Environmental, Health and Safety Services

Biological Safety Program Summary

Applies to:

  • Biohazardous materials used in research and teaching, including:
    • biological agents known to, or suspected to, cause disease in humans
    • toxins of biological origin which may cause death or severe incapacitation at relatively low exposure level
    • human, non-human primate, and mammalian blood, blood products, cells, and unfixed tissue
    • animal/plant pathogens and products, specific genetically engineered organisms requiring a USDA APHIS permit for transportation or use and veterinary biologics requiring a permit for research, evaluation, or transportation
    • select agents and toxins which includes specific agents, toxins, and related genetic material determined by HHS and USDA to pose a severe threat to human health, animal health/products, or to plant health/products

Requirements:

  • Review and approval by appropriate university oversight committee(s):
    Committee Reviews and approves the use of....
    Institutional Biosafety Committee (IBC)

    Recombinant DNA/RNA research

    Human Risk Group 2 or 3 agents (including human, NHP, and mammalian blood, blood products, cells, and unfixed tissue),

    Toxins of biological origin

    Select agents and toxins

    Plant and animal pathogens/products requiring a USDA permit
    Institutional Animal Care and Use Committee (IACUC) Vertebrate animals in research and teaching
    Radiation Safety Committee (RSC) Radiation or radioactive materials
    Institutional Review Board (IRB) Human subjects (including nonviable fetuses, fetal material, and placental material)
  • Research-specific safety and facility maintenance SOPs and biosafety manual developed and then reviewed and approved by University Biosafety Officer
  • Appropriate engineering controls (e.g., class II biosafety cabinet) and personal protective equipment available
  • Personnel trained on hazards, equipment use, protective measures, and incident response procedures prior to start of work
  • Medical surveillance requirements completed prior to start of work
  • Evaluation of facilities by University Biosafety Officer to ensure compliance with applicable regulations and standards
  • If select agent and toxins are used, additional security measures are required for personnel, agent handling, and the facilities in which they are used and stored