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

项目摘要 消费产品越来越多地含有工程纳米材料(ENM)或产生可呼吸的 已知会对健康造成负面影响的颗粒物(PM)水平。而新能源管理可以改进 产品能力，消费者(甚至制造商)往往没有意识到 一些产品的使用。关键是，联邦监管和监管措施无法跟上这一速度。 在哪些地方发布包含新的ENM的新产品或发布大量未检测到的PM 已经有许多工具和分析方法可以准确地表征大小、浓度、 弹性膜和粉末冶金的组成及其他性质虽然对表征的其他改进 设备当然是有价值的--特别是关于从 PM-对人类健康的最大影响可以通过开发灵活的暴露来实现 使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建议开发一种系统的程序，用于快速生成可靠的评估方案 对消费产品释放的空气中的环氧乙烷和PM的暴露风险的独立评估-- NanoSafe TestedTM计划。暴露评估将在NanoSafe的1000级洁净室进行， 将在采样的同时测量ENM和PM的浓度和粒度分布，以获得详细的 人物刻画。在第二阶段，制定了添加剂制造产品和化妆品的测试方案 将继续完善，针对其他产品的新协议将带来较高的ENM/PM暴露风险 有待增加，包括过滤用具和口罩(具体目标1)；这包括对受欢迎的 目前医疗保健专业人员正在使用的临时个人防护装备(PPE)设计 这与新冠肺炎危机期间个人防护用品供应减少有关。有效翻译的途径和方法 并将制定向广泛的消费者基础传播技术措施(具体目标 #2)，并将与客户一起建设面向ISO认证的数据管理系统 参与改进沟通指标(具体目标3)。 在最终的商业愿景中，NanoSafe将对呈现的暴露风险进行评估、分类和发布 向含有ENM和PM-生成的消费产品的用户提供购买决策的信息。 通过NanoSafe TestedTM协议证明ENM暴露风险较低的产品可能会获得 制造商购买的NanoSafe TestedTM标签或类似的优点分类，以及WatchDog NanoSafe进行的测试将向公众通报具有特别高风险的产品。这些努力 将鼓励消费者购买更安全的含有环氧乙烷和PM的产品，反过来， 鼓励制造商开发具有较低的ENM和PM暴露风险的消费产品。

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.