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

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 from 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.