Requirements for managing your facility’s hazardous waste are directly related to the quantity of waste generated each month. The Environmental Protection Agency (EPA) under the Resource Conservation and Recovery Act (RCRA) regulations established generator categories to tailor regulatory requirements to the scale of hazardous waste generation and address potential risks associated with hazardous waste management. The three categories are Very Small Quantity Generator (VSQG), Small Quantity Generator (SQG) and Large Quantity Generator (LQG). These generator categories help determine the applicable regulations and requirements for the handling, storage, transportation, and disposal of hazardous waste. Smaller generators are subject to fewer regulatory requirements compared to larger generators and all regulations promote safe hazardous waste management practices.
Are You a Small Quantity Generator?
Small quantity generators are those who generate between 220 lbs. and 2,200 lbs. of hazardous waste per month, and less than 2.2 lbs. of acute hazardous waste per month. This classification is intermediate between a very small quantity generator (VSQG) and a large quantity generator (LQG) of hazardous waste. Most, if not all, healthcare facilities and reverse distributors operating under subpart P also generate other hazardous wastes that are not pharmaceuticals.
For reference, an 18-gallon container can hold between 20 and 30 pounds of waste. So, if your facility generates more than eight containers per month, you would most likely be considered a small quantity generator (SQG).
SQGs and Subpart P
To enhance the management of hazardous waste in the healthcare sector, the Environmental Protection Agency (EPA) recognized the unique nature of healthcare compared to other industries and developed new standards outlined in 40CFR part 266 subpart P (subpart P), which became effective in 2019. These regulations are specific to healthcare, as opposed to industry, and designed to streamline the process of managing hazardous waste pharmaceuticals. The standards apply to healthcare facilities and reverse distributors. Healthcare facilities that generate more than VSQG amounts of hazardous waste are required to manage their non-creditable hazardous waste pharmaceuticals under subpart P.
The tailored standards were necessary, in part, because pharmaceutical waste is typically generated at many points in relatively small quantities across a facility. Also, there can be hundreds of different types of pharmaceutical waste. In contrast, there may be large quantities of only a few, predictable waste streams at relatively few generation points with industrial waste generators. Managing hazardous waste pharmaceuticals under the standard RCRA generator regulations was sometimes confusing in relation to making waste determinations, hazardous waste listings, and accumulation time limits.
Some of the benefits for SQGs operating under subpart P:
- No need to specify hazardous waste codes on manifests.
- Can accumulate hazardous waste pharmaceuticals on site without a RCRA permit for 365 days.
- Do not have to comply with satellite accumulation area regulations.
- Will not become a LQG (subject to those requirements) when generating more than 2.2 lbs. of acute hazardous waste pharmaceuticals in a month.
- Basic training requirements.
When operating under subpart P, there are no generator categories with respect to hazardous waste pharmaceuticals. However, facilities must determine their generator category for other hazardous wastes, based on non-pharmaceutical hazardous waste amounts (see above).
Examples of Small Quantity Generators (SQGs):
Hospital and healthcare clinics – While larger healthcare facilities may fall into the category of large quantity generators (LQGs), smaller clinics, outpatient facilities, or specialized healthcare centers can be classified as SQGs. These facilities generate hazardous waste pharmaceuticals as a result of patient care, including expired medications, chemotherapy drugs, or contaminated materials.
Long-term care facilities – Nursing homes, assisted living facilities, or residential care facilities often have on-site pharmacies and generate hazardous waste pharmaceuticals from expired or unused medications.
Pharmacies – Retail pharmacies (including independent pharmacies and those located within larger stores or healthcare facilities) can generate hazardous waste pharmaceuticals such as expired medications, unused drugs, or contaminated products.
Veterinary Clinics and Hospitals – Animal healthcare facilities that provide medical services for pets, livestock or research animals generate hazardous waste pharmaceuticals. This can include expired animal medications, vaccines, or controlled substances.
Ambulatory Surgical Centers – Outpatient surgical facilities can generate hazardous waste pharmaceuticals from anesthesia medications, surgical supplies, or medications used during procedures.
Dental Offices – Dental practices produce hazardous waste pharmaceuticals such as expired local anesthetics, unused medications, or contaminated materials.
It’s important for healthcare facilities and entities to understand their generator category to comply with the applicable regulations and fulfill their responsibilities for proper hazardous waste management. Facilities that generate hazardous pharmaceutical waste need to be aware of requirements that are based on their generator category, including the details of managing that waste under subpart P.
Have questions? We have answers. If you’d like to learn more about requirements for SQGs or operating under subpart P, contact us for a free consultation. We provide education and smart solutions for managing hazardous pharmaceutical waste.
