Nanotechnology Lawyer & Attorney : Porter Wright Morris & Arthur : Nanotechnology Law Report - Germanium nanobead image provided by UT-Battelle, which manages Oak Ridge National Laboratory for the Department of Energy

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

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

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

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

Educational Objectives:

• Develop familiarity with new and emerging federal, State, and international nanomaterials regulations and governance strategies
• Understand Potential Public Health and Environmental Impacts and the approaches various government agencies are pursuing to promote nanotechnology while also addressing potential public health and environmental risks
• Appreciate complexities of addressing potential risks with existing governance tools and strategies while also embracing new approaches to accommodate evolving technologies

I hope to attend by telephone and encourage any interested readers to do the same.  It should be a great conference.

 

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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:

• The common or trade name, the chemical identity, and the molecular structure of each chemical substance or mixture.
• The categories or proposed categories of use of each such substance or mixture.
• The total amount of each such substance and mixture manufactured or processed, reasonable estimates of the total amount to be manufactured or processed, the amount manufactured or processed for each of its categories of use, and reasonable estimates of the amount to be manufactured or processed for each of its categories of use or proposed categories of use.
• A description of the byproducts resulting from the manufacture, processing, use, or disposal of each such substance or mixture.
• All existing data concerning the environmental and health effects of such substance or mixture.
• The number of individuals exposed, and reasonable estimates of the number who will be exposed, to such substance or mixture in their places of employment and the duration of such exposure.
• The manner or method of its disposal, and in any subsequent report on such substance or mixture, any change in such manner or method.

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For anyone who might be interested, I will be speaking on nano-related insurance issues at the opening plenary of the National Nanotechnology Initiative's upcoming Oct. 6 -7 conference and workshop on Nanomaterials and the Environment & Instrumentation.  The draft agenda for the conference can be found here, and the plenary is also supposed to be broadcast on the web.  I will post the information for the simulcast as we get closer to the conference date.  Cost, location, and registration info. is here.

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The April issue of Environmental Health Perspectives carried an interesting article by Charles W. Schmidt,  "Nanotechnology Related Environment, Health, and Safety Research: Examining the National Strategy". The article looks at what could be a disturbing development, that

Experts in nanotoxicity and risk assessment have become increasingly polarized, represented on one side by the National Research Council (NRC) and on the other by the National Nanotechnology Initiative (NNI).

Schmidt's article notes that this polarization began after the Nanotechnology Environmental And Health Implications (NEHI) Working Group, part of NNI, released Strategy for Nanotechnology Related Environmental Health and Safety Research in February 2008. The report presented the then Bush Administration's agenda for studying nanoparticle hazards and was developed and written after "extensive consultations with regulatory agencies, research organizations, the business community and non-governmental organizations". The report reflected the concerns of the established stakeholders in nanotechnology.

In February 2009, an NRC assembled panel released its own report

. . .  describing what it calls serious short comings in the strategy document. According to the NRC panel . . . the strategy exposes weaknesses in the government's understanding of potential nanotechnology risks today and doesnot adequately address how they will be assessed in the future.

. . . NRC panelists would like to see a National Health based Strategy for nanotechnology research with defined goals, milestones, and mechanisms for assessing progress. . . . The need isn't just to insure the safety of nano-enabled products, but also to avert a public backlash against the technology, which could grow if health risks aren't seen as adequately addressed.

. . . The NNI strategy document - NRC panelists claim - is simply a compendium of federally funded projects without any unifying vision or sense of shared purpose.

An advance copy of the NRC report leaked out to the press in December 2008, leading NNI to post a rebuttal on its website , presenting the strategy document not an implementation plan, "But rather a higher-level description of the inter-agency approach to nanotechnology related EHS research."

One can only hope that the growing divide can be bridged. Both sides have much to contribute to the future growth of nanotechnology and a split into opposing camps serves neither side very well.

The final part of this article turns toward a different, in many ways more worrisome, topic. In January 2008, the EPA launched its nanoscale materials voluntary stewardship program, which urged companies to report information to EPA about their use, manufacture, import, etc of nanoparticles; according to the article, as of January 2009, only 29 companies had responded.

While companies might fear that their trade secrets might be revealed to competitors, it is more likely that what companies are afraid of are potential product liability lawsuits, legitimate or not, that would keep them in court for years (the shadow of asbestos again) and giving information to groups that would use the general public lack of understanding of nanotechnology - to most people, this is still science fiction - to create a climate of fear. At this stage in its development, the nanoindustry might be compared to the nuclear industry from 1950 until the mid-1980s. For the general public in that period, nuclear power was a mysterious thing beyond the non-scientist's ability to understand. For most people, nuclear energy meant only one thing: the power to destroy, personified in the form of Godzilla. Interest groups opposed to the further development of nuclear energy were able to use companies involved in the construction and running of nuclear power plants unwillingness to provide the public with information to create an effective climate of fear and opposition to the point where the industry nearly shut down after 3 Mile Island and Chernobyl.

To avoid this fate

. . .  nanoparticle toxicity data need to be made more widely available to insure public support for the technology.

rather than burying the information in annual reports or SEC filings, such as a 10K or a 10Q, which, while they are great sources of information, are also usually great cures for insomnia.

In an age of calls for greater transparency in both government and business, one can only hope that the nanoindustry will seize the moment and release more information in a form and language that the general public can understand. As someone once observed, sunshine is the best disinfectant.

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Nanotechnology Law Report -- Spring 2009

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This Article Was Authored and Contributed by the American National Standards Intititute

This second article in a series on nanotechnology standardization introduces the international working group that, under US leadership, is creating the standards needed to support the health, safety, and environmental aspects of nanotechnology.

In the post-war era of the late 1940s, global leaders of government and industry formed a central body to “facilitate the international coordination and unification of industrial standards.” Twenty-six member nations came together in 1947 to form the International Organization for Standardization (ISO). 

ISO and its national member bodies – including the American National Standards Institute (ANSI) – are constantly evolving to meet changing demands. Today, ISO is addressing issues such as industrialization, the advancement of information technologies, quality, the environment, and the health and safety of workers and consumers. Today, roughly one of every twenty ISO standards addresses issues pertaining to health, safety or the environment.

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Research and Market recently announced the publication of a new report addressing environmental uses and applications of nanomaterials.  The report covers many applications, environmental media, and toxicology, and, "describes nanotechnologies, nanomaterials, nanotechnology companies, universities and research centers related to nanotechnologies for new environmental technologies.  Areas covered by are leading edge research in emission reduction, environmental remediation and monitoring, green manufacturing, water filtration and treatment, energy conversion and storage, alternative energy and toxicology. "

The table of contents of the report is available here, and the full report can be purchased for EUR 1,584 (approximately $2,100.00).
 

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AUTHORED BY ANDREW BERGMAN

On October 27, 2006, the ABA Section on Environment, Energy and Resources sponsored a teleconference on the science of nanotechnology.  The speakers were Kristen Kulinowski, Ph.D., from Rice University, and John Balbus, M.D., from Environmental Defense, and the moderator was Sunil Garg, Ph.D., Esq., from the Ecoshelf Group.

Kulinowski described nanotechnology as understanding and controlling of matter between the molecular and particulate levels, where the properties of materials change and new properties emerge. For example, gold at nanoscale is red or blue and has a much higher chemical reactivity.  Major changes can be made to a material's magnetism, friction and electrical conductivity. There are already 200-300 products on the market today that are touted as nanomaterials, and success is predicted for nanomaterials with regard to solar panels, replacing copper wires, defense applications, medicine and environmental technology. However, nanomaterials cause come concern. Some materials appear to be fairly cytotoxic, and larger cell organisms show the effects of nanomaterials in hazard studies (inject in lab).

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