On December 2, 2008, the U.S. Environmental Protection Agency (“EPA”) proposed new rules allowing hospitals, medical facilities and other healthcare providers to handle pharmaceuticals which may be “hazardous wastes” as a “universal waste.” (73 Fed. Reg. 73520). These rules are part of EPA’s program to identify the source of pharmaceuticals which have been identified in surface waters and to reduce the amount of pharmaceuticals in the environment. These rules may reduce regulatory burdens for medical providers which are already handling waste pharmaceuticals as hazardous wastes but may significantly increase this burden for others. Comments are currently due to the EPA by February 2.
These rules will apply to all providers of pharmaceuticals including hospitals, pharmacies, ambulatory centers and physician offices. Compliance will require identification of which pharmaceuticals, when discarded, would be defined as “hazardous wastes” under the Resource Conservation and Recovery Act (“RCRA”) which establishes the federal hazardous waste program for industrial and other chemicals. The definition is extremely complicated and may apply due to hazardous substances in the pharmaceuticals or because of the hazardous characteristics of the pharmaceuticals. It would not include pharmaceuticals handled in reverse distribution agreements.
Because hazardous waste disposal rules are complex and burdensome, EPA proposes to place pharmaceuticals in a special category called “universal wastes.” These are materials frequently discarded in high volumes by a broad range of commercial entities, such as car batteries or fluorescent light bulbs. Under the proposed rules, all medical providers using and discarding pharmaceuticals classified as hazardous wastes would have to adopt and implement programs for specialized storage, appropriate disposal, employee training, and recordkeeping.
While less burdensome than the hazardous waste requirements which currently apply, these rules will create tremendous hurdles for providers similar to the transition to handling bio-hazard waste. The initial identification of pharmaceuticals subject to these requirements will be extremely difficult and it will take some time for the providers and pharmaceutical companies to fully populate a list to which these rules apply. In light of this, EPA suggests in its proposal that all pharmaceutical waste be treated as a universal waste. While EPA has no authority to require that level of disposal, and acknowledges that disposing all waste pharmaceuticals as universal waste may be far more expensive, these rules may force providers to make that choice.
Providers still have some time to influence this proposal by filing their comments with EPA by February 2, 2009.