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Posted: Jun 05, 2007

Regulating nanotechnology - incremental approach or new regulatory framework?

(Nanowerk Spotlight) In 2005, the Project on Emerging Nanotechnologies released a report by Dr. J. Clarence Davies (Managing the effects of nanotechnology; pdf download, 1 MB) that found that U.S. legislation was inadequate. Davies concluded that nanotechnology is difficult to address using existing regulations and a new regulatory framework was needed in order to take the unique properties and risks of nanomaterials into account. This was in somewhat contradiction to what the EU Commission had found after its preliminary risk assessment workshop in 2004. The European Commission concluded that the European Union could protect health and environment by using an incremental approach and adapt existing legislation. Although there are cultural and legal differences between the EU and U.S., some people had a hard time understanding how the conclusions of the two reports could be so different. Among them, a group of scientists in Denmark and Italy decided to take a very product-specific approach and analyze the existing legislation along the life-cycle of three different commercially available products containing nanomaterials. They conclude that the 'incremental approach' could work effectively, provided due explanations and amendments are taken where necessary.
"The major conclusion of our study is that almost every aspect of the various laws and legislations along the life-cycle of products containing nanomaterials needs to be adapted so that nanomaterials are covered within the scope of the laws, definitions are applicable, etc." Steffen Foss Hansen explains to Nanowerk. "The implications for the legislative process are many, but most importantly our findings stress that amendments are needed now before thousands of products become commercially available and before the environment and thousands of workers become exposed on a regular basis. Legislation needs to be proactive in scope and focused on prevention of emission and exposure rather than assessment of risks and establishment of safe exposure levels. The development of such an oversight framework requires considerable political courage, health and safety research, technical insight and support, and stakeholder and public participation."
Hansen and Antonio Franco, researchers in the Institute of Environment & Resources at Technical University of Denmark (DTU), together with colleagues from DTU and the University of Padua in Italy, published a report on their findings in Regulatory Toxicology and Pharmacology ("Limits and prospects of the 'incremental approach' and the European legislation on the management of risks related to nanomaterials"). In contrast to previous reports, the team's findings are new in that they are product-specific and avoid talking about products containing nanomaterials in general.
It is generally believed that the risk of nanomaterials will depend on the properties of the material itself as well as the way it is used in a product. "However" says Hansen, "most policy analysis we have come across have ignored the second element and talk about nanomaterials in general when analyzing the applicability of the existing legislation in regards to nanomaterials."
In their study, the scientists investigated the effectiveness of the incremental approach that was proposed by the European Commission. In order to adequately determine the effectiveness, which is most likely product-specific, they used three commercially available nano-enabled products to reflect the diversity of available carbon-based nanomaterials. The products were:
1) A badminton racquet, produced by Yonex in Japan and sold in the EU and U.S., where fullerenes were dispersed in a resin between carbon fibers to strengthen the composite material. Since the fullerenes are fixed in a solid matrix, no particle release is expected during the lifetime. Eventually the racquet becomes a waste, and it can be assumed that the racquet will be disposed of as a municipal solid waste at the end of its life, either in a landfill or burnt in an incinerator (which potentially could release airborne nanoparticles).
2) An oil lubricant produced by Bardahl in the U.S. and sold in Italy, where soot containing fullerenes is mixed together with other chemical additives in order to improve the sliding between metallic surfaces and thereby enhance the performance of the lubricant. Here, two different waste-scenarios are possible: a) either the fullerenes stay attached to metal surfaces and end-up as vehicle waste at the end of the vehicleís life cycle or b) the fullerenes are dissolved in the exhausted oil, which is then removed from the motor. In the first scenario, fullerenes will follow the metallic waste and probably be degraded during recycling of the metal. Alternatively, they may transfer to liquid or solid wastes during treatment operations or be slowly released from landfills.
3) A baseball bat containing carbon nanotubes (CNTs) produced by Easton Sports. Similar to the badminton racquet, the CNTs are added to the resin to strengthen the composite material. Again, due to the fixed nature of the nanomaterial within the bat, there seems to be little concern for exposure during the productís lifetime and eventually the bat will be disposed of in a similar way as the badminton racquet.
In a next step, the life cycle of these materials was defined in order to capture all relevant aspects of human and environmental health related to nanoparticles during production, extraction and refining, manufacturing, use, and final disposal.
Based on this framework, the researchers mapped current European regulations along the life cycle of each product in order to (1) analyze their applicability in relation to nanomaterials, (2) identify their gaps, and (3) suggest proper solutions. The analysis identified four relevant areas of legislation:
• The Safety at Workplace Directives (e.g. EU Council Directives 31/1989, 24/1998)
• Directive on the Integrated Pollution Prevention and Control (EU Council Directive 61/1996)
• The European Unionís Directive on the Registration, Evaluation, Authorization of Chemicals (Regulation (EC) No. 1907/2006)
• The Waste Management Directives (EU Council Directives 12/2006, 689/1991, 439/1975, 53/2000)
"Most of the specific issues and problems we have identified can be solved individually such as for instance changing the definition of substances in the new chemical legislation in the EU termed REACH" says Hansen. "The problem is that if you consider all the individual problems identified along the life-cycle of the individual products and consider them as a whole, it seems like a daunting task to amend all the existing definitions, laws, guidelines, etc. and raises the question of whether such a patchwork exercise is really the most efficient way forward. Another serious problem is that the guidelines that support existing legislation (such as the Technical Guidance Document in regard to chemicals) is seriously inadequate both in regard to assessing the risk of nanomaterials to human health and to the environment."
Although Hansen and his collaborators – for now – advocate a product-by product approach, they think it is a serious problem that many of the existing laws and legislation are based on risk assessment and the establishment of safe exposure levels.
"Having to do risk assessment of each individual use of nanomaterials does not seem to be a viable option given the problems experienced in the past with doing substance-by-substance risk assessment of the 'only' 100.000 bulk chemicals in the EU" he says. "If this approach were to be adopted for nanomaterials we would have to do risk assessment on millions of nanomaterials because of all the possible ways one can change and combine the unique properties of the bulk chemicals at the nanoscale."
Nevertheless, identifying the key risk characteristics of nanomaterials is of vital importance in assessing their impact on health and environment. "Somehow we need to make sure that all studies of health, safety, and environment measure and report the properties of the nanomaterial they test in a comparable way" says Hansen. "This will be vital in identifying these key risk characteristics. Once this has been done, we might be able to develop some kind of hazard screening that could support risk management decision in an informed manner."
Another set of problems that the scientists point out is that, so far, nobody knows how to set emission standards for nanomaterials on which existing laws could be based, and that the techniques to monitoring emissions into air, soil, and water do not exist yet.
Hansen cautions that, although some work is going on internationally to address these issues, "we fear that this process might take too long, given the speed with which nanomaterials are introduced into commercial products. We need to think about limiting exposure of humans and the environment to nanomaterials in order to be on the safe side, should it later turn out that some nanomaterials entail some risks."
"At the moment, issuing a specific long-term regulation on nanotechnology seems technically problematic and politically improbable" he says. "It is therefore necessary to make a consistent use of existing legislation where it can be easily applied as such or suitably amended. In Europe, the incremental approach is considered the only practical method to tackle the risks caused by engineered nanoparticles, although no specific intervention has been made on existing regulation to date."
Analyzing the gaps within regulations along the life cycle of the three products, the researchers found that it is often unclear if nanoparticles are covered by current legislation. The main problems seem to be that metrology tools are unavailable, thresholds are not tailored to the nanoscale and are based on bulk material, and (eco-) toxicological data and limits cannot be established with existing methodologies.
The researchers point out that the difficulty to generate universally recognized data along the life cycle of commercially available products puts a limit on the applicability of many laws.
Based on their findings, the Danish-Italian team concludes that the European 'incremental approach' could work. In the short-term, they specifically have six recommendations for amending current rules and regulations:
1) Define standards for labs and other workplaces handling nanoparticles.
2) Actively promote research and development of usable metrological tools.
3) Establish a Technical Working Group within the EU Bureau of Integrated Pollution Prevention and Control to organize an exchange of information.
4) Adapt the Chemical Abstract Service (CAS) to properly classify nanoparticles.
5) Establish a specific regime for nanoparticles within REACH requiring industry to submit information on nanoparticles characteristics and health, safety and environmental information.
6) Add free nanoparticles to the list of Annex II in Directive 689/1991 on hazardous wastes.
By , Copyright Nanowerk LLC

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