Nanotechnology Law Report

EPA to Reverse Position on 'Existing' Nanomaterials

John C. Monica, Jr. — Thu, 04 Feb 2010 11:10:12 -0500

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 . . .

The Nanotechnology Education Act

Robert Oszakiewski — Mon, 01 Feb 2010 14:34:40 -0500

The Nanotechnology Education Act (H.R. 4502), was introduced early last week by Rep. David Wu (D-1st-OR) and co-sponsored by Rep. Daniel Lipinski (D-3rd-Ill). The bill has as it's purpose the establishment of a grant program aimed at helping secondary schools, colleges and universities to established and improve nanotechnology education programs and facilities.

The bill notes that nanotechnology "is generating scientific and technological breakthroughs that will benefit society by improving the way many things are produced" and that

Nanotechnology is likely to have a significant, positive impact on the security, economic well-being, and health of Americans as fields related to nanotechnology expand.

the bill announces its formidable goal:

In order to maximize the benefits of nanotechnology to individuals in the United States, the United States must maintain world leadership in the field, including nanoscience and microtechnology, in the face of determined competition from other nations.

To maintain that level of world leadership

the United States must make a long-term investment in educating United States students in secondary schools and institutions of higher education, so that the students are able to conduct nanoscience research and develop and commercialize nanotechnology applications.

Preparing United States students for careers in nanotechnology, including nanoscience, requires that the students have access to the necessary scientific tools, including scanning electron microscopes designed for teaching, and requires training to enable teachers and professors to use those tools in the classroom and the laboratory.

H.R. 4502 states it's purpose:

is to strengthen the capacity of United States secondary schools and institutions of higher education to prepare students for careers in nanotechnology by providing grants to those schools and institutions to provide the tools necessary for such preparation.

The Director of the National Science Foundation would be directed to "establish a nanotechnology in the schools program". To support the program, "the director shall award grants of not more than $400,000 to eligible institutions". The bill would define "eligible institutions" very broadly and would include:

1) public, private, parochial and charter schools offering one or more advanced placement science courses,

2) community colleges,

3) four year institutions of higher learning (colleges and universities), and

4) "informal learning science and technology centers". The bill does not define these informal centers any further, but this may be clarified and defined further in a committee mark-up session.

Grant funds would be used for

1) the acquisition of equipment and software for use in classrooms

2) to develop and provide educational services; that is, it would be used by teachers and other instructors to develop classes in nanotechnology

3) to pay for teacher education in nanotechnology

Equipment and software purchased with grant funds by colleges and universities would be required by the bill to be used primarily by undergraduate programs and would also be required to be mostly made in the United States.

The Director of the NSF, no later than six months following passage of HR 4502 and it's being signed into law, would need to establish the process and procedures for eligible institutions to apply for the grants. The procedures, like all other procedures for applying for government grants, would need to be published in the Federal Register and commented on by the public before going into effect. Although the bill doesn't state it, the procedures would probably also be posted to a government website for downloading. In selecting recipients for these grants, the Director would

(1) select geographically diverse institutions; grants could not all be given to institutions in one area, for example, schools in New England or California. The grants would need to be spread around the United States.

2) The Director of NSF would be required to encourage the applications of Historically Black Colleges and Universities and minority institutions as defined by section 365 of the Higher Education Act of 1965 (20 U.S.C. 1067k).

3) Select recipients located in states participating in the Experimental Program to Stimulate Competitive Research.

Institutions receiving these grants would need to raise funds equal to 1/4 of the grant amount. And, if the grant exceeds $100,000, the institution would need to wait for 2 years before it could apply for another grant. Each institution would be required to submit a report to the Director of the NSF no later than one year after the grant was awarded regarding its use of grant funds. Every three years, the Director would, on the basis of these reports, evaluate the program, assessing both short and long term impacts of activities supported by the grants. No later than six months after the evaluation, the Director would submit a report to Congress - in its current form, the bill doesnot specify which committee or committees the report would be submitted to. Again, this is something that may be clarified in a committee mark-up session. The Director's report would contain "recommendations concerning the continued need for Federal support of the program. . . ."

HR 4502 authorizes an appropriation of $40 million for FY 2011 and necessary funds for 2012-2014. The bill has been assigned to the House Committee on Science and Technology. No hearings have been scheduled.

To date, only a handful of colleges and universities offer courses or degree programs in nanotechnology, leading to a shortage of trained workers available for the jobs that are and will be created in nanoindustries. The grants that the Nanotechnology Education Act would distribute would represent an investment in preparing a trained workforce capable of stepping into those jobs.

It should be noted, however, that the bill is being introduced against the shadow of President' Obama's statement in in State of the Union speech to freeze all discretionary spending by the federal government for three years:

Starting in 2011, we are prepared to freeze government spending for three years. Spending related to our national security, Medicare, Medicaid, and Social Security will not be affected. But all other discretionary government programs will. Like any cash-strapped family, we will work within a budget to invest in what we need and sacrifice what we don't. And if I have to enforce this discipline by veto, I will.

As with other nanotechnology related legislation filed during the 111th Congress, we'll monitor HR 4502's progress and provide updates.

The Nanotech Regulatory Document Archive

Robert Oszakiewski — Fri, 29 Jan 2010 18:44:36 -0500

The Center for the Study of Law, Science & Technology, part of the Sandra Day O'Connor College of Law at Arizona State University, Monash University Law School, and the Institute of Environmental and Energy Law jointly created the Nanotech Regulatory Document Archive in 2009. The archive is a free and easily searchable database of, as the name implies, documents regarding the regulation of nanotechnology, nanomaterials and nanoindustry produced by national and state governments, government agencies, and others throughout the world. Users are supposed to create an account in order to access the documents, which are in PDF formats, however the documents seem to be accessible even without setting up an account. Users may also add documents to the archives collection, which does require registering and setting up an account. Documents can either be accessed via the "Recent Documents" tab at the top of the page, by clicking on one of the countries listed on the left hand side of the page or via the search box

The database will prove useful for various groups, ranging from the general public who are just curious to business people in the nanoindustrial field who want to see what the rules and regulations are in other countries to elected representatives ( or more likely their staffs who would need to do the research in the area) who, inevitably, will be engaged in debates over the writing and enforcement of laws and regulations. Corporate Counsels for nanotech companies and outside counsels may also find it a useful place to do research for their clients who are thinking of expanding into other countries and need to see what regulations are already in place.

The database was funded by a multi-year grant from the US Department of Energy. Due to its relatively recent establishment, there are a limited number of documents available, but I suspect that as word of it gets around and more people realize its usefulness, the database will grow.

The Nanotechnology Safety Act of 2010

Robert Oszakiewski — Mon, 25 Jan 2010 13:50:08 -0500

On Thursday 01/21/2010, Senator Mark Pryor (D-Ark) introduced S. 2942, "The Nanotechnology Safety Act of 2010", the first nanotechnology related bill of the 2nd session of the 111th Congress. The bill is co-sponsored by Senator Benjamin Cardin (D-MD). The text of S. 2942 has not yet been made available by the Government Printing Office; the link above is to Senator Pryor's introductory remarks in the Congressional Record. The text of S. 2942 as introduced follows the Senator's remarks.

In his introductory remarks Senator Pryor stated that the bill would "authorize a program of scientific investigation by the Food and Drug Administration on nanotechnology based medical and health products . . . . [to] enable the FDA to properly study how nanomaterials are absorbed by the human body, how nanomaterials designed to carry cancer fighting drugs target and kill tumors, and how nanoscale texturing of bone implants can make a stronger joint and reduce the threat of infection."

Senator Pryor also noted in his remarks that

The FDA needs the tools and resources to assure the public that nanotechnology-based medical and health products are safe and effective. The development of a regulatory framework for the use of nanomaterials in drugs, medical devices, and food additives must be based on scientific knowledge and data about each specific technology and product. Without a robust scientific framework there is no way to know what data to collect. More than a dozen material characteristics have been suggested even for relatively simple nanomaterials. Without better scientific knowledge of nanomaterials and their behavior in the human body, we do not know what data to collect and examine.

. . . the Nanotechnology Safety Act of 2010 will provide the FDA the authority necessary to scientifically study the safety and effectiveness of nanotechnology-based drugs, delivery systems, medical devices, orthopedic implants, cosmetics, and food additives regulated by the agency. This bill is a sound investment on the promise of nanotechnology to improve human health and reduce costs in the 21st Century.

The Nanotechnology Safety Act of 2010 would amend Chapter X of the Federal Food, Drug and Cosmetic Act by adding section 1011. There would be three major parts to this new section.

Part 1 would establish a program within the FDA to investigate

(A)nanomaterials included or intended to be included in products regulated by the FDA

(B) the potential toxicity of such nanomaterials

(D) the interaction of nanomaterials with biological systems.

S.2942 would also establish that the new program's purpose would include (1) assessment of the scientific literature and data on the general interaction of nanomaterials with biological systems and on specific nanomaterials of concern to the FDA (2) develop and organize information using databases and models that would enable the formation of general principles about the behavior of classes of nanomaterials with biological systems (3) promote collaborative efforts to understand the properties of nanomaterials that might contribute to possible toxicity (4) promote and participate in collaborative efforts at measurement and detection of nanomaterials (5) collect, interpret and make available scientific information and data about the interaction of nanomaterials and biological systems (6) build scientific expertise on nanomaterials (7) insure ongoing training and dissemination of new information (8) encourage FDA participation in international and national standards activities and (9) carrying out other activities that the Secretary of Health & Human Services (HHS) determines are necessary.

Part 2 of the new section, "Program Administration" would create the position of a program manager. The position's duties would include developing "a detailed strategic plan for achieving specific short and long term technical goals . . . .", co-ordinate and integrate the strategic plan with investments from FDA and other agencies and departments that participate in the National Nanotechnology Initiative (NNI) and the development of the legal instruments (Memorandums of Understanding, etc) for cooperative arrangements necessary for meeting the long term goals of the program.

Part 2 would also require the Secretary of HHS to submit reports by 03/01/2011 and 03/01/2014 to the House and Senate Appropriations Committees, the Senate Health, Education, Labor and Pensions Committee and the House Committee on Energy and Commerce. The reports would review the short and long term goals of the program, the coordination of activities under the program with other participants in the NNI and the current and proposed funding levels for the program and if those funding levels would support the work of the program adequately.

Part 3 would authorize an appropriation of $25 million per fiscal year from 2011 through and including 2015.

S. 2492 has been assigned to the Senate Committee on Heath, Education, Labor and Pensions. No hearings are scheduled at this time. As with legislation introduced in the first session of the 111th Congress, we will monitor and report on the bill's progress.

The French Nanotech debates

Robert Oszakiewski — Fri, 22 Jan 2010 17:24:35 -0500

Last year, the French Commission of Public Debates launched a series of public debates about nanotechnology, with the purpose of presenting all aspects of nanotechnology and nanoindustry to the general public and to use the views expressed by all sides in shaping future government policies in the nanotech area.

However, according to a recent report on Science magazine's blogsite, the debates have not quite gone according to Robert's Rules of Order. A faction of French environmentalists have appeared at three of the debates using tactics similar to those of the "Tea Partiers" during last summers town hall meetings about the health care reform bills. Two of the debates had to be canceled while a third saw the audience sent away while the debate was conducted as a webcast.

Five more debates are scheduled to be held this month and February. One hopes that the remaining debates, where stakeholders and the general public can exchange views and concerns, can be held as scheduled.

Analysis: "Stanford University Responds to California's DTSC Data Call-In for Carbon Nanotubes"

John C. Monica, Jr. — Fri, 15 Jan 2010 16:20:44 -0500

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:

Article: "Nanotechnology: The Next Battleground for Mass Torts?"

John C. Monica, Jr. — Tue, 05 Jan 2010 14:37:45 -0500

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. :)

IEEE Blogger Comments on Nanosilver Article

John C. Monica, Jr. — Tue, 05 Jan 2010 12:38:32 -0500

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."

Strategic Nanotechnology Action Plan Consultation

Robert Oszakiewski — Wed, 30 Dec 2009 18:14:18 -0500

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.

Frosty the Nanoman

Robert Oszakiewski — Wed, 23 Dec 2009 18:42:11 -0500

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:

Australia Considers Proposal for Nano-Regulatory Reform

John C. Monica, Jr. — Wed, 23 Dec 2009 14:29:00 -0500

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.

Working Group Makes Important Contribution to EPA's Scientific Advisory Panel on Nanosilver

John C. Monica, Jr. — Fri, 18 Dec 2009 09:54:24 -0500

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.

Rep. Bart Gordon announces his retirement

Robert Oszakiewski — Mon, 14 Dec 2009 16:27:55 -0500

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.

Cosmetics, Nanoparticles and FOE-AUS

Robert Oszakiewski — Fri, 04 Dec 2009 17:44:45 -0500

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.

Medvedev and the Future of Russian Nanotechnology

Robert Oszakiewski — Tue, 01 Dec 2009 18:03:11 -0500

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.

UK Nanotechnology Health, Safety & Environment Directory

Robert Oszakiewski — Mon, 16 Nov 2009 14:42:16 -0500

The UK's Nanotechnology Knowledge Transfer Network recently published the above entitled directory (due to copyright restrictions, we cannot provide a link to the directory itself. Here is a link to the page on the NanoKTN site where the directory can be accessed; registration is required).

The directory lists 32 organizations, ranging from businesses to universities to government agencies. Each organization has a one page entry, giving the name of the business, government agency, etc, a brick and mortar physical address, website, phone numbers, general e-mail address, the name of a contact person, that person's specific e-mail address, legal status (private limited company, government agency, etc), a description of what the organization does, and which markets it focuses on.

Although relatively small at 32 organizations - which may be due to the information being drawn from publicly available sources of information - the directory is a well put together and well researched guide that should be of great use to the British nanocommunity and to multi-national nanoindustries that would need to know who to contact for testing their products and whom at government agencies they would need to contact and smooze with to get their products into the UK market.

The directory could also serve as a model for similar directories for the EU and the US.

Nanotubes in Space

Robert Oszakiewski — Fri, 13 Nov 2009 17:47:40 -0500

Space, the final frontier.

Captains James T. Kirk and Jean-Luc Picard

One of the most significant challenges facing NASA in the development of the next generation of vehicle to replace the aging Space Shuttles and carry astronauts back to the Moon and the International Space Station (and beyond) is weight. The less a vehicle weighs, the more it can conserve on fuel. NASA is now looking into the possibility of using carbon nanotubes in the construction of the Orion Crew Exploration Vehicle and future spacecraft. By using carbon nanotubes, NASA estimates that the weight of Orion and other vessels could be reduced by up to 50%.

In order to achieve efficient and consistent production of carbon nanotubes at a reasonable cost, NASA has been working with the private sector, awarding Phase I and Phase II Small Business Innovation Research Contracts to SouthWest Nanotechnologies, Inc of Norman OK. Using these research contracts, SWeNT has been able to develop production methods that produce consistent high quality CNTs at lower cost. In turn, this has lead to increased business from other companies for CNTs to be used in a variety of products, including body and vehicle armor for use in Iraq and Afghanistan, where it replaces Kevlar.

Those readers who grew up watching and following the Apollo lunar missions and can still recall where they were and what they were doing when Neil Armstrong stepped onto the Moon's surface, may also recall the wide range of spin-offs from government sponsored technology that made their way into everyday use. As many have observed, the development of high quality lost cost CNTs and other nanomaterials has the potential to transform industry and commonly used products. If the use of CNTs in spacecraft plays a part in returning humans into space and averts tragedies such as Challenger or Columbia, it will be funds well spent.

They will continue the voyages we have begun and journey to all the undiscovered countries, boldly going where no man - where no one - has gone before.

Captain Kirk, Star Trek VI: The Undiscovered Country

The Centre for Nano Safety

Robert Oszakiewski — Thu, 12 Nov 2009 18:09:39 -0500

The Centre for Nano Safety , at Edinburgh - Napier University in Scotland, officially opened it's doors on November 11, 2009. The Centre's mission is to study the possible toxicity of nanoparticles and to determine which ones might be able to penetrate human skin tissue or could possibly cause harm to the environment.

Information that the Centre develops will be used by nanoindustries to produce less toxic and safer products and by British government agencies to develop appropriate regulations. Parliament may also use the Centre's research as a basis for legislation affecting nanotechnology research and nanoindustries.

New Edition of Nanotechnology Law Report

John C. Monica, Jr. — Wed, 11 Nov 2009 11:20:15 -0500

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

EPA Proposes Significant New Use Rules for Single and Multi Walled Carbon Nanotubes

Robert Oszakiewski — Mon, 09 Nov 2009 11:36:31 -0500

On Friday, 11/06, 2009, the Environmental Protection Agency (EPA) published a "Proposed Significant New Use Rules on Certain Chemical Substances" in the Federal Register (74 FR 57430). The "certain chemical substances" that the new use rules would affect are multi-walled carbon nanotubes and single-walled carbon nanotubes. This would amend 40 CFR Pt. 721 by adding Pts 721.1055 and 721.1056. The text of these new parts can be found at the end of this entry.

The proposed SNURs on these substances are based on and consistent with the
provisions in the underlying consent orders. The proposed SNURs
designate as a ``significant new use'' the absence of the protective
measures required in the corresponding consent orders. This action
would require persons who intend to manufacture, import, or process
either of these two substances for an activity that is designated as a
significant new use by this proposed rule to notify EPA at least 90
days before commencing that activity. The required notification would
provide EPA with the opportunity to evaluate the intended use and, if
necessary, to prohibit or limit that activity before it occurs.

Information on submitting comments may be found in the link to the proposed rule. Comments must be filed on or by December 7, 2009.

The EPA had issued a direct final rule regarding SWCNs and MWCNs in the Federal Register of June 24, 2009 (74 FR 29982), but this was withdrawn after EPA received notice that adverse comments were going to be filed.

As explained in the notice, based on test data, the EPA has concluded that SWCNs and MWCNs pose risks to human health, particularly the lungs. To reduce that risk, EPA would require that workers exposed to carbon nanotubes wear an NIOSH approved full face respirator and protective clothing. Any purposeful disposal of these substances into US waters or waterways would be illegal under the proposed rules. The proposed rule would be applicable to manufacturers, importers and processors.

The record for the proposed SNURs may be found on Regulations.gov as docket EPA-HQ-OPPT-2008-0252.

The text of the proposed new sections to be added to 40 CFR 721 :

Sec. 721.10155 Multi-walled carbon nanotubes (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as multi-
walled carbon nanotubes (PMN P-08-177) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63 (a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), (a)(5) (National
Institute for Occupational Safety and Health (NIOSH)-approved air-
purifying, tight-fitting full-face respirator equipped with N100
filters), (a)(6)(i), and (c).
    (ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (k) and (q).
    (iii) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), (d), (e), (i), and (k) are applicable to
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to this section.
    3. By adding new Sec. 721.10156 to subpart E to read as follows:

Sec. 721.10156 Single-walled carbon nanotubes (generic).

    (a) Chemical substance and significant new uses subject to
reporting. (1) The chemical substance identified generically as single-
walled carbon nanotubes (PMN P-08-328) is subject to reporting under
this section for the significant new uses described in paragraph (a)(2)
of this section.
    (2) The significant new uses are:
    (i) Protection in the workplace. Requirements as specified in Sec.
721.63 (a)(1), (a)(2)(i), (a)(2)(ii), (a)(3), (a)(4), (a)(5) (National
Institute for Occupational Safety and Health (NIOSH)-approved air-
purifying, tight-fitting full-face respirator equipped with N100
filters), (a)(6)(i), and (c).
    (ii) Industrial, commercial, and consumer activities. Requirements
as specified in Sec. 721.80 (k) and (q).
    (iii) Release to water. Requirements as specified in Sec. 721.90
(a)(1), (b)(1), and (c)(1).
    (b) Specific requirements. The provisions of subpart A of this part
apply to this section except as modified by this paragraph.
    (1) Recordkeeping. Recordkeeping requirements as specified in Sec.
721.125 (a), (b), (c), (d), (e), (i), and (k) are applicable to
manufacturers, importers, and processors of this substance.
    (2) Limitations or revocation of certain notification requirements.
The provisions of Sec. 721.185 apply to this section.
    (3) Determining whether a specific use is subject to this section.
The provisions of Sec. 721.1725(b)(1) apply to this section.