Pharmaceutical drugs in drinking water are a growing concern for both aquatic and human health. Water samples from the Great Lakes and other waterbodies often reveal potentially harmful levels of many drugs, including antibiotics, steroids and other hormones, cancer therapies, lipid regulators and anti-inflammatory drugs. These drugs may get into our water supply from direct disposal or through human waste, since the body does not fully break down all drugs taken in.
Unfortunately, our wastewater treatment plants don’t have the technology to filter the drugs out – one study showed that up to 93% of active drug compounds leave the wastewater treatment plant at a concentration that is just as active as when the waste entered the sewers. As a result, the drugs enter the environment and wreak havoc on wildlife and human health. For example, many pharmaceuticals contain endocrine disrupting chemicals which can harm sexual reproduction organs in both fish and humans. For more background on this issue, see Elizabeth Royte’s article Drugging Our Waters from NRDC’s OnEarth magazine. Or for something a bit lighter, check out Stephen Colbert’s segment on the subject – funny and scary at the same time.
The federal Food and Drug Administration (FDA) is supposed to review new drugs to be sure they are safe when they enter the environment. However, the FDA has adopted a loophole (a “categorical exclusion” codified at 21 CFR § 25.31) in which it exempts new drugs from environmental review if the estimated concentration of the new drug in the water supply will be below 1 part per billion. This may sound miniscule, but with many drugs entering our water supply, the science is clear that the exemption threshold is just not adequate to protect our health and should be repealed.
To close this loophole, the Great Lakes Environmental Law Center and the Natural Resources Defense Council recently submitted a petition to the FDA to revoke the exemption and conduct a full environmental review of new drugs that enter the environment. (The petition is the result of great work on this issue by Wayne Environmental Law Clinic student Kaitlyn Sundt.) The environmental review sought by the Great Lakes Environmental Law Center and NRDC would not prohibit new drugs, even if they are found to cause public health and environmental harm, but it would require the FDA to study the potential harm and acknowledge environmental risks.
If the FDA does not address the petition within a reasonable time or denies the petition without explanation, then legal action may be necessary to compel the FDA to act. Regardless of the FDA’s ultimate decision, the petition brings a critical topic to the forefront and has the potential to start a productive policy discussion about how to address the issue of controlling pharmaceuticals in the environment.