The United States Environmental Protection Agency is working with the New York State Department of Environmental Conservation to address two pharma facilities and their associated public wastewater treatment plants fingered by the U.S. Geological Survey as the source of drugs in the environment.
The New York environmental officials are taking steps with one of the drugmakers by starting discussions with corporate officials regarding pretreatment of pharmaceutical waste streams, according to an EPA spokesperson via email. The state agency asked the unnamed company for a commitment to work with USGS on pre-treating wastes prior to discharge to the sewer system. State officials have visited the site and plan to speak with company officials, the spokesperson says.
The state agency also is modifying the wastewater treatment plant's permit to impose toxicity testing. EPA says it will continue to work with New York officials and is prepared to impose monitoring requirements for the pharma waste streams if necessary.
Meanwhile, the FDA says it is "carefully evaluating" the USGS data. "We are in communication with USGS and EPA to provide our perspective," says an FDA spokesperson via email. "We don't believe these low levels of pharmaceuticals pose any risk to human health."
The findings are not directly relevant to the FDA's regulation of drugs, but environmental effects of manufacturing are a consideration in all drug approvals, the spokesperson says.
The EPA, in conjunction with the states, is the primary regulator of discharge from manufacturing facilities.
USGS researchers stumbled on the connection between pharma manufacturing facilities and the traces of drugs found in the wastewater discharged after processing by treatment plants. Researchers were checking processed wastewater as part of a survey, and examining the surroundings for contamination sources (eg, landfills) that may find pathways to the environment.
Lab analysis of the wastewater processed at the two New York plants showed chromatographic peaks that researchers didn't expect to see, and that didn't show up in the analysis of output from wastewater treatment plants having no connection with pharma plants. "It was in trying to explain why the peaks were there that got us to the pharma plants," says Herb Buxton, manager of USGS toxic substances hydrology program, in a phone interview.
"We were surprised by these findings," he says, because of the "common belief that good manufacturing practices and the inherent value of the product would limit the loss of pharmaceuticals" from drug plants.
Buxton adds that the USGS has not tested for the presence of these pharmaceuticals in finished drinking water. Now that we know that these pharmaceuticals are found in the environment, we will include them in future drinking water studies.
- here's a USGS Q&A on the effort