EPA Proposes Changes to Hazardous Waste Generator Rules and a New Management of Hazardous Waste Pharmaceuticals Rule
The U.S. Environmental Protection Agency (EPA) is proposing two new hazardous waste rules that EPA believes will strengthen environmental protection and reduce regulatory burdens. The first is an update to the hazardous waste generator rules; the second is a new set of management standards for hazardous waste pharmaceuticals.
These proposed rules have had a very long gestation, and the generator proposals have been decades in the making. Both proposed rules were signed by EPA on August 31, 2015 and will be published in the Federal Register for public comment within the next few weeks.
Hazardous Waste Generators
The proposed updates to the Hazardous Waste Generator Rules include more than 60 changes. Among the more notable changes is EPA’s proposal to allow a waste generator to avoid changes in generator status when generating larger amounts of waste only occasionally, provided the episodic waste is properly managed and additional notifications are submitted. In addition, the updated rules would explicitly allow a conditionally exempt small quantity generator facility to send hazardous waste to a large quantity generator facility under common control. In this case, a company could transfer waste from one of its locations to another.
There are numerous other changes proposed, or highlighted for comment, some of which are likely to make waste management and compliance more complicated. These provisions include:
- New provisions on documenting waste determinations
- Regular reporting by Small Quantity Generators
- Additional labelling of containers for contents and hazards
- Longer record keeping period for inspection logs
- Required arrangements with responders (not just attempts)
- Additional procedures for closure
- Additional training for employees at Satellite Accumulation Areas
These proposed changes are sure to provoke comments and controversy.
Hazardous Waste Pharmaceuticals
The newly proposed Hazardous Waste Pharmaceuticals Rule includes a tailored, sector specific set of regulations for the management of hazardous waste pharmaceuticals by “Health Care Facilities” (including pharmacies) and “Reverse Distributors” (businesses that accept the return of pharmaceuticals). The rule would only apply to pharmaceuticals that already meet the definition of RCRA hazardous waste and that are generated by health care facilities. However, for the first time, “Reverse Distributors” would be regulated under hazardous waste rules.
EPA is not proposing to change the list of pharmaceutical wastes that are considered hazardous wastes, with the exception of possible changes to address low-concentration nicotine products. The Agency is also generally requesting comment on what criteria it might use to identify new pharmaceutical wastes. The Agency abandoned its 2008 proposal that would have added new pharmaceuticals and applied new universal waste standards. In fact, EPA has announced that universal waste management is prohibited.
Although already prohibited under most circumstances, EPA is adopting an explicit ban on flushing pharmaceuticals down the sink and toilet. EPA estimates that this will prevent the flushing of more than 6,400 tons of hazardous waste pharmaceuticals annually.
EPA hopes that the new rule will make hazardous waste management easier for health care professionals by removing the traditional manufacturing-based hazardous waste generator requirements and instead providing a new set of regulations that are “designed to be workable in a health care setting.” While simplified as compared to existing hazardous waste rules, the proposed management standards are far from simple.
If you have questions about either of these rulemakings, or are interested in commenting, or would like to discuss how they might affect you, please do not hesitate to contact Ken Gray (207-791-1212) or Michelle O’Brien (617-488-8146).
The pre-publication versions are available on EPA’s website: