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

The American Bar Association Section’s of Environment, Energy, and Resources held the fifth in its series of eight Quick Teleconferences on Nanotechnology this afternoon. This particular teleconference dealt with “Nanotechnology and the Federal Insecticide, Fungicide, and Rodenticide Act" (“FIFRA”). Mark Duvall, Managing Counsel for The Dow Chemical Company moderated the teleconference, which also included speakers from US EPA and the ETC group from Canada.

Jim Jones represented EPA’s Office of Pesticides Programs, Office of Prevention, Pesticides and Toxic Substances, and discussed the agency’s efforts to-date under FIFRA. Mr. Jones indicated that there are currently no pesticides registered under FIFRA that claim to contain nanomaterials, nor have any applications for such products been submitted to EPA. However, he indicated that the agency anticipates receiving such applications in the near future and is currently preparing itself so it can “stay ahead of the curve” when/if such an application is submitted. The key question facing EPA in this regard appears to be whether or not nanomaterials behave the same as their bulk counterparts for EHS purposes. Another question is how to adequately identify nanomaterials when they are in fact presented in an application.

Mr. Jones also provided some insight into EPA’s position on the Samsung washing machine “silver nano” issue that has been in the press over the past few months. He indicated EPA intended to publish a statement in the Federal Register by “late-spring 2007” which will specifically focus on ion generators.  Additionally, Mr. Jones offered the position previously advanced here that the size of the particles allegedly emitted by the washing machine in question are “immaterial” for FIFRA purposes. Rather, the focus is on whether or not the product claims to control a pest (or microbe in this instance). If it does, then it is subject to regulation.  Mr. Jones also indicated that he suspects that Samsung’s machine may not even truly employ nanotechnology, and he does not know whether Samsung ultimately intends to file a FIFRA application.

JCM:  As I stated here before, my continued prognosis is that "while EPA's upcoming notice to be published in the Federal Register will be of great interest, . . . . it will not use the Samsung issue as a reason for treating nanomaterials any differently from the way it treats other microbial killing materials."

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"Nanotechnology: The Future is Coming Sooner Than You Think," Joint Economic Committee, United States Congress, March 2007.

This new committee paper begins by providing the reader with an overview of several competing definitions of nanotechnology, the stages in which the industry is likely to develop, and the technology's interdisciplinary nature.  The paper also disposes of existential concerns such as "grey goo" and "Luddite" opposition to nanotechnology, and then touches upon the possible environmental, health and safety risks potentially associated with exposure to certain types of nanomaterials.  The paper provides a well-written, basic summary covering these topic areas.

The committee paper also gives a strong vote of confidence to the National Nanotechnology Initiative ("NNI") and its efforts to coordinate federal nanotechnology efforts between 25 constituent government agencies.  To this end, the paper quotes a National Science Foundation report finding that "the NNI is successfully establishing R&D programs with wider impact than could have been expected from separate agency funding without coordination," and "federal agencies have been motivated by their participation in NNI activities . . . to a degree that has proved very effective."  The paper backs up its praise by suggesting that NNI move beyond its traditional coordinating activities and be provided with an independent budget to fund certain nanotechnology research needs.

On another topic, the paper is notable for its suggestion that "the use of nanotechnology should be clearly labeled on products so that consumers can make an informed choice about whether to use a particular product."

Equally interesting is the paper's suggestion that "private companies should be required to disclose to the [FDA] the results of any safety testing that they conduct and the FDA should immediately publicize any results that show a clear negative health effect."  The paper encourages Congress to promote this type of safety testing by making it easier for companies to collaborate on pre-competition EHS research.

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Michigan State's Institute for Food and Agricultural Standards ("IFAS") recently issued a report regarding a nanotechnology standards workshop it held last September.

The report begins with the observation that voluntary standards often become a basis for future government regulation and/or become a "de facto" mandatory standard if widely adopted in the marketplace. For example, the report suggests that "Wal-Mart is now a de facto standards-setting body for quality standards" because of its dominant position in the retail industry.

Regarding nanotechnology, the report notes "[v]arious US government agencies are collaborating with ANSI and ISO in standards development. ASTM’s E-56 committee is also involved in nanotechnology standards development, and has recently released its standard ‘E-2456, Terminology for Nanotechnology’ (ASTM E-56 2006). " The report further notes IFAS's work with the ANSI nanotechnology panel "from which [it is] able to observe and to some extent participate first-hand in the standards facilitation process."

The report also makes the following specific recommendations:

*     "Research standards should initially entail the use of Good Laboratory Practices, e.g., special gloves, respirators, and hoods (although even these standards may need further development)."

*     "Standards are needed to protect workers from exposure. The highest risks are likely to be during the production phase, and not in the final products. "

*     "Food and drug products will likely need standards as soon as products are developed. In contrast, there is less urgency for nonconsumable products, although environmental issues still need to be addressed."

*     "Given the differences in the behavior of chemicals at the nano level, it is conceivable that the Environmental Protection Agency will need to re-review every chemical in its database."

*     "[S]tandard setting should start early and be seen as a strategic and iterative process.

"An Issues Landscape for Nanotechnology Standards: Report of a Workshop." Cowles House, 11- 12 September 2006. East Lansing, MI: Institute for Food and Agricultural Standards, Michigan State University. An electronic copy of the report can be found on the IFAS website.

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John Monica is speaking at Intertech-Pira's upcoming 3 day nanomaterials workshop and symposium taking place in Denver, Colorado from June 25 - 27, 2007.  John is speaking on "Possible Adverse Consequences of Premature Nanotechnology Regulation" on the morning of June 26.  You can find online registration information here.

Other presenters will be appearing from:

• ALD NanoSolutions
• Air Products
• Applied NanoWorks
• BYK-Chemie
• Ciba
• Cornell University
• Crown Cork & Seal
• Delphi Corporation
• Fuji Dimatix
• Lux Research
• Michigan State University
• NanoReg News
• Nanocor
• Nano-Tex
• NASA Glenn Research Center
• National Institute of Standards and Technology
• Pira International
• Rosseter Holdings
• Small Times
• US Army
• Zyvex

Intertech-Pira's recent February 2007 conference in Washington, D.C. -- "Regulations for Nanotechnology in Consumer Products" -- was a great success, and the Denver conference is sure to present similar learning and networking opportunities.

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Ed. note: every Friday (more or less) Nanotechnology Law Report's David Fischer will look back at the week’s news and analysis of nano related issues.  If you have something you’d like to bring to our attention, email him. 

• Nanobot highlights the portion of a NSF report on nanotechnology for undergrads.
• Nanotechnology Law Report's John Monica on the "fuzzy line" distinction between “engineered,” “incidental,” and “natural” nanoparticles and Michael Heintz on nanotechnology risks in cosmetics.
• UPI reports on a recent survey that reveals, surprise, individuals who know little or nothing about nanotechnology tend to "in an emotionally charged way " to it.
• Advanced Nanotechnology has been focused on the superlens and hyperlens (with cool graphics!).
• Nanodot on a nanotechnology coffee table book and on molecular machines.
• Nanoscale Views has a thought provoking post on long term research at companies and universities.
• Soft Machines has a lengthy post on "nanoscale swimmers."

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The distinction between “engineered,” “incidental,” and “natural” nanoparticles is beginning to blur.  A vocal contingent advocates regulation of the first category without much focus on the later two. We recently asked whether this distinction is meaningful for certain EHS purposes. The human body may not differentiate between exposure to the three categories of materials. On the other hand, it makes sense to be concerned with reducing man-made risks first.

Here is a related question: What happens to this definitional scheme when naturally occurring nanomaterials (ex/ carbon nanotubes and fibers) are harvested/mined and then used for commercial purposes? While they are not “man-made” in the traditional sense, they presumably pose the same exposure risks as engineered nanomaterials created in a lab. The industry is currently exploring cheaper ways to mass-produce nanomaterials. Consequently, we will undoubtedly see more "natural" nanomaterials being used in commercial applications.  This issue merits serious consideration in any attempt to regulate nanotechnology and/or create uniform standards and nomenclature.

"Engineered" = purposefully created; man-made. "Incidental" = unintentionally created; by-product of human activity. "Natural" = found in nature; volcanic rock; smoke.

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Two NIOSH researchers recently theorized about the possible adverse health effects of nanoparticles in the December 2006 edition of Environmental Health Perspectives. I list the scientists' "pros" and "cons" and some of the literature upon which the scientists rely below.

Near the end of the article, the authors present a table of hypothetical adverse health effects which might accompany the translocation of nanoparticles throughout the human body after inhalation and/or dermal exposure. While the table is useful for discussion purposes (and the authors make it clear that it is based on current limited toxicology studies and human data), a tremendous amount of research is still needed to determine whether the table approaches reality. 

The authors conclude with the following thoughts:

". . . the benefits of nanotechnology dominate our thinking, the potential for undesirable human health outcomes should not be overlooked . . . Development of safety guidelines by government for the nanotechnology industries, including manufacturing, monitoring of worker exposure, ambient release of [nanoparticles], and risk examinations, is mandatory to promote nanotechnology for its economic incentives and medicinal applications.  

M. R. Gwinn, et al., “Nanoparticles: health effects--pros and cons,” Environ Health Perspectives, Vol. 114, No. 12 (Dec. 2006).

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By Tim Cahill:

On February 20, 2007, the Investor Environmental Health Network ("IEHN") issued a report entitled "Beneath the Skin: Hidden Liabilities, Market Risk and Drivers of Change in the Cosmetics and Personal Care Products Industry." IEHN represents 20 investment organizations with $22 billion under management that are seeking to ensure that the companies they invest in are taking appropriate steps to reduce risks associated with the toxic chemicals used in their products. The IEHN's report warns that nanotechnologies represent one of the significant health risks in the cosmetics industry and that investors in this industry must be aware that sweeping changes are likely to occur in this market. The report describes the Food and Drug Administration's ("FDA") current oversight of cosmetics as a "a porous and ill-defined regulatory framework" and cites to the fact that "cosmetics are generally exempt from pre-market review" as a major limitation in the FDA's ability to regulate cosmetics. As a result, the report recommends that cosmetics manufacturers take independent steps to monitor the safety of their products in order to avoid potential liability and gain a competitive advantage by increasing their brand trust.

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A recent editor’s memo in the February 1, 2007 edition of Biomechanics criticized the National Nanotechnology Initiative’s (“NNI”) level of attention to environmental, health and safety issues.  The publication states: “while some of the government’s actions have been admirable, the overall attitude – epitomized by a lack of long-term planning and goals, lack of oversight and hands-off approach – smacks of the present administration, and will leave yet another problem for the next one.”

JCM: I disagree with the strong political overtones of the editor. The NNI is dealing with very complex issues – ones that are getting more and more complex every day. Additionally, let’s not forget the NNI was created by a prior administration and no one ever envisioned it as an immediate fix for all perceived nano-ills. Further, one would hope such heavy criticism would be accompanied by at least a smattering of remedial suggestions.

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Nanopublic recently brought to our attention a report from Stratfor, a global intelligence consultancy, that focused on predictions for global industry regulations, including nanotechnology.  You have to subscribe to the website to read the report but Nanopublic passes on a key excerpt:

Many countries are beginning to investigate methods for regulating nanotech applications, particularly with consumer safety considerations in mind, but none yet have put forth a comprehensive regulation. If a successful movement for regulation of nanotechnology develops in Europe or Japan, the precedent would change the situation facing the industry markedly. With that in mind, the U.S. nanotech industry could drum up support for its preferred regulatory structure from a group considered credible in the United States (for example, the Harvard Medical School or the National Research Council), but this would not ensure that a country with greater influence among U.S. legislators (the European Union or Japan) wouldn't be able to sway the course of U.S. policy.

The crucial point, of course, has little to do with the future of nanotechnology regulation, but rather with the fact that industry and other interest groups increasingly will find themselves monitoring social and political events worldwide -- including regions in which they have no market ambitions -- simply in order to shore up their regulatory efforts in the United States or other countries of primary concern.

This is a timely reminder that we in the Untied States need to keep up with EU and Japanese regulation of nanotechnology too.  As with dot coms, there is a "first mover" advantage which is one reason this blog spent a significant amount of time focusing on the Berkeley regulations.

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Consider the four below-listed definitions of nanotechnology. Each contains a “novel properties” component. That is, in addition to defining nano by its scale, they suggest the very essence of “nano-ness” is the way nanomaterials exhibit unique/novel properties when compared to their parent materials. While the “novel properties” concept rests at the center of the world-wide interest in nanotechnology, it also presents materials characterization and regulatory problems. What exactly are these “novel properties,” how are they defined, are they consistent from one type of nanomaterial to the next, do they vary in intensity under certain circumstances, are they measurable and capable of standardization? If not, how are we going to handle this aspect of the definition when it comes to materials characterization projects and/or regulations? Scientists – not lawyers – will have to answer these questions, of course. Yet this basic issue will have to be addressed in any well-thought-out nanotechnology EHS regulation/legislation. Without further work and definition, the concept may only create vagueness, subjectivity, and loopholes if included at the level of current understanding.

1. National Nanotechnology Initiative: “Nanotechnology is the understanding and control of matter at dimensions of roughly 1 to 100 nanometers, where unique phenomena enable novel applications. Encompassing nanoscale science, engineering and technology, nanotechnology involves imaging, measuring, modeling, and manipulating matter at this length scale.”

2. Arkansas: “‘Nanotechnology’ means the materials and systems whose structures and components exhibit novel and significantly improved physical, chemical, and biological properties, phenomena, and processes due to their nanoscale size.” A.C.A. §15-4-2103(5)

3. Oklahoma: “‘Nanotechnology' means technology development at the molecular range (1 nm to 100 nm) to create and use structures, and systems, that have novel properties because of their small size.” 74 Okl St. Ann. §5060.4(12).

4. Virginia: “technology, research, and development at the atomic, molecular, or macromolecular levels, in the 1 – 100 nanometer range, to create and use structures, devices, and systems that have novel properties and to integrate such structures, devices, and systems into large material components, systems, and architectures.” House Bill No. 1939 establishing the Virginia Technology, Nanotechnology, and Biotechnology Investment Fund.

Finally, the only voluntary nanotechnology standard issued in the United States thus far -- ASTM E2456-06 -- at least recognizes this issue in its definition of nanoparticle:  "a subclassification of ultrafine particle . . . . which may or may not exhibit a size-related intensive property."  The standard goes on to recognize the difference between "transitive" and "non-transitive" nanoparticles; maintaining the former exhibit novel properties while the latter do not.

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Michael Heintz, of the Nanotechnology Law Report, and JD Gibbs, of ENVIRON, will be co-presenting on nanotechnology issues at the upcoming Ohio Chemistry Technology Council annual conference on March 19.  JD will discuss the technical aspects of nanotechnology, and Michael will discuss regulatory developments in nanotechnology, including the EPA White Paper, Berkeley ordinance, and TSCA inventory reviews. 

The presentation is part of the larger "regulatory forum" session conducted by the environmental attorneys from Porter Wright, and is always one of the most well attended events of the conference.  For more information on attending the conference, see here.

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Ed. note: every Friday (more or less) Nanotechnology Law Report's David Fischer will look back at the week’s news and analysis of nano related issues.  If you have something you’d like to bring to our attention, email him. 

• As mentioned last time, the EPA's White Paper was big news.  On this site, Michael Heintz analyzed the White Paper.  The Pesticide and Toxic Chemical News also reports on the paper.
• The Global Cosmetic Industry Magazine reports on potential nanotechnology related regulations on cosmetics.
• The Dayton Daily News reports on a nanodiamond trial on rodents.
• Nanopublic reports on Volkswagen's "Nanospyder," which is "an environmentally-friendly concept car for the California market to the LA Auto Show Design Challenge."
• Advanced Nanotechnology brings us news about a nanomaterial that reflects virtually no light.
• Nanodot lets us know that thanks to some competition, there are several nanotechnology magazines that are freely available on the web.
• At Nanotechnology Now, Mike Treder and Chris Phoenix answer the question "What is molecular manufacturing, and how does it relate to nanotechnology?"
• At Responsible Nanotechnology, Chris Phoenix takes apart an article by Dr. Donald Bruce, head of the Church of Scotland's Society, Religion and Technology Project, on nanotechnology ethics.
• At Accelerating Future, Michael Anissimov addresses The Bulletin of Atomic Scientists' statement on nanotechnology and the dangers from "highly destructive missiles the size of an insect."
• Finally, I have always thought the phrase "ball lightning" was inherently humorous (which is not to say that ball lightning is itself humorous) and use it whenever I need to add some humor to the conversation at the local pub.  Which is why I have to direct your attention to the post at Soft Machines about ball lightning and nanotechnology.

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A recent European survey of 375 lay people and 46 nanotechnology experts founds that lay people in Germany and Switzerland perceive nanotechnology poses a greater risk than experts believe.  The authors conclude  from the survey “experts might not be inclined to initiate the risk assessments that are expected by the public.”  

In a second survey conducted by the same scientists, Sixty-five percent of responding companies admitted they perform no risk assessment “where nanoparticulate materials are involved.” Just over thirty-to percent answered the same question affirmatively. 

The authors contrasted the lack of industry risk assessment found in the second survey with the public concern found in the first survey and concluded that experts and the industry must guard against a “preventable event with significant negative consequences” involving nanotechnology in order to maintain public trust. The authors advocated voluntary initiative and regulations to protect against such an event.

M. Siegrist, et al., “Correspondence, Risks and Nanotechnology: the public is more concerned than experts and industry,” Nature Nanotechnology, February 2007.

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