PURPOSE OF THIS POLICY

Colorado State University is committed to protecting people and the environment from potential occupational exposure to biohazardous materials (defined below) by ensuring that all activities involving biohazardous materials are conducted in compliance with applicable federal and state laws, regulations and guidelines. This policy is designed to ensure safe handling, storage, and disposal of biohazardous and potentially biohazardous materials, and in doing so provide a safe working environment.

APPLICATION OF THIS POLICY

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. University projects involving the use of biohazardous materials at other institutions should receive Institutional Biosafety Committee (IBC) approval from the cooperating institution.

DEFINITIONS USED IN THIS POLICY

Biosafety is the containment principles, facility design, and practices and procedures to prevent occupational infections in the workplace or release of the organisms to the environment.

Biohazardous Materials include:

1. Infectious agents requiring handling at BSL1-BSL3; this applies to animal, human, and plant infectious agents
2. Human and non-human primate blood and blood products, body fluids, tissues, and/or primary cells
3. Biological toxins
4. Non-exempt recombinant and/or synthetic nucleic acids, and experiments using gene editing tools (for example, CRISPR/Cas9, ZFNs, TALENs, etc.)

POLICY STATEMENT

All University research and instructional activities involving biohazardous materials, as defined above, must be reviewed and approved by the Institutional Biosafety Committee prior to the use of any such materials. Projects submitted for external review shall be submitted for IBC review prior to acceptance of funding. The IBC review process is coordinated by the IBC Coordinator in the Research Compliance and Integrity Review Office.

POLICY PROVISIONS

1. Administrative heads of colleges, departments and other units have responsibility for the biosafety of people, animals, plants and the environment within their jurisdiction. Appropriate planning, provision of appropriate space and equipment, and training of personnel are essential in all potentially biologically hazardous activities.
2. Principal investigators, instructors, clinical supervisors and other personnel in charge of potentially biologically hazardous activities are key in this biosafety effort. They are expected to set an example by their own actions and to ensure compliance with the regulations and the University’s Biosafety policy, directives and guidelines regarding the work they supervise. They are expected to be familiar with the provisions of this Policy, as well as related IBC procedures, and the CSU Biosafety Manual. They must obtain IBC approval prior to initiating work with potentially biohazardous materials and they must ensure that all personnel are appropriately trained. They must promptly report biologically hazardous incidents to the Biological Safety Officer and assist in any resulting decontamination, investigations and/or reporting which may be required.
3. All persons involved in biologically hazardous and potentially biologically hazardous activity share biosafety responsibility and must follow specified procedures, take appropriate training, act responsibly, and report incidents and hazardous circumstances. They should also keep the supervisor informed of any personal condition such as an illness, use of medication, pregnancy, or reduced immunity which could make the work more hazardous to themselves or others.
4. The Biological Safety Director and the Biosafety Officers (BSOs) are appointed by the University and resides within the Office of the Vice President for Research. The BSOs are responsible for:
   • Advising the IBC members, faculty and staff concerning biologically hazardous materials and their control
   • Reviewing and inspecting biologically hazardous activities
   • Inspecting/Auditing facilities
   • Those specific duties required of the BSO in Federal and State directives
   • Providing technical advice to investigators on laboratory containment facilities, safety equipment, security and research safety procedures
   • Developing emergency plans for containment and handling spills and personnel contamination
   • Investigating incidents involving biologically hazardous materials
5. The Institutional Biosafety Committee (IBC) is a faculty-governed committee appointed by the Vice President for Research (VPR) to review and approve the use of biohazardous materials in research. The IBC reports to and is advisory to the VPR and will recommend actions necessary to maintain and/or improve biosafety. Membership of the IBC shall be constituted in accordance with the NIH Guidelines (see References, below), and collectively the members shall have experience and expertise in the relevant research areas of review. IBC members are appointed for three-year terms and may be reappointed. The BSO is a permanent, voting member of the IBC. The IBC is responsible for:
• Review and development of policies, programs and directives regarding biological hazards in academic, research, and clinical activities to ensure compliance with federal and state requirements
• Review and approval of research that involves potentially biohazardous materials (as defined in this Policy), as required by University, State and Federal directives. Review includes an assessment of the containment levels, facilities, procedures and practices, and training and expertise of the personnel. The IBC will review such activities in accordance with the criteria outlined in the most current versions of either the NIH Guidelines, select agent regulations (42 CFR Part 73, 7 CFR Part 331, 9 CFR Part 121), the Biosafety in Microbiological and Biomedical Laboratories (“BMBL”) manual, and other federal and state regulations, and university rules and procedures. The committee may approve, disapprove, or request revisions which would lead to approval.
• Periodic review of research and facilities involved in biohazardous activities, through renewals and/or laboratory inspections.
• Review of emergency plans covering accidental spills and personnel contamination, and the oversight of investigations and reporting of incidents which may be required.
• Advising the Administration regarding problems of a biologically hazardous nature and recommending actions. Such recommendations may include denial of proposed activities where suitable facilities, equipment or personnel are not available; modifications to facilities or equipment beyond the capability of those involved to attain biosafety; and/or sanctions against individuals who are non-cooperative in matters concerning biosafety. Under defined circumstances, the committee may temporarily suspend any biohazardous activity judged to pose a significant danger to health or safety

COMPLIANCE WITH THIS POLICY

Compliance with this policy is required. For assistance with interpretation or application of this policy, contact the Biosafety Director.

REFERENCES

NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (NIH Guidelines)

CDC Biosafety in Microbiological and Biomedical Laboratories (BMBL)

Institutional Biosafety Committee (IBC)

Biosafety Office

CSU Biosafety Manual

PROCEDURES, FORMS AND TOOLS

IBC Policy on When to Submit an IBC Approval Request Form

IBC Policy on Biosafety and Biohazards Noncompliance

APPROVALS

Original Effective Date April 21, 1978

Revision approved by Lynn Johnson, Vice President for University Operations on June 19, 2017

Revision approved by Lynn Johnson, Vice President for University Operations on August 20, 2020