Introduction

The FDA final rule on amalgam is based on a superficial review of the literature on the health effects of mercury vapor, and estimates of mercury vapor exposure from dental amalgam, both of which that are incomplete, ill-composed, ill-conceived and inaccurate.

Although purporting to be a ‘risk assessment’, the documentation is nothing of the sort. An effective and defensible risk assessment complies with the standards of practice endorsed and espoused by the professional risk assessment community.

Those standards of practice have been well presented and expressly documented by the US EPA (2004, 1998, 1994) and most recently, bythe US National Academy of Sciences (US NAC, 2008). Those standards of practice demand:

1) a methodical analysis of the ‘weight of evidence’ of the toxicological literature;

2) a detailed quantitative analysis of that toxicological database towards the determination of a defensible regulatory reference exposure level

3) a methodical, transparent and defensible quantification of exposure for comparison to that reference exposure level.

All three of these critical steps are missing from the FDA final rule.

 

[readon url=”index.php?option=com_content&view=article&id=186&Itemid=236″]What is a defensible regulatory risk assessment?[/readon]

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