Biological, Medical, Sharps and Pharmaceutical Waste (Regulated)

Microbiological waste includes:

1. Discarded cultures and stocks of infectious agents and associated biologicals;
2. Discarded cultures of specimens from medical, pathological, pharmaceutical, research, clinical, commercial, and industrial laboratories;
3. Discarded live and attenuated vaccines, but excluding the empty containers thereof;
4. Discarded, used disposable culture dishes; and
5. Discarded, used disposable devices used to transfer, inoculate, or mix cultures.

NOTE: In vitro tissue cultures that have not been intentionally exposed to pathogens are exempt from these regulations

Animal Waste includes:

1. Carcasses and body parts of animals
2. Whole blood, serum plasma, and/or blood components from animals
3. Bedding of animals intentionally exposed to pathogens

Human blood and blood products include:

1. Human blood, serum, plasma, other blood components, and body fluids
2. Disposable item contaminated with human blood or body fluids

Regardless of Contamination

Sharps include but are not limited to the following, regardless of contamination:

1. hypodermic needles;
2. hypodermic syringes with attached needles;
3. scalpel blades;
4. razor blades, disposable razors, and disposable scissors used in surgery or other medical procedures; and
5. glass Pasteur pipettes.

When Contaminated

Sharps-like waste includes but are not limited to the following, when contaminated:

1. glass pipettes;
2. broken glassware;
3. specimen tubes;
4. blood culture bottles;
5. and microscope slides.

Contaminated - is defined as the presence or the reasonably anticipated presence of blood, body fluids, or other infectious materials.

Pathological waste includes but is not limited to:

1. Human materials removed during surgery, labor and delivery, autopsy, embalming, or biopsy, including: body parts and tissues or fetuses;
2. Products of spontaneous or induced human abortions, regardless of the period of gestation, including: body parts, tissues or fetuses, organs, and bulk blood and body fluids;
3. Laboratory specimens of blood and tissue after completion of laboratory examination; and
4. Anatomical remains.

Pharmaceutical wastes can be regulated by the Environmental Protection Agency regulates hazardous chemicals through the Resource Conservation and Recovery Act, Texas Control on Environmental Quality which is an authorized agency of the EPA, the City of Austin or the Drug Enforcement Agency.

If a substance is regulated by the DEA refer to the information on Controlled Substances

The following information is not all inclusive and is meant as a guide to assist in understanding how to identify which Pharmaceuticals are regulated. When these chemicals become waste, they must be disposed  of according to EPA “Lists” or “Characteristics” of hazardous substances, including:

• Discarded Commercial Chemical Products (U-Listed)
• Acute Hazardous Waste (P-Listed)
• Characteristic Waste
• Ignitable
• Toxic
• Corrosive
• Reactive

Refer to the information on Chemical Waste for a more detailed explanation of the categories listed above.

Common P-Listed Chemicals in Healthcare

• Epinephrine
• Nicotine
• Nitroglycerine
• Osmium Tetroxide
• Sodium Azide
• Strychnine
• Arsenic Acid

Common P-Listed Drugs in Healthcare

• Warfarin (Coumadin, Jantoven)
• Nicotine patches, lozenges or gum
• Physostigmine, physostigmine salicylate
• Arsenic trioxide (Trisenox)
• Cyclophosphamide

Common U-Listed Chemicals in Healthcare

• Acrylamide (* gels not included)
• Benzene
• Formaldehyde
• Formic Acid
• Hydrofluoric Acid
• Methyl Methacrylate
• Phenol

Common U-Listed Drugs in Healthcare

Most chemotherapy drugs fall into the U-Listed category. While chemotherapy drugs make up the majority in terms of volume of waste generated at healthcare facilities, other U-listed drugs include:

• Mitomycin C
• Chloral hydrate
• Lindane
• Selenium sulfide

For Clinics and Medical facilities only

To make the determination between Non-RCRA and RCRA pharmaceutical waste you will need to provide EHS – HMM a total list of medications used.

Prior to generating microbiological waste ensure you have the appropriate waste container

• For solid microbiological waste this would be a Biohazardous Red Bag Unit
• For liquid waste this may be an Erlenmeyer flask

1. Carcasses and Body Parts of Animals

Carcasses and body parts of animals that have not been preserved must be double bagged to prevent leakage and kept frozen until collection by EHS – HMM  or transferred to the Animal Resources Center. Carcasses and body parts of animals that have been preserved must be separated from the preservative prior to collection (refer to Chemical Waste for the packaging and disposal requirements of the preservative) and double bagged to prevent leakage.

2. Whole Blood, Serum, Plasma, and/or other Blood Components from Animals

All should be disposed of through EHS – HMM. Place into a non-breakable, leak-proof container then place into a biohazardous red bag unit. If you need advice on what kind of container to use, call EHS – HMM at (512) 471-3511.

3. Bedding of Animals Intentionally Exposed to Pathogens

This waste stream can be treated on-site in the lab by following all the treatment standards in Section III. Procedures for Treatment or Removal of Regulated Medical, Biological, and Sharps Waste. If incineration is required for treatment then the waste must be submitted to EHS – HMM  for disposal. Place the waste into a Biohazardous Red Bag Unit.

NOTE: If animals are intentionally exposed to chemicals that can be secreted through urine and/or fecal matter you may be required to handle the bedding as Chemical Waste.

1. Human Blood, Serum, Plasma, other Blood Components, and Body Fluids

All should be disposed of through EHS – HMM . Place into a non-breakable, leak-proof container then place into a biohazardous red bag unit. If you need advice on what kind of container to use, call EHS – HMM at (512) 471-3511.

2. Disposable Items Contaminated with Human Blood or Body Fluids

Non-sharp: should be accumulated in a biohazardous red bag unit.

Sharps or Sharp-like: Follow waste management standards in Section II. Part D Sharp and Sharp-like Waste Management.

1. Accumulation of Sharps Waste

Prior to generating sharps waste or contaminated sharp-like waste ensure you have a sharps waste container that complies with sharp waste management regulations. All sharp and contaminated sharp-like wastes must be accumulated in a sharps waste container and disposed of through EHS – HMM . Sharp and sharp-like wastes that are chemically contaminated must be managed as Chemical Waste.

NOTE: If you suspect that generated sharp-like waste is either biologically or chemically contaminated you must disposed of through EHS.

2. Sharps Waste Packaging and Closure Instructions

Prior to accumulation, set up an appropriately sized sharps waste container near where sharps or contaminated sharp-like waste will be generated. The lid should securely lock in place.

Carefully place sharps into the appropriate sharps waste container and do not fill containers more than 3/4^th  full. There is a line on the side of all sharps containers that denotes the maximum allowable fill.

• Segregate chemically contaminated sharps from biologically contaminated sharps.
• To avoid accidental sticks, place needles directly into containers and DO NOT recap, bend, break, clip, or remove needles from disposable syringes.
• Do not dispose of sharps containers with the regular trash. When the sharps waste container is full close the container by inserting all locking tabs into the lid of the sharps container.

Pathological waste must either be preserved or kept frozen until pick-up by EHS – HMM. Pathological waste that has been preserved must be separated from the preservative prior to collection (refer to Chemical Waste for the packaging and disposal requirements of the preservative) and double bagged to prevent leakage.

For Clinics and Medical facilities only

Treatment standards and disposal costs differ between Non-RCRA and RCRA pharmaceutical waste. It is important to properly segregate this waste stream by:

• Non-RCRA pharmaceutical waste will be accumulated in the blue and white containers provided by EHS – HMM.
• RCRA Pharmaceutical waste must be accumulated in the black and while containers provided by EHS – HMM.​

Once 3/4^th full close the container and place in the designated waste storage rooms. EHS – HMM will manage the waste from there.

NOTE: For DEA regulated substances refer to Controlled Substances

Biological safety level (BSL) I or II microbiological waste, does not require incineration as the method of treatment and should be treated on-site using an available autoclave or in the lab through chemical disinfection. If a microbiological waste requires treatment by incineration or an autoclave is not readily available and treatment standards do not allow chemical disinfection then it can be given to EHS – HMM  for disposal. The following requirements must be met when treating biological waste using an autoclave or chemical disinfection in the lab:

1. Record Keeping

All lab personnel who treat and dispose of microbiological waste on site in accordance with the guidelines described below, must keep the following records that include:

1. Date of treatment;
2. Amount of waste treated;
3. Method / conditions of treatment;
4. Name (printed) and initials of person(s) performing treatment; and
5. Written procedure for the operation and testing of any equipment used and a written procedure for the preparation of any chemicals used in treatment.

2. Performance Monitoring

A minimum 4 log₁₀ reduction shall be demonstrated on routine performance testing using appropriate Bacillus species biological indicators. This testing needs to be performed on autoclaves that are used to treat special waste. EHS has a program in place for the testing of autoclaves.

3. Treatment Methods

Acceptable methods of treatment of microbiological waste include:

Steam Disinfection

• To allow for sufficient steam access to or penetration of the waste, the waste shall be:
  1. Packaged according to the recommendations provided by the manufacturer, and
  2. loaded into the chamber so as to not exceed the capacity limits as set by the manufacturer.
• When subjecting waste to steam under pressure, the temperature in the chamber of the autoclave must reach at least 121°C and there must be at least 15 pounds per square inch (psi) gauge pressure for at least 30 minutes.
• The autoclave must be operated according to the manufacturer's instructions.

Chemical Disinfection

• Use a chemical agent that is registered with the Environmental Protection Agency (EPA) and the Texas Department of Agriculture as a disinfectant and in accordance with the manufacturer's instructions; or
• Immerse the waste for not less than three minutes in:
  1. A freshly prepared solution of household chlorine bleach diluted 1:10 (chlorine bleach / water) with water; or
  2. A solution of 70% by volume 2-propanol (isopropyl alcohol).
• Waste that has been immersed in a liquid chemical agent must be thoroughly drained before disposal otherwise the waste may be considered chemically hazardous.

1. Disposal Treated Biohazardous Waste

Microbiological waste which has been treated in accordance with the methods described above can be disposed of through the regular trash as long as the following procedures are followed:

• Place a label on the original bag or container stating "Treated in Accordance with 1.136 of the TAC SWFHCRF" (available from EHS, Laboratory Safety), and
• Place the bag or other container into another bag or container that is a different color and is opaque, e.g., a black trash bag.

Note: If the treated waste is in a liquid form it can be disposed of through the sanitary sewer.

2. Disposal of Untreated Regulated Medical, Biohazardous, and Sharps Waste

To request the removal of untreated regulated medical, biohazardous or sharps waste by EHS - HMM, complete and email a Disposal Request Form to EHS-HMM EHS-HazardousMaterials@austin.utexas.edu at when the waste is ready for pickup. Follow all packing instruction outlined in Section II. Regulated Pharmaceutical, Medical, Biological and Sharps Waste Management.

3. Disposal of Pharmaceutical Waste

For DEA Controlled Substances, follow disposal guidance outline HERE

For Clinics and Medical facilities only

EHS – HMM will collect this waste from designated waste storage rooms at a frequency established by your facilities liaison or Director and EHS – HMM. Follow all packing instruction outlined in Section II. Regulated Biological, Medical, Sharps and Pharmaceutical Waste Management.