UPDATE: NNI Bill in Senate
Perhaps the Senate is not as deliberate a body as I thought. On Thursday (7/31) the Commerce, Science, and Transportation Committee is set to "mark-up" S. 3274, the bill that would complete the next step in reauthorizing the National Nanotechnology Initiative. It is possible that the Committee will also vote the measure to the full Senate for further consideration. Remember, I suggested that if the Senate did not act quickly enough, the NNI was in danger of expiring entirely.
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Cambridge City Council Adopts Advisory Committee's Recommendations
This article was authored and contributed by Terrence F. Smith, Director of Government Affairs, Cambridge Chamber of Commerce.
The report of the Nanomaterials Advisory Committee was on the agenda at the July 28 meeting of the Cambridge City Council. The Council’s actions bode well for continued manufacturing, processing, research and development using nanotechnology in Cambridge. The Council accepted the report of the Nanomaterials Advisory Committee with little comment and placed the report on file.
The discussion was brief. Councillor Davis, who filed the original order, said she was satisfied with the report. City Manager Healy stated that the report is balanced and the next steps will provide the City with a better idea of who does what in Cambridge. He also said that the LEPC has prepared the survey recommended in the report. Councillor Murphy said that the report reflects on the strengths of the Cambridge Public Health Department and the ability of the City to bring together “World Class” experts on the Nanomaterials Advisory Committee.
There was a question about nanomaterials getting into the City water supply. The Manager stated that he did not know whether it is possible to test for nano, as the City had done for pharmaceutical products several months ago, but would look into it. It should be noted that Massachusetts strictly regulates industrial wastewater. The Council took no formal action regarding this request but this issue may come up again.
If readers wish to view the discussion, the video of the meeting should be posted later this week on the City of Cambridge website at http://www.cambridgema.gov/council-archive.cfm. The discussion took place beginning around 8:15 p.m. which would be about 2 hours and 45 minutes into the meeting.
Terrence F. Smith
Director of Government Affairs
Cambridge Chamber of Commerce
859 Massachusetts Ave.
Cambridge, MA 02139
Phone: 617-876-4213
tsmith@cambridgechamber.org
Cambridge Nanotechnology Advisory Committee Recommends Nanoscale Material Registration
Cambridge, Massachusetts Nanotechnology Advisory Committee
Recommends Registration of Engineered Nanoscale Materials
Deadline for Similar Voluntary Registration Program by U.S. EPA Closes
Washington, D.C. – July 28, 2008 – Porter Wright attorney John C. Monica, Jr., served as part of the Nanotechnology Advisory Committee of Cambridge, Massachusetts (NAC), which, after a year of deliberation and information gathering, recommended that the City require the registration of engineered nanoscale materials within city limits. The Cambridge City Counsel is set to adopt those recommendations at a meeting scheduled for tomorrow. Cambridge – host to approximately one dozen nanotechnology-related businesses – is just the second U.S. city (behind Berkeley, California) to require registration of nanomaterials.
“Interest in regulating nanotechnology has increased in recent years due to the recognition that certain materials may take on new and unexpected properties when they are engineered at the nanoscale,” said Monica, a partner in the Washington, D.C. office of Porter Wright Morris & Arthur, LLP and a recognized national authority on nanotechnology product liability and environmental health and safety issues. “The City of Cambridge has approached nanotechnology in a very deliberate, considered manner and appears poised to take steps that promote public safety without stifling nanoscale innovation,” he continued.
The NAC – comprised of citizens, scientists, industrial hygienists, university faculty, nano-businesses, and private environmental consulting firms – also recommended that Cambridge’s City Counsel act to assist businesses with updates to health and safety plans for workers; educate the public; track health and safety developments; and monitor regulatory initiatives in other jurisdictions.
The City’s steps follow closely on the heels of the July 28, 2008 deadline for the first phase of the United States Environmental Protection Agency’s (EPA’s) voluntary registration program – the Nanoscale Materials Stewardship Program (NMSP). NMSP asked companies to report voluntarily to EPA existing data concerning nanoscale materials’ uses, hazards, exposure levels, and risk-management practices. To date, about 20 companies have provided or promised to provide information.
For more information regarding nanotechnology-related legal issues, visit www.nanolawreport.com.
Porter Wright Morris & Arthur LLP is a nationally recognized law firm with more than 250 lawyers in its offices in Washington, D.C.; Cincinnati, Cleveland, Columbus, and Dayton, Ohio; and Naples, Florida. Porter Wright provides counsel to a worldwide base of clients.
EPA's Nanoscale Materials Stewardship Program Receives New Submissions
The first phase of EPA's voluntary Nanoscale Materials Stewardship Program (NMSP) closes on Monday. For those keeping track, the most up-to-date NMSP participation statistics as of July 24, 2008 follow. It is shaping up to be a very respectable list of participants.
Submissions Under Basic Program: (9 submissions - covering 68 nanoscale materials) DuPont; Nanophase Technologies Corporation; Nantero; Office ZPI; Quantum Sphere; Strem Chemicals; Swan Chemicals Inc.; Unidym; and one Confidential Business Information Submission.
Commitments to Submit Information Under Basic Program: (11) Arkema; BASF Corporation; Bayer Material Science; Dow Chemical; Evonik/Degussa; General Electric; International Carbon Black Association; Nanocyl North America; PPG Industries; Sasol North America; and Synthetic Amorphous Silica and Silicate Industry Association.
Commitments to Participate in the In-Depth Program: (2) Swan Chemicals Inc.; and Unidym.
Recommendations for New Nano-Specific Regulation
As Mike Heintz reported earlier today, the Woodrow Wilson International Center for Scholars' Project on Emerging Nanotechnologies issued a report yesterday providing some guidance regarding where it believes the next administration should start with the issue of nanotechnology regulation next January.
J. Clarence Davies, "Nanotechnology Oversight: An Agenda for the New Administration," Woodrow Wilson International Center for Scholars, Project on Emerging Nanotechnologies, PEN 13, July 2008.
Among other suggestions, Mr. Davies advocates enacting new nano-specific legislation in the following areas.
TSCA: Mr. Davies offers specific legislative language for amending TSCA "to make clear that nanomaterials are covered as new substances." Other changes he suggests: "remove the catch-22 that requires EPA to show that a new chemical poses a risk before the agency can obtain enough information to determine whether it actually poses a risk;" "remove the conditions and requirements that guarantee that EPA can never regulate an existing substance;" and narrow TSCA’s confidential business information and data sharing provisions.
FFDCA: Mr. Davies argues the FFDCA should be amended to require submission and review by FDA of cosmetic active ingredient registration information. He further maintains that "FDA should also be authorized to forbid marketing of any cosmetic containing an ingredient that is not safe or for which adequate test data are not available," and that applicable FDA laws should be altered "to make clear where and how to draw the line between a drug and a cosmetic." Mr. Davies additionally recommends requiring premarket safety testing on food and cosmetic ingredients incorporating nanoscale materials, and increased post-marketing surveillance and reporting.
DSHEA: Mr. Davies calls for amending DSHEA so that it does not prohibit "FDA from imposing testing or approval on dietary supplements (vitamins, herbs, etc.) and placing the burden of proof on FDA to provide that a supplement is safe."
Other recommendations by Mr. Davies beyond long-term regulatory action are:
Research: dramatically increase federal nano-related EHS research funding (FY 2009 - $100 million; FY 2010 - $150 million), require a federal peer-reviewed EHS research plan; strengthen NNI; encourage separation of NNI promotional and oversight functions; and establish a Nanotechnology Effects Institute.
Regulatory Coordination: establish an interagency group devoted solely to nanotechnology regulation; develop a nanotechnology plan within each agency; and improve intergovernmental coordination.
Resource Requirements: increase regulatory agency budgets and staffing.
EPA: define nanomaterials as "new" chemical substances and/or "significant new uses" of existing chemical substances under TSCA; promulgate a new compulsory information collection rule under TSCA Section 8; expand regulation of anti-microbials under federal pesticide law; promote "green" technology; and evaluate the application of other EPA statutes to nanotechnology.
FDA: establish criteria for determining which nanomaterials are "new" for regulatory purposes; collect information on safety testing, forthcoming products and adverse effects; regulate cosmetics and dietary supplements.
OSHA: communicate to workers and firms about nanotechnology; use existing OSHA regulations to deal with nanoparticles; issue OSHA standards for nanomaterials.
CPSC: hire new staff to study nanotechnology exposure; create a chronic hazard advisory panel for nanotechnology products posing significant exposure risks.
Voluntary Efforts: use the DuPont-Environmental Defense framework as a basis for analyzing nanotechnology risks; issue a nanotechnology handbook for small businesses.
Public Involvement: give the public more information about nanotechnology; obtain the public's views about nanotechnology; convene a stakeholder dialogue.
Mr. Davies concludes his article with an interesting analogy: "[N]anotechnology comes in a treasure chest of riches and a Pandora's box of evils. The challenge of the new century and to the new administration is to use the treasure while keeping shut the lid on the Pandora's box."
Nanotechnology Blueprint for the Next President
J. Clarence Davies, formerly of the Environmental Protection Agency, has written and released a nanotechnology policy "roadmap" for the next White House Administration. The 28-page document outlines the immediate and long-term issues present with nanotechnology regulation and oversight.
Published by the Project on Emerging Nanotechnologies, the report focuses on use of existing laws and regulations, but suggests that policy changes will be needed to account for long-term regulatory efforts. He cites specifically to the Food, Drug, and Cosmetic Act, Toxic Substances Control Act, and Consumer Product Safety Act as those statutes that need "radical revision" in order to adequately address nanotechnology concerns.
I tend to agree with Mr. Davies overall thoughts and conclusions that the fate of nanotechnology regulation (or the lack thereof) rests with the next President, and that significant shifts in policy or conventional thinking will be needed in certain circumstances to protect people and the environment. However, I am surprised at the abbreviated nature of the paper. Perhaps there is more detail coming from Mr. Davies in the future, and this is simply the first of many more lengthy policy and/or regulatory specific thoughts from him.
California Considering Statewide Nano Regs
At least one California legislator is said to be considering statewide legislation to "monitor and regulate" nanotechnology in the state. Assemblyman Mike Feuer chaired a meeting on April 23 at UCLA to discuss options for developing nanotech regulation without impairing its growth. Assemblyman Feuer is one of the leading voices in California concerning nanotechnology regulation.
Continue Reading...Nanotechnology Standards for Health, Safety, and Environmental Factors
This Article Was Authored and Contributed by the American National Standards Intititute
This second article in a series on nanotechnology standardization introduces the international working group that, under US leadership, is creating the standards needed to support the health, safety, and environmental aspects of nanotechnology.
In the post-war era of the late 1940s, global leaders of government and industry formed a central body to “facilitate the international coordination and unification of industrial standards.” Twenty-six member nations came together in 1947 to form the International Organization for Standardization (ISO).
ISO and its national member bodies – including the American National Standards Institute (ANSI) – are constantly evolving to meet changing demands. Today, ISO is addressing issues such as industrialization, the advancement of information technologies, quality, the environment, and the health and safety of workers and consumers. Today, roughly one of every twenty ISO standards addresses issues pertaining to health, safety or the environment.
Continue Reading...Canada Issues Report on Regulatory Challenges Facing Nanoscale Materials
An expert panel on nanotechnology was convened by Health Canada to conduct an eight month research project assessing "the state of knowledge with respect to existing nanomaterials properties and their health and environmental risks, which could underpin regulatory perspectives on needs for research, risk assessment and surveillance."
Council of Canadian Academies, "Small is Different: A Science Perspective on the Regulatory Challenges of the Nanoscale," July 2008.
Notable findings by the panel were: uncertainty in regulation and science can hamper commercial development of new products, the private sector prefers regulatory certainty, "[a]t present, it is not possible to implement a robust and reliable 'science based' regulatory approach to nanoproducts," the cornerstone of Canada's use of the precautionary principle means that there should be prior approval of a product before entry into commerce if any health uncertainty is displayed, and regulation should only follow after meaningful public input.
As a result of its broad survey, the panel found that while "it is not necessary to create new regulatory mechanisms to address the unique challenges presented by nanomaterials, existing regulatory mechanisms could and should be strengthened." Specific recommendations include:
- Development of interim terminology and classification for nanomaterials to facilitate EHS research;
- Possible modification of regulatory triggers for when a new nanoscale material/substance should be reviewed for possible EHS risks;
- Development of standard safe-handling procedures/techniques for nanoscale materials;
- Development of new worker, consumer, and environmental surveillance metrologies;
- Use of an adaptive life-cycle approach when analyzing potential nano-related EHS risks; and
- Facilitation of adequately funded intra and inter government EHS research.
The panel's report concludes with what has become the "gold-standard" summation for nanotechnology reports: "Research is needed to identify these properties of a nanomaterial that enables it to elicit an adverse biological response. Further research is needed to identify appropriate regulatory responses regarding nano-material exposure."
Nano-Silver EHS Backgrounder
With all of the interest in nanosilver generated by the recent EPA petition filed by the International Center for Technology Assessment, I thought I would post some background material on EHS issues surrounding silver. A couple of disclaimers: the material is not comprehensive, and you might see parts of it again in "Nanotechnology Law and Policy" which should be published by Thomson-West legal publishers sometime in 2009 (if I can keep pace with the production schedule).
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NNI Reauthorization Stalling in Senate
Today's lesson is: never count your chickens before they hatch. You'll remember a few months back, the House overwhelmingly passed legislation reauthorizing the National Nanotechnology Initiative, and slightly modifying some of the work they do. At the time, I surmised (to myself) that passage through the Senate was likely to be quick. Perhaps not.
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Senators Propose New Nanotechnology Prize
Earlier today, Senators Snowe and Widen introduced a bill in the Senate that would create a Nanotechnology Innovation Prize in up to four areas: green nanotechnology, alternative energy applications, improvements in human health, and the commercialization of consumer products. Senator Wyden stated that the prize is "a vital tool to help ensure that public and private resources will be utilized in a coordinated way and will be devoted to solving the complex and pressing problems that America faces today. This bill will also spur technological investment and create jobs here at home." You can see Senator Wyden's full statement regarding the bill here, and Senator Snowe's press release here.
"nano" The Magazine for Small Science
Our readers might be interested in this month's edition of nano magazine which features a short article entitled "Asbestos Repeated? Assessing Risk in Nanotube Technologies." The article discusses the recent Poland/Donaldson paper published in nature nanotechnology that has been getting so much attention. Beyond the article, this much recommended magazine is published in the UK and features articles on international nanotechnology research, development, and commercialization. You can download a copy of the magazine here. Be sure to sign up for future editions by emailing subs@nanomagazine.co.uk.
The Geckos Are Back!
Remember way back, when we first started related interesting nanotechnologies of note, and there was a short story on the gecko's ability to walk on walls? (Here's a hint: go read this story). Well, they're back!
Earlier this week, the NPR show Marketplace did a story on the research currently being done to study the gecko's ability to climb walls and ceilings by using nano-hairs on its feet to create new adhesives that are strong and reusable. Its a fun story to listen to and is a good reminder of the things that are already out there in nature making use of nanomaterials that may have other uses in our lives. Sometimes the best idea is right in front of us in nature. Enjoy!
New Lux Nano-EHS Summary
A new Lux Research quarterly report -- "Nanomaterials State of the Market Q3 2008: Stealth Success, Broad Impact" -- contains a section summarizing the state of nano-related environmental, health, and safety issues in the United States. The report contains a very helpful time-line of key nano-related EHS events occurring between the fourth quarter of 2007 and the third quarter of 2008.
Other highlights are Lux's findings that the rate of nano-related publication has doubled in recent years; studies regarding the potential EHS concerns of nanoscale metals are approaching parity with publications concerning carbon and ceramic nanoscale materials; research papers on possible nano-related hazards far exceed those on possible nano-related exposures; there has been a demonstrable increase in research studies on possible nano-related ecological risks; public opinion regarding nanotechnology is mixed, but not negative; and NGO's are still pushing for more regulatory action. Lux, of course, offers detailed analysis on all of these issues, and you can find out how to purchase a copy of Lux's highly regarded report at http://www.luxresearchinc.com/contact.php
Lux, however, reached one conclusion with which we respectfully disagree. Lux thought the media coverage of the recent Poland Nature Nanotechnology article was "reassuringly judicious." You can see our prior post here which reflects our view that the media coverage of the asbestos-carbon nanotube analogy posited in the Poland article was overblown in our opinion.
C. Poland, et al., "Carbon nanotubes introduced into the abdominal cavity of mice show asbestos-like pathology in a pilot study," Nature Nanotechnology, May 20, 2008.
New Australian Nano-Regulation Report
The Australian Office of Nanotechnology recently released a report prepared for the Australian government by the Centre for Regulatory Studies at Monash University -- "A review of possible impacts of nanotechnology on Australia's regulatory framework."
Among other things, the report identifies six possible gaps in existing Australian law and regulations which might be of concern in the context of nanotechnology:
1. Some nanoscale materials may not be considered the same chemical substances as their bulk counterparts;
2. Weight or volume-based regulatory triggers may not be appropriate for nanoscale materials;
3. There is insufficient knowledge concerning the potential adverse environmental, health, and safety affects of nanotechnology;
4. Current risk assessment protocols may be insufficient for nanoscale materials;
5. Current research and development exemptions in Australian law may need to be closed; and
6. To the extent the existing Australian regulatory framework incorporates external guidelines and standards, those may need to be adjusted to adequately cover nanotechnology.
Additionally, pages 25 through 27 of the report provide a handy chart of the existing Australian regulations which the authors believe may be applicable to nanotechnology.
Clearly, a lot of thought and work went into the report. It is well worth reading.
Potential Ocular Uptake of Nanoscale Materials
Last week we said we would look and see what we had on this topic. Of the articles we found, the one most on point was:
J. Roberts, "Phototoxicity and cytotoxicity of fullerol in human lens epithelial cells," Toxicology and Applied Pharmacology, Vol. 228, at 49-58 (2008).
The article reports on a study of the ocular toxicity of hydroxylated fullerenes which "determined that fullerols are both cytotoxic and phototoxic to human lens epithelial cell model system in the presence of either UVA or visible light." The researcher exposed human lens cells and whole rat eye lenses to a fullerol suspension for 24 and 1 hour periods, both in the dark and in visible light. Both the human lens cell and the rat lenses absorbed some of the fullerene solution. The author reports that "fullerol exhibits both dark cytoxicity and phototoxic effects on human lens epithelial cells." This could theoretically cause a loss of lens transparency, leading to cataracts. The study concludes that "before fullerols are used in the future to deliver drugs to the eye, their potential side effects on the human eye should be further examined."
Other articles we found were:
A. de Compos, et al., "Chitosan nanoparticles as new ocular drug delivery systems: in vitro stability, in vivo fate, and cellular toxicity," Pharmaceutical Research, Vol. 21, No. 5 (May 2004). ("No inherent toxicity can be attributed to the [Chitosan] nanoparticles at concentrations as high as 2mg/ml. In addition, the viability of the recovered cells was totally preserved irrespective of the nanoparticles concentration.");
M. Alonso, et al., "The potential of Chitosan in Ocular Drug Delivery," Journal of Pharmacy and Pharmacology, Vol. 55, at 1451-1563 (2003). ("Preliminary studies performed in conjunctival cell cultures have shown the low toxicity of Chitosan nanoparticles.");
B. Short, "Safety Evaluation of Ocular Drug Delivery Formulations," Techniques and Practical Considerations, Toxicology Pathology, Vol. 36, at 49-62 (2008);
Y. Diebold, et al., "Ocular drug delivery by liposome-chitosan nanoparticles complexes (LCS-NP)," Biomaterials, Vol. 28, at 1553-1564 (2007);
J. Bourges, et al., "Ocular Drug Delivery Targeting the Retina and Retinal Pigment Epithelium Using Polyactide Nanoparticles," Investigative Ophthalmology & Visual Science, Vol. 44, No. 8 (2003); and
R. Bejjani, et al., "Nanoparticles for gene delivery to retinal pigment epithelial cells," Molecular Vision, Vol. 11 at 124-132 (2005);
NanoMedicine Summit 08
Our friends at NorTech, Case Western Reserve University, and the Cleveland Clinic have just announced their NanoMedicine Summit 08 which will be held in Cleveland, Ohio on September 25 and 26, 2008. The Summit will cover the use of nanotechnology in imaging, drug delivery, biological investigation, basic nanomedicine research, and gene therapy. September is a great time to visit Cleveland, so make plans now to attend.
Nanotechnology Oversight: An Agenda for the New Administration
On July 23, 2008, the Woodrow Wilson International Center for Scholars' Project on Emerging Nanotechnologies is releasing a new report written by J. Clarence (Terry) Davies:
"Nanotechnology Oversight: An Agenda for the New Administration"
Regular readers will recall Mr. Davies is a former high-ranking EPA official and is currently a senior advisor to PEN and also to Resources for the Future. PEN has previosuly previously published Mr. Davies' widely cited report "EPA and Nanotechnology: Oversight for the 21st Century," and Mr. Davies also spoke on a panel at the Nanogovernance 2008 conference which was co-sponsored by GW Law, Porter Wright, and the Environmental Law Institute.
We look forward to the release of Mr. Davies' new report and will post an article with our initial thoughts about it shortly thereafter. Stay tuned . . .
DuPont/ED Nano Risk Framework Published in Three New Languages
Nano Conferencing
Every now and again, we post information on upcoming conferences and seminars that might be of interest to our readers. We hope you like them, everyone needs a good conference to go to now and again. But, its hard to keep up on everything. Not to worry! Keep an eye on www.NanoConferences.com, a one-stop shop for nanotechnology conferences! The site is date, keyword, and location (for those extra warm or sandy locales) searchable, and includes conferences and seminars worldwide. Given how quickly the sector continues to move, having one source for all conference listings is certainly worth checking now and again. Enjoy and travel safely!
Environmental Pollution from Nanosilver Socks?
A recent study by two Arizona State University researchers found that socks made of fabric incorporating nanoscale silver may potentially release that silver into wash-water.
T. Benn, et al., "Nanoparticle Silver Release into Water from Commercially Available Sock Fabrics," Environmental Science & Technology, Vol. 42, at 4133-4139 (2008).
Why put silver in your socks? Because it is a well-known antimicrobial agent and microbes cause sock odor. Kill the microbes, and your feet smell fresh. At least that's the marketing angle.
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Nano Contact Lens
While it's not really related to legal issues, it certainly is a captivating idea. The Guardian reports that a University of Washington Scientist is developing a contact lens LED display that uses nanoscale circuits. If it works, the lenses may be powered by either solar or radio-frequency power transmission, and could be theoretically used to superimpose text messages, direction indicators, or even close captioning on the eye itself. Bio-compatibility is an issue. If the idea seems futuristic, readers may recall Arnold Schwarzenegger's Terminator character had this same set up way back in 1984. Hmm . . . it seems to me that there were some fairly recent papers on potential ocular uptake of nanoscale materials a while back. We will track this down over the next week or so. Stay tuned . . .
OECD To Begin Testing Nanoparticles
On June 2, 2008 the Organization for Economic Co-operation and Development (OECD) released the first stage in its effort to study the impacts of certain nanoparticles. In 2006, the OECD formed its Working Party on Manufactured Nanomaterials to implement the "Project on Safety Testing of a Representative Set of Manufactured Nanomaterials." The Project was divided into two parts: 1) develop a priority list of nanomaterials currently, or soon to be, in commerce, for health impact study, and 2) develop a program for the testing and understanding of those nanomaterials. The June 2 report is the culmination of the first step--the creation of list of nanomaterials to be studied.
Continue Reading...REACH and Labor Unions
Labor unions in Europe have called for stricter regulation of nanomaterials under the EU's REACH regulations of chemicals. The unions are concerned about the protection of worker safety throughout the life cycle of nanomaterials.
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