial news, or any other news item related to nanoscale carbon which it then makes available to all of its subscribers. CNT Report welcomes timely contributions from its readers and makes sure that their articles receive proper attribution and credit.
One June 9, the President’s Office of Budget and Management, United States Trade Representative, and Office of Science and Technology Policy issued a joint memorandum directed to all Executive branch departments and agencies entitled "Policy Principles for the U.S. Decision-Making Concerning Regulation and Oversight of Applications ofNanotechnology and Nanomaterials."
The Policy Statement is important because it confirms a "best-science" approach to potential nano-EHS issues, rather than a reactionary approach. While this has been the stated approach of various federal agencies in the past, it is nice to see it reaffirmed across the entire federal government at the highest levels. The memorandum also reaffirms the importance of nanotechnology to the US economy, and recognizes the potential adverse economic consequences that knee-jerk regulation might have.
Perhaps most interesting is that the memorandum repeatedly refers to the sufficiency of existing regulations to deal with potential nano-related EHS risks. Some advocacy groups may have been holding out hope that the Obama administration would enact new nano-specific regulations. That is very doubtful given the tenor of the memorandum, which should provide industry with a measure of reassurance in this regard.
A food safety strategist for "As You Sow" recently indicated that the group is conducting a survey "of a wide selection of food manufacturers and retailers regarding their use of nanomaterials in food products." The group is also creating a "Nanofood Sourcing Framework" designed to guide food-related companies on the issues they should be considering before using engineered nanoscale materials in their products.
Interestingly, the strategist asked some major food-related corporations about their use of engineered nanoscale materials and believes that companies are "taking a precautionary approach." Evidently, McDonald’s, Pepsi, and Kraft all claim to be "nano-free." McDonald’s has an interesting post about the issue on its website:
McDonald’s Corporation is working to understand the use of nanotechnology and its applications in food and packaging products. Given the current uncertainty related to potential impacts of nano-engineered materials, McDonald’s does not currently support the use by supplies of nano-engineered materials in the production of any of our food, packaging or toys.
Regarding Kraft, the strategist wrote that Kraft "first posted a statement on their website in 2009 announcing that they are not using nanotechnology, although they did admit to be exploring nano applications for packaging. Two year later, Food Production Daily reports that ‘Kraft is one company to have taken a deliberate step away from the emerging technology.’" …
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 just published its "Recommendations for Addressing Potential Health Risks from Nanomaterials in California” which was commissioned by California’s Office of Environmental Health Hazard Assessment (OEHA). The document is 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. We previously provided our comments on the May 2010 draft of this document here. A year later, many of our same concerns still apply to the final document.
The new document makes a range of recommendations, which are set forth below:
Recommendations to address health risks from nanomaterials for OEHHA that can be achieved under the existing regulatory structure:
1. Develop a definition of nanomaterials that can be used to identify them.
2. Identify and define priority properties for risk characterization and collect information about them for each nanomaterial.
3. Develop characteristics by which to define, describe, and group nanomaterials according to conventional or unique properties.
4. Establish a publicly accessible clearinghouse and inventory of nanomaterial sources and products.
5. Identify and/or develop methods for monitoring nanomaterials in environmental media and through human biomonitoring.
6. Collect information on the fate and transport of nanomaterials, including through monitoring in environmental and biological media.…
Here is an advance copy of a new multi-walled carbon nanotube significant new use rule being published tomorrow in the federal register. It applies only to the specific carbon nanotubes that were the subject of PMN P-08-199, and binds anyone who intends to manufacture, import, or process the specific chemical substance. It is largely consistent with past SNURs and Consent Orders for other CNTs. For those wondering, "processors" and "processing" is broadly defined under TSCA. It has been used in the past to include repackaging for commercial purposes, using the material in the manufacturing of new mixtures, and/or the production of articles using the substance.…
The May 3, 2011 edition of Chemistry World carried an interesting article by James Urqhart — Titanate cigarette filter — regarding several Chinese researchers who have developed a cigarette filter which employs nanoscale TiO2 which supposedly filters out harmful tobacco smoke constituents. One of the researchers claims that "[a] great range of harmful compounds including tar, nicotine, ammonia, hydrogen cyanide, selected carbonyls and phenolic compounds can be reduced efficiently."
The article also maintains that the researchers are "confident that titanate nanomaterials used in filters do not pose a health risk to smokers by inhalation" because "TiO2 is already widely used in consumer products including sunscreens, cosmetics and food." Readers can judge the strength or weakness of this logic for themselves.
The article draws to mind Kent cigarettes with Micronite filters which were manufactured in the early to mid 1950s. Believe it or not, these particular Kent cigarettes utilized crocidolite asbestos in their filters because of its unique filtering properties. Readers can imagine the health-related lawsuits and judgments that followed.
Despite their unique filtering properties, mixing tobacco and engineered nanoscale materials in cigarette in this litigation environment is probably a bad idea.…
The NanoSafety Consortium for Carbon just submitted a proposed toxicity testing agreement to EPA under Section 4 of the Toxic Substances Control Act covering a range of nanoscale materials including multi-walled carbon nanotubes, double-walled carbon nanotubes, single-walled carbon nanotubes, and graphene.
Key elements for the curious:
- The chemical substances to be tested may include representative (i) purified multi-walled carbon nanotubes ranging from 4 to 600 nanometers in diameter and less than 30 micrometers in length; (ii) purified double-walled carbon nanotubes ranging from 1.5 to 4 nanometers in diameter and less than 5 micrometers in length; (iii) purified single-walled carbon nanotubes ranging from .7 to 2 nanometers in diameter and less than 30 micrometers in length; and (iv) purified graphene nanoplatelets in flake/sheet form ranging from .5 nanometers to 100 nanometers thick. All test materials will be purified by the National Institute of Standards and Technology to be at least 99 percent pure. Final test materials will be approved by the EPA and will be selected to adequately represent the constituency of the final signatories to the testing agreement.
- The characteristic for which testing will be conducted is subchronic inhalation toxicity in rodents, or such other toxicity testing as may be approved by EPA to achieve the intent and purpose of the testing agreement. As appropriate, consideration will be given to using in vivo instillation rather than inhalation test methods. Test data will be developed under standards based on TSCA test guidelines in 40 CFR parts 796,
“The New Steel? Enabling the Carbon Nanomaterials Revolution: Markets, Metrology, Safety, and Scale-up” is a workshop to be held on February 28th and March 1st, 2011, at NIST’s Gaithersburg, Maryland facility. NIST has assembled an outstanding roster of speakers from industry, academia and government to address the full spectrum of issues, including a special panel on EH&S.
If you can join the workshop, please register before the registry is filled! Remember that this will be a true workshop and participants are encouraged to actively share their views and perspectives over the two days, and also to provide if possible before the workshop commences a brief (2-page) white paper on one of the three breakout session topics, listed below, to help seed the discussions. If you prepare a white paper, please send it to TheNewSteel@nist.gov
The three topic areas for the workshop breakout sessions:
• Technology Challenges and Barriers for Carbon-based Nanomaterials • EH&S – From Regulation to the Marketplace • Measurement Issues and Grand Challenges
NIST contact information is below if you have any questions or would like to receive more information regarding the workshop.
J. Alexander Liddle, Group Leader Nanofabrication Research Group Center for Nanoscale Science and Technology National Institute of Standards and Technology Bldg. 216 Rm. B153 100 Bureau Drive, Stop 6203 Gaithersburg, MD 20899-6203 tel: 301 975 6050 fax: 301 975 5314 firstname.lastname@example.org http://cnst.nist.gov …
Presenting what looks to be a very interesting line-up of top-rate speakers, the American Bar Association’s Section of Environment, Energy, and Resources (Pesticides, Chemical Regulation, and Right-to-Know Committee) is presenting a webinar on January 27, 2011:
Nano Governance: The Current State of Federal, State, and International Regulation
Here is a summary of the webinar from ABA’s online announcement:
States, federal agencies, and foreign governments are challenged to address the risks and promote the benefits of evolving technologies, including nanotechnology. Companies globally are continuing to harness the properties of nanomaterials for use in products from airplanes to pharmaceuticals and from cosmetics to food packaging. Nano Governance: The Current State of Federal, State, and International Regulation will address these issues in a half-day program. This program will explore the new and creative applications of existing regulatory tools and governance approaches to address the potential risks of nanotechnologies, implement new risk assessment approaches to evolving technologies, and maximize the potential benefits of these materials. Panelists will report on new and emerging federal, State, and international nanomaterials regulations and governance strategies. Attendees will gain insight into potential public health and environmental impacts and the approaches various government agencies and industrial stakeholders are pursuing to address these issues while also promoting nanotechnology. The program is open to attorneys and other professionals with chemical regulatory compliance practices.
- Develop familiarity with new and emerging federal, State, and international nanomaterials regulations and governance strategies
- Understand Potential Public Health and Environmental Impacts and the approaches various government
My new Nanotechnology Law & Business article — "An Industry Driven Approach to EHS Issues: ‘The NanoSafety Consortium for Carbon’" — can be found here. The abstract follows.
The NanoSafety Consortium for Carbon (NCC) is an industry-driven group formed to proactively address potential environmental, health, safety, and regulatory concerns related to the commercia-lization of its members’ nanoscale carbon products. NCC was formed to take advantage of an offer by the EPA for a consortium of companies to providing testing regarding carbon nanotube toxicity. This article provides background on NCC’s activities, purpose, and goals.…
This article originally appeared on the National Nanomanufacturing Network’s InterNano website. It is licensed under Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Unported.
In its ongoing efforts to guard against potential unintended environmental, health, or safety injuries related to possible exposure to certain nanoscale materials, the US Environmental Protection Agency (EPA) plans to issue three new proposed nano-specific regulations in January 2011. While EPA is already actively regulating certain nanoscale materials which it considers new chemical substances (e.g./ carbon nanotubes, fullerenes, etc.), the new proposed rules will provide EPA with greater latitude in regulating both new and existing nanoscale materials. Manufacturers working with nanoscale materials should keep a very close eye on these new proposed regulations to determine whether they will be required to comply with any of EPA’s final rulings. Additionally, there will be opportunities for public comment and input.
Significant New Use Rule
Advocacy groups have been asking EPA for years to treat nanoscale versions of existing chemical substances as significant new uses of those substances under the Toxic Substances Control Act (TSCA). These types of substances include nanoscale silver, nanoscale TiO2, and nanoscale zinc oxide. Among other things, treating these materials as significant new uses of existing chemical substances would allow EPA to limit their production, require the use of workplace safety measures, require companies to conduct toxicity testing, and require companies to prevent intentional/purposeful releases of the materials to water.
Although its exact parameters have not been released, it appears that EPA intends to issue a proposed significant new …
California’s Department of Toxic Substances Control (CDTSC) held a conference today during which they identified the next six nanoscale materials they intend to target in their second round of data call ins. Regular readers may remember that CDTSC targeted 26 manufacturers/importers of carbon nanotubes with its first data call in in 2009.
In addition to identifying the nanoscale materials which will be the subject of the data call in, CDTSC also provided a preliminary list of manufacturers/importers that will receive the data call in, as well as the proposed questions they will be asked. We cover each material below.
CDTSC also indicated that carbon nanotube manufacturers/importers will receive a second round of data call in questions.
CDTSC plans to issue all of these new data call ins sometime before the end of the year. Stay tuned . . .
Proposed Questions: What is the chemical composition of your nanosilver material? What is particle size of your nanosilver material used? What is the concentration of nanosilver used in your material? What are the instrumental techniques used to characterize your nanosilver material?What are the analytical methods used in your nanosilver material? How do you measure and monitor fate and transport after useful life of your nanosilver material? How do you detect, measure and monitor releases during facility operations?
Preliminary Recipients: Nano Composix, Cambrios Technologies, Seashell Technology, Sun Innovations, Stanford Materials, MTI Corporation.
Nano Zero Valent Iron
Proposed Questions: What are the analytical methods for assessment of toxic effects and safe uses of nano zero valent iron across its …
Cal. DTSC and UCLA Present — Nanotechnology VI Symposium: ‘Progress in Protection’
This one-day workshop, on Wednesday, October 13, is sponsored by the California Department of Toxic Substance Control and UCLA. Leading scientists will discuss the latest strategies in protecting workers in the research, development and manufacturing of nanomaterials, and define further research and developmental needs relating to occupational safety and health.
Nanotechnology is an expanding field that has the potential to create many new materials and products with a huge range of applications. It is already being used in cell phones, stain-resistant clothes, cosmetics, disease detection and in medicine. Business projections suggest that nanotechnology could be a $1 trillion industry in the US by 2015.
Registration for this free conference and webcast is required.
The program presenters are leaders in university research, manufacturing and industry. They include:
Maziar Movassaghi, Acting Director, California Department of Toxic Substance Control
Andre Nel, M.D., Ph.D., Chief, Division of NanoMedicine, California NanoSystmes Institute; Director, UC Center for Environmental Implications of Nanotechnology
Mark Methner, Ph.D., CIH, Team Leader NIOSH Nanotechnology Field Research Team
Hilary Godwin, Ph.D. Professor, UCLA School of Public Health – Environmental Health Sciences; Education Director, UC Center for Environmental Implications of Nanotechnology
Wednesday, October 13, from 9 a.m. to 5 p.m.
UCLA California Nano Systems Institute. 570 Westwood Plaza, Building 114. Los Angeles CA 90095. Parking available on the UCLA campus $10. For more information contact: Teresa Lara, UCLA Luskin Center, email@example.com (310) 267-5435 or Charlotte Fadipe, DTSC, Cfadipe@dtsc.ca.gov …
Here is the Summer 2010 edition of NanoLawReport. Heading out to the beach for a few days to top off the summer. :)…
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 …
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.
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.
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.
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:
- Sporting goods: 4 tons (2009) versus 270 tons (2020)
- Aerospace/defense: less than 1 ton (2009) versus 67 tons (2020)
- Wind turbines: 130
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” …
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) …
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.
"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."
"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 …
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.…