Posts Tagged Nanotechnology
A short post on manufactured nanomaterials and data. (Readers will be aware that although the blog focuses mostly on litigation, I dabble in regulatory research and practice, too. And that nanotechnology regulation has been a consistent interest of mine).
Thank you Lynn Bergeson and Carla Hutton for flagging the study by EUON on data collection and reporting methodology for manufactured nanomaterials. EUON, the European Union’s Observatory for Nanomaterials, is hosted by ECHA – the EU’s Chemicals Agency. The study’s purpose is made clear on p.15 (only) of the report: the overall context is for the regulators to have an overview of the heterogeneous market for nanomaterials. In order to do so, the study measures the reliability etc of existing reports and studies on the nanomaterials market. It concludes that a Delphi study of the existing research would be required.
For those of you with an interest in information flows and the transparency of data, the implications are clear: part of the exercise of regulating new technologies is to know what is out there; and manufacturers’ data clearly are not making it into the public domain in a transparent and coherent manner. Consider alongside this report, for instance the proposed US EPA rule on transparency in regulator science.
Denmark has adopted its regime for notification preparations and products containing nanomaterials. (Belgium ‘s regime as far as I am aware has still not been finally adopted – it is not the kind of measure which its care-taker government (coalition negotiations are underway) can justifiably adopt). The final text (Danish only) does differ from the text notified under the EU’s transparency regime, following comments by the EC and by other Member States.
The Danish text (which entered into force last Wednesday, 18 June) differs from the proposed Belgian regime: it targets consumer goods, not professional goods; it does not mutually recognise notification done in other Member States…The Belgian regime in turn differs from the French, and Norwegian (not an EU Member State but EFTA) scheme etc. Harmonisation at the European level is becoming ever more urgent: impact assessment at that level is underway and a proposal expected for the autumn. This will then presumably gazump any pre-existing national regimes.
I reported earlier on the delay incurred by the Belgian nano register. Following objections under the EU’s transparency Directive, the Belgian register stood still. The Belgian Government is now tinkering with the proposal, having reportedly adopted a new draft which is being sent to various consultative bodies.
The new draft, a little bird tells me, adds additinal requirements in the light of occupation health and safety requirements; introduces 1 January 2016 as the deadline for registration of nanomaterials already on the market and 1 January 2017 for relevant mixtures; postpones until later the cut-off date for objects and complex preparations containing nanomaterials; and cancels the exemption for cosmetics containing nanomaterials.
Strangely, for a move designed to increase transparency, the new draft itself is kept under wraps for the time being.
EC, UK et al comments on Belgian nano-register delay its roll-out. No disguise of general unease vis-a-vis EC dithering.
The European Commission, the United Kingdom, The Czech Republic, Italy and Ireland have all issued detailed comments on the ‘nano register’ notified by Belgium.
Belgium itself had summarised the draft as follows:
The draft legislation implements a register of substances manufactured at the nanoscale based on declarations of products containing such substances by the parties placing these products on the market.
To this end, the draft legislation mandates that substances manufactured at the nanoscale, and preparations containing them, be declared if more than 100 grams of these substances are placed on the market per year (the declaration covers the characteristics of the substances, the quantity of substances manufactured at the nanoscale placed on the market, the use of the preparation or substance concerned and the identity of professional purchasers and users).
The draft legislation also lays down an obligation to make a simplified declaration for articles incorporating a substance or substances manufactured at the nanoscale, as long as more than 100 grams are placed on the market per year and the article emits more than 0.1% of substances manufactured at the nanoscale when in use (only a reduced list is required of the characteristics of the substances manufactured at the nanoscale).
Provisions are laid down concerning data protection and confidentiality, as well as concerning research and development activities.
The draft additionally covers the mutual recognition of the numbers of any declarations made by non-Member States, thus reducing the impact of the draft legislation on the free movement of the products concerned.
Under the notification procedure of Directive 98/34, Member States have to notify draft ‘technical regulations’ which may impede the Internal Market. This is followed by a standstill period and by an opportunity for other Member States, and the European Commission, to issue comments. Detailed comments extend the standstill period – in the case of Belgium’s nano register, now until early January 2014.
I am not in fact entirely convinced that the nano register is a ‘technical regulation’ under the Directive – Belgium would seem to have opted for the cautious approach, apparently in contrast with its approach vis-a-vis the mirror provisions under WTO law: the WTO has a similar regime under the Agreement on Technical Barriers to Trade (see also Agapi Patsa and Anna Gergely on same) – albeit with less strict consequences if a Member fails to notify. I was not able to locate Belgium’s notification in the TBT’s IMS This database can be a bit moody, whence Belgium may have notified but I cannot find it. Alternatively, Belgium may have decided that the register does not qualify as a technical regulation under WTO law..
I have not been able (nor have I chased – perhaps some readers have) to get my hands on the comments issued by a handful of Member States and by the EC. . They are likely of course to relate to the impact on nano roll-out of a registration duty in a core Member State.
It is not unlikely that the Belgian initiative is meant in part to put pressure on the EC to beef up its own notification requirements. However the EC is dragging its feet on reporting on the public consultation re REACH and nano, and other Member States, notably Germany, which is pondering a separate notification proposal, are getting impatient, too.
Visionary or the ultimate hindsight? The European Environment Agency’s second ‘late lessons from early warnings’
The European Environment Agency published its first volume of ‘late lessons’ in 2001. Just over ten years later, the second volume covers a staggering amount of new analysis, including PCE, lead in petrol, tobacco, DBCP, nanotechnology, alien species etc. That we already need a second volume fairly soon after the first, is explained by the fact that warnings from the first volume arguably have not been heeded, and that new technologies are rolled out at staggering speed.
It is impossible to argue for or against specific chapters in the volume on scientific grounds – no doubt others will do it (included vested interests). I flag the report on the blog, for it is a treasure trove for risk management teaching and research. Indeed arguably one could teach an entire course using just the report: for the Agency does not only summarise and report on the science, it also infers risk management choices from the ‘late lessons’ learned. Particularly insightful is the review of 88 cases of ‘false positives’: in contrast with the first volume (which had been criticised for this), the second volume does look into 88 case-studies where precautionary action was alleged to have led to greater actual occurrence of harm, rather than prevent it. The EEA concludes that in only 4 cases, this was indeed the case.
Critics argue that the 88 cases are inevitably selective. They also argue that going back in time, there are many more such examples (which I must say undermines their cause somewhat, for some of the examples quoted effectively go back to the times of witchcraft – or suspicion thereof). One could also argue of course that many developments which never raised suspicion and which have changed human life for the better, are not reported on either. However there is of course no reason why humanity should not be able to adopt an and /and approach: one which encourages harmless technologies as well as protect us from harmful ones. This is not a zero sum game (compensate the misses with the hits): it surely ought to be overwhelmingly positive.
The EEA today, incidentally, in a press release feels vindicated in its stance on neonicotinoids. The European Commission, as a result of a comitology (dont’ ask; this is EU administrative procedure; very very relevant but I shall not explain it here) quirkiness banned three neonicotinoid insecticides from use in the EU, after Member States failed to agree to either adopt or reject the proposal.