NIA - Nanotechnology Industries Association

*** Please respond by COP (CEST) on Friday, 10^th September 2010***

Registered NIA Members are invited to provide suggestions for changes/additions/omissions to the DRAFT NIA Comments on SCENIHR opinion on 'Scientific Basis for a Definition of the Term "Nanomaterial" ', which can be downloaded from the secure ‘Members only’-area of the NIA website (see ‘NIA Tasks & Drafts’ or 'NIA Task Forces & Drafting Groups'). Please use ‘track changes’, and return the document to steffi.friedrichs@nanotechia.org no later than COP (CEST) on Friday, 10^th September 2010.

NOTE: The final submission needs to be conducted via a (somewhat rigid) online portal, which limits the submitted information to (a) specific multiple choice entries and (b) additional comments (no longer than 4000 characters per comment). In order to facilitate the NIA-intern consensus process, we have created a WORD DOC version of the Online Consultation Response Form, reproducing quotes from the SCENIHR Opinion (i.e. in italics) and suggesting corresponding NIA comments (given in each section below the reproduced SCENIHR Opinion quote). The NIA-intern consensus process will be finalised in this WORD document, and final Comments will be copied into the Online ‘Consultation Response Form’ and submitted as a response on behalf of the organisation Nanotechnology Industries Association before the applicable deadline on the 15^th September 2010. (Due to the limitation of 4000 characters for each comment, the text format might need to be changed slightly.)

IMPORTANT:
The final Consultation Form Section is entitled ‘Additional Comments’; we would like to use this section to formulate ‘NIA Opinion on ‘Criteria for the Development of a Definition of the Term ‘Nanomaterial’’. Even if you don’t plan on commenting on the SCENIHR Opinion, please provide input to the development of this NIA Opinion.

Registered NIA Members can download the DRAFT NIA Comments and supporting attachments from the 'Members only'-area on the NIA website by following the link to 'NIA Tasks & Drafts’ or 'NIA Task Forces & Drafting Groups'. 

Follow these links to download the full SCENIHR Opinion on ‘Scientific Basis for a Definition of the Term "Nanomaterial",’ or to find out more about the Public Consultation on the SCENIHR Opinion.

Registered NIA 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.

Background:
Recent legislative proposals to overhaul the US Toxic Substances Control Act (TSCA) aim to greatly increase the level of regulatory scrutiny of nanomaterials. The legislation would authorize EPA to regard all nanomaterials as new chemicals or as having new uses, subject to requirements for notification and review by EPA in advance of manufacture or use. This change is targeted particularly at nanoscale versions of bulk materials already on the TSCA inventory, such as nanoscale titanium dioxide. Further, manufacturers and processors would have to report to EPA about the ‘special substance characteristics’ of chemicals that may affect risk, another provision specifically targeting nanomaterials.

The ‘Safe Chemicals Act of 2010’ (SCA) bill in the Senate, S. 3209, and the discussion draft for the ‘Toxic Chemicals Safety Act of 2010’ in the House of Representatives, both released on April 15, 2010, would make extensive changes to the industrial chemicals management framework in the United States. Part of the impetus for these proposals was the idea, presented at several earlier Congressional hearings, that the current TSCA framework should be modified specifically to better address emerging technologies, particularly nanotechnology. The legislation therefore proposes to allow EPA to deem all nanomaterials to be new chemicals or as having new uses, requiring submission of information before manufacture, import, or processing. Ironically, EPA already plans to require similar information from manufacturers, importers, and processors of nanomaterials whose bulk counterparts are on the TSCA Inventory through a significant new use rule, scheduled to be proposed later in 2010.

This alert highlights and provides background on some of the changes these legislative and agency proposals would present for manufacturers and processors of nanomaterials.

Soundbites:

• Briefly, under the legislation, chemical manufacturers (including importers) and processors would, for the first time, be responsible for submitting a minimum data set for all chemicals in commerce and for establishing that their chemicals meet a safety standard of ‘reasonable certainty of no harm’.
• Manufacturers and processors would also be required to submit, within a year of enactment, a ‘declaration of current manufacture or processing,’ which would include [...]

We are grateful to the Nanotechnology Team at Beveridge & Diamond P.C. for sharing this alert with NIA Members.

Registered NIA Members can download the full Beveridge & Diamond Alert from the 'Members only'-area on the NIA website by following the link to 'Topical Briefings'.

This page provides members with a frequent update on the latest topical issues, not available in the public domain. For more information on the issues discussed in these updates, contact steffi.friedrichs@nanotechia.org.

• Information on technical Preparation of IUCLID Dossiers for Nanomaterials
• US California: UCSF report ‘on hold’ - UCLA report eagerly awaited

This page provides members with a frequent update on the latest topical issues, not available in the public domain. For more information on the issues discussed in these updates, contact steffi.friedrichs@nanotechia.org.

30^th May 2010:
NIA Weekly Update - 22/2010 (30^th May 2010) 
in this issue:

• 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’

Registered NIA Members can download the full NIA Weekly Update from the 'Members only'-area on the NIA website by following the link to 'NIA Weekly'.

*** DEADLINE: 12:00 noon CETon Wednesday, 5th May 2010 ***

 DRAFT NIA Comments on

'DRAFT Report (compiled by the University of California at San Francisco’s (UCSF) Program on Reproductive Health): A NANOTECHNOLOGY POLICY FRAMEWORK FOR CALIFORNIA: POLICY RECOMMENDATIONS FOR ADDRESSING POTENTIAL HEALTH RISKS FROM NANOMATERIALS'

Registered NIA members can download the document from the 'Members only'-area (see 'NIA Tasks & Drafts'), note suggestions for changes and/or additions in track changes, and return the document to steffi.friedrichs@nanotechia.org no later than 12:00 noon CET (Central European Time) on Wednesday, 5th May 2010.

Registered NIA 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.

Topical Briefings:
This page provides members with reviews and exclusive information on topical issues,  made available by the NIA and/or third parties for use by NIA Members only.

2^nd May 2010
US Pesticide Program Dialogue Committee discusses Nanotechnology and Pesticides
(Arlington, Virginia (US), 29^th – 30^th April 2010)

Background:
At the U.S. Environmental Protection Agency's (EPA) Pesticide Program Dialogue Committee (PPDC) meeting [held on the 29^th and 30^th April 2010], William Jordan, Senior Policy Advisor, Office of Pesticide Programs (OPP), presented slides regarding nanotechnology and pesticides. Jordan briefly described how OPP is defining nanoscale materials and how the technology is being applied to the field of pesticides. His presentation described OPP's recent consultation with EPA's Scientific Advisory Panel (SAP) concerning nanosilver and other nanometal pesticide products, as well as other ongoing regulatory activity and future actions OPP intends to take. The background materials from the meeting are available online, and the slides are available online.

Soundbites:
OPP's working definition of nanomaterial is:

• An ingredient that contains particles that have been intentionally produced to have at least one dimension that measures between approximately 1 and 100 nanometers.

Jordan also announced that OPP intends to respond in June 2010 to the International Center for Technology Assessment's (ICTA) May 2008 petition. [...]. 

Registered NIA Members can download the full Bergeson&Campbell P.C. Topical Briefing from the Members only’-area on the NIA website by following the link to 'Topical Briefings'.

Related Links:
‘Inconsistent nanosilver petition should be denied’ – NIA submits comments to EPA
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)

We congratulate the following nanotechnology experts on their election to the NIA Board of Directors.

NIA Board of Directors 2010/2011 - 2011/2012:

• Robert Muir (Naneum ltd; UK; SME)
• Hera Lichtenbeld (DSM NovioNano; The Netherlands; SME)
• François Monnet (Solvay SA; Belgium; multinational)
• Richard Pleus (Intertox Inc.; US; SME)
• * Rüdiger Iden (BASF ; Germany ; multinational)
• * Francis Quinn (L’Oreal; France; multinational)
• * Benjamin Gannon (Johnson&Johnson; US ; multinational) (for 2010/2011 only)

(* Members of the NIA Board of Directors 2008/2009 - 2009/2010) 

The elected Board is a perfect reflection of the NIA’s growing membership in terms of both geographical spread and market representation.

This page provides members with a frequent update on the latest topical issues, not available in the public domain. For more information on the issues discussed in these updates, contact steffi.friedrichs@nanotechia.org.

Registered NIA 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.

Meeting Reports (by the NIA Delegate)
The following Meeting Reports have been written by NIA delegates; these Meeting Reports are intended for the use by registered NIA Members only. 

27^th April 2010
Standardization: CEN/TC352/WG2/PG1: Guide to labelling of manufactured nanoparticles and products
(Brussels, 30^th March 2010)

Synopsys:
Since the last meeting in Paris, the draft report had undergone considerable changes and was circulated for comments from the project group. These comments were then taken into consideration and a revised draft was developed which was subject to the meetings discussion. [...]

Soundbites:

• There were concerns that being a TS, the document may become mandatory rather than voluntarily. [...]
• There was also a discussion with regards to global relevance policy. There was a suggestion that maybe the document should be changed [...]
• The term nano-enabled effect was to be replaced with nanoscale phenomena [...]

Registered NIA Members can download the full Standardization CEN/TC352/WG2/PG1 from the'Members only'-area on the NIA website by following the link to 'Meeting Reports'. 

Registered NIA 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.

Restricted Documents & Publications
This page allows access to selected documents and publications, made available by the NIA and/or third parties for use by NIA Members only.

20^th April 2010
Nanomaterials under REACH: Legal Aspects 
(kindly provided by the Nanotechnology-Team at MayerBrown, published in the newly launched European Journal for Risk Regulation (Issues 1/2010; April 2010))

Sneak Preview:
At the time that REACH was being drawn up, the issue of nanomaterials was only in its infancy, so no specific provisions were adopted in the REACH Regulation to address them.

While everyone recognises the important industrial and competitiveness potential of nanomaterials, the uncertainties over their potential impact on human health and the environment are also highlighted, triggering calls for a review and possible adaptations to the regulatory system in place. With respect to REACH, the Commission has started to consider possible legislative changes; however, these are likely to take several years to materialise.

In the meantime, some Member States are considering initiatives to impose national rules, including reporting schemes and labelling requirements. The legality of these measures is questionable, however, considering that REACH today applies to nanomaterials, as also to any other chemical substance and that the REACH Regulation is regarded as totally harmonising the market access conditions for chemical substances in the EU.

Our article summarises the current regulatory status of nanomaterials under REACH and specifies the legal framework under which the legality of national initiatives contemplated by the Member States to regulate nanomaterials must be reviewed.

Registered NIA Members can download the full REACH Article from the'Members only'-area on the NIA website by following the link to 'Restricted Docs & Pubs’.