Abstract
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.
Highlights
We have presented a comprehensive and easy-to-use tool for risk assessment when working with engineered nanomaterials
The tool is destined for laboratory research and is helpful when planning new research and setting up an Engineered nanomaterials (ENM) laboratory
After an initial hazard assessment of the ENM, which is performed using a decision tree with a series of yes/no/I do not know questions, the risk level of the laboratory is determined based on acceptable exposure scenarios
Summary
The working group concludes that more research is needed to identify biomarkers to measure exposure and long-term adverse health effects Even with these guidelines and standards for the safety assessment of ENM, the research and development phase lacks relevant safety data. No OEL has been established for ENM; many regulatory agencies are starting to make lists of recommended exposure limits for the most used ENM, for which a good selection of hazard and exposure data already exist (see Table S1) These values can be used as references for other ENM with similar properties and modes of action, applying frameworks for grouping and read-across for nanomaterials [9]. Materials with similar structures and hazardous properties are grouped into bands and protective measures are defined by the risk levels of these bands
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