New Edition of NanoLawReport
Here is the Summer 2010 edition of NanoLawReport. Heading out to the beach for a few days to top off the summer. :)
Massachusetts Issues Nano-EHS Guidance Document
This article originally appeared on the National Nanomanufacturing Network's InterNano website on August 25, 2010. It is licensed under Creative Commons Attribution-NonCommercial-NoDerivs 3.0 Unported.
Massachusetts’ Office of Technical Assistance and Technology (OTA) recently released its “OTA Technology Guidance Document: Nanotechnology - Considerations for Safe Development” which has been in development for the past couple of years. The document begins by noting the tremendous positive influence nanotechnology is predicted to have in the fields of biomedical devices, electronics, clean energy, and materials engineering, while at the same time acknowledging that “there are indications of potential harm from certain exposures and release of engineered nanoparticles.” OTA also believes that there “is little uncertainty” regarding available means to prevent potential workplace exposure to nanoscale materials. Simply put, despite unknown EHS risks, there is more than adequate knowledge to control potential exposure in OTA’s view.
The end of the report contains a bibliography of existing resources covering state-of-the-art workplace good practices for nanoscale materials. The bibliography includes the “usual suspect” documents and websites published by NIOSH, ICON, German government, British Standards Institute, ED/DuPont, NanoSafe, and ASTM. From these primary sources, OTA distills a basic set of good practices for entities working with nanoscale materials in Massachusetts.
First, establish a risk reduction plan for facilities working with nanoscale materials. Such a plan should have two levels. First, it should attempt to protect against direct and immediate worker exposure. Second, it should also attempt to protect against possible releases during transport, use, and disposal after the nanoscale materials leave the manufacturing facility.
Second, evaluate potential worker exposure to nanoscale materials during the manufacturing process and then implement a hierarchy of exposure controls, including: substituting source materials with non-nano substances where appropriate, implementing engineering controls, using administrative controls, and requiring the use of personal protective equipment. This is all standard NIOSH-fare drawn from NIOSH’s excellent “Approaches to Safe Nanotechnology: Managing the Risks and Safety Concerns Associated with Engineered Nanoparticles.” OTA’s guidance document, however, does a good job of drawing out the most important “nuggets” of information from the NIOSH document in a few short pages.
Third, analyze whether unintentional release of nanoscale materials may occur with consumer use or disposal of the product. Along these lines, OTA recommends companies consider: labeling products as already suggested by BSI and the EU, warning potentially affected downstream users and others regarding potential EHS risks through the use of the Material Safety Data Sheets and other written warnings, complying with existing environmental laws such as the Toxic Substances Control Act, conducting an open and transparent risk and hazard testing regime for the product throughout its complete lifecycle, and recognizing that proactive prevention of EHS concerns is required for successful commercialization of nanotechnology.
In the end, OTA’s document is a helpful quick reference guide, but it does not cover any new ground or delve deeply into its existing source material. Businesses involved in nanomanufacturing should still consult the underlying source material cited in the document, as well as EHS and legal experts as necessary. Massachusetts should be commended, however, for putting out this basic guidance document and attempting to proactively address these issues.
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.
New Contributing Editor for InterNano
John Monica, a partner in the DC office of Porter Wright and frequent contibutor to this blog, was announced as a new Contibuting Editor for Environmental, Health and Safety and Regulation for InterNano, a project of the National Nanomanufacturing Network.
As Contibuting Editor, John will be tasked with informing InterNano readers about the latest in EHS and regulatory developments, an area which will be of concern for nanomanufacturers and others in the nanotechnology field.
Congratulations John.
Nano Networking and Nano EHS Forum
There are often developments in the nano legal world that do not fit into our traditional Nanotechnology Law Report format, yet might be of interest to some of our readers. You can now find these short postings and other musings on twitter.com/nanolaw .
Additionally, you can find me on linkedin under "John Monica," as well as on our new "Nano EHS Forum". Please feel free to link in or to join our new discussion group.
Happy networking!
Nanotechnology Health and Safety Forum -- June 8 - 9, 2009
The Nanotechnology Health and Safety Forum which is being sponsored by Battelle, Porter Wright, University of Washington, University of Oregon, Oregon State University, and several others is taking place on June 8 - 9, 2009 at the Edgewater Hotel in Seattle, Washington.
Keynote speakers include: Dr. Leroy Hood, Co-Founder of the Institute for Systems Biology; Dr. Kenneth Dawson, Director of the Centre for BioNano Interactions; Dr. Justin Teeguarden Senior Research Scientist at Pacific Northwest National Laboratory and recent co-author of the NRC's assessment of the NNI's EHS research strategy; Dr. Vladimir Murashov from NIOSH; Dr. Saber Hussain from the Air Force Research Laboratory; former U.S. Congressman George Nethercutt; and Dr. Robert Tanguay from Oregon State University.
The program has 4 units: Framing the Unknown; nanoEHS Perspective; Insurance, Nanotechnology, and Risk; and Nanotechnology: The Next Ten Years.
I will be speaking on the Insurance, Nanotechnology, and Risk panel on the second day of the conference along with Steve Knutson from Zurich North America; Walter Andrews from Hunton & Williams; and William E. Barr from Chubb Insurance.
You can sign up for the conference here. Hope to see you there.
EMERGNANO Released
Yesterday, Safenano and Defra, UK Government Department for Food & Rural Affairs, released EMERGNANO, the first global review of environmental, health, and safety studies examining the risks of nanotechnology exposure (essentially a study of the ongoing studies). The review examined more than 250, from approximately 670, studies in the context of the 18 Research Objectives defined by the UK's Nanotechnology Research Coordination Group. The project's goal was to conduct "a detailed review and analysis of research carried out worldwide on Environment, Health and Safety aspects of engineered nanoparticles, including issues relating to hazard, exposure and risk assessment and regulation, and made an assessment of how far 18 of the [Research Objectives] have been met and which gaps still remain to be filled."
Providing comprehensive reviews and analyses of EHS research to determine exposure risks is another important step in determining the potential risks of engineered nanomaterials. This review is also likely to help fame future research studies in terms of effectiveness and need.
The full EMERGNANO report is available here. In addition, a condensed version is also available as well as commentary by EMERGNANO authors.
Nano EHS Database
The International Council on Nanotechnology (ICON) just released its newest project/tool, the Nano-EHS Database Analysis Tool. To quote ICON, "This web tool allows you to obtain a quick and thorough synopsis of our Environment, Health and Safety Database using two types of analysis. The first is a Simple Distribution Analysis (pie chart) which compares categories within a specified time range. The second type is a Time Progressive Distribution Analysis (histogram) which compares categories over a specified overall time range and data grouping period." The report will generate data in pdf or xls format as well as a report on available publications based on search categories, such as material studied, target receptors, and type of publication.
While the Tool only tracks ICON's database, it will likely become a valuable resource for literature searches. With the increased importance of regulatory schemes such as TSCA registrations, literature reviews will become more critical, even to smaller operations. ICON's Tool will assist those entities, and others seeking wide ranging topics addressing nanotechnology or nanomaterials.
GAO Report on Nanotech Guidance
Sorry for coming a little late to the party on this one, it slipped past us until recently. Back in March the Government Accountability Office, the agency that investigates tax dollar spending for Congress, released a report entitled "Nanotechnology: Better Guidance Is Needed to Ensure Accurate Reporting of Federal Research Focused on Environmental, Health, and Safety Risks."
The report, found here, made several observations and conclusions. Among the highlights are:
- $37.7 million dollars, or 3% of the federally allocated $1.3 billion for nanotechnology research, focused on EH&S risks;
- Of the 119 research projects claiming to focus on EH&S risks, GAO determined that 22 projects, or 20%, did not in fact focus on EH&S risks. Instead, these projects were environmental remediation or hazard identification focused, and the mischaracterization was due to flaws in the classification process (as an aside, GAO conducted a follow-up study to this point, and released a subsequent report in late April entitled: "NANOTECHNOLOGY Accuracy of Data on Federally Funded Environmental, Health, and Safety Research Could Be Improved");
- EH&S research projects conducted in 2006 were "generally consistent" with agency goals;
- Federal agency and NNI efforts to coordinate research activities related to EH&S risks "have been generally effective."
GAO went on to recommend that the Office of Science and Technology Policy (OSTP), the office that administers the NNI, "provide better guidance to agencies regarding how to report research that is primarily focused on EH&S risks. In commenting on a draft of this report, OSTP generally agreed with the findings and will review the manner in which agencies respond to current guidance." The same recommendations were made in the April report as well.
While not getting to nanotechnology regulations directly, GAO studies are an important indicator of where research dollars are going, and how effectively they are being used. I don't think the conclusion that better guidance is needed, or that the reporting classifications can stand to be more accurate, comes as any great shock to those working in the sector. However, having the GAO spotlight on the issue will help to resolve the problems and will force affected agencies to examine their processes and methods.
Survey Results Indicate Some North American Nanocompanies are Implementing EHS Strategies
On November 13, 2006, the International Council for Nanotechnology (ICON) published its recent survey results: “A Review of Current Practices in the Nanotechnology Industry.” While the authors of the study admit the size of their survey was too small to provide statistically significant results, the article, nonetheless, provided insightful information on current global nanotechnology environmental, health, and safety practices (EHS).
The data presented regarding North American participants in the survey was particularly interesting. Of 25 North American respondents, 21 offered their employees broad EHS training, while 18 offered nano-specific EHS programs. This training was most often in a classroom setting conducted by internal sources, using existing scientific literature as sources of health and safety information. Beyond nano-related EHS training, the survey found that 19 of the North American respondents used fume hoods to contain possible nano-particle exposure; 16 used glove boxes; 13 used clean rooms; 12 used separate HVAC systems; 6 used closed piping systems; 7 used biological safety cabinets; and 5 used air pressure differentials. Finally, 4 of the North American entities conducted their own nano-toxicology testing.
A lack of definitive scientific information regarding the potential health risks of nanotechnology was pointed to as the biggest hindrance to the further development of nano-EHS training and control.
Scientists Present "Five Grand Challenges" Regarding Future Nano-EHS Research
Earlier today, two top nanoscientists -- Dr. Andrew Maynard, Chief Science Advisor, Project on Emerging Nanotechnologies, Woodrow Wilson Center and Dr. Sally S. Tinkle, Assistant to the Deputy Director, National Institute of Environmental Health Sciences, National Institutes of Health -- made a presentation at the Woodrow Wilson International Scholar Center announcing their new article appearing in November 2006 issue of Nature.
Maynard said that the article was the result of intense collaboration between 14 top nano-experts from numerous scientific disciplines who came together to create a 10-to-15 year framework for assessing the potential health risks posed by nano-technology.
Maynard indicated the primary purpose of the article was to motivate scientists to put in place within the next 12 months a long-term plan for conducting the necessary environmental, health, and safety research in this area. Maynard expounded on five "Grand Challenges" the authors believe are key to forming a robust, world-wide nano-EHS research plan:
1. Creating new instrumentation to measure possible exposure to nanomaterials through air by 2010 and water by 2012, leading to “smart” nanosensors with the ability to detect potential exposure hazards and identify potential environmental and/or health reactions by 2017;
2. Establishing effective and relevant nanotoxicology testing methods world-wide which combine applicable existing testing methods with new cutting edge technologies. International nanotoxicology testing protocols would be established by 2012; effective alternatives to in vitro testing would be created by 2022; and a final answer to any questions regarding the potential toxicity of fiber-shaped nanomaterials (such as carbon nanotubes) by 2012;
3. Creating systems that can predict the potential impact of new nanomaterials on the environment and in the body, leading to finalized methods for engineering safely designed nanomaterials by 2017;
4. Developing systems and methods that enable scientists to assess the potential impact of nanomaterials during their entire life-cycle from cradle to grave;
5. Devising effective research programs to accomplish the four above-referenced Challenges. In order to maintain the authors’ developmental time-line, Maynard indicated that this challenge would need to be met within the next twelve (12) months and would involve collaboration, communication, and coordination between international governments, scientists, and industry representatives.
Maynard concluded by stressing that mastering these Grand Challenges will allow the nano-industry to make decisions regarding any potential nano-EHS risks posed by its products based on sound science, not continued speculation.
Tinkle further elaborated several broad concepts embedded within the Grand Challenges:
1. Establishing a research pipeline to coordinate nano-EHS research, including identifying and sealing any gaps in the pipeline between (i) basic nanoscience; (ii) nano-application engineering; and (iii) nano-decision making at the product and policy making level;
2. Identifying cross-cutting themes and research concepts that can be used between scientific disciplines;
3. Combining traditional research methods with cutting edge research strategies; and
4. Establishing partnerships among international governments and international scientists to jointly addresses research needs.
Of note, audience members asked Maynard and Tinkle follow-up questions concerning (i) budgetary requirements for the authors’ proposal, (ii) whether this time-line could somehow be sped up; (iii) how to balance this nano-EHS research time-line against the burgeoning commercial market for nano-based products; and (iv) the efficacy of existing nanotoxicology testing methods.
The authors’ article an be found at “Safe handling of nanotechnology,” Nature, Volume 444 Number 7117 pp. 243-400 (November 16, 2006)
JCM: While the authors' five Grand Challenges provide a much-needed framework, current nanomanufacturers should consider what they can and should do to protect themselves from potential consumer litigation during the next seven (7) to twelve (12) years while the scientists sort this all out. I am not sure plaintiffs attorneys and consumers will have the patience required by this proposal.
For reference purposes, the author's time-line is conveniently summarized in a graphic contained in the Nature article.
Press Release -- International Association Of Nanotechnology
International Association of Nanotechnology
2386 Fair Oaks Boulevard, Sacramento, CA 95825
1750 Montgomery Street, San Francisco, CA 94111
Tel. 916-529-4119, Toll Free 1-800-766-6008
Fax. 916-244-7029
Email: info@ianano.org
Web site: http://www.ianano.org
Press Release Press contact: Diana Rudé, Director, Government Relations
November 7, 2006 (916) 529-4119
San Francisco. The International Association of Nanotechnology (IANANO) sponsored a panel discussion on environmental health and safety at its 3rd International Congress of Nanotechnology (ICNT), held on October 30 - November 2, 2006 in San Francisco. IANANO convened the panel in recognition of the current information gap concerning the potential health risks associated with nanotechnology.
Speakers on the panel included two product liability attorneys - John C. Monica, Jr. of Porter Wright Morris & Arthur LLP, Cleveland, Ohio, and Antony Klapper of Reed Smith LLP, Washington, D.C.; and Dr. Justin Teeguarden, Senior Research Scientist, from the Pacific Northwest National Laboratory, Richland, Washington and Matthew Hull, principal Investigator from Luna Innovations, Inc, Blacksburg, Virginia.
Lloyd L. Tran, the conference chair, pointed to the dearth of toxicological data, lack of consistent nomenclature across disciplines, and currently evolving governmental regulatory schemes as presenting significant challenges to nanotechnology companies. Tran noted, “With this gap, nanotechnology companies would have difficulty in identifying any possible health risks associated with nanotechnology and determining how to best manage and avoid any such risks.”
Klapper stated "companies should implement risk management strategies they believe reasonably respond to identified risks based on available scientific data, information gleaned from analogous substances, and scientific judgment." Monica added that "this is particularly the case given recent legal developments concerning a manufacturer's duty to know its products and the commensurate duty to warn. While nano-companies should not necessarily rush out and initiate their own toxicological research, they should certainly make themselves aware of the state of current scientific literature regarding nanotechnology and health issues."
Dr. Teeguarden agreed with the need for small and large companies, insurance agencies and venture capitalists to manage their own product risks by staying abreast of health and safety issues for nanomaterials, but noted that “The field of nanotoxicology is playing catch up with the manufacture and commercial use of these nanotechnology based products… it is too early to make generalizations about either their toxicity or their safety or to make regulatory decisions.” He added that “Sound science and a significant body of basic research are necessary before we have a good basis for product safety evaluations and a credible framework for regulation, if regulation is necessary.”
Hull's presentation described a program he leads at Luna known as NanoSafe, which has emerged as a model of how facilities, particularly small businesses, can proactively manage nanotech EHS risks. The program consists of a five-point management framework and involves collaboration and information exchange with government agencies, federal and academic research labs, and industry.
About the International Association of Nanotechnology:
The International Association of Nanotechnology is a non-profit association with the goal to foster research and business collaboration in nanotechnology worldwide for the benefit of society. The Association sponsors the annual meeting of the International Congress of Nanotechnology. The Association is planning to compile a database on health, safety and toxicity data of nanomaterials
products. For further information, please visit the web site: http://www.ianano.org
2386 Fair Oaks Boulevard, Sacramento, CA 95825
1750 Montgomery Street, San Francisco, CA 94111
Tel. 916-529-4119, Toll Free 1-800-766-6008
Fax. 916-244-7029
Email: info@ianano.org
Web site: http://www.ianano.org
Press Release Press contact: Diana Rudé, Director, Government Relations
November 7, 2006 (916) 529-4119
San Francisco. The International Association of Nanotechnology (IANANO) sponsored a panel discussion on environmental health and safety at its 3rd International Congress of Nanotechnology (ICNT), held on October 30 - November 2, 2006 in San Francisco. IANANO convened the panel in recognition of the current information gap concerning the potential health risks associated with nanotechnology.
Speakers on the panel included two product liability attorneys - John C. Monica, Jr. of Porter Wright Morris & Arthur LLP, Cleveland, Ohio, and Antony Klapper of Reed Smith LLP, Washington, D.C.; and Dr. Justin Teeguarden, Senior Research Scientist, from the Pacific Northwest National Laboratory, Richland, Washington and Matthew Hull, principal Investigator from Luna Innovations, Inc, Blacksburg, Virginia.
Lloyd L. Tran, the conference chair, pointed to the dearth of toxicological data, lack of consistent nomenclature across disciplines, and currently evolving governmental regulatory schemes as presenting significant challenges to nanotechnology companies. Tran noted, “With this gap, nanotechnology companies would have difficulty in identifying any possible health risks associated with nanotechnology and determining how to best manage and avoid any such risks.”
Klapper stated "companies should implement risk management strategies they believe reasonably respond to identified risks based on available scientific data, information gleaned from analogous substances, and scientific judgment." Monica added that "this is particularly the case given recent legal developments concerning a manufacturer's duty to know its products and the commensurate duty to warn. While nano-companies should not necessarily rush out and initiate their own toxicological research, they should certainly make themselves aware of the state of current scientific literature regarding nanotechnology and health issues."
Dr. Teeguarden agreed with the need for small and large companies, insurance agencies and venture capitalists to manage their own product risks by staying abreast of health and safety issues for nanomaterials, but noted that “The field of nanotoxicology is playing catch up with the manufacture and commercial use of these nanotechnology based products… it is too early to make generalizations about either their toxicity or their safety or to make regulatory decisions.” He added that “Sound science and a significant body of basic research are necessary before we have a good basis for product safety evaluations and a credible framework for regulation, if regulation is necessary.”
Hull's presentation described a program he leads at Luna known as NanoSafe, which has emerged as a model of how facilities, particularly small businesses, can proactively manage nanotech EHS risks. The program consists of a five-point management framework and involves collaboration and information exchange with government agencies, federal and academic research labs, and industry.
About the International Association of Nanotechnology:
The International Association of Nanotechnology is a non-profit association with the goal to foster research and business collaboration in nanotechnology worldwide for the benefit of society. The Association sponsors the annual meeting of the International Congress of Nanotechnology. The Association is planning to compile a database on health, safety and toxicity data of nanomaterials
products. For further information, please visit the web site: http://www.ianano.org
