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

The European Commission's Directorate General for Research has begun a public consultation regarding developing a new action plan for nanotechnology in the European Union nations, focusing on the "technological and societal challenges of the next five years and strengthening the research and innovation efforts, with increased emphasis on sustainable development, competitiveness, health, safety and environmental issues" that will arise during the plan's 2010-2015 time frame.

The consultation seeks comments from the general public, organizations, the corporate world, and public authorities. The consultation period will close on 02/19/2010, after which the Commission will publish a summary paper. Directions on how to submit contributions are available on the European Commission's website.

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Recently, the Times of London and the Daily Telegraph carried short articles about Dr. David Cox of the National Physical Laboratory and his use of a system normally used to create nanoparticles to create, using two tin beads fused together by a "blob of platinum" and a focused ion beam to carve the eyes, nose and smile

Well, it is that time of year.

However, there are some things that even nanotechnology cannot improve upon:

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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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This article was contributed by Dr. Rosalinda Volpe, Executive Director, Silver Nanotechnology Working Group (SNWG) 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.

On November 3 – 6, 2009 the US Environmental Protection Agency (EPA) held a Scientific Advisory Panel (SAP) meeting in Arlington, Virginia to discuss the “Evaluation of Hazard and Exposure Associated with Nanosilver and Other Nanometal Oxide Pesticide Products.”[1] The meeting was well attended. Over seventy-five people from industry, regulatory, public interest, and academic sectors attended the meeting over three days. EPA received presentations and comments from the SAP panel members during the course of the meeting, as well as six presentations during the Public Comment period, and also received over 560 written comments which can be found on EPA’s website.

One group—The Silver Nanotechnology Working Group (SNWG)[2] —made a detailed presentation[3] to EPA supporting a fundamental regulatory consideration previously overlooked by many in attendance: nanosilver has been rationally manufactured, regulated, and used commercially for over a century with no significant adverse environmental, health, and safety effects. SNWG explained that nanosilver—often called by other names such as "colloidal silver" or "millimicron silver"—has been used in a wide range of consumer applications such as swimming pool treatments and drinking water filters with an established record under FIFRA of regulated and safe use dating as far back as the 1950’s. Thus, SNWG believes that nanosilver is not a “new” material requiring some type of special regulation and EPA needs to look beyond general conceptions of nano terminology and consider the broader established regulatory record of nanoscale silver products within the Agency. Simply put, SNWG believes that calls for treatment of nanosilver as a new material requiring development of expensive new test regimes and discriminatory regulation are difficult to justify.

Moreover, SNWG explained at the meeting that a detailed look at the history of silver within EPA shows that the toxicological studies that form the center of EPA’s existing general hazard limits for silver are derived from historical data from nanoscale silver materials and not conventional (bulk) silver as is often mistakenly assumed. For example, SNWG’s careful examination of EPA’s public registration database[4] for silver over a period of 6 decades revealed:

• The very first registered silver product was a colloidal nanosilver algaecide product that has been safely used by millions of consumers for over 50 years (registered since 1954).
• Every EPA silver registration between 1970 and 1990 was either a colloidal nanosilver or nanosilver-composite product.
• The very first NON-nanosilver product registered by EPA was not registered until 1994.
• An overall analysis reveals that today over 50% of all EPA registered silver products are in fact based on nanoscale silver.

Based on its analysis, SNWG took the formal position that EPA has a range of existing regulatory structures that have successfully addressed silver materials across the size spectrum for over 5 decades. Additionally, EPA has not any incidents of significance on the Agency’s formal incident reporting database (EPA OPP IDS) – indicating that thorough monitoring of real-life use supports the safety of these products.

The SWNG congratulated EPA for its record of successful monitoring and risk management for these materials despite different terminologies being used throughout this time period. Indeed, SNWG pointed out that with nanosilver there is perhaps more historical data and evidence of safe use than for many other regulatory materials, and the EPA has the opportunity to assess nanosilver products with confidence given this long history of safe use under existing EPA regulatons.

The SNWG is hopeful that the EPA and the other meeting attendees will examine SNWG’s position and supporting information in more detail to confirm that nanosilver has been successfully regulated for decades. If sufficient consideration is given, SNWG believes that EPA will conclude that there is no need to “fix” a regulatory process that is not “broken,” but has worked exceedingly well for decades in the case of nanosilver.

References

1.  EPA Scientific Advisory Panel meeting, Arlington VA (November 3 - 6, 2009).

2.  SNWG is an industry effort intended to foster the collection of data on silver nanotechnology in order to advance the science and public understanding of the beneficial uses of silver nanoparticles in a wide-range of consumer and industrial products.

3.  SNWG “Evaluation of Hazard and Exposure Associated with Nanosilver and Other Nanometal Oxide Pesticide Products”, Presentation to Scientific Advisory Panel (November 4th, 2009).

4.  NPIRS Public.

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The nanotechnology field is going to be losing a valued friend in Congress at the end of the 111th Congress in 2010. Rep. Bart Gordon's office issued a press release today announcing that the Congressman would not be seeking reelection after the end of his current term. Earlier this year, Rep. Gordon introduced H.R. 554, the National Nanotechnology Initiative Amendments Act of 2009, which was passed by the House on February 12, 2009 and was received in  the Senate and referred  to the  Senate Committee on Commerce, Science and Transportation. The bill is still in that Committee.

While there is speculation that the Congressman is retiring due to polls that indicate a tougher re-election race than the Congressman has faced in recent years, we should take the Congressman's stated reasons, that having reached the age of 60 he wants to move on to the next stage in life and spend time with his family, at face value and wish him a good and healthy retirement. His leadership on the House Committee on Science and Technology, where he has served as Chairman since 2007 and his support of nanotechnology will be much missed.

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 Friends of the Earth - Australia (FOE-Aus) recently released a new report examining the presence of nanoparticles in cosmetics produced by such well known companies as Revlon, Max Factor, and The Body Shop.

In the press release accompanying the report, FOE-Aus noted that the labeling on cosmetics containers didn't reflect the presence of nanoparticles in the product:

“Of the ten products we surveyed, only one listed the use of nano-ingredients on the label. The government’s failure to require mandatory labeling of nano-ingredients denies women the capacity to make an informed choice about what they put on their skin.”
 

While this may be a legitimate complaint for the Australian regulatory agencies to consider, FOE-Aus loses much of its credibility by suggesting that the "big cosmetics companies" and nanotechnologies companies view Australian women as "guinea pigs" and by calling for

 a stop to sales of cosmetics that contain nano-ingredients, until the safety science catches up, and new laws are introduced to make companies test the safety of their products and to label all nano-ingredients,” said Ms Miller. “We are also calling for public participation in decision making about nanotechnology management”.
 

Considering the pace of legislation through any parliamentary body tends to be a slow process and that the issuance of regulations affecting labeling of products by the appropriate agencies would also be a long process, FOE-Aus is effectively calling for a moritorium on nano-based cosmetics for an unknown period of time.

It would be one thing if the report released by FOE-Aus supported these claims and demands. However, the report supports nothing at all.

As the report notes under the heading, "A General Note on the Study's Limitations":

This study was conducted with a limited budget and should be considered to be preliminary rather than comprehensive. Only a small number of observations of each sample were made. . . . While observations in this study of certain particle sizes does indicate that they were present in the cosmetics sampled, observations may not be statistically representative of the full sample. (Emphasis added.)

In another section of the report, we find this statement:

. . .  the particulates shown are those observed via SEM [ Scanning Electron Microscopy] and may not be representative of the average particle in the analysis. Such statistical analyses are time consuming to perform . . . and furthermore require human assisted particle identification to insure correct results. (Emphasis added)

According to anarticle in the Sydney Morning Herald, the Australian Cosmetic Trade Association has dismissed the report. Considering the limited number of products that were tested - just walk into the "Beauty Aids" section of any CVS and there will be more cosmetics than anyone can count -  and the limitations of the testing procedures that were done on them, the report that FOE-Aus presents is a weak base on which to make broad assertions about the safety of those products or to demand the shut down of an industry.

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I cannot forecast to you the action of Russia. It is a riddle wrapped in a mystery inside an enigma: but perhaps there is a key. That key is Russian national interest.

Winston Churchill, 1^st Lord of the Admiralty, BBC Radio broadcast Oct. 1, 1939.

In recent speeches to the United Russia annual congress and to the Federation Council, Russian President Dmitry Medvedev has sounded anew a theme that has been present in Russian politics since the days of Tsar Peter I the Great and Tsarina Catherine II the Great: the Russian economy is not as advanced as Europe’s or the United States.

In his speech to the Federation Council, President Medvedev stated that

We need to recognise that we have not done enough over these last years to resolve the problems we inherited from the past. We have not freed ourselves from a primitive economic structure and humiliating dependence on raw materials. We have not refocused our industry on consumers’ real needs. The habit of living off export earnings is still holding back innovative development. Russian business still prefers to sell goods produced abroad, and our own goods’ competitiveness is disgracefully low.

In this same speech and in an article, “Go, Russia” , President Medvedev presented his vision of a future Russia:

The foundation of my vision for the future is the firm conviction that Russia can and must become a global power on a completely new basis. Our country’s prestige and national prosperity cannot rest forever on past achievements. After all, the oil and gas production facilities that generate most of our budget revenue, the nuclear weapons that guarantee our security, and our industrial and utilities infrastructure – most of this was built by Soviet specialists. In other words, it was not we who built it. It is still keeping our country afloat today, but it is rapidly depreciating both morally and physically. The time has come for today’s generation of Russians to make their mark and take our country to a new, higher level of civilisation.

We have a duty to heed the lessons of recent events. So long as oil prices were growing many, almost all of us, to be honest, fell for the illusion that structural reforms could wait and that what was important now was to make maximum use of the high prices. The priority was on pushing ahead the old raw materials economy, while developing unique technology and innovative products was the subject of only random individual decisions.

But we can delay no longer. We must begin the modernisation and technological upgrading of our entire industrial sector. I see this as a question of our country’s survival in the modern world.

I hope the time is not far off when Russia’s prosperity will depend on our successes in developing a market for ideas, inventions and discoveries, and on the ability of our state and society to find and encourage talented individuals capable of critical thinking, and rear young people in a spirit of intellectual freedom and civic activeness.  (“Presidential Address to the Federation Assembly of the Russian Federation”)

I recently identified five strategic vectors for the economic modernisation of our country. First, we will become a leading country measured by the efficiency of production, transportation and  use of energy. We will develop new fuels for use on domestic and international markets. Secondly, we need to maintain and raise our nuclear technology to a qualitatively new level. Third, Russia's experts will improve information technology and strongly influence the development of global public data networks, using supercomputers and other necessary equipment. Fourth, we will develop our own ground and space infrastructure for transferring all types of information; our satellites will thus be able to observe the whole world, help our citizens and people of all countries to communicate, travel, engage in research, agricultural and industrial production. Fifth, Russia will take a leading position in the production of certain types of medical equipment, sophisticated diagnostic tools, medicines for the treatment of viral, cardiovascular, and neurological diseases and cancer. (“Go, Russia”)

Although not mentioned in either  “Go, Russia” or his speech to the Federation Council, one of the ways that President Medvedev may seek to bring Russia’s economy into the 21^st  century may be via the expansion of Russia’s nanoindustries. In an earlier speech opening the 2^nd Moscow International Nanotechnology Forum, President Medvedev outlined his plans for making Russia one of the dominant players on the nanotechnology scene:

We . . . have our own immodest goal in this area: we want to become leaders here – and for that we have the intellectual potential and the organizational and financial resources.

President Medvedev’s plan to achieve Russian leadership in nanotechnology consists of :

1) Attracting Russian émigré scienticists and technicians back to Russia

2) Organizing “a system of state orders for long-term procurement of innovative products”

3) Encouraging “ large, medium-sized and small businesses . . . to invest their money in nanotechnology”

4) “ Change tax and customs regimes”. “ We also need to create a green corridor for the export of hi-tech products as well as special conditions concerning customs clearance procedures . . . .”

5) “In addition, we have to modify a number of special laws, including those I mentioned in tax law, corporate law, and other laws concerning intellectual property protection. Finally, we need to adjust the system of technical regulation and create an up to date system of national standards, because the one we currently have is problematic.”

6) Improving technical training programs to provide a pool of trained professionals.

President Medvedev has proposed an ambitious plan, one which, if successful, could establish Russia as a major force in international nanoindustry and nanotechnology. But two obstacles could derail this plan before it could achieve any results.

As noted in his speech at the 2^nd  Nanotechnology International Forum, if the world economy recovers and the export of raw materials revives, the Russian economy might become dependent on the commodities markets again and not make the necessary changes to avoid the effects of future market collapses.

The second obstacle could be one that President Medvedev could not openly name in any speech: Vladimir Putin. As even casual observers of Russian politcs know, the real power in the Russian government does not lie in the Office of the Federation President, but in the office of Prime Minister Vladimir Putin. At this point in time, no one is sure if Prime Minister Putin intends to seek re-election as Prime Minister or seek the office of President again when elections roll around. If he does run for President and wins, then President Medvedev’s plans for the Russian nanoindustry will likely be forgotten.

In the more immediate future, it may be worthwhile to keep an eye on Russian Nanotechnologies (RUSNANO), the state owned corporation established during Putin’s Presidency and headed by Anatoly Chubais. According to a recent Agence France Press report, President Medvedev has given orders for it, along with other state own companies, to be partially privatized in 2010.

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