May 14, 2024

Hazardous Waste Pharmaceutical and VSQG Guidance

In March 2022, EPA published guidance addressing multiple scenarios related to managing hazardous waste pharmaceuticals and very small quantity generators (VSQGs). [RO 14963] The first scenario is a response to an inquiry by a national waste and recycling association: can non-creditable hazardous waste pharmaceuticals be land disposed under RCRA Section 3004(h)(2) national capacity variance? The agency explained these variances are no longer applicable as they allowed EPA to extend the effective date of land disposal restrictions (LDR) treatment standards for up to 2 years after a standard was first promulgated, but those variances have all expired. Furthermore, the variance only provided temporary relief from the effective date of the LDR standards, not from the standards themselves.

In a second scenario, EPA confirmed VSQGs managing all hazardous waste under §262.14, including hazardous waste pharmaceuticals, are exempt from Part 266, Subpart P. VSQGs could then dispose of their pharmaceuticals at any applicable facility listed in §262.14(a)(5). Conversely, a VSQG that opts into Subpart P must dispose of its hazardous waste pharmaceuticals at a RCRA-permitted hazardous waste treatment, storage, and disposal facility. Disposal at an “alternative combustor,” such as those referenced under §266.506(b)(3) (e.g., a CAA-permitted municipal waste combustor), would not be allowed.

Depending on the quantity of hazardous waste pharmaceuticals and non-pharmaceutical hazardous waste generated in a calendar month, a healthcare facility’s generator category could change with respect to its non-pharmaceutical hazardous waste. In this guidance, EPA discussed a healthcare facility that is a VSQG when counting all its hazardous waste and that has not opted into Subpart P for the management of its hazardous waste pharmaceuticals. If the facility is operating under §262.14 for all of its hazardous waste and has an episodic event for non-pharmaceutical hazardous waste, the facility can choose to follow the Part 262, Subpart L provisions with respect to the episodically generated non-pharmaceutical hazardous waste. This would include manifesting and sending the non-pharmaceutical waste to a designated facility. In this situation, the healthcare facility can continue to manage its hazardous waste pharmaceuticals under §262.14 and send the hazardous waste pharmaceuticals to an alternative combustor. EPA also said a delay in waste services from a vendor does not qualify as an episodic event.

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This document addresses issues of a general nature related to the federal environmental regulations. Persons evaluating specific circumstances dealing with the environmental regulations should review state and local laws and regulations, which may be more stringent than federal requirements. In addition, the assistance of a qualified professional should be enlisted to address any site-specific circumstances.