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).
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
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:
I hope to attend by telephone and encourage any interested readers to do the same. It should be a great conference.
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 use rule under Section 5 of TSCA in January 2011 addressing these issues. While the contours of the rule are difficult to predict, a likely tactic may be to "grandfather in" nanoscale versions of existing chemical substances, but to treat any new attempts to manufacture or use nanoscale versions of existing chemical substances as significant new uses. While such an approach will likely to draw complaints from “newcomers” because companies already manufacturing in the niche would have a distinct competitive advantage, it might be the only workable approach available to EPA. It is virtually impossible to catalogue all existing uses of each nanoscale material already in the marketplace.
Testing Rule
While EPA is already requiring rigorous 90 day in vivo inhalation toxicity testing for certain new nanoscale materials, it appears that the Agency intends to propose a testing rule under Section 4 of TSCA in January 2011 requiring this same type of testing for certain nanoclays, nanoscale aluminum oxide, and nanotubes. Nanoclays and nanoscale aluminum oxide were apparently considered because no country volunteered to be lead sponsor for their testing under the Organization for Economic Cooperation and Development's comprehensive toxicity testing program. Additionally, no manufacturers have submitted premanufacturing notices for nanoclays un the U.S. which might otherwise provide EPA with the chance to require similar testing.
Conducting a 90 day in vivo inhalation test on a nanoscale material is difficult and can cost between $350,000 to $500,000 for each material tested. It will be interesting to see whether EPA’s proposed testing rule will allow for joint testing by manufacturers in order to reduce cost and increase efficiency. At least one group of manufacturers -- the NanoSafety Consortium for Carbon -- is already preparing to ask EPA to use this approach with their nanoscale carbon materials.
Data Collection Rule
Perhaps the broadest proposed rule EPA intends to issue in January 2011 will require manufacturers of nanoscale substances which have not already made formal detailed submissions to EPA to submit detailed EHS data for EPA’s review and consideration. The new proposed rule will be issued under Section 8(a) of TSCA, and will essentially make EPA's prior voluntary Nanoscale Materials Stewardship Program (NMSP) into a mandatory data collection effort. Readers may recall that the NMSP program received lukewarm industry participation, which is apparently resulting in the new mandatory approach.
Fortunately, the TSCA provision authorizing such data-call-ins allows manufacturers to apply to EPA for exemptions in instances where the subject nanoscale materials are only manufactured in small quantities (less than 500 kgs) or are being made solely for research and development purposes.
Finally, for those who might be interested, Section 8(a) of TSCA allows EPA to request information regarding:
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.
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."
Just a quick plug for our new NanoSafety Consortium for Carbon which was recently launched to address potential EHS issues concerning its members' products. You can learn more about the consortium at: www.nanosafetyconsortium.com.
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.
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:
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).
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.
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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 cytoplasm and caryoplasm, as well as aggregate around the membrane of red blood cells and exert toxicity. Patients may develop clinically serious conditions associated with damaged respiratory function including a progressive pulmonary fibrosis that is resistant to several methods of treatment.
Many critics of nanotechnology and nanoindustry may use this study as a basis for calls to end the use of nanoparticles in manufacturing processes or to call for the shutdown of nanoindustries altogether. That is unlikely to happen. Too much time, money and effort has been invested for a shutdown to become a reality. The genie has left the bottle and it's not going back.
Further, as the authors state throughout their article, the women's workplace contributed as much, if not more, to the women's illnesses as the nanoparticles did:
A survey of the patients' workplace was conducted. It measures about 70 square meters. . . has one door, no windows, and one machine used to air spray materials, heat and dry boards. This machine has three atomizing spray nozzles, and one gas exhauster (a ventilation unit) that broke 5 months before the occurrence of the disease.
Accumulated dust particles were found at the intake of the gas exhauster. During the five months preceding illness the door of the workspace was kept closed due to cold outdoor temperatures. The workers . . . had no knowledge of industrial hygiene and possible toxicity from the materials they worked with. The only personal protective equipment (PPE) used on an occasional basis was cotton gauze masks. According to the patients, there were often some flocculi produced during air spraying, which caused itching on their faces and arms. It is estimated that the airflow or turnover rates of indoor air would be very slow, or quiescent due to the lack of windows and the closed door.
In their conclusions, the authors note that
. . . more studies on the possible mechanisms, diagnosis, treatment and prevention of the nano material related disease are needed.
. . . these cases arouse concerns that long term exposure to some nanoparticles without protective measures my be related to serious damage to human beings. . . . Effective protective methods appear to be important in terms of protecting exposed workers from illness caused by nano particles. (emphasis added).
Such future studies as the authors call for may be used as the basis for new and more effective regulation of the nanoindustrial environment, to prevent tragedies such as the deaths of the two young women in this study.
Here is the Summer 2009 edition of Nanotechnology Law Report. The newsletter contains the below-listed articles (and more):
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.
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 have contributed to the erosion of oversight. Furthermore, there has been a failure to anticipate and analyze the new technologies that are being created and commercialized at an ever-increasing rate.
Mr. Davies offers what some might see as a radical solution, dissolving such agencies as EPA, CPSC, etc, and creating a new cabinet level Department of Environmental and Consumer Protection, which would have the authority to and be tasked with product and technology regulation, pollution control, etc.
No one will, I think, disagree with Davies observations on the current state of US regulatory agencies. Decades of decreasing budgets, decreasing staff, and the dominance of a political ideology that viewed government regulation of anything as evil effectively rendered agencies such as CPSC impotent and unable to perform their duties. This impotence extended to other agencies as well- we have only to look at the near collapse of the economy to see that agencies charged with regulating economic matters failed as well. With a change in administrations and public outrage the various failures of regulatory agencies, those agencies are finally beginning to see an increase in their budgets, manpower and authority.
Certainly also, one cannot disagree with Davies assertion that the agencies that he focuses on were designed to regulate products created by 19th and early 20th century technologies and industries and are in need of a review and updating. However, one has to wonder if Davies proposal of tearing the regulatory structure down and starting over is a practical solution.
Davies assumes that a new Department of Environmental and Consumer Protection's budget would equal the combined total of the budgets of the agencies and departments it would be replacing. Given the way that the federal budget process operates, that's an assumption that is unlikely to happen. Further, it's also unlikely that moving agencies from one department to another and merging agencies to create an new department would be a smooth and easy process. Each one would have it's own particular office culture which might create friction among personnel. Also, aside from the lobbying of various interest groups to contend with, Congressional Committees and Subcommittees that have budgetary control might not be willing to give that control and power up.
Having said this, Davies report does serve as a starting point for a long overdue discussion of needed changes in regulatory agencies that have and will have responsibility for regulation of nanotechnology and nanoindustry. As Davies points out early on in the report, the purposes of regulation are to safeguard the public and create conditions that allow for the safe growth of, in this case, nanoindustry, something that I think most of us reading and writing on this blog want to see.
"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.
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:
First, a forthcoming paper from the American Chemistry Society, "The Impact of Toxicity Testing Costs on Nanomaterial Regulation," analyzes the costs of testing the toxicity of nanoparticles in relation to the regulating agencies that bear the burden of this risk analysis. The author suggests a tiered regulatory system, such as the EU's REACH program.
Second, Michael Berger of Nanowerk published an article discussing the adequacy of current regulations in relation to nanomaterials. The article draws heavily from a PhD thesis, "Regulation and Risk Assessment of Nanomaterials– Too Little, Too Late?" Mr. Berger uses this thesis to reopen the discussion concerning the adequacy of current regulation as it relates to nanotechnology development.
Third, the International Medical Device Regulatory Monitor reports that FDA "has no plans to toughen its regulations on nanotechnology." The article quotes Norris Alderson, FDA's Associate Commissioner for science, as saying, "the science does not dictate that there is a need to do more than what we're already doing now." The article also reports that FDA has no plans to update its 2007 Task Force report. The article points out this may be a departure from the considerations of international counterparts.
Finally, the Risk Policy Report indicates that California may be getting ready to move forward on nanotechnology regulation. AB 935 has been proposed, and it is expected that the bill will be amended "to propose a detailed nanotechnology regulatory program for California." As it currently sits, AB 935 is a general, place-holder, bill “to state the Legislature’s intent to enact legislation to address emerging toxicity issues surrounding the increasingly widespread utilization of engineered nanomaterials."
I hope this is enough reading material for your Monday morning. Enjoy!
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:
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.
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.
Earlier today, the EPA published an interim status report regarding its Nanoscale Materials Stewardship Program. A final report is expected in early 2010.
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:
EPA's overall conclusion is that:
"[T]he NMSP can be considered successful. However, a number of the environmental health and safety data gaps the Agency hoped to fill through the NMSP still exist. EPA is considering how to best use testing and information gathering authorities under the [TSCA] to help address those gaps."
My own view is that response to the NMSP has been lukewarm, at best.
Analysis of Current Submissions
As of December 8, 2008 information under the Basic Program has been submitted by 29 companies/associations, covering 123 nanoscale materials. Seven additional companies have also committed to submitting data under the Basic Program at a future date. The In-Depth Program has commitments from four companies thus far. Additionally, the American Chemistry Council (ACC) has expressed an interest in coordinating In-Depth data submissions.
A chart from the interim report breaking down Basic Program submissions by material type follows. Nanoscale metals and metal oxides predominate. Many materials are still in the research and development stage.
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Beyond numbers and types of nanoscale materials, EPA also notes that "very few submissions provided either toxicity or fate studies." This lack of information provides EPA with several challenges to meeting the NMSP's basic goal of determining whether certain nanoscale materials or categories may present risks to human health and the environment. No doubt these challenges have contributed to EPA's recent attempt to use TSCA consent orders and SNURs to generate animal inhalation toxicity data.
An Ill-Fated Comparison
As apparent justification for the number and quality of submissions, EPA compares the information it has received under the NMSP thus far with the information available in two publicly available databases: (i) Nanowerk's Nanomaterials Database; and (ii) Project on Emerging Nanotechnologies Inventory of Nanomaterials in Consumer Products. EPA selected these two databases because "[a]s far as EPA is aware, there is no comprehensive database of nanoscale materials, which is a critical need for better understanding the universe of commercially available nanoscale materials." Unfortunately, neither database was designed for this purpose (although I am a big fan of both). Using these databases in this manner further points out the difficulties facing EPA. Simply put, both Nanowerk and PEN appear to have far better data collections than EPA -- an unacceptable condition.
Nonetheless, EPA's search of the Nanowerk database identified 2,084 potential nanoscale materials, which the Agency then condensed to a list of 1332 potential submissions by excluding new chemical substances under TSCA (e.g./ carbon nanotubes and fullerenes), eliminating materials in which it has no interest, and grouping materials with the same molecular identity. EPA then identified 55 commercially relevant chemicals from this truncated list. EPA, however provides, no good reason for excluding new chemical substances from its analysis, nor does it make a convincing case that it can actually determine molecular identity from Nanowerk's database.
A similar analysis of PEN's database identifies 566 nanoscale materials, out of which EPA finds that 48 are commercially relevant chemicals.
It is clear that despite all of this winnowing, the amount and quality of data submitted thus far under the NMSP is dwarfed by that available in both the Nanowerk and PEN databases. Given this situation, it is hard to imagine that advocacy groups will remain muted until EPA's final NMSP report is released in 2010. Another table from the report summarizing this comparison data follows.
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."
Consequently, those companies that use or import CNTs will have to ensure such materials are registered on the TSCA inventory before manufacturing commences or importation occurs. To determine if a particular type of CNT is already on the Inventory, manufacturers and importers can submit a bona fide intent to manufacture or import letter to EPA under 40 CFR 720.25, and EPA will respond as to the particular listing. Further, "sometime after March 1, 2009, EPA anticipates focusing its compliance monitoring efforts to determine if companies are complying with TSCA section 5 requirements for carbon nanotubes."
The message here couldn't be more clear: if you are manufacturing or using CNTs, you must comply with TSCA. EPA admits that some of the confusion over listing/not listing may be due to prior communications, but this notice removes all confusion. EPA indicates that it is reviewing "several" premanufacture notices for carbon nanotubes, so it is likely many of the "common" CNTs will be registered soon. In the meantime, expect CNTs to be treated as "new" chemicals under TSCA.
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.
This article was authored and contributed by Terrence F. Smith, Director of Government Affairs, Cambridge Chamber of Commerce.
The report of the Nanomaterials Advisory Committee was on the agenda at the July 28 meeting of the Cambridge City Council. The Council’s actions bode well for continued manufacturing, processing, research and development using nanotechnology in Cambridge. The Council accepted the report of the Nanomaterials Advisory Committee with little comment and placed the report on file.
The discussion was brief. Councillor Davis, who filed the original order, said she was satisfied with the report. City Manager Healy stated that the report is balanced and the next steps will provide the City with a better idea of who does what in Cambridge. He also said that the LEPC has prepared the survey recommended in the report. Councillor Murphy said that the report reflects on the strengths of the Cambridge Public Health Department and the ability of the City to bring together “World Class” experts on the Nanomaterials Advisory Committee.
There was a question about nanomaterials getting into the City water supply. The Manager stated that he did not know whether it is possible to test for nano, as the City had done for pharmaceutical products several months ago, but would look into it. It should be noted that Massachusetts strictly regulates industrial wastewater. The Council took no formal action regarding this request but this issue may come up again.
If readers wish to view the discussion, the video of the meeting should be posted later this week on the City of Cambridge website at http://www.cambridgema.gov/council-archive.cfm. The discussion took place beginning around 8:15 p.m. which would be about 2 hours and 45 minutes into the meeting.
Terrence F. Smith
Director of Government Affairs
Cambridge Chamber of Commerce
859 Massachusetts Ave.
Cambridge, MA 02139
Phone: 617-876-4213
tsmith@cambridgechamber.org
As Mike Heintz reported earlier today, the Woodrow Wilson International Center for Scholars' Project on Emerging Nanotechnologies issued a report yesterday providing some guidance regarding where it believes the next administration should start with the issue of nanotechnology regulation next January.
J. Clarence Davies, "Nanotechnology Oversight: An Agenda for the New Administration," Woodrow Wilson International Center for Scholars, Project on Emerging Nanotechnologies, PEN 13, July 2008.
Among other suggestions, Mr. Davies advocates enacting new nano-specific legislation in the following areas.
TSCA: Mr. Davies offers specific legislative language for amending TSCA "to make clear that nanomaterials are covered as new substances." Other changes he suggests: "remove the catch-22 that requires EPA to show that a new chemical poses a risk before the agency can obtain enough information to determine whether it actually poses a risk;" "remove the conditions and requirements that guarantee that EPA can never regulate an existing substance;" and narrow TSCA’s confidential business information and data sharing provisions.
FFDCA: Mr. Davies argues the FFDCA should be amended to require submission and review by FDA of cosmetic active ingredient registration information. He further maintains that "FDA should also be authorized to forbid marketing of any cosmetic containing an ingredient that is not safe or for which adequate test data are not available," and that applicable FDA laws should be altered "to make clear where and how to draw the line between a drug and a cosmetic." Mr. Davies additionally recommends requiring premarket safety testing on food and cosmetic ingredients incorporating nanoscale materials, and increased post-marketing surveillance and reporting.
DSHEA: Mr. Davies calls for amending DSHEA so that it does not prohibit "FDA from imposing testing or approval on dietary supplements (vitamins, herbs, etc.) and placing the burden of proof on FDA to provide that a supplement is safe."
Other recommendations by Mr. Davies beyond long-term regulatory action are:
Research: dramatically increase federal nano-related EHS research funding (FY 2009 - $100 million; FY 2010 - $150 million), require a federal peer-reviewed EHS research plan; strengthen NNI; encourage separation of NNI promotional and oversight functions; and establish a Nanotechnology Effects Institute.
Regulatory Coordination: establish an interagency group devoted solely to nanotechnology regulation; develop a nanotechnology plan within each agency; and improve intergovernmental coordination.
Resource Requirements: increase regulatory agency budgets and staffing.
EPA: define nanomaterials as "new" chemical substances and/or "significant new uses" of existing chemical substances under TSCA; promulgate a new compulsory information collection rule under TSCA Section 8; expand regulation of anti-microbials under federal pesticide law; promote "green" technology; and evaluate the application of other EPA statutes to nanotechnology.
FDA: establish criteria for determining which nanomaterials are "new" for regulatory purposes; collect information on safety testing, forthcoming products and adverse effects; regulate cosmetics and dietary supplements.
OSHA: communicate to workers and firms about nanotechnology; use existing OSHA regulations to deal with nanoparticles; issue OSHA standards for nanomaterials.
CPSC: hire new staff to study nanotechnology exposure; create a chronic hazard advisory panel for nanotechnology products posing significant exposure risks.
Voluntary Efforts: use the DuPont-Environmental Defense framework as a basis for analyzing nanotechnology risks; issue a nanotechnology handbook for small businesses.
Public Involvement: give the public more information about nanotechnology; obtain the public's views about nanotechnology; convene a stakeholder dialogue.
Mr. Davies concludes his article with an interesting analogy: "[N]anotechnology comes in a treasure chest of riches and a Pandora's box of evils. The challenge of the new century and to the new administration is to use the treasure while keeping shut the lid on the Pandora's box."
At least one California legislator is said to be considering statewide legislation to "monitor and regulate" nanotechnology in the state. Assemblyman Mike Feuer chaired a meeting on April 23 at UCLA to discuss options for developing nanotech regulation without impairing its growth. Assemblyman Feuer is one of the leading voices in California concerning nanotechnology regulation.
While the legislation isn't expected to be introduced until sometime next year, different options are said to be under consideration. One option creates a multi-agency task force led by the University of California and the California EPA, while another option calls for quick action by EPA itself.
This is another example of state and local regulatory bodies stepping in to create nanotechnology oversight regulation in the absence of federal activity. California's consideration joins Berkeley, Cambridge, and Wisconsin as the potential "first-movers."
The multi-agency approach is a new concept that I've not seen attempted before (admittedly, that is hard to accomplish on the municipal level), but it makes sense on a lot of levels. We'll all have to watch what California does towards the end of this year and into next year.
Throughout the report, the author addresses the unique, and in some cases, not so unique, concerns raised by using nanomaterials in food packaging, all through the use of hypothetical applications. The purpose of the report is to "tee-up" the regulatory issues faced by the FDA, as the primary regulatory agency in charge of food packaging, and the EPA as a secondary regulating authority. The report provided a broad based look at the issues raised by this specific nanomaterial application.
Like other areas of potential regulation, the use of nanomaterials in such close proximity to food raises its own concerns and potential. Beyond the discussion raised by the paper itself, which are absolutely worth considering, it is encouraging to see the GMA involved in this study. Because of the number of regulatory topics that are emerging, and each one seemingly unique to its own industry of application, it becomes critical for stakeholders to involve themselves in the debate.
In the paper (find an abstract here), the authors focus on the potential shortcomings of federal regulation of nanomaterials, and ultimately, "suggest some ways government agencies can be better prepared to address nanotechnology risk knowledge gaps and risk management." The primary thrust of the paper is that state and local government will likely have to address risks and concerns of nanomaterials in the absence of complete information.
State and local regulation of nanomaterials is quickly becoming a favorite topic, and one we've been discussion for a while now (see two of our more recent posts here and here). And while it appears that Wisconsin may jump into the pond soon on nano regulation, nothing concrete has developed yet.
How states address the risks and concerns of nanomaterials, which at the same time addressing the existing data gap, will be just as important as federal action on the subject. States are in the precarious position of not wanting to stifle an emerging, and potentially lucrative in terms of jobs and tax revenue, industry, but at the same time they have an obligation to keep their residents safe. I look forward to reading the full paper and read the suggestions proposed by Maria Powell, Martin Griffin, and Stephanie Tai.
The author, Michael Berger, lists the following five problems with regards to a lack of consistent nanotechnology standardization:
In addition, there are no fewer than seven organizations with competing nanotechnology standards statements, including ASTM, ANSI, IEEE, and ISO--all well respected organizations. In addition, the nanotechnology standards debate has been going since at least December of 2003.
Well, this got me to thinking. In an instance of life imitating life, the competing technical standards for nanotechnology closely resembles the diverging regulatory standards that are developing (oh, c'mon, you knew where I was going with this didn't you?).
For example, take a look at the three state statutes concerning the definition of "nanotechnology." Each of Michigan, Arkansas, and Oklahoma have enacted binding, statewide laws concerning what defines nanotechnology:
Now, take a look at the bold sections. All three of these statements concerning the size of nanotechnology have slightly different meanings. In fact, only one, Oklahoma, actually defines nanotechnology as existing between 1-100 nanometers. While this may not seem to be an overly important consideration now, imagine what these further regulations in these states will look like with diverging bases. Add to these emerging state statutes the previously discussed Berkeley standards, and the forthcoming Cambridge standards, and a very murky picture begins to develop indeed.
While I am not suggesting that there should be one, all-inclusive set of regulatory standards for nanotechnology, I am suggesting that we need to be mindful of these diverging paths and strive to reduce uncertainty and confusion by the regulated community as these standards develop. Just like consistent technical standards will provide certainty to the scientific community, developing regulatory standards with an eye towards consistency will provide certainty for the regulated community.
The information is coming from EurActive (via Nanowerk because the EurActive website is down as of this posting), and it is citing a European Commission official who stated a document to be published this Spring will argue that current EU laws and regulation sufficiently cover nanotechnology and nanomaterials.
The European Food Safety Authority is expected to release a study on risk assessment and nanotechnology issues, but there are no indications as to what that report may reveal at this stage. It is also unclear if this is the report that EurActive is referring to.
I think its too early in the process to try and predict what the official recommendations to the Commission will be. And, even then, the Commission will be free to take or leave the recommendation as it sees fit. Just because the recommendation is to not enact new legislation or regulation, doesn't mean new legislation won't be forthcoming. But, it looks like a report is imminent, which will shed some light on this rumor. Stay tuned.
This morning's New York Times features an editorial discussing Peter Barton Hutt's before the House subcommittee responsible for FDA oversight. Mr. Hutt warned that the FDA was "barely hanging on by its fingertips;" others testifying before the subcommittee suggested the agency lacked funds and staffing to do its job:
In a hearing before a House Energy and Commerce subcommittee, members of the agency’s own scientific advisory board outlined the F.D.A.’s many weaknesses. It lacks scientists who understand rapidly emerging technologies — including genomics and nanotechnology — relevant to product safety. The agency is further hobbled by a high turnover rate of scientists, a decrepit information technology system, a weak organizational structure, and a shrinking inspection force.
That said, FDA has been researching nanotechnology issues for some time -- it formed its Nanotechnology Task Force in August 2006. Still, it's interesting that nanotechnology safety issues have even found their way to the editorial page of the New York Times.
Back in October, we reported on a $314,000 grant three Arizona State University professors received from DOE to study nanotechnology regulation. It seems that grant has already begun to bear fruit, as Nanowerk reports one of the grant recipients - law professor Doug Sylvester - will be teaching a two-hour interdisciplinary class in the Spring entitled "Nanotechnology And The Law." Professor Sylvester describes the import of his class:
“It’s not just about the law, it’s about our lives,” says Sylvester, a College of Law professor and faculty fellow in the College’s Center for the Study of Law, Science, & Technology. “For the first time in history, we know something is coming that carries great potential and possible grave danger. The technology will revolutionize much of how we live in the world. The question becomes, how, as a society, can we prepare ourselves to best promote the benefits and prevent the risks?”
Professor Sylvester's course will be geared toward public policy, bioengineering, medicine, law and other students, and, according to the Nanowerk article, the class is designed to encourage students to collaborate to find ways of using public policy and regulation to balance the potential threat nanotechnology may pose to the environment against the need to develop the technology.
I look forward to seeing what research comes out of this grant and out of this course.
Environmental Science & Technology recently released an editorial discussing nanotechnology safety issues and, more importantly, the recent debate over whether EPA should regulate nanoscale materials as new chemicals under TSCA. The editorial succinctly sets forth EPA's position, as expressed by Jim Willis, EPA's Chemical Control Division Director, on the TSCA issue this way:
In an EPA document, TSCA Inventory Status of Nanoscale Substances—General Approach, released on July 12, the agency explained why it could not group all nanomaterials as new substances solely on the basis of size. This is because the definition of a new chemical under TSCA is based on only molecular structure or identity. If a nanomaterial contains the same molecules as a chemical already in the TSCA inventory, it is an existing chemical, says Willis. And almost all nanomaterials being researched and manufactured today are chemically identical to existing chemicals in the TSCA inventory. Thus, EPA has no authority to regulate them. Carbon nanotubes and fullerenes, for example, are made of carbon, an existing chemical in the inventory.
h/t to TGDaily.com.
Andrew Maynard of the Project on Emerging Nanotechnologies at the Woodrow Wilson Institute testified on October 31st before the House Science Committee. PEN's press release is here and the full text of Maynard's remarks are here. In his testimony, Maynard advocated six steps to improve nanotechnology safety and criticized what he believed was a lack of coordination and focus on environmental, health & safety issues.
Among the items Maynard criticized is the practice of carbon nanotube manufacturers to submit MSDS sheets for SWNTs that effectively mirror those for regular graphite. This is a practice I also identified as problematic in my remarks before the Nano App Summit in Cleveland on October 22nd. However, in the absence of clearer safety data, I don't know that it's unreasonable to provide warnings to workers based on the source material and then to additionally warn workers of "potential" inhalation and other risks.
In any event, among the six steps Maynard advocates are the following:
Create a new federal advisory committee to allow transparent input and review from industry, scientists, labor groups, nongovernmental organizations and other stakeholders; [and]
***
Appoint a top-level government leader responsible for the action needed to address the environmental, health and safety challenges of nanotechnology.
In his comments, Maynard criticizes what he terms as disconnects between administrative agencies and contends that NNI is not sufficiently well-funded and is not focused clearly enough on environmental, health and safety issues. One example of the "disconnect" Maynard dislikes is the fact that NIOSH filed a public comment on EPA's TSCA paper from this past summer in which NIOSH disagreed with EPA's proposed regulatory framework for nanomaterials under TSCA. Instead, Maynard believed that NIOSH should have been communicating with EPA through "back channels." While I recognize Maynard's general point that the federal government needs to coordinate as well as it can, I actually don't mind the transparency that comes with agencies communicating through "front channels" rather than "back channels." Say what you will, but the public disagreement between NIOSH and EPA on the TSCA regulatory issue certainly has drawn attention to the issue and enriched the public debate in a way that "back channel" lobbying would not have.
First, Johns Hopkins University recently announced that students will be able to minor in "nanotechnology risk assessment and public policy." Faculty from the engineering and public health programs received a grant to offer the curriculum.
"The new minor will involve courses on topics such as risk science and public policy, ethics and law, environmental engineering, public health and toxicology. Faculty members who will develop or teach the courses are affiliated with the Institute for NanoBioTechnology, Whiting School of Engineering, Bloomberg School of Public Health and Krieger School of Arts and Sciences, as well as the Risk Sciences and Public Policy Institute, Berman Institute of Bioethics and Center for Law and the Public's Health."
Second, in Tempe, Arizona, three professors at the University of Arizona's Sandra Day O'Connor College of Law received a $314,000 grant from the US Department of Energy to "develop models for the international regulation of nanotechnology." The grant will cover approximately 3 years worth of work, and will be used to:
These two schools are essentially turning out the first generation of nanotechnology regulators. While those of us in the system now are learning as we go, students in both programs will be taught nanotech regulatory issues from the beginning of their careers. What's also interesting is that these programs are addressing the regulatory issues from different perspectives, which should lead to differing views and debates on laws and regulation. Perhaps even a cross-university conference is in the making here?
SmallTimes's September/October print edition just recently hit newsstands. Featured in that magazine is our own John Monica's article entitled "Ramping up the EPA's Nanoscale Material Stewardship Program." (Co-blogger Michael Heintz has previously blogged about this program here and here.)
The issue also contains a great article by Lynn Bergeson -- "The EPA's Toxic Substances Control Act: What you must know," and another by Barbara Goode -- "Framing the DuPont/ED Nano Risk Framework."
The article begins by setting forth the arguments that have been presented for stricter regulation of nanotechnology, as well as the context for why stricter regulation is being called for. The Group then sets forth the arguments against stricter regulation, and an analysis of each objection. Each analysis, while brief, is thoughtful and presented to provide a balanced look at both sides of the debate for stricter regulation.
However, what makes this article particularly noteworthy is that it presents a straightforward, and rather simple, alternative to stricter controls. Noting that passing new laws and promulgating new regulations is not easy, the Group suggests "running faster to catch up." That is to say, testing methods and regulatory planning should be accelerated in order to keep pace with nanotechnology development. In that way, the data gap that everyone admits exists will begin to close, while contingency regulatory plans are put into place should testing data reveal a serious problem. In this way, nanotechnology research and development, as well as testing and regulatory development can all proceed in concert.
This is a novel approach (novel in the sense that I haven't seen anyone suggest it), which deserves thought and consideration. Like most other "hot topics," the solution to the question of regulation will need to consist of a compromise between all interested parties. Those interested and involved in the debate should read this article and give some thought to the solution proposed. The Group admits that there are questions present with its proposed compromise, and even then it is likely only a temporary measure while more is learned. However, it strikes me as a reasonable step in the development and control of this technology.
Finally, the Group touches on a thought that I wanted to state more plainly here. The article asks the question that assuming "current laws are inadequate, would new or stronger laws be enough to fill that gap?" To me, that poses the next logical thought (well, logical to me anyway): perhaps then, the answer is not more or stronger laws and regulations, but rather, different laws and regulations. Specifically, those that take into account this new area of science and technology that current laws were not designed to address. Perhaps the long-term answer is a new set or series of laws and regulations that are developed and authored to directly address the development and control of nanotechnology. Admittedly, we are not there yet, but, along with the other issued raised by the Group, something to consider.
About The Nano Ethics Group:
Founded in 2003, The Nanoethics Group is a research & education organization - not an advocacy, activist or watchdog group. What makes us different is that, where other organizations have already made up their minds either for or against nanotechnology, or are tied to certain interests, we have no agenda other than to keep an open mind and go where analysis & common sense lead us. More information can be found here.
According to this recent article in the Jerusalem Post, the European Union is the top public financier of nanotechnology:
With €1.4 billion allocated to 550 projects in the field of nanosciences and nanotechnology, the EU's 6th Research Framework Program accounts for one-third of total public funding for nanotechnology and is the world's largest single funding agency worldwide for this field.
The article notes, however, that private funding for nanotechnology research in Europe lags the U.S. and Japan.
The Europeans appear to be taking an integrated approach to nanotechnology safety, by investing €28 million in safety research as part of each of its programs. Much like in the U.S., European regulators are also exploring whether the EC's environmental, health and safety laws require change to deal with these issues:
The European Commission is currently undertaking a review of existing legislation to see whether the current regulatory framework appropriately addresses health, safety and environmental risks. Moreover, it has taken steps to establish an observatory to provide decision-makers with dynamic assessments of scientific and market developments.
It looks like the U.S. might be moving faster on nanotechnology regulatory issues, so I will be interested to see whether the Europeans take our lead or chart their own course. So far, they seem to be taking a sensible approach to the problem. I especially like the integration of safety research into their primary research grants (which, among other benefits, reduces the likelihood that scientists will overstate the results of safety issues in an effort to attract more funding) and the inclusion of private industry in the regulatory process.
In response to the Samsung Washing Machine "nanosilver" controversy last year, EPA indicated it would issue a federal notice concerning how it intends to treat silver ion generators under FIFRA. Many urged EPA to use this opportunity to issue a broad proclamation that all products containing nanoscale silver would be required to be registered as pesticides under FIFRA. NanoLawReport believed EPA would issue a significantly narrower ruling.
On Monday, EPA finally published its promised federal notice requiring products that emit silver ions or other antimicrobial substances to be registered as pesticides under FIFRA. EPA was clear that the notice is not intended to regulate nanotechnology as a whole, nor has the Agency even received information suggesting that the Samsung washing machine in question uses nanotechnology. Whether EPA will require other products containing nanosilver to be registered under FIFRA is likely to be decided on a case-by-case basis.
Small Times is reporting that the National Nanotechnology Coordination Office at NNI is requesting public comment, until September 17, 2007, on its proposed "Prioritization of Environmental, Health and Safety Research Needs for Engineered Nanoscale Materials: An Interim Document For Public Comment."
According to the Small Times article,
"The comment period is an opportunity for public input into the prioritization of research and information needs related to environmental, health, and safety aspects of nanomaterials," groups note, adding that the research priorities will be an important part of the NNI EHS research strategy, which will be used by the Federal agencies to support research within their mission areas.
The NNCO established 25 research priorities. However, to make the list more manageable, it broke the 25 priorities into five broad categories. Overall, I like the approach the government is taking on these research priorities. They are asking the right questions about (1) how engineered nanomaterials interact with biological systems and the environment, (2) how to measure exposure to nanomaterials -- both in workers and to the general public, and (3) what impact nanomaterial exposure has on health. The report also calls for risk management to be a research priority.
These are NNCO's five proposed categories:
Instrumentation, Metrology, and Analytical Methods
The priority research needs for this category provide an integrated approach essential to understanding, predicting, and quantifying the chemical and physical properties and behavior of nanomaterials. The priorities under this research category underpin, and are fundamental to, all five categories of EHS research and information needs.
Nanomaterials and Human Health
Research on human health often involves complex, interrelated scientific concepts that are investigated most efficiently by a parallel, rather than serial, research paradigm. This parallel structure permits the investigation of single or integrated research questions and the leveraging of progress in related areas. Evaluation of the human health research needs against this paradigm and the value-of-information principle led to identification of an overarching research priority. The task force identified five broad research needs that are critical to addressing this overarching priority and to establishing the fundamental principles for nanomaterial interactions with living systems. Overarching Research Priority: Understand generalizable characteristics of nanomaterials in relation to toxicity in biological systems.
Nanomaterials and the Environment
The priority research needs for this category represent those that were presented in the EHS Research Needs document, with revisions to ensure complete coverage of environmental issues.
Health and Environmental Exposure Assessment
Research in this category is aimed at assessing exposure to, rather than hazards of, nanomaterials * * *. The priority research needs for this category identify work to enable the collection of exposure information. Data collection should group individuals into exposure categories and relate groups potentially exposed to nanomaterials, including workers, patients, consumers, and neighbors of production or utilization plants. * * * Information on the process, task, and location variables should be evaluated to understand how nanomaterials behave in workplace environments and what factors determine the exposures to nanomaterials in such environments.
Risk Management Methods
The many research needs for this category, as identified in the EHS Research Needs document, were grouped by the risk management methods task force into five broad research needs, which were then prioritized. The broad research needs are listed below, ranked from highest to lowest priority. The task force recognized one of the research needs identified in the EHS Research needs document as encompassing the overarching research priority for this category. Overarching Research Priority: Evaluate the appropriateness and effectiveness of current and emerging risk management approaches for identifying those nanomaterials with the greatest potential risks.
By Tim Cahill:
Yesterday the FDA's Nanotechnology Task Force released its report on the scientific and regulatory challenges related to the use of nanotechnology in products regulated by the FDA. As reported in our July 10, 2007 post, the Task Force's report did not call for additional FDA regulatory authority in this area. The Task Force concluded that the use of nanomaterials in products regulated by the FDA presents challenges similar to those products using existing technologies and other emerging technologies. Further, the Task Force determined that the current science on nanotechnology does not suggest that products using nanomaterials require additional labeling.
The Task Force, however, did recognize that the unique properties of nanomaterials could at some point create challenges with respect to product safety and effectiveness. To that end, the Task Force recommended the consideration of agency guidance that would clarify what information manufacturers should provide to the FDA about products utilizing nanotechnology and would clarify the circumstances under which the use of nanomaterials would change the regulatory status of particular products. The report also recommends that the FDA assess its data needs to better regulate nanotechnology products, develop in-house expertise on nanotechnology issues, and create mechanisms that will ensure the consideration of new nanotechnology information as it becomes available. Finally, the report encouraged the FDA to evaluate the adequacy of current testing approaches to assess the safety, effectiveness, and quality of nanoscale materials.By: Tim Cahill and Michael Heintz:
FDA Week reported on July 6, 2007 that the FDA's Internal Nanotechnology Task Force is close to issuing its first report and is going to recommend that the agency not create "regulatory policies" for nanomaterials. Instead, the task force is likely recommending that FDA create guidelines for "best practices." The Task Force report will also likely urge FDA to work with academia and the National Nanotechnology Initiative to gather more information about nanotechnology risks and benefits.
FDA Week also observes that an agency official stated as early as 2005 that the agency would not regulate products containing nanotechnologies any different than conventional products, and "The agency does not regulate the technology as a separate entity so products such as drugs or medical devices that employ nanotechnology are scrutinized while cosmetics are not. " The Task Force report will also likely urge FDA to work with academia and the National Nanotechnology Initiative to gather more information about nanotechnology risks and benefits.
One downside to our focus on the safety of nanomaterials is that it can cause us to lose focus on the potential upsides of nanotechnology in the environmental, health and safety arena. CORDIS is reporting on a study funded by the European Parliament's Scientific Technology Options Assessment ("STOA") committee which looked into whether nanomaterials could serve as substitutes for hazardous materials.
In particular, the study focused on two areas where nanotechnology is already making inroads -- coatings and catalysts:
Two areas where nanotechnology is already making inroads as a substitute for hazardous chemicals are coatings and catalysts. Coatings can create anti-adhesive surfaces which resist things sticking to them, such as dirt, or have biocidal properties to prevent living organisms from sticking to them.
Nanoparticles are also widely used in catalysts, although the authors point out that research in this field was already on the nanoscale, and so it is not clear to what extent future developments could be attributed to nanotechnologies.
The Woodrow Wilson Center released a study entitled "EPA and Nanotechnology: Oversight for the 21st Century," authored by a former high-level EPA administrator, J. Clarence Davies. Mr. Davies argues that EPA oversight and regulation of nanotechnology is "urgently" needed. The Wilson Center has the full text of the report available here.
The report is summarized in this Science Daily article. The article notes the reaction from the Wilson Center's Project on Emerging Nanotechnologies:
"This new report seeks to encourage EPA, Congress, and others to create an intelligent oversight approach that empowers EPA and promotes investment and innovation in new nanotechnology products and processes," said David Rejeski, director of the Project on Emerging Nanotechnologies at the Wilson Center (PEN). "As both the chair and ranking minority member of the U.S. House of Representatives Committee on Science and Technology stated last year, 'Nanotechnology is an area of research that could add billions of dollars to the U.S. economy, but that won't happen if it is shrouded in uncertainty about its [environmental, health and safety] consequences.' "
The Science Daily article also summarizes the approach Davies recommends. Specifically, it appears that Davies is focusing on creating an industry-EPA partnership to study the toxicity of nanotechnologies and creating an inter-agency coordinating group (possibly involving FDA and OSHA) to oversee nanotechnology regulation. The eventual goal, it seems, is to amend the Toxic Substances Control Act (TSCA) to expand EPA's power to regulate the area. It is promising that Davies' proposal involves significant industry cooperation in the development of any standards. One must hope that any actual regulations or amendments to the TSCA that come from this type of approach are properly balanced to encourage innovation and America's entrepreneurial spirit while significantly mitigating any significant risk of harm from the use of nanomaterials.
By Tim Cahill:
The April 20, 2007 edition of FDA Week reports that the former deputy commissioner in the FDA's policy office, Michael Taylor, repeated his call for Congress to grant FDA enhanced regulatory authority with respect to products that utilize nanotechnology, particularly cosmetics, dietary supplements, and foods.
Mr. Taylor believes that FDA should have the authority to force companies to disclose information about the nanotechnology they use in these products so the agency can better monitor the associated risks. Mr. Taylor made this assertion while speaking at a Food and Drug Law Institute conference on April 12th, and he initially raised this issue in a report he wrote last October for the Wilson Center's Project on Nanotechnology entitled "Regulating the Products of Nanotechnology: Does FDA Have the Tools It Needs?"
The White Paper, as expected, lays out the Agency's thoughts and ideas concerning nanotechnology and how EPA will treat it. While the Paper begins with the Agency's role in the larger government plan concerning nanotechnology, it provides many EPA-specific items as they relate to research and regulation.
The Paper begins with EPA explaining EPA's role with regards to nanotechnology, as well as why nanotechnology is important to the Agency. It then addresses issues such as risk assessment and development of nanotechnology from EPA's perspective. Not surprisingly, EPA identifies several areas in which clear data gaps exist and must be filled in order to progress with nanotechnology. However, of particular interest to those in the regulated community, the Paper provides some of EPA's thoughts on both potential regulation of nanotechnology, as well as its possible environmental benefits.
First, with regards to possible regulation by EPA, the Paper explains that the Agency maintains the position that current environmental statutes provide it with the authority to regulate nanomaterials. This statement alone is not surprising as it is a generally accepted thought. However, the Paper fails to discuss how some of these statutes contain trigger levels that may be inappropriate measures of nanomaterials. For example, statutes such as the Clean Air Act and Resource Conservation Recovery Act contain measurable levels at which regulation begins, such a specific concentration or weight emitted or discharged. Because nanomaterials may be a concern at vastly smaller measurements, many of these triggers that are measured in parts-per-million or pounds or tons emitted may be inapplicable; a point EPA does not fully develop. Similarly, EPA spends significant space on potential environmental harms, but also explains that nanotechnology may also provide environmental benefits, especially in terms of ground water or Superfund site remediation projects. It is important to remember that nanotechnology can be a positive in remediation efforts, not just something to regulate for protection. EPA does a good job remember this point, and should be commended for taking a two-vision approach: understanding remediation possibilities and understanding risk possibilities.
Second, the Paper goes into great detail concerning risk assessment. EPA believes it is very important to develop sound risk assessment concerning nanomaterials before moving to the next step. The Agency then reiterates its desire to work with stakeholders to develop the necessary information to make educated decisions.
Finally, the Paper concludes with a series of recommendations directed at EPA offices and staff. If EPA holds to these recommendations, the Paper provides a good road map as to the Agency's priorities in the near future. While EPA's work in nanotechnology will be largely driven by the research of research and risk assessment projects, its overall thoughts on nanotechnology provide a well-reasoned beginning its work in the field.
Nanotechnology Law Report's own John Monica was recently interviewed by Melina Vissat, the news editor of “The Rose Sheet,” published by FDC Reports and formally known as the Toiletries, Fragrances & Skin Care on-line trade report. The interview was a followup to John's recent presentation on the perils of preemptive nanotechnology litigation at a recent conference regarding the regulation of nanotechnology in consumer products, in Washington, D.C. Ms. Vissat’s interview is below the fold.
MV: Why would Berkeley, specifically, make this a regulation? Is there a lot of handling of nano-materials there? Or would this set precedent for California state, and/or perhaps the rest of the country?
JCM: The short answer is Berkeley primarily wanted to be a trendsetter, and secondarily wanted a forward looking ordinance to prevent any potential future problems. Officials in Berkeley have openly criticized the federal government and the state of California for failing to enact nano-specific safety regulations. They have also openly said they enacted their own ordinance because state and federal governments failed to act first. Also, while the ordinance is not binding legal precedent, Berkeley has openly encouraged other governments -- city, state, and federal -- to follow their lead.
As for actual application, currently there are very few companies using engineered nanoscale materials in Berkeley. (In fact, several newspapers have reported there are "none," but I do not believe this is accurate.) So, I would not say the ordinance was enacted because of any impending current safety concern.
On the other hand, University of California Berkeley labs and Lawrence Berkeley National Laboratory are both in the city limits. Both are involved in nanomaterials research. Berkeley says the ordinance was initially prompted by a lack of nanomaterials handling procedures at these two labs. The city claims to have asked the labs what nano-specific safety procedures they had in place, and the answer was "none or very few." This prompted Berkeley's original concern and ultimately the ordinance. However, Berkeley has also now stated that the ordinance does not apply to either lab because they are federally funded. The labs, on the other hand, intend to voluntarily comply with the final ordinance.
MV: Why specifically is this legislation unnecessary? Is it because we don't yet know whether nanomaterials are actually a threat? Or because there is simply a lack of data proving either way - dangerous vs. safe?
JCM: I believe this specific legislation is unnecessary because (i) it is virtually impossible to comply with in its current form, (ii) the federal government should take the lead in labeling any material/chemical as "hazardous," not Berkeley (iii) all "manufactured nanoparticles" - whatever that broad definition used in the ordinance implies - have not been label as "hazardous," nor is there any current scientific consensus that they all should be.
There are data on both sides of the safety/hazard issue, but I do not believe any responsible scientist is dismissing the potentially negative data out of hand. It is a real concern. However, most scientists say more research is still needed and it will take several years. They also advocate the standardization of research techniques to make sure they are all talking about the same thing as they move forward with research.
MV: Who should be doing this research to determine whether nanomaterials are safe? Companies, etc.?
JCM: The federal government is funding nano-related environmental, health, and safety research - about $44 million is in the 2007 budget. However, there seems to be a consensus among scientists that federal funding should be increased to at least $100 million annually. On the other hand, the federal government takes the position that manufacturers are primarily responsible for the research necessary to ensure the safety of their nano-products. Ultimately, product liability law imposes this same burden on manufacturers. As they must ultimately bear the social and financial burden of any liability, I believe manufacturers should plan accordingly. However, my personal belief as a policy matter is that manufacturers and the federal government have equal responsibility.
MV: Now, regarding this regulation, who does the burden fall to to provide the required information? The companies? Will this cost companies time, money, manpower? Could you please provide more detail on how this legislation is a burden to industry?
JCM: The burden falls on the companies to provide the required toxicology information. There are a couple of ways to answer the question depending on what the city wants, which isn't crystal clear.
If the city says all that is required is a literature search (most likely), then my response is that reviewing the universe of existing toxicology studies and then reporting/summarizing them to the city is a very expensive prospect. You will have to ask a toxicologist for an estimate of the actual hours this research would take. There are over 1600 EHS studies in the best nano-database. A lot of them, of course, might not be applicable to any individual company or situation. But if you take the Cosmetics, Toiletry and Fragrance Association’s white paper on nanoparticles in personal care products to the FDA as an example of the type/level of analysis required, the required effort will be quite large and expensive indeed.
If new toxicology research is required (less likely), then that is a whole different (greater) level of expense. There are also additional expenses associated with implementing the materials handling plan portion of the ordinance once the toxicology issue has been resolved. Of course, this is hard to estimate without having the toxicology part nailed down.
MV: Where else is this pre-emptive legislation surfacing?
JCM: This same type of current preemptive legislation is being considered in Cambridge, Massachusetts. I would look for similar efforts in nano-university communities across the country. Additionally, companies located in "top ten" states for nanotechnology development should be closely watching what's going on at the municipal level.
MV: Also, at what stage would it NOT be considered pre-emptive? Once safety data is in-hand?
JCM: City governments are not well-equipped to analyze these issues. Thus, I would always consider municipal regulations of this specific type to be "preemptive" and ill-advised. The federal government is looking very closely at nano-EHS issues, I would leave the decision to it as to whether or not to label a nanomaterial as "hazardous" and all the burdens that come with that label.
The 2007 United Nations Environment Program "GEO Year Book 2007" report was recently released, which explicitly calls for nanotechnology regulation on a global scale. The abstract to the Year Book contains this overview:
The emerging scientific and policy challenges of nanotechnology are examined from an environmental perspective. Nanotechnology will bring environmental benefits but it is vital that we adopt appropriate assessment and legislative process to address the unique challenges presented by nanomaterials and their life cycles.
The AP provides more background in a February 5th report from Nairobi, the site of this year's Global Ministerial Environment Forum, where this report was unveiled. More from the report:
In its annual report of the global environment, the U.N.'s Environment Program said ''swift action'' was needed by policy makers to properly evaluate the new science of nanotechnology.
Although nanotechnology could transform electronics, energy industries and medicine, more research is needed to identify environmental, health and socio-economic hazards, Achim Steiner, who heads UNEP, said in the 87-page report.
The UN is calling for cooperation between the nanotechnology industry and government, and also cooperation between developed nations and developing nations, in formulating a regulatory response to potential EHS nanomaterial concerns. On that note, the National Science Foundation's proposed 2008 budget includes a $29 million request for a Program Component Area entitled "Societal Dimensions: Environmental Health & Safety (EHS)."
John Monica, Michael Heintz and I have recently had an article published in the magazine Nature Nanotechnology (Vol. 2, No. 2, pp. 68-70 (Feb. 2007)) entitled "The Perils of Preemptive Regulation." The full text of the article is available here (subscription required). The lede/abstract of the article is:
In its rush to introduce new regulations about the handling of nanomaterials, the city of Berkeley in California has made mistakes that should not be repeated elsewhere.
In it, we analyze and critique the approach that Berkeley, California has taken in its quest to become the first American jurisdiction to regulate nanomaterials. In particular, we question whether a "reporting requirement" that forces nanotechnology companies to do comprehensive literature reviews of environmental, health and safety ("EHS") literature pertaining to nanomaterials on an annual basis will significantly advance nanotechnology safety. We also wonder whether the de facto characterization of nanomaterials as "hazardous" by the city of Berkeley will invite unmeritorious litigation. That sort of litigation might well cripple this industry and hamper efforts to research, develop, and commercialize this potentially revolutionary new technology.
On the heels of Berkeley, California's decision last December to impose regulations on nanotechnology businesses, the Boston suburb of Cambridge, Mass -- home to MIT and my alma mater, Harvard -- is now looking at nanotechnology regulation. According to the linked article from the Boston Globe, it appears that the Cambridge City Council is aware of the potential for stifling nanotechnology innovation with regulation:
We hope that nanotech is going to be a big part of new industry in Cambridge," said council member Henrietta Davis. But Davis said the city should make sure that nano-based businesses ply their trade safely. "It's not my intention to stifle it," she said. "It's more to be proactive."
This concept of "proactive" regulation, on which my co-blogger John Monica will be speaking this week, raises the question of how well government regulators can strike the balance between the need for innovation and the need of safety in the absence of good information about the probability and magnitude of risks associated with a given activity. On that note, I am glad that Cambridge has decided to explicitly bring industry representatives to the table when deciding whether to impose nano regulations:
Igor Linkov, managing scientist at Intertox Inc., a technology consulting firm in Brookline, said there is some evidence that nanoparticles could pose health risks. He cited a study that found that rats developed scar tissue when liquid mixed with carbon nanoparticles was sprayed into their lungs. But Linkov said far more research is needed before jumping to conclusions about the safety of nanoparticles.
"We know that some nanomaterials, at some point during their life cycle, may pose risks," said Linkov. "We really cannot quantify how high the risk is."
On Jan. 8, the Cambridge City Council voted to ask Lipson to study the nanotechnology regulation enacted in Berkeley last year, and recommend a similar statute for Cambridge. * * * The City Council ordered Lipson to study the Berkeley law and determine whether it makes sense to draw up a similar statute.
We at the Nanotechnology Law Report will continue to follow these developments.
I am pleased to announce that John Monica will be speaking on "The Possible Adverse Consequences of Pre-emptive Nanotechnology Regulation" at the two-day conference and workshop, Regulations for Nanotechnology in Consumer Products, February 8-9, 2007, Washington Marriott, Washington, D.C. This conference is aimed at those interested in doing more than simply scratching the surface of nanotechnology regulatory concerns. A copy of the preliminary agenda can be found here.
Speakers will include:
The American Industrial Hygiene Assocation has identified nanotechnology safety as among its members' top concerns for 2007, according to this report in Occupational Hazards. AIHA identified nanotechnology as an OSHA concern and characterized the concern this way:
Nanotechnology – The increased use of nanotechnology for consumer products raises concerns that a clearer understanding is needed to accurately assess the occupational health and safety risks posed by working with this new technology. AIHA supports increased research into the possible hazards involved with nanotechnology.
Moreover, AIHA's 2007 annual AIHce conference will feature a panel on nanotechnology -- it will be interesting to see what, if any, recommendations come out of the conference about nanomaterial handling.
Given Berkeley, California's recent decision to regulate occupational and other exposure to nanomaterials through its hazardous materials ordinance, and recent Congressional and other pressures to regulate nanotechnology, it's good to see organizations like AIHA taking a look at nanotechnology regulatory issues. As John argued here, we need a scientifically-based, rational regulatory approach to nanomaterial safety; the sooner such an approach is taken, the better. The last thing this industry needs is a highly public "scare" -- such as the Magic Nano scare last year -- to pique the interest of the trial lawyers.
According to a December 21, 2006 press release, both outgoing House Science Committee Chairman Sherwood Boehlert (R-NY) and incoming Chairman Bart Gordon (D-NT) urged the Bush administration "to establish a research agenda with clear priorities to ensure a greater understanding of the potential environmental, health, and safety risks associated with nanotechnology."
I suspect that in 2007, the new Congress may well push a nanotechnology safety initiative. Nanotechnology safety issues are increasingly being publicly discussed, especially given Berkeley's new regulations and NIOSH's recent interest in occupational nanotechnology safety. Andrew Maynard's proposal, discussed in Nature in connection with the National Nanotechnology Initiative, so far looks to be the most comprehensive public proposal -- the press release expressly references it. We previously reported on Maynard's proposal here and here.
The draft agenda for Council's December 5 meeting includes, as "new business," a first reading of an ordinance entitled "Manufactured Nanoparticle Health and Safety Disclosure." This ordinance is an amendment to Berkeley Municipal Code Sections 15.12.040 and 15.12.050, addressing disclosure requirements for hazardous materials and waste management. Those immediately impacted include the University of California-Berkeley and the Lawrence Berkeley National Laboratory, both of which conduct nanotechnology research within Berkeley City Limits. The San Francisco Chronicle reports that the amendment is being urged by the Community Environmental Advisory Committee "because so little is understood about the possible impact of the materials on human health."
The draft ordinance is also asking that letters be sent to elected officials asking them to earmark a percentage of funds included in the National Nanotechnology Initiative's annual budget for health and safety research.
Updates on the progress of this ordinance will be posted as they become available.
Since first being reported in the Washington Post, and relayed here, more information concerning EPA's proposed regulation of nanosilver under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) has been uncovered.
As initially reported, the EPA's Office of Pollution Prevention reversed its course from earlier statements, and ultimately decided to regulate nanosilver under the FIFRA. EPA reasoned that because manufacturers were producing products containing nanosilver as a method of killing bacteria, such uses were properly the province of the FIFRA as a pesticide. Nanosilver is found in several products available today, including food containers, shoes, air fresheners, and bandages. The concern is that the silver may pose a threat to aquatic systems as a bio-accumulative toxin.
Upon further research into EPA's announcement, it has been determined that EPA plans to issue a Federal Register notice that will explain the requirements for using nanosilver as an anti-bacterial agent. Greenwire is reporting that the rule will be issued "within the next few months." It is expected that those falling under this new rule will need to show that the nanosilver additive will not pose an environmental risk when placed into commerce. However, as reported in the November 23, 2006 Washington Post article, EPA states that to be subject to FIFRA regulation, there has to be a claim that the product will "kill pests" in order for it to be a pesticide. Consequently, products containing nanosilver may not be subject to FIFRA regulation absent a claim that the product kills bacteria, viruses, or the like.
The most important piece of information to come out of this subsequent research is the knowledge that EPA will indeed begin regulating nanomaterials, and plans to do so soon. Silver is already regulated under the FIFRA in several products as a pesticide, so for EPA to regulate forms of nanosilver is potentially a new step. The Federal Register notice should provide additional details as to how nanosilver will be regulated under the FIFRA and the procedures EPA will use in determining which uses are subject to regulation and which are not. It is important to note that nanomaterials are not currently regulated, however it appears as though regulation is now imminent, starting with nanosilver in anti-bacterial uses.
The three panelists discussed their views on regulation of nanomaterials. All agreed that more information is needed before firm policy can be developed and that additional funding, especially in the area of health and safety research, is also needed. Of particular note, Mr. Alwood noted that the EPA is focusing nanomaterials regulation under the Toxic Substances Control Act (TSCA) when those materials exhibit "unique properties" from those chemicals already appearing on the TSCA Chemical Inventory. Mr. Alwood explained that a difference in the sizes of chemicals is not new to TSCA, and that to track with the National Nanotechnology Initiative definition of "nanotechnology," nanomaterials will likely have to display unique behavioral characteristics to warrant a repeated entry on the TSCA Chemical Inventory. Mr. Alwood also referenced the Stewardship Program that EPA is developing, and referred listeners to the letter that was released by EPA on October 18, 2006 requesting the voluntary submission of nanotechnology research data to supplement EPA's research efforts concerning TSCA regulation. That letter is available at http://epa.gov/oppt/nano/nano-letter.pdf
Next, Dr. Sass addressed the health and safety concerns raised by the manufacture of nanomaterials. She was particularly concerned with the toxicological impacts nanomaterials may have when introduced into biological systems. She believes more information is needed to properly address the risks posed by nanomaterials, and that research budgets should be increased accordingly. She is particularly concerned over the inhalation dangers posed by nanomaterials, and cited to several laboratory experiments providing epidemiological data on health impacts.
Finally, Mr. Gulledge presented the manufacturer's perspective on nanotechnology, and tended to agree with the other panelists concerning data gathering and funding issues. Of note, Mr. Gulledge pointed to recently released survey results presented by the International Council of Nanotechnology at Rice University. Those survey results, available at, icon.rice.edu/projects.cfm, outline the findings from an international survey conducted to determine current environmental, health, and safety, and stewardship efforts being made by manufacturers. Mr. Gulledge also provided a brief overview of the international efforts being made by the Organisation for Economic Co-operation and Development (OECD, www.oecd.org/department/0,2688,en_2649_37015404_1_1_1_1_1,00.html). That organization, in which the United States is an active participant, is taking an international approach to stewardship, environmental, and health concerns posed by manufactured nanomaterials.
The teleconference provided a good opportunity to hear basic information concerning current and potential research and regulatory activities being pursued by different organizations. The panelists largely agreed on several topics including the need for additional research funding and the authority given to EPA to regulate nanomaterials within current statutory framework. As these teleconferences continue, further updates will be posted here.
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