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Posted: May 29, 2008

German nanotechnology risk research strategy

(Nanowerk Spotlight) Germany, with an almost 40% share of European public funded nanoscience research, is the clear nanotechnology leader in Europe. It is also one of the leaders globally in pushing research into potential risk and safety concerns associated with nanotechnology.
The Federal Ministry of Education and Research (BMBF) is the ministry responsible for federal activities in the nanotechnology sector in Germany. Within its framework of 'leading-edge innovations' the BMBF supports key areas of nanotechnologies with promising prospects (NanoMobil, NanoChem, NanoFab, NanoforLife,NanoLux). The project NanoChance aims to support small and medium-sized companies in particular. The cooperative project NanoCare currently mainly focuses on studying possible risks of engineered nanoparticles. Beyond that, the federal agencies BAuA (Federal Institute for Occupational Safety and Health), UBA (Federal Environment Agency) and BfR (Federal Institute for Risk Assessment) have developed a joint research strategy that addresses especially health and environmental risks of engineered nanoparticles. The strategy has been finalized in December 2007 and a final report has just been published (Nanotechnology: Health and environmental risks of nanomaterials – Research Strategy; pdf download, 438 KB).
This research strategy falls within the framework of the Federal Environment Ministry's (BMU) NanoCommission, which coordinates and accompanies strategically the dialogue on the opportunities and risks of nanotechnology in three working groups. These working groups have the following foci of interest:

Working group 1: Opportunities for the environment and health

Working group 2: Risks and safety research

Working group 3: Guidance document for responsible handing of nanomaterials

The above-mentioned research strategy coordinated by BAuA has influenced the work performed by the Working Group 2.
Here is the summary of BAuA's proposed Research Strategy, taken from the above-mentioned document:
Chemicals legislation (e.g. REACH) does not provide for a specific procedure for testing (e.g. toxicological studies) and assessment of nanomaterials such as, for example, titanium dioxide, zinc oxide, iron oxide, silicon dioxide or carbon black which represent a nanoscale modification of an existing HPV3 substance with the same CAS number. Up to now, there has been no specific regulation for nanomaterials in the areas foodstuffs, consumer products and cosmetic products, either. For example, no particle sizes have been defined in the purity criteria for the authorized food additives silicon dioxide (E 551) and titanium dioxide (E 171). In addition, nanomaterials can be used as auxiliaries in plant protection products and biocides and in formulation. Here, too, no guidelines or guidance documents for testing and no requirements regarding identification and size or other physico-chemical properties currently exist. Due to the small number of available studies, it is hardly possible to make comparative statements on the basis of the results available.
Since the toxicological properties and risks with regard to exposure of humans and the environment cannot yet be evaluated, the need to conduct further investigations and close gaps in knowledge by means of research and assessment activities is generally recognized. Similar to technology-oriented research, in safety research, too, there are demands for a shift away from pure fundamental research and a new orientation which enables the translation of the results into risk-oriented and comprehensive assessments (or recommendations for measures) and the covering of the relevant toxicological and ecotoxicological end points.
As a matter of principle, it is therefore necessary that the toxicological and ecotoxicological studies that are to be performed can be utilized in regulatory toxicology. In addition, the goal is to achieve a balance between in vitro and in vivo methods, which is influenced to a large extent by the validity of the in vitro methods. To achieve this, a validation of the in vitro methods by in vivo methods is required.
However, consideration should also be given to the fact that nanoscale particles are not entirely new. Natural and unintentionally produced particles of this size have long been entering the environment and resulting in the exposure of humans and the environment.
The following strategic aims should be considered in order to achieve coordinated, targeted and effective research and promotion:
  • Risk-oriented approach
  • Comprehensive risk characterizations and risk assessments
  • Integration into the statutory and sub-statutory regulatory framework
  • Research that is application-oriented and relevant from the regulatory viewpoint
  • Assessment of the novelty of nanomaterials
  • International cooperation and coordination
  • Sustainability and the precautionary principle
  • More efficient structures for a targeted promotion of research
  • Transparency and public discourse
  • The report notes that the bodies to prepare and support risk assessment within the current statutory framework have not been established and supported up to now. A transfer of the research funds to the spheres of responsibility is urgently required to enable efficient and targeted research that takes account of the statutory framework.
    Since nanotechnology is a cross-cutting subject, there is an obvious need to examine, the extent to which nano-specific aspects and particularities have to be considered in the various areas of chemicals assessment and management. For the purpose of high-level structuring, the research and work areas can be assigned to various topics:
  • Identification of nanomaterials and characterization of the physico-chemical properties, determination of the chemical reactivity
  • Exposure of workers and consumers (oral, dermal, inhalative), development of measurement methods
  • Exposure of environment (development of measurement methods for the use of nanomaterials in the environment, life-cycle analyses and exposure scenarios, accumulation and persistence etc.)
  • Improvement of the comparability and standardization of the studies on toxicology/ecotoxicology and the behavior of nanomaterials in the environment
  • Toxicological assessment of nanomaterials (test methods: in vitro, in vivo, epidemiology/occupational medicine, relevant end points, kinetics, effect mechanisms etc.)
  • Toxicological test strategies and risk-assessment procedures (formation of groups, SAR)
  • Ecotoxicological assessment of nanomaterials (test methods, effect hypotheses, relevant end points etc.)
  • Ecotoxicological test strategies and risk-assessment procedures (formation of groups, QSAR, intelligent test strategy)
  • Risk management
  • Information and communication (handling aids, safety data sheets, training of workers)
  • Databases
  • Public discourse: nanotechnology
  • International cooperation and promotion of research
  • The review status and the urgency of treatment vary, however, in the individual areas. Some topics follow on from each other so that sequential treatment is advisable. In current research practice, topics are often dealt with in parallel; one reason cited for this is that strictly sequential treatment would lead to a situation in which some topics would be tackled only in the distant future. What is required is a close and timely exchange of findings and experience between the topics dealt with simultaneously as well as an iterative and flexible development process in the course of further research in order to obtain results for use in risk assessment as soon as possible.
    The following research projects and support initiatives are considered to be particularly urgent for the common needs of occupational health, consumer protection and environmental protection, whereby they in part follow on from each other:

    1) Identification of relevant nanomaterials

    2) Research initiative for the assessment of nanomaterials within the existing statutory framework

    3) Minimum requirements for publications

    4) In vivo studies for assessment of the risks of nanomaterials

    5) Assessment and validation of the in vitro methods as a contribution to the assessment of the risks.

    From the point of occupational health, research is urgently needed in the following areas:

    1) Development of the measurement methodology and measurement strategies for the determination of exposures to nanomaterials by inhalation

    2) Provisional handling aids for certain frequently occurring activities involving nanomaterials in the workplace.

    From the point of view of consumer protection, research is urgently needed in the following areas:

    1) Investigations into absorption, systemic availability, accumulation and elimination of nanomaterials after oral exposure (foodstuffs and food packaging materials)

    2) Assessment of the toxicity of nanomaterials after oral exposure.

    From the point of view of environmental protection, research is urgently needed in the following areas:

    1) Identification of relevant parameters for behavior and fate in the environment

    2) Exposure, persistence and accumulation of nanomaterials in the compartments water, soil and sediment

    3) Development of uniform standards for the testing of nanomaterials.

    The report concludes that the currently foreseeable research topics and requisite activities in fundamental areas will require specific support in the next 5 to 10 years. In particular, this also applies to conceptual aspects relating to the procedures and strategies. With increasing experience and consolidation of the procedures and methods for testing and assessment, it will be possible to change to a more routine form of investigation and assessment of nanomaterials (individual substances and substance classes) which will continue for as long as new nanomaterials with relevant exposure of humans and the environment are developed.
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