Biological & Infectious Waste

Regulations imposed by local, state, and federal agencies dictate that infectious waste must be segregated, packaged, and disposed of in a specific manner. The primary purpose of the regulations is to limit on-the-job exposure to blood and other potentially infectious materials. The following guidelines were implemented by the University during November 1988 and revised in July 1997.

Contact DEHS (502-852-6670) for any questions regarding biological and infectious wastes.

All wastes listed in this section must be segregated from other wastes, packaged, and disposed of in accordance with DEHS procedures. DEHS requires infectious waste to be classified as one of three types of waste:

Medical Waste

• Microbiological waste - i.e., stocks and/or cultures of etiological or infectious agents, including culture plates, test tubes, swabs, etc. contaminated with these Agents
• Human blood and blood products - i.e., all liquid blood, serum and plasma
• Potentially Infectious Medical/laboratory glassware including slides, pipettes, blood tubes and vials, and contaminated broken glass
• Transgenic Plant Material - plant's genetic material that has been altered by the introduction of genes from another organism.

Sharps

• Syringes
• Needles
• Scalpel blades
• Glass and plastic pipettes and vials
• All needles, scalpels, syringes or other sharps, regardless of their use are to be managed as Sharps.

Pathological Waste

• Human organs, body parts and surgical specimens or body parts removed during surgery or invasive procedures i.e.
• Obstetrical, autopsy, and laboratory procedures.
• Contaminated animal parts/tissues, and carcasses.
• Chemotherapy waste

Infectious Waste Segregation

At the point of generation, infectious waste is to be segregated by type and placed into separate containers for shipment. Laboratories and other infectious waste generator areas will separate each infectious waste stream into 32-gallon red containers lined with an approved biohazard bag. It will be the responsibility of all University employees or students that generate infectious waste to segregate the waste accordingly. Infectious waste that has not been segregated appropriately will remain in the laboratory or treatment area and an "Incomplete Work Notice" will be issued through Custodial Services. For more information please contact DEHS (502-852-6670).

Medical Waste and Sharps Segregation

Medical waste consisting of microbiological waste, human blood and blood products, potentially infectious medical/laboratory glassware, transgenic plant material, and sharps will be managed in the following manner:

• Medical waste will be placed in 32-gallon red infectious waste containers lined with an approved biohazard bag.
• All sharps must be placed in an approved sharps container. When the sharps container is full, it must be placed into a 32-gallon red infectious waste container lined with an approved biohazard bag.
• When the 32-gallon red container is full, laboratory or clinical staff will tie the bag shut. Custodial staff will pick up the waste whenever they find the bag has been tied shut. There is no need to notify Custodial Services to have infectious waste picked-up as custodians routinely collect infectious waste each evening.
• Infectious waste must be properly secured for collection by the custodians. "Properly secured" is defined as all biohazard (red or orange) bags tied, fastened or secured in the most efficient manner prior to custodians removing the container from a work area. If the bags are not closed, custodians are required to leave the bag/container where it was left and issue an "Incomplete Work Notice".

Pathological Waste

Pathological waste consisting of human organs, body parts, surgical specimens, contaminated animal parts/tissues and carcasses, and chemotherapy waste will be managed in the following manner:

• Pathological waste will be placed in 40 pound, square, fiberboard, DOT approved shipping containers lined with an approved biohazard bag.
• Custodial staff will pick up the waste whenever they find the bag has been tied shut, and the boxes taped closed. The generating location must be on the box. There is no need to notify Custodial Services to have infectious waste picked-up as custodians routinely collect infectious waste each evening.
• Infectious waste must be properly secured for collection. If the boxes are not closed, custodians are required to leave the boxes and issue an "Incomplete Work Notice."
• All biohazard bags are to be kept in containers designated for infectious waste only. These containers are supplied by the University's infectious waste contractor and are made available through Custodial Services (502-852-7174). Any biohazard bag found in a regular trash container will be left in the work area where it was discovered.

Resources

• Biohazardous Waste Management Guide
• Regulated Medical Waste Box Guide
• Waste Disposal Quick Guide for Research Labs

Dual Use of Research of Concern

Dual Use Research of Concern (DURC) is life sciences research that, based on current understanding, can be reasonably anticipated to provide knowledge, information, products, or technologies that could be directly misapplied to pose a significant threat with broad potential consequences to public health and safety, agricultural crops and other plants, animals, the environment, materiel, or national security. The United States Government’s oversight of DURC is aimed at preserving the benefits of life sciences research while minimizing the risk of misuse of the knowledge, information, products, or technologies provided by such research.

DURC Policy

The United States Government Policy for Institutional Oversight of Life Sciences Dual Use Research of Concern (PDF) , effective September 24, 2015, describes the policies, practices, and procedures required to ensure DURC is identified and risk mitigation measures are implemented. The Institutional Biosafety Committee (IBC) and the Executive Vice President for Research and Innovations are responsible for developing and implementing the University's DURC policy.

Agents and toxins subject to DURC policy:

1. Avian influenza virus (highly pathogenic)
2. Bacillus anthracis
3. Botulinum neurotoxin (there are no exempt quantities of botulinum neurotoxin)
4. Burkholderia mallei
5. Burkholderia pseudomallei
6. Ebola virus
7. Foot-and-mouth disease virus
8. Francisella tularensis
9. Marburg virus
10. Reconstructed 1918 Influenza virus
11. Rinderpest virus
12. Toxin-producing strains of Clostridium botulinum
13. Variola major virus
14. Variola minor virus
15. Yersinia pestis

Experimental categories of concern:

• Enhances the harmful consequences of the agent or toxin
• Disrupts immunity or the effectiveness of an immunization against the agent or toxin without clinical and/or agricultural justification
• Confers to the agent or toxin resistance to clinically and/or agriculturally useful prophylactic or therapeutic interventions against that agent or toxin or facilitates their ability to evade detection methodologies
• Increases the stability, transmissibility, or the ability to disseminate the agent or toxin
• Alters the host range or tropism of the agent or toxin
• Enhances susceptibility of a host population to the agent or toxin
• Generates or reconstitutes an eradicated or extinct agent or toxin listed above

U of L DURC Policy and Procedures

1. DURC Application: PIs are required to complete and submit a DURC application[HA1] to Biosafety Office if research involves any agents subject to DURC policy. This is required initially and all active risk mitigation plans at the institution will be reviewed at least annually.
2. DURC Institutional Review Entity (IRE): A DURC IRE (Institutional Dual Use Research of Concern Committee (IDURCC)) is required to assess all research with agents subject to DURC policy. The IDURCC will be a standing subcommittee of the IBC comprised of faculty, staff, and consultants with expertise in select agent research and regulations, biomedical and infectious disease research, biosafety, bioethics, animal research, environmental health and safety, export control, and U of L policies and procedures.
3. Risk Mitigation Plan: If research with the listed agents is anticipated to involve any experimental effects of concern and is considered DURC, the IDURCC will work with the PI and the funding sponsor to develop a risk mitigation plan that will be updated annually or more frequently as needed.

Resources

• DURC Application Form
• Institutional Duel Use Research of Concern Committee Bylaws
• IDURCC Protocol Review Procedures

Bloodborne Pathogens Program

All university employees who have reasonably anticipated exposure to human blood, body fluids, unfixed tissues, cells, cell lines or other potentially infectious materials (OPIM) are covered by the OSHA Bloodborne Pathogens Standard.

Responsibility for compliance rests with individual departments and includes:

• Developing a written unit specific Exposure Control Plan
• Providing and ensuring the hepatitis B vaccination available to workers with exposure potential
• Ensuring Initial and Annual training
• Post Exposure Evaluation and Follow-up
• Recordkeeping

Researchers maintaining or working with human cell lines, cell strains or products derived from human blood such as albumin, must also comply with the BBP Standard.

Questions about how the Bloodborne Pathogens standard impacts your work at UofL should be directed to the DEHS , phone number 502-852-6670.

Resources

• University of Louisville Bloodborne Pathogens Exposure Control Plan
• University of Louisville Hepatitis B Vaccine Policy
• Hepatitis B Vaccine Offer Form

Institutional Biosafety Committee (IBC)

In compliance with NIH Guidelines and University policies, an Institutional Biosafety Committee (IBC) exists and functions at the University of Louisville (UofL). The University's Institutional Biosafety Committee reviews all institutional activities involving the use of biohazardous agents and recombinant and synthetic nucleic acid molecules that require approval for "biosafety activities" as described in current governmental regulatory requirements. These regulatory requirements include, but are not limited to, the National Institutes of Health (NIH) Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines), the Centers for Disease Control and Prevention (CDC) Guidelines, and the Occupational Safety and Health Administration (OSHA) regulations and compliance directives as adopted and adhered to by KYOSH.

The Institutional Biosafety Committee's charge is to ensure that all persons, procedures and facilities involving the use of biological agents, recombinant or synthetic nucleic acid molecules and large scale activities meet the best interests of laboratory safety, effective research, as well as the environment and general public. The Institutional Biosafety Committee is appointed by and reports to the Executive Vice President of Research. The composition of the committee meets the requirements as specified in the NIH Guidelines and includes four community members that are not affiliated with UofL. The Department of Environmental Health and Safety (DEHS) provides the necessary administrative support for the functions and business of the Institutional Biosafety Committee.

Registration and Meeting Dates

In order for registrations or amendments to approved registrations to be considered on the monthly agenda, submit a registration in iRIS prior to the IBC Registration deadline. If there are no IBC registrations or amendments to approved registrations submitted by the monthly deadline, the standing IBC meeting may be cancelled.

Excluding the December meeting, IBC meetings are held in KCCTRB 125 from 9:00 AM - 10:00 AM

• 2023 IBC Submission Deadlines and Meeting Dates

Resources

• University of Louisville IBC Procedures
• IBC Bylaws (PDF)
• Primary Reviewer Form (PDF)
• Procedure for Investigating and Reporting Potential Violations of NIH Guidelines (PDF)

Select Agents and Toxin

As a consequence of the 9/11 terrorist attacks, Congress passed and the President signed the USA PATRIOT Act on October 26, 2001 which affects the possession of "Select Agents", biological agents and toxins determined by the Centers for Disease Control (CDC) and the USDA (United States Department of Agriculture)/APHIS (Animal and Plant Health Inspection Service) to have bioterrorism potential. This legislation extends previous regulations that restricted the transport, but not the possession of these agents.

Due to ongoing national concerns regarding the security and possession of "Select Agents", additional legislation entitled the Public Health Security and Bioterrorism Preparedness and Response Act was passed and signed into law on June 12, 2002. Regulations implementing this law became effective February 7, 2003 and include many new provisions such as: a revised list of Select Agents and Toxins; registration with the Centers for Disease Control to possess Select Agents and Toxins; submission of names of individuals with access to Select Agents and Toxins to Department of Justice for security clearance; development of security and safety plans; record keeping (including inventory) and training; and significant criminal penalties that extend to individuals for failure to comply.

If you possess Select Agents OR intend to perform future research or work involving any Select Agent and Toxins, you must immediately inform the Biological Safety Officer, or call 502-852-6670, so that appropriate arrangements can be made.

Program Requirements

1. The possession, transport and acquisition of Select Agent and other than permissible quantities of toxins requires registration with Health and Human Services (HHS) Centers for Disease Control (CDC) prior to possession. If you possess Select Agents or any amount of Select Toxins OR intend to perform future research or work involving any Select Agent or Toxins, you must immediately inform the Biological Safety Officer, or call 502-852-6670, so that appropriate arrangements can be made.
2. The intended use of all biological agents and Select Agents or Toxins in particular, requires university registration with the Institutional Biosafety Committee (IBC). Registration with UofL's IBC assists the investigator in understanding these regulatory requirements, avoiding liability and fines and ensures the safe use of the agents and toxins.

Resources

• Select Agent List

• Acute Biological Toxins

• Requirements for Possession of Permissible Quantities of Select Toxins (PDF)

Shipping and Receiving of Biohazardous/ Infectious Materials

Federal and international laws require that anyone who transports, offers advice for transport, or prepares hazardous materials for transport must be trained.

Faculty, staff and students involved in shipping hazardous materials must be trained or work with someone who has completed hazardous materials shipping training. Generally, training is required every two years.

Hazardous materials include:

• Biological Materials
• Diagnostic Specimens
• Genetically Modified Organisms / Micro-Organisms
• Infectious Substances
• Hazardous Chemicals
• Radioactive Materials
• Dry Ice