NanoSafe Tested Third Party Verification Process for Characterizing Exposures to Products Containing Engineered Nanomaterials

项目摘要 消费品越来越多地含有工程纳米材料（ENM）或产生可吸入的 颗粒物（PM）在已知的水平引入负面健康影响。虽然ENM可以改善 由于产品的性能，消费者（甚至制造商）往往没有意识到 使用一些产品。最关键的是，联邦的监督和监管措施跟不上这一速度 在该温度下，释放含有新的ENM或释放大量未检测到的PM的新产品。 已经存在许多工具和测定法，其可以准确地表征样品的大小、浓度， 组合物以及ENM和PM的其他性质。虽然对表征的额外改进 设备当然是有价值的-特别是关于碳质ENM的辨别， PM-对人类健康的最大影响可以通过敏捷暴露的发展来实现 利用现有的尖端表征设备和广泛的大众传播提供评估服务 支持具有安全意识的制造商和保护消费者的途径。 NanoSafe建议开发一个系统的程序，用于快速生成强大的评估协议， 对消费品释放的空气环境物质和颗粒物的暴露风险进行独立评估， NanoSafe TestedTM程序。暴露评估将在NanoSafe的1000级洁净室进行， 将测量ENM和PM的浓度和粒度分布，同时进行采样， 特征化在第二阶段，为增材制造产品和化妆品开发了测试方案 将继续完善，其他产品的新协议具有高ENM/PM暴露风险 包括过滤器具和口罩（具体目标#1）;这包括对受欢迎的 医疗专业人员目前正在使用的临时个人防护设备（PPE）设计， 2019冠状病毒病危机期间个人防护装备供应减少。有效翻译的途径和方法 并将技术测量结果传达给广大的消费者（具体目标 #2），并将与客户一起沿着构建面向ISO认证的数据管理系统 参与完善沟通指标（具体目标#3）。 在最终的商业愿景中，NanoSafe将评估、分类和发布所呈现的暴露风险 向含有ENM和产生PM的消费品的用户提供购买决策信息。 通过NanoSafe TestedTM协议证明ENM暴露风险较低的产品可能会获得 NanoSafe TestedTM标签或制造商和监管机构购买的类似价值分类 NanoSafe进行的测试将告知公众特别高风险的产品。这些努力 将鼓励消费者购买更安全的含ENM和产生PM的产品，反过来， 鼓励制造商开发降低ENM和PM暴露风险的消费品。

Project Summary Consumer products increasingly contain engineered nanomaterials (ENMs) or generate respirable particulate matter (PM) at levels known to introduce negative health effects. While ENMs can improve product capabilities, consumers (and even manufacturers) are often unaware of the dangers presented by use of some products. Crucially, federal oversight and regulatory measures cannot keep pace with the rate at 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 characterization equipment is certainly valuable- especially with regard to the discernment of carbonaceous ENMs from PM- the greatest impact on human health can be realized through the development of an agile exposure assessment service using available cutting-edge characterization equipment and broad mass communication avenues to support safety-conscious manufacturers and protect consumers. NanoSafe proposes to develop a systematic procedure for rapidly producing robust evaluation protocols for the independent assessment of exposure risk to airborne ENMs and PM released by consumer products- the NanoSafe TestedTM program. Exposure evaluations will occur in NanoSafe’s Class 1000 cleanroom, where ENM and PM concentration and size distribution will be measured alongside sampling for detailed characterization. In Phase II, developed test protocols for additive manufacturing products and cosmetics will continue to be refined, with new protocols for other products presenting high ENM/PM exposure risk to be added, including filtration appliances and masks (Specific Aim #1); this includes evaluation of popular makeshift personal protective equipment (PPE) designs currently under use by healthcare professionals due to diminished supplies of PPE during the COVID-19 crisis. Avenues and methods for effectively translating and 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 customer engagement to refine communication metrics (Specific Aim #3). In the ultimate commercial vision, NanoSafe will evaluate, classify, and publish the exposure risk presented to 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 a NanoSafe TestedTM label or similar classification of merit for purchase by manufacturers, and watchdog testing performed by NanoSafe will inform the public about products of especially high risk. These efforts will 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.