EPA Proposes Changes to Hazardous Waste Generator Rules and a new Management of Hazardous Waste Pharmaceuticals Rule – One Step Forward, One Step Back?

Posted on October 12, 2015 by Kenneth Gray

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 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.  

While touted as providing needed flexibility, the rules are far from simple.  The axiom of environmental regulation holds true: complex rules only become more complex over time.

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 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.  That sounds logical, but there are “strings attached” to both proposals in the form of additional requirements or conditions for access. 

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. In several of these areas, there will be more “opportunities for environmental excellence” (also commonly referred to as opportunities for violations).

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.  The Agency estimates that this will prevent the flushing of more than 6,400 tons of hazardous waste pharmaceuticals annually.  (Really? That seems pretty high…)  

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.”  The Agency was sympathetic to the view that the existing hazardous waste rules were viewed as complex and difficult to comply with in a health care setting.  (Gee, haven’t all generators reached that conclusion for their industries?)  While these may be simplified as compared to existing hazardous waste rules, complying with the management standards will still require effort and diligence.  

The pre-publication versions are available on EPA’s website:

http://www2.epa.gov/hwgenerators/pre-publication-version-hazardous-waste-generator-improvements-proposed-rule

http://www2.epa.gov/hwgenerators/pre-publication-copy-management-standards-hazardous-waste-pharmaceuticals-proposed-rule