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Tag Archives: regulation

Nanotechnology Law — New 2011 Edition

The new 2011 edition of Nanotechnology Law published by West/Thomson/Reuters is now out.  I update the book every year and the new edition has lots of new stuff.  They make excellent Christmas and Birthday gifts, and are a general cure for insomnia.  All proceeds go to my underprivileged daughters’ college fund.  Everyone should have one (or two). …

RTI International to Host Policy Forum on Regulation in the Nanotechnology Field

 

 On May 4, 2011, research institute RTI International will host a policy forum entitled, "Nanotechnology: The Huge Challenge of Regulating Tiny Technologies." The forum will be held at the National Press Club in Washington, DC, where experts will discuss the issues and concerns regarding the difficulties faced by agencies in drafting federal regulation and trying to keep pace with the rate of evolution in some areas in the field of nanotechnology. The forum will address regulations and public policies "needed to maximize the benefits of this emerging technology while minimizing the risks in order to encourage further development, scientific exploration, and responsible commercialization of this technology."

 

Participants include:

 

MODERATOR

James "Jim" Trainham, PhD, Vice President, Strategic Energy Programs, RTI International

SPEAKERS

Jim Alwood, Toxic Substances Control Act Nanotechnology Coordinator, U.S. Environmental Protection Agency

Cole Matson, PhD, Executive Director, Center for the Environmental Implications of NanoTechnology at Duke University

Michele Ostraat, PhD, Senior Director, Center for Aerosol and Nanomaterials Engineering, RTI International

Sally Tinkle, PhD, Deputy Director, National Nanotechnology Coordination Office

 

Please visit the forum’s website for more information:

http://www.rti.org/page.cfm?objectid=4F1E41AF-5056-B100-31FE7BB610DB5A3C…

ABA Program on Nano Governance

Presenting what looks to be a very interesting line-up of top-rate speakers, the American Bar Association’s Section of Environment, Energy, and Resources (Pesticides, Chemical Regulation, and Right-to-Know Committee) is presenting a webinar on January 27, 2011:

Nano Governance: The Current State of Federal, State, and International Regulation

Here is a summary of the webinar from ABA’s online announcement:

States, federal agencies, and foreign governments are challenged to address the risks and promote the benefits of evolving technologies, including nanotechnology. Companies globally are continuing to harness the properties of nanomaterials for use in products from airplanes to pharmaceuticals and from cosmetics to food packaging. Nano Governance: The Current State of Federal, State, and International Regulation will address these issues in a half-day program. This program will explore the new and creative applications of existing regulatory tools and governance approaches to address the potential risks of nanotechnologies, implement new risk assessment approaches to evolving technologies, and maximize the potential benefits of these materials. Panelists will report on new and emerging federal, State, and international nanomaterials regulations and governance strategies. Attendees will gain insight into potential public health and environmental impacts and the approaches various government agencies and industrial stakeholders are pursuing to address these issues while also promoting nanotechnology. The program is open to attorneys and other professionals with chemical regulatory compliance practices.

Educational Objectives:

  • Develop familiarity with new and emerging federal, State, and international nanomaterials regulations and governance strategies
  • Understand Potential Public Health and Environmental Impacts and the approaches various government

New Nano-specific Regulations Forthcoming from U.S. EPA

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

In its ongoing efforts to guard against potential unintended environmental, health, or safety injuries related to possible exposure to certain nanoscale materials, the US Environmental Protection Agency (EPA) plans to issue three new proposed nano-specific regulations in January 2011. While EPA is already actively regulating certain nanoscale materials which it considers new chemical substances (e.g./ carbon nanotubes, fullerenes, etc.), the new proposed rules will provide EPA with greater latitude in regulating both new and existing nanoscale materials. Manufacturers working with nanoscale materials should keep a very close eye on these new proposed regulations to determine whether they will be required to comply with any of EPA’s final rulings. Additionally, there will be opportunities for public comment and input.

Significant New Use Rule

Advocacy groups have been asking EPA for years to treat nanoscale versions of existing chemical substances as significant new uses of those substances under the Toxic Substances Control Act (TSCA). These types of substances include nanoscale silver, nanoscale TiO2, and nanoscale zinc oxide. Among other things, treating these materials as significant new uses of existing chemical substances would allow EPA to limit their production, require the use of workplace safety measures, require companies to conduct toxicity testing, and require companies to prevent intentional/purposeful releases of the materials to water.

Although its exact parameters have not been released, it appears that EPA intends to issue a proposed significant new …

Wisconsin Legislature to Study Potential Regulation of Nanomaterials

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

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

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

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

EPA Set to Rule on FIFRA Nanosilver Petition in June

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

Australia Considers Proposal for Nano-Regulatory Reform

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 …

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

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 …

New Article: Examples of Recent EPA Regulation of Nanoscale Materials Under the Toxic Substances Control Act

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

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

Nanoparticles and Deaths in the People’s Republic

By now, I think that most readers of this blog have either read "Exposure to Nanoparticles is Related to Pleural Effusion, Pulmonary Fibrosis, and Granuloma" by Yuguo Song, Xue Li, and Xuqin Du, recently published in the European Respiratory Journal or any of the news articles based on it, such as this one from Reuters. The paper makes for very sobering reading.

For anyone who hasn’t read the article,a brief synopsis is in order:

From January 2007 to April 2008, seven female patients were admitted to Chaoyang Hospital in Beijing. All seven worked in the same department of a printing plant and all seven were suffering from the same symptom – shortness of breath, pleural effusion and pericardial effusion, and were treated with antibiotics and surgery and placed on oxygen to assist their breathing. Five of the women stabilized; two, ages 29 and 19, died of respiratory failure. Further investigations revealed accumulations of nanoparticles in their lungs, nanoparticles that the women had been exposed to for various lengths of time in their workplace.

The authors reached the following conclusion:

. . . it is the nano materials containing nano-sized particles that appear to produce the toxicities seen in the exposed workers.

Therefore, we have more evidence to show that the nano particles contained in the polyacrylate emulsion had possibly caused the disease. There is an indication from this report that shows the possible dangerous nature of nano particles. Nano particles can penetrate the membrane of pulmonary epithelial cells and lodge in the …

New Edition of Nanotechnology Law Report

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

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

Regulating Nanotechnologies

How to regulate nanomaterials, nanotechnologies, and nanoindustries has become and will continue to be for the foreseeable future a major focus of US and European regulatory agencies, legislatures on local and national levels and of NGOs.

This Fall in London, from 10-11 September, US and European regulators and researchers from NGOs such as the Woodrow Wilson Center’s Project on Emerging Nanotechnologies, the London School of Economics, (a tidbit for the trivia buffs: Among the London School of Economics better know alumni, one Michael Philip Jagger, aka Mick Jagger) etc will meet and present a collaborative report and other papers. Attendance at the conference is by invitation only and e-mails should be addressed to nanotech@lse.ac.uk attention Ms. Carmen Gayson. For more information, look here.

The Woodrow Wilson Center’s Project on Emerging Nanotechnologies is also presenting a meeting and webcast in connection with the conference on September 23, 2009. For more information, take a look here.

Oversight of Next Generation Nanotechnology

In a recent speech to the IFT International Nanoscience Conference, Dr. Annette McCarthy of the FDA, is quoted as saying "We believe that the regulatory authority is sufficient to address nanotechnology. But there are further questions we need to address".

J. Clarence Davies, currently with the Woodrow Wilson International Center  project on Emerging Nanotechnologies, might agree with the latter part of  that statement, but certainly not with the former.

In the recently published "Oversight of Next Generation Nanotechnology", Davies looks at existing regulatory agencies that would have oversight of nanoproducts and finds them lacking:

The current oversight system was designed to deal with the problems of steam engine technology in the context of a pre-computer economy. . , ,

It was based on assumptions that most programs are local, that programs can be segmented and isolated from each other, that technology changes slowly and that all the important problems have been identified. All of these concepts are no longer valid. . . .  The antiquated conceptual basis of the system has been made more evident by the massive erosion of money and manpower from a system that always suffered from inadequate resources.

The inadequacy of the current system to deal with new technologies is obvious. Especially in the United States, regulatory oversight has always been somewhat deficient, and over the past 30 years it has been allowed to deteriorate to the point where only major changes can rescue it. On both sides of the Atlantic, extreme free market ideologies …

International Approaches to the Regulatory Governance of Nanotechnology

"How have Canada and other jurisdictions reacted to the recent emergence of nanotechnology-based products in the marketplace (and what is the current state of affairs)?"

That was the question that the Carlton University Regulatory Governance Initiative posed. To answer it, Jennifer Pelley and Marc Saner produced "International Approaches to the Regulatory Governance of Nanotechnology", which examines how Canada, the United States, the United Kingdom, the EU, and Australia, arrived at their regulatory policies affecting nanotechnology, summarizing the policy papers that informed those decisions, and looking at the external pressures on those governments from industry, unions, consumers, etc.

The report makes for very dry reading, but its a good reference source and worth reading. Just make sure you have a large cup of strong coffee nearby.…

Nanotechnology Regulation: Various Items

It’s amazing how items accumulate in an in-box when you’ve been out of town.  Such is the case here.  Several articles and other items of interest have come to my attention, but posting them here has been difficult lately.  With that, here are some regulatory items that may be of interest to readers:…

“Regulation and Risk Assessment of Nanomaterials — Too Little, Too Late?”

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

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

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

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

 

 …

UPDATE: Canada Regulation of Nano

Updating yesterday’s information that Canada anticipates enacting national regulation concerning the reporting and tracking of nanomaterials, there is some additional confirmation.  CBC News is similarly reporting that Environment Canada anticipates enacting a national reporting regulation next month.  While Environment Canada is not commenting directly on the news, CBC states, "Department officials said the plan is to send out a notice that requires companies and institutions that used more than one kilogram of nanomaterials in 2008 to provide information to the government."  The release also indicates that Environment Canada has been "negotiating with private industry" for over year concerning nanotechnology regulation in Canada.…

National Nanotechnology Regulation in Canada?

The Project on Emerging Nanotechnologies, via Nanowerk, is reporting that Canada will announce, in February, that it will release a national regulation aimed at requiring the submission of the "use of engineered nanomaterials" by manufacturers and users.  "The information gathered under the requirement will be used to evaluate the risks of engineered nanomaterials and will help to develop appropriate safety measures to protect human health and the environment."  No further information is available concerning the nature of the regulation, the eventual scope, release date, and no statement is readily available directly from Environment Canada.

However, this announcement does follow on the heels of both US EPA’s interim report on the Nanoscale Materials Stewardship Program, and the 2007 announcement by Environment Canada concerning nanomaterials’ treatment under Canada’s New Substance Program.

Should Canada release a national regulation concerning the tracking and reporting of nanomaterials for use by the government in developing additional health and safety regulations, that will be a significant step (perhaps more than a step?) towards the full regulation of nanomaterials.  To this point, only isolated state and local governments have made binding regulations with regard to nanotechnologies, while all national governments have remained aware, but mostly disengaged on the question of regulation.  Case in point, Canada, the United States, and the United Kingdom have all studied nanomaterials, or sought voluntary data submission, but none have regulated nanotechnology coast-to-coast.  This could be the first signal that national governments are becoming more comfortable with nanotechnology and believe they can …

Interim Report: Lukewarm Response to EPA’s Nanoscale Material Stewardship Program

Earlier today, the EPA published an interim status report regarding its Nanoscale Materials Stewardship Program.  A final report is expected in early 2010.

Nanoscale Materials Stewardship Program, Interim Report, January 2009, U.S. Environmental Protection Agency, Office of Pollution Prevention and Toxics.

At the outset, EPA notes that "[t]he findings and conclusions [of the] report should not be construed or interpreted to represent any Agency regulatory or statutory guidance or statement of official Agency policy."   Several companies submitting NMSP data should be relieved by this disclaimer, as EPA identified 18 nanoscale materials in NMSP submissions which may be considered new chemical substances under TSCA and subject to premanufacturing notice requirements.  Whether EPA takes any enforcement steps in this regard remains to be seen.

Getting to the highlights of the report, EPA concludes that the NMSP has (thus far) produce mixed results:

  • "In the aggregate, the NMSP has sufficiently advanced EPA’s knowledge and understanding to enable the Agency to take further steps towards evaluating and, where appropriate, mitigating potential risks to health and the environment."
  • "It appears that nearly two-thirds of the chemical substances from which commercially available nanoscale materials are based were not reported under the Basic Program."
  • "It appears that approximately 90% of the different nanoscale materials that are likely to be commercially available were not reported under the Basic Program."
  • "The low rate of engagement in the In-Depth Program suggests that most companies are not inclined to voluntarily test their nanoscale materials."

EPA’s overall conclusion is that:

"[T]he NMSP can be considered …

Carbon Nanotubes and TSCA Registrations

Today, US EPA issued a Federal Register notice stating the Toxic Substances Control Act (TSCA) registration requirements are "potentially applicable to carbon nanotubes."  EPA confirmed its position the CNTs are "chemical substances distinct from graphite or other allotropes of carbon listed on the TSCA inventory."  The bottom line is stated succinctly by EPA: "Many CNTs may therefore be new chemicals under TSCA Section 5."…

New Communication from the EU Concerning Nanomaterials

The following was provided by Luca Escoffier, a PhD student at Queen Mary, University of London a Transatlantic Technology Law Forum (TTLF) fellow at Standford writing his dissertation on patenting medical nanotechnology inventions, and currently a visiting fellow at the University of Washington.  He is also the author of the Nanomedicine and IP Blog, and watches European developments for us.   

COMMUNICATION FROM THE COMMISSION TO THE EUROPEAN PARLIAMENT, THE COUNCIL AND THE EUROPEAN ECONOMIC AND SOCIAL COMMITTEE – REGULATORY ASPECTS OF NANOMATERIALS

In June 2008, the European Commission, in light of the aims and principles contained in the Communication “Nanosciences and nanotechnologies: an action plan for Europe 2005 – 2009,” which asked for a full compliance when using and applying nanosciences and nanotechnologies with all existing and future rules on health, safety, workers’ protection, and environment, adopted a Communication also reflecting the commitment to adapt the current regulation to such current an future uses and applications. The Communication is a document covering nanomaterials currently in production and/or placed on the market. The Communication does not regard naturally occurring or unintentionally produced nanomaterials or nanoparticles. Please see the text of the Communication and accompanying document for more information.…

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