Who Needs to Submit?
Do I need to submit an application to the Institutional Biosafety Committee (IBC) for the use of regulated/biohazardous materials in research and instruction?
You must submit an Institutional Biosafety Committee (IBC) application to the Office for Research Protections for review and approval by the IBC prior to the use of a biohazardous material in any activities conducted under the auspices of the University.
What type of regulated/biohazardous material requires review?
As stated in Penn State Policy SY24 - Use of Regulated and Biohazardous Materials in Research and Instruction, the categories below represent the areas of primary concern. Research and instruction activities involving material(s) included in any of these categories must be submitted for review and approval by the IBC:
- Chemical Carcinogens used in conjunction with animals.
- Toxic/Infectious agents used in conjunction with animals.
- Infectious agents requiring handling conditions above Biosafety Level-1. (Biosafety Level determinations are based on the recommendations outlined by the CDC-NIH publication Biosafety in Microbiological and Biomedical Laboratories .)
- Recombinant DNA
Definitions For Clarification:
Recombinant DNA (rDNA) molecules are defined as either: (i) 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 (ii) molecules that result from the replication of those described in (i) above.
Nucleic acids that are not and cannot be replicated inside organisms, cells, or viruses are not considered rDNA. Commonly encountered examples of synthetic DNA not considered to be rDNA include Polymerase Chain Reaction (PCR) products, synthetic oligonucleotides/primers, and complementary DNA (cDNA) obtained by reverse transcription of RNA.
- Human or non-human primate blood and blood products, human or non-human primate body fluids, and/or human or non-human primate tissue.
- Toxins produced by living organisms (>1 mg of pure toxin, or
solutions with concentrations of >1 mg/ml pure toxin). This
provision excludes toxins covered by the Select Agent regulations (see #8 below).
- Whenever a contractual agreement or grant proposal requires Institutional Biosafety Committee approval for the safe handling of a biological or chemical product.
- HHS and USDA Select Agents and Toxins, as defined in Federal Regulations 7CFR331, 9CFR121, and 42CRF73, Additional Requirements for Facilities Transferring or Receiving Select Agents, Public Law 107-188, Public Health Security and Bioterrorism Response Act. The current list is available at http://www.selectagents.gov/Select%20Agents%20and%20Toxins%20List.html. These regulations also apply to nucleic acids that can produce infectious forms of any select agent virus, and recombinant nucleic acids that encode the functional forms of any select agent toxin.
- USDA Restricted Animal Pathogens, as determined by the United States Department of Agriculture (USDA), which are listed in Appendix A.
- Wild Poliovirus or materials that may contain wild poliovirus [contact Environmental Health and Safety (814) 865-6391 for additional information on this subject].