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."
Continue Reading...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.
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.
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.
Continue Reading...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.
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:
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:
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.
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."
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."
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.
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