Tuesday, November 25, 2008

Administrative law, the environment, and mercury

21 CFR 25.34 (Code of Federal Regulations) is eye-opening. It allows the FDA to basically ignore the environmental implications of certain things in that list, such as Class II medical devices and electronic products (Class II means that they could be unsafe, but probably aren't).

In 67 FR 7620 (enjoy the ugly document, courtesy of the federal government!), the FDA made its move to finally reclassify dental mercury from a Class I medical device (completely safe) to a Class II medical device.

In section VII, it states this:

VII. Environmental Impact

The agency has determined under 21 CFR 25.34(b) that this action is of a type that does not individually or cumulatively have a significant effect on the human environment. Therefore, neither an environmental assessment nor an environmental impact statement is required.

How cute. Meanwhile, in 2005 the WHO stated that mercury from dental amalgams + laboratory and medical devices contributed 53% of total mercury emissions.[1]

For those curious as to how I ended up reading the CFR, I was reading an article[2] from the Journal of Law and Health.