There are now three COVID-19 vaccines with emergency use authorization from the Food and Drug Administration (FDA) in the US. With over 300 million adults to be vaccinated, using approximately 500-600 million individual doses, the US will produce a lot
of vaccine-related waste over the next six months.
Whether it is the result of the COVID-19 vaccine campaigns or waste produced from other vaccinations or self-medication shots (e.g., insulin shots), recent events have raised the question: What requirements apply to the management of vaccine wastes and other syringe-related activities?
To identify relevant compliance standards, facilities must first determine whether the material is a solid waste as defined by RCRA regulations (40 CFR 261.2) and if so, determine whether the material meets the regulatory definition of hazardous waste (40 CFR 261.3).
What is a Solid Waste?
Materials are consider discarded and therefore solid waste whenever they are stored before or in lieu of disposal or incineration [40 CFR 261.2(b)]. This can include materials that have been used and no longer serve a purpose for use–a syringe that has already delivered the prescribed medicine, for example. However, it can also include unused materials that are being discarded. One example could be vials of off-specification (e.g., expired) vaccines.
Discarded unused vaccines would be listed hazardous waste if they contained a constituent listed at 40 CFR 261.33 as the sole active ingredient (i.e., P- or U-listed). If the discarded vaccine is not listed, they may still be hazardous waste if they exhibit one or more of the hazardous waste characteristics at 40 CFR 261, Subpart C.
Since vaccines are uniquely formulated and often tightly held by the manufacturer, it is impossible to determine in this article whether COVID-19 vaccines or any other vaccine would be a hazardous waste when discarded.
However, if they are hazardous waste, these would likely be subject to EPA special hazardous waste pharmaceuticals requirements at 40 CFR 266, Subpart P.
Managing Used Syringes
Discarded used syringes would be considered a process waste
under the hazardous waste identification rules. However, there is no listing in either 40 CFR 261.31 or 261.32 which describes used discarded syringes. So, these discarded syringes would only be a hazardous waste if they met one of more hazardous waste characteristics. Syringes, like any other sharp, are not
included in the EPA’s definition of pharmaceuticals under hazardous waste pharmaceutical rule [40 CFR 266.500].
So, if a discarded syringe exhibited a characteristic of hazardous waste, it would be subject to the standard generator requirements at 40 CFR 262 (e.g., accumulation time limits, manifesting, RCRA training, etc.).
If discarded vaccine wastes do not meet the definition of hazardous waste, they would be subject to state RCRA, Subtitle D regulations. Many or all of these vaccine-related waste may meet a state’s criteria for regulated medical waste.
Unlike hazardous waste regulations, state solid waste requirements are widely different, including state regulated medical waste regulations. These state programs may be run by the state’s environmental protection agency or in some instances a state’s health department. State requirements may specify certain storage, treatment or disposal practices requirements, require waste shipment tracking, and require generator, transporter, or treatment and disposal facility registration.
OSHA's Bloodborne Pathogens Standard
Some of these vaccine-related waste may meet the Occupational Safety and Health Administration (OSHA) criteria as potentially infectious materials under the Bloodborne Pathogens Standard [29 CFR 1910.1030].
These rules require employers to maintain safe and well communicated storage as well as develop exposure control plans and provide employee training in the safe handling of blood and other potentially infectious materials, including certain medical wastes.
US DOT Hazmat Regulations for Medical Waste
The US DOT Hazardous Materials Regulations or HMR (49 CFR 171-180) include regulated medical waste in their Division 6.2 hazard category [49 CFR 173.134].
Shipments of Division 6.2 materials, including regulated medical waste require specific packaging, communications (e.g., markings, labels, placards, shipping papers), and handling. In addition, employees involved in any aspect of preparing these regulated medical waste shipments must meet DOT training requirements.
While vaccine-related waste is not commonly hazardous waste, there are numerous safety, transportation, and waste management requirements that generating facilities must address. Since the waste management is typically a state matter, waste managers may need to carefully review multiple states’ programs, depending on the locations of their facilities.
Training to Safely Manage and Ship Medical Wastes
Employee training is critical to ensure regulated materials and wastes and properly handled, stored, shipped, and disposed of. These interactive online courses are designed to inform employees of the requirements that apply to their jobs and help satisfy US DOT, EPA, and OSHA training mandates.
The Shipping Regulated Medical Waste online course
provides required hazmat training for employees who package, mark, label, handle, and offer packages of medical waste subject to US DOT hazmat regulations in 49 CFR.
The Bloodborne Pathogens online course
provides training (or annual re-training) for employees who may be exposed to blood or other potentially infectious materials at work.
For RCRA hazardous waste training required for personnel, Lion offers a variety of online hazardous waste courses, including the comprehensive RCRA Hazardous Waste Management online course
Plus, find courses that cover unique, state-specific requirements that apply in California
, New York
, and Washington