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专业判断在化学危害评估与交流中的作用。

The role of professional judgment in chemical hazard assessment and communication.

作者信息

Hamilton John D, Daggett Daniel A, Pittinger Charles A

机构信息

RD&E Operations, JohnsonDiversey, Inc., Sturtevant, WI 53177, USA.

出版信息

Regul Toxicol Pharmacol. 2006 Oct;46(1):84-92. doi: 10.1016/j.yrtph.2006.05.009. Epub 2006 Jul 14.

Abstract

Most hazard assessment guidelines and regulatory requirements--both nationally and internationally--explicitly advocate the use of professional judgment in hazard assessment. However, the practical application of such judgment (i.e., how and when that judgment should be applied) is often left to the assessor's discretion. This can lead to inconsistent guidance on the use, handling, and disposal of chemicals and can ultimately result in ineffective hazard communication and chemical management. This paper traces the regulatory rationale and legislative conventions for applying professional judgment in hazard assessment to key global regulations and professional standards. A series of guidelines for applying professional judgment are drawn from these regulations and standards, consistent with sound toxicological concepts and principles. The guidelines are illustrated by cogent examples drawn from the experiences of professional toxicologists and industrial hygienists charged with complying with the norms of hazard assessment. We contend that these guidelines and supporting examples are fully compliant with international regulations, decision-neutral with regard to the stringency of the assessment, and reflective of the harmonized efforts to develop more effective and complete hazard communications. We discuss the regulatory ramifications and needs for better definition of professional judgment in hazard assessments under GHS and REACH.

摘要

大多数危害评估指南和监管要求——无论是在国内还是国际上——都明确提倡在危害评估中运用专业判断。然而,这种判断的实际应用(即应如何以及何时应用该判断)往往由评估人员自行决定。这可能导致在化学品的使用、处理和处置方面的指导不一致,并最终导致无效的危害沟通和化学品管理。本文追溯了在危害评估中应用专业判断的监管依据和立法惯例,涉及关键的全球法规和专业标准。从这些法规和标准中得出了一系列应用专业判断的指南,这些指南与合理的毒理学概念和原则相一致。这些指南通过从负责遵守危害评估规范的专业毒理学家和工业卫生学家的经验中提取的有说服力的例子加以说明。我们认为,这些指南和支持性例子完全符合国际法规,在评估的严格程度方面不偏向任何一方,并反映了为制定更有效和完整的危害沟通而做出的协调努力。我们讨论了全球化学品统一分类和标签制度(GHS)及《化学品注册、评估、授权和限制法规》(REACH)下危害评估中专业判断的监管影响以及对其进行更明确界定的必要性。

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