Policy SY24 USE OF REGULATED AND BIOHAZARDOUS MATERIALS IN RESEARCH AND INSTRUCTION

Policy Steward: Director of Environmental Health and Safety

Contents:

  • Purpose
  • Applicability
  • Policy
  • Responsibilities
  • Definitions
  • Requests for Biohazards Reviews
  • Approval Procedure
  • Compliance
  • Further Information
  • Cross References
  • Appendix A

  • PURPOSE:

    To ensure safe handling, storage, and disposal of potentially 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.

    APPLICABILITY:

    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 Hershey Medical Center which conducts independent biosafety committee reviews), and to research conducted off-site by University personnel. University projects involving the use of biohazardous materials at other institutions shall receive Institutional Biosafety Committee (IBC) approval from the cooperating institution. In the case of collaboration between the Hershey Medical Center 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 Penn State IBC may require approval from the cooperating institution prior to granting their approval.

    POLICY:

    All University research and instructional activities involving biohazardous materials, as defined below, shall be reviewed and approved by the Institutional Biosafety Committee (IBC) prior to the use of any such reagent. Projects submitted for sponsorship by external agencies should be submitted for IBC review prior to acceptance of funding. The Office for Research Protections (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 of biohazardous material as approved hereunder.

    RESPONSIBILITIES:

    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.

    DEFINITIONS:

    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.

    1. Chemical Carcinogens used in conjunction with animals.

    2. Toxic/Infectious agents used in conjunction with animals.

    3. Oncogenic viruses used in conjunction with animals.

    4. 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.)

    5. Recombinant DNA.
    6. 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.
    7. Human or non-human primate blood and blood products, human or non-human primate body fluids, and/or human or non-human primate tissue.

    8. 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).

    9. Whenever a contractual agreement or grant proposal requires Institutional Biosafety Committee approval for the safe handling of a biological or chemical product.

    10. 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.

    11. USDA Restricted Animal Pathogens, as determined by the United States Department of Agriculture (USDA), which are listed in Appendix A.

    12. 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 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.

    REQUESTS FOR BIOHAZARDS REVIEWS:

    IBC submission forms can be obtained from the ORP web site.  Completed forms should be returned via email to ORP-Biosafety@rtto.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 biohazardous materials used in conjunction with animals, for project using Select Agents, for projects involving USDA Restricted Plant Pathogens, and for any project conducted at Biosafety Level 3 or higher. The safety protocol will require signatures from the Biosafety Officer and the appropriate facility manager.

    APPROVAL PROCEDURE:

    The IBC consists of the following subcommittees:

    Each IBC submission received by ORP will be pre-reviewed by the Compliance Coordinator and forwarded to a member of the appropriate IBC subcommittee(s). The subcommittee member will either approve the Application for the Use of Biohazardous Materials, and determine the appropriate biosafety requirements, request a second review by another member of the subcommittee, or schedule the project for consideration at the monthly meeting of the full IBC. In some instances, the PI may be asked to appear before the IBC. The Biosafety Officer will determine if a lab inspection is needed. Once the reviewer ballot and notification regarding the lab inspection are received from the subcommittee member and the Biosafety Officer, ORP will either issue an approval letter or request additional information. Additional information could consist of clarification of comments posed by the reviewer or the need for scheduling a lab inspection. The principal investigator will be responsible for responding to the request for additional information in a timely manner.

    Once approval is granted, it is the responsibility of the PI to ensure that approval letters are properly directed to any funding agency or sponsor.

    COMPLIANCE:

    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 and Dean of the Graduate School penalties and sanctions for non-complaint investigators. The IBC, through the Office for Research Protections, shall report such noncompliance to EH&S and may request their assistance in implementing sanctions, penalties, and/or suspensions.

    FURTHER INFORMATION:

    For questions, additional detail, or to request changes to this policy, please contact the Office of the Director of Environmental Health and Safety.

    CROSS REFERENCES:

    Other Policies in this Manual should also be referenced, especially:

    RA14 - The Use of Human Subjects in Research

    RA15 - Care and Use of Vertebrate Animals

    SY01 - Environmental Health and Safety Policy

    SY14 - Use of Radioactive Materials

    SY20 - Hazardous Waste Disposal.


    APPENDIX A:

    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
    *Export license required by Department of Commerce

    Effective Date: May 10, 2011
    Date Approved: May 4, 2011  
    Date Published: May 10, 2011 (Editorial changes- June 18, 2014)

    Most Recent Changes:

    Revision History (and effective dates):

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