Policy Library - Office of Policy & Compliance

Policy Title: Biosafety	Category: Research
Owner: Vice President for Research	Policy ID#: 7-2001-015
Contact: Office of Research Collaboration and Compliance (Biosafety) Web: https://www.research.colostate.edu/orcc/ Email: BSO_Biosafety@colostate.edu	Original Effective Date: 4/21/1978 Last Revision: 7/11/2025
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PURPOSE OF THIS POLICY

Colorado State University (CSU) is committed to protecting people and the environment from potential occupational exposure to biological and Biohazardous Materials. This policy ensures that all activities with Biological Materials are conducted responsibly and in compliance with applicable federal and state laws, regulations, and guidelines. This policy is designed to ensure the safe handling, storage, and disposal of biological and Biohazardous Materials, thereby providing a safe workplace and protecting the environment.

APPLICATION OF THIS POLICY

This Policy applies to all uses of Biological Materials in any research, diagnostic, 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 must receive Institutional Biosafety Committee (IBC) approval from the cooperating institution.

EXEMPTIONS FROM THIS POLICY

None.

DEFINITIONS USED IN THIS POLICY

Biosafety: the safe working practices associated with the handling of Biological Materials, particularly infectious agents. It addresses containment principles, technologies and practices that are implemented to prevent unintentional exposure to pathogens or their accidental release, facility design, and practices and procedures to prevent occupational infections in the workplace or release of the organisms to the environment.

Biological Materials: any substance derived from or produced by living organisms. This includes, but is not limited to, cells, tissues, blood, bodily fluids, microbial cultures, genetic materials, and other biological specimens used in research, diagnostic, or educational activities. Not all Biological Materials are inherently hazardous; their potential risk depends on their origin, composition, and the context in which they are used.

Biohazardous Materials: a subset of Biological Materials that pose a risk to human health, animals, agriculture, or the environment. They include:

Biological agents that are classified as risk group (RG) 2 or RG3, and RG1 agents that are human, animal, or plant pathogens
Human and non-human primate blood and blood products, body fluids, tissues, and/or primary cells that fall under the Occupational Health and Safety Administration Bloodborne Pathogens Standard
Biological toxins
Non-exempt recombinant and/or synthetic nucleic acids, as defined by the NIH Guidelines (see References, below); including, but not limited to, experiments using genetically modified organisms (such as animal, plants, microorganisms, and certain cell lines) regardless of how or where they were made, and experiments generating genetically modified organisms regardless of the methods used to generate them

POLICY STATEMENT

All University research, diagnostic, and instructional activities involving Biological Materials are subject to oversight by the CSU Biosafety Office. In addition, all University research and instructional activities involving Biohazardous Materials must be reviewed and approved by the Institutional Biosafety Committee (IBC) prior to the use of any such materials. The IBC review process is coordinated by the Office of Research Collaboration and Compliance.

POLICY PROVISIONS

Administrative heads of colleges, departments and other units are responsible for the appropriate planning, provision of space and equipment, and personnel training for activities with Biological Materials within their authority.
Principal investigators, instructors, clinical supervisors, and other personnel in charge of activities involving Biological Materials are expected to be familiar with the provisions of this Policy, as well as related Biosafety and IBC procedures and guidelines. 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 incidents involving Biological Materials to the Biosafety Office and assist in any resulting follow-up actions and/or reporting which may be required.
All individuals working with Biological Materials share Biosafety responsibility and must follow procedures, complete training, and report hazards and incidents. They should inform their supervisor of any conditions, health-related or otherwise, which could make the work more hazardous to themselves or others.
Members of the Biosafety Office are appointed by the university and reside within the Office of the Vice President for Research. The Biosafety Office is responsible for:
- Advise IBC members, the Vice President for Research (VPR), researchers, students, other University personnel, and visitors concerning Biological Materials and their control
- Review and oversee activities involving Biological Materials
- Inspect facilities
- Perform specific duties required of the Biosafety Office in Federal and State laws, regulations, policies, and guidelines
- Provide technical advice to researchers on laboratory containment facilities, safety equipment, personal protective equipment, incident response and emergency plans, and research safety and security procedures
- Investigate incidents involving Biological Materials
- Temporarily suspend any activity with Biohazardous Materials judged to pose a significant danger to health, safety, or the environment
- Oversight and compliance with the Federal Select Agent Program
The IBC is a faculty-governed committee appointed by the VPR to review and approve the use of Biohazardous Materials in research. Membership of the IBC is constituted in accordance with the NIH Guidelines. IBC members are appointed for three-year terms and may be reappointed. A member from the Biosafety Office is a permanent, voting member of the IBC. The IBC is responsible for:
- Review and development of policies, programs, and directives regarding Biohazardous Materials in academic, research, and clinical activities to ensure compliance with federal and state requirements
- Review and approve research that involves potentially Biohazardous Materials, as required by University, State and Federal directives. Review includes an assessment of the containment levels, facilities, personal protective equipment, procedures and practices, and training and expertise of the personnel. The IBC will review activities in accordance with the criteria outlined in the most current versions of 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 incident response and emergency plans covering accidental spills and personnel contamination
- Review incidents and report them as required. Lead investigations as warranted.
- Advise leadership regarding issues associated with Biohazardous Materials and recommend actions. They also provide recommendations on the appropriate sanctions for non-compliant individuals.
- The IBC may deny or temporarily suspend any activity with Biohazardous Materials judged to pose a significant danger to health, safety, or the environment

COMPLIANCE WITH THIS POLICY

Compliance with this policy is required. For assistance with interpretation or application of this policy, contact the Office of Research Collaboration and Compliance.