The Resource Conservation and Recovery Act (RCRA), which is the federal statute that regulates the generation, handling, transportation and disposal of hazardous waste, was enacted in 1976.  Since that time, EPA has largely expanded the application of RCRA into areas that most people never thought was intended, such as retail and the healthcare sector’s management of hazardous waste pharmaceuticals.  This has resulted in some fairly significant enforcement cases in recent years affecting these sectors.  However, EPA is now recognizing that the hazardous waste rules promulgated under RCRA are designed largely for industrial hazardous wastes and are not a good fit for management of pharmaceuticals.  Accordingly, EPA has proposed new hazardous waste pharmaceutical rules just for healthcare facilities and pharmaceutical reverse distributors.  Please click here for the pre-publication version of the proposed rule.  The official version is expected to be published in the Federal Registerlater this month.  Comments will be due 60 days after the official publication date.

The EPA’s proposal defines a “healthcare facility” broadly, covering hospitals, surgical centers, medical providers’ offices, clinics, long-term care facilities, pharmacies, over-the-counter medicine retailers, veterinary facilities, and other facilities.  It would not, however, apply to hazardous wastes generated from pharmaceutical manufacturing or production activities.  The proposed provisions are designed to ease regulatory burdens, improve overall RCRA compliance, and provide the appropriate protections for human health and the environment.  Anyone potentially impacted by the rule should review the proposal carefully and consider providing comments.