The Impact of Toxicological Standards on Governance

这项历史性的研究探讨了毒理学家和监管机构如何制定良好的制药规范（GLP）法规，以确保支持药物和化学品监管和贸易的毒理学数据的可靠性。书房？的中心目标是了解毒理学数据是如何走出实验室并跨越政治管辖区的。 该研究追溯了最初为解决毒理学危机而制定的GLP规则如何用于规范国内和国际化学品测试和贸易。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卫生的影响，并制定更有效的政策。这项研究旨在了解GLP是如何以及为什么在美国发展的，以及为什么GLP在经合组织国家看来是解决监管协调和促进国际贸易问题的一个很好的办法。它提出了这样一个问题：实验室工作的一种特殊方式是如何被赋予权威性的，以及这对政府控制化学品的努力产生了什么样的影响。研究人员将分析来自监管机构、毒理学家和国际标准制定机构的档案记录和出版文件，并与参与者进行口述历史。该研究的结果将为STS领域的文献提供毒理学和风险分析的历史，监管政策的发展以及科学价值观的信息。

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.