On Aug. 12, 2008, EPA began a process toward possible regulation of the disposal of unused pharmaceuticals into sanitary sewer systems, by publishing notice of its intent to submit an Information Collection Request in order to better understand and document the current handling and disposal practices of unused pharmaceuticals. See, 73 FR 46903. Just last week, EPA announced a separate but related proposed rulemaking, in which EPA is proposing changes to the handling and disposal of unused pharmaceuticals that are currently classified and handled as hazardous waste (the “Unused Pharmaceuticals Rulemaking”). In this proposed Unused Pharmaceuticals Rulemaking, EPA plans to add pharmaceutical wastes that are RCRA hazardous waste to the list of materials that are classified as universal wastes. See, 73 FR 73519. This proposed change will potentially reduce costs for facilities that currently dispose of their unused pharmaceuticals as RCRA hazardous waste. The impact of EPA’s overall efforts to regulate the large and unknown volume of pharmaceutical waste not currently handled as hazardous waste is unclear.  

For facilities that generate pharmaceutical waste that is currently handled and disposed of as hazardous waste, this Unused Pharmaceuticals Rulemaking could have significant advantages. The changes will likely result in reduced costs and requirements for storage, labeling, shipment off site, employee training, responses to releases, and notification. The changes would allow for (1) an increased accumulation threshold; (2) an increased on-site accumulation limit; (3) an increased storage time limit; and (4) no manifest requirement.  

While this Unused Pharmaceuticals Rulemaking has no immediate adverse regulatory and economic impact, it should be considered in light of EPA’s ongoing efforts to reduce the impact of disposal of unused pharmaceuticals. EPA estimates that more than 600,000 individual facilities in the United States may be generators of hazardous pharmaceutical wastes. This number includes 40,000 retail pharmacies, more than 7,000 hospitals, and more than 300,000 physicians and dental offices. However, only 94 hospitals and 19 pharmacies report themselves to be Large Quantity Generators (“LQGs”) of hazardous waste. While EPA believes that the vast majority of pharmaceutical waste generators are Small Quantity Generators (“SMQs”) or Conditionally Exempt Small Quantity Generators (“CESQGs”), they admit that their information about pharmaceutical waste management is limited. Based upon their communications with pharmaceutical waste generators, EPA believes that numerous health care facilities are unaware of how the hazardous waste regulations apply to pharmaceutical wastes, and that much of the waste is being disposed of either in medical waste incinerators, or discharged into the municipal sanitary sewer.