Beveridge & Diamond
 

EPA Inspector General Recommends Classification of Additional Pharmaceuticals as Hazardous Wastes When Discarded

Beveridge & Diamond, P.C., May 30, 2012

On May 25, 2012, the U.S. Environmental Protection Agency (“EPA”) Office of Inspector General (“OIG”) issued a report finding that inaction by the Agency in identifying pharmaceuticals that are hazardous wastes when discarded “may result in unsafe disposal and releases of dangerous pharmaceuticals into the environment.”  See EPA-OIG Report No. 12-P-0508.  To address this concern, the OIG made specific recommendations, which the EPA Office of Solid Waste and Emergency Response must respond to within 90 days. 

The OIG asserted that EPA’s hazardous waste regulations under the Resource Conservation and Recovery Act (“RCRA”) “are not keeping up with drug development,” noting that the Food and Drug Administration (“FDA”) has approved hundreds of new drugs since the current list of hazardous waste pharmaceuticals was developed in 1980, and that none of the new drugs have been evaluated for potential regulation under RCRA.  To remedy this problem, the OIG recommended that EPA evaluate existing pharmaceuticals for potential regulation as hazardous wastes, and develop a process for reviewing new pharmaceuticals on a continuing basis.    

The Report also expressed concern that “confusion and a lack of awareness exist among health care facilities, such as hospitals, regarding the applicability of RCRA regulations to their pharmaceutical wastes.”  For this reason, the OIG also recommended that EPA develop a national outreach and compliance assistance plan to improve compliance with the existing rules.

The OIG noted that EPA proposed in 2008 to streamline the requirements for collection and transport of hazardous waste pharmaceuticals by classifying and regulating them as “universal wastes.”  See 73 Fed. Reg. 73,519 (December 2, 2008).  However, the Agency subsequently determined that the 2008 proposal could not be used as a basis for a final rule.  EPA is now planning to develop an alternative proposal for healthcare facility-specific regulations addressing the unique issues that such facilities face.  The Agency currently expects to issue such a proposal for public comment in Spring 2013.   

These developments come in the midst of increasing concerns about pharmaceuticals entering the environment, particularly through discharges into water as a result of manufacturing, use, and disposal.  These issues are also complicated by the fact that many pharmaceuticals are controlled substances subject to regulation by the Drug Enforcement Administration (“DEA”). 

The OIG Report and related developments are likely to affect a wide range of companies, including pharmaceutical manufacturers, retailers, healthcare facility operators, reverse distributors, and waste services companies.

For more information about the OIG Report and related RCRA and DEA developments, please contact Aaron Goldberg at agoldberg@bdlaw.com.  For more information about related developments under the Clean Water Act, please contact khansen@bdlaw.com.  

Overview

News

Presentations

Media Contact





Attorney Contacts
Attorney Contacts