The Impact of Toxicological Standards on Governance

毒理学标准对治理的影响

基本信息

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

项目摘要

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.

这项历史研究探讨了毒理学家和监管机构如何制定良好的实验室（GLP）法规，以确保支持药物和化学调节和贸易的毒理学数据的可靠性。这项研究的中心目标是了解毒理学数据如何从实验室和跨政治司法管辖区中传播出来。该研究追踪了最初为解决毒理学危机而制定的GLP规则用于规范国内和国际化学测试和贸易。这项研究将有助于我们理解贸易与公共卫生法规的相互作用。这项研究将有助于评估对公共卫生的影响并制定更有效的政策。这项研究旨在了解美国如何以及为什么在美国开发GLP，以及为什么GLP在经合组织中似乎是对监管统一和促进国际贸易的良好解决方案。它询问了一种特定的实验室方式的权威，以及这在政府努力控制化学物质方面产生了什么后果。研究人员将分析监管机构，毒理学家和国际标准设定机构的档案记录和发布的文件，并与参与者进行口述历史。该研究的结果将为STS领域的文献提供有关毒理学和风险分析史，监管政策的发展以及科学价值观的文献。