Buitrago Elina, Novello Anna Maria, Fink Alke, Riediker Michael, Rothen-Rutishauser Barbara, Meyer Thierry
Ecole Polytechnique Fédérale de Lausanne (EPFL), Occupational Health and Safety (OHS), Station 6, CH-1015 Lausanne, Switzerland.
BioNanomaterials, Adolphe Merkle Institute, University of Fribourg, Ch. des Verdiers 4, CH-1700 Fribourg, Switzerland.
Nanomaterials (Basel). 2021 Oct 19;11(10):2768. doi: 10.3390/nano11102768.
Research in nanoscience continues to bring forward a steady stream of new nanomaterials and processes that are being developed and marketed. While scientific committees and expert groups deal with the harmonization of terminology and legal challenges, risk assessors in research labs continue to have to deal with the gap between regulations and rapidly developing information. The risk assessment of nanomaterial processes is currently slow and tedious because it is performed on a material-by-material basis. Safety data sheets are rarely available for (new) nanomaterials, and even when they are, they often lack nano-specific information. Exposure estimations or measurements are difficult to perform and require sophisticated and expensive equipment and personal expertise. The use of banding-based risk assessment tools for laboratory environments is an efficient way to evaluate the occupational risks associated with nanomaterials. Herein, we present an updated version of our risk assessment tool for working with nanomaterials based on a three-step control banding approach and the precautionary principle. The first step is to determine the hazard band of the nanomaterial. A decision tree allows the assignment of the material to one of three bands based on known or expected effects on human health. In the second step, the work exposure is evaluated and the processes are classified into three "nano" levels for each specific hazard band. The work exposure is estimated using a laboratory exposure model. The result of this calculation in combination with recommended occupational exposure limits (rOEL) for nanomaterials and an additional safety factor gives the final "nano" level. Finally, we update the technical, organizational, and personal protective measures to allow nanomaterial processes to be established in research environments.
纳米科学研究持续不断地推出大量正在研发和推向市场的新型纳米材料及工艺。尽管科学委员会和专家组在处理术语协调和法律挑战问题，但研究实验室中的风险评估人员仍需应对法规与快速发展的信息之间的差距。目前，纳米材料工艺的风险评估进展缓慢且繁琐，因为它是逐材料进行的。（新型）纳米材料很少有安全数据表，即便有，也常常缺乏纳米特定信息。暴露估计或测量难以进行，需要精密且昂贵的设备以及个人专业知识。在实验室环境中使用基于分级的风险评估工具是评估与纳米材料相关职业风险的有效方法。在此，我们基于三步控制分级方法和预防原则，展示我们用于处理纳米材料的风险评估工具的更新版本。第一步是确定纳米材料的危害等级。决策树可根据对人类健康已知或预期的影响，将材料归入三个等级之一。第二步，评估工作暴露情况，并针对每个特定危害等级将工艺分为三个“纳米”级别。使用实验室暴露模型估计工作暴露情况。该计算结果结合纳米材料的推荐职业暴露限值（rOEL）和一个额外的安全系数，得出最终的“纳米”级别。最后，我们更新技术、组织和个人防护措施，以便在研究环境中开展纳米材料工艺。
