Petition addresses pharmaceuticals in Great Lakes

CHICAGO — The Great Lakes Environmental Law Center (GLELC) and the Natural Resources Defense Council (NRDC) want pharmaceutical residues out of waterways, and have taken a stand through a petition sent to the US Food & Drug Administration.

The petition requests 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 seep into the Great Lakes. The challenged provision provides categorical exclusions to the assessments for new drug applicants.

The petitioning parties contend that established safe thresholds for categorical exclusions are not supported by available scientific data. The goal of the advocacy group, Great Lakes Boating Federation, is to ask the FDA to establish limits on drug residues that enter the lakes (primarily through waste water), as not to cause harm to those living near the lakes and who use the lakes for recreation.

Under present rules, the FDA provides categorical exclusions for pharmaceuticals expelled from wastewater plants in concentrations below one part per billion (ppb). The petitioners say, however, that this threshold permits active compounds to spread through our waterways at unsafe, even harmful, concentrations. The effects of these concentrations in lake water supply has not been fully studied, according to the group’s statement, but researchers have observed endocrine disruption in fish in close proximity to wastewater treatment plants.

Ned Dikmen, chairman of the Great Lakes Boating Federation, 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 FDA should regulate and enforce safe water standards,” he said in a statement. “We should not have to be scared of swimming, sport fishing and boating within these waterways.”

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