OMB reviewing pharmaceutical waste proposal
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August 27, 2015
OMB reviewing pharmaceutical waste proposal

In a brief report, EPA’s Office of Inspector General (OIG) says that the Agency’s Office of Solid Waste and Emergency Response (OSWER)  has developed a proposed rule regarding the management of pharmaceutical wastes, which has been submitted to the Office of Management and Budget (OMB).

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According to the OIG, the OSWER says the proposal will be used to get information about hazardous pharmaceuticals through public comments.  The OIG adds that the proposal satisfies two recommendations regarding both existing and new pharmaceuticals the OIG made to the Agency in a 2012 report.  A third OIG recommendation regarding outreach and assistance for hazardous pharmaceutical waste remains open with corrective action pending, says the OIG.

Limited training

Pharmaceuticals that enter the wastestream have been a persistent human health, environmental, and regulatory challenge for multiple entities, including healthcare facilities, wastewater treatment facilities, manufacturers of pharmaceuticals, and federal and state environmental agencies.  For example, in hospitals, pharmaceutical waste apart from chemotherapy agents, is generally discarded down the drain or landfilled.

These practices were developed before more was known about the potential adverse effects of introducing waste pharmaceuticals into the environment. A hospital pharmacy generally stocks between 2,000 and 4,000 different items, each of which must be evaluated against state and federal hazardous waste regulations. Pharmacists and nurses generally do not receive training on hazardous waste management, and safety and environmental services managers may not be familiar with the active ingredients and formulations of pharmaceutical products.

2008 proposal dropped

In 2008, the EPA attempted to address the problem with a proposal to add hazardous pharmaceutical wastes to its universal waste rule.  EPA’s plan was to implement a pharmaceuticals take-back program by removing Resource Conservation and Recovery Act (RCRA) barriers to the collection of pharmaceutical wastes from healthcare and other regulated facilities and facilitate the collection of pharmaceutical wastes from households, including nonhazardous pharmaceutical wastes. 

But the EPA subsequently reported that comments on the proposal were strongly negative.  In particular, numerous concerns were raised over the lack of proposed notification requirements for those facilities that generate, handle, or transport pharmaceutical universal wastes, as well as the lack of tracking requirements for the shipment of these wastes. The Agency decided to take no further action on the 2008 proposal and develop another proposal for healthcare facility-specific regulations for the management of hazardous waste pharmaceuticals.

Recommendations

In its 2012 report, the OIG recommended that the OSWER (1) identify and review existing pharmaceuticals to determine whether they qualify for regulation as hazardous wastes; and (2) establish a process to review new pharmaceuticals to determine whether they qualify for regulation as hazardous waste.

The OIG says the proposal the OSWER submitted to the OMB in March 2015 satisfies both recommendations. According to the OSWER, the proposal includes ways to identify new sources of information to identify hazardous waste pharmaceuticals, as well as alternative approaches for addressing pharmaceutical waste generally.

“The action satisfies Recommendations 1 and 2 by creating, on a recurring basis, a process to review all pharmaceuticals to determine whether they qualify for regulation as hazardous waste,” says the OIG. 

The OIG adds that the OSWER has yet to satisfy its third recommendations that the OSWER develop a nationally consistent outreach and compliance assistance plan to help states address challenges that healthcare facilities and others have in complying with RCRA regulations for managing hazardous waste pharmaceuticals. 

OIG’s August 2015 report

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