Nanotechnology Law Report

EPA Issues Significant New Use Rules for Two Nanomaterials

jmonica@porterwright.com (John C. Monica, Jr.) — Wed, 19 Nov 2008 11:47:59 -0500

This article, which appeared in the Nov. 17, 2008 issue of Pesticide & Toxic Chemical News, Volume 37, No. 3, was reproduced with permission from Agra Informa. Further use of this article is prohibited without the express written permission of the publisher. For more information about Pesticide & Toxic Chemical News, Food Chemical News or other Agra Informa publications, go to: www.foodregulation.com .

EPA earlier this month announced it is promulgating significant new use rules (SNURs) under TSCA for two nanomaterials — siloxane modified silica nanoparticles and siloxane modified alumina nanoparticles — that were subject to premanufacture notices (PMNs). Some stakeholders view the move as a further sign that EPA is willing to use its authority to regulate nanomaterials, although to what extent remains uncertain.

The rules take effect on Jan. 5, 2009 unless the agency receives critical comments before Dec. 5.
The SNURs are the latest action from EPA on the nanotechnology front. The agency recently issued a consent order for carbon nanotubes (see PTCN, Oct. 20, Page 1). In addition, EPA provided clarification of TSCA requirements for carbon nanotubes last month (see PTCN, Nov. 3, Page 23).

Fewer than 10 SNURs for nanomaterials have been promulgated, according to EPA spokesperson Enesta Jones, but she could not name the materials or when the SNURs had been promulgated because of confidential business information protections.

With the most recent SNURs, anyone who intends to manufacture, import or process either siloxane modified silica nanoparticles or siloxane modified alumina nanoparticles for a significant new use, which includes using either substance without gloves or a respirator and using either substance as a powder, is required to notify EPA at least 90 days before beginning to do so. "The required notification will provide EPA with the opportunity to evaluate the intended use and, if necessary, to prohibit or limit that activity before it occurs," the agency said in a Nov. 5 Federal Register notice.

According to their PMNs, siloxane modified silica nanoparticles and siloxane modified alumina nanoparticles will be used as additives. Based on data from tests of unidentified analogous material and the substances' physical properties, EPA has determined that there are concerns for lung effects from inhalation and systemic effects from dermal exposure. However, the PMNs indicate worker inhalation exposure to the alumina nanoparticles is expected to be minimal, inhalation exposure to the silica nanoparticles is not expected, and dermal exposure to both materials is also not expected.

"Therefore, EPA has not determined that the proposed manufacture, processing, or use of the substance[s] may present an unreasonable risk," the agency said in the FR notice. "EPA has determined, however, that use without impervious gloves or a NIOSH-approved respirator with an [Assigned Protection Factor] of at least 10; the manufacture, process, or use of the substance[s] as a powder; or uses of the substance[s] other than as described in the PMN[s] may cause serious health effects."

EPA would have to be notified at least 90 days before anyone began to manufacture, process or use the nanomaterials in such ways.

The agency has also determined that the results of a 90-day inhalation toxicity test would help characterize the human health effects of the two nanomaterials, although the test isn't required.
"Manufacture can occur as long as the manufacturer does not engage in the significant new uses," Jones told Pesticide & Toxic Chemical News via e-mail.

"[The 90-day inhalation toxicity test] is the test EPA recommends to be conducted to address health concerns cited in the SNUR. In other words, if a manufacturer wants to engage in the new uses or have EPA modify or revoke the SNUR, then conducting these tests could help EPA change its original findings."

The 90-day inhalation study is the same study that is required under the recently issued carbon nanotube consent order. But the study is not designed for determining chronic effects or for nanomaterials, according to John Monica, head of the nanotechnology practice group at the law firm of Porter Wright Morris & Arthur.

Monica told PTCN that EPA can recommend alterations to a study to make it more relevant for a specific material, and in fact did so for the inhalation studies requested in some of the other non-nanomaterial SNURs also announced in the Nov. 5 FR notice.

The SNURs and consent order are a "great opportunity" to get testing done on nanomaterials, but EPA needs to sit a group of experts down to determine how chemical test guidelines need to be modified for nanomaterials, Monica said. "During the request for comments [on the SNURs], someone will raise or should raise the issue."

Monica added he would expect someone to ask EPA to identify the analagous materials and test data it used to determine there are concerns for certain effects.

The SNURs, consent order, and carbon nanotube notice indicate what EPA has maintained all along — that EPA has the authority to regulate nanomaterials under TSCA and is willing to use it, Monica said.

Betsy Mason, an associate in the law firm Goodwin Procter's Environmental and Energy Practices, echoed Monica, telling PTCN that EPA's recent actions show "the agency is willing — perhaps more now than previously — to use the different legal tools available to it under TSCA Section 5 to regulate nanomaterials."

But Mason also noted that it isn't yet clear whether the agency is shifting away from relying on voluntary industry efforts like the Nanoscale Materials Stewardship Program to "bona fide regulation and enforcement" or if it's using the SNURs and consent order as a supplement to encourage more volunteers to participate in such initiatives.

"In either case, I think it's reasonable to expect that EPA will issue more nano-related consent orders and more nano-related SNURs in the future," she said.

U.K. commission urges testing

While EPA is starting to use some of its regulatory powers to address the potential risks of nanomaterials, the United Kingdom's Royal Commission on Environmental Pollution is urging quick action on testing and regulating nanomaterials in a report published Nov. 12.

The commission, which is appointed by the Queen and funded by the government, publishes in-depth reports on critical environmental issues. In its current report, "Novel Materials in the Environment: The Case of Nanotechnology," the commission finds no evidence of harm to human health or the environment from nanomaterials.

"However, it is very early in the development of this technology, and the amount of testing has been relatively limited," the commission said in a statement. "We are aware that laboratory tests on some nanomaterials suggest that they have properties which could cause concern. This strengthens our case for an increase in the amount and type of testing to assess whether these theoretical risks are real, and to monitor their behavior in the environment."

Furthermore, this research has to be done "on a more systematic and strategic" basis, which includes evaluating methods for predicting the fate and effects of nanomaterials, better understanding of the principles that determine nanomaterial toxicity, and enhancing nanomaterial monitoring and surveillance methods, the commission says in its report.

As for the U.K. government, the commission recommends that any revisions to existing regulations should be focused on the properties of nanomaterials, not their size. "Since these properties and functionalities will often differ substantially from those of the bulk material, strict chemical equivalence does not preclude the need for a separate risk assessment," the report says. Furthermore, the government should prioritize testing, starting with those materials with properties suggesting they pose a risk to human health or the environment. The government should also require companies to report any "reasonable suspicion" that a nanomaterial poses a risk "at the earliest opportunity."

The commission's report is available at www.rcep.org.uk/novelmaterials.htm.

— Liz Buckley elizabeth.buckley@informa.com

New Registry and Label

mheintz@porterwright.com (Michael E. Heintz) — Mon, 17 Nov 2008 14:02:32 -0500

Nanosafe, Inc. has recently announced the launch of its new website, the Nanotech Register™ and its new product labeling system, Nanosafe Tested™. The Register is itself the location of all of the products receiving the Nanosafe Tested label. The Nanosafe Tested program, as described by Nanosafe, Inc. is a "program to provide clients with independent third-party testing of nanotechnology products." Specifically, "Products that have been NANOSAFE TESTEDTM are subjected to defined testing criteria developed from peer-reviewed literature and comparable standardized testing methods. Test results are reported in two ways: first, a comprehensive, proprietary test report is provided to the client; second, a one-page, non-proprietary summary report is posted to the NANOTECH REGISTERTM where it may be viewed freely by the general public." The only product on the Registry to this point is, XPert® Nano™ System by
LABCONCO INC.

This is the second (or third, depending on how you count "registries") that are available to the public at this stage (if you know of more, please let us know!). In addition to the Nanosafe Registry, there is also PEN's inventory of products containing nanotechnology and the responses EPA received under the Nanoscale Materials Stewardship Program. While still in its early stages, having an additional registry should be helpful for tracking and continuing to evaluate nanomaterials on the market.

Nano EHS Database

mheintz@porterwright.com (Michael E. Heintz) — Tue, 11 Nov 2008 10:00:13 -0500

The International Council on Nanotechnology (ICON) just released its newest project/tool, the Nano-EHS Database Analysis Tool. To quote ICON, "This web tool allows you to obtain a quick and thorough synopsis of our Environment, Health and Safety Database using two types of analysis. The first is a Simple Distribution Analysis (pie chart) which compares categories within a specified time range. The second type is a Time Progressive Distribution Analysis (histogram) which compares categories over a specified overall time range and data grouping period." The report will generate data in pdf or xls format as well as a report on available publications based on search categories, such as material studied, target receptors, and type of publication.

While the Tool only tracks ICON's database, it will likely become a valuable resource for literature searches. With the increased importance of regulatory schemes such as TSCA registrations, literature reviews will become more critical, even to smaller operations. ICON's Tool will assist those entities, and others seeking wide ranging topics addressing nanotechnology or nanomaterials.

PDF of "A Nano-Mesothelioma False Alarm"

jmonica@porterwright.com (John C. Monica, Jr.) — Sat, 08 Nov 2008 15:41:57 -0500

Nanotechnology Law and Business was kind enough to let us post a PDF of "A Nano-Mesothelioma False Alarm" here after several readers requested a copy.

Please be sure to visit the journal to see the rest of this issue's articles:

Grading of Fullerene Nanotubes for Composite Applications
Next Generation Carbon Fiber
Patenting Graphene: Opportunities and Challenges
Oxonica v. Neuftec: Nanoparticle Fuel Additive Litigation in the United Kingdom
Mediating the Uncertainty and Abstraction of Nanotechnology Promotion and Control: “Late” Lessons from Other “Early Warnings” in History
The Implications of Recent Nanomaterials Toxicity Studies for the Nanotech Community
A Nano-Mesothelioma False Alarm
Convergence of Cleantech and Nanotech and the Benefits to the Nanotech Sector
French and European Community Law on the Nanometric Forms of Chemical Substances: Questions About How the Law Handles Uncertain Risks
The Validity of European Nanotechnology Patents in Germany
Book Review of Nanotechnology & Society: Current and Emerging Ethical Issues
Top Ten Ways Nanotech Will Impact Cleantech
Updates

A Nano-Mesothelioma False Alarm

jmonica@porterwright.com (John C. Monica, Jr.) — Mon, 03 Nov 2008 15:13:21 -0500

For those who are interested, below is the abstract of our new article published in the Fall edition of Nanotechnology Law & Business. You can find the full edition here: www.nanolabweb.com

A Nano-Mesothelioma False Alarm

In May 2008, a scientific study (the “Poland Study”) was published in Nature Nanotechnology—which sparked a rash of popular media claims that like asbestos, exposure to carbon nanotubes may cause mesothelioma. In this article, a team led by lawyer John Monica evaluates the Poland Study in a potential litigation context to determine its significance, if any, in legally establishing that the inhalation of multiwalled carbon nanotubes (“MWCNTs”) causes mesothelioma. After first considering the reliability of the Poland Study's design and execution, they conclude that it would not be admissible in a court of law because it fails Daubert standards. Specifically, they argue that: (i) the design and execution of the Poland Study are not generally accepted in the scientific community for the purposes offered; (ii) in order to reach the conclusion that inhalation of MWCNTs may cause mesothelioma, an expert would have to use the Poland Study in such a manner as to extrapolate from an accepted premise to an unfounded conclusion; and, (iii) the Study's authors failed to adequately account for obvious alternative explanations (confounders), including surface chemistry, sample contamination, sample commingling, spontaneous formation of granulomas, and possible mouse colony infections.

Carbon Nanotubes and TSCA Registrations

mheintz@porterwright.com (Michael E. Heintz) — Fri, 31 Oct 2008 09:10:27 -0500

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.

Registration of Carbon Nanoscale Materials Required Under REACH

jmonica@porterwright.com (John C. Monica, Jr.) — Wed, 29 Oct 2008 10:40:57 -0500

The EC's 2006 Registration, Evaluation, Authorisation and Registration of Chemicals ("REACH") regulations place "the responsibility for the management of the risks of [chemical] substances with. . .[the companies that] manufacture, import, place on the market or use [the] substances in the context of their professional activities." Guidance on Registration, Guidance for the Implementation of REACH, European Chemicals Agency, Version 1.3, May 2008, at p. 12.

To this end, REACH requires companies manufacturing or importing chemical substances in quantities greater than one ton per year to register those substances before they "can be manufactured, imported or placed on the market." As part of these requirements, "manufacturers and importers need to collect or generate data on the substances and assess how risks to human health and environment can be controlled by applying suitable risk management measures." This can often be an expensive and time consuming process.

Providing some relief in certain circumstances, Article 2(7)(a) of Regulation (EC) No 1907/2006 provides that certain substances are exempt from registration under REACH because "sufficient information is known about these substances that they are considered to cause minimum risk because of their intrinsic properties." These substances are listed in REACH Annex IV.

On October 8, 2008, the EC removed carbon and graphite from Annex IV "due to the fact that the concerned Einecs and/or CAS numbers are used to identify forms of carbon or graphite at the nano-scale, which do not meet the criteria for inclusion in" Annex IV. We first posted on this possibility last June.

Commission Regulation (EC) NO 987/2008 of 8 October 2008 Amending Regulation (EC) No 1907/2006 of the Council on the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) as regards Annexes IV and V.

This decision is consistent with the U.S. Environmental Protection Agency's reasoning that nanoscale substances with new molecular identities -- such as fullerenes and carbon nanotubes -- are considered new chemical substances for purposes of premanufacturing notice submissions under the Toxic Substances Control Act.

Massachusetts Interagency Nanotechnology Committee

mheintz@porterwright.com (Michael E. Heintz) — Mon, 27 Oct 2008 08:19:06 -0500

Inside EPA is reporting that the Massachusetts Interagency Nanotechnology Committee is developing a set of "best practices" for labs and companies working with materials in order to protect nano-sector workers, the public, and the environment from potentially harmful exposures.

The interagency group was formed in April 2007 and has since held one workshop on nanotechnology risks in November 2007, and was seeking to create a website as an information clearinghouse for nanotechnology. The proceedings have been published and are available for review, however, the on-line clearinghouse could not be located.

The best management practices are reportedly going through "internal review" and then will be revealed to "stakeholders" before full publication. The group plans to build its best management practices on knowledge gained from prior attempts, such as by NIOSH and the Nano Risk Framework.

Another set of best management practices is another example of the level of attention nanotechnology continues to get, especially by state and local governments. These new publications also serve as an iterative process for the prior versions that may or may not be continually revised. By using prior attempts at developing best management practices, current versions can revise the information, and maintain developed institutional knowledge, in an effort to reach better sets of principles.

Should we find the Committee's best management practices when published, or locate the on-line clearinghouse, we will be sure to update this post.

New Communication from the EU Concerning Nanomaterials

mheintz@porterwright.com (Michael E. Heintz) — Thu, 16 Oct 2008 08:45:01 -0500

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.

EPA Consent Order for Multi-Walled Carbon Nanotubes

jmonica@porterwright.com (John C. Monica, Jr.) — Wed, 15 Oct 2008 17:28:15 -0500

Last month we reported on a press release by Thomas Swan & Co. Ltd. of the United Kingdom indicating the company had recently entered into a PMN consent order with the EPA under the Toxic Substances Control Act (“TSCA”) concerning one of its multi-walled carbon nanotube (MWCNT) products. Barring an unusual coincidence, it appears that EPA has recently published a redacted version of the Swan Consent order here.

The order makes it clear that the PMN was submitted pursuant to § 5(a)(1) of TSCA, and that it covers a MWCNT product. Additionally, the consent order places several requirements on the manufacturer. Specifically, the manufacturer is required to:

Deliver 1 gram of the MWCNTs to EPA with a copy of MSDS for the product;
Conduct “90 day inhalation toxicity study in rats with a post exposure; observation period of up to 3 months, including bronchoalveolar lavage fluid (“BALF”) analysis (OPPTS 870.3465 or OECD 413);
Submit material characterization data within six months (see below);
Ensure employees “use gloves impervious to nanoscale particles and chemical protective clothing;” and
Ensure employees “use a NIOSH-approved full-face respirator with an N-100 cartridge while exposed by inhalation in the work area.”

Regarding the second requirement, the consent order also provides the manufacturer with an opportunity to submit toxicity testing data under the Agency’s new Nanoscale Material Stewardship Program as an alternative to the 90 day mouse inhalation test: “If, for example, a consortium of companies commit to testing a representative set of MWCNT for subchronic mammalian toxicity, EPA may consider waiving the triggered testing requirement. EPA would be willing to facilitate the process in coordination with other ongoing health effects testing for MWCNT nationally and internationally. EPA would consider accepting the results of such testing in lieu of triggered testing in this order.”

Regarding material characterization information, EPA is requiring the manufacturer to submit the following within six months:

Type of multi-walled carbon nanotube (concentric cylinders or scrolled tubes; number of walls/tubes);
Configuration of nanotube ends (e.g., open, capped);
Description of any branching;
Width/diameter of inner most wall/tube (average and range);
Carbon unit cell ring size and connectivity;
Alignment of nanotube along long axis (straight, bent, buckled);
Hexagonal array orientation used in the manufacture of the nanotube;
Particle size of catalyst used in the manufacture of the nanotube;
Molecular weight (average and range); and
Particle properties: shape, size (average and distribution), weight (average and distribution), count, surface area (average and distribution), surface to volume ratio, aggregation/agglomeration.

Finally, manufacturers of MWCNTs (other than Thomas Swan) will be interested in two of EPA’s general legal conclusions expressed in the consent order:

“EPA is unable to determine the potential for human health effects from exposure to the PMN substance. EPA therefore concludes, pursuant to § 5(e)(1)(A)(i) of TSCA, that the information available to the Agency is insufficient to permit a reasoned evaluation of the human health effects of the PMN substance.”

“In light of the potential risk to human health posed by the uncontrolled manufacture, import, processing, distribution in commerce, use, and disposal of the PMN substance, EPA has concluded, pursuant to § 5(e)(1)(A)(ii)(I) of TSCA, that uncontrolled manufacture, import, processing, distribution in commerce, use, and disposal of the PMN substance may present an unreasonable risk of injury to human health.”

No doubt other MWCNT manufacturers will feel the need to file PMN’s for their products similar to Thomas Swan given the language of the consent order.

EPA Office of Inspector General to Evaluate Agency's Nanotechnology Efforts

jmonica@porterwright.com (John C. Monica, Jr.) — Wed, 15 Oct 2008 15:25:02 -0500

The U.S. Environmental Protection Agency's Office of Inspector General (OIG) "helps the Agency protect the environment in a more efficient and cost effective manner. [It] consist[s] of auditors, program analysts, investigators, and others with extensive expertise" who are tasked with evaluating EPA's ability to deliver on key Agency policies. Risk Policy Report ran an article yesterday (October 14, 2008) indicating that EPA's OIG intended to assess EPA's nanotechnology efforts in FY 2009. We tracked down the underlying document which is attached here. Specifically, EPA OIG intends to conduct an "[a]ssessment of EPA's Efforts to Monitor, Evaluate, and Act on Threats from the Production, Use and Disposal of Nanotechnology Products/Nanomaterials."

Quantum Dot Skin Penetration Study

jmonica@porterwright.com (John C. Monica, Jr.) — Wed, 15 Oct 2008 14:52:36 -0500

A recent in vivo study published in NanoLetters focuses on the impact of ultraviolet radiation on the ability of Quantum Dots (QD) to penetrate skin.

L. Mortensen, et al., "In Vivo Skin Penetration of Quantum Dot Nanoparticles in the Murine Model: The Effect of UVR," NanoLetters, Vol. 8, No. 9, pp. 2779-2787 (August 2008).

The article begins by noting that "[n]anoparticles (NP) are commonly used in sunscreens and other cosmetics, and since consumer use of sunscreen is often applied to sun damaged skin, the effect of UVR on NP skin penetration is a concern due to potential toxicity;" and "[t]he question of whether or not NP can penetrate the healthy stratum corneum skin barrier in vivo remains largely unanswered."

The authors note that there are conflicting results from recent studies in this area, which they attribute to different researchers using different nanoscale materials with different sizes/diameters. The authors point out that the inconsistent results of prior studies "highlight the need for standardization of experimental techniques in ex vivo skin models are to be useful."

Despite the authors’ stated concern with possible dermal penetration of NP contained in cosmetics and sunscreens, they chose to test a nanoscale material which is not used in any cosmetic or sunscreen – Quantum Dots.

The authors explain:

We selected to investigate QD, as they posses ideal characteristics for in vivo experimentation including broad excitability, narrow emission bandwidth, high fluorescence quantum yield, photostability, and ease of surface functionalization. Moreover, QD are of a similar size to TiO2 NP used in sunscreen applications, they intrinsically generate ROS species, and the carboxyl terminated QD have a similar negative oxide surface chemistry to the TiO2 and ZnO raw materials often used in sunscreen applications.

There are no lack of manufacturers selling the very type of nanoscale zinc oxide and titanium oxide used in consumer cosmetics and sunscreens. Quantum dots are very remote cousins to these particles. Why not test the substances themselves rather than a surrogate?

Regarding the animals used in the experiment, the researchers selected 6-7 week old SKH-1 hairless, albino mice. The QD mouse application vehicle was a solution of 75% glycerol/25% carboxyl QD Stock Solution (pH=9.0 borate buffer, 8μm QD). One half of the mice received an acute single UVR dose, which was administered by using UVA Sun 340 lamps (320-400 nm (UVA)) (290-320 nm (UVB)).

The scientists found increased QD penetration for 8 hr and 24 hr treatment conditions after UVR exposure. However, "[m]ost strikingly, under no circumstances is there evidence for massive QD penetration, even for UVR exposed mice 24 hr after QD application." "[N]one of the penetration observed was at a very high level."

The scientists conclude that "[t]hese studies demonstrate the importance of skin condition to effect the penetration of QD nanoparticles . . . in the . . . mouse model. We have shown that QD work their way between corneocytes of the stratum corneum and penetrate deep in the epidermis and dermis of an in vivo model with UVR penetration exacerbation." "The minimal QD penetration observed in our study on barrier intact (non-UVR exposed) skin suggests the preponderance of current literature suggesting TiO2 and ZnO NP used in commercial sunscreens exhibit limited penetration in layers below the lower SC."

Nanotechnology Law Report -- September 2008

jmonica@porterwright.com (John C. Monica, Jr.) — Fri, 10 Oct 2008 13:25:10 -0500

Nanotechnology Law Report -- September 2008

New Poll Results on Public Awareness of Nanotechnology

mheintz@porterwright.com (Michael E. Heintz) — Mon, 06 Oct 2008 11:21:40 -0500

It's election season, which means an inundation of polls. While most address "who's a better leader" and "who's more trustworthy," the Project on Emerging Nanotechnologies has released its third (quickly becoming annual) poll on the public's awareness and acceptance of nanotechnology. This year's poll also asked questions concerning "synthetic biology" in addition to nanotechnology. In my opinion, the results of the poll are not encouraging.

While the full report goes into significant detail concerning questions and answers, some of the highlights are as follows (+/-3.1% margin of error):

7% of Americans have heard "a lot" about nanotechnology
17% of Americans have heard "some" about nanotechnology
26% have heard "just a little" about nanotechnology
49% have heard "nothing at all" about nanotechnology

That last figure is rather stunning to me. Despite the number of products on the market and other instances of nanotechnology (even including Michael Crichton's Prey), still almost half of the American adult population has not heard of nanotechnology. At all. Further, the polling data reports that those who have heard "a lot" or "some" about nanotechnology has declined over the three years of polling (to 24% in 2008 from 27% in 2007 and 30% in 2006).

Not surprisingly, there seems to be a correlation between those who have a familiarity with nanotechnology and the beliefs as to the risks and benefits associated with it. In short, the more one knows about nanotechnology, the more likely they are to believe that the benefits will outweigh the risks. However, the largest group remains unsure as to the risks and benefits.

My concern, though, falls with the numbers highlighted above. Regardless of what you think about the risks and benefits of nanotechnology, it is our responsibility, as those considering themselves "in the sector" to help educate the public. A real, substantive discussion on nanotechnology cannot happen with 49% of the population ignorant of what it is. The PEN poll is a useful tool for determining where we need to focus our efforts. Clearly, we need to do a better job of engaging the public on these issues.

Standards for Nanotechnology Material Specifications

jmonica@porterwright.com (John C. Monica, Jr.) — Mon, 29 Sep 2008 14:35:47 -0500

This fifth and final article in a series on standards for the nanotechnology community contributed by ANSI explains the development of specifications that will look at raw nanomaterials in terms of their use in a variety of applications.

By 2007, the development of international guidelines for nanotechnology was well underway within the International Organization for Standardization (ISO). Each of the projects of ISO Technical Committee (TC) 229, Nanotechnologies, had been categorized into one of the TC’s working groups: WG 1, Terminology and Nomenclature, WG 2, Measurement and Characterization, or WG 3, Health, Safety, and Environment.

But when the Standardization Administration of China (SAC), China’s national standards body, submitted two new work item proposals in October 2007, TC 229 members recognized that the proposed areas of technical activity – addressing specifications for nanomaterials in terms of possible applications – did not fit easily into any of the existing WGs.

Material specifications had already been identified as a priority area in the TC 229 business plan, which was based on the results of a 2006 survey, “ISO TC 229 Nanotechnologies Survey of Standardization Needs.” Some aspects of the SAC-proposed work items, however, fell under the scope of each of the WGs and yet other parts of the proposals didn’t fit into any of the groups.

In response to these newly identified needs, a new working group on Material Specifications (WG 4) was formed in early 2008.

Leadership and Work Items for WG 4

Given their important role in the creation of WG 4, China holds the convenorship of the group through SAC and Professor Limin Wang. The scope of the group is still being drafted with the help of several international stakeholders, including many from the United States. This scope, once established, will serve as a roadmap for how to further the efforts of the WG.

TC 229/WG 4 currently has three work items in development to examine raw materials in terms of their purpose in a variety of uses. The first two of these are the original SAC-submitted work items that sparked the formation of WG 4, and are currently being led by SAC:

• Nano TiO2 (Titanium Dioxide) specifies the characteristics and measurement methods for engineered nanoscale titanium dioxide (powder form). The material has numerous industrial applications, including use in sunblock, certain fibers and plastics, paints, printing ink, coatings, ceramics, and catalysts and catalyst carriers.

• Nano CaCO3 (Calcium Carbonate) specifies the characteristics and measurement methods for engineered nanoscale calcium carbonate (powder form). Industrial applications for this material include fillers in rubbers, plastics, coatings, paint, and printing ink.

Each of these work items will be divided into two parts: characterization of measurement and methods; and use of the nanoscale material in applications.

The third work item under WG 4 is being led by BSI British Standards, the national standards body for the United Kingdom:

• Guide to specifying nanomaterials will provide guidance on the preparation of comprehensive technical specifications for manufactured nanomaterials in order to ensure the delivery of a product that behaves in a reproducible manner.

Impact on Industry

As the standards developed under WG 4 can be used in industrial applications and consumer products from paint and coatings to textiles and sunblock, they will have a tremendous impact on manufacturers in a wide variety of industries, both in the U.S. and abroad. Interested stakeholders are encouraged to provide input that can help to formulate the strategy for WG 4.

U.S. involvement in ISO/TC 229 and its Working Groups begins with the U.S. Technical Advisory Group (TAG) to ISO/TC 229, administered by the American National Standards Institute (ANSI). Led by Clayton Teague, director of the National Nanotechnology Coordination Office, the TAG is organized into Working Groups that mirror their efforts on the scope of each TC 229 WG.

The mirror group for WG 4 is led by Dr. David S. Ensor, of RTI International.

“American industry has a rare opportunity to shape the content of these very early stage working draft standards and influence the strategic direction of WG 4,” said Dr. Ensor.

How to Participate

Participation in the U.S. TAG to ISO/TC 229 WG 4 is open to all nationally interested stakeholders. The TAG actively seeks participants who have expert knowledge in all aspects of nanotechnology material specifications.

“I encourage interested organizations to participate in the U.S. TAG and help develop U.S. positions to guide the deliberations of our experts to WG 4,” Dr. Ensor added. “We expect WG 4 will likely become an important ISO/TC 229 activity with time because it will eventually build on the standards developed by the other working groups.”

To join the ANSI-accredited U.S. TAG for ISO/TC 229 or any of its WGs, contact Heather Benko (hbenko@ansi.org; 212.642.4912).

For more information on the U.S. TAG for ISO/TC 229, visit http://www.ansi.org/isotc229tag.

ISO Publishes Nanotechnology Definition

mheintz@porterwright.com (Michael E. Heintz) — Fri, 26 Sep 2008 14:48:49 -0500

Nanowerk is reporting that the International Standards Organization (ISO) completed its first step in developing standards for nanotechnology regulation. The definitions are revealed in ISO/TS 27687:2008, Nanotechnologies – Terminology.

The three main materials covered by this first set of definitions and terminology are:

Nanoparticle;
Nanofibre; and
Nanoplate.

ISO expects this release to be the first of a series of standards for definitions and terms related to the nanotechnology sector.

Because ISO sells the standards it releases (56 CHF (Swiss Francs), about 51USD), publishing the definitions and other portions of the release would be inappropriate here. However, it is encouraging to see the first results of ISO's three year (and counting) effort to establish standards for the sector. As we've opined before, meaningful regulation cannot occur without a standardized set of definitions and language. However, the release of additional definitions now begins to raise the next question/problem: resolving the competing standards in an effort to have standardization in the sector in order to provide certainty when regulation begins.

First Commercial Insurance Exclusion for Nanotechnology

jmonica@porterwright.com (John C. Monica, Jr.) — Wed, 24 Sep 2008 17:16:51 -0500

Earlier today, Continental Western Insurance Group issued what appears to be one of the first nano-specific commercial insurance exclusions in the United States. Although Continental originally posted the exclusion and two supporting documents on its website, the materials were removed after BNA published an article about the exclusion this morning. We managed to print out the material before it was taken down and we provide links to it in this article.

Regular readers will recall that we have been covering nano-related insurance coverage issues for some time. Prior posts are here, here, here, here, here, and here.

A summary of each of Continental's three documents follows:

Background on Nanotubes

Continental's "Background on Nanotubes" document explains the policy behind its exclusion:
"The intent of this exclusion is to remove coverage for the, as of yet, unknown and unknowable risks created by products and processes that involve nanotubes. The exclusion is being added to make you and your customers explicitly aware of our intent not to cover injury and/or damage arising from nanotubes, as used in products and processes…"

The primary reason for the exclusion appears to be recent reports comparing carbon nanotubes to asbestos. You can find information about the press coverage of the May 2008 articles comparing multi-walled carbon nanotubes to asbestos here. Another factor in Continental's decision appears to be the often cited nano consumer product inventory published by the Project on Emerging Nanotechnologies.

Based on the asbestos analogy and PEN's product database, Continental concludes that it "would not be prudent for us to knowingly provide coverage for risks that are, as of yet, unknown and unquantifiable. We are all too aware of what happened to companies involved with asbestos-related exposure in the past, and see this as a very similar issue."

Notice to Policyholders

Continental's draft Notice to Policyholders makes it clear that it covers most of Continental's insurance groups, including: Acadia Insurance Company; Continental Western Insurance Company; Fireman's Insurance Company of Washington, D.C.; and Union Insurance Company. The notice references the actual exclusion which is attached and explains that this "endorsement excludes bodily injury, property damage, and personal and advertising injury related to the exposure of nanotubes and nanotechnology in any form. This include the use of, contact with, existence of, presence of, proliferation of, discharge of, dispersal of, seepage of, migration of, release of, escape of, or exposure to nanotubes or nanotechnology."

Nanotubes and Nanotechnology Exclusion

The exclusion itself reiterates that this "endorsement excludes bodily injury, property damage, and personal and advertising injury related to the exposure of nanotubes and nanotechnology in any form. This include the use of, contact with, existence of, presence of, proliferation of, discharge of, dispersal of, seepage of, migration of, release of, escape of, or exposure to nanotubes or nanotechnology."

It further contains specific exclusions for "existence, storage, handling, or transportation of 'nanotubes' or 'nanotechnology'…any manufacturing processes or products including same, and any losses arising from lawsuits related to 'nanotubes' and/or 'nanotechnology.'"

The exclusion defines "nanotubes" as "hollow cylinders of carbon atoms or carbon fibers or any type or form of "nanotechnology" which contains remarkable strength and electrical properties used in any products, goods, or materials. "Nanotechnology" is defined as "engineering at a molecular or atomic level."

Both definitions are vague. For example, a hollow carbon fiber fishing rod that makes no claim to contain nanoscale materials would still technically be included in the definition of 'nanotubes" because it is a hollow cylinder made of carbon atoms. Similarly, attempting to entirely exclude "nanotechnology" is unworkable because it is really just science on an extremely small scale.

Rather than excluding all "nanotechnology," Continental more likely meant to exclude all nanoscale materials. Even then, such a blanket exclusion would be extremely broad because many nanoscale materials have not been shown to pose any environmental, health, or safety risks. Further, even within the category of carbon nanotubes, recent researchers' warnings about potential EHS risks have been largely confined to long, thin, needle-like carbon nanotubes, while excluding other varieties.

Stay tuned. We will attempt to find out what happened to Continental's documents and will continue to monitor nano-related insurance coverage issues.

Nanotechnology and the Consumer Product Safety Commission

jmonica@porterwright.com (John C. Monica, Jr.) — Wed, 24 Sep 2008 13:05:33 -0500

Late last month, the Woodrow Wilson International Center for Scholar's Project on Emerging Nanotechnologies (PEN) published a paper on the ability of the U.S. Consumer Product Safety Commission (CPSC) to deal with possible environmental, health, and safety risks potentially posed by the use of some nanoscale materials in certain consumer products.

E. Marla Felcher, "The Consumer Product Safety Commission and Nanotechnology," Project on Emerging Nanotechnologies, PEN 14, August 2008.

The article begins with an analysis of PEN’s online consumer nanoproduct inventory which is used to support the author’s claims that "nanotechnology-enabled products" have made their way into every category of product under the CPSC's jurisdiction. Of the 60 products on PEN’s website, the author claims that "all of them are available for purchase by consumers," and approximately "half of nanotechnology consumer products currently on the market would fall under CPSC's jurisdiction." She notes that "[e]very day, new nanoengineered products make their way into stores’ shelves, among them kids’ pants, teddy bears, baby bottles, pacifiers, teething rings, plastic food storage containers, socks, chopsticks, humidifiers, mobile phones, computer processors and tennis rackets."

In a loaded rhetorical follow-up question the author asks: "Is it safe for an infant to spend hours each day sucking on a nano-enhanced pacifier?" The question does more to cement the author’s predilection against the use of nanoscale materials in consumer products than it does to present readers with a true quandary. Moreover, while PEN’s online inventory is a great tool, the author fails to take into account that many of the products on the site have never been commercialized, or have long been taken off the market. Such an analysis would provide a helpful balance to the article’s "pending emergency" tone.

Getting beyond initial issues, the author’s key concerns appear to have less to do with potential nano-specific product risks than with CPSC foundational issues. The author’s primary complaint appears to be that the CPSC has no premarket testing authority. She also believes that there is "[a]mple evidence" that companies do not do premarket testing or self-report hazards and defects -- a conclusion many dispute.

In keeping with her general approach, the author lists "Five Generic Weaknesses in CPSC's Product Oversight Capacity:" 1. "CPSC's Data Collection System is Not Nano Ready;" 2. "CPSC has Limited Ability to Tell the Public About Health Hazards Associated with Nanoproducts;" 3. "CPSC Has Limited Ability to Get Recalled Nanoproducts Out of Use;" 4. "CPSC Lacks Sufficient Enforcement Staff to Identify Manufacturers That Fail to Report Nanoproduct Hazards;" and 5. "CPSC Does Not Have Sufficient Authority to Promulgate Mandatory Safety Standards for Nanoproducts."

While some of these points are valid, they are not nano-specific. In fact, this section of the article would suffer little if the prefix "nano" and the term "nanotechnology" were eliminated from the text. (Try it.) The same could be said for several of the prior papers published by PEN in which the authors’ complaints and cautions appear more related to broader governance issues than to nano-specific difficulties.

To get to the heart of the paper, most readers will want to flip to the last section where the author lists several recommendations to correct the problems she perceives with the CPSC.

The author recommends that the CPSC should: 1. "Build the agency’s nanotechnology base and expertise;" 2. Identify companies making "nanoproducts and request that they submit research studies, risk assessment data and any information they hold that will enable CPSC scientists to assess the safety of nanoproducts;" (Although she notes that the Consumer Product Safety Act provides sufficient authority to accomplish this recommendation); 3. "Coordinate with other health and safety agencies, and combine efforts to evaluate the risks associated with nanoproducts;" and 4. "Convene a CHAP to evaluate the health and safety risks associated with nanoproducts currently on the market that are intended for use by children."

The author’s second CPSC recommendation is the most interesting and could benefit from further development. If the Consumer Product Safety Act provides sufficient authority to allow the CPSC to ask companies making nanoproducts to submit safety and risk assessment data (as the author suggest), that should go a long way to satisfying the author’s nano-information gathering concerns. The potential civil liability facing companies marketing nanoproducts without first collecting such data after it has been specifically requested by the CPSC would act as a hefty deterrent to the potential misconduct she fears.

The author also recommends two Congressional remedies:

1. "Amend the Consumer Product Safety Act to give CPSC the authority to require manufacturers to identify the presence of nanomaterials in their products;" and 2. "Adopt Section II of the Consumer Products Safety Act Bill recommended to Congress by the NCPS in its 1970 Field Report." This would give the CPSC the ability to promulgate "safety standards for any 'new' consumer products" . . . "where there exists a lack of information adequate to determine the safety of such product in use by consumers."

It is hard to argue against the author’s first Congressional recommendation. Collecting more information is a good thing as long as the requirements are not onerous and the CPSC actually has the ability to process and use the data productively. Although mentioned in the "Foreword," left out of the author’s Congressional "should do" list is more CPSC funding specifically dedicated to nanotechnology safety issues. Arguably, many of the author’s issues with the CPSC could be diminished with additional funding, staff, and resources to more fully address nanotechnology issues.

All in all, the paper is well worth reading as long as PEN’s and the author’s predispositions are kept in mind.

For Good Measure: Standards for Nanotechnology Measurement and Characterization

jmonica@porterwright.com (John C. Monica, Jr.) — Mon, 22 Sep 2008 11:51:59 -0500

This fourth article in a series contibuted by ANSI on standards for the nanotechnology community addresses the development of specifications for measurement, characterization, and test methods that will provide a common reference point for material manufacturers and their customers.

Measurement and characterization standards fly under the radar, affecting our lives in innumerable ways – from the number of miles driven to work to the paper loaded in the office printer. To imagine daily activities without these concepts would be nearly impossible, but that is exactly the challenge faced by scientists and manufacturers in the nanotechnology community.

For the growing number of industries that work with or are affected by nano-materials, consistent and globally accepted methods for testing, measurement, and characterization will provide a common reference point. By establishing a baseline to determine the starting properties of materials, these standards can facilitate meaningful comparisons of manufacturing and research results from different organizations and labs, and help to form a basis for the measurement of additional material properties.

When the American National Standards Institute (ANSI) Nanotechnology Standards Panel (NSP) first convened in September of 2004 to discuss priority recommendations for nanotechnology standardization, participants earmarked metrology, methods of analysis, and test methods as areas needing urgent attention. In particular, guidelines for particle size and shape, as well as particle number and distribution, were considered critical.

These needs are being addressed by the International Organization for Standardization (ISO) through its Technical Committee (TC) 229, Nanotechnologies, Working Group (WG) 2, Measurement and Characterization. Convened by Japan under the Japanese Industrial Standards Committee (JISC), WG 2 focuses on the development of standards for consistent descriptions, assessment, and test methods for nanotechnologies, taking into consideration the need for metrology and reference materials.

U.S. participation in ISO/TC 229 WG 2

U.S. participation in ISO/TC 229 and its Working Groups is centered in the U.S. Technical Advisory Group (TAG) to ISO/TC 229, chaired by Clayton Teague, director of the National Nanotechnology Coordination Office. The TAG, which is administered by ANSI, is organized into Working Groups that mirror their efforts on the scope of each TC 229 WG.

The U.S. mirror group for WG 2 is led by Dr. Ray Tsui of Motorola. The TAG WG plays an important role in establishing ANSI’s positions on the issues addressed in the group with the help of experts from the industry, government, and academia.

Several other U.S. organizations actively participate in the both the international and domestic WG 2 work efforts, including the National Institute of Standards and Technology (NIST) and the National Aeronautics and Space Administration (NASA), as well as Honeywell, Hyperion Catalysis, and others.

Guidance Documents in Progress

Representative of its efforts over the past three years, WG 2 is currently developing 10 work items; most involve single-walled or multi-walled carbon nanotubes, and how to characterize them using specific instrumentation methods. Four of these work items are led or co-led by the United States:

• ISO/Approved Work Item (AWI) Technical Specification (TS) 10797, Nanotubes – Use of transmission electron microscopy in walled carbon nanotubes (co-led by the U.S. and Japan)

• ISO/AWI TS 10798, Nanotubes – Scanning electron microscopy and energy dispersive X-ray analysis in the characterization of single walled carbon nanotubes (led by the U.S.)

• ISO/New Work Item Proposal (NP) TS 10812, Nanotechnologies – Use of Raman spectroscopy in the characterization of single-walled carbon nanotubes (led by the U.S.)

• ISO/AWI TS 11308, Nanotechnologies – Use of thermo gravimetric analysis in the purity evaluation of single-walled nanotubes (co-led by the U.S. and Korea)

“The activities in WG 2 are strongly coupled to the other efforts within ISO/TC 229,” said Dr. Tsui. “The work of WG 1, Terminology and Nomenclature, defines the materials being measured, while the output from WG2 provides important information regarding intrinsic material properties and measurement methods that can be used by WG 3, Health, Safety, and Environment, and WG 4, Material Specifications.”

This overlap is apparent in one work item that is currently in the domain of WG 3: Guidance on physico-chemical characterization of engineered nano-objects for toxicologic assessment. This document, being developed under U.S. leadership, will serve as a reference for characterizing nano-objects to be used in toxicology testing. WG 3 is presently creating toxicology guidelines as they relate to health and safety; WG 2 may join the effort to assist in the development of methods used to characterize toxicity.

Getting Involved in ISO/TC 229 WG 2

Participation in the U.S. TAG ISO/TC 229 Working Group is open to all nationally interested stakeholders. The TAG actively seeks participants who have expert knowledge in all aspects of nanotechnology measurement and characterization. To join the ANSI-accredited U.S. TAG for ISO/TC 229 or any of its WGs, contact Heather Benko (hbenko@ansi.org; 212.642.4912).

For more information on the U.S. TAG for ISO/TC 229, visit http://www.ansi.org/isotc229tag.

Stay Tuned: The next article in this series will introduce ISO/TC 229/WG 4, Material Specifications.

EPA Consent Order

mheintz@porterwright.com (Michael E. Heintz) — Mon, 22 Sep 2008 08:28:34 -0500

Last week, EPA and Thomas Swan & Co. Ltd. released the agency's first manufacturing consent order with regards to nanotubes. The consent order was entered into between the two parties through the pre-manufacture notice (PMN) portion of the Toxic Substances Control Act (TSCA).

The consent order addresses the manufacture of a multi-walled nanotube product at the Swan Chemical, Inc. plant in New Jersey. Additionally, the consent order is the result of several months of collaboration between the company and the agency. The consent order addresses the Elicarb (r) MW product.

The Order itself has not been released to the Federal Register, or another source, for first hand review. While it is being touted by Thomas Swan & Co. as setting "the standard for future control of" nanotube products, I am unable to determine the extent of the agreement. Once the Order is released for public consumption, there will be a follow-up post relating our thoughts on the contents.