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Biological Waste Regulations

Biohazardous waste includes any waste item that is contaminated with a biological material that is an infectious disease transmission risk or an environmental release risk (i.e., recombinant DNA).

In the state of Tennessee, some forms of biohazardous waste are defined as “medical wastes” and are regulated for disposal purposes by the Tennessee Department of Environment and Conservation (TDEC Rule 0400-11-01-.04(2)(k)(4)). These regulated “medical wastes” include the following categories which may be applicable to UT researchers:

  1. Wastes generated by hospitalized patients who are isolated to protect others from communicable diseases;
  2. Cultures and stocks of infectious agents, including specimen cultures from medical and pathological labs, cultures and stocks of infectious agents from research and industrial labs, wastes from the production of biological, discarded live and attenuated vaccines, and culture dishes and devices used to transfer, inoculate and mix cultures;
  3. Waste human blood and blood products such as serum, plasma and other blood components;
  4. Pathological wastes (i.e., tissues, organs, body parts, and body fluids) that are removed during surgery and autopsy;
  5. All discarded sharps (i.e., hypodermic needles, syringes, Pasteur pipettes, broken glass, scalpel blades) used in patient care or which have come into contact with infectious agents during use in medical, research or industrial labs;
  6. Contaminated carcasses, body parts, and bedding of animals that were intentionally exposed to pathogens in research in the production of biologicals, or in the in vivo testing of pharmaceuticals.

Unlike hazardous chemical or radioactive waste, there is no one federal agency that clearly defines and regulates biohazardous waste. Several agencies associated with research funding have unique waste disposal requirements that may go above and beyond what TDEC regards as regulated “medical waste”. Therefore, it is the researcher’s responsibility to have a general knowledge of biosafety regulations & guidelines and how they apply to their work and the waste that is generated through the research and diagnostic service process.

Please review the regulatory/agency information in the following table. If your work will involve generating any of the wastes previously described, or any of the wastes in the table, then you will most likely need to segregate and manage some portion of your research waste as biohazardous waste.

Other Agencies with Biohazardous Waste Requirements

Regulation/Federal Guidelines Activities covered by this standard Biohazardous wastes
OSHA’s Bloodborne Pathogens Standard Work with human-derived materials including clinical and unfixed anatomical specimens, human cells and cell lines. Those wastes that are contaminated to the extent where fluids can drip off or flake off of waste; liquid wastes; fresh (unfixed) tissues; sharps.
NIH Guidelines
for Research Involving Recombinant DNA Molecules
Work with molecules that are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell, or molecules that result from the replication of those previously described; regardless of whether work meets “exempt” criteria or not, all recombinant DNA work is to be carried out in accordance with biosafety level 1 containment practices at a minimum. All contaminated solid and liquid wastes including sharps.
CDC/NIH “Biosafety in Microbiological and Biomedical Laboratories” (BMBL) Lab and animal studies involving work with microorganisms that can cause disease in humans; under certain circumstances, lab and animal studies involving microorganisms that are infectious to animals; diagnostic laboratory operations involving human or animal clinical specimens. All cultures, stocks and items contaminated with these materials; in some cases, animal bedding and carcasses; biohazardous sharps.
USDA APHIS Permits Work with any animal or plant-derived materials or pathogens that require an APHIS permit to receive or retain the material. Permits will outline specific waste treatment requirements for the material in question.  However, this usually involves segregation and biological inactivation of the material prior to disposal.