This policy is to formalize the University of Colorado Boulder’s obligation to ensure that research activities involving recombinant or synthetic nucleic acid molecules (rsNA) and bio hazardous material are conducted safely and in accordance with applicable governmental regulations, laws, and required guidelines. To assist in the accomplishment of safe biological research, the University has established an Institutional Biosafety Committee (IBC) and appointed a Biosafety Officer (BSO). The IBC and BSO have been charged with providing necessary leadership, direction and institutional policies necessary to ensure that all activities of a potentially bio hazardous nature are conducted safely so as to protect faculty, employees, students, the public, and the environment as well as the public service interests of the University. In addition, the IBC and BSO are charged with the authority to take all necessary and appropriate actions related to non-compliance with regulations, policy and best practice standards. All research involving biohazards, irrespective of the source of funding, must be carried out in accordance with this policy.
The University recognizes the need to study and research in an environment free of undue risks. A University user shall be defined as any faculty, student, staff, or visitor of the University and anyone conducting activities involving rsNA and/or bio hazardous materials either on property owned or operated by the University. This policy provides for the oversight of all activities that use rsNA and/or bio hazardous materials. Bio hazardous materials includes, but are not limited to, any biological agents; microorganisms; toxins; cultures of tissues; organs, cells, bodily fluids, and tissues of human or animal origin; transgenic plants and animals; infected animals or tissues (including field work); and exempt quantities of Select Agent Toxins as defined by federal law. The IBC will provide guidance and oversight intended to ensure that the use of rsNA and bio hazardous materials is in compliance with all applicable federal, state and local laws, rules, regulations, and guidelines. All research involving rsNA must be conducted in accordance with the most current edition of the NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules.
The biosafety program and the IBC at the University are structured in accordance with the following:
- NIH Guidelines for Research Involving Recombinant or Synthetic Nucleic Acid Molecules (most current version)
- CDC-NIH Biosafety in Microbiological and Biomedical Laboratories (BMBL) (most current version)
- NIH Grants Policy Statement, Public Policy Requirements and Objectives, Health and Safety Regulations and Guidelines (Part II, 4)
- NIH Guidelines for Research Using Human Embryonic Stem Cells
- Public Health Security and Bioterrorism Preparedness and Response Act
- Select Agents Regulations:
- 42 CFR Part 73
- 9 CFR Part 121
- 7CFR Part 331
- USA PATRIOT Act, P.L. 107-56
- OSHA Standards:
- 29 CFR 1910.1030, Bloodborne Pathogens Standard;
- 29 CFR 1910.1450, Occupational exposure to hazardous chemicals in laboratories
- 29 CFR 1910.1200, Hazard Communication Standard
- 29 CFR 1910.132, Personal Protective Equipment
- 29 CFR 1910.133, Eye and Face Protection
- 29 CFR 1910.134, Respiratory Protection
- U.S. Dept. of Transportation, Hazardous Materials Regulations, 49 CFR
- The International Air Transport Association (IATA) – Dangerous Goods Regulations
- EPA Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), Anti-Microbial Pesticide Products & Registration, products used to disinfect, sanitize, reduce, or mitigate growth or development of microbiological organisms on inanimate objects and surfaces.
- USDA-APHIS Regulations for Animal and Plant Materials
- State of Colorado Regulations:
- State of Colorado Solid Waste Regulations, 6 CCR 1007-2, Section 13, Regulated Medical Waste Regulations
- State of Colorado Epidemic and Communicable Disease Control Regulations, 6 CCR 1009-1
- Colorado Department of Agriculture: Division of Animal Industry – animal pathogens
- Other Best Practices References:
- Prudent Practices in the Laboratory, National Academies Press
The IBC, in conjunction with the University's Environmental Health and Safety Department, will establish, monitor adherence with, and periodically review procedures, Federal and State regulations, and best management practices for the safe use of rsNA and bio hazardous materials. The IBC will provide oversight for rsNA activities as specified in the NIH Guidelines. All persons using rsNA and/or bio hazardous materials at the University, or in activities sponsored by the University, will be responsible for compliance with the NIH Guidelines, the BMBL, all applicable governmental rules and regulations and the University's policies, procedures and guidelines.
The IBC will operate administratively under the purview of the Vice Chancellor for Research and report directly to the Office of Research Integrity. Governance, membership, member training, meeting conduct and functions of the IBC will comply with the NIH Guidelines and any other applicable government rules and regulations.
The Chair and Committee Members will be appointed by the Vice Chancellor for Research upon recommendation of the Research Integrity Officer and the Biosafety Safety Officer (BSO). The BSO is an employee of the University's Environmental Health and Safety Department and a voting member of the IBC.
Continued work with rsNA and/or bio hazardous agents will require strict adherence to rules and regulations. The BSO with authority from EHS and the IBC may temporarily stop activities deemed unsafe pending review by EHS and/or the IBC as appropriate. Those activities will not resume until the EHS and/or IBC review is complete and any required changes or modifications to those activities have been made.
All University users of rsNA and/or bio hazardous materials must obtain approval from the IBC prior to the use of these materials and must successfully complete all applicable training through the University's Biosafety program. The NIH Guidelines require that all non-exempt rsNA research be reviewed and approved by the full IBC.
Not all IBC applications are required to be reviewed by the full committee. Administrative Approval may be granted for research that falls into the categories outlined below. Administrative Approval requires review by the IBC Chair, the BSO and at least one additional member of the IBC (subject matter expert). Anyone may request a full IBC review of the application(s). All results of administrative review are recorded in the IBC meeting minutes.
Administrative Approvals are allowed for the following:
- Research considered exempt under the NIH rsNA Guidelines – Experiments as defined in section III-F.
- Infectious Agents classified as Risk Group 1 (RG1)
- Research that only involves the addition of an organism classified at the same biosafety level and the same sections of the NIH rsNA Guidelines for which the user has already been approved by the full IBC
- Laboratory/room changes
- Addendums and renewals for which there have been no significant changes or modifications since the last submittal
|Risk Group 1 (RG1)||Agents that are not associated with disease in healthy adult humans|
|Risk Group 2 (RG2)||Agents that are associated with human disease which is rarely serious and for which preventive or therapeutic interventions are often available|
|Risk Group 3 (RG3)||Agents that are associated with serious or lethal human disease for which preventive or therapeutic interventions may be available (high individual risk but low community risk)|
|Risk Group 4 (RG4)||Agents that are likely to cause serious or lethal human disease for which preventive or therapeutic interventions are not usually available (high individual risk and high community risk)|
Wednesday, October 1, 2014
Philip P. DiStefano