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The Biosafety Program

The University of Tennessee, Knoxville-area campuses, including Knoxville (UTK), the Institute of Agriculture (UTIA); College of Veterinary Medicine (CVM); and Graduate School of Medicine (GSM); hereafter referred to in total as UTK-A; are committed to protecting faculty, staff, students, visitors, the general public and the environment from exposures (or potential exposures) to biological hazards, and to ensuring that all activities involving biological hazards and the facilities used to conduct such work are in compliance with applicable U.S. Federal, State and local laws, regulations and guidelines.

The Biosafety Program is composed of the Institutional Biosafety Committee and EHS Lab Safety Services.  The University of Tennessee Institutional Biosafety Committee (IBC) oversees the use of biological hazards at UTK-A.

The IBC considers the following biological hazards, which require review and approval:

  1. Recombinant or synthetic nucleic acid molecules as defined in the National Institutes of Health Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (hereafter NIH Guidelines), including transgenic plants and animals (see details below)
  2. Biological agents (bacteria, viruses, fungi, protozoa, parasites, and prions) which: 1) cause or are reasonably expected to cause disease in immunocompetent humans; or 2) cause or are reasonably expected to cause significant disease in local livestock (including poultry), agricultural crops, or indigenous wildlife; 3) are covered by the Federal Select Agent Program; or 4) otherwise require enhanced safety and/or containment procedures
  3. Acute biological toxins having an LD50 < 100 ng/kg in mammals and/or those listed as select toxins by the Federal Select Agent Program
  4. Human or nonhuman primate blood, blood products, tissues, secretions, excretions, or cell lines unless documented to be free of bloodborne pathogens (BBP) or are otherwise low risk as per written risk assessment
  5. Venomous animals housed and/or manipulated in laboratories or other indoor facilities
  6. Poisonous plants posing a risk to humans via dermatological contact, inhalation, or other route of exposure housed and/or manipulated in laboratories, greenhouses or other indoor facilities
  7. Novel nanoparticles conjugated to biologically active or cell-modifying molecules
  8. Diagnostic specimens or environmental samples likely to contain any of the above and posing a significant risk to humans or local livestock (including poultry), agricultural crops, or indigenous wildlife as per documented risk assessment

The IBC advocates the use of biosafety precautions that effectively mitigate the risk of exposure to potentially hazardous agents.  These precautions are established by regulations, guidelines, and institutional policy:

  1. At the FEDERAL level:
    1. Occupational Safety and Health Administration (OSHA) Bloodborne Pathogens (BBP) Standard and Lab Safety Standard
    2. NIH Guidelines for Research Involving Recombinant and Synthetic Nucleic Acid Molecules (see details below)
    3. USDA Animal & Plant Health Inspection Service (APHIS)
    4. US Federal Select Agent Program
    5. Center for Disease Control (CDC)/NIH published Biosafety in Microbiological and Biomedical Laboratories, 5th ed. (BMBL)
    6. Department of Transportation and the International Air Transport Association (DOT/IATA) Hazardous Materials/Dangerous Goods Regulations.
  2. At the STATE level:
    1. Tennessee Occupational Safety and Health Administration (TOSHA) oversight of federal OSHA requirements (Bloodborne Pathogens Standard and Lab Safety Standard)
    2. Tennessee Department of Environment and Conservation (TDEC) oversight of regulated medical waste
  3. At the LOCAL/INSTITUTIONAL level:
    1. UT System Policy SA0450-Biological Safety
    2. Institutional Biosafety Committee (IBC)
    3. Institutional Animal Care & Use Committee (IACUC)
    4. Laboratory Safety Committee

The NIH Guidelines mandate the establishment of an IBC for the review and approval of research involving recombinant and synthetic nucleic molecules (rsNA).  To familiarize you with the NIH Guidelines:

  • The NIH Guidelines cover rsNA, defined as two or more adjoined molecules that can base pair and replicate, and which are not found contemporaneously in nature, and/or any synthetic counterparts meeting the same definition.  rsNA that do not encode proteins or functional elements are not excluded from coverage.
    • All research use of rsNA must be communicated to the Biosafety Program for determination of review/approval requirements.  This includes the creation/use of transgenic plants or animals and any project involving genome editing (CRISPR/Cas9, TALES/TALENS, zinc fingers, directed mutagenesis, etc.).
    • Some projects involving rsNA require IBC (and sometimes NIH) approval prior to commencement.
    • The IBC can only approve projects in containment.  Environmental releases of rsNA-containing organisms is subject to review and approval by an applicable federal agency (USDA, FDA or EPA)
  • Compliance with the NIH Guidelines is not optional.  These are a term/condition of NIH funding, which all UTK-area campuses receive.
  • The NIH Guidelines apply to all institutional research involving recombinant or synthetic nucleic acids regardless of funding status or funding agency (i.e. they are not exclusive to NIH-funded projects).
  • The NIH Guidelines outline roles/responsibilities for the institution, IBC, biosafety officer, and PIs (outlined in the following module).
  • As required by the NIH Guidelines, the IBC is staffed with expertise to competently review the safety and containment of recombinant/synthetic nucleic acids.  Additionally, at least two local non-affiliated members are appointed to represent the safety interests of the community.

The UTK Biosafety Officer (BSO) supports the IBC and research community by:

  • Providing IBC administrative support
  • Assisting faculty with registration of research projects and keeping project information current (amendments & updates)
  • Performing risk assessments
  • Monitoring & maintaining institutional records
  • Providing training for faculty, staff & students
  • Conducting laboratory inspections and post-approval monitoring
  • Investigating spills/accidents/exposures involving biological hazards and recommending remedial actions
  • Monitoring for updates or changes to Federal, State & local standards/regulations
  • Assisting with biological hazard and dry ice shipping
  • Providing guidance and support for federal/state permits

Guidance and support for federal/state permits includes:

  1. United States Department of Health and Human Services/Center for Disease Control (U.S. DHHS/CDC) permits.
    The CDC Import Permit Program, or IPP, regulates the importation of infectious biological materials that could cause disease in humans in order to prevent their introduction and spread into the U.S.  Materials             requiring import permits include:

    1. Infectious biological agents capable of causing illness in humans
    2. Materials known or reasonably expected to contain an infectious biological agent
    3. Vectors of human disease (such as insects or bats)
  2. United States Department of Agriculture (USDA) Animal and Plant Health Inspection Service (APHIS) permits – these permits are issued for the import, transit and release of regulated animals, animal products, infectious agents/vectors affecting poultry/livestock, veterinary biologics, plants, plant products, plant pests, plant pathogens, soil, and genetically engineered organisms.
    1. Veterinary Services (VS)
    2. Plant Protection and Quarantine (PPQ)
    3. Biotechnology Regulatory Services (BRS)
    4. Center for Veterinary Biologics (CVB)
  3. United States Fish and Wildlife Service (USFWS) permits – these permits are issued under various wildlife laws and treaties at different offices at the national regional and/or wildlife port levels.  These permits cover a wide range of import/export regulations including the trapping, buying, selling, and trading of live animals (non-agricultural), preserved animal trophies, animal hides, and animal tissues.
  4. Department of Commerce (DOC) export of biological agents – The DOC has developed a list of biological agents (among other products and technologies) that are restricted by licensing requirements for export.

Per the Tennessee state law and University policies, no person will be discriminated or retaliated against for reporting any safety or compliance concerns.  While Federal labor law prohibits an employer from discriminating against an employee for engaging in certain protected activities such as filing of safety complaints with the federal Occupational Safety and Health Administration (OSHA), employees are encouraged to first exhaust all internal mechanisms for addressing safety issues, including supervisory staff, departmental safety officers, safety committees, EHS, or University Risk Management.

Section 11(c) of the Occupational Safety and Health Act (OSH Act) prohibits employers from discriminating against their employees for exercising their rights under the OSH Act. These rights include filing an OSHA complaint, participating in an inspection or talking to an inspector, seeking access to employer exposure and injury records, reporting an injury, and raising a safety or health complaint with the employer. If workers have been retaliated or discriminated against for exercising their rights, they must file a complaint with OSHA within 30 days of the alleged adverse action.

Whistleblowers are free to disclose lawfully whatever information supports a reasonable belief of research misconduct as defined by HR0580 (Code of Conduct).  An individual or institution that retaliates against any person making protected disclosures engages in prohibited obstruction of investigations of research misconduct as defined by the Office of Research and Engagement.  Whistleblowers must respect the confidentiality of sensitive information and give legitimate institutional structures an opportunity to function. Should a whistleblower elect to make a lawful disclosure that violates institutional rules of confidentiality, the institution may thereafter legitimately limit the whistleblower’s access to further information about the case.