While FDA’s new leadership touts the importance of exemplary science at the agency, a 47-page petition seeking the reconsideration of the agency’s August 4 final rule on mercury-containing dental amalgam trashes the science FDA used in it. The petition also alleges a selective literature search and says that the agency’s clear priority was to “defend at all costs the continued use of mercury in dentistry.” The petition was filed on September 3 by Tulsa, OK, lawyer James M. Love for 17 others, including the Washington group Moms Against Mercury and celebrity osteopath and Internet natural products marketer Joseph Mercola. It seeks a formal ban on encapsulated mercury amalgam fillings or, alternatively, their reclassification into Class III instead of the final rule’s Class II. The petition says a “defensible” amalgam risk assessment would require a detailed and quantitative analysis of the exposure to mercury vapor in the general population, but FDA’s analysis “only alludes to average or typical exposure levels, citing dated (predating 1993) reviews which they themselves only cite other yet older reviews.” Further, it says, FDA’s assessment omits measure of those maximally exposed to mercury vapors—patients with up to 25 mercury-filled teeth. FDA stops at 10, it says. Further, the petition says, FDA’s risk assessment did not assess mercury vapor exposure from fillings in infants as young as 3, notwithstanding evidence that fillings are made in such teeth and notwithstanding EPA’s stipulation in 1998 that such exposures are especially pronounced. In sharp contrast to FDA, the petition says, Health Canada did consider all such extreme exposures when recommending against the use of mercury amalgams in 1995. On the agency’s previously much-criticized literature search to support its position, the petition says the agency failed to utilize “a methodological ‘weight of evidence’ of the toxicological literature.” The petition says that although FDA has the resources and expertise to properly assess amalgam’s risks, its “clear priority is to defend at all costs the continued use of mercury in dentistry—even at the expense of the public health. It is not surprising, therefore, that FDA declined to validly and defensibly compare its estimate of the average or typical mercury vapor exposure to the very reference exposure levels it represents to be safe for the general population.” —James G. Dickinson [Washington Wrap-Up, November]