On September 25, 2015, the Environmental Protection Agency (EPA) published a proposed rule altering the regulatory regime governing the handling and disposal of hazardous waste pharmaceuticals generated at healthcare facilities and managed at pharmaceutical reverse distributors. The proposal is intended to simplify the regulatory burden of complying with the Resource Conservation and Recovery Act’s (RCRA) cradle-to-grave management of hazardous wastes at healthcare facilities by providing an industry-specific approach to hazardous waste regulations that takes into account the realities of waste management within the industry. Currently, facilities that generate, ship, store, or dispose of hazardous waste pharmaceuticals must comply with all of the requirement of RCRA Subtitle C.

EPA proposes to streamline and simplify the management of hazardous waste pharmaceuticals by creating a new subpart P to 40 C.F.R. Part 266 that:

  • Provides that hazardous waste pharmaceuticals are not counted towards the quantity of hazardous waste generated at the facility for purposes of determining its generator status;
  • Exempts hazardous waste pharmaceuticals at healthcare facilities from the satellite accumulation area regulations generally applicable to generators of hazardous waste;
  • Simplifies the hazardous waste manifesting requirements for healthcare facilities; and
  • Extends to 365 days the maximum time a healthcare facility can accumulate hazardous waste pharmaceuticals on site without a RCRA permit.

However, the proposal also includes a prohibition on the disposal of hazardous waste pharmaceutical into the sanitary sewer system (e.g., disposal by flushing down the toilet or pouring down a sink drain,which is currently an acceptable disposal practice under RCRA.

The regulations also provide specific management requirements for hazardous waste pharmaceuticals sent to a reverse distributor for a determination as to whether the pharmaceutical is eligible for manufacturer credits. Under EPA’s proposal, these “potentially creditable hazardous waste pharmaceuticals” will be shipped from a healthcare facility to a reverse distributor using a simplified process providing for notification of the shipment to the reverse distributor and confirmation of receipt by the reverse distributor. The proposal provides specific notification, recordkeeping, security, planning, and reporting requirements for reverse distributors and limits to 90 days the amount of time a reverse distributor can accumulate potentially creditable hazardous waste pharmaceuticals.

Interested parties have until November 24, 2015, to comment on the proposal. The proposed rule and supporting documents are available at Regulations.gov in Docket No. EPA-HQ-RCRA-2007-0932. Holland & Hart’s healthcare and environmental attorneys are available to help assess the applicability and impact of EPA’s proposal on your business.