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NIA submits comments to EC’s Public Consultation on Risk Assessment of Nanotechnologies

Released on Tuesday 30th June 2009

The Nanotechnology Industries Association has submitted comments to the European Commission’s Public Consultation in preparation of a Scientific Hearing on Risk Assessment of Nanotechnologies.

 
The full set of comments includes:
 
‘Risk assessment of nanomaterials:
          We [the NIA] agree with SCENIHR on their conclusion that ‘[t]he hypothesis that smaller means more reactive and thus more toxic cannot be substantiated by the published data. In this respect nanomaterials are similar to normal substances in that some may be toxic and some may not.’
          We furthermore support the ‘case by case approach for the risk assessment of nanomaterials’, as recommended by SCENIHR.
          We agree with the finding that ‘[f]or (partially) soluble nanomaterials the toxicity may be governed at least in part by the soluble species released from the nanomaterial.’
          It is important to distinguish the linearly particle size dependent increase of surface area from the unique properties that are observable below a primary particle size of approximately 100 nm only. More research is needed, in order to characterise the transport properties of primary particles in biological systems, determine if agglomerates or aggregates can revert to primary particles in biological systems, and to ultimately shed light on SCENIHR’s suggestion that ‘[f]or low solubility or a slow release, the particulate nature of the substance may be relevant with regard to tissue distribution and local release of toxic species which should then be considered in the risk assessment of such nanomaterials.’
 
Definition:
          SCENIHR recommends the introduction of an additional parameter to uniquely describe nanoscale properties by ‘extending the current definition based on physical size by the addition of a limit of the specific surface area to be above 60 m²/g of material volume (the value of 60 m²/g corresponds to the specific surface area of 100 nm solid spheres of unit density) [...].’ We do not support the addition of a limit of the specific surface area into the unique definition of nanomaterials, since it represents a direct dependence on particle size and contradicts SCENIHR’s conclusion that ‘[t]he hypothesis that smaller means more reactive and thus more toxic cannot be substantiated by the published data.’ 
 
Follow this these links to download the submitted NIA Comments (this version has been shortened and heavily abbreviated due to restrictions), to download the full NIA Comments (un-abbreviated and available from this website only), to find out more about the European Commission’s Public Consultation, or to register for the Scientific Hearing (to be held on the 10th September 2009).
 
 
Related Links:
The European Commission (DG Health and Consumers) has opened the registration for the Scientific Hearing on Risk Assessment of Nanotechnologies (to be held in Brussels, on the 10 September 2009; Venue: Centre de Conference A. Borschette, Rue Froissart 36, 1040 Brussels). (24th June 2009)
 
The European Commission has launched a Public Consultation to prepare for a one-day Scientific Hearing on Nanotechnology, which will take place on 10 September 2009 in Brussels. (20th April 2009)
 
The EC’s Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) has published its opinion on the most recent developments in the risk assessment of nanomaterials. (18th February 2009)

 

Event Annoucement

Released on Friday 26th June 2009

OECD Conference on Potential Environmental Benefits of Nanotechnology: Fostering Safe Innovation-Led Growth 

Venue: OECD Conference Centre
Starts: Wednesday 15th July 2009
Ends: Friday 17th July 2009

The OECD Working Party on Manufactured Nanomaterials (ENV) and OECD Working Party on Nanotechnology (STI) jointly present an OECD Conference on Potential Environmental Benefits of Nanotechnology: Fostering Safe Innovation-Led Growth.

The conference will cover both the opportunities and the challenges of the use of nanotechnologies for potential environmental benefit. The aim is to learn from international expertise and to identify ways in which to improve in a timely manner policies with the potential to enhance both short- and long-term economic growth. [...]


 

 

International Conference: "Transatlantic Regulatory Cooperation: Securing the Promise of Nanotechnologies"

Venue: Chatham House, London, UK
Starts: Thursday 10th September 2009
Ends: Friday 11th September 2009

Nanotechnology will impact our lives on a global scale. Over the past year experts from the London School of Economics, Environmental Law Institute, Chatham House and the Project on Emerging Nanotechnologies at the Woodrow Wilson International Center for Scholars have been examining issues of transatlantic regulatory cooperation. Their research findings are to be published in a major report, which will be launched at this international conference on 10-11 September 2009. [...]

For further details on the research project and a conference agenda (available from late June), please see the project website: http://www.lse.ac.uk/nanoregulation.

Participation in the conference is by invitation only. Please send an email to Ms. Carmen Gayoso at nanotech@lse.ac.uk if you would like to attend.


 

1st Nanosafety Autumn School

Venue: Venice (Italy)
Starts: Monday 16th November 2009
Ends: Friday 20th November 2009 

The increasing use of engineered nanomaterials, especially nanoparticles (NP), in various applications will likely lead to a significant exposure to these new materials. Over 500 NP-based consumer products are already marketed, such as sunscreens and cosmetics, detergents, pigments, tires, lubricants and healthcare/medical application products.  [...]

Target Audience:
Industry, governmental agencies, (post)- graduates and Ph.D. students, dealing with nanotechnologies and related topics.

Follow these links to find out more about the 1st Nanosafety Autumn School, or to download the flyer.


 

 

Summary report of EC Scientific Committees published

Released on Thursday 25th June 2009

The European Commission has published a Final Report on the Scientific Committees 2004-2009. The report outlines the mandates, running costs, published opinions and meeting participation by Scientific Committees of the European Commission in 2004-2009:

Follow these links to find out more about the EC’s Scientific Committees, or to download the full Final Report 2004-2009.

 
Related Links:
The EC’s Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) has published its opinion on the most recent developments in the risk assessment of nanomaterials. (18th February 2009)
 
The European Commission’s Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) has adopted an opinion entitled ‘Assessment of the Antibiotic Resistance Effects of Biocides’. (27th January 2009)
 
The EC has published the Minutes of the most recent meeting of its Scientific on Emerging and Newly Identified Health Risks (SCENIHR); during its 27th plenary meeting, held on the 26th November 2008, SCENIHR concluded that the 2nd Dialogue on Nanotechnology – Safety for Success, held in Brussels in October 2008, ‘was considered a useful and informative initiative in particular for establishing a regular dialogue with different stakeholders. [...] The launch of a network on risk assessment on nanomaterials was foreseen as a result of this meeting to exchange and pool information.’ (23rd January 2009)

 

 

EPA includes single- and multi-walled carbon nanotubes in ‘significant new use’-rule

Released on Wednesday 24th June 2009

The US Environment Protection Agency (EPA) has issues Significant New Use Rules on Certain Chemical Substances (Fedral Register, 24th June 2009), including multi-walled carbon nanotubes and single-walled carbon nanotubes.

The notice explains:
‘A. Rationale: During review of the PMNs submitted for the chemical substances that are subject to these SNURs, EPA concluded that for 4 of the 23 chemical substances, regulation was warranted under TSCA section 5(e), pending the development of information sufficient to make reasoned evaluations of the health or environmental effects of the chemical substances. The basis for such findings is outlined in Unit IV. Based on these findings, TSCA section 5(e) consent orders requiring the use of appropriate exposure controls were negotiated with the PMN submitters. The SNUR provisions for these chemical substances are consistent with the provisions of the TSCA section 5(e) consent orders. These SNURs are promulgated pursuant to § 721.160.

In the other 19 cases, where the proposed uses are not regulated under a TSCA section 5(e) consent order, EPA determined that one or more of the criteria of concern established at § 721.170 were met, as discussed in Unit IV.

B. Objectives: EPA is issuing these SNURs for specific chemical substances which have undergone premanufacture review because the Agency wants to achieve the following objectives with regard to the significant new uses designated in this rule:
  • EPA will receive notice of any person’s intent to manufacture, import, or process a listed chemical substance for the described significant new use before that activity begins.
  • EPA will have an opportunity to review and evaluate data submitted in a SNUN before the notice submitter begins manufacturing, importing, or processing a listed chemical substance for the described significant new use.
  • EPA will be able to regulate prospective manufacturers, importers, or processors of a listed chemical substance before the described significant new use of that chemical substance occurs, provided that regulation is warranted pursuant to TSCA sections 5(e), 5(f), 6, or 7.
  • EPA will ensure that all manufacturers, importers, and processors of the same chemical substance that is subject to a TSCA section 5(e) consent order are subject to similar requirements.’

The substances included are:

PMN Number P–08–177

Chemical name: Multi-walled carbon nanotubes (generic).

CAS number: Not available.

Effective date of TSCA section 5(e) consent order: August 11, 2008. [...]

 

PMN Number P–08–328

Chemical name: Single-walled carbon nanotubes (generic).

CAS number: Not available.

Effective date of TSCA section 5(e) consent order: September 15, 2008. [...]

 

The Direct Final Procedures are described as follows:

‘EPA is issuing these SNURs as a direct final rule, as described in § 721.160(c)(3) and § 721.170(d)(4). In accordance with § 721.160(c)(3)(ii) and § 721.170(d)(4)(i)(B), this rule is effective August 24, 2009 without further notice, unless EPA receives written adverse or critical comments, or notice of intent to submit adverse or critical comments before July 24, 2009.

If EPA receives written adverse or critical comments, or notice of intent to submit adverse or critical comments, on one or more of these SNURs before July 24, 2009, EPA will withdraw the relevant sections of this direct final rule before its effective date. EPA will then issue a proposed SNUR for the chemical substance(s) on which adverse or critical comments were received, providing a 30–day period for public comment.'

 

Follow this link to download the full federal Register Notice.

 
Related Links:
On the 11th May, the US Environmental Protection Agency (EPA) published notice in its Regulatory Agenda, stating that ‘a TSCA section 4(a) test rule may be needed to determine the health effects of multiwall carbon nanotubes.’ (22nd May 2009)
 
Topical Briefings
This page provides members with reviews and exclusive information on topical issues.
17th November 2008
EPA Threatens Enforcement against Manufacturers of Carbon Nanotubes and Enacts Significant New Use Rules for Two Other Nanoparticles 
(20th November 2008)
 
EPA plans stricter manufacturing conditions and data-call in for nanomaterials
In October 2008, the US Environment Protection Agency (EPA) published a notice on the TSCA inventory status of carbon nanotubes and announced that, some time after 1st March 2009, ‘EPA anticipates focusing its compliance monitoring efforts to determine if companies are complying with TSCA section 5 requirements for carbon nanotubes.’ (21st February 2009)

US EPA publishes notice on TSCA inventory status of carbon nanotubes
The US Environmental Protection Agency (EPA) published in the Federal Register a notice entitled ‘Toxic Substances Control Act Inventory Status of Carbon Nanotubes’, giving notice of the Toxic Substances Control Act (TSCA) requirements potentially applicable to carbon nanotubes (CNTs). (31st October 2008)

US EPA publishes scientific evidence on carbon nanotube inhalation studies
BASF Corporation submitted to the US Environment Protection Agency (EPA) (under Section 8(e) of the Toxic Substances Control Act (TSCA)) results of ‘A Subchronic Inhalation Study in Wistar Rats with Carbon Nano Tube’. (31st October 2008)

 

Registration for EC Scientific Hearing on Risk Assessment of Nanomaterials now open

Released on Wednesday 24th June 2009

The European Commission (DG Health and Consumers) has opened the registration for the Scientific Hearing on Risk Assessment of Nanotechnologies (to be held in Brussels, on the 10 September 2009; Venue: Centre de Conference A. Borschette, Rue Froissart 36, 1040 Brussels).

According to the website, the main objectives of this Hearing are to identify:

  • any possible scientific topics which have not been covered in the opinions from the relevant EU Risk Assessment Committees and Bodies;
  • what are -according to current scientific knowledge- the main potential risks that could emerge from the use of nanomaterials in the future; and
  • provision of relevant background information and comments on those issues.

Follow these links to download a DRAFT Programme of the Hearing, or to register for the Hearing.

 
Related Links:
The European Commission has launched a Public Consultation to prepare for a one-day Scientific Hearing on Nanotechnology, which will take place on 10 September 2009 in Brussels. (20th April 2009)
 
The EC’s Scientific Committee on Emerging and Newly Identified Health Risks (SCENIHR) has published its opinion on the most recent developments in the risk assessment of nanomaterials. (18th February 2009)

 

Coalition of industries association provides ‘need to know’ documentation to UN discussion on nanomaterials

Released on Saturday 20th June 2009

A coalition of industries association, orchestrated by the Nanotechnology Industries Association (NIA), representing nanotechnology producers and users, and CEFIC, representing the European chemical industry, and including Eurometaux, representing the non-ferrous metals industry, and the American Chemistry Council, representing the North American chemical industry, has provided a background paper of comments on the paper entitled ‘Ongoing work on the safety of nanomaterials’ (transmitted by the experts from France) as part of the United Nations Sub-Committee of Experts on the Globally Harmonized System of Classification and Labeling of Chemicals. 

The background paper was not officially submitted to the Committee meeting, but provided as ‘need to know’ material, in case of a detailed discussion of the French paper.

Registered NIA Members can download the full Comments on the paper ‘Ongoing work on the safety of nanomaterials’  (CEFIC/NIA/Eurometaux/ACC) from the ‘Members only’-area on the NIA website, by following the link to ‘Restricted Documents and Publications’.

 
Related Links:
From the 29th June to the 1st July 2009, the 17th session of the United Nations Committee of Experts on the Transport of Dangerous Goods and on the Globally Harmonized System of Classification and Labelling of Substances (Sub-Committee of Experts on the Globally Harmonized System of Classification and Labelling of Chemicals) will discuss a paper entitled ‘Ongoing work on the safety of nanomaterials’ (submitted by the expert from France). (8th May 2009)

 

‘Nano or not nano’ – no silver for Friends of the Earth

Released on Thursday 11th June 2009

In a joint report entitled ‘Nano & Biocidal Silver’, Friends of the Earth Australia and Friends of the Earth Unites States ‘calls for a immediate moratorium on the commercial release of products that contain manufactured nanosilver until nanotechnology-specific regulation is introduced to protect the public, workers and the environment from their risks, and until the public is involved in decision making.’

The authors of the report point out that ‘undoubtedly silver and nanosilver have useful applications in the medical arena (for instance as coatings for medical devices or as wound care for severe burns victims), [...]’.

The report claims to highlight many examples of the application of silver as a ‘bulk material’, as ‘nanosilver’, and in the form of soluble silver compounds, but the distinction between these is not always clear. Nevertheless, Friends of the Earth conclude with a nano-specific call upon governments to:

  • Establish comprehensive and precautionary legislation to manage the risks associated with nanotechnology in general and nanosilver technology in particular.
  • All nanomaterials must be subject to new safety assessments as new substances, even where the properties of larger scale counterparts are well-known.

Follow these links to read the press release accompanying the launch of the report, or to download the full report.

 
Related Links:
Following a mandatory data call-in on carbon nanotubes, and the expression of a similar interest in ‘reactive metal oxides’,  the California Department of Toxic Substances Control (DTSC/Department) has now updated its website with an announcement that the following materials have been added ‘to the list of nanomaterials of interest: [...]. (6th June 2009)
 
The Nanotechnology Industries Association (NIA) has submitted Comments to the US Environmental Protection Agency (EPA) on the ‘Petition for Rulemaking Requesting EPA Regulate Nanoscale Silver Products as Pesticides’. (20th March 2009)
 
In just one day, the Los Angeles Times dedicated three articles to the debate on the use on nanosilver as an antibacterial. (4th August 2008)
 
The US Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) has published a statement clarifying its competence to regulate products containing nanoscale materials, and its ongoing activities to do so. (22nd July 2008)
 
A coalition of consumer protection, health and environmental groups, led by the Washington-based International Center for Technology Assessment (CTA), filed a legal petition with the US Environmental Protection Agency (EPA), demanding the agency to halt the sale of consumer products containing silver nanoparticles. (1st May 2008)

 

EPA exempts silver residues from food contact materials from the requirement of a tolerance

Released on Thursday 11th June 2009

On the 10th June 2009, the US Environment Protection Agency (EPA) issued a Final Rule entitled ‘Residues of Silver in Foods from Food Contact Surface Sanitizing Solutions; Exemption from the Requirement of a Tolerance’. According to Notice in the Federal Register (10th June 2009), the ‘regulation amends the exemption from the requirement of a tolerance for residues of silver (excludes silver salts) in or on all foods when applied or used in public eating places, dairy processing equipment, and foodprocessing equipment. [...] The regulation being established will exempt all foods from the requirement of a tolerance for residues of silver resulting from contact with surfaces treated with solutions in which the end-use concentration of silver is not to exceed 50 parts per million (ppm).’

‘This revised tolerance expression excludes any other silver-containing compounds whether they are other silver salts, complexes with inorganic polymers such as zeolites, or metallic silver in any form or dimension including nanoscale.’

Follow these links read the full Federal Register Notice, or to find out more about the EPA Rule.

 

Registered NIA Members can download a legal briefing on this EPA Rule (kindly provided by Bergeson & Campbell, P.C.), by accessing the ‘Members only’-area on the NIA website and following the link to ‘Topical Briefings’.
 
Related Links:
In a joint report entitled ‘Nano & Biocidal Silver’, Friends of the Earth Australia and Friends of the Earth Unites States ‘calls for a immediate moratorium on the commercial release of products that contain manufactured nanosilver until nanotechnology-specific regulation is introduced to protect the public, workers and the environment from their risks, and until the public is involved in decision making.’ (11th June 2009)
 
Following a mandatory data call-in on carbon nanotubes, and the expression of a similar interest in ‘reactive metal oxides’,  the California Department of Toxic Substances Control (DTSC/Department) has now updated its website with an announcement that the following materials have been added ‘to the list of nanomaterials of interest: [...]. (6th June 2009)
 
The Nanotechnology Industries Association (NIA) has submitted Comments to the US Environmental Protection Agency (EPA) on the ‘Petition for Rulemaking Requesting EPA Regulate Nanoscale Silver Products as Pesticides’. (20th March 2009)
 
In just one day, the Los Angeles Times dedicated three articles to the debate on the use on nanosilver as an antibacterial. (4th August 2008)
 
The US Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) has published a statement clarifying its competence to regulate products containing nanoscale materials, and its ongoing activities to do so. (22nd July 2008)
 
A coalition of consumer protection, health and environmental groups, led by the Washington-based International Center for Technology Assessment (CTA), filed a legal petition with the US Environmental Protection Agency (EPA), demanding the agency to halt the sale of consumer products containing silver nanoparticles. (1st May 2008)

 

Nanotechnology highlighted as priority area for EU-Malaysia cooperation

Released on Wednesday 10th June 2009

European Commission Director of International Cooperation in Science and Technology Mary Minch, has called for a full utilisation of the EU New Framework Programme 7. Explaining that the new Framework Programme 7 -- from 2007-2013-- had a total budget of 54 billion Euros, she noted that it was aimed at boosting innovation and research capacity, and that it would, at the same time, enhance EU cooperation with Malaysia.  

According to an interview with Bernama.com, Minch said that there were already five projects being undertaken with Malaysia, and that she expected that others would be selected in the near future.

During a 2-day workshop with over 60 Malaysian research institutes at the Putrajaya International Convention Centre, ‘participants had an opportunity to learn about the Framework Programme, European policy and EU aspirations in cooperating with Malaysia.’

Minch, who also participated in a number of bilateral meetings with the Malaysian Ministry of Science, Technology and Innovation (MOSTI), said ‘a number of fields, like climate change including technology transfer, carbon capture and storage, bio fuels and renewable energy, nanotechnology and ICT were highlighted as priority areas for EU-Malaysia cooperation.’

Follow this link to read the full interview.

 
Related Links:
The OECD Working Party on Manufactured Nanomaterials (ENV) and OECD Working Party on Nanotechnology (STI) jointly present an OECD Conference on Potential Environmental Benefits of Nanotechnology: Fostering Safe Innovation-Led Growth.  (29th May 2009)
 
According to the latest ‘State of the Market’ Report, published by Lux Research, intermediate nanotechnology-enabled promise the biggest return on investment. According to an accompanying press release, ‘Lux Research used its value chain framework to measure and forecast adoption across four major industry sectors – manufacturing and materials, electronics and IT, healthcare and life sciences, and energy and environment – from 2004 to 2015.’  (22nd January 2009) 
 
The European Commission has published an FP7 call entitled ‘Energy Second Generation Biofuels - EU Brazil Coordinated Call’. (6th January 2009) 

 

‘Nanotechnology can make a world of difference in virtually every facet of wind and solar energy generation’

Released on Wednesday 10th June 2009

An IndustryWeekly.com editorial, entitled Taking the NanoPulse -- Put Some Energy Into It’, revisits the debate around the cost-effectiveness and reliability of renewable energies and finds that opinions seem to be shifting at the speed of wind and sunlight. People are looking in new directions and at new technologies for solutions. At the top of the list: nanotechnology.’

‘For alternative energy,’ he concludes, ‘there's no alternative to nanotechnology.’

In support of this statement, Rickert highlights a few of the many examples in which nanotechnologies already help to make renewable energies reliable and viable:

  • nanomaterials for light absorption: [...]  By using quantum dots, nanoparticles, nanodots and nanocrystals, the achievable efficiency could climb to 60%.
  • environment for solar generation: [...] New self-cleaning and dirt-repelling nano-coatings keep the sun shining through. Others increase the life expectancy of a system with a layer of protection that prevents the micro-scratches and gouges that come from windblown dirt pounding the surface glass day after day.
  • wind energy generation: [...] ice-phobic nanocoatings is enabling a surface that impedes ice formation and actually helps shed ice.

Follow this link to read the full editorial on IndustryWeekly.com.

 
Related Links:
European Commission Director of International Cooperation in Science and Technology Mary Minch, has called for a full utilisation of the EU New Framework Programme 7. Explaining that the new Framework Programme 7 -- from 2007-2013-- had a total budget of 54 billion Euros, she noted that it was aimed at boosting innovation and research capacity, and that it would, at the same time, enhance EU cooperation with Malaysia. (10th June 2009)
 
The OECD Working Party on Manufactured Nanomaterials (ENV) and OECD Working Party on Nanotechnology (STI) jointly present an OECD Conference on Potential Environmental Benefits of Nanotechnology: Fostering Safe Innovation-Led Growth.  (29th May 2009)
 
The European Commission has published an FP7 call entitled ‘Energy Second Generation Biofuels - EU Brazil Coordinated Call’. (6th January 2009)