The Status of Federal Hazardous Waste Pharmaceutical Regulation

By: Erik S. Mroz, Drewry Simmons Vornehm, LLP

Last year, the United State Environmental Protection Agency (“EPA”) proposed a new rule establishing a specific regulatory framework for the management of pharmaceutical wastes under the Resource Conservation and Recovery Act, 42 U.S.C. § 6901, et seq. (“RCRA”).  EPA has been trying to put together a pharmaceutical waste rule for several years.  In 2006, EPA funded the development of “A 10-Step Blueprint for Healthcare Facilities” (Amended 2008).  EPA’s recent rulemaking attempt is seen by the agency, and by many stakeholders, as an attempt to streamline the management of waste pharmaceuticals generated by healthcare facilities.  EPA’s proposed hazardous waste pharmaceutical rule eliminates many of the RCRA requirements that generally govern the management of hazardous waste.  For example, healthcare facilities will be prohibited from disposing of hazardous waste pharmaceuticals through the sewer; but, the volume of hazardous waste pharmaceuticals generated by a facility may not be counted towards the site generator category.

Until the new rule is finalized, the generation, treatments, storage and disposal of hazardous waste pharmaceuticals will continue to be regulated under current RCRA regulations.   These include the regulations governing large quantity generators (“LQGs”), small quantity generators (“SQGs”) and conditionally exempt small quantity generators (“CESQGs”).  RCRA subjects generators to certain accumulation limits, and manifesting and disposal requirements.  Failure to comply with RCRAs regulatory system can lead to legal and administrative actions, civil and criminal liability, fines and other costs.

EPA continues to enforce the existing RCRA rules.  EPA has found that certain generators have misreported their site generator categories and are underreporting the quantities of hazardous wastes generated, treated or disposed.   Some of these generators include healthcare facilities.  During the last five years, EPA has brought thirty-three formal enforcement actions against health services providers for violations of RCRA, resulting in over $2 million in penalties and other costs.

It is critical that healthcare providers review the types and volumes of hazardous waste they generate (including hazardous waste pharmaceuticals).  Healthcare facilities should be sure to correctly identify their site generator category and implement the required reporting.