EPA Issues New Regulations

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On August 31, 2015 EPA issued proposed new rules for management of hazardous waste for the pharmaceutical industry and for general industry under the Resource Conservation and Recovery Act (RCRA).

The proposed pharmaceutical rule is focused on healthcare facilities and pharmacies. The intent is to make both drinking water and surface water safer and healthier by reducing the amount of pharmaceuticals entering our waterways. The focus of these new regulations is to prevent flushing more than 6,400 tons of hazardous waste pharmaceuticals annually by banning these facilities from flushing hazardous waste pharmaceuticals down sinks and toilets. The regulations will be tailored specifically for distributers, healthcare facilities, clinics, and other end-users of pharmaceutical products, not manufacturing (as is presently the case). This rule seeks to reduce the regulatory burden for these types of facilities and increase compliance by proposing a more flexible, common sense approach for healthcare providers by eliminating unnecessary management practices.

The concern the EPA is attempting to address is that persons who inadvertently generate this waste – nurses, doctors, and pharmacists – are focused on providing health care, and are not experts in hazardous waste identification and management. To achieve its intended purpose, it’s vital for these proposed rules be both easy to understand and implement by the end users of these materials.

For general industry, the changes for hazardous waste generators proposes an update to the regulations to make the rules easier to understand, facilitate better compliance, provide greater flexibility in how hazardous waste is managed, and close important gaps in the regulations. The EPA has proposed the following changes:

  1. Allow a hazardous waste generator to avoid the increased burden of a higher generator status when generating episodic waste, provided that the episodic waste is properly managed; and
  2. Allow a conditionally exempt small quantity generator (CESQG) to send its hazardous waste to a large quantity generator under control of the same person.

The new rules will also improve hazardous waste risk communication among facilities, employees, and the general public and help ensure that emergency management requirements for these facilities meet today’s needs.

The EPA is also proposing a number of clarifications without increasing regulatory burdens, including a reorganization of the hazardous waste generator regulations. The goal is to have all generator regulations in one place.

The final regulations have not yet been published. Once they are published EPA will accept public comments on the proposals for 60 days following publication in the Federal Register

For more information about this proposed regulation, please contact Chris Chapman at cchapman@ecslimited.com.