RP11 Use of Regulated and Biohazardous Materials in Research and Instruction

Contents:

• Purpose
• Definitions
• Policy
• Applicability
• Submission Procedure
• Compliance
• Further Information
• Cross References

PURPOSE:

This policy governs:

1. The safe and ethical use of recombinant or synthetic nucleic acid molecules and regulated biohazardous materials (collectively within the definition of regulated materials, as defined below) in research and instruction. 
2. Research involving regulated materials is conducted in a well-controlled environment that minimizes associated risks to individuals and the environment. 
3. Concerns regarding the use of regulated materials at the University are addressed in a professional and responsible manner. 
4. Research involving the use of regulated materials comply with applicable federal, state, and University regulations and policies. 

This policy implements the necessary provisions of the National Institutes of Health Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines), the Biosafety in Microbiological and Biomedical Laboratories (BMBL), the Select Agent Regulations (7 CFR Part 331, 9 CFR Part 121, 42CFR Part 73) and all other applicable regulations governing the use of regulated biohazardous materials.

DEFINITIONS:

Regulated Material -

Any substance that meets the description in any one of the following:

1. Infectious agents or toxic substances used in conjunction with animals.
2. Infectious agents requiring handling conditions above Biosafety Level-1.
3. Activities involving recombinant or synthetic DNA technology. For the purpose of this policy, this will be defined as:

     a. molecules that a) are constructed by joining nucleic acid molecules and b) that can replicate in a living cell, i.e., recombinant nucleic acids;

     b. nucleic acid molecules that are chemically or by other means synthesized or amplified, including those that are chemically or otherwise modified but can base pair with naturally occurring nucleic acid molecules, i.e., synthetic nucleic acids, or

     c. molecules that result from the replication of those described in (a) or (b) above.

4. Biological specimens (e.g., saliva, blood, urine, or tissues) collected from humans or non-human primates.
5. HHS and USDA Select Agents and Toxins, as defined in Federal Regulations 7CFR331, 9CFR121, and 42CRF73. The current list is available at http://www.selectagents.gov/SelectAgentsandToxinsList.html.  
6. Chemical carcinogens are considered a regulated material by the University Park IBC, but not by the College of Medicine IBC. 

IBC

The Institutional Biosafety Committee (IBC) located at University Park and the College of Medicine (COM) are appointed to review all proposed research, testing or teaching activities involving regulated materials to be conducted under the auspices of the University. Projects are reviewed for compliance with University Policy as well as the regulations governing the use of regulated materials as set forth by policies and regulations promulgated by the NIH, Center for Disease Control (CDC), United States Department of Agriculture (USDA) and other federal agencies. The membership of these Committees provides for a balanced review of all submitted activities by inclusion of the Biological Safety Officer, faculty, staff, and local community representatives. 

POLICY:

Review and, if required, approval by the appropriate Institutional Biosafety Committee (IBC; Committee), Chair, or designee of the Chair is required prior to the use of regulated materials in any research, testing or teaching activities.  Additionally, regulated materials requiring handling conditions at BSL-2 or higher must have Committee review and approval prior to synthesis, purchase or transfer of said materials to the University.  Both IBCs are vested with the right and authority to monitor the use and/or procurement of regulated material as approved hereunder.  For activities at University Park and all other campus locations except the College of Medicine/Penn State Health (CoM), the University Park IBC is the responsible Committee. Use of regulated materials in research, teaching, or testing at the CoM is reviewed and approved by the CoM IBC. 

Committee records are subject to unannounced inspections by representatives of the NIH Office of Science Policy (OSP).  The Office for Research Protections (ORP) is responsible for coordinating University Park IBC reviews and approvals for all University campuses and colleges except for the COM.  The Office of the Vice Dean for Research and Graduate Studies is responsible for coordinating COM IBC reviews and approvals. 

Concerns regarding the use of regulated materials in University research can be reported to the ORP, the Office of the Vice Dean for Research and Graduate Studies, a Biological Safety Officer, the Institutional Official at University Park or the College of Medicine, the University Park IBC or COM IBC Chair or the Penn State Hotline (https://universityethics.psu.edu/penn-state-hotline). All reports of concern will be handled confidentially, investigated by the appropriate Committee and resolved in a timely manner as outlined in the applicable Committee’s Standard Operating Procedures (SOP) or Charter. 

APPLICABILITY:

This Policy is applicable to all research, testing, or teaching activities involving regulated materials conducted under the auspices of the University and applies to all University campus locations and colleges. University projects involving the use of regulated 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/Penn State Health (PSH) and any other University location, PSH will be treated as a cooperating institution.  Copies of IBC approvals from cooperating institutions should be forwarded to the appropriate Administrative Office (ORP or Office of the Vice Dean for Research and Graduate Studies) along with a completed IBC application. The IBC may require documentation of approval from the cooperating institution prior to granting its approval.  If the cooperating institution does not have an IBC or comparable body, then the work may require review by the appropriate University Committee.

SUBMISSION PROCEDURES:

​Applications for the use of regulated materials in research, testing and teaching activities are submitted to either the ORP or the Office of the Vice Dean for Research and Graduate Studies (see https://www.research.psu.edu/ibc for submission instructions for the IBC and https://infonet.pennstatehershey.net/web/research-quality-assurance for submission instructions for the COM IBC).  These administrative offices will coordinate the review and approval by the applicable Committee, Chair, or designee of Chair for all applications received.  The applicant is responsible for responding to any requests for additional information in a timely manner.

The Committee has final authority to approve, disapprove or suspend indefinitely an activity involving the use of regulated materials. 

Appeals will be heard by the University Park IBC or COM IBC; however, the IBC/COM IBC has final authority and disapprovals cannot be overruled by any administrator at the University. 

COMPLIANCE:

The Committee has express authority (1) to monitor research covered by this policy; and (2) to enforce biosafety requirements, including the suspension of research, or recommending to the Institutional Official penalties and sanctions for non-complaint investigators. Committees will review and investigate as necessary all allegations of noncompliance as outlined in the applicable Committee’s Standard Operating Procedures (SOP) or Charter.  

FURTHER INFORMATION:

For questions, additional detail, or to request changes to this policy, please contact the Office of the Associate Vice President for Research, Director of the Office for Research Protections. 

CROSS REFERENCES:

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

SY20 - Hazardous Waste Disposal

SY29 - Infectious Waste Disposal

Most Recent Changes:

• September 1, 2023 - Updated Subject Matter Expert to Debra Thurley, Associate Vice President for Research.  

Revision History (and effective dates):

• March 18, 2022 - Updated Hershey Medical Center to Penn State Health; minor editorial updates.
• March 4, 2020 - Updated name of College of Medicine IBC from "Biosafety and Recombinant DNA Committee" to College of Medicine IBC; change made throughout policy.
• February 28, 2019 - Revisions to Purpose, Definitions, Policy, Applicability, and Submission Procedure sections.
• 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
• 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.