U-M Guidance for Animals Administered Human-Derived Substances
In partnership with the Animal Care & Use Program, the department of Occupational Safety & Environmental Health (OSEH), and the Unit for Laboratory Animal Medicine (ULAM), the U-M Institutional Biosafety Committee (IBC) has approved new guidance regarding the containment housing practices required for animals administered human-derived substances (tissues, fluids, cells, or cell lines).
All animals that are administered human-derived substances must now be housed under ABSL-2 conditions unless those substances have been documented to be free from blood-borne pathogens and other specific human viruses as described below.
Documentation that the human-derived substances used in your laboratory are free from pathogens of concern is the key to being able to house the animals used in those studies under standard (ABSL-1) conditions. If not already performed by the supplier, you can have such testing done by commercial laboratories.
- For human-derived substances obtained from vendors/repositories that routinely screen for human pathogens (e.g., ATCC), investigators may submit the screening results from the vendor.
- For human-derived substances obtained from vendors that do NOT routinely screen for human pathogens, investigators must have the substances screened.
- Please note that human-derived substances obtained directly from patients cannot be tested, and therefore must be moved to ABSL-2 housing.
ULAM has worked with both Charles River Laboratories and IDEXX-RADIL to enable an appropriate panel to be tested at a discounted price. Details on these panels are outlined here:
| Charles River (U-M custom) | IDEXX-RADIL (U-M custom) | |
| HIV 1-2 | ✓ | ✓ |
| Hep B | ✓ | ✓ |
| Hep C | ✓ | ✓ |
| HPV | HPV 16 | HPV 16 and 18 |
| EBV | ✓ | ✓ |
| CMV | ✓ | ✓ |
| HTLV 1-2 | ✓ | ✓ |
| Polyoma (JCV) | ✓ | ✓ |
| Pricing & Submission Instructions | View Charles River |
View IDEXX-RADIL |
Please note: Links marked with a lock icon can only be accessed using valid Level-1 U-M login credentials.
ABSL housing classifications are defined as:
- ABSL-2: Human tissues (normal or diseased), body substances (e.g., stool, blood, urine), cells, or cell lines.
- ABSL-1: Human cells or other body substances that have been demonstrated to be free from blood-borne pathogens and other infectious agents (i.e., through screening and documentation of screening results).
Having the testing completed and/or requesting documentation from your material provider, and providing the documentation to the Animal Care & Use Office (ACUO) by the time your laboratory is required to house these animals under ABSL-2 conditions is strongly recommended.
For those laboratories currently working with human-derived substances, testing documentation should be obtained and submitted to the ACUO no later than November 30, 2016. Laboratories that are NOT currently using human-derived substances in their work, but anticipate doing so in the future, will be required to answer additional questions when submitting a new eRAM application after October 31, 2016.
This will enable your laboratory to operate more efficiently and without any unnecessary expenses; it will also enable ULAM to better estimate the number of animals that must now be housed under ABSL-2 conditions, and prepare accordingly.
ACUO/ULAM/OSEH may, upon verification of screening results, re-classify animal housing containment to ABSL-1. Screening results must be maintained by investigators and made available to ACUO/ULAM/OSEH upon request.
If you have questions or concerns about this new guidance, or would like more information on how to obtain the appropriate panel testing, please contact the Animal Care & Use Office at acuoffice@umich.edu or (734) 763-8028.
A list of Frequently Asked Questions is also available via PDF download.