As a result of a national scare from needles and other medical waste washing up on eastern shores in the late 1980’s the USEPA passed the Medical Waste Tracking Act of 1988, which was only effective in a limited number of eastern states and expired June 21, 1991. In the absence of specific Federal regulations to manage medical waste, states moved forward with their own regulations; thus Illinois passed regulations to manage what it identified as Potentially Infectious Medical Waste in 1993.
Illinois’ PIMW regulations are administered by the Bureau of Land within the Illinois Environmental Protection Agency and can be found in 35 Illinois Administrative Code: Subtitle M.
Before reviewing the requirements for managing PIMW in Illinois, a potential generator must determine if what they have meets the definition of a Potentially Infectious Medical Waste as defined at 35 IAC 1420.102 and summarized below from the IEPA’s PIMW webpage:
PIMW is waste generated in connection with the diagnosis, treatment (i.e., provision of medical services), or immunization of human beings or animals; research pertaining to the provision of medical services; or the provision or testing of biologicals.
It includes but is not limited to:
- Cultures and stocks of agents infectious to humans and associated biologicals.
- Human pathological waste including tissue, organs, body fluids & specimens of body fluids, and body parts (except teeth and bone).
- Human blood, blood components, or material saturated with free flowing blood.
- Used sharps, discarded after use in animal or human patient care, medical research, or a lab. It may include needles or syringes, pasteur pipettes, scalpel blades, blood vials and also glass (broken and unbroken) in contact with infectious agents.
- Unused sharps.
- Animal waste including discarded carcasses, body parts, fluids, blood, fluids, & etc. if originating from animals used in the testing of agents infectious to humans.
- Isolation waste, which means discarded materials contaminated with blood, excretions, exudates, and secretions from humans who are isolated due to ‘highly communicable diseases’.
Potentially Infectious Medical Waste does not include:
- General household waste.
- Waste, except for sharps, where the infectious potential has been eliminated by treatment.
- Sharps that meet both of the following:
- Infectious potential removed by treatment; and,
- Rendered unrecognizable by treatment.
The added emphasis is important because it helps to support the IEPA’s interpretation that these regulations apply only to a medical facility and not to a commercial or industrial facility that happens to generate some type of medical waste. Any medical waste generated at a non-medical industrial or commercial facility will meet the definition of a general household waste and thus is excluded from the definition of PIMW. A conversation with Beverly Albarracin of IEPA provided this quote:
The Potentially Infectious Medical Waste regulations are meant to apply to a medical facility (not defined but understood to mean the operations of a doctor, dentist, veterinarian or other in the medical field). The PIMW regulations are not meant to be an unnecessary burden to industry.
So, unless your business is in the medical field, it is unlikely that you generate any PIMW at all. Even if you have a Nurses’ Station where employees come for minor treatment.
And what about those hypodermic needle collection containers some businesses provide for employee or public use? Does that meet the definition of PIMW as sharps? The answer, again, is no. And the reason, again, is the exclusion to PIMW allowed for general household waste. Again, Beverly Albarracin:
A sharps collection container at a non-medical facility is a general household waste and excluded from the definition of PIMW.”
If your PIMW is mixed with other waste it must still be managed in compliance with the PIMW regulations, though it is not exempt from other applicable regulations [35 IAC 1421.111(b)]. This means that your determination doesn’t end with PIMW. A full hazardous waste determination will determine if your waste (perhaps already a PIMW) is also a characteristic or listed hazardous waste.
On-Site Management of PIMW:
An Illinois industrial facility whose medical waste is excluded from the definition of PIMW may dispose of it with its Municipal Solid Waste. The following guidelines are recommended:
- Place medical waste in a sturdy container such as a sharps container, laundry detergent bottle, or soda bottle.
- When full, the lid should be placed on securely and taped in place.
- Mark the container “Do not recycle” and place in regular trash. CHECK WITH YOUR LANDFILL!
Further, a medical facility is not required to manage bandages or other materials contaminated with blood as a PIMW unless it contains “free flowing blood”. A medical facility, or a person who chooses to manage their medical waste as a PIMW, is subject to the following requirements (35 IAC 1420 & 1421):
- PIMW must be segregated by the generator as follows:
- Oversized PIMW, and;
- All other PIMW.
- Except for oversized PIMW, containers must be:
- Impervious to moisture.
- Of a strength sufficient to prevent tearing or bursting under normal conditions of use and handling.
- Sealed to prevent leakage during transport.
- Sharps must also be in a package that is puncture-resistant.
- Oversized PIMW must be covered or packaged in a manner that minimizes contact with transport workers and the public.
- The outer package must be marked and labeled on two opposing sides with the International Biohazard Symbol and the word “Biohazard”.
- Waste-specific requirements for labels and markings include:
- Sharps. The word “Sharps” on two opposing sides.
- Oversized PIMW. The International Biohazard Symbol and the word “Biohazard” on one side.
- The package must also be marked with the generator’s name, address, and phone number (24-hour number, if available).
- The regulations of other agencies, including: OSHA and the Illinois Department of Public Health may apply as well.
Off-Site Transportation of PIMW:
- PIMW can only be transported by a licensed PIMW hauler [exceptions @ 35 IAC 1420.105(b)].
- The transportation of a PIMW will require an Illinois-specific PIMW manifest [exceptions @ 35 IAC 1420.105(e)].
- PIMW transporter must mark the outer package with the following:
- Transporter’s name, address, phone number (24-hour phone number, if available), and permit number.
- For each PIMW package, the shipment date or a unique identification number which directly corresponds to the initial date of shipment.
- Transporter must develop and keep an emergency response plan in the vehicle.
- PIMW must not be in transport for more than ten (10) calendar days.
- Transporters must submit annual reports to the IEPA.
- There are more requirements for PIMW transporters codified @ 35 IAC 1421, Subpart E.
- The regulations of the PHMSA/USDOT may apply to off-site transportation of PIMW.
Transfer, Storage, or Treatment of PIMW:
- The destination facility for a PIMW can only be a permitted transfer, storage, or treatment facility [exceptions @ 35 IAC 1420.105(c)].
- Only after treatment (including special requirements for sharps) may PIMW be placed in a landfill.
- All PIMW must be treated to eliminate the infectious potential.
- Sharps must be treated to eliminate the infectious potential and either made unrecognizable by treatment or packaged properly prior to disposal.
The key to compliance with the PIMW regulations of the IEPA is the applicability determination. Make certain you are subject to these regulations before your pursue compliance. If you are a generator of Potentially Infectious Medical Waste, then you must review and comply with all of the requirements of 35 IAC, Subtitle M. If your medical waste is not PIMW, then the recommendations of IEPA identified above and common sense will be enough.
If you are not located in Illinois, your state will have different regulations related to the management of medical waste; you must research these in order to ensure compliance. Also, be aware that the regulations of other agencies may affect the management of some medical waste, including:
- Occupational Safety and Health Administration (OSHA) program for bloodborne pathogens.
- Illinois Department of Public Health (IDPH) regulations for healthcare facilities.
- Pipeline and Hazardous Materials Safety Administration (PHMSA) of the USDOT for the transportation of Infectious Substances (Hazard Division 6.2).
If you have questions about the management of medical waste in your state or the USEPA regulations for the management of hazardous waste, please don’t hesitate to contact me.