What is Regulated Waste?

The guidelines for determining regulated waste are very specific and unambiguous. Despite clear guidelines, there is a great deal of confusion around this topic. It is widely (and incorrectly) held that all body fluid waste is regulated waste. In reality, regulated waste falls into five distinct categories. Regulated waste is:

  1. liquid or semi-liquid blood,
  2. blood-soaked items that would release blood if squeezed,
  3. pathological and microbiological waste (cultures and specimens),
  4. contaminated sharps and
  5. isolation waste.

Based on guidelines from OSHA and state regulations, the most likely generators of regulated waste would be healthcare, laboratory and research organizations or so-called medical waste generators. A medical waste generator is a person/entity whose act or process produces medical waste. Medical waste generators include hospitals, clinics (such as medical, dental, and veterinary), surgery centers, dialysis centers, blood banks, long term care facilities, hospices, funeral homes, laboratories (such as clinical, diagnostic, pathological, veterinary, and biomedical research), pharmacies, body art establishments, acupuncture facilities, trauma scene cleanup sites, facilities holding shot clinics or health fairs, and pet shops.

Vomit, urine, feces and solidified (non liquid) blood are generally not considered regulated waste in federal or state waste guidelines. Foodservice organizations like grocery stores, restaurants and schools are not considered medical waste generators. Solidified blood, vomit and feces waste collected from body fluid spills in foodservice environments would not be considered to meet the definitions of regulated waste.

The labeling and disposal of regulated waste is heavily regulated and expensive. OSHA requires that warning labels be affixed to containers of regulated waste that are used for storage, transporting or shipping. This label is required as a means of communicating the hazards to employees. Red biohazard bags are acceptable forms of storage containers and commonly used.

The treatment and disposal of red bags or containers is governed by state and local regulations. These treatment and disposal rules are usually published by state environmental agencies and/or departments of health. Prescribed methods of treatment include incineration, sterilization, chemical disinfection, thermal inactivation and other methods. Medical waste generators contract with medical waste companies to properly manage the disposal of regulated waste. These companies pick up materials and coordinate their treatment and disposal at state-approved landfills or other locations. The route-based services provided by waste management companies can be costly. It is important that organizations investing in these services aren’t contracting for materials that are not considered regulated waste.

(a) Regulated Waste Definition – OSHA Bloodborne Pathogen Standard

The OSHA Bloodborne Pathogens Standard directly defines “regulated waste” to be:

  • liquid or semi-liquid blood or other potentially infectious materials (OPIM);
  • items contaminated with blood or OPIM and which would release these substances in a liquid or semi-liquid state if compressed;
  • items that are caked with dried blood or OPIM and are capable of releasing these materials during handling;
  • contaminated sharps; and
  • pathological and microbiological wastes containing blood or OPIM [1]

OPIM is defined as a specific list of human body fluids including semen, vaginal secretions, cerebrospinal fluid and amniotic fluid and any body fluid that is visibly contaminated with blood. OPIM also includes any (a) unfixed tissue or organ from a human; (b) HIV or HBV infected cells, tissue or organ cultures, culture medium or other solutions; or (c) blood, organs or other tissues from experimental animals infected with HIV or HBV.

It is the employer’s responsibility to determine the existence of regulated waste.  This determination should not be based on actual volume of blood, but rather on the potential to release blood, (e.g., when compacted in the waste container). OSHA provides additional guidance for the determination of regulated waste: OSHA states that bandages which are not saturated to the point of releasing blood or OPIM (if compressed) would not be considered as regulated waste.

(b) Regulated Waste – State Regulations

Some state regulations use a general definition for regulated medical waste, while others list specific wastes and categories of waste that are considered infectious. The following six medical wastes are commonly regulated by states (none of which include vomit or feces or even small amounts of blood):

  • Pathological waste. Tissues, organs, body parts, and body fluids removed during surgery and autopsy.
  • Human blood and blood products. Waste blood, serum, plasma and blood products.
  • Cultures and stocks of infectious agents(microbiological waste). Specimens from medical and pathology laboratories. Includes culture dishes and devices used to transfer, inoculate, and mix. Also includes discarded live and attenuated vaccines.
  • Contaminated sharps. Contaminated hypodermic needles, syringes, scalpel blades, Pasteur pipettes, and broken glass.
  • Isolation waste. Generated by hospitalized patients isolated to protect others from communicable disease.

[1] http://www.hercenter.org/rmw/osha-BPS.cfm