A petition was recently submitted to the federal Food & Drug Administration by the Great Lakes Environmental Law Center (GLELC) and the Natural Resources Defense Council (NRDC), requesting the revocation of the regulation addressing pharmaceutical residues in the environment, especially in our waterways. The petition is requesting the immediate revocation of the FDA’s broad rule providing a categorical exclusion for human drugs and a wide range of biologics, including vaccines, tissues, blood and blood components, allergenics, somatic cells, gene therapy, and recombinant therapeutic proteins created by biological processes, that are allowed to seek into the Great Lakes. The challenged provision provides categorical exclusions to the assessments for new drug applicants.

The established safe thresholds for categorical exclusions are not supported by available scientific data. A goal of the Great Lakes Boating Federation is to call on the FDA to set a protective level of drug residue scientifically determined to prevent harm to all citizens of the Great Lakes and, in particular, the 4.3 million boaters who boat and swim within these waterways.

Although wastewater treatment plants are currently equipped to remove chemicals, foreign materials and microorganisms from the water prior to moving them into natural waters, such as streams, lakes and oceans, active drug compounds from humans are not eliminated from the water in the treatment process. Treatment systems permit up to 93% of highly concentrated, active drug compounds to leave the treatment plant. These high concentrations of active drug compounds are harmful to the aquatic ecosystems they are discharged into and for their negative consequences to humans. These compounds, such as Bezafibrate, Ciprofloxacin and Lincomycin—antimicrobials found in small amounts in ground water, and also surface water—can have profound negative effects on endocrine functions, especially during certain stages of the human life cycle, including childhood.

The harm caused by the discharge of highly concentrated, active drug compounds into our waterways is not precisely known, due to the unknown effects of pharmaceutical drugs on organisms and fi sh not intended to consume the drugs. Although extensive scientific research is needed to better understand the impacts of these chemicals, researchers have already observed endocrine disruptions in fi sh in close proximity to wastewater treatment plants. In light of such harm to fi sh and boaters utilizing these waterways, the FDA is called upon to act. Boaters and fi shermen interact more with these affected waters than average citizens do, and thus have more exposure to these compounds than other residents, who normally use the water for daily needs.

Under present rules, the FDA provides categorical exclusions for pharmaceuticals expelled from wastewater plants in concentrations below one part per billion (ppb). However, this threshold permits active compounds to spread through our waterways at unsafe, even harmful, concentrations. Developments in scientific fi ndings strongly support amending this limit.

The Great Lakes Boating Federation, voice to the 4.3 million boaters who use these waterways for swimming, water sports and recreation, is calling on the FDA to review the categorical exclusions for pharmaceuticals at concentrations below 1 ppb, in light of the presently available scientific impacts on the environment and the health of those who use these waterways.

The Great Lakes have taken much abuse. It is time for us to conserve and protect these waters, for our children and grandchildren. We have an opportunity to stand up for the lakes and to help them heal.

The emphasis of this publication’s motto has been to impress upon the boating community the importance of remaining in good stead by enjoying the waters that they sail without taking away or adding anything to them, but leaving them as they are: “Don’t take, don’t deposit.”