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TRAAC framework to improve regulatory acceptance and wider usability of tools and methods for safe innovation and sustainability of manufactured nanomaterials
NanoImpact ( IF 4.9 ) Pub Date : 2023-04-09 , DOI: 10.1016/j.impact.2023.100461
Neeraj Shandilya 1 , Marie-Sophie Barreau 1 , Blanca Suarez-Merino 2 , Andrea Porcari 3 , Daniela Pimponi 3 , Keld Alstrup Jensen 4 , Wouter Fransman 1 , Remy Franken 1
Affiliation  

There has been an increasing use of advanced materials, particularly manufactured nanomaterials, in industrial applications and consumer products in the last two decades. It has instigated concerns about the sustainability, in particular, risks and uncertainties regarding the interactions of the manufactured nanomaterials with humans and the environment. Consequently, significant resources in Europe and beyond have been invested into the development of tools and methods to support risk mitigation and risk management, and thus facilitate the research and innovation process of manufactured nanomaterials. The level of risk analysis is increasing, including assessment of socio-economic impacts, and sustainability aspects, moving from a conventional risk-based approach to a wider safety-and-sustainability-by-design perspective. Despite these efforts on tools and methods development, the level of awareness and use of most of such tools and methods by stakeholders is still limited. Issues of regulatory compliance and acceptance, reliability and trust, user-friendliness and compatibility with the users' needs are some of the factors which have been traditionally known to hinder their widespread use. Therefore, a framework is presented to quantify the readiness of different tools and methods towards their wider regulatory acceptance and downstream use by different stakeholders. The framework diagnoses barriers which hinder regulatory acceptance and wider usability of a tool/method based on their Transparency, Reliability, Accessibility, Applicability and Completeness (TRAAC framework). Each TRAAC pillar consists of criteria which help in evaluating the overall quality of the tools and methods for their (i) compatibility with regulatory frameworks and (ii) usefulness and usability for end-users, through a calculated TRAAC score based on the assessment. Fourteen tools and methods were assessed using the TRAAC framework as proof-of-concept and for user variability testing. The results provide insights into any gaps, opportunities, and challenges in the context of each of the 5 pillars of the TRAAC framework. The framework could be, in principle, adapted and extended to the evaluation of other type of tools & methods, even beyond the case of nanomaterials.



中文翻译:

TRAAC 框架,以提高监管机构的接受度和更广泛的工具和方法的可用性,以实现制造纳米材料的安全创新和可持续性

在过去二十年中,工业应用和消费品中越来越多地使用先进材料,尤其是人造纳米材料。它引发了对可持续性的担忧,特别是关于人造纳米材料与人类和环境相互作用的风险和不确定性。因此,欧洲及其他地区投入了大量资源用于开发支持风险缓解和风险管理的工具和方法,从而促进人造纳米材料的研究和创新过程。风险分析的水平正在提高,包括对社会经济影响和可持续性方面的评估,从传统的基于风险的方法转向更广泛的安全和可持续性设计视角。尽管在工具和方法开发方面做出了这些努力,但利益相关者对大多数此类工具和方法的认识和使用水平仍然有限。监管合规性和接受性、可靠性和信任、用户友好性和与用户需求的兼容性等问题是传统上已知阻碍其广泛使用的一些因素。因此,提出了一个框架来量化不同工具和方法对不同利益相关者更广泛的监管接受和下游使用的准备情况。该框架根据其透明度、可靠性、可访问性、适用性和完整性(TRAAC 框架)来诊断阻碍监管机构接受和更广泛使用工具/方法的障碍。每个 TRAAC 支柱都包含标准,通过基于评估计算出的 TRAAC 分数,这些标准有助于评估工具和方法的整体质量 (i) 与监管框架的兼容性和 (ii) 对最终用户的实用性和可用性。使用 TRAAC 框架评估了 14 种工具和方法作为概念验证和用户可变性测试。结果提供了对 TRAAC 框架 5 个支柱中每个支柱背景下的任何差距、机遇和挑战的见解。原则上,该框架可以适应并扩展到其他类型的工具和方法的评估,甚至超出纳米材料的范围。通过基于评估计算出的 TRAAC 分数。使用 TRAAC 框架评估了 14 种工具和方法作为概念验证和用户可变性测试。结果提供了对 TRAAC 框架 5 个支柱中每个支柱背景下的任何差距、机遇和挑战的见解。原则上,该框架可以适应并扩展到其他类型的工具和方法的评估,甚至超出纳米材料的范围。通过基于评估计算出的 TRAAC 分数。使用 TRAAC 框架评估了 14 种工具和方法作为概念验证和用户可变性测试。结果提供了对 TRAAC 框架 5 个支柱中每个支柱背景下的任何差距、机遇和挑战的见解。原则上,该框架可以适应并扩展到其他类型的工具和方法的评估,甚至超出纳米材料的范围。

更新日期:2023-04-14
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