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Office of Research -- Biosafety Compliance

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Animal-Related Biosafety Resources

This section of the website is devoted to biological safety topics and resources related to studies involving animals. This information is not intended to place obstacles in the way of conducting studies. Rather, it is intended to assist lab and research personnel with designing procedures in a manner that will reduce the risk of occupationally-acquired infections, cross-contamination, and environmental release.

Please check this page frequently as more information will be added to serve the ongoing needs of the University community. If you have any questions, please contact the Biosafety Office.

UT Institutional Biosafety Committee (IBC) Compliance

Animal Use

All research activities that involve the use of live animals must be registered, reviewed and approved by UT’s Institutional Animal Care and Use Committee (IACUC) before the work is initiated.

UT Institutional Animal Care and Use CommitteeUT Institutional Animal Care and Use Committee (IACUC) -- Website

The UT Office of Laboratory Animal Care (OLAC) can also provide assistance for planning future projects involving animals.

UT Office of Laboratory Animal CareUT Office of Laboratory Animal Care (OLAC) -- Website

Sharps in Animal Research and Teaching Environments

This document outlines the biosafety practices which apply to all UT animal-related activities under the purview of the UT Institutional Biosafety Committee (IBC) and Institutional Animal Care and Use Committee (IACUC).

Safe Handling of Sharp DevicesUT Safe Handling of Sharp Devices in Animal Research
and Teaching Environments -- PDF

Recombinant DNA Molecule Use

Recombinant DNA molecules are defined as “molecules that are constructed outside living cells by joining natural or synthetic DNA segments to DNA molecules that can replicate in a living cell, or molecules that result from the replication of those previously described.”

All research activities (unless classified as exempt based on current NIH Guidelines) that involve in the use of recombinant DNA molecules must be registered, reviewed and approved by the Institutional Biosafety Committee (IBC).

Relative to animal use, studies involving animals in conjunction with recombinant DNA molecules are not likely to be classified as exempt. However, the purchase or transfer of transgenic rodents for experiments requiring BSL-1 containment are exempt.

Recombinant DNA Registration FormIBC Registration Form for Use of Recombinant DNA Molecules (updated 01/08) -- Word

Recombinant DNA User's GuideUT Recombinant DNA User's Guide -- PDF (provides guidance for completion of the Recombinant DNA Molecule Registration Form)

NIH Guidelines for Research Involving Recombinant DNA MoleculesNIH Guidelines for Research Involving Recombinant DNA Molecules (updated 10/09) -- PDF

For further assistance regarding the committee review process, please contact the Biosafety Officer or John Sanseverino, IBC Chair at (865) 974-8080.

Permits and Transportation Regulations

Biological materials permits and transportation requirements have a broader application to the University environment than you might think.

There are a number of ways that biological materials can be introduced or removed from research facilities. When conducting studies, it is common to exchange research materials with other collaborators. It is also common for research personnel to visit collaborating institutions to learn new techniques. Faculty and research personnel can join or leave the University, and take materials with them.

Permit requirements are intended to ensure that biological materials that may bear an infectious disease or environmental impact risk are not inadvertently released, and to minimize the potential for clandestine use of such materials.

Transportation regulations apply to biological materials that are moved in commerce that meet the definition of a diagnostic specimen or infectious substance. Specific packaging, paperwork and training are required in some instances.

Please contact the Biosafety Officer for assistance before you send any biological materials by way of a commercial courier (i.e., FedEx, UPS)!

Additional note: Do not attempt to transport undeclared biological materials (or items that resemble these) in your carry-on or checked luggage while flying!

Guide to Biological Materials PermitsAre You Permitted? A Guide to Biological Materials Permits -- PDF

USDA Animal and Plant Health Inspection Service -- Veterinary Services Import/Export Permits

A USDA veterinary permit is generally needed for materials derived from animals or exposed to animal-source materials.

Examples include: animal tissues, blood, cells or cell lines of livestock or poultry origin, RNA/DNA extracts, hormones, enzymes, monoclonal antibodies for IN VIVO use in non-human species, certain polyclonal antibodies, antisera, bulk shipments of test kit reagents, and microorganisms including bacteria, viruses, protozoa, and fungi.

National Center for Import and ExportAnimal and Plant Health Inspection Service's National Center for Import and Export (NCIE) -- Website

USDI/USFWS Permits

The U.S. Fish & Wildlife Service issues permits under various wildlife laws and treaties at different offices at the national, regional, and/or wildlife port levels.

U.S. Fish & Wildlife Service PermitsU.S. Fish & Wildlife Service Permits Overview -- Website

Tennessee Wildlife Resources Agency Import and Collection Permits

Live wildlife animal species may require a TWRA importation permit before being brought into the state of Tennessee. A scientific collector’s permit may also be required for capture of certain species for study in Tennessee.

Tennessee Wildlife Resources AgencyTennessee Wildlife Resources Agency -- Website

Animal Importation RegualtionsTennessee Wildlife Resources Agency Animal Importation Regualtions -- PDF

Requirements for Export of Biological Agents

The Department of Commerce (DOC) has developed a list of biological agents (among other products and technologies) that are restricted by licensing requirements for export. The list includes many items on the current DHHS/USDA “select agent” list as well as specific viruses and Escherichia coli, serotype O157, and other verotoxin producing strains. Please contact the Biosafety Officer for assistance if you plan to ship any infectious agents or toxins.

Commerce Control ListCommerce Control List -- PDF (a listing of pathogens begins on page 54)

Additional Resources

Health Canada Material Safety Data Sheets for Infectious Agents

The agent summary sheets at this site are limited to agents that are infectious to humans but many are agents with broad host ranges that may include research animals.

Material Safety Data SheetsPublic Health Agency of Canada Material Safety Data Sheets for Infectious Agents -- Website

CDC/NIH Biosafety in Microbiological and Biomedical Laboratories

This document provides a good overview of biosafety principles and risk assessment, and is a standard reference used by regulatory agencies. Personnel who are designing studies that involve animals in conjunction with infectious agents should review:

Infected Vertebrate Animal ActivitiesTable 1 -- “Summary of Recommended Biosafety Levels for Activities in Which Experimentally or Naturally Infected Vertebrate Animals Are Used” -- Website

Vivarium Research FacilitiesSection V -- “Vertebrate Animal Biosafety Level Criteria, for Vivarium Research Facilities” -- PDF

Biosafety in Microbiological and Biomedical LaboratoriesBiosafety in Microbiological and Biomedical Laboratories (BMBL) 5th Edition -- Website

FDA/CFSAN “Bad Bug Book”

This is a handbook of foodborne pathogens and toxins. Once again, a resource for infectious diseases affecting humans, but often carried and shed by animals.

Website Link IconFoodborne Pathogenic Microorganisms and Natural Toxins Handbook (“Bad Bug Book”) -- Website

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Contact Information

Biological Safety Officer
Brian Ranger
336 Ellington Plant Sciences
Knoxville, TN 37996
Phone: (865) 974-1938
Email: branger@utk.edu

Biological Safety Specialist
Sarah DiFurio
336 Ellington Plant Sciences
Knoxville, TN 37996
Phone: (865) 974-9836
Email: sbottoml@utk.edu