Research Protections Policies
RP11 Use of Regulated and Biohazardous Materials in Research and Instruction (Formerly SY24)
Policy Steward:Associate Vice President for Research, Director of the Office for Research Protections>
- Requests for Biohazards Reviews
- Approval Procedure
- Further Information
- Cross References
- Appendix A
To ensure safe handling, storage, and disposal of potentially regulated/biohazardous materials, as defined below, used in University research or instructional projects. Compliance with the provisions of this policy will provide a safe working environment, as well as protect the people and facilities of the larger University community and the surrounding areas. Institutional Biosafety Committee (IBC) review also assists the University and its employees in their compliance with federal regulations on the use of recombinant DNA, as well as federal and state regulations regarding pathogens,toxins, toxicants, and carcinogens.
This policy applies to any research and instructional activities,sponsored and unsponsored, conducted under the auspices of the University. This policy is applicable to all University locations (except the College of Medicine and Hershey Medical Center which conducts independent biosafety committee reviews), and to research conducted off-site by University personnel. University projects involving the use of regulated/biohazardous materials at other institutions shall receive Institutional Biosafety Committee (IBC) approval from the cooperating institution. In the case of collaboration between the College of Medicine/Hershey Medical Center (Hershey) and any other University location, Hershey will be treated as a cooperating institution.Copies of IBC approvals from cooperating institutions should be forwarded to the Office for Research Protections (ORP) along with a completed IBC application. The IBC may require approval from the cooperating institution prior to granting its approval.
All University research and instructional activities involving regulated/biohazardous materials, as defined below, must be reviewed and approved by the IBC prior to the use of any such reagent. Additionally, the acquisition of Regulated/Biohazard Material requiring handling conditions at BSL-2 or higher must have IBC review and approval prior to the purchase or transfer of said materials to the University. Projects submitted for sponsorship by external agencies should be submitted for IBC review prior to acceptance of funding. The ORP, The 330 Building, Suite 205, University Park, PA 16802 (814-865-1775) coordinates IBC reviews and approvals. The IBC is vested with the right and authority to monitor the use and/or procurement of regulated/biohazardous material as approved hereunder.
Budget executives and budget administrators shall ensure that all supervisors in their area are familiar with the provisions of this policy.Supervisors (department chairs, faculty and other employees with direct oversight of University employees and students) shall ensure that all University research is conducted in compliance with this policy. Employees and students shall ensure that their activities comply with any and all safety policies and procedures mandated by this policy.
Regulated/Biohazardous Material -
The categories below represent the areas of primary concern with respect to biosafety. Projects involving material(s) included by any of these categories should be submitted for IBC approval.
- Chemical Carcinogens used in conjunction with animals.
- Toxic/Infectious agents used in conjunction with animals.
- Oncogenic viruses 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 #9).
- 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/SelectAgentsandToxinsList.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].
The IBC also serves as an advisory committee for University projects that involve possible biohazards that do not appear to fall into one of the above areas. When it is unclear as to whether a material constitutes a potential biohazard, the IBC should be consulted. Questions should be directed to ORP or to Environmental Health and Safety at 6 Eisenhower Parking Deck.
IBC--the Institutional Biosafety Committee -
A Committee appointed by the Vice President for Research to review and approve the use of regulated/biohazardous materials in research. The membership of this Committee includes Penn State faculty and staff with expertise in relevant areas. In addition, at least two members of the local community are appointed to the committee to represent local concerns. Membership of this Committee is consistent with federal regulations on the review of projects involving the use of recombinant DNA.
IBC submission forms can be obtained from the ORP web site. Completed forms should be returned via email to ORP-Biosafety@psu.edu. The Principal Investigator is responsible to provide sufficient information to allow the IBC to determine if this work can be conducted safely and appropriately.
A written safety protocol will be required for projects that involve regulated/biohazardous materials used in conjunction with animals, for project using Select Agents, for projects involving USDA Restricted Plant Pathogens, and forany project conducted at Biosafety Level 3 or higher. The safety protocol will require signatures from the Biosafety Officer and the appropriate facility manager.
The IBC consists of the following subcommittees:
- Recombinant DNA
- Pathogens and Oncogenes
- Carcinogens and Toxins
Each IBC submission received by ORP will be processed and reviewed in accordance with the process outlined in the Biosafety Committee Charter maintained by the ORP on behalf of the IBC. The PI will be responsible for responding to any requests for additional information in a timely manner.
Once IBC approval is granted, it is the responsibility of the PI to ensure that approval letters are properly directed to any funding agency or sponsor.
The IBC has express authority (1) to monitor research covered by approval letters it has issued; and (2) to enforce biosafety requirements,including the suspension of research, or recommending to the Vice President for Research penalties and sanctions for non-complaint investigators. The IBC, through the ORP, shall report such noncompliance to EH&S and may request their assistance in implementing sanctions, penalties, and/or suspensions.
For questions, additional detail, or to request changes to this policy, please contact the Office of the Director of Environmental Health and Safety.
Other Policies in this Manual should also be referenced, especially:
RP03 - The Use of Human Participants in Research (Formerly Policy RA14)
RP04 - Care and Use of Vertebrate Animals (Formerly Policy RA15)
SY01 - Environmental Health and Safety Policy
SY14 - Use of Radioactive Materials
SY20 - Hazardous Waste Disposal.
USDA Restricted Animal Pathogens/Diseases:
- African horse sickness
- African Swine fever virus*
- Akabane virus
- Avian Influenza virus
- Besnoitia besnoiti
- Bluetongue virus*
- Bovine spongiform encephalopathy
- Bovine infectious patechial fever agent
- Brucella abortus
- Brucellosis melitensis*
- Burkholderia mallei * (Pseudomonas mallei - Glanders)
- Camelpox virus
- Classical Swine fever
- Cochliomyia hominivorax (Screwworm)
- Cowdria ruminantium (heartwater)
- Creutzfeldt-Jacob Disease variant
- Ephemeral fever virus
- Foot and mouth disease virus*
- Histoplasma (Zymonema) farciminosuim
- Louping ill virus
- Lumpy skin disease virus
- Mycobacterium bovis
- Mycoplasma agalactiae
- Mycoplasma mycoides (mycoides)
- Mycoplasma Capricolum/M.F38/M.
- Mycoides Carpi (Contagious Bovine Pleuropneumonia Agent
- Nairobi sheep disease virus (Ganjam virus)
- Newcastle disease virus* (velogenic strains)
- Peste des petits ruminants* (plague of small ruminants)
- Rift Valley fever virus*
- Rinderpest virus*
- Sheep and goat pox*
- Swine vesicular disease virus*
- Teschen disease virus*
- Theileria annulata
- Theileria lawrencei
- Theileria bovis
- Theileria hirci
- Trypanosoma brucei
- Trypanosoma congolense
- Trypanosoma equiperdum (dourine)
- Trypanosoma evansi
- Trypanosoma vivax
- Venezuelan equine encephalomyelitis
- Vesicular exanthema virus
- Vesicular stomatitis virus
- Viral hemorrhagic disease of rabbits
- Wesselsbron disease virus
Effective Date: December 2, 2016
Date Approved: November 30, 2016
Date Published: December 2, 2016
Most Recent Changes:
- June 7, 2018 - Policy moved from SY24 to RP11; Policy Steward changed from Assistant Vice-President for Police and Public Safety / Director of Environmental Health and Safety to Associate Vice President for Research, Director of the Office for Research Protections
Revision History (and effective dates):
- December 2, 2016 - Edits to PURPOSE, APPLICABILITY, POLICY, REQUESTS FOR BIOHAZARDOUS REVIEWS, APPROVAL PROCEDURE and COMPLIANCE sections; minor clarifications as approved by the Institutional Biosafety Committee.
- November 19, 2015 - Editorial changes in COMPLIANCE section. Title changes FROM "Vice President for Research and Dean of the Graduate School" TO "Vice President for Research."
- June 18, 2014 - Editorial changes. Addition of policy steward information, in the event that there are questions or requests for changes to the policy.
- May 10, 2011– Clarified responsibilities.
- January 1, 2010 – Editorial change made in "Compliance" section. Title changed FROM "Senior Vice President for Research and Dean of the Graduate School" TO "Vice President for Research and Dean of the Graduate School," to reflect position changes, effective January 1, 2010.
- March 11, 2009– Editorial changes made in "Definitions" section, adding 'non-human primate' to the materials defined in #6 which require IBC approval, in observance of biosafety requirements.
- November 11, 2008– Editorial changes have been made, as follows: policy title has been amended to include "Regulated" materials; DEFINITIONS section modified to include regulated materials, and #5 revised; link to SY14 added in CROSS REFERENCES section.
- October 24, 2007 – Added clarification on nucleic acids from select agent viruses and toxins, as approved by the University Biosafety Committee.
- November 8, 2006 - Editorial change - changed Vice President for Research to Senior Vice President for Research.
- September 27, 2005 - Procedures modified and link to Select Agent list added.
- December 5, 2002 - Definitions of Biohazardous Materials expanded and responsibilities added.
- September 1, 1994 - Updated office addresses and revised procedure for requesting biohazards reviews.
- March 24, 1992 - New Policy.
Date Approved:November 30, 2016>
Date Published:June 7, 2018>