Medical Waste

Hazwaste Pharmaceutical Rule—What They’re Saying

Last fall, the U.S. Environmental Protection Agency (EPA) issued a proposed rule that would make significant changes to regulatory requirements for the management of hazardous waste pharmaceuticals. Comments were accepted until December 24, 2015. Let’s take a look at what a sampling of stakeholders had to say about EPA’s proposed amendments to the management of hazardous waste pharmaceuticals under the Resource Conservation and Recovery Act (RCRA).

The EPA proposed what it calls the Management Standards for Hazardous Waste Pharmaceuticals on September 25, 2015. An extended comment period closed on December 24, 2015. The Agency has received just under 300 comments on the proposal. The Advisor reviewed a number of them and will give you the gist of what people are saying about the proposed amendments to hazardous waste pharmaceuticals requirements. All the comments can be reviewed at regulations.gov.

What They Had to Say

Granted that there are numerous changes in EPA’s proposal, and there are many stakeholders. After reviewing comments, we will address concerns specific to healthcare facilities, pharmaceutical manufacturers, and retailers. Today we will review comments gleaned from some healthcare facilities. Tomorrow we will review some comments from manufacturers and retailers.

Healthcare facilities

Healthcare facilities had many comments concerning, among others, the definition of healthcare facility and long-term care facility (LTCF), the definition of hazardous waste pharmaceutical, waste determination, the exemption of conditionally exempt small quantity generators (CESQGs), the exemption of Drug Enforcement Administration (DEA) -controlled substances, the ban on sewer disposal, and requirements for the destruction of packaging material.

Healthcare facility and LTCF. The EPA proposes to define an LTCF as “a licensed entity that provides assistance with activities of daily living, including managing and administering pharmaceuticals to one or more individuals at the facility. This definition includes, but is not limited to, assisted living, hospices, nursing homes, skilled nursing facilities, and the assisted living and skilled nursing care portions of continuing care retirement communities.”  A number of commenters suggested that assisted living facilities should be excluded because, by their nature, they encourage that clients be as independent as possible and most clients manage their own medications. In addition, commenters suggested that if hospices are included in the definition that there be a threshold number of patients for the facility to be subject to the regulation.

Hazardous waste pharmaceutical (HWP). Under the proposal, when a healthcare facility generates a solid waste pharmaceutical, the facility would still be required to determine if the pharmaceutical waste is a listed hazardous waste or if it exhibits one or more of the four characteristics of hazardous waste.  A number of commenters requested that the EPA be more clear on which pharmaceuticals are HWPs. Some said that there is no single source for healthcare professionals to use in making hazardous waste determinations and that  EPA’s Hazardous Waste Pharmaceutical wiki is inadequate for the task. Some commenters contend that rather than have healthcare providers evaluate pharmaceuticals, it would be much simpler and cost-effective if the EPA determined which pharmaceuticals are hazardous and which are not.

CESQGs. Most commenters supported the proposal that healthcare facilities that are CESQGs be exempt from the new requirements. However, some commenters contend that the proposal to include personal protective equipment (PPE), spill cleanup materials and items containing residual pharmaceuticals in the definition of “pharmaceutical” will increase costs for healthcare facilities without any environmental benefit.

DEA-controlled substances. While there is support for EPA’s proposal that HWPs that are also DEA-controlled substances be exempt from the definition of HWP for the regulation, there is some concern for the requirement that these substances be incinerated. Some pointed to a variety of nonincineration DEA technologies that minimize environmental impact.

Ban on sewer disposal. Pharmaceutical wastes and unused pharmaceutical products are widely disposed of “down the drain.”  The proposal would ban the sewering of HWPs for all healthcare facilities. Some commenters suggest that there be an exemption for certain controlled substances for which there are DEA-compliant technologies.

Packaging material. The EPA proposes that “RCRA empty” pharmaceutical containers in the original packages be destroyed before being put in the trash. Some smaller healthcare facilities suggested that they do not have the equipment for that and that such facilities operating as CESQGs and that have chosen to operate under the new rule should have the option of putting that material in red-sharp containers or nonhazardous waste pharmaceutical containers.

Tune in tomorrow for  concerns pharmaceutical manufacturers and retailers and commenters expressed about EPA’s proposed Management Standards for Hazardous Waste Pharmaceuticals.