Nanotechnology Lawyer & Attorney : Porter Wright Morris & Arthur : Nanotechnology Law Report

Rumors from "across the pond" indicate that a forthcoming official recommendation to the European Union will be that nano-specific regulations are not needed in the EU.

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On May 7, 2008 the House Committee on Science and Technology unanimously approved H.R. 5940, the National Nanotechnology Initiative Amendments Act of 2008.  The bill now moves onto the full House, and then Senate for full consideration.  As stated by the Committee, "H.R. 5940, does not substantially alter NNI, but makes adjustments to some of the priorities of the program and strengthens one of the core components – environmental and safety research."

The full text of the bill can be found here, and we now wait to see what the full House will do with the bill.  However, the fact that H.R. 5940 is receiving bi-partisan support in committee, and was referred back to the full House so quickly (the bill was originally introduced on May 1, 2008), is positive for future action.

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Our friends at Rice University's International Council on Nanotechnology (ICON) is proposing an idea that will essentially take the idea of "best practices" straight to the stakeholders in the form of a living document that is continually updated.  Through using a "wiki," ICON proposes creating a set of "good practices" that companies can update along the way with their own ideas and suggestions.

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On May 1, 2008, a group of 14 NGOs sued the EPA asking the agency to issue new rules regulating products containing nanoscale silver particles. The NGOs are: The International Center for Technology Assessment; The Center for Food Safety; Beyond Pesticides; Friends of the Earth; Greenpeace; The Action Group on Erosion, Technology and Concentration; Center for Environmental Health; Silicon Valley Toxics Coalition; Institute for Agriculture and Trade Policy; Clean Production Action; Food & Water Watch; Loka Institute; The Center for the Study of Responsive Law; and Consumers Union.

The petition points to the consumer product inventory published on the Project on Emerging Nanotechnologies website of the Woodrow Wilson International Center for Scholars which identifies approximately 260 products purporting to contain or use nanoscale silver.  Petitioners claim the EPA has failed to adequately regulate these and other similar products.

In support of its call for new regulation, the petition takes the petition that while the specific long-term health effects of human and environmental exposure to nanoscale silver particles are still being studied, scientific studies “indicate that nanosilver materials pose serious risks to human health and the environment.”  According to the petitioners, some of these studies allegedly show:

• Nanoscale silver is more toxic than other nanoscale metals.  Braydich-Stolle, et al., In Vitro Cyctotoxicity of Nanoparticles in Mammalian Germline Stem Cells, 88(2): Toxicological Sciences 412-419 (2005)

• Nanoscale silver exhibits “effective antibacterial action” at much lower levels than silver ions.  Lok, et al., Proteomic analyses of the mode of antibacterial action of silver nanoparticles, 5 J. Protean Res. 916-924 (2007).

• Nanoscale silver produces reactive oxygen species, which can result in toxic oxidative stress.  Hussain, et al., In vitro toxicity of nanoparticles in BRL 3A rat liver cells, 19 Toxicology in Vitro 975-983 (2005).

• Nanoscale silver is toxic to mammalian liver cells.  Hussain, et al., In vitro toxicity of nanoparticles in BRL 3A rat liver cells, 19 Toxicology in Vitro 975-983 (2005).

• Nanoscale silver is toxic to mammalian stem cells.  Braydich-Stolle, et al., In Vitro Cyctotoxicity of Nanoparticles in Mammalian Germline Stem Cells, 88(2): Toxicological Sciences 412-419 (2005)

• Nanoscale silver is toxic to mammalian brain cells.  Hussain, et al., In vitro toxicity of nanoparticles in BRL 3A rat liver cells, 19 Toxicology in Vitro 975-983 (2005).

• Mammalian cell function abnormalities result from contact with nanoscale silver. Hussain, et al., In vitro toxicity of nanoparticles in BRL 3A rat liver cells, 19 Toxicology in Vitro 975-983 (2005).

• Inhaled nanoscale silver may be transported throughout the body and into the kidney, brain, and heart.  Health and Safety Laboratory, Health and Safety Executive NewsAlert Service, December 2006 at p. 26.

• Nanoscale silver penetrates cell membranes agglomerates in cell cytoplasm.  Skebo, et al., Assessment of Metal Nanoparticle Agglomeration, Uptake, and Interaction Using High-Illuminating System, 26 International Journal of Toxicology 135 (2007).

• Nanoscale silver causes embryonic contamination in Zebrafish.  Lee, et al., In Vivo Imaging of Transport and Biocompatibility of Single Silver nanoparticles in Early Development of Zebrafish Embryos, 1 ACS NANO 133, 141 (2007).

Because of these alleged risks, as well as others claimed in the petition, Petitioners ask EPA to take a litany of specific actions, including:

1. Classify nanoscale silver as a new pesticide (or new use of an existing pesticide) and require detailed product registration and data submissions under the Federal Insecticide Fungicide and Rodenticide Act (FIFRA).

2. Analyze the potential EHS risks of nanoscale silver under FIFRA, the Food Quality Protection Act (FQPA), the Endangered Species Act (ESA), and the National Environmental Policy Act (NEPA).

3. Take action against unregistered products containing nanoscale silver including issuing stop sale and/or removal orders.

Finally, the petition appears to be driven by the EPA’s September 2007 public notice that it intends to regulate silver ion generators as pesticides under FIFRA.  Petitioners do not believe that the notice went far enough in addressing potential nanoscale silver issues:

In the FR notice no mention is given to the rest of the existing fleet of nano-silver products (besides the “ion generating” equipment) or any proposed action by the agency regarding it, contrary to the reports of the quotes from EPA officials in the November 2006 announcement.  Nowhere does the notice request information about such products or in any way solicit comment from interested parties or the public on the regulation of nano-silver products.

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Yesterday, the Government Accountability Office (GAO) published a statement indicating that the National Nanotechnology Initiative (NNI) previously overestimated FY 2006 federal funding of nano-related EHS research by about 18%: "Nanotechnology: Accuracy of Data on Federally Funded Environmental, Health, and Safety Research Could be Improved."

NNI reported that federal agencies spent a total of $37 million in FY 2006 researching the potential EHS risks of nanotechnology.  GAO found that this figure was off by about 18%, and that 22 of the 119 projects identified by NNI had little to do with how nanotechnology may pose EHS risks.  Rather, GAO found the studies were primarily related to detecting or remedying environmental hazards unrelated to nanotechnology.  For those keeping score, 20 of the mislabeled projects were sponsored by NSF, two were sponsored by NIOSH, and funding totaled approximately $6.5 million.  On the other side of the coin, GAO also found that NNI failed to capture some ongoing federal nano-related EHS research in its estimate "because the agencies that conduct this research do not systematically track it as EHS-related."  GAO could not value this research.

GAO attributed any mistakes to a federal reporting structure that does not allow easy categorization of research projects, and also to a lack of guidance to agencies regarding how to correctly apportion funding across multiple topics for reporting purposes.

GAO's statement concludes:

Federal Funding for studying the potential EHS risks of nanotechnology is critical to enhancing our understanding of these new materials and we must have consistent, accurate, and complete information on the amount of agency funding that is being dedicated to this effort.  However, this information is not currently available because the totals reported by the NNI include research that is more focused on uses for nanotechnology, rather than the risks it may pose. . . [T]he inventory of projects designed to address these risks is inaccurate and cannot ensure that the highest-priority research needs are met.

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The President's Council of Advisors on Science and Technology (PCAST) recently published "The National Nanotechnology Initiative: Second Assessment and Recommendations of the National Nanotechnology Advisory Panel," April 2008.   For those interested, The 21st Century Nanotechnology Research and Development Act of 2003 requires the National Nanotechnology Advisory Panel (NNAP) to review the National Nanotechnology Initiative's (NNI) performance every two years.  The President prevsiously designated PCAST to serve as the NNAP.  PCAST published its first NNI assessment in 2005.

In its second assessment, PCAST states that the NNI is by-in-large a "model program" and is "highly successful," "well organized," and "well managed" -- although it also has some specific recommendations for improvement.  To improve, PCAST believes NNI should increase its emphasis on (i) public communication and outreach regarding the perceived benefits and risks of nanotechnology; (ii) developing unified standards for nanomaterial identification, characterization, and risk assessment; and (iii) coordinating strategic EHS research which should "include balanced assessments of risks and benefits in the context of specific, real world applications."

Regarding this last issue, PCAST believes the current "approach for addressing EHS research under the NNI is sound," and that "calls for a separate agency or office devoted to nanotechnology EHS research or to set aside a fixed percentage of the budget for EHS research are misguided and may have the unintended consequence of reducing the research on beneficial applications and on risk."  Further countering NNI critics, PCAST believes that "while there is much to learn, the process is certainly not broken." 

Finally, despite expressing its support for the NNI, PCAST is also "concerned that nanoscience is losing a public relations contest. The value of nanotechnology to the U.S. economy and the contribution of nanotechnology to actually improve EHS conditions in our country and is being drowned out by the emphasis on uncertainties and by speculation that is unconstrained by examination of actual exposure and hazard in realistic use settings."    

NNAP also intends to publish an addendum to its report after reviewing NNI's EHS strategy document published in February 2008.

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We recently commented on the tangle of federal nano-related EHS research roadmaps.  Environment and Energy Daily (E&E Daily) recently reported on a debate before the House Science and Technology Committee regarding funding for such efforts and whether or not several existing federal roadmaps are adequate.  Chairman Bart Gordon (D-Texas) is quoted as saying the NNI's EHS plan "must be improved quickly by developing and implementing a strategic research plan that specifies near-term and long-term goals, sets milestones and timeframe for meeting near-term goals . . ."  However, a representative from the President's Council on Advisors on Science and Technology evidently responded to E&E Daily by indicating "We have a high-level strategy already, but for some reason people don't want to face it.  I'm confused by it."  The debate (and tangle) thickens.

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The Christian Science Monitor (CSM) recently reported on findings by the National Institute of Standards and Technology (NIST) that nanoscale materials may exhibit novel ductility not exhibited by their bulk counterparts.  For example, CSM explains that silica is normally brittle in its bulk form, but became "as ductile as gold at the nanoscale" in NIST studies.  Evidently particle size plays an important role in ductility:  "the smaller particles in the material aggregate, the more ductile the material becomes."

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The Woodrow Wilson International Center for Scholars’ Project on Emerging Nanotechnologies (PEN) recently published S. Keiner’s, "Room at the Bottom? Potential State and Local Strategies for Managing the Risks and Benefits of Nanotechnology," March 2008. Readers can see some of our prior posts regarding local nano-regulation in Berkeley here, here, here, here, here, here, and here; Cambridge here and here; and Wisconsin here.

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