Why did FDA wait until mandated by Congress under FDAMA 1997 to examine the use of preservatives containing mercury?
Several factors led to examination of mercury-containing preservatives in childhood vaccines. Over the past decade there has been increased attention focused on the health effects of human exposure to mercury, particularly methyl mercury. In 1994, the EPA revised its Reference Dose (RfD) for methylmercury exposure, lowering its guideline for safe exposure from 0.3 to 0.1 microgram per kilogram body weight per day. Prospective studies (in the Seychelles, Faroe Islands and others) of the effects of low dose exposure to methylmercury in the diet were published , and some of these studies raised concern that neurodevelopmental outcomes in children may be subtly affected when their mothers were exposed to methylmercury from dietary sources at levels that were previously thought to be safe. Also in the 1990’s, the CDC’s Advisory Committee on Immunization Practices (ACIP) and other recommending bodies added new vaccines (e.g., hepatitis B, Hib), some of which contained thimerosal as a preserv
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