Workshop: A roadmap for developing and implementing minimum nonomaterial characterization reporting requirements within regulatory ..., Summer/Fall 2012, Research Triangle Park, NC

摘要#1239092本提案旨在为研讨会提供与会者差旅支持，以便在监管和开发社区内启动最低纳米材料表征报告要求的制定和实施。该研讨会是由国际生命科学研究所(ILSI)研究基金会风险科学创新与应用中心(RSIA)开发并领导的一个项目(NanoCharacter)的一部分。尽管对工程纳米材料对环境和健康的影响的研究越来越多，但在确保新兴材料和产品安全方面的进展仍然受到以下因素的限制：已发表的研究中对材料的定性较差，研究界对表征标准和准则的采纳程度很低。NanoCharacter项目正在制定一个框架和路线图，详细说明需要做些什么来提高纳米材料影响研究的质量和用途，方法是鼓励在特定研究领域内采用表征一致性；在国际上、在烟囱和利益攸关方之间就路线图达成共识，并建立一个多方利益攸关方小组，以监测和报告路线图的实施情况，并根据需要调整路线图，以促进采用一致的表征和报告。计划于2012年8月至10月在北卡罗来纳州三角研究园区的国家环境健康科学研究所举行研讨会(确切日期取决于设施和参与者的可用性)。它将为纳米字符项目-S指导委员会和专家小组提供一个论坛，与学术界、政府和监管机构的领导人、标准制定机构和主要出版社的编辑接触，以征求和考虑那些最有可能影响任何此类框架的成功实施的人的意见。研讨会的输出将包括制定和实施最低纳米材料表征报告要求的框架和路线图。这将是一份单独出版的文件，将由项目小组在随后的几个月内编写。拟议活动的智力价值：对纳米材料-生物相互作用的严格、可重复的研究严重依赖于相关和一致的材料物理化学表征。同样，这一领域越来越多的研究的价值取决于公认的定性方法和程序。拟议的活动将大大提高在该领域进行的研究的质量和价值。拟议活动产生的广泛影响：利用工程纳米材料的产品的可持续和负责任的商业化取决于合理的风险评估。这项活动将进一步加强国家和国际两级此类评价的基础。

Abstract#1239092MaynardThis proposal is to provide participant travel support for a workshop to initiate the development and implementation of minimum nanomaterial characterization reporting requirements within regulatory and development communities. The workshop is part of a project (NanoCharacter)developed and led by the Center for Risk Science Innovation and Application (RSIA) at theInternational Life sciences Institute (ILSI) Research Foundation. Despite increasing research on the environmental and health impacts of engineered nanomaterials, progress in ensuring the safety of emerging materials and products remains limited by poormaterial characterization in published studies and minimal adoption of characterization standards and guidelines within the research community. The NanoCharacter project is developing a framework and roadmap detailing what needs to be done to improve the quality and utility of nanomaterial impact research through encouraging the adoption of characterization consistency within particularstudy domains; building consensus on the roadmap internationally, across stovepipes, and across stakeholders, and establishing a multi-stakeholder panel to monitor and report out the implementation of the roadmap and to adapt the roadmap as necessary to facilitate adoption of consistent characterization and reporting.The planned workshop will be held between August and October 2012 at the National Institute for Environmental Health Sciences in Research Triangle Park, NC (the precise dates are dependent on facility and participant availability). It will provide the NanoCharacter project?s Steering Committee and Expert Panel with a forum to engage with leaders from academia, government and regulatory agencies, standard setting bodies and editors of the key publishing houses in order to solicit and consider input from those who are most likely to affect the successful implementation of any such framework.Outputs of the workshop will include a framework and roadmap for developing and implementing minimum nanomaterial characterization reporting requirements. This will be a standalone document for publication and will be developed by project teams over the subsequent months.Intellectual merit of the proposed activity: Rigorous, reproducible research into nanomaterial-biologicalinteractions is critically dependent on relevant and consistent materials physicochemical characterization. Likewise, the value of a growing body of research in this area depends on accepted characterization approaches and procedures. The proposed activity will strengthen significantly the quality and value of research undertaken in this domain.Broader impacts resulting from the proposed activity: Sustainable and responsible commercialization of products that utilize engineered nanomaterials depends on sound risk evaluation. This activity will further strengthen the basis for such evaluations, nationally and internationally.