May 25, 2021
Given the ongoing implementation of the Environmental Protection Agency’s (EPA) Final Rule on the disposal of hazardous waste pharmaceuticals, commonly referred to as Subpart P, there is no better time for healthcare organizations to review their hazardous waste generator status. Making a status determination is not always easy, but the following sections aim to provide clarity and guidance on how to determine your status. The first step is determining if your healthcare facility generates hazardous waste.
Hazardous waste is a broad term that encompasses a range of dangerous chemicals, pharmaceuticals, and other potentially toxic materials. To comply with EPA regulations, every organization, including hospitals and health systems, must determine whether they generate hazardous waste, and if they do, how much of it they generate. Note that hazardous waste is not the same as regulated medical waste, such as sharps waste or red bag waste. These are completely different types of wastes and must be handled differently.
Most healthcare organizations generate hazardous waste to some degree, whether that’s lab reagents, certain cleaning products, hazardous pharmaceuticals, or other items. However, quantifying these wastes can become tricky because many of the materials that fall under this category are not labeled as hazardous, and there is no “master list” organizations can check. Your waste hauler cannot make this decision for you either. It is up to every organization to figure out whether it generates hazardous waste and how much of it there is. To ensure compliance, someone in your organization should be tapped to oversee the process.
One approach to identifying hazardous waste involves walking through the organization and identifying potential materials. Once you have compiled a list, there are three questions to ask to clarify whether those items are hazardous and if there are any more materials you haven’t considered:
To answer these questions, you can review Safety Data Sheets (SDS), which supply technical information, such as pH, flash point, and chemical composition. There are also external resources available. Formulary experts at Stericycle can assist in making hazardous pharmaceutical determinations by reviewing data associated with the drug’s National Drug Code (NDC).
Once you determine what types of hazardous wastes you produce, the next step is to estimate how much is generated during each calendar month and which of the EPA’s waste categories apply. On the federal level, there are three generator categories:
The category you choose governs how you dispose of hazardous wastes, addressing issues like how much waste you can accumulate onsite, how you store that waste and for how long, reporting requirements, staff training guidelines, contingency planning, and more. LQGs have the most stringent requirements and conversely, VSQGs the least. The EPA website offers a detailed list of requirements by generator status.
Some common hazardous waste items such as batteries, lightbulbs, paint, and more may be classified as universal waste and therefore may be managed per simpler regulations for such types of wastes. However, if you choose to manage these items under the universal waste regulations, they would no longer count toward your generator category. This can impact your generator status, and in some cases allow you to reach a lower quantity group and avoid stricter regulation.
Note that not all states follow the federal rules, and some are authorized to create different waste generator categories. To be sure you comply, it is important to review your state’s regulations.
SQGs and LQGs must follow the EPA’s Subpart P in those states that have adopted the rule. As part of this regulation, these organizations no longer have to count hazardous waste pharmaceuticals in their waste generator determination. They only need to count things like solvents, lab reagents, chemicals, cleaning products, and so on.
SQGs and LQGs must also let the EPA know that they will be following Subpart P and fill out relevant paperwork within 60 days of the rule’s adoption in their state—and many states have either adopted or will adopt the rule soon. The key to filling out this paperwork correctly is knowing your generator status, so this is a critical and timely exercise for your organization to work through.
No matter what the generator status, organizations are not allowed to flush hazardous waste pharmaceuticals down the sink or toilet. Also known as sewering, this practice can have severe environmental ramifications because typical waste treatment processes do not remove hazardous drug residue from wastewater. By banning sewering, the EPA hopes to prevent thousands of tons of hazardous waste pharmaceuticals from passing into the environment.
To learn more about hazardous waste compliance and why it should matter to you, review Stericycle’s recent webinar on Pharmaceutical Waste Management: Steps to Compliance. For information on how Stericycle can support your organization’s waste and compliance needs, visit our Pharmaceutical Waste Service Solutions Hub.