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化学品职业接触起草指南:荷兰评估生殖风险的经验

Drafting guidelines for occupational exposure to chemicals: the Dutch experience with the assessment of reproductive risks.

作者信息

Stijkel A, van Eijndhoven J C, Bal R

机构信息

Department of Science, Technology and Society, Utrecht University, The Netherlands.

出版信息

Am J Ind Med. 1996 Dec;30(6):705-17. doi: 10.1002/(SICI)1097-0274(199612)30:6<705::AID-AJIM7>3.0.CO;2-P.

DOI:10.1002/(SICI)1097-0274(199612)30:6<705::AID-AJIM7>3.0.CO;2-P
PMID:8914717
Abstract

The Dutch procedure for standard setting for occupational exposure to chemicals, just like the European Union (EU) procedure, is characterized by an organizational separation between considerations of health on the one side, and of technology, economics, and policy on the other side. Health considerations form the basis for numerical guidelines. These guidelines are next combined with technical-economical considerations. Standards are then proposed, and are finally set by the Ministry of Social Affairs and Employment. An analysis of this procedure might be of relevance to the US, where other procedures are used and criticized. In this article we focus on the first stage of the standard-setting procedure. In this stage, the Dutch Expert Committee on Occupational Standards (DECOS) drafts a criteria document in which a health-based guideline is proposed. The drafting is based on a set of starting points for assessing toxicity. We raise the questions, "Does DECOS limit itself only to health considerations? And if not, what are the consequences of such a situation?" We discuss DECOS' starting points and analyze the relationships between those starting points, and then explore eight criteria documents where DECOS was considering reproductive risks as a possible critical effect. For various reasons, it will be concluded that the starting points leave much interpretative space, and that this space is widened further by the manner in which DECOS utilizes it. This is especially true in situations involving sex-specific risks and uncertainties in knowledge. Consequently, even at the first stage, where health considerations alone are intended to play a role, there is much room for other than health-related factors to influence decision making, although it is unavoidable that some interpretative space will remain. We argue that separating the various types of consideration should not be abandoned. Rather, through adjustments in the starting points and aspects of the procedure, clarity should be guaranteed about the way the interpretative space is being employed.

摘要

荷兰针对化学品职业接触的标准制定程序,与欧盟程序一样,其特点是一方面的健康考量与另一方面的技术、经济和政策考量在组织上相互分离。健康考量构成了数值指南的基础。这些指南随后会与技术经济考量相结合。接着提出标准,最终由社会事务与就业部确定标准。对这一程序进行分析可能对美国具有参考价值,在美国采用的是其他程序且受到批评。在本文中,我们聚焦于标准制定程序的第一阶段。在这个阶段,荷兰职业标准专家委员会(DECOS)起草一份标准文件,其中提出基于健康的指南。起草工作基于一套评估毒性的起点。我们提出这样的问题:“DECOS是否仅局限于健康考量?如果不是,这种情况会有什么后果?”我们讨论DECOS的起点,并分析这些起点之间的关系,然后探究八份标准文件,其中DECOS将生殖风险视为可能的关键影响。出于各种原因,可以得出结论,这些起点留下了很大的解释空间,而DECOS运用这些起点的方式进一步扩大了这个空间。在涉及性别特异性风险和知识不确定性的情况下尤其如此。因此,即使在仅旨在让健康考量发挥作用的第一阶段,除健康相关因素外,仍有很大空间让其他因素影响决策,尽管不可避免地会留下一些解释空间。我们认为不应摒弃对各类考量进行分离。相反,应通过调整起点和程序的各个方面,确保对解释空间的运用方式清晰明了。

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