"Nano Risk Governance: Current Developments and Future Perspectives"

Posted on July 21, 2009 by John C. Monica, Jr.

Nanotechnology Law & Business just published its new edition.  For those who might be interested, Volume 6.2 contains an article I co-authored with several nano-friends entitled: "Nano Risk Governance: Current Developments and Future Perspectives."  You can find the article here.  An abstract follows.

As with many new technologies, developing a framework for making risk management decisions for nanotechnology is a challenge. Risk assessment has been proposed as the foundation for many regulatory frameworks for nanomaterials. Although the traditional risk assessment paradigm successfully used by the scientific community since the early 1980s may be generally applicable, its application to nanotechnology requires a significant information base. The authors’ experience supporting federal agencies in the United States, Canada, and the European Union—as well as state agencies in Massachusetts and New York and cities such as Berkeley and Cambridge—suggests that nanomaterial regulatory frameworks could be built upon existing regulatory approaches with the addition of a more rigorous and transparent method for integrating technical information and expert judgment. The authors argue that the current focus on studying the amount of risk acceptable for a specific technology or material should be shifted toward comparative assessment of available alternatives, and the use of science and policy to identify alternative nanotechnologies and opportunities for risk reduction and innovation. This approach involves the use of both quantitative and qualitative decision analysis tools, offering roadmaps for assessing different information sources and making policy decisions. Two representative methods presented are the Alternatives Assessment method and the Multi-Criteria Decision Analysis method.

Igor Linkov, U.S. Army
F. Kyle Satterstrom, Harvard University
John C. Monica Jr., Porter Wright Morris & Arthur LLP
Steffen Foss Hansen, Technical University of Denmark
Thomas A. Davis, University of Montreal

 

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International Approaches to the Regulatory Governance of Nanotechnology

Posted on May 28, 2009 by Robert Oszakiewski

"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.

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Nanotechnology Law Report -- Spring 2009

Posted on April 21, 2009 by John C. Monica, Jr.

Nanotechnology Law Report -- Spring 2009

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UPDATE: Canada Regulation of Nano

Posted on January 29, 2009 by Michael E. Heintz

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.

Interestingly, the primary resource for this latest release continues to be the Project on Emerging Nanotechnologies, who has since removed its original posting on this same news (as of this post). This latest article gives more, and more specific, information concerning the potential regulation by Canada, but I still find it odd that agency in charge of this regulation, Environment Canada, is not making any direct statements on the issue. But see another statement of note from the article, "Officials said this request for information under the Canadian Environmental Protection Act does not require companies to submit information beyond 2008. However, Ottawa could make similar requests for such information in the future." Who the "officials" are remains unknown, but we seem to be getting closer to the regulatory action becoming reality.
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National Nanotechnology Regulation in Canada?

Posted on January 28, 2009 by Michael E. Heintz

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 begin putting reasonable requirements in place.  Or, this could signal that national governments are beginning to crack under increased calls for action and are putting requirements in place in order to answer the growing list of critics.  Without knowing the details of Canada's plan, we won't know for sure until its ultimate release and effective date.  February starts next week, so we should know soon enough.

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Nanotechnology Law Report -- July 2008

Posted on July 30, 2008 by John C. Monica, Jr.
Nanotechnology Law Report -- July 2008
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Discussion Paper for Canadian Nanotechnology Policy

Posted on June 24, 2007 by Michael E. Heintz
One March 16, 2007, the Canadian Institute of Environmental Law and Policy conducted a one-day symposium on policy considerations related to nanotechnology.  The Institute recently released a discussion paper summarizing the thoughts concerning nanotechnology regulation in Canada.  The paper identifies those areas that the Institute believes will help drive a nanotechnology policy framework.

The report, available on the Institute's website, lists twelve policy considerations that it believes should be considered as a policy framework is developed.  Those policy considerations are: 1) societal goals, 2) public education and engagement, 3) activity and information inventories, 4) identification of lead agencies, 5) technical issue identification such as terminology and metrology, 6) regulatory framework priority identification including risk assessment, science, and stakeholder involvement, 7) labeling and consumer protection, 8) liability and intellectual property issues, 9) support for science and research, 10) commercialization and economic benefits, 11) training, and 12) security.

The report delves into each consideration in more detail, but the Institute believes that each should be developed in order to establish a solid nanotechnology framework in Canada.

Interestingly, the report also touches on barriers to a national nanotechnology policy in Canada, many of which are the same as those facing the United States.  The report cites such policy development challenges as the lack of information and lack of tools to "deal responsibly" with nanomaterials already in commerce.  The needed tools the Institute points to include: standard definitions, labels, and data sheets, as well as "structures and resources for public education and engagement."  These are some of the very challenges facing policy development in the United States.

Through consideration of the twelve points above, the Institute believes that Canada can begin to create a policy framework.  The Institute states that at this early stage, "our proposed policy framework focuses on goals; on what needs to be attended to; and to a lesser extent how it should be done: the elements of a policy framework."

Clearly nanotechnology policy development is an international issue, with many, if not all, of the same challenges and questions arising for each country to delve into the regulatory questions surrounding nanotechnology.
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