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A. Introduction

Each Principal Investigator (PI) is responsible for the preparation of an IBC Registration for all research involving biological materials or agents. This includes research involving:

• Recombinant and synthetic nucleic acid molecules, including experiments that are exempt under the NIH Guidelines
• Microorganisms and viruses that are potentially pathogenic to humans, animals or plants
• Human-derived material
• Biological toxins
• Animal tissues that pose zoonotic disease concerns

B. Registration and Approval Process

Prior to work with any of the materials listed above, the PI must submit a completed IBC Registration form to Research Integrity and Assurance. Registrations are pre-reviewed by members of the IBC. All Registrations involving the use of recombinant and synthetic nucleic acids that is not exempt from the NIH Guidelines must be reviewed by IBC at a fully convened meeting. Registrations that do not involve non-exempt recombinant and synthetic DNA can be reviewed and approved by the BSO and the IBC Chair, with input from members of the Committee as needed. The BSO and the IBC Chair may request full IBC review at any time for a submitted Registration.

To assist the Principal Investigator in determining the appropriate Biosafety Level for the proposed research, the PI is directed to the Agent Summary Statements in the BMBL and Appendix B, classification of Human Etiologic Agents on the Basis of Hazard in the NIH Guidelines.

C. Additional Approvals and Requirements

Select Biological Agents and Toxins

The US Department of Health and Human Services (HHS) and the US Department of Agriculture (USDA) have developed a list of select biological agents and toxins that have the potential to pose a severe biosecurity threat to public health, animals, and agricultural crops. As directed by the US Patriot Act, HHS and USDA have adopted strict regulations for the obtaining, possession, use, or transfer of any of these selected agents. Failure to comply with the established regulations can result in significant civil and criminal penalties.

Therefore, any investigator considering the use of select agents or toxins must contact the University Biosafety Officer (Meagan Fitzpatrick at 8-6258 or [email protected]) to discuss the specifics of the requirements. HHS regulations in 42 CFR Part 73 Possession, Use, and Transfer of Select Agents and Toxins and the companion USDA regulations in 9 CFR Part 121 require federal registration and inspection; restricted lab access; development of written and strictly followed safety and security plans; personnel background checks by the FBI (including fingerprinting); specialized training; strict recordkeeping and reporting of agent use, transfer, loss, or destruction.

In determining whether to use select agents, researchers are encouraged to give careful consideration to the personal responsibilities, financial costs, and lengthy application and permit process involved with compliance. Any plans for use of select agents could easily take several months to get the appropriate permits and approvals and establish the security and protocols necessary to comply with the regulations. Sources of research funds to cover the cost of facility security improvements will need to be identified.

There is a small quantity exemption available for some of the select toxins. If the aggregate amount of toxin in the possession of a researcher can be kept below the specified exempt quantity (see agent listing), most of the rules do not apply. It should be noted that even when taking advantage of the small quantity exemption, the investigator is required to establish an inventory system to ensure the limit is not exceeded. Regardless of the amount, the University Biosafety Officer must be contacted prior to beginning work