NIA - Nanotechnology Industries Association

The US Research Triangle Environmental Health Collaborative has published the final White Paper, containing conclusions reached during the Collaborative’ summit on ‘Environmentally Responsible Development of Nanotechnology’ (held on the 8^th and 9^th October 2009).

According to an article by Bergeson& Campbell P.C., ‘[t]he charge for summit attendees was to explore issues regarding potential risk across nano-enabled product lifecycles, with the goal of generating a set of recommendations for North Carolina businesses regarding how to address such risks. The White Paper, to which Lynn L. Bergeson contributed, summarizes near-term recommendations resulting from the summit, as well as questions that should be considered in the interim to arrive at more solid long-term recommendations. The White Paper is available online.’

The White Paper makes some preliminary recommendations, outlining actions that may be taken by a mix of nanotech stakeholders or leaders, such as the participants of the summit, to support industries in developing guidelines for the responsible commercialization of nanotechnologies.

The White Paper conclusions note that ‘[the recommendations] require the input of the business community and the assistance of a greater network of supporting stakeholders, including regulatory bodies, research communities, legal, insurance, and other risk management service providers, venture capitalists and financial services firms, public interest groups, and non-profit organizations.'

Follow these links to find out more about the US Environmental Health Collaborative, or to download the complete White Paper.

According to an article on NutraIngredients.com, ‘[a] group of eight Members of the European Parliament (MEPs) [including Environment Committee Chair, Jo Leinen] met with EFSA representatives last week to discuss matters including health claims, nutrient profiling, GMOs and nanotechnology in food.'

‘We need to defend consumers against food products carrying unfounded health claims,’ Leinen said, and continued to explain that ‘MEPs want EFSA to maintain a tough stance on rejecting claims that are supported only by lobbying and marketing, instead of sound science. The European Parliament is fully committed to restoring consumers' trust in the safety and quality of all food sold in the European Union.

Follow this link to read the full article.

‘Well over 2000 companies worldwide [are] already involved in nanotechnology’ reads the headline of a NanoWerk News article; it continues to explain that, '[a]t the latest count, over 2100 companies from 48 countries are involved in nanotechnology research, manufacturing or applications - a number that keeps growing at a considerable pace.' 

'With more than 1100 companies, the U.S. is home to roughly half of all nanotechnology firms. 670 companies are in Europe, 230 in Asia and 210 elsewhere in the world. Within Europe, Germany is represented with 211 companies, followed by the U.K. with 146 companies.' 

'Over 270 companies are involved in the manufacture of raw materials such as nanoparticles, nanofibers and -wires, carbon nanotubes, or quantum dots. More than 340 companies are active in life sciences and pharmaceutical fields. The vast majority with well over half of all companies are involved in manufacturing instruments, devices, or advanced materials and components.' 

NanoWerk supports the statistics with a link to the Nanotechnology Company Directory, which groups nanotechnology companies into four main categories: 

• raw materials
• biomedicine and life sciences
• products, applications, and instruments
• services and intermediaries.

Follow this link to read the NanoWerk News article, or to find out more about the Nanotechnology Company Directory.

The European Commission’s Joint Research Centre (JRC) has published a report on the ‘Considerations on a Definition of Nanomaterial for Regulatory Purposes’ (JRC Reference Report EUR 24403 EN), which aims ‘to discuss elements of a definition of the term ‘nanomaterial’ based on a scientific analysis of related issues as well as a review of currently available definitions.’ It furthermore aims to ‘provide a practical approach and guidance for a definition aimed for regulatory use.’

The report makes specific reference to the European Parliament’s ‘Own Initiative Report’, which demands, inter alia, a comprehensive science-based definition of the term ‘nanomaterial’.

The JRC clarifies that the term ‘nanomaterial’ ‘usually refers to materials with external dimensions, or an internal structure, measured in nanometres that exhibit additional or different properties and behaviour as compared to coarser materials with similar chemical composition.’  It notes, that ‘[a] definition aimed for regulatory purposes should target a class of material which requires specific attention. Hence, the more specific term ‘particulate nanomaterial’ is considered to be more appropriate since macroscopic materials with internal structures at the nanoscale, also often denoted as nanomaterials, are not of concern in this context.’

The question of ‘true nano-anbeld effects’ is clarified by acknowledging 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 report provides a good overview of a number of proposed nanomaterial definitions; after discussion of a number of possible criteria for a definition of ‘nanomaterials’, giving special consideration on the strong need for enforceability of any regulatory definition, the JRC report recommends:

• For a definition aimed for regulatory purposes the term ‘nanomaterial’ in its current general understanding is not considered appropriate. Instead, the more specific term ‘particulate nanomaterial’ is suggested.
• The term ‘material’ is proposed to refer to a single or closely bound ensemble of substances at least one of which is a condensed phase, where the constituents of substances are atoms and molecules.
• For a basic and clear definition of ‘particulate nanomaterial’, which is broadly applicable and enforceable, it is recommended not to include properties other than size.
• For the size range of the nanoscale, a lower limit of 1 nm and an upper limit of 100 nm or higher should be chosen.
• The questions of size distribution, shape, and state of agglomeration or aggregation, may need to be addressed specifically in subsequently developed legislation. It is also likely that certain particulate materials of concern that fall outside a general definition might have to be listed in specific legislation.
• Additional qualifiers, like specific physico-chemical properties or attributes such as ‘engineered’ or ‘manufactured’ may be relevant in the scope of specific regulations.

Follow these links to find out more, or download the full JRC Reference Report.

The US GAO (Government Accountability Office) has published a report, in which it identifies severe challenges to the EPA regarding the regulation of potential risks associated with nanotechnology. According to the report summary, in this ‘Report to the Chairman, Committee on Environment and Public Works, U.S. Senate’ , entitled ‘Nanotechnology: Nanomaterials Are Widely Used in Commerce, but EPA Faces Challenges in Regulating Risk’, GAO: (1) identified examples of current and potential uses of nanomaterials, (2) determined what is known about the potential human health and environmental risks from nanomaterials, (3) assessed actions EPA has taken to better understand and regulate the risks posed by nanomaterials as well as its authorities to do so, and (4) identified approaches that other selected national authorities and actions U.S. states have taken to address the potential risks associated with nanomaterials.’

GAO identified ‘a variety of products that currently incorporate nanomaterials already available in commerce across the following eight sectors: automotive; defense and aerospace; electronics and computers; energy and environment; food and agriculture; housing and construction; medical and pharmaceutical; and personal care, cosmetics and other consumer products. Within each of these sectors, GAO also identified a wide variety of other uses that are currently under development and are expected to be available in the future.’

GAO notes that ‘[a]lthough EPA is planning to issue additional regulations later this year, these changes have not yet gone into effect and products may be entering the market without EPA review of all available information on their potential risk. Moreover, EPA faces challenges in effectively regulating nanomaterials that may be released in air, water, and waste because it lacks the technology to monitor and characterize these materials or the statutes include volume based regulatory thresholds that may be too high for effectively regulating the production and disposal of nanomaterials.’

GAO makes a number of recommendations for executive action by the EPA:

• The Administrator of EPA should complete its plan to issue a Significant New Use rule for nanomaterials.
• The Administrator of EPA should modify Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) pesticide registration guidelines to require applicants to identify nanomaterial ingredients in pesticides.
• The Administrator of EPA should complete its plan to clarify that nanoscale ingredients in already registered pesticides, as well as in those products for which registration is being sought, are to be reported to EPA and that EPA will consider nanoscale ingredients to be new.
• The Administrator of EPA should make greater use of the agency's authorities to gather information under existing environmental statutes. Specifically, EPA should complete its plan to use data gathering and testing authorities under TSCA to gather information on nanomaterials, including production volumes, methods of manufacture and processing, exposure and release, as well as available health and safety studies.
• The Administrator of EPA should make greater use of the agency's authorities to gather information under existing environmental statutes. Specifically, EPA should use information-gathering provisions of the Clean Water Act to collect information about potential discharges containing nanomaterials.
• The Administrator of EPA should consider revising the Inventory Update Rule under Toxic Substances Control Act of 1976 (TSCA) so that it will capture information on the production and use of nanomaterials and so that the agency will receive periodic updates on this material.

Follow these links to read the GAO Report Summary (on the GAO website), to download the Report Highlights, or to download the full GAO Report.

In its Annual Report 2009, the European Committee for Standardisation (CEN) summarises its continuing work on Nanotechnologies Standardisation:

During a European Parliament hearing on the Future of European Standardisation, held on the 23^rd June 2010 by the European Parliament Internal Market and Consumer Protection Committee (IMCO), MEPs decided to include nanotechnology, IT, communication and environmental protection in a portfolio of new areas to be covered by standardisations.

According to the Parliament’s press release, the hearing ‘was a first step for the IMCO Committee to lay out its views on the future of standardisation in an own initiative report to be presented shortly before the Commission presents its "Standardisation package" in November.’

Follow this link to find out more about the European Parliament hearing on the Future of European Standardisation.

In an interview with Skip Lockard, co-chair of Alston & Bird’s Nanotechnology practice, representatives of the US regulatory authorities and the chemical industries discuss current and future US regulation of nanotechnology.

Tom Jacob, former DuPont Manager of Government Affairs for the Western Region and currently of T.R. Jacobs & Associates, LLP, notes that ‘industry recognizes potential benefits from nano-regulation.’ ‘Regulations based on sound science and the best collective understanding of environmental, health, and safety (“EH&S”) issues is unquestionably beneficial to the reasonable, appropriately-controlled development of nanoproducts,’ he adds.

The Nanotechnology Panel of the American Chemical Counsel (ACC) agrees: ‘The ACC welcomes reasonable regulation, as opposed to uncertainty about how nanomaterials should be regulated,’ says Bill Gulledge, Managing Director of the ACC’s Chemical Products & Technology Division and Chair of its Nanotechnology Panel.

Dr. Jeff Wong, Chief Scientist at the California Department of Toxic Substances Control (DTSC), explains the DTSC’s Mandatory Nanomaterials Data Call-In, which started in January 2009 and went into effect on the 1^st January 2010: ‘We are looking at data and trying to reach meaningful, factual, “boots on the ground” conclusions that will help companies make good decisions. In a sense, our goal is simply for these conclusions to help companies incorporate environmental protection principles through rational product design at the front end, rather than dealing with problems on the back end.’ But the American chemical industry does not support California’s initiative: ‘We’d [...] like to see a uniform national approach to nanomaterial regulation, rather than something piecemeal on a state-to-state basis.’ ‘ACC advocates the use of existing regulatory frameworks for the responsible development of nanotechnology. In particular, we’d like to see a modernization or revision of the Toxic Substances Control Act (“TSCA”) to address all chemical management issues including nano [...],’ he added. ‘In terms of future regulation, I also think it’s important to keep in mind that different nanomaterials clearly have different properties. As a result, different materials have different environmental or health implications. One broadly shared concern within the chemical industry is whether future regulations properly take these differences into account,’ cautions Tom Jacob.

So, what’s next for nanomaterial regulation in the US?

Bill Gulledge predicts that ‘EPA will continue data call-ins and other TSCA regulatory efforts for nanomaterials. [...] On the legislative front, I do think it’s just a matter of time before TSCA is amended and generally updated. There could be a significant debate about how nanomaterials should be treated under a revised version of TSCA.’

In California, DTSC doesn’t follow a strict prioritization, but will certainly remain interested in titanium dioxide and zinc oxide, as well as zero-valent iron.

'In addition to expanding the list of specific materials agencies are interested in, [...] they are starting to look further down the product value chain and ask questions not just about raw nanomaterials themselves, but what the implications might be for workers and product end-users. Looking at the entire product chain may become increasingly important,’ concludes Tom Jacob.

Follow this link to read the full interview.

The OECD Working Party of Manufacture Nanomaterials (WPMN) has added two documents to its OECD Publication Series on the Safety of Manufactured Nanomaterials:

1. OECD WPMN Publication Number 24: ‘Preliminary Guidance Notes on Sample Preparation and Dosimetry for the Safety Testing of Manufactured Nanomaterials’.

Text excerpt:

‘The WPMN recognised that it was essential to develop a guidance document on sample preparation and dosimetry, based on the discussion held in preparing the ‘Preliminary Review of OECD Test Guidelines for their Applicability to Manufactured Nanomaterials.’ It called special attention to this guidance as crucial in using test guidelines when considering the unique chemical and physical characteristics of nanomaterials.
It is important to note that this document [...] is a “living document” and as such, it will be updated and amended based upon knowledge accumulation and evolving communication and as experience is gained with nanomaterial testing.’

Additional, specific guidance and protocols on sample preparation, dosimetry and characterisation of nanomaterials has been developed by PROSPEcT - Ecotoxicology Test Protocols for Representative Nanomaterials in Support of the OECD Sponsorship Programme; follow these links to download a Protocol for Nanoparticle Dispersion, Guidelines and Protocol for Sampling, or to watch a Dispersion Protocol Video.

2. An updated version of the OECD WPMN Publication Number 14 ‘Guidance Manual for the Testing of Manufactured Nanomaterials: OECD's Sponsorship Programme’; according to the Executive Summary, the OECD WPMN Publication Number 25: ‘Guidance Manual for the Testing of Manufactured Nanomaterials: OECD Sponsorship Programme: First Revision’ , the revised version contains 'a Data Sharing Template Format , [which] was finalised at the 6th meeting in October 2009 and it was agreed to its inclusion to this documentas an annex (Annex III).'

The following additions were made during the 1^st revision:

• ANNEX III: Data Sharing Template Format
• PART I: Essential Elements for the Dossier and Template
• PART II: Examples
• Example: Acute toxicity to fish
• Example: Mammalian Toxicity: Repeated Dose Toxicity
• PART III: Draft Proposal for Data Sharing Format for non-standardised Test Methods
• ANNEX IV: Alternative Test Methods in the Sponsorship Programme

Follow these links to access all OECD WPMN Publications, or to find out more about the OECD Publication Series on the Safety of Manufactured Nanomaterials.

The European Commission Directorate-General for Research, Technology and Development has published a paper entitled ‘Communicating Nanotechnology - Why, to whom, saying what and how? - An action-packed roadmap towards a brand new dialogue’, but according to NanoWerk, which was the first to report in its Spotlight-series on the publication of this document, it’s too little too late: ‘this is the European Commission – notorious for its massive bureaucracy; slow; expensive; and being run by committee. The fact alone that they come up with a meaningful communications roadmap only many years and many billions of euros after embarking on a huge R&D effort speaks for itself (the situation in the U.S. isn't much better; on the contrary, they don't even have this kind of communications roadmap),’ criticises the respective Spotlight article.

In the paper’s foreword, Herbert von Bose, Director of Industrial Technologies, Directorate G, Research DG of the European Commission, notes that ‘[t]his communication exercise should, indirectly, have two major, desirable effects: increasing the consensus between stakeholders, society and policymakers on EC decisionmaking about nanotechnology; and strengthening the image of the EC as an impartial, transparent and trustworthy communicator on nanotechnology.’

According to Christos Tokamanis, Head of Unit for Nano- and Converging Sciences and Technologies Directorate G, Research DG of the European Commission, ‘[t]he EC takes this whole communication effort on nanotechnology so seriously, that it now wants to prepare for an appropriate dialogue among stakeholders about the social challenges of nanotechnology: this has been the focus of two further publications issued at the beginning of 2008 and of other projects launched during this and next year, with special emphasis on television and Web media, as well as on young people.

Reaching the right audiences, with the appropriate message and means is of essence.

All these dialogue efforts will culminate into the European Platform on Nano Outreach and Dialogue (NODE): it will deal with a specific system of mechanisms to enliven and coordinate the continuous and open dialogue on nanotechnology within the whole EU society, empowering both EC and Member States with a very challenging tool for delivering technical democracy on nanotechnology.’

Follow these links to download the full paper (and Annex).