On Aug. 12, 2008, EPA announced its intention to submit an Information Collection Request (“ICR”) to the Office of Management and Budget, for collection of information from the Health Services Industry. 73 FR 46903 This ICR is the first step by EPA toward possible regulation of the disposal of unused pharmaceuticals, and the implementation of effluent limitations for disposal of unused pharmaceuticals to sanitary sewer systems.

In 2006, EPA identified the Health Services Industry as a candidate for possible effluent guidelines as part of its Clean Water Act (“CWA”) Section 304b Effluent Guidelines Review. 71 FR 76661. The Health Services Industry includes establishments engaged in various aspects of human health (e.g., hospitals, dentists, long-term care facilities) and animal health (e.g., veterinarians). EPA has expressed concerns about the disposal of unused pharmaceuticals and, through the ICR, is seeking to collect information to better understand the current management practices and magnitude of discharges of unused pharmaceuticals to the waters of the United States. Recent studies have indicated the presence of significant concentrations of pharmaceuticals in waters of the United States, particularly downstream of municipal wastewater treatment plants. EPA believes that Health Services Industry facilities may dispose of unused, expired and unwanted medications to the sanitary sewer, where these compounds may pass through the local Publicly Owned Treatment Works (“POTW”) and enter surface waters. The discharges of Health Services facilities are not currently regulated or monitored under the CWA, and EPA has only limited data regarding this practice. Through this ICR, which is a mandatory data collection effort, EPA plans to investigate the following areas:

  • What are the current industry practices for disposing of unused pharmaceuticals?
  • Which pharmaceuticals are being disposed of and at what quantities?
  • What are the options for disposing of unused pharmaceuticals, other than to the local sewer system? 
  • What factors influence disposal decisions? 
  • Do disposal practices differ within industry sectors? 
  • What Best Management Practices (“BMPs”) could facilities implement to reduce the generation of unused pharmaceuticals? 
  • What reductions in the quantities of pharmaceuticals discharged to POTWs would be achieved by implementing BMPs or alternative disposal methods? 
  • What are the costs of current disposal practices, compared with the costs of implementing BMPs or alternative disposal methods?

If EPA moves forward with implementation of a national, categorical pretreatment standard, there is the potential for significant impacts to the affected parties. Affected parties include the Health Services Industry and the nation’s municipalities, but could also extend to the pharmaceutical industry itself. EPA is encouraging the submission of comments on the proposed ICR. If you have further questions or require advice on preparing comments on EPA’s intention to submit an ICR, please contact one of the attorneys listed below, or the Reed Smith attorney with whom you regularly work.