Showing posts with label reach. Show all posts
Showing posts with label reach. Show all posts
, ,

Stratfor on Nanotechnology

Saturday, August 25, 2007

Startfor issued a short article on regulating nanotechnology. There's nothing in this article that we have not discuss, it seems, but one conclusion captures my attention:
Many see REACH as more protective of public health and the environment than TSCA. As such, there is a growing movement in the United States for the adoption of REACH-like chemical regulations. For those calling for a complete reassessment of TSCA, the revolution in nanotechnology has come at the right time. They argue that TSCA cannot cope with the challenges of nanotechnology, so therefore the law should be revamped to prepare for the next wave of technology. A number of states are currently considering their own REACH-like laws, and the "opening" of TSCA (Capitol Hill-speak for rewriting the law) seems increasingly likely in the coming years.
We have discussed this possibility on the EU-US "gap" post, but we see that if this conclusion is correct, then the US is moving towards filling the gap somewhere in the future.

The rest of the article is worth to read. It provides a good introduction in problems surrounding present-day nanotech regulation. Read more here.

 

, , , ,

Regulating Nanotechnology Wihtin Precautionary Principle

Tuesday, July 17, 2007

A Report from the Institut fuer oekologische Wirtschaftsforschung for the European Parliament benchmarked precutionary principle embodied in several environmental legislations, from the REACH in EU to TSCA in the US.

From the report, you can tell which side of the world advocates stronger precautionary principle and how it affects future nanotechnology regulation. Read the report here.

 

, , , ,

EU's "incrimental approach" in regulating nanomaterials

Thursday, June 28, 2007

We've had discussions on the Berkeley's regulation and I have posted some articles on EU's REACH. Here's an article explaining existing EU's regulatory infrastructure applicable to nanomaterials/nanoparticles and its weaknesses:
The European Commission has adopted a so-called ‘‘incremental approach’’, which focuses on adapting existing laws to regulate nanotechnologies, and therefore this paper aims to test the effectiveness of the ‘‘incremental approach’’. Three commercially available products containing fullerenes (C60 and carbon nanotubes) were analysed in a life cycle perspective in order to (1) map current applicable regulations, (2) analyse their applicability to nanomaterials, (3) identify their gaps, and (4) suggest proper solutions.
Read the full paper here.

My general observation: the paper still based itself on "emission" paradigm. Thus, the playing field is in the lowering of permissible emission. An important point here is that the paper suggested "free nanoparticles" to be exclusively categorized under the REACH and that it should be specifically registered. Interestingly, the paper recommends bottom-up nanoparticle to be regarded as "new substance".

 

, , , , ,

Precautionary Principle Urged (Again?)

Friday, June 15, 2007

A news from the EU (but it turned out to be not so new):
"Current scientific risk-assessment methods [for nanomaterials] are really not reliable. We don't have the knowledge. Nanomaterials are so small and reactive and we don't have natural defences in the body against them," said Eva Hellsten, from the Commission's DG Environment, Directorate Water, Chemicals and Cohesion.
EU are still debating as to whether nanomaterials/nanoparticles would be sufficiently regulated in its REACH directive. To sum up, their position on regulating engineered nanoparticles remans the same:
1. IS REACH enough or not?
2. We don't have "sufficent knowledge"
3. More money required for research
4. Precautionary Principle vs 'non' Precautionary Principle

So in this part of nanotech regulation, there is really nothing new in any part of the world. Boring!

 

, , , , , , ,

Nanotechnology Regulation in EU

Wednesday, January 17, 2007

Prof. Van Calster's article for NLB on european nanotechnology regulation is available for download at Nanoforum's website here (free signup required). Here's a quote:
The expectation is that the EU will adopt a cautious approach, following the example of the European Chemicals policy under REACH. In that case, the burden of proof of safety is shifted from the authorities to the manufacturer. Product liability law is less likely to be applied, because this area is not harmonised at EU level. Geert van Calster compares the EU and US legislative framework and trends.

 

, , ,

Is TSCA sufficient to cover nanotech?

Tuesday, January 9, 2007

The debate over TSCA in nanotech hovers primarily around the issue of putting engineered nanoparticle as a "new substance". Some expert considers TSCA adequate to overcome new technologies while other is pessimistic on the approach and cries for chemical reform.

This week's article in Chemicals and Engineering highlights the role of TSCA and compares it to the new EU's REACH. Only very small part of the article is dedicated to discuss nanotech. Click here to read.

 

, , ,

REACH directive in force this June

Sunday, January 7, 2007

European Commission announced that the REACH Directive will be in force in June 2007. According to the Commission in its website "The new regulatory framework will improve the protection of human health and the environment by identifying the properties of chemical substances earlier and more accurately. Particular attention is given to the most toxic properties which cause cancer, infertility in men and women, genetic mutations and birth defects. The new approach is likely to improve the innovative capability and competitiveness of the EU chemicals industry."

REACH -- after some modification -- might be applied to Nanotechnology. However, to date there has been no official announcement from the EU that REACH will govern nanoparticles and nanomaterials.

The factbook on REACH is downloadable here, the summary of the legislation is available here.

 

, , , , , , , ,

REACH is not enough, new labelling method might be required

Monday, December 4, 2006

Scientific Committee on Emerging and Newly-Identified Health Risks (SCENIHR) is one of the three independent scientific committes managed by the EU's directorate general of health and consumer protection. Its task is in giving considerations and insights into "where amendments are needed to procedures for assessing risk of the products of nanotechnologies, and identifies areas where major gaps in knowledge exist."

The EU Comission launched a public consultation in December 2005 and published its recommendations based on the consultation:

With regards to Hazard Evaluation, "The SCENIHR opinion highlights that the paradigm for nanotoxicology does not exist and there is a need for a case-by-case assessment of environmental and health impacts of nanotechnology products" and consider it beneficial to "bench mark studies, including reference materials with very well understood toxicology in man, such as quartz and asbestos."

In its report, it acknowledges that "Due to the lack of available data on the risk characterisation of different nanoparticle-based products, no generic conclusions are possible at this stage.
Consequently, each product and process that involves nanoparticles must be considered
separately.."

The SCENIHR listed a few type of risks associated with certain circumstances:
  • Worker safety during the manufacture of nanoparticles.
  • Safety of consumers using products that contain nanoparticles.
  • Safety of local populations due to chronic or acute release of nanoparticles from manufacturing and /or processing facilities.
  • The impact on the various environmental compartments per se resulting from production, formulation and use, and on the potential for human re-exposure through the environment.
  • The environmental and human health risks involved in the disposal or recycling of nanoparticle dependant products.
These characterisation by the SCENIHR reflects the possibility of regulating nanotechnology in each economic chains, from production, to consumption, to dumping, to the re-usage. If this is adopted, then the future EU regulation will comprise of a process-focus regulation, product-focused regulation and sectoral regulations.

The SCENIHR also suggest a precautionary approach with respect to "nanoparticles which are likely to be highly biopersistent in humans and/or in environmental species." It also stresses that "there is no reliable information on the effect of the simultaneous exposure to multiple forms of nanoparticles, where it would be appropriate to assume the effects are additive, or on the interaction between nanoparticles and other stressors (either physical, chemical or biological), which should be considered on a case-by-case basis."

Nanoparticle as stressor is particularly important as it means that a hazardous effect may not be resulted not from the nanoparticle itself but due to its surroundings. This means that each producer of nanoproduct will have the obligation to dilligently provide information on how consumer should treat their product. Possible allergic reaction should also be provided and this may not be an easy task. In my opinion, this will carry several legal consequences:
  1. There has to be a regulation on the storage and transportation of nanoproducts which contain hazardous nanoparticle
  2. Some nanoproducts shall not be sold for free
  3. Producer can be exempted from liability if they can prove that they have provided adequate information on how a product should be treated
It is interesting to note that the SCENIHR regards the current REACH proposal may be inadequate:
The regulation of products containing nanoparticles based on tonnage, as proposed for existing chemicals under REACH, needs to be considered further because there are many more nanoparticles to the tonne than is the case for larger particles, and their behaviour in the body and in the environment may be different. If the nanoparticle form of a chemical does have distinctly different properties in biological systems from other physical forms of the same chemical, it will be necessary to readily identify the nanoparticle form of each chemical for the purposes of hazard warning labels etc. One approach to ensure that the effects of the nanoparticle form of a chemical is properly assessed would be to have a unique identification for it, either assigning different CAS numbers to the nanoparticle form, or adding a code (CAS-NP50) to existing CAS numbers leaving the CAS number for identifying similar chemical compounds . It is also inappropriate to assume that current workplace exposure standards for dusts can be applied directly to the nanoparticle form of the dust component. New standards will therefore need to be considered. Similarly, classification and labelling for human health and the environment may need to be reconsidered.
This point is especially important. This suggest that nanoproduct shall not and cannot be treated as chemicals, because their properties are different from chemical bulk. A legal consequences of this is that, producers cannot rely merely on REACH in conducting their safety standard as their duty to care with regards to nanoproduct is different than those established under the REACH. Another important thing is: there is going to be another classification/labelling method for nanoparticles that is different from normal chemical classifications.

You can download the complete report here, and the summary here.

Email me for suggestions, or leave a comment.

 

, , , , ,

European Nanotechnology Law?

Friday, December 1, 2006

A few days ago the European Parliament issued an action plan on Nanoscience and Nanotechnologies. This action plan is not legally binding and is deemed simply as a declaration of intention in regulating nanotechnology further. In general, there is nothing special under the action plan as it only stresses on the importance of research and impact assessments. There are, however, some paragraphs that reflects the position of the European Union with regards to nanoscience and nanotechnologies.

For example, the action plan:
  • Recommends that lists of ingredients in consumer products identify the addition of manufactured nanoparticulate material;
  • Regrets the fact that the patenting of nanoscience and nanotechnology inventions in Europe is developing slowly; calls on the EU to create a nanoscience and nanotechnology patent monitoring system governed by the European Patent Office;
  • Encourages general reforms in the field of the European patent system in order to cut the costs of patenting and to improve accessibility to patents for SMEs; stresses the need for greater transparency and clear limits to the scope of patent protection;
  • Emphasises the need to respect high ethical principles and welcomes the planned reviews on issues such as non-therapeutic human enhancement and links between nanosciences and nanotechnologies and individual privacy; expects the reviews to be public and to include a thorough analysis of nanomedicine;
The above points suggests the EU position toward labelling and patent reform. The last point on human enhancement is especially important and this shows EU's high awareness on the interconnectedness between human enhancement and nanotechnologies. You can compare it with UNESCO's view on human enhancement here.

Currently, the status of european nanotechnology regulation is more or less equal to the US': There are no specific law regulating it. It is questionable whether existing regulations in the field of environmental (such as the REACH proposal), health, workplace and food and drugs can directly apply to nanotechnology, due to differences of characters. There are suggestions to put nanotechnology under the REACH proposal but there are also worries that it may not be able to cover "finished product" such as a transistor.

Nevertheless, there are general environmental regulations under EU auspices which applies to every risky activities, including nanotechnologies. The factories, laboratories and storing facilities of nanoproducts could be subjected to environmental impact assessment directive 85/337/EEC, or IPPC Directive 96/61/EC. Nevertheless, this is NOT without difficulties. Nanotechnology projects are not listed in the mandatory impact assessment list under the EU impact assessment directive (see Annex II), so states may exempt them from impact assessment obligation, by relying solely on the directive . Lack of effects data will also prevent stakeholders from conducting assessments.

The case with the IPPC directive is similar. The IPPC deals with limiting the amount of "emission" of pollutants, which is irrelevant with regards to nanoparticles. It has been mentioned in several researches that it is the size, surface structure, solubility and shape of the nanomaterials that contributes to its toxicity, and not the amount/weight.

Last but not least, although nanotech is not specifically regulated, there are general principles of EU Law that will safeguard public health and the environment. The EU is known to be a strict adherent of precautionary principle, so recklessness with regards to the production or research of nanomaterials will arise liability. There could be special cases where nanotech is categorized under strict liability, for example in its connection with military uses. There is yet an established due dilligence rule with regard to nanotechnology, but to avoid law suit, it could be safer to refer to the emerging "best practices" and to the formal position of the EU as reflected on its action plans, communications or existing directives and regulations.

(Hat Tip to Nanologue and Prof Geert van Calster!)