Technology characterization and context analysis

Innovations, including those oriented toward sustainable development, always come with certain risks. The step "technology characterization" in the study is based on the assumption that technologies are not neutral with respect to the environment, that specific characteristics can give us clues to potential risks, that evidence derived from the technology characterization can serve as the basis for risk management measures following the precautionary principle, and that such evidence can and should be incorporated into development of the formative model.

A basic message of this analysis was that environmentally non-contained processes should be avoided at least until more is known about the behavior of the relevant substances and their interaction with the "tar gets." This approach corresponds, for example, to the handling of many substances within the framework of the chemical industry regulations.

• Non-contained applications involving nanoparticles are to be avoided.

• Critical aspects include, for example, the mobility of nanostructural materials, permeability of cell membranes, solubility in water and fat, bio-

persistence, and accumulation.

Much more difficult is the next step in the selected approach, the consideration of the application contexts and the analysis and characterization of affected systems. Technological impacts are revealed not only by the "character of a technology" but, rather more so, by the corresponding application contexts (in both quality and quantity). A prospective assessment of the potential environmental and health impacts of nanotechnology therefore must not only concentrate on the technology characterization and nano-specific impacts, it must also consider social trends and the specific application contexts.

At this point in time, the risks of nanotechnology are difficult to evaluate. In the current debates it is above all the long-term visions that are dominating discussions with respect to risks and opportunities. The current opportunities for nanotechnology, to the extent that they are significant to production, exist essentially in the use of the potential of nanoparticles and, above all, their unique properties. The unique properties of nanoparticles and nanostructures should, on the one hand, be developed for technical, economic, and environmental reasons, but they bring with them, on the other hand, potential risks. Within the scope of a comprehensive risk assessment, it is not possible to quantify these risks when exposure data is lacking. Research data on fine and ultra-fine particulate from a hazards analysis of toxicological and epidemiological aspects is available, however the data, in many cases, are not - and that should be emphasized - based on industrially manufactured nanoparticles, but rather particulate from combustion processes. Investigations of the behavior of nanoparticles in the human body indicate that airborne nanoparticles can penetrate the body and brain through the lungs and even the bulbus olfactorius. Little is known so far about the possible effects. Toxicological investigations have demonstrated adverse effects in laboratory experiments; however the results of these experiments are still somewhat contradictory.

With respect to the environmental impacts of nanotechnology, current knowledge is even less developed; there has been particularly little research done on the behavior of the particles, for example, in the various environmental compartments. Central questions arise particularly with a view to the behavior of nanoparticles in the air, for example the question to what extent and in what time frame do agglomerations take place and how stable are they? More rapidly formed and more stable agglomerations would in some cases "defuse" potential problems.

The analysis of various production processes makes clear that for many of them the issue of emissions in the air pathway is less problematic. Likewise, over the entire life cycle of nanotechnological products, only a limited number of problems - at least from the present viewpoint - are to be seen. At the very least, in the case of nanoparticles incorporated into a solid matrix, particle emissions are hardly to be expected. All in all, much too little is known about these issues; there is an enormous need for further research.

In the majority of applications investigated so far, the results presented indicate that particulate emissions, when handled appropriately throughout the life cycle, very likely do not represent a fundamentally unsolvable problem. In manufacturing particles, the problems seem to be manageable, at least in principle. During the use phase, the particles should essentially be immotile; at the end of the life cycle - dependent, of course, on the recycling method - there should not be any emissions; however further research is necessary. This is fundamentally the approach that was established in the framework for the analysis (avoidance of non-contained applications).

In the assessment of nanotechnology with respect to opportunities and risks, it became clear in the expert survey that the opportunities far overshadow the risks. However, we are also reminded that the necessary concurrent investigations and risk assessments must be carried out. The need for research includes:

• Toxicological and ecotoxicological analyses within the scope of integrated research programs

• Investigation of the behavior of nanoparticles and nanostructural surfaces in the environment and their classification

Despite the problem of comparing different risk structures, with the help of the technology characterization carried out here and in accordance with current knowledge with respect to foreseeable nano-specific effects (including self-organization), no "especially great cause for concern" could be established. The foreseeable and anticipatable risks appear most likely to be comparable to the risks associated with (synthetic) chemistry; these are, accordingly, by no means negligible, as chemical risks have historically shown themselves to be quite substantial. Early technological assessment and design intervention as well as early regulation and precautionary measures to avoid many or most of the mistakes made in the field of chemistry are therefore advisable. The REACh system, being developed by the EU as a part of ongoing chemical regulatory reform, may well anticipate the needed steps in the risk analysis (with the exception of the nec essary transition from a regulatory approach based on bulk weight to one based on particle quantity). In addition, much can be learned about risk management from the chemical industry and chemical handling procedures. However one must be cautious with this analogy that weaknesses in current risk management procedures are not also carried over, as risk management in the chemistry industry exhibits enormous loopholes, for example in the implementation of the precautionary principle (keyword: "intrinsically safe substances," techniques, and application systems; keyword: "substitution principle").

Above and beyond the case studies investigated, which very much focused on inorganic applications, there is a particular need for further research on:

• the application of self-organization in the inorganic as well as organic fields with a view to still-to-be-done and much-further-reaching eco-efficiency potentials.

• "active nanosystems" and, furthermore, on the ongoing, long-term application fields of self-organization, particularly in the case of a possible merger of nanotechnology and bio- and/or genetic engineering, with a view to the question of a gradual transition from self-organization to self-reproduction.

This fundamental assessment of nanotechnology likewise leaves unresolved questions concerning risk assessment and management with respect to nanotechnology. This concerns, first of all, the question of classification of substances; this currently is being done unsystematically or not at all. Here, as the expert survey also demonstrated, there is a need for action. Furthermore, it must be determined how the unique properties of the nanoparticle can be addressed through modifications to the existing regulatory system (beginning with the systems of measurement) and how these properties can appropriately be dealt with. Here, too, the chemical regulatory framework offers significant clues, although in its current form it does not address the specifications of the nanoparticle.

• The existing regulations are as a rule applicable to nanotechnology, but in their current form, they do not address the nanoparticle. A classification system for nanotechnological products must be established; appropriate methods of measurement must be developed.

• An adaptation of REACh is possible, but at the same time a series of further accommodations in the areas of environmental and health law must follow; the issue of worker safety must be given priority.

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