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University of Minnesota (University) faculty, staff, and students must comply with federal and state regulations and University of Minnesota policies and procedures when conducting research and teaching activities with, or storage of, potentially hazardous biological agents. These requirements include review and approval of research and teaching activities by the Institutional Biosafety Committee (IBC), and compliance with inventory, inspection, reporting, storage, security, handling, and disposal procedures. This policy applies to University faculty, staff, or researchers working at the University as well as those individuals using biological materials under grants and contract to the University at off-campus sites. Non-University entities renting, leasing or otherwise using University property, equipment or facilities, and that are using or storing biological material must notify the Department of Environmental Health and Safety. University as well as non-University entities using University property are subject to inspection of their storage, security, and handling facilities.

The use of recombinant DNA is regulated by federal guidelines and state statute. The use of recombinant DNA requires review by and approval from the IBC. This includes all research involving the joining of natural or synthetic DNA segments to other DNA molecules, as well as all synthetic or natural DNA segments that are being used for gene transfer into an in vivo system. All research must be conducted in accordance with the National Institutes of Health (NIH) Guidelines for Research Involving Recombinant DNA Molecules (NIH Guidelines).

Persons using, storing, or transferring Select Agents must follow additional procedures described in the University procedure "Additional Procedures for Storing and Using Select Agents."

This administrative policy implements Board of Regents' policy: Research Involving Recombinant DNA and Hazardous Biological Material. In addition, the University has the responsibility to protect researchers, the University community and its assets, and the environment, by assuring the safe use and storage of potentially hazardous biological material in research or teaching at the University of Minnesota. The University also has the responsibility to assure compliance with all federal, state, and internal requirements to prevent the theft, diversion, or misuse of potentially hazardous biological agents.

• Activities Involving Potentially Hazardous Biological Agents
• Additional Procedures for Storing and Using Select Agents

There are no forms for this policy.

Subject	Contact	Phone	Fax/Email
Primary Contact	Moira Keane	612-626-5654	keane002@umn.edu

Biological Safety Officer (BSO)

The University of Minnesota Biological Safety Officer

Biosafety Levels

Standard and special microbiological practices, safety equipment, and facilities recommended for work with a variety of infectious agents in various laboratory settings. These levels are defined by the U.S. Department of Health and Human Services in the latest edition of Biosafety in Microbiological and Biomedical Laboratories. Biosafety Level 1 (BL1) has the least restrictive containment requirements, Biosafety Level 2 (BL2) and Biosafety Level 3 (BL3) have increasingly more stringent containment requirements and Biosafety Level 4 (BL4) requires a dedicated facility. Four animal Biosafety Levels (ABSL) describe the practices, safety equipment, and facilities for work with infected research animals.

Department of Environmental Health and Safety (DEHS)

The University of Minnesota Department of Environmental Health and Safety

Disposal

The entrance of biological agents that are surplus or no longer intended for use into the waste stream.

Handling Biological Agents

Manipulation of biological material. Can also refer to manipulation of material at a specific Biosafety Level.

HHS

United States Department of Health and Human Services

Institutional Animal Care and Use Committee (IACUC)

The committee established by the president or delegate in accordance with federal regulations to review University activities involving the use of animals.

Institutional Biosafety Committee (IBC)

The committee established by the president or delegate in accordance with federal regulations to review University activities involving potentially hazardous biological agents or recombinant DNA.

Institutional Review Board (IRB)

The committee established by the president or delegate in accordance with federal regulations to review University research involving human subjects.

Institutional Official

The official appointed by the president or delegate who ensures compliance with ethical standards, laws, regulatory requirements, institutional policies, and mandatory reporting requirements.

NIH Guidelines

The NIH Guidelines for Research Involving Recombinant DNA Molecules

Office of Regulatory Affairs (ORA)

The University of Minnesota Office of Regulatory Affairs

Potentially Hazardous Biological Agent

Recombinant DNA(rDNA), biologically derived toxins (including mutated, truncated, or inactivated toxins), and infectious agents (including non-virulent and vaccine strains) that require handling at Biosafety Level 2 (BSL2) or above.

Research

Any investigative activity engaged in by University personnel using University facilities or resources regardless of funding source.

Research Animal Resources

The program established by the president or delegate to provide veterinary services and support for activities covered under the Animal Care and Use Policy.

Responsible Official (RO)

The University of Minnesota official designated to act on behalf of the University regarding the possession, receipt or transfer of Select Agents.

RSPP

The University of Minnesota Research Subjects' Protection Programs.

Security

Policies, procedures, or devices intended to control access to biological materials

Select Agent

Refers to the HHS Select Agent and Toxin list (42CFR part 73), the Overlap Select Agent and Toxin list (42CFR Part 73 and 9CFR Part 121), the plant pathogens (7CFR Part 331) and the High Consequence Livestock Pathogens and Toxins (9CFR Part 121) as amended or revised.

SPA

The University of Minnesota Sponsored Projects Administration

Storage

Retention of biological materials by University employees or on University property, including materials kept in open laboratory space, incubators, refrigerators, or freezers.

Teaching

Teaching activities include classroom demonstrations, laboratory exercises and research projects that are required for completion of a course at the undergraduate, graduate, or professional level.

USDA

United States Department of Agriculture

Biological Safety Officer (BSO)

Oversee the inspection of research facilities. Approve or disapprove research protocols, practices, and procedures. Take such actions that are necessary, including the enforcement of cessation of research activities in the event of an unresolved safety hazard.

Department of Environmental Health and Safety (DEHS)

Manage the Select Agent Program and appoints the RO. Conduct inspections of laboratories where biological agents are used and/or stored. Assess risks and provide information and training to the University community on the safe handling, storage, security, or disposal of biological agents.

Institutional Biosafety Committee (IBC)

Review and grant approval for research proposals involving the use of biological agents. Mandate practices or procedures for the handling, storage, security and disposal of biological agents used in research or teaching. Inspect research facilities or delegate inspections. Halt research in the event of noncompliance or an unresolved safety hazard.

Institutional Official (IO)

Responsible for taking steps to ensure compliance with ethical standards, laws, regulatory requirements, institutional policies, and mandatory reporting requirements. The IO also ensures adequate resources are available for proper functioning of the IBC and RSPP.

Investigators/Researchers

Register any projects or activities involving potentially hazardous biological materials with the IBC. Inform the IBC of any modifications to activities or storage locations. Ensure the safe use and storage of biological agents in the laboratory. When requested, inventory biological agents in the laboratory. Ensure the proper disposition of biological agents when the project is terminated. Abide by the policies and decisions of the University and the IBC.

Office of Regulatory Affairs (ORA)

Provide compliance support for the IBC and the BSO.

Research Subjects Protection Programs (RSPP)

Provide administrative support for the IBC

Responsible Official (RO)

Ensure compliance with regulations governing the possession, receipt or transfer of Select Agents. Report to appropriate federal agencies as required. Appoint alternate ROs.

Sponsored Projects Administration (SPA)

Verify IBC approval before setting up new awards.

Vice President for Research

Provide oversight for the regulatory committees or offices involved with this policy.

There are no appendices for this policy.

There is no FAQ for this policy.

Board of Regents Policies:

• Research Involving Recombinant DNA and Hazardous Biological Material
• Research Involving Human Subjects
• Animal Care and Use

Other:

• NIH - Guidelines for Research Involving Recombinant DNA Molecules
• Antiterrorism and Effective Death Penalty Act of 1996
• 42 CFR Part 73 - Possession, Use and Transfer of Select Agents and Toxins
• 7 CFR Part 331 - Possession, Use and Transfer of Biological Agents and Toxins (plant pathogens)
• 9 CFR Part 121 - Possession, Use and Transfer of Biological Agents and Toxins (animal agents)
• Uniting and Strengthening America Act by Providing Appropriate Tools Required to Intercept and Obstruct Terrorism (USA Patriot Act) of 2001
• Public Health Security and Bioterrorism Preparedness and Response Act of 2002
• Biosafety in Microbiological and Biomedical Laboratories (CDC/NIH)
• Institutional Biosafety Committee
• Department of Environmental Health and Safety
• Office of Regulatory Affairs

Effective:

January 2004

To obtain a copy of a historical policy, e-mail the U Policy Librarian at policy@umn.edu or call 612-624-4372.