NIA - Nanotechnology Industries Association

Registered members can now download the following exclusive documents (i.e. Meeting Presentations, Meeting Notes, etc.), recently uploaded onto the secure ‘Members-only’ area of the NIA website (access the ‘Members only’-area here).

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 

The Environmental Protection Agency (EPA) recently published two Federal Register notices concerning the regulation of nanomaterials under the Toxic Substances Control Act (TSCA), 15 U.S.C. §§ 2601-2692.

In the first notice, EPA clarified the TSCA Inventory status of carbon nanotubes (CNTs), explaining to manufacturers and importers that many CNTs may be “new” chemicals under TSCA subject to the premanufacture notice (PMN) requirements. This first notice warns that the agency may soon begin to initiate enforcement actions against persons in violation of the PMN provisions.

In the second notice, EPA enacted significant new use rules (SNURs) for two different siloxane-modified nanoparticles, representing the agency’s first nanotechnology-specific regulations and potentially signaling more aggressive regulation of nanomaterials in the future.

Registered NIA Members can download additional legal comment and background information on both EPA publications.
(we are grateful to the nanotech team at Beveridge&Diamond P.C. for providing this briefing to NIA Members)

Restricted Documents & Publications

This page allows access to selected documents and publications, made available by third parties for use by NIA Members only.

19th November 2008

NIA: No support for mandatory reporting of manufactured nanomaterials

5th November 2008 

The UK consumers association WHICH? published a report entitled ‘Small wonder? Nanotechnology and cosmetics’. The report is based on the findings of a survey of 67 cosmetics companies, which asked the companies about their use of nanotechnology, what benefits they thought it brought and how they ensured product safety.

The US Environmental Protection Agency published a Notice of Availability in the Federal Register, making available for public review and comments a petition for rulemaking and collateral relief, filed by the International Center for Technology Assessment (ICTA) and others.

The notice entitled ‘Petition for Rulemaking Requesting EPA Regulate Nanoscale Silver Products as Pesticides’ states that, ‘in general, the petition requests that the Agency classify nanoscale silver as a pesticide, require formal pesticideregistration of all products containing nanoscale silver, analyze the potential human health and environmental risks of nanoscale silver, take regulatory actions under the Federal Insecticide,Fungicide, and Rodenticide Act (FIFRA) against existing products that contain nanoscale silver, and take other regulatory actions under FIFRA as appropriate for nanoscale silver products. The Agency has determined that the petition raises issues that potentially affect private and public sector stakeholders. Through this notice, EPA is asking for public comment on the petition.’

The UK Royal Commission on Environmental Pollution (RCEP) has launched a report entitled ‘Novel Materials in the Environment: The case of nanotechnology’ (follow this link for the summary of the RCEP report). The Commission explains that the underlying study was originally described to examines issues related ‘novel materials’, but that, the evidence received by the Commission was almost entirely focused on manufactured nanomaterials.

• The validation of in vitro tests against in vivo models.
• Evaluation of methodologies for predicting the likely fate and effects of nanomaterials based on their physical and chemical properties as well as their novel properties, and where possible, the development of exposure scenarios.
• Based on the significant gap in our knowledge, the programme of directed research should ensure a concerted and co-ordinated effort to understand better the principles that determine toxicity of manufactured nanomaterials and how individual properties interact to enhance or diminish toxicity profiles both in vitro and in vivo with a long-term objective of developing predictive toxicology.
• The enhancement of in situ monitoring and surveillance methods to provide early warnings of unexpected effects of nanomaterials and to permit timely remedial action.
• The research programme should pave the way for much greater interdisciplinary co-operation, including co-operation between those engaged in medical toxicology and those in ecotoxicology, […].

• In any revisions to existing regulations, the relevant authorities should focusspecifically on the properties and functionalities of nanomaterials, rather thansize. Since these properties and functionalities will often differ substantially fromthose of the bulk material, strict chemical equivalence does not preclude theneed for a separate risk assessment.
• The UK Government should press the European Commission to proceed withurgency, in consultation with Member States, the European Chemicals Agencyand the Scientific Committee on Emerging and Newly Identified Health Risks(SCENIHR), to review REACH and the product- or sector-specific regulations.
• The object of this review should be to amend the regulations to facilitate their effective application to nanomaterials and the provision of adequate testing arrangements.
• Clear priorities for testing, beginning with those nanoparticles with functionality which suggests that they might pose the greatest risk of harm to the environment or human health should be established.
• As REACH is adapted to meet the challenges presented by nanomaterials, particular attention should be given to the issue of weight thresholds. In view of the persistent uncertainties involved, a precautionary approach should be adopted when determining new, lower thresholds for nanomaterials.
• Responsible organisations should set up structured systems to keep a watching brief on the development of novel materials and to enhance the sharing of information and the opportunities to work together to identify and manage emerging problems.
• The idea of a simple checklist as part of an early warning system should be developed and defined further by the Government to investigate the potential for development amongst the wider materials community.
• Experience suggests that checklist reporting will need to be compulsory if it is to be effective. The Department for Environment, Food and Rural Affairs (Defra) should make nanomaterials reporting mandatory.
• The Government should impose an additional legal duty on companies to report at the earliest opportunity to the competent authorities any reasonable suspicion that a material presents a risk to people or the environment. Compliance with this requirement should offer duty holders a degree of immunity from criminal liability, should problems associated with the nanomaterials arise in future.
• Environmental monitoring to detect manufactured nanoparticles should be the responsibility of the Environment Agency in England and Wales, the Scottish Environment Protection Agency (SEPA) and the Northern Ireland Environment Agency to ensure that robust processes are used.
• Government should move beyond one-off public engagement ‘projects’ to recognise the importance of continual ‘social intelligence’ gathering and the provision of ongoing opportunities for public and expert reflection and debate.
• We see these functions as crucial if, as a society, we are to proceed to develop new technologies in the face of many unknowns.

During the course of the study, the Nanotechnology Industries Association (NIA) and its member companies contributed to the evidence gathering process in a number of ways, including a presentation delivered at the launch event, a written response to a questionnaire circulated by the RCEP, initiation of a meeting between the RCEP review panel assigned to the study and industry representatives, as well as invited visits of the RCEP panel representatives to NIA member companies.

Follow these links to find out more about the RCEP’s work on nanomaterials, to download the complete RCEP Report, to download the RCEP Report summary, or to read the full press release.

Registered members can now download the following exclusive documents (i.e. Meeting Presentations, Meeting Notes, etc.), recently uploaded onto the secure ‘Members-only’ area of the NIA website. (access the ‘Members only’-area here)

NIA Press Briefings, FAQs & Positions

The following Press Briefings, FAQs and Positions have been prepared by NIA expert Task Forces, in order to brief the NIA Membership on the NIA's agreed position (for example: in preparation of upcoming media releases).

7th November 2008

NIA recommends Clarification or Retraction of Insurance Exclusion 

In a letter to the Iowa Insurance Commissioner,* the Nanotechnology Industries Association recommended that the Continental Western Group (CWG) clarified or retracted the proposed endorsement, recently submitted to the state insurance commissioners. The proposed endorsement would exclude coverage under specified insurance policies for various claims involving nanotubes and nanotechnology.

For more information, follow these links to download a screen-print of the original website entry, the original Notice to Policy Holders, and the Endorsement ‘Nanotubes and Nanotechnology Exclusion’. [...]

NIA Meeting & Workshop Documents

This page contains the documentation for future NIA Meetings and Workshops, as well as minutes and reports of previous NIA Meetings and Workshops.

Past NIA Events

'Celebrating Nanotechnology - 3 Years NIA' (held on the 23rd October 2008)

FINAL Meeting of the DTI-funded NIA Project. This members meeting and workshop will concluded the 3-year project Nanotechnology Industries Association, funded by the DTI since January 2006, and celebrated the successful conduct of the 3-year NIA project (still globally the only industry-focused nanotechnology representation).

NIA Masterclass & Workshop: Measurement and Characterisation on the Nanoscale

Follow these links to download the Workshop Agenda, or a full set of the speaker's presentation slides (as PDFs):

• 3 Years NIA (Mike Pitkethly, Barry Park, and Steffi Friedrichs)
• Nanotechnology in the UK – a UK Government Perspective (Sue Bolton, DIUS)
• Nanotechnology @ BERR (Brian Greenwood, BERR)
• Nanotechnology @ the Technology Strategy Board (Peter Flinn)
• The Responsible Nano Forum (Hilary Sutcliffe)

Meeting Reports (from the NIA delegate)

This page contains exclusive meeting/conference/workshop reports written by attending representatives of the NIA.

9th October 2008: 
New & Emerging Technologies in Medical Devices (NET MD)
Working Group Meeting
(held at: EC, Breydel Building, Room 12A, 9th October 2008, 10:00 – 17:00)

Earlier this year, the New & Emerging Technologies in Medical Devices (NET MD) Working Group received a new mandate from the European Commission. [...]

Soundbites from the meeting:

The NET MD Chair had received many questions on this paragraph: ‘How does this fall in line with the report that the current legislative framework is appropriate’; comments: [...]

APPENDED Documents:
ANNEX A0: NIA Meeting Note
ANNEX A1: Draft Agenda
ANNEX A2: NET WG Report on Nanotechnology to the Medical Device Expter Group - Findings and Recommendations (July 2007)
ANNEX A3: Draft MEDDEV Nanotechnology (September 2008)
ANNEX A4: NET MD Special Interest Groups (result of NET MD Meeting, 10th April 2008)

The US Environmental Protection Agency (EPA) published in the Federal Register a notice entitled ‘Significant New Use Rules on Certain Chemical Substances’ for 56 chemical substances, including the following manufactured nanomaterials:

• Siloxane modified silica nanoparticles (generic)
• Siloxane modified alumina nanoparticles (generic)

In both cases, the EPA quotes the following ‘significant new uses’:

• use without impervious gloves or a NIOSH-approved respirator with an APF of at least 10;
• the manufacture, process, or use of the nanoparticle as a powder;
• or uses of the nanoparticle that are ‘different’ than the uses described in the PMN that the original manufacture submitted to EPA in order to receive permission to manufacture the chemical when it was still considered a ‘new’ chemical.

The UK consumers association WHICH? published a report entitled ‘Small wonder? Nanotechnology and cosmetics’. The report is based on the findings of a survey of 67 cosmetics companies, which asked the companies about their use of nanotechnology, what benefits they thought it brought and how they ensured product safety.

• the Government should require companies to report their use of manufactured nano materials
• potentially unsafe products should be removed from sale (ie. effectively enforce the current Cosmetics Directive)
• an independent expert group should be established to advise the Government on the risks and benefits of nano sunscreens
• the new EU Cosmetics Regulation should include a positive list of manufactured nano materials that are permitted to be used in cosmetic products based on an independent safety assessment
• clear information should be provided to consumers about the use of nano materials in cosmetic products, as well as nanotechnology more broadly.

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).

EPA clarifies that it ‘generally considers CNTs to be chemical substances distinct from graphite or other allotropes of carbon listed on the TSCA Inventory. Many CNTs may therefore be new chemicals under TSCA section 5. Manufacturers or importers of CNTs not on the TSCA Inventory must submit a premanufacture notice (PMN) (or applicable exemption) under TSCA section 5 […]. In order to determine the TSCA Inventory status of a CNT, a manufacturer may submit to EPA a bona fide intent to manufacture or import […].’

The US Consumers Union petitioned the US Food and Drug Administration to ‘require a full safety assessment on the use of engineered nanoparticles particularly in cosmetics, sunscreens and sunblocks, and to investigate possible enforcement action to ensure accurate labeling as to the presence or absence of nanoparticles.’

According to the Consumers Union, the petition is based on new findings published in the latest edition of the Consumer Reports.

• to require manufacturers to disclose the presence of nanoparticles on the label of any cosmetic or over-the-counter drug product that contain such particles, and to immediately investigate misstatements by manufacturers to Consumer Reports about absence of these nanoparticles in sunscreen products.
• FDA to investigate whether the failure to disclose the presence of nanoparticles renders these sunscreen products misbranded, within the meaning of Section 201(n) of the Federal Food, Drug, and Cosmetic Act, codified at 21 U.S.C. § 321(n), in violation of 21 U.S.C. § 332(b).

The German nanotechnology initiative ForumNano published the meeting report of its 1^st Frankfurt NanoDialogue, held on the 17^th June 2008.

Follow these links to find out more about ForumNano, or to download the full meeting report (in German).

Following the publication of its ‘Draft Opinion of the Scientific Committee on the Potential Risks Arising from Nanoscience and Nanotechnologies on Food and Feed Safety’, the European Food and Safety Authority (EFSA) today launched a public consultation on this draft scientific opinion.

• [the Authority] looks at the scientific evidence and data relevant to its specifc risk assessment remit. Important and relevant feedback will be any further evidence or data that EFSA may not have been able to access that should be considered in the final opinion. Views on wider issues, for example ethical or other societal issues, are not part of EFSA’s remit.
• [the authority] will assess all relevant comments from interested parties which are submitted in line with the criteria above. The comments will be further considered by the EFSA Scientific Committee and taken into consideration where these will enhance the scientific quality or understanding of the document. Following this exercise EFSA will publish the relevant comments received, as well as a short report on the outcome of the consultation. [...]
• If interested parties wish to contribute scientific studies or data to support a particular comment, these should be preferably have been published or accepted for publication and clear reference to where the supporting information is found should be made.