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New EPA Interpretation for Acute Hazardous Waste Should Reduce Regulatory Burden for Managing Hazardous Waste at Health Care Facilities

December 13, 2011

On November 4, 2011, the U.S. Environmental Protection Agency (EPA) issued a memorandum outlining EPA's interpretation of its rules regarding disposal of empty containers that have previously held P-listed pharmaceuticals. States with delegated authority under RCRA may follow EPA's interpretation. For example, on December 2, 2011, Wisconsin Department of Natural Resources (DNR) issued a memorandum clarifying that DNR concurs with EPA's guidance with one exception. Health care facilities should consider seeking legal counsel for guidance on the potential changes EPA's interpretation my have on their hazardous waste management procedures.

EPA's memorandum clarifies that under its interpretation of hazardous waste rules, a health care facility disposing of empty containers that have previously held P-listed pharmaceuticals is not required to include the weight of the container in its determination of the amount of acute hazardous waste it generates. Such containers include nicotine blister packs and Coumadin pill bottles which until now have been routinely interpreted as being acute hazardous waste when empty. A common problem for health facilities has been that the combined weight of empty containers often exceeded the 1 kg per month threshold for becoming a Large Quantity Generator of hazardous waste.

According to EPA's November 4 memorandum, health care facilities need only count the actual weight of the residual pharmaceutical in an empty container towards the amount of acute hazardous waste generated by the facility. EPA indicates in its memorandum that while it cannot generalize on what is a reasonable method to determine the exact weight of residue in a visually empty container, using conservative assumptions may be sufficient to demonstrate that the 1 kg per month threshold has not been exceeded. Alternatively, health care facilities may consider limited testing to determine typical residual weights.

Health care facilities classified as Large Quantity Generators that are counting empty P-listed pharmaceutical containers as acute hazardous waste should reconsider their generator status based on EPA's new clarification of its rules. Doing so will likely reduce the regulatory burden for managing hazardous waste at such facilities if they can reasonably demonstrate Small Quantity Generator status.

Please contact Duncan Moss should you have questions concerning hazardous waste rules for health care facilities.

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