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Implementation of risk governance: meeting the needs of nanotechnology

Project number: F 2477 Institution: Federal Institute for Occupational Safety and Health (BAuA) Status: Ongoing Project Planned end: 2022-12-31

Description:

Gov4Nano will design and establish a well-positioned and broadly supported Nano Risk Governance Council (NRGC). Organizing, connecting and engaging are key activities in Gov4Nano and its creation of a sustainable NRGC. Engaging stakeholders (including regulators) to proactively address nano-specific safety and seek dialogue for joint activities. NRGC and its precursor project Gov4Nano will engage, in order to support these activities, with the broad variety of stakeholders across all relevant nano-disciplines (chemical, biocides, food and feed, pharma and medical devices and materials development) and draft a review on our knowledge progress over the last decade whilst initiating dialog. To boost the quality of the dialog it will create a platform for dialogues between stakeholders in a "trusted environment" inclusive of civil society. The NRGC core business is to coordinate, guide and harmonize in order to overcome the fragmentation of current knowledge, information and needs over various sectors and disciplines (workers, consumers/patients, environmental safety) and to prepare the transfer of this knowledge. To that end, the NRGC will be equipped with a self-sustainable NanoSafety Governance Portal (NSGP) consolidating state-of-the-art and progressive nanosafety governance tools including ones for dialogues and measuring risk perception. Major efforts will be towards requirements for data harmonization and data curation to be defined and laid down in guidance on obtaining harmonized and standardized quality-scored data collections promoting a big data approach for nanotoxicology. Research activities will be initiated for regulatory sound knowledge in support of harmonized (OECD) guidance for characterization and testing of nanomaterials.

Within Gov4Nano BAuA coordinates work package 2 "Research and Development towards guidance and guidelines for testing of nanomaterials". WP2 will accelerate and underpin the development of overarching and specific guidance documents as well as standardized and harmonized test guidelines for e.g. physico-chemical characterization, transformation, exposure and hazard assessment. Specific endpoints that will be addressed include surface chemistry, solubility, reactivity and dustiness of nanomaterials. It includes experimental work and the translation of scientific results for regulatory methodical adaptation. All work will be performed in close collaboration with the OECD WPMN and WNT. The SOPs will be validated, as appropriate, by ring tests to ensure their applicability and reproducibility. The developments will always consider the availability and practicability of the methods to facilitate their implementation and widespread use while also giving full attention to the data quality to allow data comparability and use for regulatory and scientific purposes.

Contact

Unit 4.6 "Hazardous Substances Management"

Phone: +49 231 9071-1971 Fax: +49 231 9071-2070