The Impact of Toxicological Standards on Governance

毒理学标准对治理的影响

• 批准号: 1754980
• 负责人: Naomi Oreskes
• 金额: $ 1.58万
• 依托单位: Harvard University
• 依托单位国家: 美国
• 项目类别: Standard Grant
• 财政年份: 2018
• 资助国家: 美国
• 起止时间: 2018-02-01 至 2023-01-31
• 项目状态: 已结题
• 来源: https://www.nsf.gov/awardsearch/showAward?AWD_ID=1754980&HistoricalAwards=false
• 关键词: Impact; Toxicological; Standards; Governance

This historical study examines how toxicologists and regulators developed Good LaboratoryPractice (GLP) regulations to ensure the reliability of toxicology data supporting drug andchemical regulation and trade. The study?s central goal is to understand how toxicological data have traveled out of the laboratory and across political jurisdictions. The study traces how GLP rules that initially crafted to resolve a crisis in toxicology were used to regulate domestic and international chemical testing and trade. This study will contribute to our understanding of the interaction of trade and public health regulations. This study will help to evaluate impacts on public health and develop more effective policies.This study seeks to understand how and why GLP was developed in the U.S., and why GLP appeared to OECD states to be a good solution to the problem of regulatory harmonization and facilitation of international trade. It asks how a particular way of doing laboratorywork was rendered authoritative, and what consequences this has had in governmental efforts tocontrol chemicals. The investigators will analyze archival records and published documents from regulatory agencies, toxicologists, and international standard-setting bodies, and conduct oral histories with participants. Findings from the study will inform the literature in the field of STS on the history of toxicology and risk analysis, the development of regulatory policies, and values in science.

这项历史研究考察了毒理学家和监管者如何制定良好的实验室实践(GLP)法规，以确保支持药品和化学品监管和贸易的毒理学数据的可靠性。S研究的核心目标是了解毒物数据是如何走出实验室并跨越政治司法管辖区的。这项研究追溯了最初为解决毒理学危机而制定的GLP规则是如何被用来规范国内和国际化学测试和贸易的。这项研究将有助于我们理解贸易和公共卫生法规之间的相互作用。这项研究将有助于评估对公共健康的影响，并制定更有效的政策。本研究试图了解美国如何以及为什么发展普洛斯，以及为什么普洛斯在经合组织国家看来是监管协调和国际贸易便利化问题的良好解决方案。它询问一种特定的实验室工作方式是如何变得具有权威性的，以及这对政府控制化学品的努力产生了什么后果。调查人员将分析来自监管机构、毒物学家和国际标准制定机构的档案记录和公布的文件，并与参与者进行口述历史。这项研究的结果将为STS领域的文献提供关于毒理学和风险分析的历史、监管政策的发展和科学价值的信息。

项目成果

Creating Regulatory Harmony: The Participatory Politics of OECD Chemical Testing Standards in the Making

创造监管和谐：经合组织化学测试标准制定中的参与政治

• DOI: 10.1177/01622439211029369
• 发表时间: 2021
• 期刊: & Human Values
• 作者: Lanier-Christensen, Colleen