Proper Bulk and Trace Chemotherapy Waste Handling

chemomedicalwastebins.jpg The importance of properly segregating your practice’s  medical waste comes clearly into focus when addressing chemotherapy waste. Out of all pharmaceutical waste, chemotherapy drugs can be some of the most highly toxic and corrosive, if disposed of incorrectly.  It is your responsibility, as the waste generator, to determine if your waste is hazardous, and you must maintain compliance with federal, state, and/or local environmental regulations. See how proper chemotherapy disposal can help protect the health and safety of your employees, patients, and the environment.

RCRA Hazardous Waste

RCRA is the acronym for the Resource Conservation and Recovery Act — the federal law enacted by the Environmental Protection Agency (EPA) to regulate hazardous and medical waste (as well as to manage non-hazardous wastes and underground storage tanks.)

EPA authorizes individual state hazardous waste programs as long as they are at least as stringent as, and consistent with, the federal program. EPA still maintains oversight of such programs and has the authority to take independent enforcement actions. RCRA regulates pharmaceutical wastes that are listed as hazardous waste or exhibit one or more characteristics of hazardous waste.

A pharmaceutical is considered a hazardous waste under RCRA if 1) it is a commercial chemical product that is listed under RCRA’s P- or U-list, and has not been used for its intended purpose or 2) if it exhibits one or more of the hazardous waste characteristics — ignitable, corrosive, reactive or toxic.

What are the P and U Lists?

RCRA defines hazardous waste more specifically through four lists — P, U, K, and F. The P and U lists  are the only ones that are relevant to hazardous waste pharmaceuticals. They designate pure and commercial grade formulations of certain unused chemicals as hazardous waste.

There are three criteria that waste must meet to be considered a P- or U-listed waste:

  1. Contain one of the chemicals listed on the P or U list
  2. The chemical must be unused
  3. The chemical must be in the form of a commercial chemical product

The P-list identifies acute (highly toxic) hazardous wastes from discarded commercial chemical products and the U-list identifies hazardous wastes.

“RCRA Empty” — What Does it Mean?

Some items that once contained chemotherapy drugs may be classified as “RCRA empty.” This means that a container that once held a U-listed substance has less than three percent of the former volume in it. For containers that held P-listed substances, triple-rinsing will render them RCRA empty. If these criteria are met, the waste can be considered trace waste, which means it can be managed as regulated medical waste, but must be medically incinerated.

Bulk vs. Trace Chemotherapy Waste

You’ve probably heard the words “bulk” and “trace” used to describe chemotherapy waste. The terms are not official EPA designations, but are commonly used in the industry.

Bulk Chemotherapy waste includes items that are used to contain chemotherapy agents and that do not qualify as “RCRA empty” because they contain more than 3% of chemo waste by volume. These items may include:

  • Unused/partially empty IV bags, syringes or vials
  • Materials used to clean up chemo spills

This type of chemotherapy waste goes into the black container (RCRA Hazard) or a drum labeled “Hazardous.”

Trace chemotherapy waste is made up of materials that are used to prepare and administer chemotherapy drugs. They do not have any liquid or powder that can be scraped or poured (only residual amounts of the drug remain) and include:

  • Gloves
  • Gowns
  • Pads
  • Syringes
  • IV tubing and bags without visible blood
  • Empty chemotherapy vials/bags/bottles

This type of chemotherapy waste is regulated medical waste. It goes into the yellow container or a container marked as “Trace Chemo.”

Trace chemotherapy waste must legally go through medical waste incineration, which exposes the waste to much higher temperatures and reduces the contents to ash (or nearly ash) rather than going through an autoclaving process. After sending the waste to the appropriate medical waste treatment facility, it is then processed. At that time, the waste no longer poses a health risk and it can be landfilled.

What Chemotherapy Drugs are on the Hazardous Waste List?

There are currently nine chemotherapy drugs whose waste is listed by the EPA as hazardous; obviously, many more drugs have been introduced since the list was first compiled in 1976. A  2012 report by the EPA Office of Inspector General identified more than a hundred drugs that met RCRA standards for hazardous waste, but may not have been reviewed by the EPA. The report included an Occupational Safety and Health Administration (OSHA) list with 61 drugs identified as hazardous waste and a 2010 National Institute for Occupational Safety and Health (NIOSH) list of 157 drugs. On August 31, 2015, EPA signed a rule that proposes a specific set of regulations for managing hazardous waste pharmaceuticals. Until that rule is finalized, these wastes must be managed in accordance with EPA’s RCRA waste management standards.

To help in identifying hazardous pharmaceutical waste, EPA has developed a Hazardous Waste Pharmaceuticals Wiki to facilitate collaboration among healthcare professionals. This platform can help determine whether the pharmaceuticals your practice discards meet the RCRA definition of hazardous wastes.

It’s no wonder that healthcare professionals often seek help from their waste disposal services company in managing such a fluid and complex process. Compliant chemotherapy disposal begins with segregating your waste streams correctly and then making sure that your waste disposal services company does their job. Proper management of your waste streams, including hazardous medical waste and chemotherapy waste, can safeguard the health of your employees, patients, and the general public — while saving you time, money, and worry. For more information and a handy reference tool, download our waste handling guide.


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