Biosafety Program
Welcome to the Environmental Health and Safety Biosafety Web page. Cal Poly Pomona and the Department of Environmental Health and Safety (EHS) are committed to providing a safe and healthy work environment for students, faculty, staff and visitors.
Biosafety encompasses many different areas of study including but not limited to:
- Biologics
- Recombinant DNA (rDNA),
- Select Agents; and
- Infectious Agents
This webpage is designed to link many areas under the biosafety discipline in an effort to facilitate research and compliance with constantly changing regulatory requirements. In addition, this site will provide numerous resources that pertain to the field of biosafety.
The Biosafety Manual establishes a framework for safe practices in the use of biological materials, prioritizing the health and safety of personnel, students, and the community. It promotes a proactive safety culture by providing practical guidelines for handling, storing, and disposing of biological agents.
Aligned with the CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL), NIH Guidelines, Cal/OSHA standards, and Cal Poly Pomona Biosafety Program, this manual serves as a foundation for educating laboratory personnel and ensuring safe and compliant research practices.
Institutional Biosafety Committee
The Institutional Biosafety Committee (IBC) provides guidance to University researchers who use Biologics, Infectious Agents and Recombinant DNA within the scope of their work.
Such work must be approved by the IBC before work may begin and any funding made available. The IBC was designed to facilitate researchers and their goals by streamlining the process of submitting proposals for approval in a way that reduced the redundancies within various regulatory requirements.
The following are functions performed by the IBC to adequately regulate research in the area of Biologics, Infectious Agents and Recombinant DNA. These functions are focused on reducing the regulatory burden imposed on researchers, while maintaining safe work environments for all employees who work with those materials.
- Recognize and assess dangers associated with respective research in Biologics, Infectious Agents and Recombinant DNA;
- Assure Federal, State and Local agencies of compliance in regards to IBC related research;
- Assisting faculty researchers in upholding safe laboratory and research practices in the areas of Biologics, Infectious Agents and Recombinant DNA;
- Review research proposals to effectively assess the safety of proposed work;
- Publish templates for Standard Operating Procedures, written programs, plans and policies for researchers to reduce the regulatory burden.
- Collaborate with the Office of Research and Sponsored Programs to ensure that funding is released to the Principal Investigator (PI) when IBC approval is reached.
- Promote open collaboration between on-campus committees to facilitate the transfer or sharing of information pertinent to proposed research projects and to reduce the amount of information required for submittal when already required for another committee's approval. Such overlap can occur between the Animal Care and Use Committee (IACUC) and Radiation Safety Committee.
View the NIH Guidelines which are referenced by the IBC when reviewing research protocols.
Please note that in certain situations, the Cal Poly IBC reserves the right to impose stricter requirements than what is required under the NIH Guidelines. Such changes require a majority consensus within the committee.
NIH Exempt Experiments
Certain experiments have been exempted from IBC approval as recommended by NIH.
As stated in Section III-F of the NIH Guidelines, experiments are exempt when they involve recombinant DNA that is:
- Not in organisms and viruses;
- Entirely DNA segments from a single nonchromosomal or viral DNA source;
- Entirely from a prokaryotic host including its indigenous plasmids or viruses when propagated only in that host or when transferred to another host by well established physiological means;
- Entirely from a eukaryotic host including its chloroplasts, mitochondria, or plasmids when propagated only in that host or a closely related strain of the same species,
- Entirely segments from different species that exchange DNA by known physiological processes, through one or more may be a synthetic; see Appendix A of the NIH Guidelines; or
- Not a significant risk to health or the environment as determined by the NIH Director, with advice from the RAC and public comment; See Appendix C of the NIH Guidelines for a detailed listing;
Unless these experiments also involve:
- The deliberate transfer of a drug resistance trait to microorganisms that are not known to acquire the trait naturally, if such acquisition could compromise the use of the drug to control disease agents in humans, veterinary medicine or agriculture [Section III-A];
- Deliberate formation of recombinant DNA containing genes for the biosynthesis of toxin molecules lethal for vertebrates at an LD50 of less than 100 nanograms per kilogram of body weight [Section III-B]; or
- The deliberate transfer of recombinant DNA, or DNA or RNA derived from recombinant DNA into one or more human research subjects [Section III-C].
Details on certain other experiments that may be exempt, as well as exceptions, may be found in Appendix C of the NIH Guidelines.
Additional resources are available through the Office of Science Policy (OSP), a division under NIH.