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“What began as an investigation to help me diagnose mercury-related symptoms in my patients grew into another diagnosis – that of a broken, misused and abused regulatory system.”

– Jane M. Hightower (2009)

How Chemicals Are Regulated

Most Americans are under the impression that the government is out there actively protecting us from exposure to harmful chemicals. If you asked the average citizen on the street for their ideas on the matter, most would assume that every chemical we’re exposed to must pass rigorous safety testing before it’s allowed to be used.

I’ve run this experiment over and over again. I ask someone: “Out of the 80,000-plus chemicals that are in commercial use today, how many do you think have been tested for safety?” Usually the answer is something like, ‘I would assume all of them.’ Their jaw drops when I tell them that only around 4% of the 80,000 have ever been submitted with any kind of health safety data. This includes just 15% of the 21,000 or so chemicals KNOWN TO BE HARMFUL. As for the rest, we have no idea whether they’re harmful or not, because no one has ever studied them.

If you’ve read this book, you no longer have such illusions. But you still might wonder: How does this happen? Why isn’t the government protecting us? For the answer to these questions we need to delve deeper into the way that chemicals are regulated and how the EPA and other such agencies function.

Who regulates toxic chemicals and substances?

Chemical regulation usually falls under the jurisdiction of the Environmental Protection Agency (EPA), although the Food and Drug Administration (FDA) also gets involved, as does the U.S. Department of Agriculture (USDA). But the primary two are the EPA and the FDA. Sometimes the two agencies overlap and it isn’t exactly clear who should be doing the monitoring. For example, pesticides are a matter for the EPA, since they are sprayed into the environment. But they can also be an FDA matter, since they leave chemical residues in food.

The FDA has taken the lead on nanotechnology thus far (as much as you can call putting out a position statement and voluntary guidelines as “taking the lead”), but with all the potential nanotechnology uses, this potential toxin could fall under the jurisdiction of multiple agencies. The Centers for Disease Control and Prevention (CDC) may also publish research from time to time related to toxic exposures, but they are not involved in actual regulation.

Basically, you have a patchwork of agencies involved in chemical regulation. Even the EPA, the main agency in charge, was a bit of an afterthought President Nixon was forced to create the Environmental Protection Agency by executive order in response to public concern (a feat no republican would dare attempt today). These regulatory agencies are largely controlled by a separate government entity known as the Office of Management & Budget, or OMB. This agency is essentially in charge of regulating the regulators, providing guidelines on how they should do their job and what their regulatory functions should be. Because the OMB is basically a group within the White House that can be largely directed by the president, the policies of the Office can change considerably from administration to administration. Unfortunately, politics play a role in all of these agencies, and many of the appointees to key positions in these regulatory agencies come from the industries they are regulating, giving corporate interests an enormous amount of power.

All new chemicals must be submitted to the EPA for approval. But this submission process merely lists the chemical name, its rough structure (actual details are hidden behind patent laws), and data on acute toxicity. There’s nothing that would assess its overall health effects, so in that regard, the approval is more akin to a patent application than an actual safety approval. Once a chemical is approved, it is typically available for unrestricted use. Anybody can use it in any quantity they desire without informing the EPA, with just a few exceptions.

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