PDF(Pubmed)
Abstract：
UNASSIGNED: In 2015, the U.S. Consumer Product Safety Commission (CPSC) received and then, in 2017, granted a petition under the Federal Hazardous Substances Act to declare certain groups of consumer products as banned hazardous substances if they contain nonpolymeric, additive organohalogen flame retardants (OFRs). The petitioners asked the CPSC to regulate OFRs as a single chemical class with similar health effects. The CPSC later sponsored a National Academy of Sciences, Engineering, and Medicine (NASEM) report in 2019, which ultimately identified 161 OFRs and grouped them into 14 subclasses based on chemical structural similarity. In 2021, a follow-up discussion was held among a group of scientists from both inside and outside of the CPSC for current research on OFRs and to promote collaboration that could increase public awareness of CPSC work and support the class-based approach for the CPSC\'s required risk assessment of OFRs.
UNASSIGNED: Given the extensive data collected to date, there is a need to synthesize what is known about OFR and how class-based regulations have previously managed this information. This commentary discusses both OFR exposure and OFR toxicity and fills some gaps for OFR exposure that were not within the scope of the NASEM report. The objective of this commentary is therefore to provide an overview of the OFR research presented at SOT 2021, explore opportunities and challenges associated with OFR risk assessment, and inform CPSC\'s work on an OFR class-based approach.
UNASSIGNED: A class-based approach for regulating OFRs can be successful. Expanding the use of read-across and the use of New Approach Methodologies (NAMs) in assessing and regulating existing chemicals was considered as a necessary part of the class-based process. Recommendations for OFR class-based risk assessment include the need to balance fire and chemical safety and to protect vulnerable populations, including children and pregnant women. The authors also suggest the CPSC should consider global, federal, and state OFR regulations. The lack of data or lack of concordance in toxicity data could present significant hurdles for some OFR subclasses. The potential for cumulative risks within or between subclasses, OFR mixtures, and metabolites common to more than one OFR all add extra complexity for class-based risk assessment. This commentary discusses scientific and regulatory challenges for a class-based approach suggested by NASEM. This commentary is offered as a resource for anyone performing class-based assessments and to provide potential collaboration opportunities for OFR stakeholders. https://doi.org/10.1289/EHP12725.
UNASSIGNED: Given the extensive data collected to date, there is a need to synthesize what is known about OFR and how class-based regulations have previously managed this information. This commentary discusses both OFR exposure and OFR toxicity and fills some gaps for OFR exposure that were not within the scope of the NASEM report. The objective of this commentary is therefore to provide an overview of the OFR research presented at SOT 2021, explore opportunities and challenges associated with OFR risk assessment, and inform CPSC\'s work on an OFR class-based approach.
UNASSIGNED: A class-based approach for regulating OFRs can be successful. Expanding the use of read-across and the use of New Approach Methodologies (NAMs) in assessing and regulating existing chemicals was considered as a necessary part of the class-based process. Recommendations for OFR class-based risk assessment include the need to balance fire and chemical safety and to protect vulnerable populations, including children and pregnant women. The authors also suggest the CPSC should consider global, federal, and state OFR regulations. The lack of data or lack of concordance in toxicity data could present significant hurdles for some OFR subclasses. The potential for cumulative risks within or between subclasses, OFR mixtures, and metabolites common to more than one OFR all add extra complexity for class-based risk assessment. This commentary discusses scientific and regulatory challenges for a class-based approach suggested by NASEM. This commentary is offered as a resource for anyone performing class-based assessments and to provide potential collaboration opportunities for OFR stakeholders. https://doi.org/10.1289/EHP12725.
摘要：
■2015年，美国消费品安全委员会（CPSC）收到了，2017年，根据《联邦有害物质法》批准了一份请愿书，宣布某些消费品类含有非聚合物的有害物质为违禁有害物质，添加剂有机卤素阻燃剂（OFR）。请愿人要求CPSC将OFR作为具有类似健康影响的单一化学品类别进行监管。CPSC后来赞助了美国国家科学院，Engineering,和医学（NASEM）在2019年的报告中，最终确定了161个OFR，并根据化学结构相似性将其分为14个亚类。2021年，CPSC内部和外部的一组科学家进行了后续讨论，以进行当前对OFR的研究，并促进合作，以提高公众对CPSC工作的认识，并支持基于班级的方法。CPSC对OFR进行必要的风险评估。
■鉴于迄今为止收集的大量数据，有必要综合有关OFR的知识以及基于类别的法规以前是如何管理这些信息的。本评论讨论了OFR暴露和OFR毒性，填补了一些不在NASEM报告范围内的OFR暴露空白。因此，本评论的目的是概述在SOT2021上提出的OFR研究，探索与OFR风险评估相关的机遇和挑战，并告知CPSC关于基于OFR类别的方法的工作。
■基于类别的OFR调节方法可能是成功的。在评估和管理现有化学品方面，扩大使用读码和使用新方法方法（NAM）被认为是基于类别的过程的必要部分。OFR类别风险评估的建议包括需要平衡火灾和化学安全，并保护弱势群体，包括儿童和孕妇。作者还建议CPSC应该考虑全球，联邦,和国家OFR法规。缺乏数据或毒性数据缺乏一致性可能会给某些OFR亚类带来重大障碍。子类内或子类之间累积风险的可能性，OFR混合物,以及多于一种OFR常见的代谢物都增加了基于类别的风险评估的额外复杂性。本评论讨论了NASEM建议的基于班级的方法的科学和监管挑战。本评论是为进行基于班级的评估的任何人提供的资源，并为OFR利益相关者提供潜在的合作机会。https://doi.org/10.1289/EHP12725.
■鉴于迄今为止收集的大量数据，有必要综合有关OFR的知识以及基于类别的法规以前是如何管理这些信息的。本评论讨论了OFR暴露和OFR毒性，填补了一些不在NASEM报告范围内的OFR暴露空白。因此，本评论的目的是概述在SOT2021上提出的OFR研究，探索与OFR风险评估相关的机遇和挑战，并告知CPSC关于基于OFR类别的方法的工作。
■基于类别的OFR调节方法可能是成功的。在评估和管理现有化学品方面，扩大使用读码和使用新方法方法（NAM）被认为是基于类别的过程的必要部分。OFR类别风险评估的建议包括需要平衡火灾和化学安全，并保护弱势群体，包括儿童和孕妇。作者还建议CPSC应该考虑全球，联邦,和国家OFR法规。缺乏数据或毒性数据缺乏一致性可能会给某些OFR亚类带来重大障碍。子类内或子类之间累积风险的可能性，OFR混合物,以及多于一种OFR常见的代谢物都增加了基于类别的风险评估的额外复杂性。本评论讨论了NASEM建议的基于班级的方法的科学和监管挑战。本评论是为进行基于班级的评估的任何人提供的资源，并为OFR利益相关者提供潜在的合作机会。https://doi.org/10.1289/EHP12725.
