NanoSafe Tested™ Facilities: Point-of-Need Exposure Assessment for Ultrafine Particulates, Microplastics, and Engineered Nanomaterials in Production Environments

ITA International, LLC Response to NIEHS; NIH, PA-23-230, R43 SBIR Phase I PROJECT SUMMARY New production technologies, e.g., 3D printers, generate high concentrations of airborne ultrafine particulates (UFPs), micro- and nano-plastics (MNPs), and engineered nanomaterials (ENMs) such as nanometals and carbon nanotubes (CNTs); likewise, the community is now recognizing legacy production techniques, e.g., injection molding, also produce these respiratory threats to human health. Guidance from occupational health bodies is still under development for many of these emerging materials, leaving users with serious gaps regarding exposure assessment and mitigation. Current exposure assessment methodologies are unable to reliably quantify airborne concentrations of UFP/MNP/ENMs in realistic production settings, where these particulates are co-mixed with each other and additional ambient or process-related particulates. Under established guidance, facilities that handle carbonaceous nanomaterials such as CNTs, for instance, are directed to use thermogravimetric methods (NIOSH Method 5040) for quantification of total elemental carbon, which cannot distinguish CNTs from many common production materials such as carbon black. This is problematic, since their recommended exposure levels (RELs) differ by 3500x (1 µg/m3 for CNTs vs. 3.5 mg/m3 for carbon black). Further, toxicological determinations are still developing for UFP/MNP/ENMs, with new compositions generated by emerging technologies adding to the backlog yearly. ENMs that have been in use for decades now have recommended exposure levels established based on robust toxicological studies, and these are very low compared to general dust standards. Current established guidance suggests the total dust permissible exposure level (PEL) of 15 mg/m3 be applied to UFPs and MNPs, despite a growing body of literature cataloguing negative health effects at a fraction of this concentration. ITA proposes to develop a holistic methodology for quantifying UFP/MNP/ENM concentrations in production settings that can reliably quantify compositional contributions for comparison to established RELs. Concurrently, ITA will expand its model for the assessment of toxicological potential of UFP/MNP/ENMs for which specific RELs are yet to be established. Ultimately, these tools will be leveraged in the creation of the NanoSafe Tested™ Facilities service, an expansion to the successful, NIEHS-supported NanoSafe Tested™ program which has generated ~$250,000 in revenue for commercial product testing while the Phase II SBIR project is yet ongoing. ITA will provide a holistic UFP/MNP/ENM exposure assessment and remediation consultation service to manufacturers to quantify and reduce worker and environmental exposures. Facilities who choose to become NanoSafe Tested™ will earn the use of the accompanying label to attract and retain premier talent in their production facilities as well as advertise their dedication to environmental health and safety to their customers and shareholders.