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Large Quantity Generators (LQGs) and Hazardous Pharmaceutical Waste

The management requirements for hazardous waste at your facility depend on the amount of waste generated each month. To address potential risks and ensure appropriate management, the Environmental Protection Agency (EPA) established generator categories under the Resource Conservation and Recovery Act (RCRA) regulations. These categories include Large Quantity Generator (LQG), Small Quantity Generator (SQG), and Very Small Quantity Generator (VSQG). By categorizing generators based on the scale of hazardous waste generation, these classifications determine the specific regulations and obligations for handling, storing, transporting, and disposing of hazardous waste. Larger generators, such as LQGs, are subject to more comprehensive regulatory requirements compared to smaller generators.

Are You a Large Quantity Generator?

Large quantity generators are those who generated more than 2,200 lbs. of hazardous waste per month or more than 2.2 lbs. of acute hazardous waste per month. This classification signifies a significant volume of hazardous waste generation. LQGs must comply with specific regulations tailored to their waste generation scale and potential risks associated with managing hazardous waste.

For reference, an 18-gallon container holds between 20 and 30 pounds of waste. (Note: It’s very important to not overfill containers.) If your facility generates more than 80 containers per month, you would most likely be classified as an LQG.

LQGs and Subpart P

To enhance the management of hazardous waste specifically in the healthcare sector, EPA recognized the unique nature of healthcare compared to other industries. The agency developed new standards outlined in 40CFR part 266 subpart P (subpart P), which became effective in 2019. These regulations are designed to streamline the process of managing hazardous waste pharmaceuticals by being specific to healthcare, as opposed to industry. The standards apply to healthcare facilities as well as reverse distributors. Healthcare facilities that generate hazardous waste pharmaceuticals in large quantities are required to manage their non-creditable hazardous waste pharmaceuticals under subpart P.

Pharmaceutical waste is typically generated at many points in relatively small quantities across facilities, which made the tailored standards necessary. And there can be hundreds of different types of pharmaceutical waste. Industrial waste generators, on the other hand, may have relatively few generation points and large quantities of only a few, predictable waste streams. Because of these differences, managing hazardous waste pharmaceuticals under the standard RCRA generator regulations was sometimes difficult. Making waste determinations, hazardous waste listings, and accumulation time limits were confusing for generators.

Some of the benefits for LQGs operating under subpart P include:

  • Hazardous waste pharmaceuticals can be accumulated on site, without a RCRA permit, for 365 days.
  • There are no satellite accumulation area regulations.
  • Manifests do not need specified hazardous waste codes.

There are no generator categories with respect to hazardous waste pharmaceuticals, when operating under subpart P. Facilities must determine their generator category for other hazardous waste based on non-pharmaceutical hazardous waste amounts (see above).

Examples of Large Quantity Generators (LQGs):

Hospitals – A substantial amount of hazardous waste is produced by hospitals due to the wide range of medical procedures, treatments, and diagnostic activities they carry out. Hospital waste can include expired medications, contaminated materials, sharps (needles, syringes), chemical reagents, and other potentially hazardous substances.

Ambulatory Surgical Centers – Outpatient surgical facilities can generate hazardous waste from anesthesia medications, surgical supplies, or medications used during procedures.

Pharmaceutical Manufacturers – Facilities involved in pharmaceutical manufacturing can generate substantial amounts of hazardous waste during the production process. This waste can include byproducts, rejected batches, expired, or damaged medications, and packaging waste. These waste materials may contain hazardous chemicals or pharmaceutical compounds.

Research Laboratories – Research facilities in the medical industry, such as those involved in pharmaceutical research, biotechnology, or clinical trials, can generate significant amounts of hazardous waste. This can include chemical waste, expired or unused experimental drugs, contaminated materials, and laboratory glassware. 

Healthcare facilities and entities must comply with applicable regulations and fulfill their responsibilities for proper hazardous waste management to maintain compliance and avoid costly fines. For example, a teaching hospital was fined $360,000 for alleged improper disposal of hazardous pharmaceutical waste. The lack of a proper hazardous waste compliance program was the root cause of the violations. Facilities that generate hazardous pharmaceutical waste must be aware of requirements specific to their generator category, including how to manage their waste under subpart P. 

Have questions? Need a hazardous waste compliance program? We have answers and smart solutions for compliant hazardous waste management. Contact us now for a free quote or consultation.


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