Welcome to the UT Biosafety site
Biosafety Resources for Animal-Related Activities
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. Please feel free to Robin Lyn Trundy, Biological Safety Officer at 865-974-1938 or by email at rtrundy@utk.edu for further assistance or to provide feedback on this site.
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).
Click below to access this document:
Sharps in Animal
Research and Teaching Environments
Biological Materials in Transit- Permits & 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’s 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!
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.
Website for more information:
http://www.aphis.usda.gov/vs/ncie/
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.
Website for more information:
http://permits.fws.gov/overview/overview.shtml
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.
Link to the regulation:
http://www.state.tn.us/sos/rules/1660/1660-01/1660-01-15.pdf
A scientific collector’s permit may be required for capture of certain species for study in Tennessee.
TWRA website for contact information about these state requirements:
http://www.state.tn.us/twra/
Department of Commerce - Requirements for export of biological agents
The 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.
Below is a link to the
Commerce Control List. The listing of pathogens begins on
page 54.
http://www.access.gpo.gov/bis/ear/pdf/ccl1.pdf
Please contact the Biosafety Officer for assistance if you plan to ship any infectious agents or toxins!
UT Research Compliance Links
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.
Resources:
UT’s IBC registration form
Recombinant DNA User's Guide - This document
provides guidance for completion of the UT IBC
recombinant DNA molecule registration form
pdf\3_07RDNAUSER.pdf
NIH Guidelines for Research Involving Recombinant DNA Molecules
http://www4.od.nih.gov/oba/rac/guidelines/guidelines.html
For further assistance regarding the committee review process, please contact
the Biosafety Officer or John Sanseverino, IBC Chair at
974-8080.
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.
Website for IACUC registration information:
http://iacuc.tennessee.edu/
The UT Office of Laboratory Animal Care (OLAC) can also provide assistance for planning future projects involving animals.
Website for more information:
http://www.vet.utk.edu/research/olac/
Other 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.
http://www.phac-aspc.gc.ca/msds-ftss/index.html
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
Table 1- “ Summary of Recommended Biosafety Levels for Activities in Which Experimentally or Naturally Infected Vertebrate Animals Are Used.”
( http://www.cdc.gov/od/ohs/biosfty/bmbl5/Section%205_Laboratory%20Vertebrate%20%20Level%20Criteria_FINAL%20TABLE.pdf ) and
Section 5- “Vertebrate Animal Biosafety Level Criteria, for Vivarium Research Facilities” ( http://www.cdc.gov/od/ohs/biosfty/bmbl5/Section%205_Vertebrate%20Animal%20Biosafety%20Level%20Criteria_Final.pdf)
Link to entire document:
http://www.cdc.gov/od/ohs/biosfty/bmbl5/bmbl5toc.htm
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.
http://www.cfsan.fda.gov/~mow/intro.html
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