NIA - Nanotechnology Industries Association

The US Food and Drug Administration (FDA) has published announced a Public Workshop on Medical Devices and Nanotechnology: Manufacturing, Characterization, and Biocompatibility, to be held on the 23^rd September 2010 in Washington D.C..

According to the notice in the 21^st August 2010 Federal Register (Vol. 75, No. 162, page 51829), ‘FDA is holding this public workshop to obtain information on a number of specific questions regarding manufacturing and characterization requirements and the biocompatibility evaluation for medical devices utilizing nanotechnology.‘

The FDA is seeking public comments; comments are to be submitted by the 15^th September 2010, if they are to be considered for the workshop; all other comments are to be submitted by the 22^nd October 2010.

Follow this link to download the full Federal Register notice.

Market research and advisory firm Lux Research has published a report comparing ‘nanotech innovation and technology development in 19 countries in order to provide government policymakers, corporate leaders and investors a detailed map of the nanotech’s international development landscape.’

Entitled ‘Ranking the Nations on Nanotech: Hidden Havens and False Threats’, the report found ‘global investment in nanotech held steady through the recent financial crisis, drawing $17.6 billion from governments, corporations and investors in 2009, a 1% increase over 2008’s $17.5 billion. Only venture capitalists dialed back their support, cutting investments by 43% relative to 2008.'

The press release notes that Lux Research set out to analyse ‘the emerging possibility that ambitious new government funding in Russia and China represented a threat to U.S. dominance in nanotech innovation,’ but found that ‘while the field certainly gained momentum in both countries as a result of the increased funding, both countries have economic and intellectual property protection issues that prevent them from being real threats just yet.’

Excerpts from the report summary:

• The U.S. continues to dominate in nanotech development… for now. Last year saw the U.S. lead all other countries in terms of government funding, corporate spending, VC investment, and patent issuances. But its capacity to commercialize those technologies and leverage them to grow the economy is comparatively mediocre. U.S. competitiveness in long-term innovation is also at risk, as the relative number of science and engineering graduates in its population is significantly lower than it is in other countries.
• Other countries stand to get more bang for their nanotech buck. Japan, Germany, and South Korea continued their impressive trajectories from 2008, earning top spots in publications, patents, government funding, and corporate spending. Compared to the U.S., all three also remain more focused on nanotech and appear more adept at commercializing new technology. The relative magnitude of the technology manufacturing sectors in these three countries are the world’s highest, meaning their economies stand to benefit the most from nanotech commercialization.
• Russian and Chinese investment in nanotech yields slow progress. While both governments launched generous nanotech investment programs last year, the technology hasn’t gained momentum in either country’s private sector, both of which have a history of skimping on R&D. The relative lack of momentum was further underscored by the abysmal number of new nanotech patents for either country last year.

Follow these links to find out more about Lux Research, or to download the full report (for purchase or Lux Research clients only).

The International Organisation for Standardization (ISO) has published a new technical report (TR) entitled ‘Nanotechnologies – Methodology for the classification and categorization of nanomaterials’ (ISO/TR 11360:2010)’.

Aimed at scientist and researchers, who meet in the field of nanotechnologies coming from various different backgrounds and who have many divergent understandings and assumptions associated with emerging scientific concepts in this area, the technical report offers a comprehensive, globally harmonized methodology for classifying nanomaterials; it introduces a system called the “nano-tree”, which places nanotechnology concepts into a logical context by indicating relationships among them as a branching out tree.

‘The document provides users with a structured view of nanotechnology, and facilitates a common understanding of its concepts,’ says Peter Hatto, Chair of the committee that developed the standard (ISO/TC 229). ‘It offers a systematic approach and a commonsensical hierarchy’.

Dr. Hatto adds that'the benefits for this emerging field are enormous. Most importantly, ISO/TR 11360 will promote clear and useful communication amongst industry consumers, governments and regulatory bodies.'

Follow these links to find out more about the work of ISO in the field of nanotechnology, to read the press release on the publication of ISO/TR 11360:2010, or to access the ISO portal, on which to download the full report.

• European Nanomaterials to be regulated far beyond 100 nm?
• California UCSF Report to OEHHA ‘on hold’
• UK BSI implements ISO TS ‘Nanotechnologies — Vocabulary Part 3: Carbon nano-objects’

The US Environmental Protection Agency (EPA) announced that it is proposing to register conditionally a pesticide product containing nanosilver as a new active ingredient for a period of four years. According to a posting on Nanotechnology Law Blog, maintained by Bergeson & Campbell, P.C., the announcement was made simultaneously with the EPA’s publication of and opening of a public consultation on a draft case-study on nano-silver in disinfectant sprays.

According to EPA, the antimicrobial pesticide product, HeiQ AGS-20, is a silver-based product that is proposed for use as a preservative for textiles. As a condition of registration, EPA is proposing to require additional product chemistry, toxicology, exposure, and environmental data. EPA states that it will ‘evaluate these data as they are submitted during the period of the conditional registration to confirm the product will not cause unreasonable adverse effects to human health and the environment.’

Under EPA’s new policy concerning public involvement in registration decisions, EPA is providing a 30-day opportunity for public comments on the proposed registration. Public comments will be accepted until the 11^th September 2010. All relevant documents can be found on the regulations.gov website (search for EPA docket numberEPA-HQ-OPP-2009-1012: ‘Registration of a new active ingredient for Nanosilver used as a antimicrobial and perservative additive used to treat fibers, plastics, polymers, latex products and ceramics’): follow these links to download the Public Participation document, to download the initial announcement of registration application (31^st March 2010 Federal Register  (Vol. 75, No. 61, page 16109), or to Submit Comments/Attachments.

The EPA’s initiative is understood to be based largely on meeting and report by the EPA Scientific Advisory Panel (SAP) on the topic ‘Evaluation of Hazard and Exposure Associated with Nanosilver and Other Nanometal Oxide Pesticide Products’ (held in Arlington VA, on the 3^rd to the 5^th November 2009). 

The US Environmental Protection Agency (EPA) has published a draft document entitled ‘‘Nanomaterial Case Study: Nanoscale Silver in Disinfectant Spray’’ (EPA/600/R–10/081), intended to ‘serve as part of a process to help identify and prioritize scientific and technical information that could be used in conducting comprehensive environmental assessments (CEA) of selected nanomaterials.’

According to the announcement in the 13^th August 2010 Federal Register (Vol. 75, No. 156, page 49487), the draft document ‘is intended to highlight what is known and unknown about nanoscale silver (nano-Ag) as part of a process to identify and prioritize information gaps relevant to assessing the broad environmental implications, including potential ecological as well as human health impacts, of nanomaterials’, and ‘does not attempt to draw conclusions regarding potential environmental risks of nanoscale silver; rather, it aims to identify what is known and unknown about nanoscale silver to support future assessment efforts.’

The draft document, which is being issued by the National Center for Environmental Assessment within EPA’s Office of Research and Development, is available on the NCEA home page.

The draft document is open for a 45-day public consultation (beginning on the 13^th August 2010, ending on the 27^th September 2010); public comments may be submitted online via the commenting website (see Federal Register Notice for more information on other ways to submit comments); deadline: 27^th September 2010.

Follow these links to download the full Federal Register Notice(13^th August 2010, Vol. 75, No. 156, page 49487), or to download the draft Case-Study document.

Safe Work Australia, an independent statutory agency with primary responsibility to improve occupational health and safety and workers’ compensation arrangements across Australia, has published two research reports on engineered nanomaterials and a nanotechnology risk assessment tool.

According to the accompanying press release, Safe Work Australia had commissioned the Royal Melbourne Institute of Technology to undertake a survey for the report titled Engineered Nanomaterials: investigating substitution and modification options to reduce potential hazards. The survey assessed the current substitution and modification practices used in Australian nanotechnology activities. A literature review was also conducted to determine the potential substitution and modification options that may reduce the toxicity of engineered nanomaterials.

Key findings in the report include:

• Australian researchers and companies use a range of methods to substitute or modify engineered nanomaterials.
• Currently, substitution or modification is mainly used to change the properties of products for end-use.
• Methods including surface modification, particle size control, and functional group addition can also be used to decrease the potential toxicity of engineered nanomaterials. There is potential for researchers, developers and manufacturers of engineered nanomaterials to apply these methods more broadly to address work health and safety related issues.

• Benchmark exposure levels are precautionary limits that can be assigned to groups of nanomaterials.
• Benchmark exposure levels may be adopted as guidance initially and may be converted into National Exposure Standards as further hazard, risk and measurement data become available.
• Exposure levels below the benchmark exposure levels can be achieved using conventional engineering controls.
• The choice of appropriate workplace controls for nanomaterials can be facilitated using the control banding approach to risk management.
• Control banding should be used in conjunction with current jurisdictional work health and safety regulations.
• The use of both benchmark exposure levels and control banding are consistent with a precautionary approach to handling nanomaterials, as recommended by Safe Work Australia where limited information about hazards and risks is available.

Safe Work Australia has furthermore released the Work Health and Safety Assessment Tool for Handling Engineered Nanomaterials,aims to provide risk assessment organisations and regulators with a tool that records the types of nanomaterials manufactured or supplied, the processes and controls used to prevent exposure to nanoparticles and problems faced with managing nanotechnology work health and safety.

Follow these links to find out more about the work on nanotechnologies, conducted by Safe Work Australia, or to download the Royal Melbourne Institute of Technology report on substitution and modification options, to download the Monash report on control banding, or to download the Safe Work Australia assessment tool.

On the 10^th July 2010, the European Union rapid alert system for all dangerous consumer products, RAPEX, featured notification from Denmark, that a product called ‘NanoCover’ (i.e. described as a ‘Pump-spray detergent - NanoCover Floor Seal, Non-absorbent’) was to be removed from the market, with the justification that ‘[t]he product poses a chemical risk because it contains trioxytridecafloursilane which should be classified as toxic by inhalation’ (see RAPEX database, search term ‘NanoCover’).

Clarification:
Similar to the case of ‘MagicNano’, a sealing spray for glass and ceramics, which had been recalled from the market in 2006 (see RAPEX notification, search term ‘MagicNano’), the ‘danger’ associated with the use of the product is based to the presence of chemicals in the product, and is not connected to any nanospecific property of the product: the offending chemical ‘trioxydecafloursilane’, found in NanoCover, is a colourless liquid, which can create a thin hydrophobic (i.e. water- and dirt-repellent) layer on the surface.

When MagicNano was recalled in 2006, the cause of the breathing problems, observed in number of users of the product, was initially unknown; in 2009, however, the German Federal Institute for Risk Assessment (BfR), which had lead an in-depth investigation into the toxic effects of impregnation aerosols, reported that ‘the spray [MagicNano] most probably contained ‘floursilanes’’, which adhered to the lung-walls, after a rapid evaporation of the solvent, caused by the use of an inappropriate spray head on the can.

NOTE: The RAPEX consumer alert system allows those that post alerts to chose from a list of ‘keywords’, describing the associated ‘Danger’ of a product; the keyword list is a mix of both harmful effects (such as ‘choking’, ‘damage to hearing’, ‘injuries’, ‘strangulation’), physical processes (such as ‘inhalation’), as well as substance (such as ‘chemical’), which can be used in any combination to describe the reason for product removal. To the NIA’s knowledge, an inclusion of ‘nano’ in this list is not foreseen.

Follow these links to find out more about RAPEX, or to view the RAPEX listings of both NanoCover and MagicNano on RAPEX.

During the 2^nd reading, on the 7^th July 2010, the European Parliament plenary voted to adopt a set of amendments to the Novel Foods Regulation; the proposed text changes to the Novel Foods Regulation specifically represent (a) additions or (b) changes to the position of the European Council, adopted on the 15^th March 2010.

Commented excerpts from the amending acts proposed by the European Parliament (follow this link to download an NIA-Summary of the nanospecific amendments).

In contrast to the European Council, the Parliament’s amendments make a point of including ‘new production processes, such as nanotechnology and nanoscience’ in the definition of ‘Novel Foods’:
Amendment 10; Council position – amending act; Recital 6: (6)  It should also be clarified that a food should be considered as novel when a production technology which was not previously used for the production of foods to be marketed and consumed is applied to that food. In particular, emerging technologies in breeding and food production processes, which have an impact on food and thus might have an impact on food safety, should be covered by this Regulation. Novel food should therefore include foods derived from plants and animals, produced by non-traditional breeding techniques, and foods modified by new production processes, such as nanotechnology and nanoscience, which might have an impact on food. Foods derived from new plant varieties, or animal breeds produced by traditional breeding techniques, should not be considered as novel foods.

The Parliament furthermore proposes the addition of food packaging materials in the scope of the Novel Foods Regulation:
Amendment 13; Council position – amending act; Recital 7 a (new): (7a)  Only nanomaterials entered in a list of approved substances should be present in food packaging, accompanied by a limit on migration into or onto the food products contained in such packaging.

The Parliament also adds a paragraph on labelling of nano-ingredients:
Amendment 75; Council position – amending act; Article 9 - paragraph 2 c (new): 2c.  All ingredients present in the form of nanomaterials shall be clearly indicated in the list of ingredients. The names of such ingredients shall be followed by the word 'nano' in brackets.

In case the Council rejects the Parliament’s position, the conciliation procedure between the Parliament and the Council will be launched in September 2010.

Follow these links to find out more about the current recast procedure of the Novel Foods Regulation, to find out more about the Council position,  to download an NIA-Summary of the nanospecific amendments, or to view the full set of proposed amendments, adopted by the Parliament on the 7^th July 2010.

Only two weeks after the official publication of the European Commission’s JRC Reference Report on the ‘Considerations on a Definition of Nanomaterial for Regulatory Purposes’ (EUR 24403 EN), another policy-informing body of the European Commission, the Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) has published an opinion paper that, similar to the JRC Reference Report, aims to provided ‘advice on the essential scientific elements of a working definition for the term “nanomaterial” for regulatory purposes.’

Entitled ‘Scientific Basis for the Definition of the Term ‘Nanomaterial’’, the SCENIRH Opinion reviews and discusses existing definitions formulated by various governing bodies, given special emphasis to the ‘enforceability’ of a definition of the term ‘nanomaterial’.

In contrast to the JRC Reference Paper, however, the SCENIHR Opinion makes the following recommendations:

• Within a regulatory context, it seems useful to specify an upper and lower limit to facilitate a uniform interpretation.
• [...] there seems to be a need for validated standardised methods to determine size and its corresponding distribution as these would ensure comparability of results.
• [...] the definition should aim to be over-arching to also include next-generation nanomaterials to avoid quickly becoming obsolete.
• The size distribution should not be ignored and should be taken into account when defining and describing a nanomaterial. [...] any material is a nanomaterial when >0.15% of the material, based on number concentration, has a size below the upper limit.[1]
• The volume specific surface area can be considered as an additional criterion that could be used to identify dry solid powders as nanomaterial. However, for inclusion in a general definition a limitation is that not all nanomaterials are amenable to VSSA determination.
• [...] each combination of a nanomaterial with a coating has to be considered as an individual case for safety evaluation.
• [...] none of the [16 physico-chemical characteristics identified by the OECD WPMN] appears to meet the criterion of universal applicability required for a definition.
• The inclusion of “internal structure” as an element of the definition is needed to include nanocomposites into the definition of nanomaterials.
• [...] a general definition should cover all these three types [natural, man-induced, manufactured] of nanoscale materials, the distinction being provided by the use of the terms natural, man-induced, and/or manufactured.

The Committee specifically pints out that, ‘[a]t the moment, no scientific data are available to indicate that a specific size associated with special properties due to the nanoscale can be identified for nanomaterials in general. There is no scientific evidence in favour of a single upper limit.’ This statement stands in contrast to the JRC Reference Report, which highlighted that ‘there are intrinsic nanoscale properties which result from the confinement of atoms and electrons within boundaries of a few nanometres. These effects are most dominant at sizes below a few tens of nanometres (less than about 30 nm). They can considerably change fundamental physical material characteristics like the optical, electrical, and magnetic properties of the nanomaterial.’

The SCENIHR Opinion concludes that ‘[a]n upper limit of 100 nm is commonly used by general consensus but there is no scientific evidence to qualify the appropriateness of this value. The use of a single upper limit value might be too limiting for the classification of nanomaterials and a differentiated approach might be more appropriate.’ It subsequently proposes a tiered approach ‘based on a relatively high upper threshold for materials for which further information is missing. In this case it is assumed that the size distribution at the lower end will always be above the lower, more critical upper threshold. The low upper threshold would be the critical threshold for which extensive nano-specific information has to be provided in order to perform case-by-case risk assessment.

An example is presented [...] using 500 nm as high upper threshold and 100 nm as low upper threshold [...].

• Category 1 median size >500 nm for materials for which further information is missing: If the median size of the material is above 500 nm it is assumed that the size distribution at the lower end will always be above the designated lower threshold of 100 nm. Thus, no further information regarding possible nanospecific properties may be needed and classical risk assessment can be performed taking into consideration the particulate nature of the material.
• Category 2 median size <500 nm: When the median size is <500 nm a material is considered to be a nanomaterial 5 and a more detailed nanospecific risk assessment is necessary taking into consideration possible nanospecific characteristics of the material. When the size is <500 nm but >100 nm the nanospecific risk assessment may be waived when additional information is provided that the number size distribution demonstrates that the material has <0.15% (or any specified percentage) of the number size distribution <100 nm. For dry materials, the VSSA (<60 m2/cm3) may be used as an additional qualifier. In these cases a classical risk assessment can be performed taking into consideration the particulate nature of the material.
• Category 3 median size <100 nm and >1 nm: The material is considered to be a nanomaterial and nanospecific risk assessment has to be performed when >0.15% (or a specified percentage) of the number size distribution is <100 nm. For dry materials, the VSSA (>60 m2/cm3) may be used as an additional qualifier.’

The SCENIHR Opinion is open for public consultation; all interested parties are invited to submit comments via the online public consultation form by Wednesday, 15 September 2010.

Follow these links to find out more about the EC’s SCENIHR Committee, download the press release on the publication of the SCENIHR Opinion, to download the full SCENIHR Opinion, or to access the consultation website.

• Belgium is pushing for REACH-Registration of Nanomaterials
• California DTSC Data Call-Ins on nano-TiO2, -Ag, -ZnO, and –Fe(0)
• European Commission to set a Regulatory Working Definition of Nanomaterials

In the US Federal Register published on the 6^th July 2010 (Vol. 75, No. 128), the US White House Office of Science and Technology Policy (OSTP) posted a Request for Information (RFI) in support of the National Nanotechnology Initiative (NNI) Strategic Plan 2010. According to the notice, the RFI aims to ‘enhance the value of the National Nanotechnology Initiative (NNI) by reaching out to the nanotechnology stakeholder community for specific input for the next NNI Strategic Plan to be published in December 2010.’

‘This RFI refers to the NNI Goals identified from the 2007 [NNI] Strategic Plan [...] as a starting point for questions covering themes such as research priorities, investment, coordination, partnerships, evaluation, and policy.’

The OSTP is interested in responses that address one or more of the following questions (for background information and examples on these questions, please download the relevant Federal Register notice:

A. Goals and Objectives

• A1. What specific and measurable objectives should be established to help achieve the four stated NNI goals?
• A2. Are there other overarching goals that would enable the NNI to better support the vision of a future in which the ability to understand and control matter at the nanoscale leads to a revolution in technology and industry that benefits society?

B. Research Priorities

• B1. What are the most important gaps in the NNI R&D portfolio (i.e., specific underfunded areas ripe for success) that should be addressed to achieve the NNI goal(s) (please specify 1, 2, 3, and/or 4)?
• B2. What nanotechnology R&D areas should NNI member agencies pursue under the Nanotechnology Signature Initiatives model of close and targeted program-level interagency collaboration to help accelerate nanotechnology innovation?
• B3. What are the most important scientific and technical challenges that would need to be met to realize the NNI goal(s) (1, 2, 3, and/or 4) and objectives?

C. Investment

• C1. What types of research and development investments (e.g. support for individual investigators, small teams, centers, research infrastructure, etc.) should the NNI agencies create, sustain, and/or expand to achieve the NNI goal(s) (please specify 1, 2, 3, and/ or 4)?
• C2. What relative distribution of research and development investment among the PCAs is needed to achieve the NNI goal(s) (1, 2, 3, and/or 4), and why?
• C3. What is the appropriate balance for investment in nanotechnology among US private and public entities (i.e., government, corporate R&D, and venture capital) to achieve the NNI goal(s) (please specify 1, 2, 3, and/or 4), and why?

D. Coordination and Partnerships

• D1. How could the NNI strengthen interagency coordination and collaboration towards specific NNI goal(s) (please specify 1, 2, 3, and/or 4) and objectives?
• D2. What improved mechanisms may be utilized to facilitate innovative cross-disciplinary research supporting the NNI goal(s) (please specify 1, 2, 3, and/or 4)?
• D3. What are the most effective roles of the government, industry, academia, and other stakeholders in achieving this NNI goal (1, 2, 3, and/or 4)?
• D4. What new forms of collaboration between stakeholders should be explored to facilitate nanotechnology-based innovation into applications?
• D5. What existing activities in the public and private sector could the NNI develop or model to achieve the NNI goal(s) (please specify 1, 2, 3, and/or 4)?
• D6. What partners or types of partners would need to collaborate (i.e., government, specific foundations and industry groups, new ideas for consortia) to accomplish the NNI goal(s) (please specify 1, 2, 3, and/or 4)?
• D7. What are effective mechanisms to leverage and/or coordinate USfunded research and development with international efforts?
• D8. What mechanisms could NNI use to regularly engage experts in academia and industry and other organizations for input on its approach to addressing specific NNI goals (please specify 1, 2, 3, and/or 4)?
• D9. What is the role of public engagement in achieving specific NNI goals? In what ways can the Federal government best engage with citizens to ensure the sustainable development of nanotechnology-based products with the broadest economic and societal benefits?

E. Evaluation

• E1. What specific criteria (e.g., nanotechnology publications and citations, nanotechnology patent activity, nanotechnology-related job creation, relative international nanotechnology investments) should the NNI use to evaluate its progress towards the NNI goal(s) (please specify 1, 2, 3, and/or 4) and in what priority order?
• E2. Which organizations (e.g., government committees, independent organizations, international bodies) should perform the evaluation of progress towards the NNI goal(s) (please specify 1, 2, 3, and/or 4)?
• E3. How can NNI best balance fundamental and applied research and development towards the NNI goal(s) (please specify 1, 2, 3, and/or 4)?

F. Policy

• F1. What new, or existing, specific policies should the NNI agencies develop or adjust to support the NNI goal(s) (please specify 1, 2, 3, and/or 4) and to realize the broader economic and societal benefits associated with advances in nanotechnology?
• F2. What best practices can be drawn from nanotechnology- and innovation-related policies in other sectors and countries?

Response Deadline: Responses to this RFI should be submitted by 11:59 p.m. Eastern Time on 15^th August 2010.(Submissions priorto the 13^th and 14^th July 2010 ‘‘NNI Strategic Plan Stakeholder Workshop’’   may alsoinform dialogues at this event.)Responses must be deliveredelectronically in the body of or as anattachment to an e-mail sent toNNIStrategy@ostp.gov.

Follow these links to find out more about the NNI, or to download the relevant pages of the US Federal Register (6^th July 2010), giving more details on the Request for Information.