Final Rule: EPA Management Standards for Hazardous Waste Pharmaceuticals

MARCH 15, 2019

Healthcare facilities, including nursing, skilled nursing and inpatient hospital facilities, are facing several changes when it comes to managing pharmaceuticals considered to be hazardous waste.

These changes are coming because of the U.S. Environmental Protection Agency (EPA) Management Standards for Hazardous Waste Pharmaceuticals final rule. The rule, released in the Federal Register on Feb. 22, has a six-month federal implementation process of the rule with states to follow.

Healthcare facilities for both humans and animals, as well as and reverse distributors, will manage their hazardous waste pharmaceuticals under this new set of sector-specific standards instead of existing regulations.

The rule now mandates that long-term care (LTC) facilities be included in the requirements set out by the Resource Conservation Recovery Act (RCRA). These requirements regard the generation, management, storage, treatment and disposal of hazardous wastes. While the final rule does not increase the number of pharmaceuticals considered to be hazardous waste, it does include many changes that will impact LTC and healthcare facilities.

What are the changes?

• Eliminates “sewering” of hazardous waste pharmaceuticals. Reducing intentional sewer disposal is one mechanism to help reduce the environmental loading of pharmaceuticals into our nation’s waters.
• Provides regulatory clarity on how pharmaceuticals must be managed. These new regulations eliminate the dual regulation of RCRA hazardous waste pharmaceuticals that are also Drug Enforcement Administration (DEA) controlled substances. The new rules also maintain the household hazardous waste exemption for pharmaceuticals collected during pharmaceutical take back programs and events, while ensuring their proper disposal.
• Offers regulatory relief to healthcare facilities for management of hazardous waste pharmaceuticals. The rule outlines that hazardous waste pharmaceuticals do not count toward generator status, eases labeling and manifesting and clarifies what wastes should be shipped to reverse distributors.
• Amends the listing of nicotine patches, gums and lozenges. These items no longer have to be managed as hazardous waste.

State-by-state adoption will be a long process with varying timelines and outcomes as states have the ability to be more stringent.

In Alaska and Iowa, the rule is effective on Aug. 21, as these states don’t have a state-authorized RCRA program. In Kentucky, New Jersey and Pennsylvania, the rule is also effective on Aug. 21, as these states adopt rules on their effective dates.

North Carolina will adopt the nicotine exception on Aug. 21, but it will take at least nine months and up to one year for Subpart P to go into effect in that state.

Customers currently utilizing Clean Earth's pharmaceutical waste services are compliant under the current regulations. At this time, no major changes are necessary to services.

Clean Earth has been following EPA activity on this rulemaking since its proposal in 2015. The new regulations were detailed in hundreds of pages and have been summarized on the Clean Earth website to provide highlights of how the final rule affects healthcare facilities.

For more information, click here. For questions, email epanewrules@stericycle.com.