SBIR-STTR Award

Consumer products increasingly contain engineered nanomaterials (ENMs) or generate incidental nanoparticles (INPs). ENMs often improve the capabilities of a product, such as through the imbuement of added functionalities in 3D printing filaments or anti-staining ability in construction materials. Other products, such as cosmetic airbrushes and aerosol applicators, disburse small particulates by design which often reach the nanoscale (INPs). Studies continue to reveal adverse human health effects to exposure to ENMs and INPs, especially when airborne. Numerous tools and assays already exist which can accurately characterize the size, concentration, composition, and other properties of ENMs and INPs. While additional improvements to characterization equipment is certainly valuable- especially with regard to the discernment of carbonaceous ENMs from INPs- the greatest impact on human health can be realized through the development of a robust exposure assessment protocol using the equipment already available. We propose to develop an evaluation protocol for the independent assessment of exposure risk to airborne ENMs and INPs released by consumer products- the NanoSafe VerifiedTM protocol. Exposure evaluations will occur in NanoSafe’s Class 1000 cleanroom, where ENM and INP concentration and size distribution will be measured while also sampling released airborne and surface-deposited nanomaterial for compositional characterization using electron microscopy, mass spectroscopy, and Raman spectroscopy. In Phase I, three 3D printer models using seven ENM-containing filaments and three INP-generating cosmetic airbrushes using a variety of formulations will be assessed for exposure risk during operation. These assessments will guide Protocol development, while additional products will be tested in Phase II. In the ultimate commercial vision, NanoSafe will evaluate ENM-containing and INP-generating consumer products for user exposure risk to respirable particulates. Products demonstrating low ENM exposure risk by this NanoSafe VerifiedTM protocol will earn the use of the accompanying label, analogous to UL® or NSF® marks acquired on other products. This mark will encourage consumer purchase of safer ENM- containing and INP-generating products, and in turn, inspire manufacturers to develop consumer products that present lessened ENM and INP exposure risk.

Public Health Relevance Statement:
PROJECT NARRATIVE Engineered nanomaterial (ENM) is increasingly included in consumer products, yet studies continue to reveal negative health effects of prolonged exposure to many ENMs and incidental nanoparticles (INPs). Increasing numbers of consumer products contain ENMs (such as 3D printer filaments and construction materials) and/or generate INPs (including cosmetic airbrushes and aerosols). NanoSafe proposes to provide a third-party evaluation and certification protocol for ENM-containing and INP-generating consumer products to thoroughly assess human exposure to guide consumers toward purchase of units demonstrating lesser risk and to provide incentive for manufacturers to create products with reduced exposure potential.

Project Terms:
3-Dimensional; 3D Print; Address; Aerosols; Airborne Particulate Matter; Atomic Force Microscopy; Attention; base; Biological Assay; building materials; Caliber; Categories; Certification; Construction Materials; consumer product; Cosmetics; Data; Deposition; design; Development; Devices; Electron Microscopy; Engineering; Ensure; Equipment; Equipment Design; Evaluation; exposed human population; Exposure to; Filament; Filler; Filtration; Formulation; Future; Health; Human; improved; Incentives; Inductively Coupled Plasma Mass Spectrometry; Intake; Knowledge; Label; Laboratories; Location; Manufacturer Name; Mass Spectrum Analysis; Measurement; Measures; metallicity; Methodology; Methods; Modeling; nanomaterials; nanoparticle; nanoparticle exposure; nanoparticulate; nanoscale; operation; packaging material; Particulate; Phase; phase 1 testing; Pigments; prevent; Printing; Process; Production; Property; protocol development; Protocols documentation; Raman Spectrum Analysis; reinforcer; research and development; Risk; Safety; Sampling; scaffold; Scanning; sensor; Silicon; skills; Slide; Stains; Surface; temporal measurement; Testing; Time; tool; Transmission Electron Microscopy; Vision

Consumer products increasingly contain engineered nanomaterials (ENMs) or generate respirableparticulate matter (PM) at levels known to introduce negative health effects. While ENMs can improveproduct capabilities, consumers (and even manufacturers) are often unaware of the dangers presented byuse of some products. Crucially, federal oversight and regulatory measures cannot keep pace with the rateat which new products are released which contain new ENMs or release large amounts of undetected PM.Numerous tools and assays already exist which can accurately characterize the size, concentration,composition, and other properties of ENMs and PM. While additional improvements to characterizationequipment is certainly valuable- especially with regard to the discernment of carbonaceous ENMs fromPM- the greatest impact on human health can be realized through the development of an agile exposureassessment service using available cutting-edge characterization equipment and broad mass communicationavenues to support safety-conscious manufacturers and protect consumers.NanoSafe proposes to develop a systematic procedure for rapidly producing robust evaluation protocols forthe independent assessment of exposure risk to airborne ENMs and PM released by consumer products- theNanoSafe TestedTM program. Exposure evaluations will occur in NanoSafe's Class 1000 cleanroom, whereENM and PM concentration and size distribution will be measured alongside sampling for detailedcharacterization. In Phase II, developed test protocols for additive manufacturing products and cosmeticswill continue to be refined, with new protocols for other products presenting high ENM/PM exposure riskto be added, including filtration appliances and masks (Specific Aim #1); this includes evaluation of popularmakeshift personal protective equipment (PPE) designs currently under use by healthcare professionals dueto diminished supplies of PPE during the COVID-19 crisis. Avenues and methods for effectively translatingand communicating technical measurements to a broad consumer base will be developed (Specific Aim#2), and data management systems toward ISO certification will be constructed along with customerengagement to refine communication metrics (Specific Aim #3).In the ultimate commercial vision, NanoSafe will evaluate, classify, and publish the exposure risk presentedto users of ENM-containing and PM-generating consumer products to inform purchasing decisions.Products demonstrating low ENM exposure risk by NanoSafe TestedTM protocols may earn use of aNanoSafe TestedTM label or similar classification of merit for purchase by manufacturers, and watchdogtesting performed by NanoSafe will inform the public about products of especially high risk. These effortswill encourage consumer purchase of safer ENM-containing and PM-generating products, and in turn,inspire manufacturers to develop consumer products that present lessened ENM and PM exposure risk.

Public Health Relevance Statement:
Project Narrative Engineered nanomaterial (ENM) is increasingly included in consumer products, yet studies continue to reveal negative health effects of prolonged exposure to many ENMs or high concentrations of respirable particulate matter (PM). Increasing numbers of consumer products contain ENMs (such as 3D printer filaments and construction materials) and/or generate PM (including cosmetic airbrushes and aerosols). NanoSafe proposes to provide a third-party evaluation and certification protocol for ENM-containing and PM-generating consumer products to thoroughly assess human exposure to inform scientific evaluations, guide consumers toward purchase of units demonstrating lesser risk, and to provide incentive for manufacturers to create products with reduced exposure potential.

Project Terms:
<3D Print><3-D print><3-D printer><3D printer><3D printing>