Following the Belgian Presidency's proposal for a mandatory register of nanomaterials, as well as a (paper-)traceability mechanism to trace nanomaterials back to their source, and the overwhelming resonance this proposal struck amongst other European Member States, it's clear that these national regulations will go forward and that the worse-case scenario will be for industries to be faced with nanomaterial-specific regulations in at least half a dozen (but potentially many more) European Member States (not to forget the recently proposed regulation in the US ((EPA & FDA), US California, Australia, Canada, etc.).
These developments call for immediate (pro)action by the Nanotechnology Industries in working with the regulators on the best possible outcome to take these regulatory developments forward.
The Nanotechnology Industries Association (NIA) continues to support voluntary reporting (and has done so since the heydays of the UK's Voluntary Reporting Scheme) to the extent of being proactively engaged in enabling large and small nanotechnology companies to
- gather existing data in a regulatory relevant format (in collaboration with the regulators), and
- conduct measurements and testing on nanomaterials, in order to obtain nano-specific information, as currently prescribed by the OECD.
However, the voices that doubt the reliability of voluntary initiatives (even over some governments' positive reviews of the data obtained and the economic reality reflected by that data now have the upper hand in the debate, and the regulators are now moving forward with rulemaking on nanomaterials.
The Silver Lining:
Most stakeholders, regulatory review projects and individual governments (cf. Italian and Dutch presentation at the Belgian Presidency Meeting) that are now calling for nano-specific reporting, and that are moving forward in implementing their own national (regulatory) initiatives in this, are engaged in the OECD Working Party on Manufactured Nanomaterials (WPMN) and advocate the findings and recommendations of the OECD WPMN as the internationally agreed action on nano-specific policies.
- Since commencing its work in November 2004, the OECD Working Party on Manufactured Nanomaterials (OECD WPMN) has, amongst other things, agreed a long-list of 59 endpoints (incl. physicochemical characterisation, eco-toxicology, mammalian toxicology), that are to be addressed for nanomaterials (cf. publication Number 25 of the OECD Publications Series on the Safety of Manufactured Nanomaterials).
- At the beginning of 2009, the OECD WPMN concluded that 'many of the OECD Test Guidelines are applicable, with conditions in some cases, while some are inadequate for testing Manufactured Nanomaterials (MN) as measuring, dosing, delivery and tracking nanomaterials are not reliably accomplished at this stage.' (cf. publication Number 15 of the OECD Publications Series on the Safety of Manufactured Nanomaterials).
The necessary Action by the Nanotechnology Industries:
Through the NIA, the nanotechnology industries are uniquely positioned to be working with the regulators on the best possible outcome to take these regulatory developments forward; such collaboration is based on:
- harmonisation of the regulatory initiatives going forward, and
- consideration and use of the information that is already available (i.e. existing information as well as newly generated information), and
- support and advancement of agreed testing strategies, such as the OECD Sponsorship Programme, and
- forstering Mutual Acceptance of Data (MAD) through - amongst other things - the storage of data in databases based on OECD Harmonised Templates (OECD HTs), and
- protection of confidential business information.
The NIA's unique Role and Position:
The NIA has initiated and is now coordinating the majority of nanomaterial- and data-contribution to the OECD Sponsorship Programme, as well as other regulatory relevant projects (download an update on the NIA (Pro)Activities within the OECD Sponsorship Programme); specifically, we provide:
- direct representation of (currently) 14 companies to the OECD Sponsorship Programme (i.e. contributions of (a) funding for nanomaterials testing, (b) reference nanomaterials, (c) data, recorded and reported in regulatory relevant formats), and
- provision of 12 nanomaterials to the European Reference Nanomaterials Repository, and
- data to the OECD Sponsorship Programme (incl. gathering of existing and new data, uploading of data into a (potentially regulatory-relevant) online database (i.e. based on IUCLID, MAD, and OECD HTs), and
- training on database use, and
- real-world Industrial Case-Studies to the current REACH Implementation Plans (RIP-oNs 2&3) (i.e. on behalf of seven companies within the nanotechnology industries, we have provided 13 Exposure Scenario Case-Studies with measurement value and modelled estimates to the RIP-oN project, in order to inform the experts of potential needs for changed of the guidance manual to REACH); the nanomaterials considered in this exercise are all amongst the 'Reference Nanomaterials' of the OECD Sponsorship Programme (stored at the Reference Nanomaterials Repository), thus combining a unique dataset on both hazard profiles and exposure scenarios for these nanomaterials in the regulatorily-relevant database.
The NIA has thus proactively and entirely voluntarily on behalf of its member companies already made available the largest single collection of nano-specific data that (from a scientific viewpoint) is understood to be relevant additional information with regard to nanomaterials (cf. OECD Guidance Manual for Sponsors); this information is available to the authorities (since most of which are involved in the RIP-oN review process and the OECD Process), and thus perfectly suited to address the requirements for additional reporting on nanomaterials, as taken forward by the individual regulators.
In response to the Belgian Presidency's proposal, the NIA has already strongly urged those authorities that are currently in favour of implementing such a 'raw material database' in their respective European Memberstate to (a) do so in full harmonisation amongst each other, and (b) consider for the requirements of such a database the parameters and limitations already agreed by the OECD WPMN.
In addition to our engagement with regard to 'raw' nanomaterials (as described above), we have also started exploring the public engagement that industries situated at the end of the nanotech value-chains might need to consider. We would be very happy to explore further with the authorities, as well as NGOs and consumer organisations, what is considered necessary and adequate for such an engagement in a voluntary context.
We can, however, at this stage not agree with a concept of 'paper traceability' that would amount to a connection between the two elements described above: i.e. the (voluntarily and proactively) well-documented material at the beginning (or at the early stages) of any nanotechnology value chain and the final product that is placed on the market.
The NIA stands for science- and technology-based expertise in nanotechnologies, and can thus act within this mission statement only. The NIA can furthermore speak for those companies that are members of the NIA only, and, although some might also be members of other industries association, such associations should not be assumed to share the views of the NIA.
We are grateful to our members for their support in securing the NIA's unique role and position and are looking forward to an ongoing fruitful representation of the nanotechnology industries in support of reliable, safe ongoing innovation and commercialisation of the next generation of technologies.
Please do not hesitate to contact us, in case you have any questions on the above NIA Members news release.
Your NIA Team
Follow this link to download an update on NIA (Pro)Activities within the OECD Sponsorship Programme.